CN115813989A - Traditional Chinese medicine effective part composition for treating asthma and preparation method and application thereof - Google Patents
Traditional Chinese medicine effective part composition for treating asthma and preparation method and application thereof Download PDFInfo
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- 235000012424 soybean oil Nutrition 0.000 description 1
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Classifications
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a traditional Chinese medicine effective part composition for treating asthma and a preparation method and application thereof, wherein the composition comprises a total polysaccharide extract, a total polypeptide extract, a total flavone extract and a total phenolic acid extract; the total polysaccharide extract is extracted from momordica grosvenori, red tangerine peel and cuttlebone, the total polypeptide extract is extracted from earthworms and mussel meat, the total flavone extract is extracted from pine pollen and poppy flowers, and the total phenolic acid extract is extracted from myrobalan meat. Experiments prove that the effective part composition has obvious synergistic effect in the aspect of treating asthma, the product has clear components, stable curative effect, small dosage and high safety, not only accords with the formula principle of treating asthma by using traditional Chinese medicines, but also accords with the development requirement of modernization of traditional Chinese medicines, and has important significance in promoting the transformation of imitation of the medicine industry to autonomous innovation and the internationalization of traditional Chinese medicines in China.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine effective part composition for treating asthma, and a preparation method and application thereof.
Background
Asthma is also called bronchial asthma, is a common disease and frequently occurs, and has the main symptoms of paroxysmal wheeze, dyspnea, chest distress and cough. Bronchial asthma is a chronic inflammatory disease of the airways involving various cells and cell components, which is associated with airway hyperresponsiveness, and is usually characterized by wide and variable reversible airflow limitation, resulting in recurrent wheezing, shortness of breath, chest tightness and cough. Epidemiological survey results show that: the prevalence rate of asthma in China is increased from 7.3% in 2001 to 8.4% in 2010, and two large-scale pediatric asthma prevalence surveys in 1990 and 2000 show that the prevalence rate of childhood asthma is increased from 0.91% to 1.54%, and is increased by 64.84% in more than one decade, and it is estimated that about 3 hundred million people worldwide suffer from asthma at present. Therefore, the treatment of bronchial asthma is not optimistic.
The western medicines for treating bronchial asthma include anti-airway inflammation medicines, bronchodilators and specific immunotherapy. The anti-inflammatory drug can inhibit and prevent the development of airway inflammation and reduce airway hyperresponsiveness; bronchodilators can relieve the symptoms of airway obstruction. However, the single use of bronchodilators is not suitable for symptomatic treatment, particularly for patients with moderate to severe asthma. Because the bronchia relax, more allergen enters the airway, and if the anti-inflammatory drug is not given for effective anti-inflammation, the airway inflammation will be aggravated continuously, which is the important reason that the illness condition can be aggravated continuously by simply using the airway spasmolytic drug for a long time. Furthermore, patients with moderate to severe asthma have different degrees of airway remodeling, and airway hyperresponsiveness is not only related to inflammation, but also related to vessel wall thickening and lumen narrowing caused by smooth muscle proliferation, so that anti-inflammatory and spasmolytic treatment must be applied at the same time to effectively control the disease condition.
The traditional medicine considers that: the lung is the main part of qi, and the kidney is the root of qi. When asthma attacks, the lung fails to control qi, and the kidney deficiency fails to receive qi, which leads to the adverse flow of qi to the upper part of the body and causes dyspnea. Spleen is the source of generation and transformation, and spleen deficiency produces phlegm, phlegm obstructs the airway, so cough and asthma, short breath are seen. Therefore, asthma is the symptom of deficiency of kidney, lung, spleen and three. The asthma is clinically divided into a remission stage and an attack stage. In the remission stage, the deficiency of the three zang organs of the lung, spleen and kidney is caused by kidney yang deficiency, and the latent internal diseases are remained, so syndrome differentiation and treatment mainly aims at tonifying the kidney and warming yang, and also has the functions of tonifying the spleen and benefiting the lung, eliminating phlegm and removing turbidity.
