Traditional Chinese medicine composition for respiratory system and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for a respiratory system and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 200 to 400 parts of herba ephedrae, 400 to 600 parts of radix scutellariae, 350 to 550 parts of semen armeniacae amarae, 200 to 300 parts of rhizoma chuanxiong, 300 to 400 parts of herba taxilli, 150 to 250 parts of fructus psoraleae, 100 to 200 parts of cortex cinnamomi, 100 to 200 parts of liquorice root and 300 to 600 parts of rhizoma pinellinae praeparata. The preparation method comprises the following steps: weighing materials, decocting for the first time, carrying out enzymolysis, decocting for the second time, later adding, concentrating, integrating, granulating and the like. The traditional Chinese medicine composition provided by the invention is mainly used for freeing lung and relieving asthma, warming kidney and absorbing qi and simultaneously treating qi and blood, and can be used for treating respiratory system diseases such as deficiency in root and excess in superficies, phlegm and blood stasis and the like through precise compatibility of monarch, minister, assistant and guide by virtue of precise compatibility of monarch, minister, assistant and guide.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for respiratory system and a preparation method thereof. Background Art

[0002] The main organ associated with respiratory diseases is the lung. Traditional Chinese medicine believes that the lung is a "delicate organ" that is easily invaded by internal and external evil spirits: external evils such as wind evil invasion, often mixed with cold, heat, and dryness, can cause exogenous cough or asthma; dry evil invasion, in autumn, can easily damage the lung fluid, leading to dry cough and dry throat; cold evil invasion, can stagnate the qi, leading to white and thin sputum, chest tightness; hot evil invasion, refining liquid into sputum, can cause yellow sputum and fever. Internal injuries such as fatigue and long-term illness can lead to lung, spleen and kidney deficiency, and weak defense. In general, traditional Chinese medicine believes that the core pathogenesis of lung diseases lies in abnormal descending and qi disorder. When treating, it is necessary to distinguish between deficiency and excess, cold and heat, and take into account both eliminating evil and strengthening the body.

[0003] At present, in the treatment of lung and related diseases, common prescriptions in traditional Chinese medicine include Qingfei Paidu Decoction, Ma Xing Shi Gan Decoction, Bufei Decoction and Xiaoqinglong Decoction, while commonly used drugs in Western medicine include antibiotics, bronchodilators, glucocorticoids, antiviral drugs, etc.

[0004] However, Western medicine has the disadvantage of large toxic and side effects during use, such as drug resistance caused by abuse of antibiotics, palpitations and tremors caused by bronchodilators, and osteoporosis caused by hormone use. Traditional Chinese medicine prescriptions only focus on the therapeutic effect of a certain aspect, such as focusing on relieving cough and reducing phlegm, ignoring other pathological or drug side effects. For example, the Chinese invention patent with the authorization announcement number CN100450514C provides a Chinese patent medicine for treating acute exacerbation of bronchial asthma, which is composed of 8 medicinal materials including ephedra, scutellaria, bitter almond, coltsfoot flower, French pinellia, cinnamon, licorice and wolfberry, and has the effects of relieving lung and relieving asthma, reducing phlegm and lowering adverse reactions. However, although wolfberry has the effect of tonifying liver and kidney, it will increase the viscosity of sputum, which is unfriendly to patients with chronic obstructive pulmonary disease (COPD). At the same time, traditional Chinese medicine preparation processes such as water decoction will cause the loss of volatile oil in the medicinal materials, making the composition of the finished drug unstable. Summary of the invention

[0005] The invention provides a Chinese medicine composition for the respiratory system and a preparation method thereof, which are used to solve the problems that the existing Chinese medicine prescriptions have a single efficacy and backward preparation process when treating diseases related to the respiratory system.

[0006] The invention provides a traditional Chinese medicine composition for respiratory system. The traditional Chinese medicine composition is composed of the following raw materials in proportion by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almonds, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice and 300-600 parts of pinellia tuber.

[0007] Optionally, the Chinese medicine composition for the respiratory system is composed of the following raw materials in the following weight proportions: 250-350 parts of ephedra, 400-500 parts of scutellaria, 350-450 parts of bitter almonds, 230-270 parts of chuanxiong, 330-370 parts of mistletoe, 180-220 parts of psoralea corylifolia, 130-170 parts of cinnamon, 130-170 parts of licorice, and 400-500 parts of pinellia.

[0008] Optionally, the Chinese medicine composition for the respiratory system is composed of the following raw materials in the following weight proportions: 300 parts of ephedra, 450 parts of scutellaria, 400 parts of bitter almonds, 250 parts of chuanxiong, 350 parts of mistletoe, 200 parts of psoralea corylifolia, 150 parts of cinnamon, 180 parts of licorice, and 450 parts of pinellia.

[0009] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0010] (1) Weigh the following raw materials in parts by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almond, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice, and 300-600 parts of pinellia tuber;

[0011] (2) First decoction: Take cinnamon bark and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil at 80°C for 30 minutes, collect volatile oil by condensation and reflux, filter the remaining material, and obtain the residue and the first decoction residue;

[0012] (3) Enzymatic hydrolysis: Take Ephedra, Scutellaria, Psoralea corylifolia, Pinellia ternata and Morus alba, adjust their water content to 40-50%, and evenly spread enzyme powder on the surface of the medicinal materials for enzymatic hydrolysis;

[0013] (4) Second decoction: Combine the residue obtained from the first decoction with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and moss parasite, add the decoction liquid and decoct twice, with the decoction time being 1 hour and 0.5 hours respectively;

[0014] (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 90-95°C. After the decoction is completed, filter the residue to obtain the medicine solution;

[0015] (6) Concentrating the medicinal liquid: The residual liquid of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with a drying aid for concentration. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.20-1.25;

[0016] (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring;

[0017] (8) Granulation: Take 20% of the weight of the concentrate of microcrystalline cellulose and put it into a fluidized bed granulator. Preheat it to 40°C. Spray the concentrate mixed with volatile oil and micro-powdered silica gel into the fluidized bed as a spray liquid to obtain wet granules. After granulation, dry it.

