CN112494598B - Effective part composition for treating pharyngitis and application thereof - Google Patents

Effective part composition for treating pharyngitis and application thereof Download PDF

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CN112494598B
CN112494598B CN202011543847.6A CN202011543847A CN112494598B CN 112494598 B CN112494598 B CN 112494598B CN 202011543847 A CN202011543847 A CN 202011543847A CN 112494598 B CN112494598 B CN 112494598B
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ethanol
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CN112494598A (en
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尹雷
仲米存
衣洁菡
王桐
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YANTAI NEW ERA HEALTH INDUSTRY CO LTD
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • AHUMAN NECESSITIES
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
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    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
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    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/55Liquid-liquid separation; Phase separation

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Abstract

The invention discloses a traditional Chinese medicine effective part composition for treating pharyngitis, which comprises a total flavone extract and a total saponin extract; the total flavone extract is extracted from wild chrysanthemum, tangerine pith and physalis alkekengi, and the total saponin extract is extracted from ophiopogon japonicus. The composition comprises 2-8 parts of total flavone extract and 2-10 parts of total saponin extract according to parts by weight. Experiments prove that the effective part composition has a remarkable synergistic effect in the aspect of treating pharyngitis. The product has definite components, stable curative effect, small dosage and high safety, not only accords with the formula principle of the traditional Chinese medicine for treating the chronic pharyngitis, but also accords with the development requirement of the modernization of the traditional Chinese medicine, and has important significance for promoting the transformation of imitation of the medicine industry to independent innovation and the internationalization of the traditional Chinese medicine in China.

Description

Effective part composition for treating pharyngitis and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to an effective part composition for treating pharyngitis and application thereof.
Background
Chronic pharyngitis is a chronic inflammation of the pharyngeal mucosa, submucosa and lymphoid tissues. Diffuse pharyngeal inflammation is often part of chronic inflammation of the upper respiratory tract; localized pharyngeal inflammation is usually inflammation of pharyngeal lymphoid tissue. The disease is common in clinic, the course of disease is long, and the symptoms are easy to recur. Chronic pharyngitis is common in adults and also in children. The general symptoms are not obvious, and the local symptoms are the main symptoms. The symptoms of various types of chronic pharyngitis are similar and various, such as pharyngeal discomfort, foreign body sensation, pharyngeal secretion difficult to be expelled, pharyngeal itching, burning sensation, dryness or irritation, and slight pain. The back wall of pharynx usually causes the adhesion of relatively viscous secretions due to chronic inflammation of the pharynx, and the mouth-opening breath at night due to lesions of the nose, sinuses and nasopharynx, which often causes irritable cough and nausea in the morning. Frequent swallowing can be manifested by a foreign body sensation in the pharynx. The patients with little pharyngeal secretion and difficult cough are usually manifested as habitual dry cough and phlegm-clearing action of throat, and bleeding of pharyngeal mucosa can be caused if cough is done forcefully or throat-clearing action is done forcefully, resulting in blood in the secretion.
According to the clinical sign examination of western medicine, the posterior pharyngeal wall or the tongue root lymph follicles are hyperplastic, and in severe cases, there is an attachment of the compound, which indicates that there is a foreign body sensation in the throat, but the food intake is normal. The diagnosis is based on that no space occupying lesion is found in the examination of the pharynx or the larynx, the local part has lymphofollicular hyperplasia, even the compound is attached, and the esophagus is examined normally. At present, the western medicines on the market, namely the throat tablet, mainly comprise a Huasu tablet and a mingzhijiekamine buccal tablet, and the two tablets do not contain antibiotics. The main component of the Huasu tablet is cydiodine, iodine molecules have super strong sterilization and anti-infection effects, and can rapidly kill various pathogenic microorganisms including bacterial propagules, fungi, spores and viruses at oral cavity and throat parts. The unique buccal anti-inflammatory mode of the Huasu tablet directly acts on the infected part of diseases, and the cool mint moistens the throat, so that the throat diseases can be effectively treated, but adverse reactions such as mental depression, nervousness and the like can be generated by taking iodine and iodine compounds for a long time. In addition, the main component of the mingzhijiolamin buccal tablet is dequalinolamin which can kill bacteria by destroying the surfaces of bacteria. The western medicine has quick response and obvious effect in a short treatment period, but has certain influence on the body, and can cause some side effects after being taken by part of people; the western medicine aims at symptomatic treatment of diseases, has obvious effect of eliminating symptoms, aims at the characteristics of symptoms, and is easy to relapse when treating chronic pharyngitis.
