WO2006007758A1

WO2006007758A1 - Traditional chinese medicine composition for treating acute and chronic nasosinusitis and preparation thereof

Info

Publication number: WO2006007758A1
Application number: PCT/CN2004/000824
Authority: WO
Inventors: Zhiquan Zhao
Original assignee: Zhiquan Zhao
Priority date: 2004-07-16
Filing date: 2004-07-16
Publication date: 2006-01-26

Abstract

The invention relates to a Traditional Chinese Medicine composition for treating acute and chronic nasosinusitis and preparation thereof. The Traditional Chinese Medicine composition is made from the starting materials comprising Flos Magnoliae Liliflorae, Fructus Xanthü, Herba Ephedrae, Radix Angelicae Dahuricae, Herba Menthae, Rhizoma ligustici, Fructus Forsythiae and like and is the form of various clinically acceptable dosage forms, such as granule, tablet, solution for oral administration or like. The Traditional Chinese Medicine composition has good benefits in treating acute and chronic nasosinusitis.

Description

Traditional Chinese medicine composition for treating acute and chronic nasal aquegia and preparation method thereof

The present invention relates to a traditional Chinese medicine composition, and more particularly to a traditional Chinese medicine composition for treating acute and chronic nasal apes and a preparation method thereof. Background technique

Modern medicine believes that the cause of acute and chronic sinusitis is mainly the reduction of human body's resistance, and the invasion of viruses and bacteria in the nasal passages and external organs, causing nasal inflammation. Acute and chronic nasal abdomen is often seen and frequently afflicted in China. According to the literature, the incidence of nasal diseases varies from 10.7 to 44.5%, especially in the south. The climate is humid and the incidence is very high, 76% of which occur. Under the age of 30, 6.4% from 40-50 years old, only 1% or 2% after 50 years old, the disease is long, easy to repeat, often accompanied by headache, dizziness, memory loss and other symptoms, bring patients with To adversely affect. Summary of the invention

It is an object of the present invention to provide a novel Chinese medicinal composition for the treatment of acute and chronic nasal apes.

Another object of the present invention is to provide a method of preparing the traditional Chinese medicine composition for treating acute and chronic nasal apes. The traditional Chinese medicine composition of the invention is guided by the theory of traditional Chinese medicine, combined with the modern medical knowledge of acute and chronic rhinitis and the latest progress of the treatment of acute and chronic nasal abdomen by Chinese medicine, through clinical observation, screening effective drugs, and developing acute and chronic treatment A new formula for the nose. In this party, Xanthium, Xinyishantong is a medicinal herb, white peony, ephedra, peppermint help Xinyi, Xanthium evade exogenous evil, Xuantong lung gas, Lizhi analgesic as a drug, Sakamoto, Astragalus, Forsythia, Wild chrysanthemum, trichosanthin, raw land, salvia, and medlar are adjuvants, and licorice is used to make medicines. Xanthium, Sexual Xin, bitter temperature, into the lungs, this medicine is both windy, and can solve the symptoms, hurricane and pain. Xinyi, Sexual Xin Wen, into the lungs, stomach, this product hurricane and cold, can rise to the head, the two drugs used to evacuate the evil, Xuantong nose, dampness and pain relief. Supplemented with ephedra and phlegm to promote the lungs, help its all-night force. White peony, Sexual Xin Wen, into the lungs, stomach, for the treatment of nasal headache, and auxiliary drugs to strengthen its role in phlegm and blood stasis, Tongqiao analgesic. Mint, light and clear, and sexual ascension, help Xinyi Xingzi to evacuate the wind and heat, and the leader. The nose is the lungs, and the lungs are suitable for the nose. Therefore, the above three herbs are used to help the lungs and evacuate the evil spirits. At the same time, it also directly treats headaches, nasal congestion and sneezing. Astragalus, forsythia, and wild chrysanthemum clear away heat and detoxification, so that the evils of wind and heat can be solved from the surface, and the sputum of headache and headache is treated by Sakamoto. Tianhua powder, Shengdi nourishing yin and moistening, cooling blood and fluid, to the dryness of the sinister hot medicine. Hey, wet the tori. Salvia, blood circulation. All kinds of medicines are combined to strengthen the work of sputum discharge; licorice is used to reconcile various medicines. The traditional Chinese medicine composition of the invention is made of the following raw materials

Xinyi 10-30 parts by weight Xanthium 30-90 parts by weight Ephedra 20-60 parts by weight

White 芷 30-90 parts by weight Mint 10-30 parts by weight 藁 5-15 parts by weight

Astragalus 20-40 parts by weight Forsythia 20-40 parts by weight

In addition to the above-mentioned raw materials, the raw material for preparing the traditional Chinese medicine composition of the present invention further includes the following raw materials: wild chrysanthemum 20-40 parts by weight, top pollen 20-40 parts by weight, rehmannia 30-60 parts by weight

Salvia 20-40 parts by weight 茯苓 40-120 parts by weight

The drug substance for preparing the traditional Chinese medicine composition of the present invention further comprises 5-15 parts by weight of licorice, that is:

Astragalus 20-40 parts by weight Forsythia 20-40 parts by weight

Trichosanthin 20-40 parts by weight Rehmannia 30-60 parts by weight

茯苓 40-120 parts by weight licorice 5-15 parts by weight

The raw material medicine for preparing the traditional Chinese medicine composition of the present invention is preferably

Xinyi 15-25 parts by weight Xanthium 50-70 parts by weight Ephedra 30-50 parts by weight

White 正 50-70 parts by weight Mint 15-35 parts by weight 藁本 8-18 parts by weight

Astragalus 30-50 parts by weight Forsythia 30-50 parts by weight Wild chrysanthemum 30-50 parts by weight

Trichosanthin 30-50 parts by weight Rehmannia 50-70 parts by weight Salvia 30-50 parts by weight

茯苓 70-90 parts by weight licorice 8-15 parts by weight,

The best is:

Xinyi 20 parts by weight Xanthium 60 parts by weight Ephedra 40 parts by weight

White peony 60 parts by weight mint 20 parts by weight 藁 10 parts by weight

Astragalus 40 parts by weight Forsythia 40 parts by weight Wild chrysanthemum 40 parts by weight

'Tianhua powder 40 parts by weight Rehmannia 60 parts by weight Salvia 40 parts by weight

茯苓 80 parts by weight Licorice 10 parts by weight

The Xanthium sibiricum in each of the above-mentioned raw material drug compositions is preferably fried.

