Traditional Chinese medicine composition for treating asthma and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating asthma and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2-10 parts of pericarpium citri reticulatae, 2-10 parts of roses, 2-10 parts of sword beans, 2-10 parts of pinellia ternate, 4-20 parts of scaphium scaphigerum, 4-20 parts of semen armeniacae amarae, 4-20 parts of radix stemonae, 4-20 parts of folium eriobotryae, 3-16 parts of polygala japonica, 3-16 parts of folium mori and 40-200 parts of lean pork. The composition disclosed by the invention has an obvious effect of treating asthma; in addition, the gelatin-containing microspheres are used for carrying out tannin removal treatment on roses and folium eriobotryae in the traditional Chinese medicine composition to reduce the influence of tannin components on other medicinal components, and the gelatin microspheres subjected to tannin removal are recycled and applied to bitter apricot kernel processing, so that the nutrition loss can be reduced while the enzyme deactivation and glycoside protection effects are improved; the asthma treatment effect of the composition is comprehensively improved; on the basis, the taste of the traditional Chinese medicine composition is improved, a specific flavoring agent is added during preparation of the composition, and the traditional Chinese medicine composition with good taste is obtained.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating asthma and a preparation method thereof. Background Art

[0002] Asthma belongs to the category of asthma in traditional Chinese medicine. It is caused by phlegm in the lungs. It is triggered by exogenous pathogens, diet, emotions, fatigue and other inducements, resulting in phlegm blocking the airway, dysfunction of the lung's descending function, and narrowing and contraction of the airway, which causes phlegm and asthma. As early as more than 2,000 years ago, the "Yellow Emperor's Internal Classic" did not have a clear name for asthma, but there were records of similar asthma characteristics. Traditional Chinese medicine has a long history of treating asthma, mainly with compound preparations and single Chinese medicines. With the development and deepening of modern medicine, most studies are conducted at the molecular level. However, due to the complex chemical composition of traditional Chinese medicine, a certain active ingredient of traditional Chinese medicine often has multiple functions or pharmacological effects, which can play a role through multiple links and targets. And because of this complexity of traditional Chinese medicine ingredients, the interaction and influence of various medicinal materials need to be considered during the preparation of traditional Chinese medicine compositions to avoid affecting the efficacy.

[0003] Common Chinese medicinal materials with antiasthmatic effects, such as loquat, contain tannins, which are also called tannins. Tannins are a common type of complex polyphenolic compounds in plants. Tannins have certain pharmacological activities and are mainly used for hemostasis, astringency and burns. Tannins have a polyphenol structure, and their aqueous solutions are easily oxidized due to heating or long-term storage. Tannins can not only condense into tannic acid or tannin red precipitation, but also combine with other ingredients in Chinese herbal medicines to form water-insoluble precipitation, affecting clarity and quality. Therefore, on the one hand, the biological activity of tannins should be considered, and on the other hand, tannins are often removed as impurities. However, the current technology generally focuses on the research on the removal of tannins from Chinese herbal medicine injections, and often ignores the influence of tannins contained in other preparations such as Chinese herbal medicine compositions (such as decoctions). In fact, when tannins are present in some medicinal materials in Chinese herbal medicine compositions, it is easy to affect the performance of effective ingredients in other medicinal materials, such as alkaloids, and then affect the efficacy. Therefore, the removal of tannins in Chinese herbal medicine compositions is also necessary.

[0004] Common tannin removal methods in the prior art include alkaline alcohol precipitation, dialysis, acid precipitation, gelatin precipitation, polyamide adsorption, lime sulfate precipitation, lead salt precipitation, etc. Hu Guanshi (Research on Tannin Removal Methods of Chinese Herbal Medicine, 1991 (11)) reported that gelatin was denatured by formaldehyde to prepare solid phase porous microspheres for tannin removal. Quantitative analysis by SS-920 fast thin layer scanner confirmed that the tannin removal microspheres were insoluble in water and alcohol, stable in nature, and could selectively remove tannins without removing effective ingredients. Although this method solves the problems of poor selectivity and easy loss of other effective ingredients in the current gelatin precipitation method, and the difficulty of removing the introduced gelatin, and achieves the selective removal of tannins from gelatin microspheres, the formaldehyde cross-linking agent used in the preparation of gelatin microspheres is toxic and has potential safety hazards. In addition, this method improves the selective tannin removal effect of gelatin microspheres at the expense of the activity of amino and carboxyl groups in gelatin molecules, and inevitably has the problem of difficulty in balancing the selectivity and efficiency of tannin removal.

[0005] Another common Chinese herbal medicine with antiasthmatic effect, bitter almond, has a main active ingredient of amygdalin, which is easily hydrolyzed by amygdalin enzyme into a highly toxic component, hydrocyanic acid. Therefore, it is necessary to process bitter almond to kill enzymes and preserve glycosides, so that amygdalin slowly decomposes hydrocyanic acid to play an antitussive and antiasthmatic effect. Existing bitter almond processing methods mainly include stewing, stir-frying, steam hot pressing and microwave. The microwave method reported by Bao Guolin (Exploration of Bitter Almond Processing Method, Shaanxi Traditional Chinese Medicine, Vol. 22, No. 12, 2001) kills enzymes in a medium- and high-end microwave oven for 4 minutes, which can achieve a more satisfactory effect of killing enzymes and preserving glycosides. Although this method overcomes the disadvantage of poor enzyme killing and glycoside preservation that is difficult to solve in conventional processing, the microwave processing efficiency is not enough (microwave time is too long and easily causes nutrient loss). In addition, bitter almonds also contain a large amount of unsaturated fatty acids. In the prior art, degreasing and extraction of effective ingredients are generally performed after processing (enzyme inactivation). When microwave enzyme inactivation is used, the presence of fatty oil easily affects the heat transfer of the medicinal material, resulting in a longer microwave time. In addition, the high temperature during the microwave enzyme inactivation process easily accelerates the oxidation and rancidity of unsaturated fatty acids in the bitter almond medicinal material, affecting the quality of the medicinal material. In addition, the prior art does not take into account the problem of protein loss in bitter almonds. Bitter almonds contain a large amount of protein nutrients, which are easily denatured by temperature.

[0006] Moreover, most Chinese medicine compositions contain bitter medicinal materials, and the taste is generally biased, and the patient compliance is low, especially the acceptance of children with a high incidence of asthma is very low. Therefore, it is very important to improve the taste of Chinese medicine compositions. In view of the bad taste of current Chinese medicine preparations, the existing technology generally interferes with the perception of bad taste by taste buds by adding sweeteners (such as aspartame, stevioside and mogroside), umami substances (such as sodium glutamate), taste blockers (adenosine monophosphate) or taste paralyzers (menthol), etc., to achieve masking and flavor correction. This method has a significant effect in chemical drugs, but the effect is not ideal when used in Chinese medicine decoctions. The reason is that the composition of Chinese medicine compositions is complex, and the bitterness of Chinese medicine preparations is the result of complex multi-to-multi spatiotemporal responses and comprehensive superposition effects between many components and bitter receptors in complex phases. For example, when a Chinese medicine composition contains tannins, the tannins themselves are prone to cause astringency, and they are very easy to combine with sugars, proteins and other ingredients to destroy the efficacy of the medicine. If the flavoring agent is stevioside or other substances, it will also affect the flavoring effect. Therefore, different flavoring agents are suitable for different types of Chinese medicines, and they need to be selected reasonably.