[0018] Optionally, the dosage ratio of β-cyclodextrin inclusion solution to cinnamon bark and Chuanxiong is (8-10):1, that is, 8-10 L of β-cyclodextrin inclusion solution is used for every 1 kg of medicinal materials.

[0019] Optionally, the enzymolysis temperature is 45° C., the enzymolysis time is 1 h, and the pH required for the enzymolysis is 5.0-5.5.

[0020] Optionally, the enzyme powder comprises cellulase and xylanase in a mass ratio of 1:1, and the mass of the cellulase and xylanase is 0.1% of the sum of the mass of Ephedra, Scutellaria, Psoralea corylifolia, Pinellia ternata and Morus alba.

[0021] Optionally, the decoction in the second decoction is a choline-lactic acid-water solution, the molar ratio of choline to lactic acid is 1:2, the amount of water in the second decoction is 8-10 times the amount of medicinal materials in the second decoction, and the amount of choline and lactic acid added is 1% of the volume of the water used for the second decoction.

[0022] Optionally, the drying aid in the concentrated drug solution is maltodextrin, and the amount used is 1% of the total mass of the combined drug solution.

[0023] Optionally, during the granulation process, the liquid spraying rate is 15 ml / min, the air inlet temperature is 60° C., and after the liquid spraying is completed, the liquid is dried by fluidized drying at 60° C. until the moisture content is ≤5%.

[0024] The beneficial effects of the Chinese medicine composition for the respiratory system and the preparation method thereof provided by the present invention include: 1. The Chinese medicine composition takes the functions of clearing the lungs and relieving asthma as the main purpose, warming the kidneys and absorbing qi as the main purpose, and treating qi and blood as the pivot. Through the precise combination of monarch, minister, assistant and guiding ingredients, it can be used for respiratory diseases such as COPD, asthma, pulmonary fibrosis, etc., which are caused by deficiency in the root and excess in the superficial part, and phlegm and blood stasis.

[0025] 2. By introducing three medicinal materials, namely, Psoralea corylifolia, Ligusticum chuanxiong and Viscum album, Psoralea corylifolia can warm the kidney and absorb qi. The psoralen contained in Psoralea corylifolia can regulate the Th1 / Th2 immune balance and has the effects of anti-inflammatory and maintaining the balance of the immune system; Ligusticum chuanxiong can promote blood circulation and qi circulation. The ligustrazine contained in Ligusticum chuanxiong can improve pulmonary microcirculation and reduce pulmonary hypertension; Viscum album can eliminate rheumatism and nourish the liver and kidney. The flavonoids contained in Viscum album can inhibit the expression of NF-κB pathway, thereby reducing the inflammatory response; at the same time, the quercetin in Viscum album can also stop the rapid heart rate caused by ephedrine, and Psoralen polysaccharide can relieve the irritation of Pinellia ternata to the gastrointestinal tract.

[0026] 3. During the preparation process, β-cyclodextrin inclusion solution is used for decoction. The hydrophobic cavity of β-cyclodextrin can include volatile oil components such as cinnamaldehyde and ligustrazine to form a stable complex, thereby reducing the volatilization loss during light, oxidation and high-temperature decoction.

[0027] 4. By enzymolyzing the medicinal materials with cellulase and xylanase before the second decoction, the precipitation of effective ingredients in the medicinal materials is improved, the subsequent decoction time is shortened, and the damage to the effective ingredients caused by high-temperature decoction is reduced.

[0028] 5. By using choline-lactic acid-water solution as the decoction liquid for the second decoction, the dissolution amount of baicalin, psoralen and other ingredients can be increased, thereby increasing the content of the active ingredients in the finished drug. At the same time, the eutectic solvent is weakly acidic, which can inhibit the activity of amygdalinase and reduce the content of its hydrolysis product, hydrocyanic acid, to reduce the toxicity of the drug. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention is clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work also fall within the scope of protection of the present invention.

[0030] The invention provides a traditional Chinese medicine composition for respiratory system, which is characterized by being composed of the following raw materials in proportion by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almonds, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice and 300-600 parts of pinellia tuber.

[0031] The properties and flavors of each medicinal material in the Chinese medicine composition provided by the present invention are as follows:

[0032] Ephedra: pungent, slightly bitter, warm. Enters the lung and bladder meridians. Has the effects of sweating, relieving exterior symptoms, and promoting lung function and relieving asthma.

[0033] Scutellaria baicalensis: bitter, cold. Enters the lung, gallbladder, spleen, and large intestine meridians. Has the effects of clearing away heat and dampness, purging fire and detoxifying.

[0034] Bitter almond: bitter, slightly warm. Enter the lung and large intestine meridians. It has the effects of relieving cough and asthma, moistening the intestines and promoting bowel movements.

[0035] French Pinellia: pungent, warm. Enters the spleen, stomach, and lung meridians. Has the effects of drying dampness and resolving phlegm, and relieving adverse reactions and vomiting.

[0036] Cinnamon: pungent, sweet, very hot. Enters the kidney, spleen, heart, and liver meridians. It has the effect of replenishing fire and yang, and guiding fire back to the origin.

[0037] Licorice: sweet, neutral. Enters the heart, lung, spleen, and stomach meridians. Has the effect of tonifying the spleen and replenishing qi, and harmonizing various medicines.

[0038] Psoralea corylifolia: pungent, bitter, warm. Enters the kidney and spleen meridians. Has the effects of warming the kidney and supporting yang, absorbing qi and relieving asthma.

[0039] Chuanxiong: pungent, warm. Enters the gallbladder, liver, and pericardium meridians. Has the effects of promoting blood circulation, promoting qi, dispelling wind and relieving pain.

[0040] Mulberry parasite: bitter, sweet, neutral. Enters the liver and kidney meridians. Has the effects of removing rheumatism, nourishing the liver and kidneys, and strengthening the tendons and bones.