The traditional Chinese medicine considers that the chronic pharyngitis is related to emotional depression and qi activity disorder. Like the plum core located in the throat, the cough cannot emerge and the throat cannot descend, so it is called "plum-stone qi". This disease is usually caused by lung-kidney yin deficiency or repeated attack of wind-heat and throat impediment, retention of the remaining pathogenic factors, impairment of body fluids and fluid consumption, impairment of yin fluid and loss of nourishment of throat, and deficient fire in combination. This disease usually occurs on the basis of deficiency of yin, yang, qi and blood of the zang-fu organs, and generally has a long course of disease. Clinically, yin deficiency is usually considered as excessive, yang deficiency is relatively rare, and there are also symptoms of excess in deficiency with phlegm accumulation or blood stasis on the basis of yin deficiency or yang deficiency, which should be carefully distinguished during differentiation. Chronic pharyngitis is mostly due to deficiency syndrome, and the major therapy is mainly tonifying, or nourishing yin to reduce pathogenic fire, or warming and tonifying spleen and kidney, leading to the origin. Because the course of disease is long and quick-acting is difficult to take, long-term administration of the medicine can nourish yin and prevent it from becoming greasy, and warm tonification should prevent it from becoming dry. For phlegm with blood stasis, it is not suitable to counteract and impair the healthy qi because of its deficiency with excess, so the pathogenic condition is more lingering. Besides the medication, it is also very important to properly dredge the mind and regulate qi.
However, the traditional Chinese medicine decoction pieces are not easily accepted by patients due to low content of effective components, large dosage, inconvenience and bitter taste of the medicines, but the content of the effective components is improved, the dosage is reduced, the taking is convenient, good medicines are not bitter, and the accepted population is increased.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the effective part composition for treating pharyngitis, which has obvious curative effect on the treatment of the pharyngitis and can be applied to various preparations.
The specific technical scheme is as follows:
the invention aims to provide a traditional Chinese medicine effective part composition for treating pharyngitis, which is characterized by comprising a total flavone extract and a total saponin extract;
the total flavone extract is extracted from wild chrysanthemum, tangerine pith and Physalis alkekengi (Physicalis Peruviana L.), and the total saponin extract is extracted from ophiopogon japonicus.
The Physalis alkekengi is a dried product of a fruit of a solanaceae plant, namely, a berry (Physicalis peruviana L.).
Experiments prove that the traditional Chinese medicine effective part composition has a remarkable synergistic effect and a remarkable curative effect on pharyngitis.
Further, the traditional Chinese medicine effective part composition comprises 2-8 parts of total flavone extract and 2-10 parts of total saponin extract in parts by weight.
Furthermore, the traditional Chinese medicine effective part composition comprises 6 parts by weight of total flavone extract and 5 parts by weight of total saponin extract.
Further, the content of total flavonoids in the total flavonoid extract is not less than 50wt%, and the content of total saponins in the total saponin extract is not less than 50 wt%.