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 traditional Chinese medicine effective part composition for treating asthma, and the preparation method and the application thereof, and the traditional Chinese medicine effective part composition has obvious curative effect on asthma treatment and can be applied to various preparations.
In order to realize the purposes, the adopted technical scheme is as follows:
the invention aims to provide a traditional Chinese medicine effective part composition for treating asthma, which comprises a total polysaccharide extract, a total polypeptide extract, a total flavone extract and a total phenolic acid extract;
the total polysaccharide extract is extracted from momordica grosvenori, red tangerine peel and cuttlebone, the total polypeptide extract is extracted from earthworm and mussel meat, the total flavone extract is extracted from pine pollen and poppy flower, and the total phenolic acid extract is extracted from myrobalan meat.
Further, the traditional Chinese medicine effective part composition comprises 9-20 parts by weight of total polysaccharide extract, 3-10 parts by weight of total polypeptide extract, 6-12 parts by weight of total flavone extract and 3-6 parts by weight of total phenolic acid extract.
Furthermore, the traditional Chinese medicine effective part composition comprises 12 parts by weight of total polysaccharide, 6 parts by weight of total polypeptide, 8 parts by weight of total flavone and 4 parts by weight of total phenolic acid.
Further, the content of total polysaccharide in the total polysaccharide extract is not less than 70wt%, the content of total polypeptide in the total polypeptide extract is not less than 80wt%, and the content of total flavone in the total flavone extract is not less than 40wt%.
Further, the weight ratio of the momordica grosvenori to the pummelo peel to the cuttlebone is 1: (1-3): (1-4).
Further, the mass ratio of the momordica grosvenori to the red tangerine peel to the cuttlebone is 1:1.5:1.
the invention also aims to provide a preparation method of the traditional Chinese medicine effective part composition, which comprises the following steps:
(1) Preparing a total polysaccharide extract: taking 4 parts by weight of momordica grosvenori, 6 parts by weight of exocarpium citri rubrum and 4 parts by weight of cuttlebone, adding 8-12 times of weight of water to extract for 1-3 times, each time for 2 hours, filtering, combining filtrates, concentrating under reduced pressure to 1g crude drug/mL, adding ethanol to the alcohol content of 50%, refrigerating and standing for 12 hours, filtering, continuously adding ethanol to the filtrate to the alcohol content of 80%, refrigerating and standing for 12 hours, collecting precipitate, repeatedly purifying the precipitate, adding 5-15 times of weight of water to fully dissolve, adding 0.5-5% of active carbon, keeping the temperature at 70-80 ℃ for decolorizing for 1-3 times, 0.5 hour/time, filtering, concentrating the filtrate under reduced pressure, and drying to obtain a total polysaccharide extract;
(2) Preparation of total polypeptide extract: taking 4 parts by weight of earthworms and 6 parts by weight of clam meat, adding 2-2.5 times of water by weight to homogenate to obtain meat pulp, adding 0.8% of papain, carrying out enzymolysis at 45 ℃ for 4 hours under the pH value of 6.5, after the enzymolysis reaction is finished, heating to 80-85 ℃, reacting for half an hour, standing at room temperature for 3 hours, and carrying out high-speed centrifugation at 12000r/min to obtain supernatant for spray drying to obtain a total polypeptide extract;
(3) Preparing a total flavone extract: taking 8 parts by weight of pine pollen and 2 parts by weight of poppy flower, adding 12-15 times of 70% ethanol by weight, extracting twice at 74-76 ℃ for 1.5 hours each time, concentrating the filtrate under reduced pressure, and drying to obtain a total flavone extract;
(4) Preparing a total phenolic acid extract: taking myrobalan pulp, adding 70% ethanol with the weight being 12-14 times of that of the myrobalan pulp, carrying out ultrasonic extraction for 2-3 times, combining filtrates, carrying out reduced pressure concentration, and drying to obtain a total phenolic acid extract.
The percentage of ethanol in the invention is volume percentage.
The invention also aims to provide application of the traditional Chinese medicine effective part composition in preparing a medicine for treating asthma.