The method of preparing the traditional Chinese medicine composition of the present invention is:

The preparation of the traditional Chinese medicine composition of the present invention is carried out in accordance with the formulation of each of the above-mentioned raw material medicinal materials. Add 5-10 times water (w/v) to the four herbs of Magnolia, Mint, Sakamoto and Wild Chrysanthemum to extract the volatile oil, and distill the aqueous solution and dregs respectively. Collect the remaining APIs and add 5-15 times water (w/v) for 1-3 hours, filter while hot, drain the filtrate, and mix the filtered slag with the above slag, add 5-15 times water (w /v) decocting 1-3 times, each time 0. 5-1. 5 hours, filtration, combining all the filtrate and the above-mentioned distilled aqueous solution, and concentrating into a clear paste; then adding pharmaceutically acceptable excipients, Conventional processes are used to prepare clinically acceptable dosage forms such as pills, tablets, granules, oral solutions, capsules, ointments, emulsions, and traditional Chinese medicine films. Wherein the dosage form is preferably a granule.

Conventional excipients used in the preparation of the traditional Chinese medicine composition of the present invention include flavoring agents, dispersing agents, binders, thickeners, lubricants, diluents, disintegrating agents, preservatives and the like.

The traditional Chinese medicine composition of the invention has remarkable effects in treating acute and chronic nasal acupoints, has the characteristics of good purulent sputum effect and quick effect, and can act on various links of inflammatory reaction, thereby reducing symptoms of inflammatory reaction and causing inflammation The reaction subsides and has a good anti-inflammatory effect on acute and chronic inflammation; it has different degrees of antibacterial activity against common pathogenic bacteria causing acute and chronic rhinitis and sinusitis; 'For non-specific immune function and specific immune function, Certain promotion. detailed description

The pharmaceutical composition of the present invention will be further described in detail below in conjunction with the examples and pharmacodynamic tests.

The traditional Chinese medicine composition has swelling of rat ankle caused by carrageenan, increased capillary permeability caused by histamine and serotonin, and leukocyte migration and ratification caused by sodium carboxymethyl cellulose. The subcutaneous cotton granuloma hyperplasia has obvious inhibitory effect. This suggests that the composition acts on multiple parts of the inflammatory response, thereby reducing the symptoms of the inflammatory response and allowing the inflammatory response to resolve. It has good anti-inflammatory effects on acute and chronic inflammation. In vitro bacteriostatic test: A total of 106 clinical isolates were selected, among which most strains were resistant to common antibacterial drugs penicillin and streptomycin, and 3 standard strains. The in vitro antibacterial effect of the traditional Chinese medicine composition of the present invention was studied. The results showed that the drug has different degrees of antibacterial activity against common pathogenic bacteria causing acute and chronic rhinitis and sinusitis, such as Staphylococcus aureus, hemolytic streptococcus, Pseudomonas aeruginosa, Proteus, and Klebsiella. The traditional Chinese medicine composition of the invention has obvious promoting effect on the non-specific immune function-mononuclear macrophage phagocytosis function of mice, and improves the colloidal clearance speed of blood in mice; in the delayed allergic reaction, the traditional Chinese medicine combination of the invention The substance can also increase the degree of swelling of the ear shell after sensitization by DNFB, improve the susceptibility of the normal body to hypersensitivity, and improve its cellular immune function: In the immune organ, the weight of the spleen is increased. In terms of humoral immunity, hemolysin production in mice with immunocompromised effects induced by cyclophosphamide has a certain effect. The above studies have initially shown that the traditional Chinese medicine composition of the present invention has a certain promoting effect on non-specific immune function and specific immune function, including cellular immunity and humoral immunity. In vitro bacteriostatic test of the traditional Chinese medicine composition of the present invention against bud-free anaerobic: a total of 24 representative anaerobic bacteria were selected, and the anti-anaerobic activity of the traditional Chinese medicine composition of the present invention was measured, and the nitrous oxide was measured. Azole was used as a positive control. The test results show that the traditional Chinese medicine composition of the present invention has three kinds of sporeless cells. Anaerobic bacteria have a certain inhibitory effect, but its antibacterial activity is much lower than the control drug metronidazole. In vivo antibacterial test: Prophylactic administration, that is, administration 3 days before infection, has a certain protective effect on mice infected with Staphylococcus aureus at a higher dose, and ED _5Q is 14.4 g/Kg. This result is consistent with the results of having anti-S. aureus action in vitro.

Pharmacodynamic test:

1, anti-inflammatory effect

I. Experimental materials and statistical methods

1. Drug: The sample of the traditional Chinese medicine composition of the present invention was subjected to the following experiment using the clearing paste of Example 10, and the crude drug concentration was 3 g/ml, and the concentrations used below were all expressed as crude drugs. Take 3g/ml of the sample of the invention 40ml, 20ml, 10ml respectively, add distilled water to 100ml to prepare 120%, 60%, 30% suspension for use, mix with time; dexamethasone tablets (Hefei Pharmaceutical Factory, batch number 890572 ), using distilled water to prepare a solution of 0.125g / ml; Aspirin tablets (Jinan Third Pharmaceutical Factory, batch number 9105812-12), dissolved in ethanol, formulated into 2% solution for use; chlorpheniramine tablets (Shandong Dezhou Pharmaceutical Factory, batch number 920401); Prepare 1% solution in distilled water for use.

2. Reagents: Carrageenan (Nacala Tesqe, Inc Japan); serotonin (Koch-Light Lab. Ltd. England); Histamine (Shanghai Institute of Biochemistry); Sodium hydroxymethylcellulose (Shanghai Celluloid Plant).

3. Animals: Wistar rats, provided by the Experimental Animal Center of Tongji Medical University.

4. Instrument: 72 type spectrophotometer, ordinary optical microscope.

5. Statistical methods: All data were expressed by means of the mean standard. Differences between the mean were analyzed by variance analysis for significance test. The significance limit was p < 0.05.

Second, methods and results

1. Effects on paw swelling in rats: 50 Wistar rats weighing 120-160 (157±12) g, male and female, randomly divided into 5 groups, 10 in each group, with distilled water and aspirin. The group and the high, middle and low dose groups of the sample of the present invention were administered once a day for 3 consecutive days, and 1 hour after the last administration, 0.1 ml of 1% carrageenan was injected subcutaneously into the right hind paw of each mouse. The ankle volume (fixed capillary measurement) at a fixed position was measured before, after, and after 1, 2, 3, 4, 5, and 6 hours, respectively, and the difference between the two was the degree of swelling. The results showed that aspirin significantly inhibited the swelling of the athlete's foot at each of the above time points. The high-dose group showed significant inhibition at 2, 3, 4, 5, and 6 hours after inflammation, and the middle and low-dose groups had inhibitory effects at 4 and 5 hours, as shown in Table 1. Effect of Chinese Herbal Medicine Composition on Swelling of Rat Foot (X Soil SD)