[0007] In summary, how to provide a Chinese medicine composition for treating asthma and a preparation method thereof, and how to improve the comprehensive efficacy and taste of Chinese medicine by processing the various medicinal materials in the composition, is an urgent problem to be solved. Summary of the invention

[0008] The object of the present invention is to overcome the deficiencies of the prior art, and to provide a Chinese medicine composition for treating asthma and a preparation method thereof, which is made of ten Chinese medicinal materials including dried tangerine peel, rose, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, loquat leaf, melon seed gold, and mulberry leaf, supplemented with lean pork, and has an obvious effect of treating asthma; in addition, the present invention uses gelatin microspheres to remove tannins from rose and loquat leaves in the Chinese medicine composition to reduce the influence of tannin components on other active ingredients, and the gelatin microspheres after tannin removal are recovered and applied to bitter almond processing, which improves the effect of enzyme inactivation and glycoside preservation, and can also reduce nutritional losses, and comprehensively improves the effect of the composition in treating asthma. On this basis, the present invention also improves the taste of the Chinese medicine composition, and adds a specific flavoring agent when preparing the composition, so as to obtain a Chinese medicine composition with a better taste.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is:

[0010] A traditional Chinese medicine composition for treating asthma comprises the following raw materials by weight: 2-10 parts of dried tangerine peel, 2-10 parts of rose, 2-10 parts of sword bean, 2-10 parts of pinellia, 4-20 parts of sterculia lychnophora, 4-20 parts of bitter almond, 4-20 parts of stemona, 4-20 parts of loquat leaf, 3-16 parts of melon seeds, 3-16 parts of mulberry leaf and 40-200 parts of lean pork.

[0011] After the rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannins. The preparation method of the gelatin microspheres comprises the following steps:

[0012] (1) Gelatin, glycerin, and water are heated (40-70° C.) under stirring conditions to form a uniform gelatin solution 1, porous ceramics are added to the gelatin solution 1 under heat preservation and stirring conditions, and after standing for 5-10 minutes, the porous ceramics are concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain the porous ceramics loaded with gelatin;

[0013] (2) Add water to gelatin and heat to (40-70° C.) under stirring to obtain a uniform gelatin solution 2. Spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 40-50° C., then continue to spray the tannic acid solution. After standing for 10-30 hours, freeze-dry the mixture at -(10-20)° C. for more than 24 hours. Finally, wash the mixture with ethanol (volume concentration 80-95%) and dry the mixture to obtain gelatin-containing microspheres.

[0014] Preferably, in step (1), the mass ratio of gelatin, glycerol and water is 1:(3-6):(10-20), the amount of gelatin added is 5-10% of the mass of the porous ceramic, and the particle size of the porous ceramic is 10-50 μm.

[0015] Preferably, when gelatin is taken and water is added in step (2), ceramide trihexoside is also added, and the mass ratio of gelatin, water, ceramide trihexoside and tannic acid is 1: (10-20): (0.4-0.7): (0.08-0.2), the injection amount of gelatin solution 2 is 3-6% of the mass of the porous ceramic loaded with gelatin, and the mass concentration of the tannic acid solution is 2-5%.

[0016] Preferably, the method for removing tannins from rose and loquat leaves comprises:

[0017] Add water to the rose and loquat leaf raw materials and reflux extract for 2-4 times, filter, combine the extracts, and concentrate to 3-6 times the amount of the raw medicine to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 10-20 minutes, then filter and take the filtrate.

[0018] Preferably, the amount of gelatin microspheres added is 5-10% of the total mass of the rose flower and loquat leaf medicinal materials.

[0019] Preferably, the amount of water added during reflux extraction is 10-30 times the mass of the rose and loquat leaves raw materials, and each extraction lasts 40-80 minutes.

[0020] The present invention also provides a method for preparing bitter almonds in the traditional Chinese medicine composition, comprising the following steps:

[0021] S1. Pretreatment of the gelatin microspheres after tannin removal: Place the gelatin microspheres after tannin removal in a 10-30 times amount of tannic acid aqueous solution (mass concentration of 4-6%) and stir to react until the tannic acid content in the solution remains unchanged, take out the microspheres and wash them with ethanol (volume concentration of 80-95%), then soak them in clean water for 0.5-2h, then freeze-dry them at -(10-20)°C for more than 24h, then wash them with clean water and ethanol (volume concentration of 80-95%) 2-4 times in turn, and dry them to obtain microspheres 1 for standby use;

[0022] S2. Defatting of bitter almonds: grind the bitter almonds into 20-60 meshes and add them into petroleum ether, then add microspheres 1, stir evenly and defatting in a 50-60°C water bath for 2-3 times, each time for 20-40 minutes. After defatting, centrifuge to separate microspheres 1, filter the remaining material, evaporate the solvent and obtain defatted bitter almonds;

[0023] S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 600-800W and 70-90℃ for 2-3 minutes.

[0024] Preferably, in step S2, the amount of petroleum ether added each time for defatting is 3-10 times the mass of the bitter almond raw material, and the amount of microspheres 1 added is 5-20% of the mass of the bitter almond raw material.

[0025] The present invention also provides a preparation method of the Chinese medicine composition, comprising the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, golden osmanthus fragrans and mulberry leaf are mixed evenly, 3-5 times the amount of water are added to soak for 30-60 minutes, then decocted for 2-3 times, each time for 10-25 minutes, filtered, combined to obtain a water decoction, and rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 3-5 times the amount of water is added to soak for 20-60 minutes, then decocted for 1-3 times, each time for 10-20 minutes, filtered, combined the filtrate, and mixed the filtrate with the medicinal liquid to obtain the Chinese medicine composition.

[0026] Preferably, the preparation method further comprises: mixing the filtrate with the medicinal solution, adding a flavoring agent and stirring evenly to obtain the Chinese medicine composition.

[0027] The flavoring agent includes stevioside and mogroside, and the mass ratio of the two is 1:(0.4-0.7). The concentration of the flavoring agent added to the mixed solution of the filtrate and the drug solution is 10-30 mg / mL.

[0028] The mogroside is any one or more of 11-O-mogroside V, mogroside V, mogroside VI, mogroside III, and mogroside IV. Preferably, the mogroside is 11-O-mogroside V.

[0029] The present invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for treating asthma.

[0030] Preferably, the asthma treatment drug is a decoction, granules, spray, oral solution, tablet or capsule.

[0031] Technical effects of the present invention:

[0032] 1. The Chinese medicine composition prepared from ten Chinese medicinal materials including dried tangerine peel, rose flower, sword bean, and pinellia tuber and supplemented with lean pork has obvious effect of treating asthma and low recurrence rate.

[0033] 2. The Chinese medicinal raw materials rose and loquat leaves of the present invention contain tannins, which not only easily affect the stability of the composition, but also easily react with stemonine in the stemonae and proteins contained in lean pork, bitter almonds, sword beans, etc. to precipitate, affecting the efficacy and stability of the composition. Therefore, the present invention uses gelatin-containing microspheres to remove tannins from rose and loquat leaves. The microspheres are made of porous ceramic balls loaded with gelatin and then coated with a gelatin and tannic acid cross-linking layer on the surface. The gelatin and tannic acid cross-linking layer coated on the surface can selectively bind to tannins and It can provide a channel for the gelatin in the cross-linked layer to combine with external tannins. The gelatin loaded in the porous ceramic balls retains the activity of the carboxyl and amino groups in the gelatin molecules and can efficiently precipitate tannins without causing the problem of difficulty in removing gelatin in the liquid medicine. Taken together, it can take into account the selectivity and efficiency of tannin removal. The amount of gelatin used is small and the effect is good. It is green and safe without introducing toxic ingredients. It can not only remove tannins in roses and loquat leaves, but also fully retain the effective ingredients such as flavonoids in roses and triterpene acid compounds in loquat leaves.