Further, the four effective part extracts are taken according to the weight ratio of each effective part, and are prepared into any one of pharmaceutically acceptable dosage forms, such as tablets, granules, hard capsules, mixtures, pills, dripping pills, effervescent tablets, injections, powder injections or soft capsules 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.
Compared with the prior art, the invention has the beneficial effects that:
the invention takes the traditional Chinese medicine theory as a guiding idea, and simultaneously combines related research results at home and abroad, and has remarkable effect in the aspect of treating the bronchial asthma. In the formula, the tangerine peel is a monarch drug, and is pungent, bitter and warm in nature. It enters lung and spleen meridians. Has the effects of regulating qi, relieving epigastric distention, eliminating dampness and resolving phlegm. Is used for treating cough with excessive phlegm, and the total polysaccharide in the pummelo peel has obvious effects of relieving cough and eliminating phlegm, so the pummelo peel is a monarch drug. The momordica grosvenori is a ministerial drug, is sweet in taste and cool in nature, enters lung and large intestine channels, has the effects of moistening lung to arrest cough, and engendering liquid to quench thirst, and modern medicine proves that the momordica grosvenori has a remarkable curative effect on diseases such as bronchitis and hypertension, has the effects of clearing heat, relieving summer-heat, reducing phlegm, arresting cough, cooling blood, relaxing bones, clearing lung, lubricating intestines, engendering liquid to quench thirst and the like, can treat diseases such as acute and chronic tracheitis, bronchial asthma and pertussis, and is therefore the ministerial drug. Earthworms are cold in nature. The earthworm total polypeptide can resist the bronchoconstriction caused by histamine and has immediate curative effect on the attack of bronchial asthma, so the earthworm total polypeptide is an adjuvant drug. Pollen pini is a guiding drug with sweet and warm properties, and can nourish yin to avoid damaging the body fluid and consuming qi, and harmonize the effects of the other drugs in the recipe. 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 reducing phlegm, ventilating lung and benefiting qi, descending qi and relieving asthma and benefiting lung and spleen are achieved together;
experiments prove that the effective part composition has obvious synergistic effect on the aspect of treating asthma;
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 asthma, 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.
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 total polysaccharide content comprises the following steps: precisely weighing 10mg of glucose reference substance dried to constant weight at 105 ℃, placing the reference substance in a 100mL volumetric flask, adding distilled water to dissolve completely, fixing the volume to a scale, and shaking up to obtain a reference solution with the glucose concentration of 100 ug/mL. Precisely absorbing 0.0mL, 0.2mL, 0.4mL, 0.6mL, 0.8mL, 1.0mL, 1.2mL and 1.4mL of glucose contrast solution into a 10mL test tube with a plug respectively, adding distilled water to supplement 2.0mL, adding 1.0mL of 6% phenol solution respectively, mixing uniformly, quickly adding 5.0mL of concentrated sulfuric acid, mixing uniformly, keeping the temperature at 60 ℃ for reaction for 15min, stopping the reaction by using an ice water bath for 15min, measuring the absorbance at 490nm by taking a No. 0 tube as a reference and calculating a linear regression equation by using the concentration of the contrast solution and the absorbance corresponding to the concentration of the contrast solution. Taking 15mg of total polysaccharide effective part, placing in a 100mL volumetric flask, adding distilled water to dissolve completely, and fixing the volume to the scale. Sucking 1mL of test solution into a 10mL test tube with a plug, adding distilled water to supplement 2.0mL, respectively adding 1.0mL of 6% phenol solution, mixing uniformly, quickly adding 5.0mL of concentrated sulfuric acid, mixing uniformly, keeping the temperature at 60 ℃ for reaction for 15min, stopping the reaction by using an ice water bath for 15min, measuring the absorbance value, substituting into a standard curve, and calculating to obtain the product.
