CN108553595B

CN108553595B - Asthma pill and preparation method thereof

Info

Publication number: CN108553595B
Application number: CN201810723174.9A
Authority: CN
Inventors: 袁任春; 万义斌; 葛友群; 左飞鸿; 张佐昌; 周莉萍; 关媛媛
Original assignee: Jiangxi Guoyao Pharmaceutical LLC
Current assignee: JIANGXI JIUHUA PHARMACEUTICAL CO Ltd
Priority date: 2018-07-04
Filing date: 2018-07-04
Publication date: 2021-03-05
Anticipated expiration: 2038-07-04
Also published as: CN108553595A

Abstract

The invention provides a preparation method of asthma pills, which comprises 20 Chinese medicinal herbs of rhizoma anemarrhenae, bulbus fritillariae cirrhosae, fried bitter apricot seed, poppy shell, radix ophiopogonis, semen ginkgo, trichosanthes kirilowii maxim, honey-fried ephedra, schisandra chinensis, areca nut, myrobalan meat, dark plum meat, rhizoma arisaematis, bamboo shavings, coptis chinensis, scutellaria baicalensis, ginger processed pinellia ternate, fried fructus aurantii, perilla leaf and radix peucedani, as well as adhesive, disintegrating agent, antioxidant, flavoring agent and refined honey. Pretreating the traditional Chinese medicine raw materials, respectively decocting in water for extraction, or pulverizing into powder, granulating, drying, pulverizing, mixing the powder with adjuvants, adding Mel, making into pill, and polishing to obtain the asthma pill. The asthma pill prepared by the invention has good stability, low contamination rate in the preservation process and good curative effect; the preparation process is simple to operate, the product percent of pass is high, the pill shape is good, and the color is uniform.

Description

Asthma pill and preparation method thereof

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to an asthma pill and a preparation method thereof.

Background

Asthma is a disease in which there is airway constriction, which is reversible due to airway hyperresponsiveness resulting from certain inflammatory stimuli. The incidence in adults is about 5%. Asthma tends to be familial with studies indicating a higher incidence of asthma in the urban population and a higher incidence in women in adult asthma. People who are engaged in certain occupations are also prone to asthma.

The traditional Chinese medicine considers that the phlegm is formed by the coagulation and the failure of water-dampness to normalize. Phlegm can flow with the air after it is formed, and causes various diseases. Cough usually occurs with abundant expectoration, and cough and dyspnea are easily caused by abundant expectoration. Therefore, phlegm, cough and dyspnea are closely related and cause each other. Asthma mainly relieves cough and asthma, and resolves phlegm.

At present, western medicines cannot effectively cure asthma, and people have great demands on medicines which can relieve asthma symptoms and effectively control asthma. There are many traditional Chinese medicine compositions for treating asthma, but a medicine which can really treat both principal and secondary aspect of disease is only reported. In addition, the traditional Chinese medicine for treating asthma prepared by the prior art has the defect that the traditional Chinese medicine is not suitable for long-time storage.

Disclosure of Invention

The invention aims to provide a preparation method of asthma pills, and the prepared asthma pills have stable quality, can be stored for a long time and improve the product qualification rate.

Specifically, aiming at the defects of the prior art, the invention provides the following technical scheme:

the preparation method of the asthma pill comprises the following raw materials of 20 traditional Chinese medicines and auxiliary materials in parts by weight: 25-35 parts of rhizoma anemarrhenae, 20-30 parts of bulbus fritillariae cirrhosae, 25-35 parts of fried bitter almond, 25-35 parts of poppy shell, 40-50 parts of radix ophiopogonis, 50-60 parts of semen ginkgo, 40-50 parts of trichosanthes kirilowii maxim, 15-25 parts of honey-fried ephedra, 15-25 parts of schisandra chinensis, 20-30 parts of betel nut, 25-35 parts of myrobalan pulp, 20-30 parts of dark plum pulp, 15-25 parts of rhizoma arisaematis, 25-35 parts of caulis bambusae in taeniam, 10-30 parts of coptis chinensis, 25-35 parts of radix scutellariae, 25-35 parts of ginger processed pinellia, 40-50 parts of fried fructus aurantii, 15-25 parts of perilla leaf and 20-30 parts of radix peucedani: adhesive, disintegrant, antioxidant, corrective and refined honey.

The traditional Chinese medicine components are mutually matched and have synergistic effect, the traditional Chinese medicine composition can be used for treating asthma in a targeted manner, the antioxidant and the flavoring agent are added into the raw materials, the stability and the taste of the product are improved, and the product is more convenient to carry and use.