[0034] 3. In the preparation of gelatin-containing microspheres, the present invention can make the surface-coated gelatin and tannic acid cross-linked layer porous by freeze drying, which promotes the combination and precipitation of tannins in the external liquid medicine and gelatin loaded in the porous ceramic. Ceramide trihexoside is also added when gelatin and tannic acid are cross-linked, which can not only regulate the pore structure of the cross-linked layer through the molecular long chain structure to ensure the high efficiency of tannin removal, but also its glycoside group can regulate the combination of gelatin and tannic acid, ensuring the firmness of the cross-linked layer coated on the surface of the gelatin-containing microspheres.

[0035] 4. When processing bitter almonds, the present invention first defats the bitter almonds and then performs microwave enzyme inactivation. During the microwave enzyme inactivation process, the unsaturated fatty acids of the medicinal materials are not prone to oxidation and rancidity. After defatting, the influence of oil on heat transfer is reduced, the enzyme inactivation speed is fast and the effect is good, and the loss of amygdalin is small. In addition, when the enzyme inactivation time is significantly shortened, the loss of protein in amygdalin that is easily affected by temperature is also significantly reduced, and the retention rate of amygdalin and protein after the bitter almonds are processed is improved.

[0036] 5. When defatting bitter almonds, the present invention adds the gelatin microspheres obtained by removing tannins from rose and loquat leaves to improve the defatting effect, thereby reducing the influence of fatty acids in the medicinal materials on subsequent enzyme inactivation, shortening the enzyme inactivation time and reducing the loss of effective ingredients.

[0037] The surface of the gelatin-containing microspheres after tannin removal contains abundant active groups such as amino, carboxyl, and hydroxyl, which can combine with carboxyl groups in fatty acids to improve the dissolution of fatty acids in medicinal materials and the degreasing effect; and the present invention reduces the reaction activity and improves the stability after pre-treatment of the gelatin-containing microspheres after tannin removal, and freeze-drying after soaking and absorbing water also improves the porosity; in addition, the tannin contained in the gelatin-containing microspheres has an antioxidant effect, which can reduce the oxidation and deterioration problems caused by the heating and degreasing process of medicinal materials, thereby reducing the impact on the active ingredient amygdalin. And the ceramide trihexyl glycoside contained in the cross-linked layer on the surface of the microspheres can also improve the dispersion of the microspheres in petroleum ether.

[0038] 6. In the Chinese medicine composition of the present invention, bitter almonds, melon seeds, loquat leaves, etc. are all bitter medicinal materials, and bitter almonds retain amygdalin to a large extent after being processed by the present invention, which is the main source of bitterness. Therefore, the Chinese medicine composition needs to be flavored to improve the taste of the medicine. Stevioside and mogroside are commonly used natural sweeteners, but in Chinese medicines containing tannins, not only their flavor correction effect is disturbed, but also the efficacy of the medicine is affected. After the present invention removes tannins from the tannin-containing medicinal materials rose and loquat leaves in the Chinese medicine composition, the flavor correction effect of stevioside and mogroside can be fully exerted, and a Chinese medicine composition with a better taste is obtained, which improves patient compliance.

[0039] 7. The mogroside contained in the flavoring agent of the present invention has the effects of moistening the lungs and relieving cough, anti-inflammatory and antibacterial, and can further improve the therapeutic effect of asthma. Since lean pork containing a large amount of protein is added to the composition of the present invention, and some medicinal materials such as bitter almonds and sword beans also contain more protein, the protein is unstable and easily denatured, agglomerated and oxidized, so the mogroside of the present invention is preferably 11-O-mogroside V, which not only has a strong antioxidant effect, but also its specific sugar ligand can improve the dispersion and molecular stability of the protein in the composition, thereby extending the shelf life of the composition and improving its applicability. DETAILED DESCRIPTION

[0040] The above scheme is further described below in conjunction with specific embodiments; it should be understood that these embodiments are used to illustrate the basic principles, main features and advantages of the present invention, and the present invention is not limited to the scope of the following embodiments; the implementation conditions adopted in the embodiments can be further adjusted according to specific requirements, and the implementation conditions not specified are usually the conditions in conventional experiments.

[0041] Unless otherwise specified in the following examples, all raw materials are commercially available or prepared by conventional methods in the art.

[0042] Example 1

[0043] The present embodiment provides a Chinese medicine composition for treating asthma, which includes the following raw materials by weight: 5 parts of tangerine peel, 5 parts of rose, 5 parts of sword bean, 5 parts of pinellia, 10 parts of sterculia lychnophora, 10 parts of (braised) bitter almonds, 10 parts of stemona, 10 parts of loquat leaves, 8 parts of melon seeds, 8 parts of mulberry leaves and 100 parts of lean pork.

[0044] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, rose, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, loquat leaf, golden melon seed and mulberry leaf are evenly mixed, soaked in 4 times the amount of water for 45 minutes, boiled twice, each time for 20 minutes, filtered, and combined to obtain a decoction; according to the formula, lean pork is washed, soaked in 4 times the amount of water for 40 minutes, boiled twice, each time for 15 minutes, filtered, combined the filtrate, and mixed the filtrate with the decoction to obtain the Chinese medicine composition.

[0045] Example 2

[0046] The difference between this embodiment and embodiment 1 is that the rose and loquat leaves are treated to remove tannins. The details are as follows:

[0047] The present embodiment provides a Chinese medicine composition for treating asthma, which includes the following raw materials by weight: 5 parts of tangerine peel, 5 parts of rose, 5 parts of sword bean, 5 parts of pinellia, 10 parts of sterculia lychnophora, 10 parts of (braised) bitter almonds, 10 parts of stemona, 10 parts of loquat leaves, 8 parts of melon seeds, 8 parts of mulberry leaves and 100 parts of lean pork.

[0048] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0049] (1) Gelatin, glycerin, and water are heated (50° C.) under stirring conditions according to a mass ratio of 1:4:15 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 8 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 8% of the mass of the porous ceramics.

[0050] (2) Add water to gelatin and heat it (50°C) under stirring to form a uniform gelatin solution 2. Spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 45°C. The amount of the gelatin solution 2 sprayed is 4% of the mass of the porous ceramic loaded with gelatin. Then continue to spray tannic acid solution (mass concentration is 3%). After standing for 20 hours, freeze-dry it at -15°C for more than 24 hours. Finally, wash and dry it with ethanol (volume concentration is 90%) to obtain gelatin-containing microspheres. The mass ratio of gelatin, water and tannic acid is 1:15:0.15.

[0051] The methods for removing tannins from rose and loquat leaves include:

[0052] Add 20 times the amount of water to the rose and loquat leaf raw materials, reflux and extract for 3 times, each time for 60 minutes, filter, combine the extracts, and concentrate to 4 times the amount of the crude drug to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 15 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 8% of the total mass of the rose and loquat leaf medicinal materials.

[0053] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, golden osmanthus fragrans and mulberry leaf are mixed evenly, 4 times the amount of water is added to soak for 45 minutes, then decocted twice, each time for 20 minutes, filtered, combined to obtain a water decoction, and then rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 4 times the amount of water is added to soak for 40 minutes, then decocted twice, each time for 15 minutes, filtered, combined the filtrate, and mixed the filtrate with the medicinal liquid to obtain the Chinese medicine composition.