In a specific embodiment, the method for determining the total polypeptide content comprises the following steps: accurately weighing 20mg of bovine serum albumin reference substance, putting the bovine serum albumin reference substance into a 100mL measuring flask, adding distilled water to dissolve completely, fixing the volume to a scale, and shaking up to obtain a reference solution with the bovine serum albumin concentration of 0.2 mg/mL. Accurately sucking bovine serum albumin control solution 0.0mL, 0.2mL, 0.4mL, 0.6mL, 0.8mL and 1.0mL respectively, placing in a test tube with a plug, adding water to 1.0mL respectively, adding alkaline copper test solution 1.0mL respectively, shaking, standing at room temperature for 10 minutes, adding Fulinfen test solution 4.0mL respectively, mixing uniformly immediately, standing at room temperature for 30 minutes, and measuring absorbance at 650nm wavelength by ultraviolet-visible spectrophotometry; while blank tube No. 0. And calculating a linear regression equation by using the concentration of the reference solution and the corresponding absorbance. Taking 20mg of total polypeptide effective part, placing in a 100mL volumetric flask, adding distilled water to dissolve completely, and fixing the volume to the scale. Sucking 1mL of test solution into a 10mL test tube with a plug, adding 1.0mL of alkaline copper test solution, shaking uniformly, standing at room temperature for 10 minutes, adding 4.0mL of folin phenol test solution respectively, mixing uniformly immediately, standing at room temperature for 30 minutes, and measuring the absorbance at the wavelength of 650 nm. And calculating the total polypeptide concentration in the test solution from a linear regression equation, and multiplying by the dilution factor to obtain the polypeptide.
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 1.0mL, 2.0mL, 3.0mL, 4.0mL and 5.0mL of reference substance solution, respectively placing in a 10m L measuring flask, respectively adding 4.0mL, 3.0mL, 2.0mL, 1.0mL and 0mL of water, adding 0.3mL of 5% sodium nitrite solution, shaking, standing for 6min, adding 0.3m L of 10% aluminum nitrate solution, shaking, standing for 6min, adding 4mL of 4% sodium hydroxide, adding water, scaling, shaking, and standing for 12min; preparing blank solution by the same method. Absorbance was measured at 510 nm. And calculating a linear regression equation by using the concentration of the reference solution and the corresponding absorbance. Taking 30mg of total flavone effective components, adding 70% ethanol into a 100ml volumetric flask to scale, shaking up, and filtering. 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 scales, shaking uniformly, and standing for 12min. And (3) measuring the absorbance at 510nm, calculating the concentration of the total flavone in the test solution according to a linear regression equation, and multiplying the concentration by the dilution factor to obtain the total flavone.
In a specific embodiment, the method for measuring the content of the total phenolic acid comprises the following steps: accurately weighing 10.0mg of gallic acid reference substance, placing the gallic acid reference substance into a 100mL measuring flask, adding distilled water to dissolve the gallic acid reference substance, fixing the volume and shaking up to obtain a gallic acid reference stock solution, accurately sucking 10mL of the gallic acid reference stock solution, placing the gallic acid reference stock solution into the 100mL measuring flask, adding water to dilute the gallic acid reference stock solution to scale, obtaining a gallic acid reference stock solution, accurately sucking 0.0mL, 0.2mL, 0.4mL, 0.6mL, 0.8mL, 1.0mL and 1.2mL of the gallic acid reference stock solution, respectively placing the gallic acid reference stock solution into the 10mL measuring flask, adding water to 2mL, accurately adding 0.5mL of Fulin phenol reagent, shaking up, accurately adding 2mL of 10% sodium carbonate solution, shaking up, adding distilled water to fix the volume to scale, carrying out water bath at 75 ℃ for 10min, cooling to room temperature, irradiating an ultraviolet-visible spectrophotometry, and measuring the absorbance at the wavelength of 750 nm; while blank tube No. 0. And calculating a linear regression equation by using the concentration of the reference solution and the corresponding absorbance. Taking 10mg of the total phenolic acid effective part, putting the total phenolic acid effective part into a 100mL volumetric flask, adding distilled water to dissolve completely, and fixing the volume to the scale. Sucking 1mL of test solution into a 5mL measuring flask, adding water to the scale, shaking up to obtain a test solution, precisely adding 0.5mL of forinophenol reagent, shaking up, precisely adding 2mL of 10% sodium carbonate solution, shaking up, adding distilled water to fix the volume to the scale, carrying out water bath at 75 ℃ for 10min, cooling to room temperature, measuring absorbance at the wavelength of 750nm by an ultraviolet-visible spectrophotometry method, calculating the concentration of total phenolic acid in the test solution according to a linear regression equation, and multiplying the concentration by a dilution factor to obtain the compound.