Preferably, the preparation method comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 65-70 ℃ according to the prescription amount, cooling, and irradiating by ultraviolet rays;

s2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water, decocting and extracting for 2 times, decocting for 2 hours each time, and combining decoction;

s3, concentrating 20% of the decoction obtained in the step S2 into a clear paste with the specific gravity of 1.02, and concentrating the rest 80% of the decoction into a thick paste with the specific gravity of 1.28-1.33;

s4, mixing the rhizoma anemarrhenae, the bulbus fritillariae cirrhosae, the fried bitter apricot seeds, the poppy shells, the ginkgo seeds, the honey-fried ephedra, the schisandra chinensis, the betel nuts, the myrobalan pulp, the dark plum pulp, the rhizoma arisaematis, the coptis chinensis, the fried bitter oranges, the perilla leaves and the radix peucedani which are processed in the step S1, and crushing and sieving the mixture to obtain fine powder;

s5, mixing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent, adding a premix of the clear paste and the adhesive, granulating and drying;

s6, crushing the dried granules to obtain medicinal powder, mixing the medicinal powder, the antioxidant, the flavoring agent and 50% of disintegrating agent, adding refined honey, and preparing pills;

and S7, drying the pills prepared in the step S6, and polishing to obtain the asthma pills.

Preferably, the composition comprises, by weight, 25-35 parts of a binder, 20-30 parts of a disintegrating agent, 15-25 parts of an antioxidant and 2-5 parts of a flavoring agent.

Preferably, at least one of the following technical features is also included:

the drying time in the step S1 is 30-40 min;

the ultraviolet irradiation time in the step S1 is 15-20 min;

in step S2, the amount of water added for decoction is 3-5 times of the weight of the raw materials in the extraction tank.

Preferably, the weight ratio of the clear paste in the premix added in the step S5 to the adhesive is 1: 1-1.2.

Preferably, the adhesive is formed by mixing polyvinylpyrrolidone and ethanol according to a ratio of 1g to 1.2-1.5mL, or is formed by mixing sodium carboxymethylcellulose and ethanol according to a ratio of 1g to 1.2-1.5 mL.

Preferably, at least one of the following technical features is also included:

the disintegrating agent is selected from one or more of low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose sodium and croscarmellose sodium;

the flavoring agent is one or more selected from sorbitol, mannitol, sucralose, ethyl maltol and aspartame.

Preferably, the antioxidant is a mixture of kaempferide, sinensetin and apigenin or one or more selected from sodium sulfite, sodium metabisulfite and vitamin C, wherein the weight ratio of kaempferide, sinensetin and apigenin is 1:1: 1-1.2.

Preferably, the refined honey has a moisture content of 14-18%.

The invention also provides the asthma pills prepared by the preparation method.

Compared with the prior art, the invention has the advantages that:

(1) the antioxidant is added into the prescription of the asthma pill, so that the stability of the medicine is improved, and the storage is convenient. The flavoring agent is added in the formula, so that the product has good taste, can improve the compliance of patients, and is convenient to take.

(2) All the traditional Chinese medicine raw materials are pretreated by heating and ultraviolet irradiation, so that the influence of harmful factors such as mould and worm damage in the medicinal materials on the product quality is effectively prevented, and the product is favorably stored.

(3) The crushing of the bamboo shavings is very difficult to meet the standard requirements, and the invention adopts a water-adding decoction extraction method to extract the effective components in the bamboo shavings, thereby avoiding the problem of low product percent of pass caused by direct crushing of the bamboo shavings into the medicine. The medicinal materials are crushed into coarse powder and then added with water for decoction and extraction, so that the extraction efficiency is improved, and the utilization rate of the medicinal materials is high.

(4) Before preparing the pills, the pills are firstly prepared into granules, dried and then crushed into medicinal powder, and then the pills are further prepared, so that the drying efficiency can be improved, the obtained medicinal powder has low water content, and the prepared pills are round and uniform in shape.

(5) When the granule is prepared, the clear paste obtained by concentrating the decoction and the premix of the adhesive are added, the clear paste also plays the role of the adhesive, the viscosity is good, and the dosage of the auxiliary materials of the adhesive is reduced.

In conclusion, the asthma pills prepared by the invention are round, uniform, consistent in color, moderate in hardness and fast to absorb; the product quality is stable, and the storage is convenient. The asthma pill has good curative effect, short treatment course, thorough treatment, no serious adverse reaction, simple preparation method and easy operation.

Detailed Description

The invention provides a preparation method of an asthma pill, which comprises 20 traditional Chinese medicine raw materials and auxiliary materials, wherein the traditional Chinese medicine raw materials comprise: 25-35 parts of rhizoma anemarrhenae, 20-30 parts of bulbus fritillariae cirrhosae, 25-35 parts of fried bitter almond, 25-35 parts of poppy shell, 40-50 parts of radix ophiopogonis, 50-60 parts of semen ginkgo, 40-50 parts of trichosanthes kirilowii maxim, 15-25 parts of honey-fried ephedra, 15-25 parts of schisandra chinensis, 20-30 parts of betel nut, 25-35 parts of myrobalan pulp, 20-30 parts of dark plum pulp, 15-25 parts of rhizoma arisaematis, 25-35 parts of caulis bambusae in taeniam, 10-30 parts of coptis chinensis, 25-35 parts of radix scutellariae, 25-35 parts of ginger processed pinellia, 40-50 parts of fried fructus aurantii, 15-25 parts of perilla leaf and 20-30 parts of radix peucedani: 25-35 parts of adhesive, 20-30 parts of disintegrating agent, 15-25 parts of antioxidant, 2-5 parts of flavoring agent and refined honey.