[0041] Among them, ephedra promotes lung function and relieves exterior symptoms, and is combined with scutellaria to clear and purge interior heat, targeting symptoms of exterior cold that has not been resolved and lung heat that is stagnant. Bitter almonds lower lung qi, and together with ephedra, they form a one-promoting and one-lowering effect, regulating lung qi stagnation, relieving cough and asthma. Banxia dries dampness and resolves phlegm, and is combined with scutellaria to clear heat, clearing heat and resolving phlegm, and is used for cough and asthma caused by phlegm-heat blocking the lungs. Chuanxiong promotes qi and blood circulation, helps ephedra to open the orifices, and relieves headaches and body pain caused by exogenous wind and cold. The combination of mistletoe nourishes the liver and kidneys, psoralea corylifolia warms kidney yang, and cinnamon leads fire back to the origin can not only target kidney yang deficiency, but also restrain the disadvantages of scutellaria's bitter and cold nature that damages yang. Licorice harmonizes the cold and hot properties of various drugs, relieves the harshness of ephedra and pinellia, and also nourishes the middle jiao. Overall, through the complex combination of relieving exterior symptoms and clearing the interior, warming the lower and clearing the upper, it takes into account both exogenous and internal injuries, and is suitable for complex symptoms of mixed cold and heat, and lung and kidney diseases.

[0042] The Chinese medicine composition provided by the present invention also has the compatibility characteristics of using both cold and warm, regulating both ascending and descending, and attacking and tonifying at the same time. Using both cold and warm means that ephedra and cinnamon warm and promote circulation, scutellaria and apricot kernel clear heat, and balance the contradiction between cold on the surface and heat on the inside. Regulating both ascending and descending means that ephedra ascends and disperses, apricot kernel and pinellia tuber descend the adverse, and restore the lung qi to descend. Attacking and tonifying at the same time means the combination of expelling evil and strengthening the body, which is suitable for mixed deficiency and excess syndromes (expelling evil means dispelling the exterior, clearing heat and resolving phlegm, and strengthening the body means warming the kidney and tonifying the liver).

[0043] In traditional treatment of lung diseases and respiratory diseases, the emphasis is mostly on "the lungs are the master of qi", while "the kidneys are the root of qi" is ignored. For example, chronic obstructive pulmonary disease (COPD) has the characteristic of kidney failure to receive qi in the interpretation of traditional Chinese medicine, but traditional prescriptions often ignore this point. The Chinese medicine composition provided by the present invention focuses on warming kidney yang, promoting lung qi, and regulating the middle jiao, achieving lung and kidney treatment, wherein the warming kidney and qi receiving effect of psoralea corylifolia is consistent with the kidney failure to receive qi in COPD.

[0044] From the perspective of traditional Chinese medicine, ephedra is the main drug in the formula, which works on lung qi congestion. Scutellaria baicalensis and psoralea corylifolia are assistant drugs; Scutellaria baicalensis restrains ephedra's warming and dryness, and cooperates with anti-inflammatory; psoralea corylifolia warms the kidney and absorbs qi, and replenishes fire and helps yang. Bitter almond, Pinellia ternata, Chuanxiong, and Viscum album are adjuvant drugs. Bitter almond helps ephedra to promote and descend, relieve cough and asthma; Pinellia ternata can achieve the effects of drying dampness and resolving phlegm, descending adverse and dispersing knots for phlegm and dampness congestion in the lungs; Chuanxiong treats qi and blood at the same time, preventing lung collaterals from stasis; Viscum album resists fibrosis, nourishes the liver and kidney, and consolidates the innate foundation. Cinnamon and licorice are guiding drugs. Cinnamon leads all drugs into the kidney to prevent the false yang from floating; licorice alleviates the harshness of ephedra, detoxifies and protects the stomach. The Chinese medicine composition provided by the present invention has the functions of clearing the lungs and relieving asthma as the main purpose, warming the kidneys and absorbing qi as the main purpose, and treating qi and blood as the pivot. Through the precise combination of monarch, minister, assistant and guiding ingredients, it can be used for chronic lung diseases such as COPD, asthma, pulmonary fibrosis, etc., in which the main cause is deficiency and the superficial part is excess, and phlegm and blood stasis are intertwined.

[0045] Furthermore, the invention is composed of the following raw materials in proportion by weight: 250-350 parts of ephedra, 400-500 parts of scutellaria, 350-450 parts of bitter almond, 230-270 parts of chuanxiong, 330-370 parts of mistletoe, 180-220 parts of psoralea corylifolia, 130-170 parts of cinnamon bark, 130-170 parts of liquorice, and 400-500 parts of pinellia.

[0046] Furthermore, it is composed of the following raw materials in the following weight proportions: 300 parts of ephedra, 450 parts of scutellaria, 400 parts of bitter almonds, 250 parts of chuanxiong, 350 parts of mistletoe, 200 parts of psoralea corylifolia, 150 parts of cinnamon, 180 parts of liquorice, and 450 parts of pinellia.

[0047] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0048] (1) Weigh the following raw materials in parts by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almond, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice, and 300-600 parts of pinellia tuber;

[0049] (2) First decoction: Take cinnamon bark and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil at 80°C for 30 minutes, collect volatile oil by condensation and reflux, filter the remaining material, and obtain the residue and the first decoction residue;

[0050] (3) Enzymatic hydrolysis: Take Ephedra, Scutellaria, Psoralea corylifolia, Pinellia ternata and Morus alba, adjust their water content to 40-50%, and evenly spread enzyme powder on the surface of the medicinal materials for enzymatic hydrolysis;

[0051] (4) Second decoction: Combine the residue obtained from the first decoction with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and moss parasite, add the decoction liquid and decoct twice, with the decoction time being 1 hour and 0.5 hours respectively;

[0052] (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 90-95°C. After the decoction is completed, filter the residue to obtain the medicine solution;

[0053] (6) Concentrating the medicinal liquid: The residual liquid of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with a drying aid for concentration. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.20-1.25;

[0054] (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring;

[0055] (8) Granulation: Take 20% of the weight of the concentrate of microcrystalline cellulose and put it into a fluidized bed granulator. Preheat it to 40°C. Spray the concentrate mixed with volatile oil and micro-powdered silica gel into the fluidized bed as a spray liquid to obtain wet granules. After granulation, dry it.