[0054] Example 3

[0055] The difference between this embodiment and embodiment 2 is that ceramide trihexoside is added when preparing gelatin-containing microspheres. The details are as follows:

[0056] The present embodiment provides a Chinese medicine composition for treating asthma, which includes the following raw materials by weight: 5 parts of tangerine peel, 5 parts of rose, 5 parts of sword bean, 5 parts of pinellia, 10 parts of sterculia lychnophora, 10 parts of (braised) bitter almonds, 10 parts of stemona, 10 parts of loquat leaves, 8 parts of melon seeds, 8 parts of mulberry leaves and 100 parts of lean pork.

[0057] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0058] (1) Gelatin, glycerin, and water are heated (50° C.) under stirring conditions according to a mass ratio of 1:4:15 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 8 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 8% of the mass of the porous ceramics.

[0059] (2) Take gelatin, add water and ceramide trihexyl glycoside, heat (50°C) under stirring conditions to form a uniform gelatin solution 2, spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 45°C, the amount of gelatin solution 2 sprayed is 4% of the mass of the porous ceramic loaded with gelatin, then continue to spray tannic acid solution (mass concentration is 3%), let it stand for 20 hours, then freeze-dry it at -15°C for more than 24 hours, finally wash and dry it with ethanol (volume concentration 90%), and obtain gelatin-containing microspheres. The mass ratio of gelatin, water, ceramide trihexyl glycoside, and tannic acid is 1:15:0.5:0.15.

[0060] The methods for removing tannins from rose and loquat leaves include:

[0061] Add 20 times the amount of water to the rose and loquat leaf raw materials, reflux and extract for 3 times, each time for 60 minutes, filter, combine the extracts, and concentrate to 4 times the amount of the crude drug to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 15 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 8% of the total mass of the rose and loquat leaf medicinal materials.

[0062] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, golden osmanthus fragrans and mulberry leaf are mixed evenly, 4 times the amount of water is added to soak for 45 minutes, then decocted twice, each time for 20 minutes, filtered, combined to obtain a water decoction, and then rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 4 times the amount of water is added to soak for 40 minutes, then decocted twice, each time for 15 minutes, filtered, combined the filtrate, and mixed the filtrate with the medicinal liquid to obtain the Chinese medicine composition.

[0063] Example 4

[0064] The difference between this embodiment and embodiment 3 is the processing method of bitter almonds. The specific method is as follows:

[0065] The present embodiment provides a traditional Chinese medicine composition for treating asthma, which comprises the following raw materials by weight: 5 parts of tangerine peel, 5 parts of rose, 5 parts of sword bean, 5 parts of pinellia, 10 parts of sterculia lychnophora, 10 parts of bitter almond, 10 parts of stemona, 10 parts of loquat leaf, 8 parts of melon seeds, 8 parts of mulberry leaf and 100 parts of lean pork.

[0066] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0067] (1) Gelatin, glycerin, and water are heated (50° C.) under stirring conditions according to a mass ratio of 1:4:15 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 8 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 8% of the mass of the porous ceramics.

[0068] (2) Take gelatin, add water and ceramide trihexyl glycoside, heat (50°C) under stirring conditions to form a uniform gelatin solution 2, spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 45°C, the amount of gelatin solution 2 sprayed is 4% of the mass of the porous ceramic loaded with gelatin, then continue to spray tannic acid solution (mass concentration is 3%), let it stand for 20 hours, then freeze-dry it at -15°C for more than 24 hours, finally wash and dry it with ethanol (volume concentration 90%), and obtain gelatin-containing microspheres. The mass ratio of gelatin, water, ceramide trihexyl glycoside, and tannic acid is 1:15:0.5:0.15.

[0069] The methods for removing tannins from rose and loquat leaves include:

[0070] Add 20 times the amount of water to the rose and loquat leaf raw materials, reflux and extract for 3 times, each time for 60 minutes, filter, combine the extracts, and concentrate to 4 times the amount of the crude drug to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 15 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 8% of the total mass of the rose and loquat leaf medicinal materials.

[0071] The preparation method of bitter almonds comprises the following steps:

[0072] S1. Pretreatment of gelatin-containing microspheres after tannin removal: Place the above-mentioned gelatin-containing microspheres after tannin removal in 20 times the amount of tannic acid aqueous solution (mass concentration of 5%) and stir to react until the tannic acid content in the solution remains unchanged, take out the microspheres, wash them with ethanol (volume concentration of 90%), soak them in clean water for 1 hour, then freeze-dry them at -15°C for more than 24 hours, and then wash them with clean water and ethanol (volume concentration of 90%) three times in turn. After drying, obtain microspheres 1 for use.

[0073] S2. Defatting of bitter almonds: grind the bitter almonds into 20-60 mesh and add 6 times amount of petroleum ether, then add microsphere 1, stir evenly and defatting in a 55°C water bath for 2 times, each time for 30 min. After defatting, centrifuge to separate microsphere 1, filter the remaining material and evaporate the solvent to obtain defatted bitter almonds; the amount of microsphere 1 added is 12% of the mass of the bitter almonds.

[0074] S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 700W and 80℃ for 2.5min.

[0075] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, stemona, golden osmanthus fragrans, mulberry leaf and processed bitter almond are mixed evenly, 4 times the amount of water is added to soak for 45 minutes, then boiled twice, each time for 20 minutes, filtered, combined to obtain a water decoction, and then rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 4 times the amount of water is added to soak for 40 minutes, then boiled twice, each time for 15 minutes, filtered, combined the filtrate, and mixed the filtrate with the medicinal liquid to obtain the Chinese medicine composition.

[0076] Example 5

[0077] The difference between this embodiment and embodiment 4 is that a flavoring agent is added during the preparation of the Chinese medicine composition. The details are as follows:

[0078] The present embodiment provides a traditional Chinese medicine composition for treating asthma, which comprises the following raw materials by weight: 5 parts of tangerine peel, 5 parts of rose, 5 parts of sword bean, 5 parts of pinellia, 10 parts of sterculia lychnophora, 10 parts of bitter almond, 10 parts of stemona, 10 parts of loquat leaf, 8 parts of melon seeds, 8 parts of mulberry leaf and 100 parts of lean pork.

[0079] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0080] (1) Gelatin, glycerin, and water are heated (50° C.) under stirring conditions according to a mass ratio of 1:4:15 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 8 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 8% of the mass of the porous ceramics.

[0081] (2) Take gelatin, add water and ceramide trihexyl glycoside, heat (50°C) under stirring conditions to form a uniform gelatin solution 2, spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 45°C, the amount of gelatin solution 2 sprayed is 4% of the mass of the porous ceramic loaded with gelatin, then continue to spray tannic acid solution (mass concentration is 3%), let it stand for 20 hours, then freeze-dry it at -15°C for more than 24 hours, finally wash and dry it with ethanol (volume concentration 90%), and obtain gelatin-containing microspheres. The mass ratio of gelatin, water, ceramide trihexyl glycoside, and tannic acid is 1:15:0.5:0.15.

[0082] The methods for removing tannins from rose and loquat leaves include:

[0083] Add 20 times the amount of water to the rose and loquat leaf raw materials, reflux and extract for 3 times, each time for 60 minutes, filter, combine the extracts, and concentrate to 4 times the amount of the crude drug to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 15 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 8% of the total mass of the rose and loquat leaf medicinal materials.