Example 1
The capsule for treating asthma is prepared by the following formula: 120g of total polysaccharide extract, 60g of total polypeptide extract, 80g of total flavone extract and 40g of total phenolic acid extract.
The preparation method of the total polysaccharide extract comprises the following steps: taking 4 parts by weight of momordica grosvenori, 6 parts by weight of exocarpium citri rubrum and 4 parts by weight of cuttlebone, adding 10 times of water for 2 times, each time for 2 hours, filtering, combining filtrates, concentrating under reduced pressure to 1g crude drug/mL, adding ethanol to reach the alcohol content of 50%, refrigerating and standing for 12 hours, filtering, continuously adding ethanol to reach the alcohol content of 80%, refrigerating and standing for 12 hours, collecting precipitate, repeatedly purifying the precipitate, adding 15 times of water to fully dissolve, adding 3% of active carbon, carrying out heat preservation and decoloration at 75 ℃ for 2 times, 0.5 hour/time, filtering, concentrating the filtrate under reduced pressure, and drying to obtain a total polysaccharide extract, wherein the total polysaccharide content is measured to be 72.3%.
The preparation method of the total polypeptide extract comprises the following steps: taking 4 parts by weight of earthworms and 6 parts by weight of clam meat, adding 2.5 times of water to homogenate to obtain meat pulp, adding 0.8% of papain, carrying out enzymolysis at 45 ℃ and pH 6.5 for 4 hours, heating to 85 ℃ after the enzymolysis reaction is finished, reacting for half an hour, standing at room temperature for 3 hours, carrying out high-speed centrifugation at 12000r/min to obtain supernatant, and carrying out spray drying to obtain a total polypeptide extract, wherein the total polypeptide content is 81.5% by measurement.
The preparation method of the total flavone extract comprises the following steps: mixing 8 parts by weight of pollen Pini and 2 parts by weight of flos Papaveris, adding 15 times of 70% ethanol, extracting at 75 deg.C twice, each for 1.5 hr, concentrating the filtrate under reduced pressure, and drying to obtain total flavone extract with total flavone content of 42.0%.
Preparing a total phenolic acid extract: adding 14 times of 70% ethanol into fructus Chebulae, ultrasonic extracting for 2 times, mixing filtrates, concentrating under reduced pressure, and drying to obtain total phenolic acid extract.
The preparation method comprises the following steps: taking the above effective part extracts according to a prescription, pulverizing, mixing, adding starch to 360g, mixing, granulating, and encapsulating into No. 1 capsule, wherein each capsule contains 0.3g of content.
Example 2
The tablet for treating asthma is prepared by the following formula: 120g of total polysaccharide extract, 60g of total polypeptide extract, 80g of total flavone extract and 40g of total phenolic acid extract.
The preparation methods of the total polysaccharide extract, the total polypeptide extract, the total flavone extract and the total phenolic acid extract are the same as the example 1.
The preparation method comprises the following steps: taking the above effective part extracts according to the prescription, pulverizing, mixing, adding hypromellose 25g, microcrystalline cellulose 20g, isomalt 10g, lactose to 360g, mixing, granulating, and tabletting.
Example 3
The soft capsule for treating asthma is prepared by the following formula: 120g of total polysaccharide extract, 60g of total polypeptide extract, 80g of total flavone extract and 40g of total phenolic acid extract.
The preparation methods of the total polysaccharide extract, the total polypeptide extract, the total flavone extract and the total phenolic acid extract are the same as the example 1.
The preparation method comprises the following steps: taking the above effective components according to the prescription, adding polyethylene glycol 400 and soybean oil 30g respectively to total amount of 360g, mixing, and making into soft capsule.