Wherein the adhesive is formed by mixing polyvinylpyrrolidone or sodium carboxymethylcellulose with 95% ethanol according to a ratio of 1g to 1.2-1.5 mL; the disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose sodium and croscarmellose sodium; the antioxidant is a mixture of kaempferide, sinensetin and apigenin or one or more selected from sodium sulfite, sodium metabisulfite and vitamin C, and the weight ratio of kaempferide, sinensetin and apigenin is 1:1: 1-1.2; the correctant is one or more selected from sorbitol, mannitol, sucralose, ethyl maltol, and aspartame.

The preparation method of the asthma pill comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 65-70 ℃ for 30-40min according to the prescription amount, cooling, and irradiating with ultraviolet rays for 15-20 min;

s2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water for decocting and extracting for 2 times according to 3-5 times of the weight of raw materials in the tank, decocting for 2 hours each time, and combining decoction;

coarse powder, which means that all can pass through the second sieve, but no more than 40% of powder is mixed to pass through the fourth sieve.

s5, mixing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent, adding a premix of the clear paste and an adhesive (the clear paste is the adhesive accounting for 1:1-1.2), granulating, and drying (the moisture content of the dried granules is less than 3.0%);

s6, crushing the dried granules to obtain medicinal powder, mixing the medicinal powder, the antioxidant, the flavoring agent and 50% of disintegrating agent, adding refined honey with the water content of 14-18% according to 80-95% of the weight of the mixed materials, and making into pills;

s7, drying the pills prepared in the step S6 until the water content is lower than 6.0%, and polishing to obtain the asthma pills.

The polishing method comprises the following steps: putting the dried pills into a coating pan (model BYC-600, Guangzhou De mechanical engineering and Equipment Co., Ltd.), rotating for 10min at 10-15r/min to completely disperse the pills, adding 75% ethanol, wherein the ethanol dosage is calculated by 20-25mL/kg of pills, the rotating speed is adjusted to 25-35r/min, adding talcum powder (dosage is 13-15g/kg of pills) when the surfaces of the pills are completely wetted, continuously rotating until the pills are dry and have no white spots and patterns on the surfaces, have no unevenness and are bright and smooth, and stopping the machine. Dipping a lubricant consisting of sesame oil and beeswax by using a brush, wherein the beeswax accounts for 8 percent of the sesame oil, coating the lubricant on the pills, starting the machine, continuously rotating for 10-12min at the rotating speed of 25-35r/min to obtain asthma pills with bright surfaces, and obtaining small honeyed pills with 1g of weight per 8 pills.

Frying bitter almonds: putting clean semen Armeniacae amarum in a pan, parching with slow fire to yellow with slight focal spot, taking out, and cooling. The product can be purchased from Guangming decoction piece processing factory in Anguo.

Mix-fried ephedra with honey: diluting Mel with appropriate amount of boiled water, adding herba Ephedrae segment, stirring, stewing thoroughly, placing in frying pan, heating with slow fire, parching to non-sticky degree, taking out, and cooling. 20kg of refined honey is used for each l00kg of the Chinese ephedra. The honey-fried ephedra herb can be purchased from Chengdu Shangcheng pharmaceutical industry Co.

Frying the bitter orange: putting the clean bitter orange slices into a pot, frying the bitter orange slices to be yellow by slow fire or frying the bitter orange slices to be brown by strong fire, spraying a little clear water to extinguish the bitter orange slices, taking out the bitter orange slices, and cooling. The product can be purchased from Ji-Shi Chinese medicinal materials GmbH in Anguo.

The invention is further described below by way of specific examples.

The materials, reagents and equipment involved in the invention are all commercially available.

Example 1

The raw materials for preparing the asthma pill comprise traditional Chinese medicine raw materials and auxiliary materials, wherein the traditional Chinese medicine raw materials comprise: 25 parts of rhizoma anemarrhenae, 20 parts of bulbus fritillariae cirrhosae, 25 parts of fried bitter almond, 25 parts of poppy shell, 40 parts of radix ophiopogonis, 50 parts of semen ginkgo, 40 parts of trichosanthes kirilowii maxim, 15 parts of honey-fried ephedra, 15 parts of schisandra chinensis, 20 parts of betel nut, 25 parts of myrobalan meat, 20 parts of dark plum meat, 15 parts of rhizoma arisaematis, 25 parts of bamboo shavings, 10 parts of coptis chinensis, 25 parts of radix scutellariae, 25 parts of ginger processed pinellia tuber, 40 parts of fried fructus aurantii, 15 parts of perilla leaf and 20 parts of radix peucedani, and the: 25 parts of adhesive, 20 parts of disintegrating agent, 15 parts of antioxidant, 2 parts of flavoring agent and refined honey.