Further, the preparation method of the traditional Chinese medicine effective part composition comprises the following steps:
(1) preparing a total flavone extract: taking wild chrysanthemum, tangerine pith and physalis alkekengi as raw materials, adding 80-95% ethanol in an amount which is 15-30 times of the total weight of the raw materials, performing reflux extraction at 70-80 ℃ for 1-3 times for 2 hours each time, filtering, combining filtrates, recovering ethanol under reduced pressure, adding water to dilute concentrated solution, passing through a macroporous resin column at a flow rate of 0.8-1 mL/min, eluting with deionized water in an amount which is 6-10 times of the volume of the column, eluting with 70% ethanol in an amount which is 8-15 times of the volume of the column, collecting eluate, recovering ethanol under reduced pressure, concentrating, and drying to obtain a total flavone extract;
(2) preparing a total saponin extract: taking ophiopogon japonicus as a raw material, adding 75-85% ethanol which is 8-10 times of the weight of ophiopogon japonicus, carrying out reflux extraction at 75-80 ℃ for 1-1.5 h, filtering to obtain filtrate, repeatedly extracting filter residues once, combining two filtrates, recovering ethanol under reduced pressure until the relative density is 1: 1-1: 2, adding water saturated n-butyl alcohol for extraction for three times, combining n-butyl alcohol parts, recovering n-butyl alcohol until each mL of the n-butyl alcohol contains 1-1.5 g of crude drugs, passing through a macroporous resin column at the flow rate of 0.8-1 mL/min, eluting with distilled water which is 4-5 times of the column volume, eluting with 70% ethanol which is 4-5 times of the column volume, collecting eluate, recovering under reduced pressure, and drying to obtain the total saponin extract.
And further, in the step (1), the mass ratio of the wild chrysanthemum flower to the tangerine pith to the physalis alkekengi is 1: (1-3): (1-4), most preferably 1: 2: 3.
and (2) further, the macroporous resin column used in the step (1) is an HPD-100 macroporous resin column, and the macroporous resin column used in the step (2) is a D101 macroporous resin column.
The percentage of ethanol in the invention is volume percentage.
The invention also aims to provide the application of the traditional Chinese medicine effective part composition in preparing the medicine for treating pharyngitis.
The extracts of the two effective parts are taken according to the weight ratio of the effective parts, and are prepared into pharmaceutically acceptable dosage forms, such as tablets, granules, hard capsules, pills, dripping pills, soft capsules and the like without adding auxiliary materials or adding pharmaceutically conventional auxiliary materials.
The above-mentioned pharmaceutically conventional excipients include, but are not limited to, binders such as cellulose derivatives, alginates, gelatin and polyvinylpyrrolidone; diluents, starch, sugar powder, dextrin, lactose, microcrystalline cellulose, mannitol; lubricants, such as talc, magnesium stearate, aerosil and polyethylene glycol; disintegrants, such as carboxymethyl starch sodium, low-substituted hypromellose, croscarmellose; absorption promoters, such as quaternary ammonium compounds; surfactants such as cetyl alcohol, sodium lauryl sulfate; excipients, such as lactose, starch, sucrose, dextrin, calcium carbonate, aluminum sulfate, magnesium oxide, magnesium stearate, sodium bicarbonate, glycerol, propylene glycol, polyethylene glycol, sorbitol, lanolin, vaseline, microcrystalline cellulose, beeswax, wood wax, liquid paraffin, resin, higher wax, pressure sensitive adhesive, semisynthetic fatty acid ester, etc.
The invention has the following beneficial effects:
the traditional Chinese medicine composition takes the traditional Chinese medicine theory as a guiding idea, and is combined with related research results at home and abroad, so that the traditional Chinese medicine composition has an obvious effect on treating chronic gastritis. The wild chrysanthemum flower is used as a monarch drug in the formula, is bitter, pungent and cool in taste, has the effects of clearing heat and removing toxicity, dispelling wind and heat, dissipating blood stasis, improving eyesight and reducing blood pressure, and is used for treating pharyngitis, pneumonia, diphtheria, gastroenteritis, furuncle, carbuncle and other symptoms, so the wild chrysanthemum flower is a monarch drug. The physalis alkekengi is a ministerial drug, has the effects of clearing heat, detoxifying and promoting urination, and is used for treating heat cough, pharyngalgia, dysentery, edema, furuncle and erysipelas. The combination of physalis alkekengi and wild chrysanthemum has the efficacy of clearing heat, reducing pathogenic fire and reading, so the physalis alkekengi is a ministerial drug. The ophiopogon root is an adjuvant drug and has the effects of nourishing yin and moistening lung; benefiting stomach and promoting fluid production; it has the actions of clearing heart fire and relieving restlessness, and is used as adjuvant drug for dry cough due to lung dryness, pulmonary abscess, cough due to yin deficiency, thirst due to body fluid consumption, throat pain, constipation due to intestinal dryness, etc. Tangerine channel is a guiding drug, and Tangerine channel is bitter and sweet in flavor and neutral in nature. Spleen and lung meridians. Dredge collaterals, resolve phlegm and stop cough. Can be used for treating cough with excessive phlegm and chest and hypochondrium pain. Huang Qi is a guiding drug because it is neutral in nature and can harmonize the other drugs and direct them to the disease. The medicines in the formula supplement each other, but lack one, and the formula is reasonable according to the monarch, minister, assistant and guide theory of the traditional Chinese medicine, so that the effects of clearing heat and removing toxicity, dispelling wind and clearing heat, clearing heart fire and relieving restlessness, nourishing yin and lowering fire, moistening dryness and relieving sore throat are achieved together.