[0084] The preparation method of bitter almonds comprises the following steps:

[0085] S1. Pretreatment of gelatin-containing microspheres after tannin removal: Place the above-mentioned gelatin-containing microspheres after tannin removal in 20 times the amount of tannic acid aqueous solution (mass concentration of 5%) and stir to react until the tannic acid content in the solution remains unchanged, take out the microspheres, wash them with ethanol (volume concentration of 90%), soak them in clean water for 1 hour, then freeze-dry them at -15°C for more than 24 hours, and then wash them with clean water and ethanol (volume concentration of 90%) three times in turn. After drying, obtain microspheres 1 for use.

[0086] S2. Defatting of bitter almonds: grind the bitter almonds into 20-60 mesh and add 6 times amount of petroleum ether, then add microsphere 1, stir evenly and defatting in a 55°C water bath for 2 times, each time for 30 min. After defatting, centrifuge to separate microsphere 1, filter the remaining material and evaporate the solvent to obtain defatted bitter almonds; the amount of microsphere 1 added is 12% of the mass of the bitter almonds.

[0087] S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 700W and 80℃ for 2.5min.

[0088] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, stemona, golden osmanthus fragrans, mulberry leaf and processed bitter almond are mixed evenly, 4 times the amount of water is added to soak for 45 minutes, then decocted twice, each time for 20 minutes, filtered, combined to obtain a water decoction, and then rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 4 times the amount of water is added to soak for 40 minutes, then decocted twice, each time for 15 minutes, filtered, combined the filtrate, mixed the filtrate with the medicinal liquid, added a flavoring agent and stirred evenly to obtain the Chinese medicine composition.

[0089] The flavoring agent includes stevioside and 11-O-mogroside V, the mass ratio of the two is 1:0.5, and the concentration of the flavoring agent added to the mixed solution of the filtrate and the drug solution is 20 mg / mL.

[0090] Example 6

[0091] This embodiment provides a traditional Chinese medicine composition for treating asthma, which is different from that of Embodiment 5 in that the flavoring agent includes stevioside and mogroside V.

[0092] Example 7

[0093] This embodiment provides a traditional Chinese medicine composition for treating asthma, which is different from that of embodiment 5 in that the flavoring agent includes stevioside and mogroside III.

[0094] Example 8

[0095] The present embodiment provides a traditional Chinese medicine composition for treating asthma, which comprises the following raw materials by weight: 2 parts of dried tangerine peel, 2 parts of rose, 2 parts of sword bean, 2 parts of pinellia, 4 parts of sterculia lychnophora, 4 parts of bitter almond, 4 parts of stemona, 4 parts of loquat leaf, 3 parts of melon seeds, 3 parts of mulberry leaf and 40 parts of lean pork.

[0096] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0097] (1) Gelatin, glycerin, and water are heated (40° C.) under stirring conditions according to a mass ratio of 1:3:10 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 5 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 5% of the mass of the porous ceramics.

[0098] (2) Take gelatin, add water and ceramide trihexyl glycoside, heat (40°C) under stirring conditions to form a uniform gelatin solution 2, spray the gelatin solution 2 evenly onto the surface of the porous ceramic loaded with gelatin at 40°C, the amount of gelatin solution 2 sprayed is 3% of the mass of the porous ceramic loaded with gelatin, then continue to spray tannic acid solution (mass concentration is 5%), let it stand for 10 hours, then freeze-dry it at -10°C for more than 24 hours, finally wash it with ethanol (volume concentration 80%) and dry it to obtain gelatin-containing microspheres. The mass ratio of gelatin, water, ceramide trihexyl glycoside and tannic acid is 1:10:0.4:0.08.

[0099] The methods for removing tannins from rose and loquat leaves include:

[0100] Add 10 times the amount of water to the rose and loquat leaf raw materials, reflux and extract for 4 times, each time for 40 minutes, filter, combine the extracts, and concentrate to 3 times the amount of the raw medicine to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 20 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 5% of the total mass of the rose and loquat leaf medicinal materials.

[0101] The preparation method of bitter almonds includes the following steps:

[0102] S1. Pretreatment of gelatin-containing microspheres after tannin removal: Place the above-mentioned gelatin-containing microspheres after tannin removal in 10 times the amount of tannic acid aqueous solution (mass concentration of 6%) and stir to react until the tannic acid content in the solution remains unchanged, take out the microspheres, wash them with ethanol (volume concentration of 80%), soak them in clean water for 0.5h, then freeze-dry them at -10℃ for more than 24h, and then wash them twice with clean water and ethanol (volume concentration of 80%) in turn, and obtain microspheres 1 after drying for use.

[0103] S2. Defatting of bitter almonds: grind the bitter almonds into 20-60 mesh and add 3 times amount of petroleum ether, then add microsphere 1, stir evenly and defatting in a 50°C water bath for 3 times, each time for 20 min. After defatting, separate the microsphere 1 by centrifugation, filter the remaining material and evaporate the solvent to obtain defatted bitter almonds; the amount of microsphere 1 added is 5% of the mass of the bitter almonds.

[0104] S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 600W and 90℃ for 2 minutes.

[0105] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, stemona, golden osmanthus fragrans, mulberry leaf and processed bitter almond are mixed evenly, 3 times the amount of water is added to soak for 60 minutes, then boiled for 3 times, each time for 10 minutes, filtered, combined to obtain a water decoction, and rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 3 times the amount of water is added to soak for 60 minutes, then boiled for 3 times, each time for 10 minutes, filtered, combined the filtrate, mixed the filtrate with the medicinal liquid, added a flavoring agent and stirred evenly to obtain the Chinese medicine composition.

[0106] The flavoring agent includes stevioside and 11-O-mogroside V, the mass ratio of the two is 1:0.4, and the concentration of the flavoring agent added to the mixed solution of the filtrate and the drug solution is 10 mg / mL.

[0107] Example 9

[0108] The present embodiment provides a traditional Chinese medicine composition for treating asthma, which comprises the following raw materials by weight: 10 parts of dried tangerine peel, 10 parts of rose, 10 parts of sword bean, 10 parts of pinellia, 20 parts of sterculia lychnophora, 20 parts of bitter almond, 20 parts of stemona, 20 parts of loquat leaf, 16 parts of melon seeds, 16 parts of mulberry leaf and 200 parts of lean pork.

[0109] After rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannin. The preparation method of the gelatin microspheres includes the following steps:

[0110] (1) Gelatin, glycerin, and water are heated (70° C.) under stirring conditions according to a mass ratio of 1:6:20 to form a uniform gelatin solution 1. Porous ceramics (particle size 10-50 μm) are added to the gelatin solution 1 under heat preservation and stirring conditions. After standing for 10 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin. The amount of gelatin added is 10% of the mass of the porous ceramics.

[0111] (2) Take gelatin, add water and ceramide trihexyl glycoside, heat (70°C) under stirring conditions to form a uniform gelatin solution 2, spray the gelatin solution 2 uniformly onto the surface of the porous ceramic loaded with gelatin at 50°C, the amount of gelatin solution 2 sprayed is 6% of the mass of the porous ceramic loaded with gelatin, then continue to spray tannic acid solution (mass concentration is 2%), let it stand for 30 hours, then freeze-dry it at -20°C for more than 24 hours, finally wash it with ethanol (volume concentration 95%) and dry it to obtain gelatin-containing microspheres. The mass ratio of gelatin, water, ceramide trihexyl glycoside and tannic acid is 1:20:0.7:0.2.