Compared with distilled water ** p<0.01

2. Effects on vascular permeability:

50 Wistar rats, weighing 150-190 (173 ± 12) g, male and female, were randomly divided into 5 groups, 10 in each group, respectively, distilled water group, chlorpheniramine group and high, medium and low doses of the samples of the present invention. Group, the drug volume was 10 ml / kg, once a day, for 3 consecutive days. One hour after the last administration, the four parts of the back were shaved, respectively, by intradermal injection of 0.1% histamine and 0.1% 5-HT 0.1 ml (two points) to form a hillock, and then immediately injected into the femoral vein 1%. Sapphire blue 4ml/kg. After 5 minutes, the head was killed; the back skin was peeled off, the colored skin was cut, chopped, and soaked in 5 ml of physiological saline-acetone solution (3:7) for 24 hours, centrifuged (3000 rpm for 20 minutes), and the supernatant was taken. , colorimetric at 610 nm wavelength (type 72 spectrophotometer). The results showed that the high and medium doses of chlorpheniramine and the samples of the present invention significantly inhibited the increase of vascular permeability caused by histamine and 5-HT, as shown in Table 2. Table 2. Effect of the traditional Chinese medicine composition of the present invention on vascular permeability (x, SD)

Compared with distilled water group *p<0.05 **P<0.01

3. Effects on leukocyte migration response:

There were 50 male Wistar rats weighing 130-180 (153 ± 13) g. They were randomly divided into 5 groups of 10, each of which was divided into a distilled water group, a dexamethasone group, and a high, medium, and low dose group of the present invention. The drug delivery capacity was 10 ml/kg, and it was administered once a day for three consecutive days. On the day before the inflammation, 5 ml of air was injected subcutaneously into the dorsal interscapular region to form a balloon. One hour after the last administration, 0.1 ml of the liquid was aspirated from the capsule for 1.5, 3, and 7.5 hours in the sac. The results showed that the dexamethasone and the high dose group of the traditional Chinese medicine composition of the present invention significantly inhibited the leukocyte migration reaction, as shown in Table 3.

Table 3. Effect of traditional Chinese medicine composition of the present invention on leukocyte migration response in rats (x±SD)

Compared with distilled water group *ρ<0.01 4. Effects on the proliferation of subcutaneous cotton granuloma in rats - 50 male Wistar rats weighing 120-160 (142 ± 12) g were randomly divided into 5 groups, 10 in each group, respectively, with steamed water group, ground The dexamethasone group and the high, medium and low dose groups of the inventive samples. Under light anesthesia, cotton balls (29 - 31 mg) were implanted into the bilateral groin. Three days before the operation, 10 times a day, for 10 consecutive days. After the end of the administration, the animals were killed by decapitation, the cotton granuloma was peeled off, dried in a 9 CTC oven, and weighed after 1 hour. The results showed that the dexamethasone and the high and medium doses of the traditional Chinese medicine composition of the present invention significantly inhibited the proliferation of subcutaneous cotton granuloma, and the inhibition rates were 24.8%, 20.0% and 13.3%, respectively, as shown in Table 4.

Table 4. Effect of the traditional Chinese medicine composition of the present invention on rat cotton granuloma (X Shi SD)

Compared with steamed water group *p<0.05 **p<0.01

Conclusion: This study tested the traditional Chinese medicine composition of the present invention on four rat animal models. The dose is converted from human consumption. The daily dose of 30-45 g (10-15 g, Tid) is equivalent to 16.- 25.2 g of crude drug, and 0.34-0.50 g/kg/day is calculated according to the weight of the kilogram. The experimental results show that the traditional Chinese medicine composition of the present invention has a diagonal fork. Rat foot spasm caused by vegetable gum, increased capillary permeability due to histamine and serotonin, rat white blood cell migration caused by sodium carboxymethyl fiber and rat subcutaneous cotton granuloma hyperplasia Both have significant inhibitory effects. It is suggested that the traditional Chinese medicine composition of the present invention has an effect on various steps of the inflammatory reaction, thereby reducing the symptoms of the inflammatory reaction and causing the inflammatory reaction to regress. It has a good anti-inflammatory effect on acute and chronic inflammation.

II. In vitro bacteriostasis

1. Experimental materials: 1. Sample: The following experiment was carried out by taking the clear paste in Example 10 as an example, and 3 g of crude drug per ml was contained. The preparation method was the same as before, and it was sterilized by steam at 100 ° C for 30 minutes. 2. Drug sensitive paper: Penicillin G, (10 IU/tablet), Lot 931211: Streptomycin (10 IU/tablet), Lot 931127: Norfloxacin (lOug/tablet). The above susceptibility papers are produced by Beijing Tiantan Pharmaceutical Biotechnology Development Department. 3. Medium: MH (M _U ller-Hinton) medium containing 3g of beef extract per 100 grams, peptone 17.5g, soluble starch 1.5g, agar 17g, pH 7.4 autoclaved (115 V, 30 minutes later) spare. Streptococcus was inoculated on a chocolate agar plate. 4, strains: choose to treat the disease with the drug A total of 109 pathogenic bacteria and some standard strains (S. aureus ATCC25925, Escherichia coli ATCC25922, Pseudomonas aeruginosa MCC27853) were isolated from clinical isolates. There were 21 strains of Staphylococcus aureus, 19 strains of Staphylococcus epidermidis, 3 strains of hemolytic streptococcus, 22 strains of Escherichia coli, 16 strains of Pseudomonas aeruginosa, 15 strains of Proteus, and 13 strains of Klebsiella. The tested strains were identified by the Department of Microbiology, Tongji Medical University and the Laboratory of the Department of Laboratory Medicine, Union Hospital.

Second, methods and results:

1. Paper-based drug susceptibility test. The test bacteria were inoculated separately into the broth and cultured at 37 ° C for 6-8 hours. The sterile cotton swabs were evenly spread on the surface of the agar and cultured at 37 ° C. The size of the inhibition zone was measured after 16-18 h. Judging according to the unified antibiotic drug susceptibility test criteria.

2. MIC measurement, the test bacteria were inoculated separately into the broth, cultured at 37 ° C for 16-18 h (E. coli and P. aeruginosa culture for 8 h), and then diluted with sterile broth into 1:1000 bacteria solution for use. 2ml of Biyuanjingqing cream with different concentrations (6g/ml, 3g/ml, 1.5g/ml-0.009375 g/ml) was added to 18ml MH medium, shake well and then inverted. In a sterile dish, the final concentration of the drug in the medium was 0.6g/ml 0.3g/ml 0.15g/ml......, 0.009375g/ml), and the drug control plate was set up (only the drug was mixed with the medium, not inoculated). Bacteria) and the test strains were compared to the plate (the medium contained no drug). After the agar was coagulated, the experimental bacteria were inoculated with an inoculation loop, and the drug concentration, the bacterial species and the strain number were indicated on the bottom of the plate, and the results were observed after incubating in a 37 °C incubator for 24 hours. MIC is the lowest drug concentration that inhibits bacterial growth.