Example 4
The preparation of the granules for treating asthma comprises the following steps: 120g of polysaccharide extract, 60g of total polypeptide extract, 80g of total flavone extract and 40g of total phenolic acid extract.
The preparation methods of the total polysaccharide extract, the total polypeptide extract, the total flavone extract and the total phenolic acid extract are the same as the example 1.
The preparation method comprises the following steps: taking the above effective components according to the prescription, adding 20% of starch by weight, and 90% of ethanol by weight, and granulating.
Example 5
The preparation of the granules for treating asthma comprises the following steps: 24kg of polysaccharide extract, 12kg of total polypeptide extract, 16kg of total flavone extract and 8kg of total phenolic acid extract.
The preparation methods of the total polysaccharide extract, the total polypeptide extract, the total flavone extract and the total phenolic acid extract are the same as the example 1.
The preparation method comprises the following steps: taking the above effective components according to the prescription, adding polyvidone K30 10 wt% and ethanol 90 wt%, granulating, and packaging 5g of the obtained granule per bag.
140 asthma patients 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, 3 times a day, and 8 weeks as a treatment course. As a result: 119 cases are improved, the obvious effect is 13 cases, the ineffective effect is 8 cases, and the total effective rate is 94.3 percent.
Comparative example 1
200g of momordica grosvenori, 120g of red tangerine peel, 60g of cuttlebone, 160g of earthworm, 120g of mussel meat, 60g of pine pollen and 100g of poppy flower are taken, 10 times of water is added for decocting for 2 hours, filtering is carried out, 8 times of water is added for decocting dregs for 1.5 hours, filtering is carried out, filtrates are combined, vacuum concentration is carried out, vacuum drying is carried out, crushing is carried out, starch is added to 360g, the mixture is filled into No. 1 capsules, 0.3g of the content in each capsule is prepared into capsules.
Comparative example 2
Taking 80g of polysaccharide extract, 80g of total polypeptide extract, 80g of total flavone extract and 60g of total phenolic acid extract prepared in the example 1, adding starch to 360g, filling into No. 1 capsules, and preparing the capsules, wherein the content of each capsule is 0.3 g.
Comparative example 3
Taking 120g of polysaccharide extract, 60g of total polypeptide extract and 80g of total flavone extract prepared in example 1, adding starch to 360g, filling into No. 1 capsules, and preparing into capsules, wherein the content of each capsule is 0.3 g.
Comparative example 4
Taking 120g of polysaccharide extract, 60g of total polypeptide extract and 40g of total phenolic acid extract prepared in example 1, adding starch to 360g, filling into No. 1 capsules, and preparing into capsules, wherein the content of each capsule is 0.3 g.
Comparative example 5
Taking 120g of polysaccharide extract, 80g of total flavone extract and 40g of total phenolic acid extract prepared in example 1, adding starch to 360g, filling into No. 1 capsules, and preparing into capsules, wherein the content of each capsule is 0.3 g.
Comparative example 6
Taking 60g of the total polypeptide extract, 80g of the total flavone extract and 40g of the total phenolic acid extract prepared in the example 1, adding starch to 360g, filling into No. 1 capsules, and preparing the capsules by 0.3g of the content of each capsule.
Comparative example 7
The capsule for treating asthma is prepared by the following formula: 120g of polysaccharide extract, 60g of total polypeptide extract, 80g of total flavone extract and 40g of total phenolic acid extract.
The difference from example 1 is that the total polysaccharide extract of comparative example 7 is extracted from a mixture of momordica grosvenori, tangerine peel and cuttlebone in a mass ratio of 1; total Polypeptides, total Flavonoids, and Total phenolic acid extract were as in example 1.
Adding starch to 360g of the above prescription medicine 300g, and encapsulating with number 1 capsule 0.3g of the content per capsule.
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 asthma of the mice is verified, and the research on the influence of the compound on the anti-inflammation and cough-relieving efficacy of the mice is focused.
