Preparation method of traditional Chinese medicine preparation for allergic cough of upper respiratory tract

Abstract

The invention provides a preparation method of a traditional Chinese medicine preparation for upper respiratory tract allergic cough, and relates to the technical field of traditional Chinese medicine, the preparation method comprises the following steps: sequentially crushing and uniformly mixing traditional Chinese medicine raw materials including platycodon grandiflorum, honeysuckle, pericarpium citri reticulatae, houttuynia cordata and rhizoma phragmitis, grinding into powder, adding water and pectinase for primary enzymolysis, and filtering to obtain filtrate; after enzymolysis is completed, cellulase is added for secondary enzymolysis, after secondary enzymolysis is completed, enzymatic hydrolysate is subjected to enzyme deactivation and centrifugation in sequence, and supernate is taken as a traditional Chinese medicine extracting solution I; accurately weighing residual traditional Chinese medicine raw materials, and preparing a traditional Chinese medicine extracting solution II according to the method; (3) preparing a fermentation culture medium from the traditional Chinese medicine extracting solution I, inoculating probiotics for fermentation, and sterilizing and filtering an obtained fermentation product to obtain filtrate; and uniformly mixing the filtrate with the traditional Chinese medicine extract II to obtain the fermented traditional Chinese medicine preparation. The traditional Chinese medicine composition has a remarkable effect of preventing and treating recurrence of recurrent respiratory tract allergic cough and is more easily accepted by patients, so that the traditional Chinese medicine composition has higher clinical application and popularization values.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a method for preparing a traditional Chinese medicine preparation for upper respiratory tract allergic cough. Technical Background

[0002] Allergic diseases are one of the diseases with a high incidence rate at present. About 20%-30% of the population have been or are suffering from this disease. Among allergic diseases, inhalation allergy is the most common, accounting for about 65% of allergic diseases. The incidence of allergic diseases is increasing year by year, especially in developed countries such as Europe, America, and Japan, where the incidence rate is higher than that in developing countries. The main diseases caused by inhalation allergens are: allergic asthma, allergic rhinitis, allergic eczema, urticaria, allergic dermatitis, allergic conjunctivitis, etc. Among inhalation allergic diseases, the most cases are caused by pollen, mites, fungi, animal fur, etc.

[0003] For the treatment of upper respiratory tract allergic cough, in the past, cough suppressants, antibiotics and other Western medicines were mainly used for treatment, which can alleviate the clinical manifestations of patients such as cough to a certain extent, but the long-term treatment effect is not ideal and it is very easy to cause the disease to recur. Therefore, in order to select better treatment measures, the present invention provides a fermented Chinese medicine preparation that can effectively prevent and treat respiratory allergic diseases and a preparation method thereof. Summary of the invention

[0004] In order to solve the problems existing in the prior art, the present invention provides a method for preparing a traditional Chinese medicine preparation for upper respiratory tract allergic cough.

[0005] To achieve the above object, the present invention proposes the following scheme:

[0006] A method for preparing a traditional Chinese medicine preparation for upper respiratory tract allergic cough comprises the following steps:

[0007] 1) crushing, mixing and grinding the Chinese medicine raw materials Platycodon grandiflorum, honeysuckle, dried orange peel, houttuynia cordata and rhizome of Phragmites australis in sequence, adding water and pectinase for primary enzymolysis, adding cellulase for secondary enzymolysis after the enzymolysis is completed, and killing enzymes and centrifuging the enzymolysis solution in sequence after the secondary enzymolysis is completed, and taking the supernatant as Chinese medicine extract I;

[0008] 2) Accurately weigh the remaining Chinese medicinal materials, and prepare Chinese medicinal extract II according to the method described in step 1);

[0009] 3) using the Chinese medicine extract I in step 1) to prepare a fermentation medium, inoculating probiotics for fermentation, sterilizing and filtering the resulting fermentation product to obtain a filtrate; and mixing the filtrate with the Chinese medicine extract II obtained in step 2) to obtain the fermented Chinese medicine preparation;

[0010] The raw material components are prepared from: 10-15 parts of platycodon, 10-15 parts of honeysuckle, 10-15 parts of forsythia leaves, 1-5 parts of ganoderma lucidum, 1-5 parts of tangerine peel, 1-5 parts of almond, 1-5 parts of houttuynia, 1-5 parts of dandelion, 1-3 parts of mint, 1-5 parts of liquorice, 1-5 parts of reed root, and 1-5 parts of lily.

[0011] Preferably, in step 1), the weight ratio of the Chinese medicinal material to water is 1:4-6, the weight ratio of the Chinese medicinal material to pectinase is 1:0.015-0.025, and the weight ratio of the Chinese medicinal material to cellulase is 1:0.02-0.03.