3. Results: The results of the paper-based drug susceptibility test are shown in Table 5. 92% of the clinical pathogens collected in this experiment were sensitive to norfloxacin, all Staphylococcus aureus and 73% of Staphylococcus epidermidis were resistant to penicillin, and 44% of Gram-negative bacilli were resistant to streptomycin. The in vitro antibacterial activity of the traditional Chinese medicine composition of the present invention is shown in Table 6. It can be seen from Table 6 that the traditional Chinese medicine composition of the present invention has different degrees of bacteriostatic action on the test strain, and the MIC _5Q of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Proteus and Klebsiella pneumoniae 0.02812, 0.02344, 0.18, 0.09, 0.206>0.6 g/ml; MIC ₉₀ is 0.0375 0.0625 0.42 0.14 >0.6 >0.6 g/ml, respectively, and the MIC range for hemolytic streptococcus is 0.075-0.6 g/ml. The drug control in this experiment did not show bacterial growth, and the test strains grew well, indicating that the drug itself does not contain live bacteria, and the culture conditions meet the test requirements.

III. Conclusion: The traditional Chinese medicine composition of the present invention is a traditional Chinese medicine compound preparation, and has the functions of clearing away heat and detoxifying. In this experiment, a total of 106 clinical isolates (including most of the strains resistant to the commonly used antibacterial drugs penicillin and streptomycin) and 3 standard strains were selected, and the in vitro antibacterial effect of the traditional Chinese medicine composition of the present invention was tested. The drug has various degrees of bacteriostatic action on common pathogenic bacteria causing acute and chronic rhinitis and sinusitis, such as Staphylococcus aureus, hemolytic streptococcus, Pseudomonas aeruginosa, Proteus, and Klebsiella. Results of paper-based drug susceptibility test of clinical isolates against three antimicrobial agents

S: number of sensitive strains, M: number of moderately sensitive strains, R (%): number of resistant strains (percentage of resistant Zhu).

Table 6 MIC determination of 109 strains of bacteria of the traditional Chinese medicine composition of the present invention

Fine strain drug concentration (g/ml) MIC ₅₀ MICx, MIC range: 0.009375 0.01875 0.0375 0.075 0.15 0.3 0.6 >0.6

Golden yellow 21 1 18 2 0.02812 0.0375 0.01875-0. Grape ball 075

Epidermal Portuguese 19 5 3 6 5 0.02344 0.0625 0.009375-0 Staphylococcus .075 Hemolysis 3 1 2 0.075-0.6 Streptococcus

Large intestine rod 22 10 6 6 0.18 0.42 0.15-0.6 bacteria

Green pus 16 6 9 1 0.09 0.14 0.075-0.6 bacteria

Deformation rod 15 4 2 3 4 2 0.206 >0.6 0.009375-> bacteria 0.6 hepatitis rod 13 3 10 >0.6 >0.6 0.6->0.6

II m. Effect on immune function

1. Effect of the traditional Chinese medicine composition of the present invention on the clearance of carbon particles in mice:

1. Material: Sample: Take the cleaning paste in Example 10 as an example, the following experiment is carried out, containing 3g of crude drug per ml, the preparation method is the same as before; Yunzhi polysaccharide capsule is the product of Nanjing Laoshan Pharmaceutical Factory, approval number: Su Wei Pharmacopoeia (87) 3612-1; the specification is 0.5 g / granule, diluted with deionized water to a 10% concentration suspension for experimental use, shaken during use; Indian ink is British Winsor & Newton products; 751 spectrophotometry , Shanghai Analytical Instrument Factory; Animals: Kunming mice, provided by the Animal Experimental Center of Tongji Medical University;

2. Methods: 50 healthy mice of 20_24g, male and female, were randomly divided into 5 groups, namely distilled water group, Yunzhi polysaccharide positive control group, high, medium and low dose groups of the present invention, each group was 10ml/kg. Oral administration of body weight, once daily for 7 days, after the 7th day of administration, 10 ml/kg body weight of Indian ink was injected into the tail vein of rats, and 0.03 ml of blood was taken from the orbital veins after 2 and 10 minutes. Shake well in 2 ml of 0.1% sodium carbonate solution, measure the optical density at 680 mm wavelength with a 751 ultraviolet spectrophotometer, and calculate the clearance index K value according to the following formula. K=(logOD ₂ -logOD ₁₀ )/ (t ₁₀ -t ₂ ) OD ₂ and OD _1Q represent the optical density of the blood samples measured in 2 and 10 minutes, respectively, and t ₁₀ and t ₂ represent the measurement time, after the blood collection is completed, small Rats were sacrificed by cervical dislocation, and the liver and spleen weights were weighed separately. Then, the phagocytic index a value was calculated according to the following formula:

a= (weight/spleen liver weight) X ³

The K value and the a value of each group were expressed by XSD, and the F test was performed to compare the significance of each group.

3. Experimental results: The K value and the phagocytic index a of the distilled water group were 5.2 ± 1.7 (KX 1000, XSD the same) and 2.75 ± 0.5 (x sD), while the Yunzhi polysaccharide group was 13.75 ±. 5.7 and 3.7 ± 9.50, there was a significant difference between the two (p < 0.01). This method was confirmed to be reliable. Consistent with the literature report ^[1()] , Yunzhi polysaccharide can increase the phagocytic function of mice. The high-, medium-, and low-dose groups of the traditional Chinese medicine composition of the present invention have a clearing index and a phagocytic index compared with the distilled water group. There was a significant difference (p<0.05), compared with Yunzhi polysaccharide, except for the significant difference in the low-dose group (p<0.05), there was no significant difference between the high and middle doses (p>0.05), indicating that at higher doses The traditional Chinese medicine composition of the invention has the effect of increasing the phagocytic function of the mouse similar to the Yunzhi polysaccharide, and the dosage index of the traditional Chinese medicine composition of the invention has a certain correlation with the dose, the dose is increased, the phagocytic activity is enhanced, and the height is low. There was a significant difference (p<0.05) between the doses, and there was no significant difference between the phagocytic index groups (p>0.05). The above results indicate that the traditional Chinese medicine composition of the present invention can increase the mononuclear macrophage system. The clearance speed of colloidal carbon in the blood increases its phagocytic function, as shown in Table 7. 7. Effect of the traditional Chinese medicine composition of the present invention on the carbon particle clearance function of mice (XSD)

*p<0.05, **p<0.01 compared with distilled water group; #p<0.05 compared with Yunzhi polysaccharide group;

Compared with the low dose group of the traditional Chinese medicine composition of the present invention @p<0.05

Second, the effect of the traditional Chinese medicine composition of the invention on delayed allergic reaction

(1) Materials: 1. The sample of the traditional Chinese medicine composition of the present invention, the Yunzhi polysaccharide capsule is the same as before, and the required concentration is tested according to the same method. 2. Tripterygium wilfordii Hook. is a product of Huangshi City Pharmaceutical Factory in Hubei Province. Approval number: E. Pharmacopoeia (89) No. 240, diluted with deionized water to 0.0033% suspension for experimental use, shaken during use. 3, 2, 4 dinitrofluorobenzene (D PB) is a product of Shanghai Jinshan Chemical Plant, formulated with acetone sesame oil solution to make 1% DNFB. 4. Animals: Kunming mice, provided by the Animal Experimental Center of Tongji Medical University