Wherein the adhesive is prepared by mixing polyvinylpyrrolidone and 95% ethanol at a concentration of 1g:1.2mL, the disintegrating agent is crospovidone, the antioxidant is prepared by mixing kaempferide, aurantiol and apigenin at a weight ratio of 1:1:1, and the flavoring agent is sorbitol.

The preparation method comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 65 ℃ for 40min according to the prescription amount, cooling to room temperature, and irradiating for 15min by using high-pressure mercury lamp ultraviolet rays.

S2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water according to 3 times of the weight of raw materials in the tank, decocting for 2 times, decocting for 2 hours each time, and combining decoction.

S3, concentrating 20% of the decoction obtained in the step S2 into a clear paste with the specific gravity of 1.02, and concentrating the rest 80% of the decoction into a thick paste with the specific gravity of 1.28.

S4, mixing the rhizoma anemarrhenae, the bulbus fritillariae cirrhosae, the fried bitter apricot seeds, the poppy shells, the ginkgo seeds, the honey-fried ephedra, the schisandra chinensis, the betel nuts, the myrobalan pulp, the dark plum pulp, the rhizoma arisaematis, the coptis chinensis, the fried bitter oranges, the perilla leaves and the radix peucedani which are processed in the step S1, crushing and sieving with a 100-mesh sieve to obtain fine powder.

S5, placing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent into a CH-50 traditional Chinese medicine mixer (Hunan Zhongcheng pharmaceutical machinery factory) and mixing for 10min at a speed of 24 r/min. Adding the premix of the fluid extract and the adhesive in a ratio of 1:1, continuously mixing for 5min at a speed of 24r/min, pouring the mixture into a YK-100 granulator, and granulating. Spreading the obtained granules on a tray, and drying at 45 deg.C with a vacuum drier to obtain dried granules with water content of less than 2.0%.

S6, crushing the dried particles, and sieving the particles by a sieve of 100 meshes to obtain medicinal powder; placing the medicinal powder, antioxidant, correctant and 50% disintegrating agent in SCH-200 double-paddle mixer, premixing for 5min, adding refined honey with water content of 14% according to 80% of the weight of the mixture, stirring and mixing for 20min, wherein the mixer has no dry powder, the materials are completely wet, uniform and consistent in color and luster, and moderate in hardness. The mixed materials are made into pills by a full-automatic high-efficiency pill making machine (model YUJ-22A), the operating frequency of a roller cutter is 40Hz, the aperture of a strip plate is 3.9mm, and the prepared pills are round, uniform and consistent in color.

S7, drying the pills prepared in the step S6 until the water content is lower than 6.0%, and polishing to obtain the asthma pills. The specific polishing method comprises the following steps: putting the dried pills into a coating pan (model BYC-600, Guangzhou De mechanical equipment Co., Ltd.), rotating for 10min at a speed of 10r/min to completely disperse the pills, adding 75% ethanol, wherein the ethanol dosage is calculated by 20mL/kg of pills, adjusting the rotating speed to 25r/min, adding talcum powder (dosage is 13g/kg of pills) when the surfaces of the pills are completely wetted, continuously rotating until the pills are dry and have no white spots and patterns on the surfaces, have no unevenness and appear a little brightness, and stopping the machine. Dipping a lubricant consisting of sesame oil and beeswax (the proportion of the beeswax to the sesame oil is 8%) by a brush, coating the lubricant on the pills, starting the machine and continuing to rotate for 10min at the rotating speed of 25r/min to obtain asthma pills with bright surfaces, wherein each 8 pills are 1g in weight and are small honeyed pills.

Example 2

The raw materials for preparing the asthma pill comprise traditional Chinese medicine raw materials and auxiliary materials, wherein the traditional Chinese medicine raw materials comprise: 30 parts of rhizoma anemarrhenae, 25 parts of bulbus fritillariae cirrhosae, 30 parts of fried bitter almond, 30 parts of poppy shell, 45 parts of radix ophiopogonis, 55 parts of semen ginkgo, 45 parts of trichosanthes kirilowii maxim, 20 parts of honey-fried ephedra, 20 parts of schisandra chinensis, 25 parts of betel nut, 30 parts of myrobalan meat, 25 parts of dark plum meat, 20 parts of rhizoma arisaematis, 30 parts of bamboo shavings, 20 parts of coptis chinensis, 30 parts of radix scutellariae, 30 parts of ginger processed pinellia tuber, 45 parts of fried fructus aurantii, 20 parts of perilla leaf and 25 parts of radix peucedani, and the: 30 parts of adhesive, 25 parts of disintegrating agent, 20 parts of antioxidant, 3 parts of flavoring agent and refined honey.

Wherein the adhesive is prepared by mixing sodium carboxymethylcellulose and 95% ethanol at a concentration of 1g:1.2mL, the disintegrating agent is low-substituted hydroxypropyl cellulose, the antioxidant is sodium sulfite, and the flavoring agent is mannitol.

The preparation method comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 65 ℃ for 35min according to the prescription amount, cooling to room temperature, and irradiating for 15min by using high-pressure mercury lamp ultraviolet rays.