1 reagents, samples and animals
1.1 reagents
Sodium chloride (AR), xylene (AR), picric Acid (AR), 25% concentrated Ammonia (AR), phenol red (AR) sodium hydroxide (AR), ammonium chloride (AR), 1mL syringe, mouse stomach syringe needle (12 # 55mm), surgical scissors, ophthalmological forceps, small test tube (5 mL)
1.2 test samples
The capsules obtained in example 1 and comparative examples 1 to 7 were used as the subjects.
Example 1 is labeled as sample 1, and comparative examples 1 to 5 are labeled as samples 2 to 8 in this order.
Control group: dingchuan Zhicouo Wan (Chinese medicine Standard Z20053992) from Tangshan Tongrentang Natural medicine (Tangshan).
Before administration, the corresponding preparation is taken, capsule content and cough relieving pills are taken, the mixture is ground, pure water is adopted to prepare a solution with the required medicine concentration of 2.6g/ml, and the administration dosage of the mouse is calculated to be intragastric 39.05 g/kg according to a conversion formula of the body surface area of the administration dosage of the mouse -1 ·d -1 ，。
1.3 Experimental animals
The Kunming white mouse has the weight of 18-22g and half of the male and female, and is provided by the experimental animal center of Shandong Chinese medicine university.
2 method of experiment
2.1 anti-inflammatory experiments
150 mice, each half of male and female, were randomly divided into blank control groups (liquid medicine is sterilized normal saline), sample 1 group, sample 2 group, sample 3 group, sample 4 group, sample 5 group, sample 6 group, sample 7 group, sample 8 group and control group, each group containing 15 mice, and fasted but not forbidden for 12h before the experiment. The gavage is carried out once a day, and the gavage is continuously carried out for 7 days. After the last gastric lavage for 30min for 1 time, 20 mu L of dimethylbenzene is respectively injected into the front and back sides of the right ear of the mouse by a pipette to cause the inflammation, and the left ear is not treated to be used as a self blank control. After 30min of inflammation, mice are sacrificed by adopting a cervical dislocation method, double ears are cut off, a puncher with the inner diameter of 6mm is used for punching wafers of corresponding parts of left and right ears, an analytical balance is used for weighing rapidly, the difference between the mass of the right ear piece and the mass of the left ear piece is used as swelling degree, swelling degree of each group is compared, and swelling inhibition rate is calculated: swelling inhibition rate = (negative control swelling degree-drug group swelling degree)/negative control swelling degree. The results are shown in Table 1.
TABLE 1 Effect of para-xylene induced auricle swelling in mice
2.2 cough-relieving experiment
150 mice, each half of male and female, were randomly divided into blank control groups (liquid medicine is sterilized normal saline), sample 1 group, sample 2 group, sample 3 group, sample 4 group, sample 5 group, sample 6 group, sample 7 group, and sample 8 group control groups, each group containing 15 mice, and fasted but not water-inhibited for 12h before the experiment. The gavage is carried out for 1 time every day and for 7 days continuously. And after the last 1-time intragastric administration for 1 hour, reversely covering a 1000mL big beaker on an experimental table, continuously spraying 25% concentrated ammonia water for 10s into the big beaker by using a sprayer, putting the mouse into the big beaker, starting timing, and recording the time for the mouse to cough for the first time and the cough frequency within 5min by taking abdominal muscle contraction, mouth-opening respiration and cough sound as indexes, wherein the experimental result is shown in table 2.
TABLE 2 inhibitory Effect on mouse cough caused by concentrated Ammonia Water
The test results show that the improvement of the sample 1 on inflammation diminishing and cough relieving is better than that of the samples 2, 3, 4 and 5, and the total condition of the sample 1 is more than that of the sample 2, the sample 3, the sample 4, the sample 5, the sample 6, the sample 7 and the sample 8 is more than that of the blank control. The selected combination ratio is better.
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 (9)
1. A traditional Chinese medicine effective part composition for treating asthma is characterized by comprising a total polysaccharide extract, a total polypeptide extract, a total flavone extract and a total phenolic acid extract;
the total polysaccharide extract is extracted from momordica grosvenori, red tangerine peel and cuttlebone, the total polypeptide extract is extracted from earthworm and mussel meat, the total flavone extract is extracted from pine pollen and poppy flower, and the total phenolic acid extract is extracted from myrobalan meat.