(B), Method: Take 18-22g healthy mice 60, male and female are randomly divided into 6 groups, namely distilled water blank control group, Yunzhi polysaccharide control group, Tripterygium wilfordii control group, Chinese medicine composition of the present invention high, medium , low-dose group, according to oral gavage 'dosing, once a day, for 7 consecutive days, while the first day of administration, each mouse abdomen hair removal, the range is about 3 X 3CM ² , with 1% D FB acetone 50 ul of sesame oil solution was evenly applied to the skin surface for sensitization. The sensitization was strengthened once the next day. On the sixth day of administration, 1% DNFB solution ΙΟιιΙ was evenly spread on both sides of the right auricle for attack, and the left ear was used as a control. After 24 hours of attack, the mice were sacrificed by whitening the neck, and the left and right ear shells were cut out. The ear piece with a diameter of 3 mm was removed with a puncher, and the weight of the two ears was the degree of ear swelling. At the same time, the spleen of each mouse was taken out. Weighed with the thymus, weighing spleen (mg) and thymus weight (mg) per 10 g of mice, respectively:

Spleen index = spleen weight (mg) / body weight (g) X 10

Thymus index = thymus weight (mg) / body weight (g) X 10

The ear shell swelling degree, spleen index and thymus index were tested by F test, and the differences of each group were judged to be significant.

(three), results

The swelling degree of the ear shell of the Tripterygium wilfordii group was 0.49±0.24, which was significantly lower than that of the distilled water group 1.24±0.47. It is consistent with the results reported in the literature that the Tripterygium wilfordii inhibits the delayed allergic reaction, while the traditional Chinese medicine composition of the present invention is in the middle and the middle. The ear shell swelling degree of the low-dose group and the Yunzhi polysaccharide-administered group were 1.83 ± 0.38, 1.66 + 0.38, 2.51, respectively. Both ±0.36 and 2.31 ±0.35 were significantly higher than the distilled water group, and the lower dose group was more effective (see Table 8). It has a certain effect on the spleen index, but it has no significant effect. The medium and high dose has a lowering effect on the thymus index, and the low dose has no effect on it. This experiment reveals that the traditional Chinese medicine composition of the invention can enhance the sensitization reaction of the mouse and participate in the body. The regulatory role of immune function.

Table 8 Effect of traditional Chinese medicine composition of the present invention on ear shell swelling, spleen index and thymus index of mice (X soil SD)

Compared with the distilled water group, *ρ<0.05, **ρ<0.01;

The effect of the traditional Chinese medicine composition of the invention on the production of serum hemolysin caused by cyclophosphamide in mice with low immune function (1), material:

1. The traditional Chinese medicine composition, tripterygium wilfordii, and Yunzhi polysaccharide capsule of the present invention are the same as the previous experiment.

2. Cyclophosphamide is a product of Shanghai Twelve Pharmaceutical Factory. The approval number is: Huwei Medicine Zhunzi (1981) No. 0364 (12).

3, SRBC preservation solution (Alsever) glucose 2.05g, sodium chloride 0. 42g, sodium citrate 0.8g, citric acid 0.05g, distilled water 100ml, dissolved and mixed filter, sterilized under 8 pounds pressure for 10 minutes, at 4 ° C saves the spare.

4. Duchen solution (used for the determination of hemoglobin): sodium hydrogencarbonate 1.0 g, high iron cyanide steel, 0.2 g, potassium cyanide 0.05 g plus distilled water 1000 ml.

5, Complement: Take fresh guinea pig (3) mixed serum by SRBC (in 10:1) volume ratio (absorbed at 4 ° C for 30 minutes, shake the centrifugation (2000 rpm, 10 minutes) to take the supernatant, press 1 with distilled water : 10 Serve the serum for later use.

6. SRBC: Under aseptic conditions, take blood from the jugular vein of healthy adult sheep, shake the blood into a triangular beaker with glass beads for 10 minutes to remove fibrin, add 2 times the amount of preservation solution, put 4 °C refrigerator spare, temporarily washed with physiological saline 3 times, 2000 rpm, 10 minutes, to accumulate red blood cells, and then diluted to the required concentration.

7. Kunming mice: provided by the Animal Experimental Center of Tongji Medical University.

(B), Method: Take 60 healthy mice, weighing 20-24g, male and female are randomly divided into 6 groups, namely distilled water group, cyclophosphamide group, cyclophosphamide plus Yunzhi polysaccharide group, cyclophosphamide plus this Inventive traditional Chinese medicine composition high, medium, Low dose group. Before administration, each mouse (except the distilled water group) was injected subcutaneously with cyclophosphamide at 110 mg/kg to cause a pathological model with low immune function, and then orally administered for 7 days continuously, and sensitized per mouse intraperitoneally on the second day after administration. . On the eighth day, the eyeballs were removed from the eyelids of the mice, the serum was separated, the serum was diluted 800 times, and the diluted serum 1 ml, 5% SRBC 0.5 ml, 10% complement lml, and 3 ml of Dud solution were added to the test tube in turn, and shaken. After 10 minutes, the absorbance was recorded at a wavelength of 540 nm, and 5% 0.25 ml of SRBC and 4 ml of turbid liquid were added. The absorbance value was recorded. This value is the value of the luminosity of the half hemolysis of the SRBC used in the experiment. The half of the hemolysis value of the sample is calculated by the following formula.

Half of the hemolysis value (HC _5G ) = absorbance value of the sample X dilution factor

Absorbance value of half of hemolysis in SRBC

(III) Results: The half hemolysis value (HC _5Q ) of the cyclophosphamide group (HC _5Q ) was significantly lower than that of the distilled water group of 464.81.85.85. The difference was significant (P<0.01), which was caused by the cyclophosphamide. The humoral immune function is low. When the cyclophosphamide is administered, the traditional Chinese medicine composition of the present invention can increase the half hemolysis value, and the HC ₅₀ values of the high, medium and low dose groups are 427.94 ± 33.63, 396.9675.66 and 397.29 ±, respectively. 71.32, compared with the cyclophosphamide group alone, the difference was significant (PO.05 or P<0.01), the effect of the Yunzhi polysaccharide group was very obvious, and its HC _5Q value was significantly higher than that of the cyclophosphamide group (PO.01). In the various groups of the traditional Chinese medicine compositions of the present invention, the high dose group has the strongest effect, as shown in Table 9.