[0056] Furthermore, the dosage ratio of the β-cyclodextrin inclusion solution to cinnamon bark and Chuanxiong is (8-10):1, that is, 8-10 L of β-cyclodextrin inclusion solution is used for every 1 kg of medicinal materials.

[0057] The hydrophobic cavity of β-cyclodextrin can include volatile oil components such as cinnamaldehyde and ligustrazine to form a stable complex, thereby reducing the volatility loss during light, oxidation and high-temperature decoction.

[0058] Further, the enzymolysis temperature is 45°C, the enzymolysis time is 1 hour, and the required pH for enzymolysis is 5.0-5.5. Further, the enzyme powder includes cellulase and xylanase in a mass ratio of 1:1, and the mass of the cellulase and xylanase is 0.1% of the sum of the mass of ephedra, scutellaria, psoralea corylifolia, pinellia ternata and loranthus parasiticus.

[0059] Cellulase and xylanase can synergistically decompose cellulose and hemicellulose in plant cell walls, thereby increasing the release rate of intracellular components. And because enzymatic hydrolysis is performed first, the precipitation of active ingredients in the medicinal materials is increased, which shortens the subsequent decoction time, thereby reducing the damage to the active ingredients caused by high-temperature decoction.

[0060] During enzymatic hydrolysis, citric acid is used to adjust the pH of the medicinal material to be hydrolyzed to a weak acidity of 5.0-5.5. In this range, cellulase and xylanase can maintain a high activity, which is conducive to the enzymatic hydrolysis (it should be noted that the medicinal material to be hydrolyzed is often a neutral or weak alkaline system).

[0061] Furthermore, the decoction in the second decoction is a choline-lactic acid-water solution, the molar ratio of choline to lactic acid is 1:2, the amount of water in the second decoction is 8-10 times the amount of medicinal materials in the second decoction, and the amount of choline and lactic acid added is 1% of the volume of the water used for the second decoction.

[0062] Choline and lactic acid can form a eutectic solvent, which can increase the solubility of baicalin, psoralen and other ingredients through hydrogen bonding, thereby increasing the content of active ingredients in the finished drug. At the same time, the eutectic solvent is weakly acidic, which can inhibit the activity of amygdalinase and reduce the content of its hydrolysis product, hydrocyanic acid, to reduce the toxicity of the drug.

[0063] Furthermore, the drying aid in the concentrated drug solution is maltodextrin, and the dosage is 1% of the total mass of the combined drug solution.

[0064] Furthermore, during the granulation process, the liquid spraying rate is 15 ml / min, the air inlet temperature is 60° C., and after the liquid spraying is completed, the liquid is dried by fluidization at 60° C. until the moisture content is ≤5%.

[0065] The present invention is further described in detail below in conjunction with specific embodiments.

[0066] Example 1

[0067] A Chinese medicine composition for the respiratory system comprises the following raw materials in proportion by weight: 200 parts of ephedra, 400 parts of scutellaria, 350 parts of bitter almonds, 200 parts of chuanxiong, 300 parts of mistletoe, 150 parts of psoralea corylifolia, 100 parts of cinnamon bark, 100 parts of liquorice, and 300 parts of pinellia ternata (the above proportions by weight are in grams, and the other embodiments and comparative examples are the same).

[0068] The preparation process of the above-mentioned Chinese medicine composition is as follows:

[0069] (1) Weigh the raw materials according to the above components;

[0070] (2) First decoction: Take cinnamon and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil slightly at 80°C for 30 minutes, collect volatile oil by condensation reflux, filter the remaining material to obtain drug residue and first decoction residual liquid, the ratio of the mass of β-cyclodextrin inclusion solution to the sum of the mass of cinnamon and Chuanxiong is 8:1;

[0071] (3) Enzymatic hydrolysis: Take ephedra, scutellaria, psoralea corylifolia and loranthus, adjust their water content to 40%, and evenly spread enzyme powder composed of cellulase and xylanase in a mass ratio of 1:1 on the surface of the medicinal materials for enzymatic hydrolysis, wherein the mass of cellulase and xylanase is 0.1% of the sum of the mass of ephedra, scutellaria, psoralea corylifolia and loranthus, and adjust the pH value of the wet medicinal material system to 5.0 with citric acid during enzymatic hydrolysis. The temperature during enzymatic hydrolysis is 45°C and the enzymatic hydrolysis time is 1 h;

[0072] (4) Second decoction: the residue obtained from the first decoction is combined with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and mistletoe, and decocted twice with a choline-lactic acid-water solution as the decoction liquid. The decoction time is 1 hour and 0.5 hours respectively. The molar ratio of choline to the lactic acid in the decoction liquid is 1:2. The amount of water used in the second decoction is 8 times the amount of the medicinal materials used in the second decoction. The amount of choline and lactic acid added is 1% of the volume of the water used in the second decoction.

[0073] (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 90°C. After the decoction is completed, filter the residue to obtain the medicine solution;

[0074] (6) Concentrating the medicinal solution: The residual solution of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with the drying agent maltodextrin for concentration. The amount of maltodextrin is 1% of the total mass of the combined medicinal solution. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.20;

[0075] (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring;

[0076] (8) Granulation: 20% of the weight of the concentrate of microcrystalline cellulose was put into a fluidized bed granulator, preheated to 40°C, and the concentrate mixed with volatile oil and micro-powdered silica gel was sprayed into the fluidized bed at a rate of 15 ml / min. The inlet air temperature was 60°C to obtain wet granules. After granulation, the granules were fluidized and dried at 60°C until the moisture content was ≤5%.