S2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water and decocting for 2 times according to 4 times of the weight of raw materials in the tank, decocting for 2 hours each time, and combining decoction.

S3, concentrating 20% of the decoction obtained in the step S2 into a clear paste with the specific gravity of 1.02, and concentrating the rest 80% of the decoction into a thick paste with the specific gravity of 1.30.

S5, placing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent into a CH-50 traditional Chinese medicine mixer (Hunan Zhongcheng pharmaceutical machinery factory) and mixing for 10min at a speed of 24 r/min. Adding the premix of the fluid extract and the adhesive in a ratio of 1:1.1, continuously mixing for 10min at a speed of 24r/min, pouring the mixture into a YK-100 granulator, and granulating. Spreading the obtained granules on a tray, and drying at 45 deg.C with a vacuum drier to obtain dried granules with water content of less than 3.0%.

S6, crushing the dried particles, and sieving the particles by a sieve of 100 meshes to obtain medicinal powder; placing the medicinal powder, antioxidant, correctant and 50% disintegrating agent in SCH-200 double-paddle mixer, premixing for 5min, adding refined honey with water content of 15% according to 90% of the weight of the mixture, stirring and mixing for 20min, wherein the mixer has no dry powder, the materials are completely wet, uniform and consistent in color and luster, and moderate in hardness. The mixed materials are made into pills by a full-automatic high-efficiency pill making machine (model YUJ-22A), the operating frequency of a roller cutter is 40Hz, the aperture of a strip plate is 3.9mm, and the prepared pills are round, uniform and consistent in color.

S7, drying the pills prepared in the step S6 until the water content is lower than 6.0%, and polishing to obtain the asthma pills. The specific polishing method comprises the following steps: putting the dried pills into a coating pan (model BYC-600, Guangzhou De mechanical equipment Co., Ltd.), rotating for 10min at 12r/min to completely disperse the pills, adding 75% ethanol, wherein the dosage of the ethanol is calculated by 22mL/kg of pills, the rotating speed is adjusted to 30r/min, adding talcum powder (the dosage is 15g/kg of pills) when the surfaces of the pills are completely wetted, continuously rotating until the pills are dry and have no white spots and patterns on the surfaces, have no unevenness and appear a little brightness, and stopping the machine. Dipping a lubricant consisting of sesame oil and beeswax (the proportion of the beeswax to the sesame oil is 8%) by a brush, coating the lubricant on the pills, starting the machine and continuing to rotate for 10min at the rotating speed of 30r/min to obtain asthma pills with bright surfaces, wherein each 8 pills are 1g in weight and are small honeyed pills.

Example 3

The raw materials for preparing the asthma pill comprise traditional Chinese medicine raw materials and auxiliary materials, wherein the traditional Chinese medicine raw materials comprise: 35 parts of rhizoma anemarrhenae, 30 parts of bulbus fritillariae cirrhosae, 35 parts of fried bitter almond, 35 parts of poppy shell, 50 parts of radix ophiopogonis, 60 parts of semen ginkgo, 50 parts of trichosanthes kirilowii maxim, 25 parts of honey-fried ephedra, 25 parts of schisandra chinensis, 30 parts of betel nut, 35 parts of myrobalan meat, 30 parts of dark plum meat, 25 parts of rhizoma arisaematis, 35 parts of bamboo shavings, 30 parts of coptis chinensis, 35 parts of radix scutellariae, 35 parts of ginger processed pinellia tuber, 50 parts of fried fructus aurantii, 25 parts of perilla leaf and 30 parts of radix peucedani, and the: 35 parts of adhesive, 30 parts of disintegrating agent, 25 parts of antioxidant, 5 parts of flavoring agent and refined honey, wherein the dosage of the refined honey is 95 percent of the total weight of all other raw materials.

Wherein the adhesive is prepared by mixing sodium carboxymethylcellulose and 95% ethanol at a concentration of 1g:1.5mL, the disintegrating agent is a mixture of low-substituted hydroxypropyl cellulose and crospovidone at a ratio of 1:1, the antioxidant is a mixture of vitamin C and sodium sulfite at a ratio of 1:1.1, and the flavoring agent is a mixture of mannitol and sucralose at a ratio of 1:1.

The preparation method comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 70 ℃ for 30min according to the prescription amount, cooling to room temperature, and irradiating for 20min by using high-pressure mercury lamp ultraviolet rays.

S2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water 5 times of the weight of the raw materials in the extraction tank, decocting for 2 times, decocting for 2 hours each time, and combining decoction.

S3, concentrating 20% of the decoction obtained in the step S2 into a clear paste with the specific gravity of 1.02, and concentrating the rest 80% of the decoction into a thick paste with the specific gravity of 1.33.