Table 9. Effect of the traditional Chinese medicine composition of the present invention on serum hemolysin production in immunocompromised mice ( _X ± SD)

^Compared with distilled water group PO.01;

*Compared with cyclophosphamide ΡΟ.05; **Compared with cyclophosphamide group Ρ<0.01. Pharmacodynamics conclusions of the traditional Chinese medicine composition of the present invention on immune function: The experimental results show that the three doses of the traditional Chinese medicine composition of the present invention have obvious promoting effects on the non-specific immune function-mononuclear macrophage phagocytosis of mice, and improve The mice were more effective in the clearance of colloids in the blood, and the lower doses in the high dose group. In the delayed allergic reaction, the three doses of the traditional Chinese medicine composition of the present invention also increased the swelling of the ear shell after sensitization by DNFB. Degree, improve the normal body's susceptibility to hypersensitivity, improve its cellular immune function, which is stronger in the low dose group: in the immune organs, the spleen weight has an increasing trend; in the body fluid immunity, three doses of the invention The sample has a certain effect on the hemolysin production in immunosuppressed mice induced by cyclophosphamide.

The above studies have initially shown that the traditional Chinese medicine composition of the present invention has a certain promoting effect on non-specific immune function and specific immune function, including cellular immunity and humoral immunity.

IV. In vitro bacteriostatic test for bud-free anaerobic

―, materials and methods: 1. Test drug, test drug: The sample clearing paste of the embodiment 10 of the present invention contains 3 g of crude drug per ml. Prepare 5000mg/ml with distilled water, sterilize with steam at 100 ° C for 30 min, and dilute with time. Positive control drug: metronidazole, Wuhan Binhu Pharmaceutical Co., Ltd., batch number 960541, formulated into 320ug/ml.

2. The test strains and the test strains are isolates of clinical case specimens in Wuhan, including 20 strains of Bacteroides fragilis and 2 strains of Bacillus gingivalis, a total of 3 strains of 24 strains. The tested strains were identified by the bacteria room of the Department of Microbiology, Tongji Medical University. The standard strain (Bacteroides fragilis 5524) was purchased from Beijing Biopharmaceutical Inspection Institute. All strains were lyophilized at -30 ° C, diluted with sterile physiological saline, inoculated in anaerobic separation medium, anaerobic cultured at 37 ° C for 48 h, and then picked up a single colony to be inoculated into anaerobic basal medium. Analyze culture at 37 ° C for 24 h, adjust the bacterial solution to 10 ⁶ cfo / ml. 3. Medium, anaerobic medium, purchased from Shanghai Medical Institute.

4. Test method, agar plate dilution method, 5000 mg/ml of the traditional Chinese medicine composition of the present invention and 320 ug/ml metronidazole 2 ml were separately diluted, and the minimum concentrations were 39 mg/ml and 0.3 ug/ml, respectively. Take 2ml of each drug and add 2ml of various concentrations of the drug solution to 18ml anaerobic agar medium, shake it and pour it into the sterile plate. After the agar was coagulated, each experimental bacterial solution was inoculated with an inoculation loop, and a plate containing no drug was inoculated. The drug concentration, the bacterial species and the strain number were indicated on the bottom of the plate, and the results were observed after 37 hours of anaerobic conditions. The MIC is the lowest drug concentration that inhibits the growth of bacteria.

2. Results: The minimum inhibitory concentration of the traditional Chinese medicine composition of the present invention and metronidazole against 24 strains of non-spore anaerobic bacteria is shown in Table 10. Table 10 In vitro antibacterial activity of the traditional Chinese medicine composition of the present invention and the nitrated azole on 24 strains of anaerobic bacteria

Discussion: In this experiment, a total of 24 representative anaerobic bacteria were selected, and the anti-anaerobic activity of the traditional Chinese medicine composition of the present invention was measured, and metronidazole was used as a positive control. The test results show that the traditional Chinese medicine composition of the invention has certain inhibitory effects on three kinds of bud-free anaerobic bacteria, but its antibacterial activity is much lower than that of the control drug metronidazole.

V. In vivo antibacterial test

1. Materials and methods: 1. Drug, test drug: The clearing paste of the embodiment 10 of the present invention is a sample, a brown liquid, and contains 3 g of crude drug per ml. Mix with different concentrations (0.3, 0.6, 0.9, 1.2, 1.5 g/ml) in distilled water and mix as needed. Control drug: Ciprofloxacin lactate injection (200mg/100ml), produced by Guangzhou Qiaoguang Pharmaceutical Factory, batch number 95091502, formulated into 0.3mg/ml with sterile physiological saline.

2. Test strains,

The bacteria used to infect animals are clinically isolated Staphylococcus aureus, which is identified by the bacteria laboratory of the Department of Clinical Laboratory of Tongji Hospital affiliated to Tongji Medical University.

3. Preparation of bacterial solution. On the day before the test, 5 colonies were transplanted into 5 ml broth test tubes, and cultured at 37 ° C for 18 hours as the original bacterial solution. The original bacterial solution was appropriately diluted with physiological saline, and 1 ml of the diluted bacterial solution was added to 5 ml of 5% gastric gas to prepare a uniform suspension. According to the results of the MLD pretest, the bacterial liquid for the infected animal was finally made with 5% of the gastric membrane. MLD is the minimum 100% lethal dose of bacteria (Minimall00% lethal dose of bacteria). In this experiment, animals were infected with 80%-90% of the dead mice.

4. Test animals, Kunming mice, weighing 18-22 g, male and female, fasting water supply 18 h before the test. The test animals were provided by the Medical Laboratory Animal Center of Tongji Medical University. 5, test methods, according to animal weight, gender stratification random group, each group of 10, a total of 7 groups, namely distilled water negative control, ciprofloxacin (3mg / kg / time) positive control, 5 groups of different doses of this The traditional Chinese medicine composition group of the invention (3, 6, 9, 12, 15 g/Kg/day). The infected animals were intraperitoneally injected with the prepared bacterial solution, 0.5 ml per mouse. The traditional Chinese medicine composition of the present invention is intragastrically administered once every day before infection and 4 days after infection, and ciprofloxacin is intravenously injected immediately after infection and 6 hours after infection, and the negative control group is given equal volume of distilled water, and the administration capacity is 0.1 ml/10 g. The observation time was 7 days, and the number of deaths of each group of mice was recorded, and ED _{5 ()} of the traditional Chinese medicine composition of the present invention was calculated according to the Bliss method.