[0077] Example 2

[0078] A Chinese medicine composition for the respiratory system comprises the following raw materials in proportion by weight: 400 parts of ephedra, 600 parts of scutellaria, 550 parts of bitter almonds, 300 parts of chuanxiong, 400 parts of mistletoe, 250 parts of psoralea corylifolia, 200 parts of cinnamon bark, 200 parts of liquorice and 600 parts of pinellia ternata.

[0079] The preparation process of the above-mentioned Chinese medicine composition is as follows:

[0080] (1) Weigh the raw materials according to the above components;

[0081] (2) First decoction: Take cinnamon and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil slightly at 80°C for 30 minutes, collect volatile oil by condensation reflux, filter the remaining material to obtain drug residue and first decoction residual liquid, the ratio of the mass of β-cyclodextrin inclusion solution to the sum of the mass of cinnamon and Chuanxiong is 10:1;

[0082] (3) Enzymatic hydrolysis: Take ephedra, scutellaria, psoralea corylifolia and loranthus, adjust their water content to 50%, and evenly spread enzyme powder composed of cellulase and xylanase in a mass ratio of 1:1 on the surface of the medicinal materials for enzymatic hydrolysis, wherein the mass of cellulase and xylanase is 0.1% of the sum of the mass of ephedra, scutellaria, psoralea corylifolia and loranthus, and adjust the pH value of the wet medicinal material system to 5.5 with citric acid during enzymatic hydrolysis. The temperature during enzymatic hydrolysis is 45°C and the enzymatic hydrolysis time is 1 h;

[0083] (4) Second decoction: the residue obtained from the first decoction is combined with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and mistletoe, and decocted twice with a choline-lactic acid-water solution as the decoction liquid. The decoction time is 1 hour and 0.5 hours respectively. The molar ratio of choline to the lactic acid in the decoction liquid is 1:2. The amount of water used in the second decoction is 10 times the amount of the medicinal materials used in the second decoction. The amount of choline and lactic acid added is 1% of the volume of the water used in the second decoction.

[0084] (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 95°C. After the decoction is completed, filter the residue to obtain the medicine solution;

[0085] (6) Concentrating the medicinal solution: The residual solution of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with the drying agent maltodextrin for concentration. The amount of maltodextrin is 1% of the total mass of the combined medicinal solution. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.25;

[0086] (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring;

[0087] (8) Granulation: 20% of the weight of the concentrate of microcrystalline cellulose was put into a fluidized bed granulator, preheated to 40°C, and the concentrate mixed with volatile oil and micro-powdered silica gel was sprayed into the fluidized bed at a rate of 15 ml / min. The inlet air temperature was 60°C to obtain wet granules. After granulation, the granules were fluidized and dried at 60°C until the moisture content was ≤5%.

[0088] Example 3

[0089] A Chinese medicine composition for the respiratory system comprises the following raw materials in proportion by weight: 300 parts of ephedra, 450 parts of scutellaria, 400 parts of bitter almonds, 250 parts of chuanxiong, 350 parts of mistletoe, 200 parts of psoralea corylifolia, 150 parts of cinnamon bark, 180 parts of liquorice and 450 parts of pinellia tuber.

[0090] The preparation process of the above-mentioned Chinese medicine composition is as follows:

[0091] (1) Weigh the raw materials according to the above components;

[0092] (2) First decoction: Take cinnamon and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil slightly at 80°C for 30 minutes, collect volatile oil by condensation reflux, filter the remaining material to obtain drug residue and first decoction residual liquid, the ratio of the mass of β-cyclodextrin inclusion solution to the sum of the mass of cinnamon and Chuanxiong is 9:1;

[0093] (3) Enzymatic hydrolysis: Take ephedra, scutellaria, psoralea corylifolia and loranthus, adjust their water content to 45%, and evenly spread enzyme powder composed of cellulase and xylanase in a mass ratio of 1:1 on the surface of the medicinal materials for enzymatic hydrolysis, wherein the mass of cellulase and xylanase is 0.1% of the sum of the mass of ephedra, scutellaria, psoralea corylifolia and loranthus, and adjust the pH value of the wet medicinal material system to 5.0 with citric acid during enzymatic hydrolysis. The temperature during enzymatic hydrolysis is 45°C and the enzymatic hydrolysis time is 1 h;

[0094] (4) Second decoction: the residue obtained from the first decoction is combined with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and mistletoe, and decocted twice with a choline-lactic acid-water solution, the decoction time being 1 hour and 0.5 hours respectively, the molar ratio of choline to the lactic acid in the decoction is 1:2, the amount of water used in the second decoction is 9 times the amount of the medicinal materials used in the second decoction, and the amount of choline and lactic acid added is 1% of the volume of the water used in the second decoction;

[0095] (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 95°C. After the decoction is completed, filter the residue to obtain the medicine solution;

[0096] (6) Concentrating the medicinal solution: The residual solution of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with the drying agent maltodextrin for concentration. The amount of maltodextrin is 1% of the total mass of the combined medicinal solution. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.20;

[0097] (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring;

[0098] (8) Granulation: 20% of the weight of the concentrate of microcrystalline cellulose was put into a fluidized bed granulator, preheated to 40°C, and the concentrate mixed with volatile oil and micro-powdered silica gel was sprayed into the fluidized bed at a rate of 15 ml / min. The inlet air temperature was 60°C to obtain wet granules. After granulation, the granules were fluidized and dried at 60°C until the moisture content was ≤5%.

[0099] Comparative Example 1

[0100] The only difference between Comparative Example 1 and Example 3 is that no Psoralea corylifolia was added to the raw materials.

[0101] Comparative Example 2

[0102] The difference between Comparative Example 2 and Example 3 is that no red mulberry leaf was added to the raw materials.

[0103] Comparative Example 3

[0104] The difference between Comparative Example 3 and Example 3 is that Rhizoma Chuanxiong is not added to the raw materials.

[0105] Comparative Example 4

[0106] The difference between Comparative Example 4 and Example 3 is that Psoralea corylifolia, Morus alba and Rhizoma Chuanxiong are not added to the raw materials.