Experiments prove that the effective part composition has a remarkable synergistic effect in the aspect of treating pharyngitis.
The product has definite components, stable curative effect, small dosage and high safety, not only accords with the formula principle of the traditional Chinese medicine for treating the chronic pharyngitis, but also accords with the development requirement of the modernization of the traditional Chinese medicine, and has important significance for promoting the transformation of imitation of the medicine industry to independent innovation and the internationalization of the traditional Chinese medicine in China. After examining the relevant documents and patents, the reports that the effective parts of the wild chrysanthemum flower, the tangerine pith, the ophiopogon japonicus and the physalis alkekengi are taken as raw materials, produced, processed and prepared into a suitable pharmaceutical preparation for treating or assisting in treating the chronic pharyngitis are not found.
Detailed Description
The principles and features of this invention are described below in conjunction with examples, which are set forth to illustrate, but are not to be construed to limit the scope of the invention. The dosage in the actual production is not limited to the dosage of the drugs in the examples, and the dosage can be measured in units of ton, kilogram, gram and the like, but the dosage proportion of the raw materials is still according to the technical scheme of the invention.
In a specific embodiment, the method for measuring the content of the total flavonoids comprises the following steps: precisely weighing rutin control substance dried at 120 deg.C under reduced pressure to constant weight of about 10mg, placing in 100mL volumetric flask, adding 70% ethanol 70mL, placing in water bath, slightly heating for dissolving, cooling, adding 70% ethanol to scale, and shaking. Precisely sucking 1.0 mL, 2.0 mL, 3.0 mL, 4.0 mL and 5.0mL of reference substance solution, respectively placing in a 10mL measuring flask, respectively adding water 4.0, 3.0, 2.0, 1.0 and 0, adding 5% sodium nitrite solution 0.3mL, shaking up, standing for 6min, adding 10% aluminum nitrate solution 0.3mL, shaking up, standing for 6min, adding 4% sodium hydroxide 4mL, adding water scale, shaking up, and standing for 12 min; preparing blank solution by the same method. Absorbance was measured at 510 nm. And drawing a standard curve by taking the absorbance as the ordinate and the concentration as the abscissa. 100mg of the sample is taken and put into a 100ml volumetric flask, 70 percent ethanol is added to the scale, and the mixture is shaken and filtered. Precisely measuring 3mL of filtrate, adding 2mL of water, adding 0.3mL of 5% sodium nitrite solution, shaking uniformly, standing for 6min, adding 0.3mL of 10% aluminum nitrate solution, shaking uniformly, standing for 6min, adding 4mL of 4% sodium hydroxide, adding water scale, shaking uniformly, and standing for 12 min. Absorbance was measured at 510nm and the content was calculated according to the standard curve equation.