S5, placing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent into a CH-50 traditional Chinese medicine mixer (Hunan Zhongcheng pharmaceutical machinery factory) and mixing for 15min at a speed of 24 r/min. Adding the premix of the fluid extract and the adhesive in a ratio of 1:1.2, continuously mixing for 10min at a speed of 24r/min, pouring the mixture into a YK-100 granulator, and granulating. Spreading the obtained granules on a tray, and drying at 45 deg.C with a vacuum drier to obtain dried granules with water content of less than 3.0%.

S6, crushing the dried particles, and sieving the particles by a sieve of 100 meshes to obtain medicinal powder; placing the medicinal powder, antioxidant, correctant and 50% disintegrating agent in SCH-200 double-paddle mixer, premixing for 5min, adding refined honey with water content of 18% according to 95% of the weight of the mixture, stirring and mixing for 20min, wherein the mixer has no dry powder, the materials are completely wet, uniform and consistent in color and luster, and moderate in hardness. The mixed materials are made into pills by a full-automatic high-efficiency pill making machine (model YUJ-22A), the operating frequency of a roller cutter is 40Hz, the aperture of a strip plate is 3.9mm, and the prepared pills are round, uniform and consistent in color.

S7, drying the pills prepared in the step S6 until the water content is lower than 6.0%, and polishing to obtain the asthma pills. The specific polishing method comprises the following steps: putting the dried pills into a coating pan (model BYC-600, Guangzhou De mechanical engineering and Equipment Co., Ltd.), rotating for 10min at 15r/min to completely disperse the pills, adding 75% ethanol, wherein the ethanol dosage is calculated by 25mL/kg of pills, the rotating speed is adjusted to 35r/min, adding talcum powder (15 g/kg of pills) when the surfaces of the pills are completely wetted, continuously rotating until the pills are dry and have no white spots and patterns on the surfaces, have no unevenness and appear a little brightness, and stopping the machine. Dipping a lubricant consisting of sesame oil and beeswax (the proportion of beeswax to sesame oil is 8%) by a brush, coating the lubricant on the pills, starting the machine and continuing rotating for 12min at the rotating speed of 35r/min to obtain asthma pills with bright surfaces, wherein each 8 pills are 1g in weight and are small honeyed pills.

Example 4

The difference between the embodiment and the embodiment 1 is that the adhesive is prepared by mixing polyvinylpyrrolidone and 95% ethanol according to the concentration of 1g:1.5mL, the disintegrating agent is a mixture of crospovidone and croscarmellose sodium according to the weight ratio of 1:1, the antioxidant is prepared by mixing kaempferide, aurantiol and apigenin according to the weight ratio of 1:1:1.2, and the flavoring agent is a mixture of sorbitol and ethyl maltol according to the weight ratio of 1:1.

The rest is the same as example 1.

Example 5

This example differs from example 2 in that the binder is polyvinylpyrrolidone mixed with 95% ethanol at a concentration of 1g:1.2mL, the disintegrant is crospovidone, a mixture of croscarmellose sodium and croscarmellose sodium at a ratio of 1:1:1, the antioxidant is a mixture of sodium sulfite and sodium metabisulfite at a ratio of 1:2, and the flavoring agent is a mixture of sorbitol and aspartame at a ratio of 1:1.

The rest is the same as example 2.

Comparative example 1

This comparative example is different from example 1 in that step S1, i.e., no pretreatment of the chinese medicinal raw material, was not performed. The rest is the same as example 1.

Comparative example 2

The raw materials and the amounts of the raw materials of the comparative example were the same as those of example 2, and the preparation method was as follows:

drying 20 traditional Chinese medicine raw materials according to the prescription amount at 65 ℃, cooling to room temperature, crushing into fine powder, mixing uniformly, adding a binder, a disintegrating agent, an antioxidant and a flavoring agent, mixing uniformly again, adding refined honey, preparing into pills, and polishing to obtain the asthma pills. The honey is added to prepare pills, and the polishing method is the same as that of example 2. In the preparation process, the bamboo shavings are not crushed thoroughly, and the filament fibers of the bamboo shavings can be observed in some products, so that the qualified rate of the products is low.

Comparative example 3

This comparative example differs from example 3 in that:

s3, concentrating all decoction into thick paste with the specific gravity of 1.33;

s5, placing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and 50% of disintegrating agent into a CH-50 traditional Chinese medicine mixer (Hunan Zhongcheng pharmaceutical machinery factory) and mixing for 15min at a speed of 24 r/min. Adding adhesive, mixing at 24r/min for 10min, and granulating by pouring the mixture into YK-100 granulator. Spreading the obtained granules on a tray, and drying at 45 deg.C with a vacuum drier to obtain dried granules with water content of less than 3.0%.

The rest is the same as example 3.

Comparative example 4

This comparative example differs from example 1 in that the starting material is free of antioxidant.

Comparative example 5

The difference between the comparative example and the example 1 is that in the step S2, the dwarf lilyturf tuber, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed pinellia tuber are directly cut into pieces, placed in an extraction tank, added with water according to 3 times of the weight of the raw materials in the tank for decoction and extraction for 2 times, each time for 2 hours, and the decoction liquids are combined. The Chinese medicinal materials are not pulverized into coarse powder before decocting in water. The rest is the same as example 1.