[0107] Comparative Example 5

[0108] The difference between Comparative Example 5 and Example 3 is that in the first decoction step, instead of using a β-cyclodextrin inclusion solution with a mass volume concentration of 0.5%, an equal volume of distilled water is used.

[0109] Comparative Example 6

[0110] The only difference between Comparative Example 6 and Example 3 is that Ephedra, Scutellaria, Psoralea, Pinellia and Morinda officinalis are not enzymatically hydrolyzed before the second decoction.

[0111] Comparative Example 7

[0112] The only difference between Comparative Example 7 and Example 3 is that the decoction liquid used in the second decoction is distilled water without adding choline and lactic acid.

[0113] Test Case

[0114] Test Example 1

[0115] Effect of xylene-induced ear swelling in mice (used to test the anti-inflammatory effect of the traditional Chinese medicine composition provided by the present invention): The effects of the traditional Chinese medicine compositions prepared in Examples 1-3 of the present invention and Comparative Examples 1-7 on xylene-induced ear swelling in mice were evaluated, and a blank group and a control group were set for comparison.

[0116] The specific experimental process is as follows: 120 Kunming mice, half male and half female, weighing 18-22g, were selected and then randomly divided into 12 experimental groups with 10 mice in each group.

[0117] Among them, experimental groups 1-3 use the Chinese medicine composition obtained in Examples 1-3, and experimental groups 4-10 use the Chinese medicine composition obtained in Comparative Examples 1-7. Experimental group 11 is a control group, using the Chinese medicine composition obtained in the embodiment of the Chinese invention patent application specification with authorization announcement number CN100450514C. The medicine obtained in experimental groups 1-11 was prepared with distilled water before the experiment, and the drug was administered by gavage. Experimental group 12 is a blank group, using the same volume of distilled water as experimental groups 1-11, and the administration method is gavage (the Chinese medicine composition in each subsequent test example is prepared with distilled water when used, and the blank group uses the same volume of distilled water, which will not be repeated).

[0118] Before the experiment, the mice were adaptively fed for 3 days, and then the mice in the experimental group were gavaged with 4.0 g / kg of the drug, and the experimental group 12 (blank group) was gavaged with the same volume of distilled water. The drug was administered for 3 consecutive days, once a day. 2 hours after the last administration, 0.05 ml of xylene was dripped on the surface of the left ear of the mouse until it was inflamed. After 15 minutes of inflamed, the left and right ears were cut off from the roots of the ears, and the two ears were overlapped. A circular piece was punched with a 7 mm diameter puncher, and the weight of the left and right ear pieces was weighed, and the difference in weight between the left and right ear pieces was used to indicate the degree of swelling of the mouse ear inflammation.

[0119] The experimental results of each experimental group in Test Example 1 are shown in Table 1:

[0120] Table 1

[0121] Number of mice Dosage Swelling degree (mg) Experimental Group 1 10 4g / kg 5.93±1.22 Experimental Group 2 10 4g / kg 6.01±1.36 Experimental Group 3 10 4g / kg 5.87±1.49 Experimental Group 4 10 4g / kg 8.21±1.35 Experimental Group 5 10 4g / kg 7.93±1.49 Experimental Group 6 10 4g / kg 6.72±1.32 Experimental Group 7 10 4g / kg 8.69±1.18 Experimental Group 8 10 4g / kg 8.26±1.43 Experimental Group 9 10 4g / kg 8.13±1.27 Experimental Group 10 10 4g / kg 8.01±1.26 Experimental Group 11 10 4g / kg 7.95±1.31 Experimental Group 12 10 - 10.01±1.54

[0122] It can be seen from the results of Table 1 that the Chinese medicine composition provided by the present invention can significantly reduce the swelling of the mouse auricle, proving that it has a good anti-inflammatory effect. It can be seen from the data comparison of experimental group 3 and experimental group 4-7 that psoralea corylifolia and mistletoe can play a good role in anti-inflammatory, and psoralea corylifolia, mistletoe and Chuanxiong three synergistic effect, and other medicinal materials in the compatibility composition can achieve the best anti-inflammatory effect. It can be seen from experimental group 8-10 that the use of β-cyclodextrin inclusion solution for decoction during the first decoction, enzymatic hydrolysis before the second decoction, and the use of choline-lactic acid-water solution as the decoction liquid during the second decoction can achieve the improvement of the effective ingredients in the finished drug, thereby improving the drug efficacy of the product.

[0123] Test Example 2

[0124] Effect on cough induced by concentrated ammonia water in mice (used to test the antitussive effect of the traditional Chinese medicine composition provided by the present invention): The effects of the traditional Chinese medicine compositions prepared in Examples 1-5 and Comparative Examples 1-7 of the present invention on cough induced by concentrated ammonia water in mice were evaluated, and a blank group and a control group were set for comparison.

[0125] The specific experimental process is as follows: 120 Kunming mice, half male and half female, weighing 18-22g, were selected and then randomly divided into 12 experimental groups with 10 mice in each group.

[0126] The experimental groups 1-3 used the Chinese medicine composition obtained in Examples 1-3, and the experimental groups 4-10 used the Chinese medicine composition obtained in Comparative Examples 1-7. The experimental group 11 was the control group, which used the Chinese medicine composition obtained in the example of the Chinese invention patent application specification with the authorization announcement number CN100450514C. The experimental group 12 was the blank group, which used the same volume of distilled water as the experimental groups 1-11.

[0127] After the mice were adaptively raised for 3 days before the experiment, the mice in the experimental group were gavaged with 4.0 g / kg of the drug, and the mice in the experimental group 12 (blank group) were gavaged with the same volume of distilled water. The drug was administered for 3 consecutive days, once a day. One hour after the last administration, the mice were placed in an inverted 500 ml beaker, and a cotton ball inhaled with 10 ml of 20% ammonia was placed in it. The number of coughs of the mice within 3 minutes was observed and recorded.