In a specific embodiment, the method for measuring the content of the total saponins comprises the following steps: precisely weighing 5.00mg of oleanolic acid reference substance, adding methanol to dissolve to constant volume of 25mL, and making into 0.2mg per mL of oleanolic acid reference substance. Precisely transferring 0, 0.1,0.2,0.3,0.4,0.5 and 0.6mL of a reference substance solution into 7 dry test tubes with plugs respectively, volatilizing the solvent in a water bath, adding 0.2mL of a freshly prepared 50mL/L vanillin glacial acetic acid solution and 0.8mL of perchloric acid respectively, heating in a constant-temperature water bath at 60 ℃ for 15min, taking out, cooling for 2min with running water, adding 5mL of glacial acetic acid, shaking up, blanking with a follow-up reagent, performing a spectrophotometry test, and measuring the absorbance at the wavelength of 544 nm. And drawing a standard curve by taking the absorbance as the ordinate and the oleanolic acid amount as the abscissa. Taking the effective part of the akebia stem and astragalus total saponin to be 10mg, adding methanol for dissolving and fixing the volume to be 10 mL. Taking 0.5mL of sample solution, placing the sample solution in a dry test tube with a plug, volatilizing the solvent in a water bath, adding 0.2mL of a freshly prepared 50mL/L vanillin glacial acetic acid solution and 0.8mL of perchloric acid, heating in a constant-temperature water bath at 60 ℃ for 15min, taking out, cooling for 2min with running water, adding 5mL of glacial acetic acid, shaking up, measuring the absorbance, substituting into a standard curve, and calculating to obtain the test solution.
Example 1
The capsule for treating pharyngitis is prepared by the following formula: 120g of total flavone extract and 100g of total saponin extract.
The preparation method of the total flavone extract comprises the following steps: taking 1 part of wild chrysanthemum flower, 2 parts of tangerine pith and 3 parts of physalis alkekengi in parts by weight as raw materials, adding 90% ethanol which is 20 times of the weight of the raw materials, carrying out reflux extraction for 3 times at 75 ℃ for 2 hours each time, filtering, combining the filtrates, recovering ethanol under reduced pressure, adding water to dilute the concentrated solution to the volume of the original filtrate, passing the concentrated solution through an HPD-100 macroporous resin column at the flow rate of 1mL/min, eluting with deionized water which is 8 times of the volume of the column, eluting with 70% ethanol which is 10 times of the volume of the column, collecting the eluate, recovering ethanol under reduced pressure, concentrating, and drying to obtain a total flavone extract, wherein the total flavone content is measured to be 52.3%.
Preparing a total saponin extract: taking ophiopogon japonicus as a raw material, adding 80% ethanol which is 10 times of the weight of the ophiopogon japonicus, performing reflux extraction at 80 ℃ for 1.5h, filtering to obtain filtrate, performing repeated operation extraction on filter residues once, combining two filtrates, recovering ethanol under reduced pressure until the relative density is 1:1.5, adding equal mass of water saturated n-butanol, performing extraction for three times, combining n-butanol parts, recovering n-butanol until each mL contains 1-1.5 g of crude drug, passing through D101 macroporous resin at the flow rate of 1mL/min, eluting with 5 times of column volume of distilled water, eluting with 5 times of column volume of 70% ethanol, collecting eluate, recovering under reduced pressure, and drying to obtain a total saponin extract, wherein the total saponin content is 56.1%.
The preparation method comprises the following steps: taking the above effective components according to the prescription, pulverizing, mixing, adding starch to 300g, mixing, granulating, and making into No. 1 capsule with content of 0.3g per capsule.
Example 2
The tablet for treating pharyngitis is prepared by the following formula: 120g of total flavone extract and 100g of total saponin extract.
The preparation method of the total flavone extract and the total saponin extract is the same as that of example 1.
The preparation method comprises the following steps: taking the above effective part extracts according to the prescription, pulverizing, mixing, adding hydroxypropyl methylcellulose 40g, microcrystalline cellulose 20g, silica gel micropowder 5g, adding lactose to 300g, mixing, granulating, and tabletting.
Example 3
The soft capsule for treating pharyngitis is prepared by the following formula: 140g of total flavone extract and 100g of total saponin extract.
The preparation method of the total flavone extract and the total saponin extract is the same as that of example 1.
The preparation method comprises the following steps: taking the above effective components according to the prescription, adding polyethylene glycol 400 to total amount of 300g, mixing, and making into soft capsule.
Example 4
The preparation of the granules for treating pharyngitis comprises the following components: 240g of total flavone extract and 200g of total saponin extract.