[0012] Preferably, the temperature of the first enzymolysis in step 1) is 40-55°C for 50-60 hours, and the temperature of the second enzymolysis is 45-55°C for 40-50 hours.

[0013] Preferably, the probiotics in step 3) are one or more of Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus faecalis and Lactobacillus bulgaricus.

[0014] Preferably, the number of probiotics is 0.9 to 2.4×10 8 Pieces / ml.

[0015] Preferably, the composition of the fermentation medium in step 3) is: 1L of fermentation medium includes 42-48g millet, 8-12g wheat bran, 20-24g glucose, 0.6-0.8g magnesium sulfate, 2.2-2.7g yeast extract, 3-5g peptone, 0.06-0.1g VB1, 0.3-0.5g K2HPO4, 0.8-1.2g KH2PO4, 1-3g white sugar, 0.01-0.02g VB6, and the rest is traditional Chinese medicine extract I.

[0016] Preferably, in step 3), the fermentation temperature is 35-38° C. and the fermentation time is 16-24 hours.

[0017] The present invention discloses the following technical effects:

[0018] 1. The following is a detailed introduction and function of each raw material component:

[0019] Platycodon grandiflorum: bitter and pungent in taste, neutral in nature; enters the lung meridian, used for clearing the lungs, relieving sore throat, removing phlegm, and discharging pus; mainly used to treat cough with excessive phlegm, chest tightness, sore throat and hoarseness, and lung abscess with pus.

[0020] Honeysuckle: sweet in taste, cold in nature; enters the lung and stomach meridians, used for clearing away heat and detoxifying, relieving inflammation and reducing swelling; mainly used to treat exogenous wind-heat or fever due to febrile disease, heatstroke, heat-toxic bloody diarrhea, carbuncles, furuncles, throat paralysis, and various infectious diseases.

[0021] Forsythia Leaf: bitter, cool in nature; enters the heart, liver, and gallbladder meridians, used to clear away heat, detoxify, disperse knots, and reduce swelling. Indications: febrile disease, erysipelas, macules, carbuncle, ulcer, scrofula, and urinary retention.

[0022] Lingzhi: sweet, neutral; enters the heart, lung, liver, and kidney meridians, used to replenish qi and calm the mind, relieve cough and asthma. Indications: restlessness, insomnia, palpitations: this product is sweet and neutral in nature, enters the heart meridian, can replenish heart blood, benefit heart qi, and calm the mind, so it can be used to treat restlessness, insomnia, palpitations, dreaminess, forgetfulness, fatigue, and loss of appetite caused by insufficient qi and blood, and malnutrition of the mind. Cough, asthma, and excessive sputum: sweet and nourishing, neutral and slightly warm in nature, enters the lung meridian, replenishes lung qi, warms the lungs and resolves phlegm, relieves cough and asthma, and can often treat phlegm and fluid syndrome, especially for those with cold cough, excessive sputum and asthma, especially for phlegm-damp type or deficiency-cold type; Asthenia syndrome: it has the effect of nourishing qi and blood, so it can often be used to treat asthenia, shortness of breath, loss of appetite, cold hands and feet, or irritability and dry mouth.

[0023] Tangerine peel: bitter, pungent, warm in nature; enters the lung and spleen meridians, used to regulate qi and strengthen the spleen, dry dampness and resolve phlegm. Indications: abdominal distension, loss of appetite, vomiting and diarrhea, cough and excessive phlegm.

[0024] Apricot kernel: warm in nature, bitter in taste; slightly toxic. Enters the lung and large intestine meridians. Used to lower qi, relieve cough and asthma, and moisten the intestines and promote bowel movements.

[0025] Houttuynia cordata: spicy in taste, slightly cold in nature; enters the lung meridian; used to clear away heat and detoxify, eliminate carbuncle and discharge pus, promote diuresis and relieve stranguria; mainly used to treat lung abscess with vomiting pus, phlegm-heat, wheezing and cough, hot dysentery, hot stranguria, carbuncle, swelling and ulcer.

[0026] Dandelion: bitter, sweet, cold in nature; enters the liver and stomach meridians, used to clear away heat and detoxify, reduce swelling and resolve stagnation, and promote diuresis and relieve stranguria. It is mainly used to treat carbuncle, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and hot stranguria with astringent pain.

[0027] Peppermint: pungent, cool in nature; enters the lung and liver meridians, used to dispel wind-heat, clear the head, relieve sore throat and rash, soothe the liver and promote qi. It is mainly used to treat exogenous wind-heat, headache, sore throat, food stagnation and bloating, mouth sores, toothache, scabies, urticaria, early stage of febrile disease, itchy urticaria, liver depression and qi stagnation, chest tightness and flank pain.