[0128] The experimental results of each experimental group in Test Example 2 are shown in Table 2:

[0129] Table 2

[0130] Number of mice Dosage Number of coughs Experimental Group 1 10 4g / kg 33.01±9.23 Experimental Group 2 10 4g / kg 32.56±9.58 Experimental Group 3 10 4g / kg 32.15±9.35 Experimental Group 4 10 4g / kg 42.76±11.26 Experimental Group 5 10 4g / kg 45.37±12.53 Experimental Group 6 10 4g / kg 41.27±11.45 Experimental Group 7 10 4g / kg 55.90±13.41 Experimental Group 8 10 4g / kg 52.78±16.53 Experimental Group 9 10 4g / kg 62.59±14.27 Experimental Group 10 10 4g / kg 60.33±14.26 Experimental Group 11 10 4g / kg 55.01±11.42 Experimental Group 12 10 - 77.43±11.72

[0131] It can be seen from the results in Table 2 that the Chinese medicine composition provided by the present invention can significantly reduce the number of mouse coughs caused by concentrated ammonia water, proving that it has a good antitussive effect. It can be seen from the data comparison of experimental group 3 and experimental groups 4-7 that the effect of mistletoe on antitussive is more important, and the quercetin contained in mistletoe can inhibit smooth muscle contraction, thereby playing an antitussive effect. It can be seen from the comparison of experimental group 9 and experimental group 3 that enzymolysis is not performed during the second decoction, which may cause incomplete release of quercetin in mistletoe, thereby reducing the antitussive effect.

[0132] Test Example 3

[0133] Effect on the writhing reaction of mice induced by acetic acid (used to test the analgesic effect of the traditional Chinese medicine composition provided by the present invention): The effects of the traditional Chinese medicine compositions prepared in Examples 1-5 and Comparative Examples 1-7 of the present invention on the writhing reaction of mice induced by acetic acid were evaluated, and a blank group and a control group were set for comparison.

[0134] The specific experimental process is as follows: 120 Kunming mice, half male and half female, weighing 18-22g, were selected and then randomly divided into 12 experimental groups with 10 mice in each group.

[0135] Among them, experimental groups 1-3 used the Chinese medicine composition obtained in Examples 1-3, and experimental groups 4-10 used the Chinese medicine composition obtained in Comparative Examples 1-7. Experimental group 11 was a control group, using the Chinese medicine composition obtained in the example of the Chinese invention patent specification with the authorization announcement number CN100450514C. Experimental group 12 was a blank group, using distilled water with the same volume of medicine as experimental groups 1-11.

[0136] Before the experiment, the mice were fed for 3 days before being gavaged with drugs at a dosage of 4.0 g / kg. The mice in the experimental group (blank group) were gavaged with the same volume of distilled water. The drugs were administered for 3 consecutive days, once a day. One hour after the last administration, each mouse was intraperitoneally injected with 0.6% acetic acid 0.2 ml / mouse. The number of twisting times of the mice within 20 minutes was recorded, and the percentage of analgesia in each group was calculated. The calculation method of the analgesia percentage is as follows:

[0137] Analgesia percentage = (number of writhings of mice in the blank group - number of writhings of mice in the experimental group) / number of writhings of mice in the blank group × 100%.

[0138] The experimental results and analgesia percentages of each experimental group in Test Example 3 are shown in Table 3:

[0139] Table 3

[0140]

[0141]

[0142] The results in Table 3 show that the Chinese medicine composition provided by the present invention can significantly reduce the number of twisting of mice caused by concentrated acetic acid, and the analgesic percentage is high, which proves that it has a good analgesic effect. The analgesic effect in Chuanxiong is mainly the volatile oil of Chuanxiong, which activates the TRPV1 channel and desensitizes it, thereby reducing pain transmission. In experimental group 6 (Comparative Example 3), Chuanxiong was not used, so the analgesic rate of the medicine decreased. In experimental group 5 (Comparative Example 8), β-cyclodextrin inclusion solution was not used for decoction, resulting in excessive loss of volatile oil, which also resulted in a decrease in the analgesic rate of the medicine.

[0143] Test Example 4

[0144] Effect on the secretion of lympholysin antibodies in mouse spleen cells (used to test the effect of the Chinese medicine composition provided by the present invention on improving the body's immune function): The effects of the Chinese medicine compositions prepared in Examples 1-5 of the present invention and Comparative Example 1 on the writhing reaction of mice induced by acetic acid were evaluated, and a blank group, a control group and a model group were set for comparison.

[0145] The specific experimental process is as follows: 130 Kunming mice, half male and half female, weighing 18-22g, were selected and then randomly divided into 13 experimental groups with 10 mice in each group.

[0146] Among them, experimental groups 1-3 used the Chinese medicine composition obtained in Examples 1-3, and experimental groups 4-10 used the Chinese medicine composition obtained in Comparative Examples 1-7. Experimental group 11 was a control group, using the Chinese medicine composition obtained in the example of the Chinese invention patent specification with the authorization announcement number CN100450514C. Experimental group 12 was a model group, and experimental group 13 was a blank group, both of which used distilled water with the same volume as the experimental group drugs.

[0147] Before the experiment, the mice were fed adaptively for 3 days, and then the mice in the experimental group were gavaged with 4.0kg / kg of distilled water. The same volume of distilled water was gavaged with experimental group 12 (model group) and experimental group 13 (blank group). The drugs were continuously administered for 10 days, once a day. On the 7th, 8th and 9th days after administration, except for experimental group 13 (blank group), the mice in other groups were intraperitoneally injected with cyclophosphamide 15mg / kg, once a day, for 3 consecutive days. After the first administration of cyclophosphamide, all mice were intravenously injected with 5% sheep red blood cells for sensitization. 96h (4d) after sensitization, the mice were bled and killed, the spleen was removed, and spleen lymphocytes were prepared. Sheep red blood cells and guinea pig serum were added to the spleen lymphocyte suspension, incubated at 37℃ for 1h, centrifuged, and the supernatant was taken and the absorbance value was measured at a wavelength of 405nm using a semi-automatic biochemical analyzer.