The preparation method of flavone extract and total saponin extract is the same as that of example 1.
The preparation method comprises the following steps: and (3) taking the extracts of the effective parts according to a prescription, adding 10% of starch and 90% of ethanol, and granulating to obtain the traditional Chinese medicine.
Example 5
The preparation of the granules for treating pharyngitis comprises the following components: 3kg of total flavone extract and 2kg of total saponin extract.
The preparation method of flavone extract and total saponin extract is the same as that of example 1.
The preparation method comprises the following steps: taking the above effective components according to the prescription, adding 10% starch and 90% ethanol, granulating, and packaging 5g of the obtained granule per bag.
140 patients with pharyngitis were treated with the granules prepared in example 5. The treatment scheme comprises the following steps: it is administered orally 1 bag at a time, 2 times daily, and 8 weeks as a treatment course. As a result: 78 cases are cured, 41 cases are improved, 13 cases are obviously effective, 8 cases are ineffective, and the total effective rate is 94.3 percent.
Comparative example 1
Taking 100g of ophiopogon japonicus, 60g of physalis alkekengi, 40g of tangerine pith and 20g of wild chrysanthemum flower, adding 10 times of water by mass, decocting for 2h, filtering, adding 8 times of water into medicine residues, decocting for 1.5h, filtering, combining filtrates, concentrating under reduced pressure, drying under reduced pressure, crushing, adding starch to 300g, filling into No. 1 capsules, and preparing into capsules, wherein the content of each capsule is 0.3 g.
Comparative example 2
Taking 20g of the total flavone extract prepared in the example 1 and 200g of the total saponin extract prepared in the example 1, adding starch to 300g, filling into No. 1 capsules, and preparing into capsules, wherein the content of each capsule is 0.3 g.
Comparative example 3
220g of the total flavone extract prepared in the example 1 is taken, starch is added to 300g, and the mixture is filled into a No. 1 capsule, wherein the content of each capsule is 0.3g, and the capsule is prepared.
Comparative example 4
220g of the total saponin extract prepared in the example 1 is taken, starch is added to 300g, and the mixture is filled into a No. 1 capsule, wherein the content of each capsule is 0.3g, and the capsule is prepared.
Comparative example 5
The capsule for treating pharyngitis is prepared by the following formula: 120g of total flavone extract and 100g of total saponin extract.
The difference from the example 1 is that the total flavone extract of the comparative example 5 is extracted from the mixture of wild chrysanthemum and tangerine pith with the mass ratio of 1:2, and the extraction method is the same as the example 1; the total saponin extract was the same as in example 1.
220g of the above prescription medicines are added with starch to 300g, and the mixture is filled into No. 1 capsules, and the content of each capsule is 0.3g, so that capsules are prepared.
Experiment of
In order to further verify the pharmacological effects of the invention, animal pharmacodynamic experiments are carried out by using the capsules of the invention.
The influence of the compound on the pharyngitis of the rats is verified.
1 reagents, samples and animals
1.1 reagents
Chemical reagent III works of xylene, Tianjin; ether (analytically pure), tempeh chemical reagent three factories; 0.9% chlorinated physiological saline, Feng boat chemical reagent science and technology Limited, Tianjin; carrageenan, SIDMA, sodium carboxymethylcellulose, beijing feng li essence trader trade llc; ampicillin sodium for injection, Shandong Lu anti-medicine, Inc.
1.2 test samples
The capsules obtained in example 1 and comparative examples 1 to 5 were used as the subjects.
Example 1 is labeled as sample 1, and comparative examples 1 to 5 are labeled as samples 2 to 6 in sequence.
Control group: manyanshu lemon pharyngitis tablet, national Standard Z61020304 Xian Keli pharmacy Co., Ltd
Before administration, the corresponding preparation is taken, capsule content and the Manyanshu lemon pharyngitis tablet are taken, ground, prepared into solution with required drug concentration of 2.6g/ml by adopting pure water, and the administration dosage of the mouse is calculated according to a conversion formula of the body surface area of the administration dosage of the mouse to the gavage of 39.05 g.kg-1·d-1The administration dose of the rat is 48.28 g.kg-1·d-1
1.3 Experimental animals
Kunming mouse (20 + -2) g, female and male half, SPF grade, provided by Shandong university of traditional Chinese medicine laboratory animal center.