[0112] The methods for removing tannins from rose and loquat leaves include:

[0113] Add 30 times the amount of water to the rose and loquat leaf raw materials, reflux and extract twice, each time for 80 minutes, filter, combine the extracts, and concentrate to 6 times the amount of the crude drug to obtain rose and loquat leaf extracts; add gelatin microspheres to the extracts, stir at room temperature for 10 minutes, then filter and take the filtrate. The amount of gelatin microspheres added is 10% of the total mass of the rose and loquat leaf medicinal materials.

[0114] The preparation method of bitter almonds includes the following steps:

[0115] S1. Pretreatment of gelatin-containing microspheres after tannin removal: Place the above-mentioned gelatin-containing microspheres after tannin removal in 30 times the amount of tannic acid aqueous solution (mass concentration of 4%) and stir to react until the tannic acid content in the solution remains unchanged, take out the microspheres, wash them with ethanol (volume concentration of 95%), and then soak them in clean water for 2 hours, then freeze-dry them at -20°C for more than 24 hours, and then wash them with clean water and ethanol (volume concentration of 95%) in turn for 4 times, and after drying, obtain microspheres 1 for use.

[0116] S2. Defatting of bitter almonds: grind the bitter almonds into 20-60 mesh and add them into 10 times amount of petroleum ether, then add microsphere 1, stir evenly and defatting in a 60°C water bath for 2 times, each time for 40 min. After defatting, separate the microsphere 1 by centrifugation, filter the remaining material and evaporate the solvent to obtain defatted bitter almonds; the amount of microsphere 1 added is 20% of the mass of the bitter almonds.

[0117] S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 800W and 70℃ for 3 minutes.

[0118] The preparation method of the Chinese medicine composition comprises the following steps: according to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, stemona, golden osmanthus fragrans, mulberry leaf and processed bitter almond are mixed evenly, 5 times the amount of water is added to soak for 30 minutes, then decocted twice, each time for 25 minutes, filtered, combined to obtain a water decoction, and rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, 5 times the amount of water is added to soak for 20 minutes, then decocted once, the time is 20 minutes, filtered, combined the filtrate, mixed the filtrate with the medicinal liquid, added a flavoring agent and stirred evenly, and the Chinese medicine composition is obtained.

[0119] The flavoring agent includes stevioside and 11-O-mogroside V, the mass ratio of the two is 1:0.7, and the concentration of the flavoring agent added to the mixed solution of the filtrate and the drug solution is 30 mg / mL.

[0120] Comparative Example 1

[0121] In this comparative example, gelatin microspheres were prepared according to the method in the literature - Hu Guanshi (Study on the Method of Removing Tannins from Chinese Herbal Medicine, 1991 (11)), and the gelatin microspheres were added to the rose and loquat leaf extracts of Example 2 of the present invention for tannin removal. The amount of gelatin microspheres added was calculated according to the amount of gelatin used in the gelatin microspheres in Example 2 of the present invention.

[0122] Comparative Example 2

[0123] The difference between this comparative example and Example 2 is that the method for preparing gelatin-containing microspheres does not include step (2).

[0124] Comparative Example 3

[0125] The difference between this comparative example and Example 2 is that the porous ceramic does not load gelatin, and the preparation method of gelatin-containing microspheres is as follows: gelatin is added with water, heated (50°C) under stirring conditions to form a uniform gelatin solution 2, and the gelatin solution 2 is uniformly sprayed on the surface of the porous ceramic at 45°C, and the amount of gelatin solution 2 sprayed is 4% of the mass of the porous ceramic, and then tannic acid solution (mass concentration is 3%) is continued to be sprayed, and after standing for 20 hours, it is placed in a -15°C environment for freeze drying for more than 24 hours, and finally washed and dried with ethanol (volume concentration 90%) to obtain gelatin-containing microspheres. The mass ratio of gelatin, water, and tannic acid is 1:15:0.15.

[0126] Comparative Example 4

[0127] The difference between this comparative example and Example 4 is that the preparation method of bitter almonds does not include steps S1 and S2, and microwave enzyme inactivation is directly performed.

[0128] Comparative Example 5

[0129] The difference between this comparative example and Example 4 is that the bitter almond preparation method does not include step S1, and the gelatin microspheres after tannin removal are not added during the defatting in step S2. In this case, step S2 is: defatting of bitter almonds: crush the bitter almond raw material to 20-60 mesh and add 6 times the amount of petroleum ether, stir and defatt in a 55°C water bath for 2 times, each time for 25 minutes, centrifuge and separate the microspheres 1 after defatting, filter the remaining material, and evaporate the solvent to obtain defatted bitter almonds.

[0130] Comparative Example 6

[0131] The difference between this comparative example and Example 4 is that the preparation method of bitter almonds does not include step S1 for pre-treating the gelatin-containing microspheres after tannin removal, and step S2 directly uses the gelatin-containing microspheres after tannin removal during degreasing. At this time, step S2 is: degreasing of bitter almonds: grind the bitter almond raw material to 20-60 mesh and add 6 times the amount of petroleum ether, then add the gelatin-containing microspheres after tannin removal, stir evenly and degrease in a 55°C water bath for 2 times, each time for 25 minutes, centrifuge and separate microspheres 1 after degreasing, filter the remaining material, and evaporate the solvent to obtain defatted bitter almonds; the amount of gelatin-containing microspheres after tannin removal is 12% of the mass of the bitter almond raw material.

[0132] Comparative Example 7

[0133] The difference between this comparative example and Example 4 is that the microwave treatment time in step S3 of the bitter almond processing method is 1.5 min.

[0134] Comparative Example 8

[0135] The difference between this comparative example and Example 4 is that the microwave treatment time in step S3 of the bitter almond processing method is 4 minutes.

[0136] Comparative Example 9

[0137] The difference between this comparative example and Example 5 is that the rose flower and loquat leaf are not subjected to tannin removal treatment.

[0138] 1. Acute toxicity test

[0139] Kunming mice weighing 20-24 g were selected and randomly divided into a drug administration group and a normal saline control group, with 10 mice in each group, half of which were male and half were female. The drug administration groups were respectively administered with the Chinese medicine compositions prepared in Examples 1-9 of the present invention, and the administration was performed by oral gavage, with the dosages being 30 g crude drug / kg, 25 g crude drug / kg, 15 g crude drug / kg, and 5 g crude drug / kg, respectively. The control group was given an equal amount of normal saline, and the experiment was repeated twice for each group. The death of the animals within 1 week after administration was observed, and the results showed that none of the animals died, and the animals had normal eating, behavioral activities, and body weight; the important organs such as the heart, liver, spleen, lungs, and kidneys were examined with the naked eye, and no abnormal changes were found. Dissection and histological examination of each organ were performed, and no abnormal pathological changes were found, and no acute toxic reaction to the mice was found.

[0140] 2. Efficacy test of Chinese medicine combination

[0141] Establishment of asthma model rats: Select SD rats weighing 200±20g, half male and half female; each rat was intraperitoneally injected with 1mL of physiological saline mixture containing 10mg OVA (ovalbumin) + 100mg aluminum hydroxide every day for 3 days; after feeding for 7 days, 1mL of physiological saline mixture containing 10mg OVA (ovalbumin) + 100mg aluminum hydroxide was injected again on the 8th day; after continuous feeding for 14 days, on the 15th day, the rats were placed in an environment containing ultrasonically atomized ovalbumin for 30 minutes to stimulate asthma attacks in rats. Once in the morning and evening every day, after 2 consecutive weeks, rats with asthma-like attacks were selected as asthma model rats. Successful stimulation was indicated by the appearance of cyanosis of the lips, abdominal muscle spasms, accelerated breathing, nodding breathing, or unstable standing.