2. The traditional Chinese medicine effective part composition as claimed in claim 1, which comprises, by weight, 9 to 20 parts of total polysaccharide extract, 3 to 10 parts of total polypeptide extract, 6 to 12 parts of total flavone extract and 3 to 6 parts of total phenolic acid extract.
3. The traditional Chinese medicine effective part composition as claimed in claim 2, which comprises 12 parts by weight of total polysaccharides, 6 parts by weight of total polypeptides, 8 parts by weight of total flavonoids and 4 parts by weight of total phenolic acids.
4. The composition of the effective fractions of traditional Chinese medicine according to any one of claims 1 to 3, wherein the total polysaccharide content in the total polysaccharide extract is not less than 70wt%, the total polypeptide content in the total polypeptide extract is not less than 80wt%, and the total flavone content in the total flavone extract is not less than 40wt%.
5. The traditional Chinese medicine effective part composition according to claim 4, wherein the weight ratio of the momordica grosvenori, the exocarpium citri rubrum and the cuttlebone is 1: (1-3): (1-4).
6. The traditional Chinese medicine effective part composition according to claim 5, wherein the mass ratio of the momordica grosvenori to the exocarpium citri rubrum to the cuttlebone is 1:1.5:1.
7. a method for preparing the composition of the effective parts of the traditional Chinese medicine according to any one of claims 1 to 6, which comprises the following steps:
(1) Preparing a total polysaccharide extract: taking 4 parts by weight of momordica grosvenori, 6 parts by weight of exocarpium citri rubrum and 4 parts by weight of cuttlebone, adding 8-12 times of weight of water to extract for 1-3 times, each time for 2 hours, filtering, combining filtrates, concentrating under reduced pressure to 1g crude drug/mL, adding ethanol to the alcohol content of 50%, refrigerating and standing for 12 hours, filtering, continuously adding ethanol to the filtrate to the alcohol content of 80%, refrigerating and standing for 12 hours, collecting precipitate, repeatedly purifying the precipitate, adding 5-15 times of weight of water to fully dissolve, adding 0.5-5% of active carbon, keeping the temperature at 70-80 ℃ for decolorizing for 1-3 times, 0.5 hour/time, filtering, concentrating the filtrate under reduced pressure, and drying to obtain a total polysaccharide extract;
(2) Preparation of total polypeptide extract: taking 4 parts by weight of earthworms and 6 parts by weight of clam meat, adding 2-2.5 times of water by weight to homogenate to obtain meat pulp, adding 0.8% of papain, carrying out enzymolysis at 45 ℃ for 4 hours under the pH value of 6.5, after the enzymolysis reaction is finished, heating to 80-85 ℃, reacting for half an hour, standing at room temperature for 3 hours, and carrying out high-speed centrifugation at 12000r/min to obtain supernatant for spray drying to obtain a total polypeptide extract;
(3) Preparing a total flavone extract: taking 8 parts by weight of pine pollen and 2 parts by weight of poppy flower, adding 12-15 times of 70% ethanol by weight, extracting twice at 74-76 ℃ for 1.5 hours each time, concentrating the filtrate under reduced pressure, and drying to obtain a total flavone extract;
(4) Preparing a total phenolic acid extract: taking myrobalan pulp, adding 70% ethanol with the weight being 12-14 times of that of the myrobalan pulp, carrying out ultrasonic extraction for 2-3 times, combining filtrates, carrying out reduced pressure concentration, and drying to obtain a total phenolic acid extract.
8. The use of the composition of the effective fraction of a traditional Chinese medicine according to any one of claims 1 to 7 in the preparation of a medicament for treating asthma.
9. The use of claim 8, wherein the composition of the effective part of the traditional Chinese medicine is used as an effective component to prepare any one of tablets, granules, hard capsules, mixtures, pills, dripping pills, effervescent tablets, injections, powder injections or soft capsules.
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