SD rats (200 + -20) g, half male and half female, were provided by the Experimental animals center of Shandong university of traditional Chinese medicine.
2 method of experiment
2.1 xylene-induced ear swelling experiments in mice
2.1.1 animal groups: 80 mice, each half of male and female, were randomly divided into 8 groups of 10 mice each, i.e., blank group, control group, sample 1 group, sample 2 group, sample 3 group, sample 4 group, sample 5 group, and sample 6 group. The administration is carried out once daily for 3 days.
2.1.2 Experimental methods: 1h after the last dose, mice were coated with 50 ul/mouse of xylene reagent in the right ear and not coated with a self-blank in the left ear. After coating xylene for 30min, the mice were sacrificed by removing the cervical vertebrae, and the corresponding round ear pieces of the left and right ears were punched out by a punch with an inner diameter of 8 mm. Weighing on a tunzi balance, taking the difference of the mass of the right ear piece minus the mass of the left ear piece as swelling degree, comparing the swelling degree of each group, and calculating the swelling inhibition ratio: the swelling inhibition rate is (negative control swelling degree-drug group swelling degree)/negative control swelling degree. The results are shown in Table 1.
TABLE 1 Effect of Paralyne on the degree of swelling of mouse auricles
Figure BDA0002855339430000101
Figure BDA0002855339430000111
2.2 rat granuloma proliferation test due to Cotton balls
2.2.1 animal groups: SD rats are randomly divided into 8 groups, and each group comprises 10 rats, namely a blank group, a control group, a sample 1 group, a sample 2 group, a sample 3 group, a sample 4 group, a sample 5 group and a sample 6 group. The administration is carried out once a day for 10 days.
2.2.2 Experimental methods: SD rats were subjected to small abdominal incisions under ether light anesthesia and sterile conditions, the subcutaneous tissues of the rats were expanded with vascular forceps and tweezers, and 1 each of 30. + -.1 mg sterilized cotton balls was subcutaneously implanted in the bilateral groin, followed by suturing. Before use, the cotton balls are added with 1mg/0.1mL of ampicillin sodium and baked in an oven at 60 ℃ to prevent infection. Except for the blank control group (normal saline), the other administration groups started intragastric administration on the day of surgery, 1 time/day, and 10 days continuously. The rats are killed by bleeding femoral artery after administration for 1h on the 10 th day, the granulation tissue of the cotton ball is stripped and taken out, the excess fat which is cut off in the week is removed, the cotton ball is taken out after drying for 5h in a 70 ℃ oven, weighing is carried out, the weight of the cotton ball is subtracted from the weighed mass to obtain the mass of the granuloma, and the granulation inhibition rate is calculated. The granulation inhibition rate is (blank control granulation quality-treatment granulation quality)/blank granulation quality. The results are shown in Table 2.
TABLE 2 Effect on the rat Cotton boll granuloma formation experiment
Figure BDA0002855339430000112
Figure BDA0002855339430000121
2.3 Carrageenan-induced swelling of rat feet
2.3.1 animal groups: SD rats are randomly divided into 8 groups, and each group comprises 10 rats, namely a blank group, a control group, a sample 1 group, a sample 2 group, a sample 3 group, a sample 4 group, a sample 5 group and a sample 6 group. The administration is carried out once a day for 5 days.
2.3.2 Experimental methods: after 30min of the last administration, 0.1mL of 1% carrageenan is subcutaneously injected into the plantar region of the right hind foot of each mouse per mouse to cause inflammation, so that the ankle joint circumference is measured at different time points before and after causing inflammation, and is measured once every hour for four times, and the swelling degree (the circumference of the ankle joint after causing inflammation-the circumference of the ankle joint before causing inflammation) is calculated. The results are shown in Table 3.