[0142] Asthma treatment effect test: 170 asthma model rats established above were randomly divided into 17 groups, half male and half female, 10 rats in each group, including 16 drug administration groups (Chinese medicine compositions prepared in Examples 1-9 and Comparative Examples 1-7 of the present invention) and a model group; in addition, 10 SD rats with a normal body weight of 200±20g, half male and half female, were selected as a normal control group. The drug administration group was gavaged with the Chinese medicine compositions prepared in Examples 1-9 and Comparative Examples 1-7 at a dose of 5g crude drug / kg per day; the model group and the normal control group were gavaged with an equal amount of physiological saline. After continuous gavage for 2 weeks, the respiratory rate of rats in each group was counted, and the results are shown in Table 1.

[0143] Table 1

[0144]

[0145]

[0146] As shown in Table 1, the respiratory rate of the rats in the model group was significantly higher than that in the normal control group, indicating that the asthma model rats were successfully constructed. The respiratory rate of the rats in Examples 1-9 was significantly lower than that in the model group, indicating that the Chinese medicine composition of the present invention has a good effect in treating asthma.

[0147] On the basis of Example 1, Example 2 removes tannins from the medicinal materials rose and loquat leaves to reduce tannin interference. As a result, the respiratory rate is significantly reduced, indicating an improvement in the effect of treating asthma. On the basis of Example 2, Example 3 adds ceramide trihexoside when preparing gelatin microspheres, and the efficacy is further improved. On the basis of Example 3, Example 4 also uses a specific method to prepare bitter almonds to kill enzymes and preserve glycosides, and the effect of treating asthma is further improved. On the basis of Example 4, Examples 5-9 add flavoring agents containing stevioside and mogroside. Since mogroside itself has the effects of moistening the lungs and relieving cough, anti-inflammatory and antibacterial, the respiratory rate is further reduced, indicating an improvement in efficacy.

[0148] Compared with Example 1, Comparative Examples 1-3 changed the gelatin microspheres used for removing tannins, and compared with Example 4, Comparative Examples 4-8 changed the preparation methods of bitter almonds respectively. As a result, the respiratory rate of rats increased, indicating that the efficacy of the drug was reduced. Comparative Example 9 added a flavoring agent without removing tannins from rose flowers and loquat leaves. The flavoring agent interacted with tannins and affected the efficacy of the drug. As a result, the respiratory rate of rats increased, indicating that the efficacy of the drug was reduced.

[0149] 3. Tannin removal effect of gelatin microspheres of the present invention

[0150] The tannin removal treatment was performed on the medicinal materials rose flower and loquat leaf using the methods of Examples 2 and 3 of the present invention and Comparative Examples 1-3. The tannin removal rate and the loss rate of the active ingredient in the medicinal solution after tannin removal were measured. The results are shown in Table 2.

[0151] Here, the tanning removal rate = 100% × (the amount of tannin contained in the solution after tannin removal - the amount of tannin contained in the solution before tannin removal) / the amount of tannin contained in the solution before tannin removal.

[0152] Table 2

[0153] Group Detanning rate (%) Total flavonoid loss rate (%) Triterpene acid loss rate (%) Example 2 95.4 0.31 0.25 Example 3 99.3 0.20 0.17 Comparative Example 1 92.2 0.35 0.30 Comparative Example 2 54.8 1.24 0.89 Comparative Example 3 71.3 0.45 0.36

[0154] As can be seen from Table 2, the tannin removal rate of the medicinal materials rose and loquat leaves was 95.4-99.3% when the methods of Examples 2 and 3 of the present invention were used to remove tannins, and the total flavonoid loss rate and triterpene acid loss rate were in the range of 0.20-0.31% and 0.17-0.25%, respectively, showing a good tannin removal effect, less loss of effective ingredients, and better selectivity for tannin removal.

[0155] On the basis of Example 2, Example 3 added ceramide trihexyl glycoside when preparing gelatin-containing microspheres, and the tannin removal effect was further improved. Compared with Example 2, Comparative Examples 1-3 changed the gelatin-containing microspheres used for tannin removal, and the tannin removal effect was reduced and the loss of effective ingredients was also increased. Among them, under the same gelatin usage, the tannin removal effect of Comparative Example 1 is not as good as that of Example 2, indicating the high efficiency of tannin removal of the gelatin-containing microspheres of the present invention.

[0156] 4. The processing effect of bitter almonds of the present invention

[0157] 1. Degreasing effect

[0158] The bitter almonds of the medicinal material were defatted by the methods of Example 4 of the present invention and Comparative Examples 5 and 6. The defatting rate was calculated by measuring the oil content of the bitter almonds before and after defatting, and the oxidative rancidity of the oil during the defatting process was evaluated by measuring the peroxide value (POV) and acid value of the oil after defatting. The results are shown in Table 3.

[0159] Among them, the defatting rate = 100% × (the oil content of bitter almonds after defatting - the oil content of bitter almonds before defatting) / the oil content of bitter almonds before defatting.

[0160] Table 3

[0161]

[0162] It can be seen from Table 2 that, compared with Comparative Examples 5 and 6, the method of Example 4 of the present invention is used to defatted bitter almonds, and the degreasing rate is high, and the peroxide value and acid value are both low, which reduces the oxidation and rancidity of the oil, reduces the possibility of its impact on the quality of bitter almonds, and ensures stability.

[0163] 2. Final processing effect

[0164] The bitter almonds were processed by the methods of Examples 4, 8, 9 of the present invention and Comparative Examples 4-8, and the enzyme inactivation rate, the amygdalin content and the protein content in the processed bitter almonds were determined. The results are shown in Table 4.

[0165] Wherein, the enzyme inactivation rate = 100% × (amygdalin activity before enzyme inactivation - amygdalin activity after enzyme inactivation) / amygdalin activity before enzyme inactivation. The amygdalin activity was determined by the dinitrosalicylic acid (DNS) method.

[0166] Table 4

[0167]

[0168]

[0169] From the results in Table 4, it can be seen that the methods for processing bitter almonds in Examples 4, 8 and 9 of the present invention have better effects of inactivating enzymes and preserving amygdalin, with an enzyme inactivation rate of 99.1-99.2% and amygdalin content of 4.24-4.25, which has very little loss compared to raw bitter almonds and less protein loss.

[0170] Compared with Example 4, Comparative Examples 4-8 changed the bitter almond processing method, so that the enzyme inactivation rate, amygdalin content, and protein content were affected to varying degrees.

[0171] V. Taste evaluation test of the Chinese medicine composition of the present invention

[0172] The taste evaluation test of the Chinese medicine compositions prepared in Examples 4-9 of the present invention and Comparative Example 9 was conducted using a volunteer sensory evaluation method. The results are shown in Table 5.

[0173] 1. Volunteer screening

[0174] Aged 22 to 28 years old, with normal taste, no severe allergies, genetic disease history, no cholecystitis, no bad habits, no recent medical history, no drinking or smoking 1 day before the experiment, fasting but not drinking water 1 hour before the experiment. Quinine sulfate, tannic acid, citric acid, salt, and sucrose were used to prepare bitter, astringent, sour, salty, and sweet solutions. Volunteers randomly tasted the three samples. If they were completely correct, they passed the test and conducted a formal sensory evaluation experiment. A total of 35 qualified volunteers (half male and half female) were screened.