Second, the results

After the mice were infected with S. aureus, the death rate of the traditional Chinese medicine composition of the present invention and the control group was shown in Table 11. The ED _5Q and 95% confidence limits of the traditional Chinese medicine composition of the present invention were 14.4 g/kg and 9.1, respectively. 22.8 g / Kg. Table 11 In vivo protection test of the traditional Chinese medicine composition of the present invention against Staphylococcus aureus-infected mice

Discussion: Due to the weak antibacterial effect of traditional Chinese medicine, it is difficult to achieve effective antibacterial concentration in the body, and traditional Chinese medicine may often work by mobilizing non-specific anti-infective ability. Therefore, the amount of infectious bacteria should be lower than MLD in formal test, so 80-90% should be selected. The amount of bacteria that died in mice infects animals, and the in vivo antibacterial action of Chinese medicines is often used for prophylactic administration. The mortality of the distilled water group and the ciprofloxacin control group in this test were 90% and 0%, respectively, indicating that the selected amount of infectious bacteria was appropriate. Test Drug The Chinese medicinal composition of the present invention is administered by prophylactic administration, i.e., 3 days before infection. The results showed that this product had a certain protective effect on mice infected with Staphylococcus aureus at a higher dose, and the ED ₅ o was 14.4 g/kg. This result is consistent with the results of having anti-S. aureus action in vitro. The following are examples of preparation of the traditional Chinese medicine composition of the present invention:

Example 1

Xinyi 10g Xanthium 30g Ephedra 20g White 芷 30g Thin Lotus 10g 藁本 5g 黄芩 20g Forsythia 20g Wild Chrysanthemum 20g Trichosanthin 20g

Rehmannia 30g Salvia 20g 茯苓 40g Licorice 5g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, and wild chrysanthemums are added with 450ml of water to extract volatile oil. The distilled aqueous solution and dregs are collected separately; the other ten herbs are added with water 2000ml for 2 hours, hot filtered; After the dregs are combined with the above-mentioned dregs, and then boiled in 2800 ml of water for 1 time, each time 0.5 hours, filtered, and the combined filtrate and the above-mentioned steamed aqueous solution of Xinyi and the like are concentrated to form a clear paste; finally, the pharmacy is added through a conventional procedure. The acceptable excipients are made into soft capsules. Example 2:

Xinyi 10g Xanthium 30g Ephedra 60g White 芷 30g Thin Lotus 10g 藁本 5g 黄芩 20g Forsythia 20g Wild Chrysanthemum 20g Trichosanthin 20g

Rehmannia 30g Salvia 20g 茯苓 40g Licorice 5g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, and wild chrysanthemums are added with 230ml of water to extract volatile oil. The distilled aqueous solution and dregs are collected separately; the other ten herbs are added with water 2000ml for 3 hours, hot filtered; After the dregs are combined with the above dregs, and then decocted with water 1600ml twice, each time for 50 minutes, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, the pharmaceutically acceptable step is added through a conventional procedure. The excipients are made into soft capsules. Example 3:

Xinyi 30g Xanthium 90g Ephedra 20g White 芷 90g Thin Lotus 30g

Sakamoto 15g yellow 芩 40g forsythia 40g wild chrysanthemum 40g trichosanthin 40g

Rehmannia 60g Salvia 40g 茯苓 120g Licorice 15g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, Wild Chrysanthemum, four flavors of water and 600ml of water to extract volatile oil, the aqueous solution and the dregs after distillation are separately collected; other ten herbs add water 2800ml decoction 2. 5 hours, hot filtered ; Filter After the dregs are combined with the above-mentioned dregs, and then boiled in 3500 ml of water twice, each time for 1.5 hours, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, the pharmacy is added through a conventional procedure. Acceptable excipients are made into soft capsules. Example 4:

Xinyi 10g Xanthium 30g Ephedra 20g White 芷 30g Thin Lotus 10g 藁本 5g Yellow 芩 40g Forsythia 20g Wild Chrysanthemum 20g Trichosanthin 20g Rehmannia 30g Danshen 20g 茯苓 40g Licorice 5g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, and wild chrysanthemums are added with 675ml of water to extract the volatile oil. The distilled aqueous solution and the dregs are collected separately; the other ten herbs are added with water 3800ml to cook for 1. 5 hours, hot filtered The filtered dregs are combined with the above dregs, and then boiled 4500 ml of water for 3 times, each time for 1 hour, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, the pharmacy is added through a conventional procedure. Acceptable excipients are made into capsules. Example 5

Xinyi 30g Xanthium 90g Ephedra 60g White 芷 90g Thin 30g 藁15g Yellow 芩 20g Forsythia 40g Wild chrysanthemum 40g Trichosanthin 40g Rehmannia 60g Danshen 40g 茯苓 120g Licorice 15g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, wild chrysanthemum four herbs add water 1725ml to extract volatile oil, distilled aqueous solution and dregs separately collected; other ten herbs add water 7575ml decoction for 2 hours, hot filtered; The above two kinds of dregs are combined, and then boiled in water at 9,300 ml for 3 times, each time for 1.5 hours, filtered, and the combined filtrate and the above-mentioned steamed aqueous solution of Xinyi and the like are concentrated to form a clear paste; finally, the pharmaceutically acceptable step is added through a conventional procedure. The excipients are made into capsules. Example 6:

Xinyi 15g Xanthium 50g Ephedra 30g White peony £50g Mint 15g Sakamoto 8g Astragalus 30g Forsythia 30g Wild chrysanthemum 30g Trichosanthin 30g Rehmannia 50g Salvia 30g 茯苓70g Licorice 8g Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, wild chrysanthemum four flavors of water plus 600ml extract volatile oil, distilled aqueous solution and dregs separately collected; other ten flavors add water 3600ml boiling for 1 hour, hot filtered; The above two kinds of dregs are combined, and then boiled in 4200 ml of water twice, each time for 1 hour, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, a pharmaceutically acceptable form is added through a conventional procedure. The adjuvant is made into a tablet. Example 7

Xinyi 15g Xanthium 50g Ephedra 30g White 芷 50g Thin Lotus 15g Sakamoto 8g Yellow 芩 50g Forsythia 30g Wild Chrysanthemum 30g Trichosanthin 30g Rehmannia 50g Danshen 30g 茯苓 70g Licorice 8g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, and wild chrysanthemums are added with 500ml of water to extract the volatile oil, and the distilled aqueous solution and the dregs are collected separately; the other ten herbs are added with water 3800ml to cook for 1. 5 hours, hot filtered The above two kinds of dregs are combined, and then boiled in 4,500 ml of water twice, each time for 1.5 hours, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, the pharmacy is added through a conventional procedure. The excipient excipients received were made into tablets. Example 8

Xinyi 25g Xanthium sinensis 70g Ephedra 50g White 芷 70g Thin Lotus 35g 藁本 18g 黄芩 50g Forsythia 50g Wild Chrysanthemum 50g Trichosanthin 50g Rehmannia 70g Danshen 50g 茯苓 90g Licorice 15g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, wild chrysanthemum four herbs add 1200ml of water to extract volatile oil, the distilled aqueous solution and dregs are separately collected; the other ten herbs add water 5600ml to cook for 3 hours, hot filtered; The above two kinds of dregs are combined, and further boiled in 5400 ml of water for 1 hour, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, a pharmaceutically acceptable form is added through a conventional procedure. The agent is made into a soft capsule. Example 9

Xinyi 25g Xanthium sinensis 70g Ephedra 50g White 芷 70g Thin Lotus 35g 藁本 18g 黄芩 30g Forsythia 50g Wild chrysanthemum 50g Trichosanthin 50g Rehmannia 70g Danshen 50g 茯苓 90g Licorice 15g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, wild chrysanthemum four herbs add 1200ml of water to extract volatile oil, the distilled aqueous solution and dregs are separately collected; the other ten herbs add water 5000ml decoction for 2 hours, hot filtered; The above two kinds of dregs are combined, and then boiled with 6000 ml of water twice, each time for 1 hour, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, a pharmaceutically acceptable form is added through a conventional procedure. The agent is made into a soft capsule. Example 10

Xinyi 20g Xanthium 60g Ephedra 40g White 芷 60g Thin Lotus 20g Sakamoto 10g Yellow 芩 40g Forsythia 40g Wild Chrysanthemum 40g Trichosanthin 40g Rehmannia 60g Danshen 40g 茯苓 80g Licorice 10 g

Among them, Xanthium is better for frying.