Comparative example 6

This comparative example differs from example 1 in that the granulation process of step S5 was not performed, and step S6 was: mixing the fine powder prepared in the step S4, the thick paste prepared in the step S3 and a disintegrating agent, adding a premix of the clear paste and the adhesive in a ratio of 1:1, an antioxidant and a flavoring agent, uniformly mixing, adding refined honey, preparing pills, drying the pills, and polishing to obtain the asthma pills. The honey is added to prepare pills, and the polishing method is the same as that of example 1. The rest is the same as example 1.

Comparative example 7

The raw materials and the use amounts of the raw materials of the comparative example are the same as those of the example 2, and the preparation method comprises the following steps:

s1, drying 20 traditional Chinese medicine raw materials at 50 ℃ for 30min according to the prescription amount, cooling to room temperature, and irradiating for 10min by using high-pressure mercury lamp ultraviolet rays.

S2, mixing the radix ophiopogonis, the snakegourd fruit, the bamboo shavings, the radix scutellariae and the ginger processed in the step S1, crushing into coarse powder, putting the coarse powder into an extraction tank, adding water 10 times of the weight of the raw materials in the extraction tank, decocting for 1 time, and decocting for 2 hours to obtain a decoction.

S3, the same as the embodiment 2.

S4, the same as the embodiment 2.

S5, the difference from the example 2 is that all the disintegrating agent is added, the prepared granules are dried at 40 ℃, and the moisture content of the dried granules is 6.5%.

S6, crushing the dried particles, and sieving the particles by a sieve of 100 meshes to obtain medicinal powder; the medicine powder, the antioxidant and the flavoring agent are placed in an SCH-200 double-paddle mixer, refined honey with 20% of water is added according to 98% of the weight of the mixed material, the mixture is mixed for 20min, the powder is adhered to the inner wall of the mixer, the material has uneven color, the mixture is continuously mixed for 30min, the color and the luster of the material are still very uneven, and therefore the process condition of the comparative example is not suitable.

Test example 1

The asthma pills prepared in examples 1 to 5 and comparative examples 1 to 6 were stored at 26 ℃ for half a year in an environment with a relative humidity of 80%, and the mold and Escherichia coli tests were carried out according to the microbial limit inspection regulations of non-sterile products in pharmacopeia formulation general rules, and the test results are shown in Table 1.

As can be seen from the data of table 1, the asthma pills prepared in each example had a significantly lower number of mold colonies than the comparative examples after half a year of storage, and the asthma pills prepared in each example were not contaminated with escherichia coli during storage. Comparative example 1 (no pretreatment of the Chinese medicinal materials) and comparative example 2 (the Chinese medicinal materials were not treated with ultraviolet irradiation, all the materials were crushed into the drug) were most seriously contaminated with mold and Escherichia coli, indicating that the heating of the Chinese medicinal materials and the pretreatment with ultraviolet irradiation are very important for the preservation of the product. The asthma pills prepared in comparative example 4 (without antioxidant) and comparative example 6 (without the granulation process of step S5) were contaminated not only with mold but also with escherichia coli during storage, indicating that the antioxidant and granulation processes have a significant impact on the storage of the product. Asthma pills prepared in comparative example 3 (only binder is added during granulation, no clear paste is prepared) and comparative example 5 (the traditional Chinese medicine raw materials extracted by decocting with water are not crushed into coarse powder) are not polluted by escherichia coli, but the number of moulds is slightly higher than that of each example. Therefore, the process conditions of the invention act synergistically, the stability of the product is improved, and the contamination rate in the preservation process is reduced.

	Total number of mold colonies (cfu/g)	Escherichia coli (cfu/g)
			Example 1	78	0
Example 2	85	0
			Example 3	80	0
Example 4	74	0
			Example 5	81	0
Comparative example 1	196	48
			Comparative example 2	173	42
Comparative example 3	90	0
			Comparative example 4	99	26
Comparative example 5	87	0
			Comparative example 6	92	5

Table 1.

Test example 2

The clinical data relating to the asthma pills prepared in examples 1 to 5 and comparative examples 1 to 6 are as follows:

selection criteria of case

Bronchial asthma, a chronic airway inflammation involving a variety of cells, particularly mast cells, eosinophils, and T lymphocytes; in susceptible individuals, this inflammation can cause recurrent wheezing, shortness of breath, chest tightness and/or coughing, which often occur at night or early in the morning; such symptoms are often accompanied by a wide and variable limitation in expiratory flow rate, but may be partially naturally or therapeutically alleviated; this condition is also accompanied by an increased responsiveness of the airways to various stimulatory factors.

All the above symptoms were used as the selection criteria of the cases.