[0175] 2. Volunteers’ taste evaluation

[0176] 35 volunteers who passed the screening were randomly divided into 7 groups, 5 people in each group, and the taste of the Chinese medicine compositions prepared in Examples 4-9 and Comparative Example 9 was evaluated. The volunteers took 20 mL of the sample solution of the Chinese medicine composition and put it in their mouths. During this time, the mouth was rinsed so that the tongue and mouth could fully feel the taste of the medicine. After 15 seconds of the sample entering the mouth, the bitterness, astringency, sourness, spiciness, and sweetness were scored. The total score was 1-10 points (tasteless: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-9 points, severe: 10 points). The higher the score, the heavier the taste of the sample.

[0177] Table 5

[0178]

[0179]

[0180] As shown in Table 5, compared with Example 4, after adding the flavor corrector to the traditional Chinese medicine composition, the bitterness, astringency and sourness of Examples 5-9 were significantly improved, and a significant sweetness was also introduced. Among them, the taste improvement of Examples 5, 8 and 9 was better.

[0181] Compared with Example 5, in Comparative Example 9, flavoring agents were added without removing tannin from rose flowers and loquat leaves. The flavoring agents interacted with tannins and affected the taste improvement, making the taste improvement worse.

[0182] 6. Shelf life of the Chinese medicine composition of the present invention

[0183] The Chinese medicine compositions prepared in Examples 4-9 of the present invention were made into decoctions according to conventional methods, vacuum-packed in conventional bags, and then refrigerated at 0-5°C. According to the microbial limit test method in the pharmacopoeia, samples were taken regularly for inspection to determine the shelf life of the Chinese medicine compositions. The statistical results are shown in Table 6.

[0184] Table 6

[0185] Group Shelf life (days) Example 4 15 Example 5 21 Example 6 16 Example 7 15 Example 8 21 Example 9 21

[0186] As shown in Table 6, compared with Example 4, after adding the flavoring agent containing stevioside and 11-O-mogroside V to the Chinese medicine composition in Examples 5, 8, and 9, the shelf life of the Chinese medicine composition is significantly extended. Compared with Example 5, Examples 6 and 7 use other types of mogrosides, and the shelf life improvement effect is not obvious.

Claims

1. A Chinese medicine composition for treating asthma, Features: The ingredients include the following by weight: 2-10 parts of dried tangerine peel, 2-10 parts of rose, 2-10 parts of sword bean, 2-10 parts of pinellia, 4-20 parts of sterculia lychnophora, 4-20 parts of bitter almond, 4-20 parts of stemona, 4-20 parts of loquat leaf, 3-16 parts of melon seeds, 3-16 parts of mulberry leaf and 40-200 parts of lean pork; After the rose and loquat leaves are extracted with water, gelatin microspheres are added to the extract to remove tannins. The preparation method of the gelatin microspheres comprises the following steps: (1) Gelatin, glycerin and water are heated under stirring conditions to form a uniform gelatin solution 1, porous ceramics are added to the gelatin solution 1 under heat preservation and stirring conditions, and after standing for 5-10 minutes, the solution is concentrated under reduced pressure until there is no free liquid outside the porous ceramics, and then dried to obtain porous ceramics loaded with gelatin; (2) Add water to gelatin and heat it under stirring to form a uniform gelatin solution 2. Spray the gelatin solution 2 evenly onto the surface of the porous ceramic loaded with gelatin at 40-50°C. Then continue to spray the tannic acid solution. After standing for 10-30 hours, freeze-dry the solution. Finally, wash with ethanol and dry the solution to obtain gelatin-containing microspheres.

2. The Chinese medicine composition according to claim 1, Features: In step (1), the mass ratio of gelatin, glycerin and water is 1: (3-6): (10-20), the amount of gelatin added is 5-10% of the mass of the porous ceramic, and the particle size of the porous ceramic is 10-50 μm.

3. The Chinese medicine composition according to claim 1, Features: When gelatin is taken and water is added in step (2), ceramide trihexoside is also added, and the mass ratio of gelatin, water, ceramide trihexoside and tannic acid is 1: (10-20): (0.4-0.7): (0.08-0.2), the injection amount of gelatin solution 2 is 3-6% of the mass of the porous ceramic loaded with gelatin, and the mass concentration of tannic acid solution is 2-5%.

4. The Chinese medicine composition according to claim 1, Features: The method for removing tannin from rose and loquat leaves comprises: adding water to rose and loquat leaf raw materials, refluxing and extracting for 2-4 times, filtering, combining extracts, and concentrating to obtain rose and loquat leaf extracts; adding gelatin microspheres to the extracts, stirring at room temperature for 10-20 minutes, and then filtering to obtain filtrate; the amount of gelatin microspheres added is 5-10% of the total mass of the rose and loquat leaf medicinal materials.

5. A method for processing bitter almonds in the traditional Chinese medicine composition according to claim 1, Features: The following steps are involved: S1. Pretreatment of the gelatin-containing microspheres after tannin removal: placing the gelatin-containing microspheres after tannin removal in a tannic acid aqueous solution and stirring to react until the tannic acid content in the solution remains unchanged, taking out the microspheres, washing them with ethanol, and then soaking them in clean water for 0.5-2h, followed by freeze drying, and then washing with clean water and ethanol in turn, and drying to obtain microspheres 1 for standby use; S2. Defatting of bitter almonds: grind the bitter almonds and add them into petroleum ether, then add microspheres 1, stir evenly and defatting in a 50-60°C water bath for 2-3 times, each time for 20-40 minutes. After defatting, centrifuge to separate microspheres 1, filter the remaining material, evaporate the solvent and obtain defatted bitter almonds; S3. Microwave inactivation of enzymes: Put defatted bitter almonds into a microwave oven and microwave them at 600-800W and 70-90℃ for 2-3 minutes.

6. The preparation method according to claim 5, Features: In step S2, the amount of petroleum ether added each time for defatting is 3-10 times the mass of the bitter almond raw material, and the amount of microspheres 1 added is 5-20% of the mass of the bitter almond raw material.

7. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, Features: The following steps are involved: According to the formula, tangerine peel, sword bean, pinellia, sterculia lychnophora, bitter almond, stemona, golden osmanthus fragrans and mulberry leaves are mixed evenly, soaked in water and boiled to obtain a decoction, and the rose and loquat leaf extracts after tannin removal are added, and stirred evenly to obtain a medicinal liquid; according to the formula, lean pork is washed, soaked in water and boiled, filtered, and the filtrate is mixed with the medicinal liquid to obtain the Chinese medicine composition.

8. The method for preparing the Chinese medicine composition according to claim 7, Features: The preparation method further comprises: mixing the filtrate with the medicinal solution, adding a flavoring agent and stirring evenly to obtain the Chinese medicine composition; The flavoring agent includes stevioside and mogroside, and the mass ratio of the two is 1:(0.4-0.7). The mogroside is any one or more of 11-O-mogroside V, mogroside V, mogroside VI, mogroside III, and mogroside IV. The added concentration of the flavoring agent is 10-30 mg / mL.

9. The method for preparing the Chinese medicine composition according to claim 8, Features: The mogroside is 11-O-mogroside V.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in preparing a drug for treating asthma.

Images