TABLE 3 Effect on carrageenan-induced group swelling
Figure BDA0002855339430000122
2.4 experiment of mice peritoneal cavity leukocyte migration caused by sodium carboxymethylcellulose
2.4.1 animal groups: 80 mice, each half of male and female, were randomly divided into 8 groups of 10 mice each, i.e., blank group, control group, sample 1 group, sample 2 group, sample 3 group, sample 4 group, sample 5 group, and sample 6 group. The administration is carried out once daily for 3 days.
2.4.2 test methods: after 30min of the last administration, the mice in each group except the control group were injected with 0.5ml of 1% sodium carboxymethylcellulose in the abdominal cavity, the animals were sacrificed after 30min, each mouse was injected with 5ml of 0.9% physiological saline in the abdominal cavity, the abdomen was gently kneaded, the abdominal cavity was dropped on a cell plate, and the white blood cells were counted under a conventional light microscope. The results are shown in Table 4.
TABLE 4 Effect on experiments on migration of leukocytes from mouse peritoneal cavity caused by sodium carboxymethylcellulose
Figure BDA0002855339430000131
Through the xylene-induced mouse ear swelling experiment, the cotton ball-induced rat granuloma proliferation experiment, the carrageenan-induced rat foot swelling experiment and the sodium carboxymethylcellulose-induced mouse abdominal cavity leukocyte migration experiment, the sample 1 group is far superior to other sample groups in the aspects of inhibiting swelling and granuloma proliferation and relieving foot swelling and leukocyte migration experiments, and the selected effective part composition has obvious effect and generates obvious synergistic effect.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (4)

1. A Chinese medicinal effective part composition for treating pharyngitis is characterized by comprising a total flavone extract and a total saponin extract;
the total flavone extract is extracted from wild chrysanthemum, tangerine pith and physalis alkekengi, and the total saponin extract is extracted from ophiopogon japonicus;
the traditional Chinese medicine composition comprises 6 parts of total flavone extract and 5 parts of total saponin extract according to parts by weight;
the preparation method comprises the following steps:
(1) preparing a total flavone extract: taking wild chrysanthemum, tangerine pith and physalis alkekengi as raw materials, adding 80-95% ethanol in an amount which is 15-30 times the weight of the raw materials, performing reflux extraction for 1-3 times at 70-80 ℃ for 2 hours each time, filtering, combining filtrates, recovering ethanol under reduced pressure, adding water to dilute concentrated solution, passing through a macroporous resin column at a flow rate of 0.8-1 mL/min, eluting with deionized water in an amount which is 6-10 times the volume of the column, eluting with 70% ethanol in an amount which is 8-15 times the volume of the column, collecting eluate, recovering ethanol under reduced pressure, concentrating, and drying to obtain a total flavone extract;
(2) preparing a total saponin extract: taking ophiopogon japonicus as a raw material, adding 75-85% ethanol which is 8-10 times of the weight of ophiopogon japonicus, carrying out reflux extraction at 75-80 ℃ for 1-1.5 h, filtering to obtain filtrate, repeatedly extracting filter residues once, combining two filtrates, recovering ethanol under reduced pressure until the relative density is 1: 1-1: 2, adding water saturated n-butanol, extracting for three times, combining n-butanol parts, recovering n-butanol until each mL contains 1-1.5 g of crude drug, passing through a macroporous resin column at the flow rate of 0.8-1 mL/min, eluting with distilled water which is 4-5 times of the column volume, eluting with 70% ethanol which is 4-5 times of the column volume, collecting eluate, recovering under reduced pressure, and drying to obtain a total saponin extract;
in the step (1), the mass ratio of the wild chrysanthemum flower to the tangerine pith to the physalis alkekengi is 1: 2: 3.
2. the composition of the effective traditional Chinese medicine parts as claimed in claim 1, wherein the content of total flavonoids in the total flavonoids extract is not less than 50wt%, and the content of total saponins in the total saponins extract is not less than 50 wt%.
3. Use of the composition of the effective fraction of Chinese traditional medicine as claimed in claim 1 or 2 in preparing medicine for treating pharyngitis.
4. The use of claim 3, wherein the composition of the effective parts of the Chinese traditional medicine is used as an effective component to prepare tablets, granules, hard capsules, pills or soft capsules.
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