Second, diagnosis standard (Standard drawn by Chinese medical society respiratory disease society)

(1) Rely on medical history and signs and rule out other diseases that can cause asthma or dyspnea. (2) The symptoms are characterized in that: wheezing episodes are associated with allergens or irritants; it is mostly a sudden wheeze at rest, followed by a cough; bronchodilator aerosol inhalation can improve or stop wheezing. (3) Reference conditions: (iii) incorporation of other allergic diseases; positive allergen skin test; FEVI can be increased by more than 15% after 1% isoproterenol or 0.2% albuterol inhalation; after administration of bronchodilators, wheezing in the lung may be reduced or eliminated.

Third, treatment scheme

The patients take 10g pills each time, 2 times daily, 15 days are 1 course of treatment, and the curative effect is evaluated after the 3 rd course of treatment.

Fourth, the evaluation criteria of curative effect

Cure (clinical control): mild with asthmatic symptoms and absence or deficiency of lung wheezing.

The effect is shown: asthmatic symptoms and pulmonary wheezing were significantly improved (+ + + → or +).

The method has the following advantages: asthmatic symptoms and pulmonary wheezing were improved (+ + + + + → + + or → +).

And (4) invalidation: wheezing symptoms and pulmonary wheezing are not improved or aggravated.

Fifth, statistical treatment

According to the treatment scheme, 660 patients are clinically used, and the age is 8 years minimum and 70 years maximum. The shortest disease course is 5 months, the longest disease course is 20 years, and the average disease course is 8.2 years. Patients were randomized to A, B, C, D for examples 1-5 and F, G, H, I, J for comparative examples 1-6, respectively, and the therapeutic effect after 3 treatment courses is shown in Table 2.

As can be seen from the data in table 2, the asthma pill prepared in each example of the present invention has better curative effect than the asthma pill prepared in each proportion, which indicates that each step and component in the preparation method of the present invention act synergistically to improve the curative effect of the asthma pill. In the treatment process, no allergy phenomenon or serious adverse reaction occurs, and the patients cured by the method do not relapse after half-year follow-up. In addition, the medicine taking patient also reflects that the product has good taste and convenient taking.

Group of	Number of people	Cure of disease	Show effect	Is effective	Invalidation	Total effective rate (%)
							A	68	24	30	12	2	97.06
B	62	19	27	16	0	100
							C	64	21	25	17	1	98.44
D	58	15	24	18	1	98.28
							E	60	16	26	16	2	96.67
F	56	10	21	17	8	85.71
							G	60	11	19	20	10	83.33
H	57	6	15	24	12	78.95
							I	56	7	14	25	10	82.14
J	63	9	18	27	9	85.71
							K	56	8	16	24	8	85.71

Table 2.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention.

Claims

1. The preparation method of the asthma pill is characterized in that the raw materials comprise 20 traditional Chinese medicine raw materials and auxiliary materials, and the traditional Chinese medicine raw materials comprise the following components in parts by weight: 25-35 parts of rhizoma anemarrhenae, 20-30 parts of bulbus fritillariae cirrhosae, 25-35 parts of fried bitter almond, 25-35 parts of poppy shell, 40-50 parts of radix ophiopogonis, 50-60 parts of semen ginkgo, 40-50 parts of trichosanthes kirilowii maxim, 15-25 parts of honey-fried ephedra, 15-25 parts of schisandra chinensis, 20-30 parts of betel nut, 25-35 parts of myrobalan pulp, 20-30 parts of dark plum pulp, 15-25 parts of rhizoma arisaematis, 25-35 parts of caulis bambusae in taeniam, 10-30 parts of coptis chinensis, 25-35 parts of radix scutellariae, 25-35 parts of ginger processed pinellia, 40-50 parts of fried fructus aurantii, 15-25 parts of perilla leaf and 20-30 parts of radix peucedani: adhesive, disintegrating agent, antioxidant, correctant and refined honey;

the preparation method of the asthma pill comprises the following steps:

2. The preparation method according to claim 1, characterized in that, calculated by weight, the adhesive is 25-35 parts, the disintegrating agent is 20-30 parts, the antioxidant is 15-25 parts, and the flavoring agent is 2-5 parts.

3. The method of claim 2, further comprising at least one of the following features: the drying time in the step S1 is 30-40 min;

the ultraviolet irradiation time in the step S1 is 15-20 min;

4. The preparation method according to claim 2, wherein the weight ratio of the fluid extract in the premix added in step S5 to the binder is 1: 1-1.2.

5. The method according to claim 2, wherein the binder is a mixture of polyvinylpyrrolidone and ethanol at a ratio of 1g:1.2-1.5mL, or a mixture of sodium carboxymethylcellulose and ethanol at a ratio of 1g:1.2-1.5 mL.

6. The method of any one of claims 1 to 5, further comprising at least one of the following technical features:

7. The preparation method according to any one of claims 1 to 5, wherein the antioxidant is a mixture of kaempferol, sinensetin and apigenin or one or more selected from sodium sulfite, sodium metabisulfite and vitamin C, wherein the weight ratio of kaempferol, sinensetin and apigenin is 1:1: 1-1.2.

8. The method according to any one of claims 1 to 5, wherein the refined honey has a moisture content of 14 to 18%.

9. An asthma pill prepared by the preparation method according to any one of claims 1 to 8.