The above fourteen flavors, Xinyi, Mint, Sakamoto, Wild Chrysanthemum, four flavors of water and 900ml of water to extract volatile oil, the aqueous solution and the dregs after distillation are separately collected; the other ten herbs add water 5200ml to cook 1. 5 hours, hot filtered The singularity of the above-mentioned two medicinal slags, and then adding the water to 6200ml, simmering, and sifting, and sifting to a concentration of 1.35-1. Clear paste; mixed with auxiliary materials, granules, dried and granulated, made into 200 capsules, sprayed with volatile oil, sealed for 24 hours, that is, granules. Each tablet is 0.3 g, which is quite raw material 2. 8 g, boiled in water, 3 times a day, 10-15 g once, 10 g per bag.

Example 11:

Xinyi 20g Xanthium 60g Ephedra 40g White Pelican 60g

Mint 20g 藁 Ben 10g Astragalus 40g Forsythia 40g

Among them, Xanthium is better for frying.

The above eight flavors, Xinyi, Mint, and Sakamoto three kinds of medicines add 450ml of water to extract volatile oil, and the distilled aqueous solution and dregs are collected separately; the other five herbs are boiled in water 2400ml for 2 hours, hot filtered; the above two kinds of dregs are combined Add 3,000ml of water to boil twice, each time for 1 hour, filter, combine the filtrate with the above distilled water solution, and concentrate to a clear paste. Finally, add pharmaceutically acceptable excipients to make soft capsules through routine procedures. . Example 12

Xinyi 10g Xanthium 30g Ephedra 60g White Pelican 30g

Mint 10g 藁 this 5g jaundice 20g forsythia 20g

Among them, Xanthium is better for frying.

The above eight flavors, Xinyi, Mint, Sakamoto three herbs add water 300ml to extract volatile oil, the distilled aqueous solution and dregs are separately collected; the other five herbs add water 1500ml boiling for 1 hour, hot filtered; combine the above-mentioned commercial dregs Add boiling water 2000ml twice, each time for 1 hour, filter, combine the filtrate with the above distilled water solution, and concentrate to a clear paste; finally add pharmaceutically acceptable excipients to make soft capsules through routine procedures. . Example 13 - Xinyi 30g Xanthium 90g Ephedra 20g White Pelican 90 _g

Mint 10g 藁 this 5g jaundice 40g forsythia 40g

Among them, Xanthium is better for frying.

The above eight flavors, Xinyi, Mint, and Sakamoto three kinds of medicines add 400ml of water to extract volatile oil, and the distilled aqueous solution and dregs are collected separately; the other five herbs add water 3000ml to cook for 1.5 hours, hot filtered; The slag is combined, and then decocted with water 3500 ml, once every 0.5 hours, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, a pharmaceutically acceptable excipient is added through a conventional procedure. The auxiliary material is made into a soft capsule. Example 7

Xinyi 20g Xanthium 60g Ephedra 40g White 芷 60g Thin Lotus 20g

Sakamoto 10g yellow 芩 40g forsythia 40g wild chrysanthemum 40g trichosanthin 40g

Rehmannia 60g Danshen 40g 茯苓 80g

Among them, Xanthium is better for frying.

The above thirteen flavors, Xinyi, Mint, Sakamoto, and wild chrysanthemums are added with 800ml of water to extract volatile oil. The distilled aqueous solution and dregs are collected separately; the other nine herbs are boiled in 4000ml for 2 hours, and hot filtered; The above two kinds of dregs are combined, and then boiled twice with water 4000 ml, one hour each time, filtered, and the combined filtrate and the above-mentioned distilled aqueous solution are concentrated to form a clear paste; finally, a pharmaceutically acceptable shape is added through a conventional procedure. The agent is made into a soft capsule.

Claims

Rights request

A traditional Chinese medicine composition for treating acute and chronic nasal apes, characterized in that the composition is prepared from the following raw materials:

Astragalus 20-40 parts by weight Forsythia 20-40 parts by weight

The traditional Chinese medicine composition according to claim 1, wherein the raw material medicinal material further comprises: wild chrysanthemum 20-40 parts by weight, trichosanthin 20-40 parts by weight, rehmannia 30-60 parts by weight

Salvia 20-40 parts by weight 茯苓 40-120 parts by weight

3. The traditional Chinese medicine composition according to claim 2, wherein the raw material medicine further comprises licorice 5-15

The traditional Chinese medicine composition according to claim 3, wherein the raw material medicine is:

White 芷 50-70 parts by weight Mint 15-35 parts by weight 藁 Ben 8-18 parts by weight

Salvia miltiorrhiza 30-50 parts by weight

茯苓 70-90 parts by weight licorice 8-15 parts by weight

The pharmaceutical composition according to claim 4, wherein the raw material medicine is:

Xinyi 20 parts by weight Xanthium 60 parts by weight Ephedra 40 parts by weight

White peony 60 parts by weight mint 20 parts by weight 藁 10 parts by weight

40 parts by weight of Tianhua powder 60 parts by weight of Dihuang. 40 parts by weight of Salvia miltiorrhiza

茯苓 80 parts by weight Licorice 10 parts by weight

6. The traditional Chinese medicine composition according to claim 1, 2, 3, 4 or 5, wherein the Xanthium is a fried scorpion

A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 6, wherein the method comprises: adding 5-10 times of water to the four flavors of Magnolia, Mint, Sakamoto and Wild Chrysanthemum ( w/v) to extract volatile oil, the distilled aqueous solution and dregs are separately collected; the remaining raw material components are added 5-15 times water (w/v) for 1-3 hours, filtered while hot, and the filtrate is reserved. The filtered dregs are combined with the above-mentioned dregs, and then added 5-15 times of water (w/v) for 1-3 times, 0.5-1.5 hours each time, filtered, and all the filtrates and the above-mentioned distilled aqueous solution are combined. , concentrated into clear 1. A pharmaceutically acceptable excipient is then added to form a clinically acceptable dosage form by conventional techniques.

8. A traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that the traditional Chinese medicine composition is present in any clinically acceptable dosage form.

9. The traditional Chinese medicine composition according to claim 6, wherein the traditional Chinese medicine composition is present in any clinically acceptable dosage form.

The pharmaceutical composition according to claim 8 or 9, wherein the dosage form is a granule.