[0148] The experimental results of each experimental group in Test Example 4 are shown in Table 4:

[0149] Table 4

[0150] Number of mice Dosage Hemolysis value (OD value) Experimental Group 1 10 4g / kg 2.030±0.053 Experimental Group 2 10 4g / kg 2.014±0.062 Experimental Group 3 10 4g / kg 2.030±0.054 Experimental Group 4 10 4g / kg 1.985±0.061 Experimental Group 5 10 4g / kg 1.972±0.057 Experimental Group 6 10 4g / kg 1.984±0.052 Experimental Group 7 10 4g / kg 1.952±0.046 Experimental Group 8 10 4g / kg 1.966±0.042 Experimental Group 9 10 4g / kg 1.959±0.059 Experimental Group 10 10 4g / kg 1.974±0.053 Experimental Group 11 10 4g / kg 1.926±0.057 Experimental Group 12 10 - 1.917±0.050 Experimental Group 13 10 - 2.132±0.067

[0151] It can be seen from the results in Table 4 that the Chinese medicine composition provided by the present invention can enhance the secretion of lymphocyte hemolysin antibodies in the spleen of immunocompromised mice, and has a strong effect of improving the immune function of the body.

[0152] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some or all of the technical features therein may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for the respiratory system, characterized in that: The invention is composed of the following raw materials in proportion by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almond, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice and 300-600 parts of pinellia tuber.

2. The Chinese medicine composition for the respiratory system according to claim 1, characterized in that: The invention is composed of the following raw materials in proportion by weight: 250-350 parts of ephedra, 400-500 parts of scutellaria, 350-450 parts of bitter almond, 230-270 parts of chuanxiong, 330-370 parts of mistletoe, 180-220 parts of psoralea corylifolia, 130-170 parts of cinnamon bark, 130-170 parts of liquorice and 400-500 parts of pinellia tuber.

3. The Chinese medicine composition for the respiratory system according to claim 1, characterized in that: The invention is composed of the following raw materials in proportion by weight: 300 parts of ephedra, 450 parts of scutellaria, 400 parts of bitter almond, 250 parts of chuanxiong, 350 parts of mistletoe, 200 parts of psoralea corylifolia, 150 parts of cinnamon bark, 180 parts of liquorice and 450 parts of pinellia tuber.

4. A method for preparing a Chinese medicine composition for the respiratory system according to any one of claims 1 to 3, characterized in that: The steps include: (1) Weigh the following raw materials in parts by weight: 200-400 parts of ephedra, 400-600 parts of scutellaria, 350-550 parts of bitter almond, 200-300 parts of chuanxiong, 300-400 parts of mistletoe, 150-250 parts of psoralea corylifolia, 100-200 parts of cinnamon bark, 100-200 parts of liquorice, and 300-600 parts of pinellia tuber; (2) First decoction: Take cinnamon bark and Chuanxiong, add 0.5% mass volume concentration of β-cyclodextrin inclusion solution, boil at 80°C for 30 minutes, collect volatile oil by condensation and reflux, filter the remaining material, and obtain the residue and the first decoction residue; (3) Enzymatic hydrolysis: Take Ephedra, Scutellaria, Psoralea corylifolia, Pinellia ternata and Morus alba, adjust their water content to 40-50%, and evenly spread enzyme powder on the surface of the medicinal materials for enzymatic hydrolysis; (4) Second decoction: Combine the residue obtained from the first decoction with the enzymatically hydrolyzed ephedra, scutellaria, psoralea corylifolia and moss parasite, add the decoction liquid and decoct twice, with the decoction time being 1 hour and 0.5 hours respectively; (5) Post-addition: 10 minutes before the end of the second decoction, add bitter almonds and licorice to the second decoction, and add 1% L-ascorbic acid nanoliposomes. In the post-addition stage, the temperature of the medicine solution is controlled at 90-95°C. After the decoction is completed, filter the residue to obtain the medicine solution; (6) Concentrating the medicinal liquid: The residual liquid of the first decoction, the second decoction and the last decoction are combined and placed in a vacuum concentration tank together with a drying aid for concentration. During concentration, the vacuum is drawn to -0.08 MPa and heated to concentrate to a relative density of 1.20-1.25; (7) Volatile oil integration: Mix the volatile oil and micro-powdered silica gel in a mass ratio of 1:3 and spray into the concentrate while stirring; (8) Granulation: Take 20% of the weight of the concentrate of microcrystalline cellulose and put it into a fluidized bed granulator. Preheat it to 40°C. Spray the concentrate mixed with volatile oil and micro-powdered silica gel into the fluidized bed as a spray liquid to obtain wet granules. After granulation, dry it.

5. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: The dosage ratio of the β-cyclodextrin inclusion solution to the cinnamon bark and the chuanxiong is (8-10):1, that is, 8-10 L of β-cyclodextrin inclusion solution is used for every 1 kg of medicinal materials.

6. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: The enzymatic hydrolysis temperature is 45° C., the enzymatic hydrolysis time is 1 hour, and the required pH for the enzymatic hydrolysis is 5.0-5.

5.

7. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: The enzyme powder comprises cellulase and xylanase in a mass ratio of 1:1, and the mass of the cellulase and the xylanase is 0.1% of the total mass of the ephedra, scutellaria, psoralea corylifolia, pinellia ternata and parasitic loranthus.

8. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: The decoction in the secondary decoction is a choline-lactic acid-water solution, the molar ratio of the choline to the lactic acid is 1:2, the amount of water in the secondary decoction is 8-10 times the amount of the medicinal materials in the secondary decoction, and the added amount of the choline and the lactic acid is 1% of the volume of the water used for the secondary decoction.

9. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: The drying aid in the concentrated medicinal liquid is maltodextrin, and the dosage is 1% of the total mass of the combined medicinal liquid.

10. The method for preparing the Chinese medicine composition for the respiratory system according to claim 4, characterized in that: During the granulation process, the liquid spraying rate is 15 ml / min, the air inlet temperature is 60° C., and after the liquid spraying is completed, the fluidized drying is performed at 60° C. until the moisture content is ≤5%.

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