[0028] Licorice: sweet, neutral in nature; enters the heart, lung, spleen, and stomach meridians, used to tonify the spleen and replenish qi, clear away heat and detoxify, eliminate phlegm and relieve cough, relieve pain, and harmonize various medicines. It is mainly used to treat spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle, sore and ulcer, and relieve drug toxicity and potency.

[0029] Reed root: sweet in taste, cold in nature. Enters the lung and stomach meridians; used to clear away heat and promote body fluid, relieve restlessness, stop vomiting, and promote urination; mainly used to treat fever, thirst, stomach heat, vomiting, lung heat, cough, lung abscess, pus vomiting, and hot and painful stranguria.

[0030] Lily: sweet in taste, cold in nature; enters the heart and lung meridians, used to nourish yin and moisten the lungs, clear the heart and calm the mind; mainly treats yin deficiency and dry cough, cough due to fatigue and hemoptysis, restlessness and palpitations, insomnia and dreaminess, and mental confusion.

[0031] 2. The present invention uses pectinase and cellulase to extract Chinese herbal medicines, so that the effective functional substances in the Chinese herbal medicine raw materials can be fully released to improve the extraction rate of effective medicinal ingredients. In addition, the present invention uses the extracts of Platycodon grandiflorum, honeysuckle, tangerine peel, Houttuynia cordata, and Phragmites australis as fermentation raw materials, uses probiotic fermentation to carry out biotransformation of medicinal materials, optimizes the fermentation culture formula, and controls the fermentation temperature and time to further optimize the content of effective active ingredients in the Chinese herbal medicine extract. For example, the chlorogenic acid content of honeysuckle is significantly increased after fermentation, and some substances with lower biological activity are converted into substances with stronger biological activity. The macromolecular substances of Chinese medicine can also be converted into small molecular components that can be directly absorbed by the body's intestines through microorganisms, which are easier to be used by the body. At the same time, a large amount of beneficial metabolites such as organic acids and lactobacilli will be produced during the fermentation process, which also helps to improve the body's immunity.

[0032] 3. The medicinal materials of the present invention can be combined with the remaining Chinese medicinal raw materials after fermentation to increase the content of effective active ingredients and maintain the efficacy of probiotics, thereby improving the content of effective ingredients of each raw material component in the finally prepared fermented Chinese medicinal preparation, so that the fermented Chinese medicinal preparation of the present invention has multiple functions such as descending lung qi, clearing away heat and detoxifying, relieving cough, promoting the balance of gastrointestinal microecology of patients, and enhancing the immune function of patients; at the same time, through the fermentation of probiotics, the active ingredients of Chinese medicine can be protected from being destroyed, the efficacy of the medicine can be enhanced, and medicinal resources can be saved.

[0033] 4. The fermented Chinese medicine preparation of the present invention takes a holistic view, combines syndrome differentiation with disease differentiation, and combines strengthening the body with eliminating pathogenic factors according to the principle of syndrome differentiation and treatment, comprehensively improves the clinical manifestations of patients such as cough, and improves their prognosis level from a comprehensive consideration of multiple targets; compared with Western medicine, the fermented Chinese medicine preparation of the present invention can not only resist allergic reactions for the treatment of allergic diseases, but also regulate the immune system, such as the functions of tonifying the spleen and replenishing qi, nourishing yin and moistening the lungs, and calming the mind, so as to achieve the effect of treating both the symptoms and the root causes; and the fermented Chinese medicine preparation of the present invention is a compound preparation composed of 12 Chinese herbal medicines, not only a single component, but also has multiple target sites and a wide range of effects, so it has less drug resistance, which has obvious advantages compared with Western medicine with a single target, relatively easy drug resistance, and long-term clinical medication that requires continuous dosage; in addition, the fermented Chinese medicine preparation of the present invention is non-toxic to animals and humans, simple to operate, safe to use, and has a significant effect on preventing and treating recurrent respiratory allergic cough recurrence, and is more easily accepted by patients, so it has a high clinical application and promotion value. DETAILED DESCRIPTION

[0034] The present invention will be further described below in conjunction with embodiments. The embodiments of the present invention are only used to describe the technical solutions of the present invention and are not intended to limit the present invention.

[0035] Example 1

[0036] Preparation method of traditional Chinese medicine preparation for upper respiratory tract allergic cough

[0037] 1. Preparation of Chinese medicine extract:

[0038] Preparation of Chinese herbal medicine extract Ⅰ:

[0039] (1) accurately weighing 10 parts by weight of Platycodon grandiflorum, 10 parts by weight of honeysuckle, 1 part by weight of dried orange peel, 1 part by weight of houttuynia cordata, and 1 part by weight of reed root, respectively, and pulverizing them through a 60-mesh sieve, then mixing all the materials and grinding them into powder to prepare a mixed material I;

[0040] (2) placing the mixed material I obtained in step (1) in an enzymolysis tank, and adding distilled water 4 times the total weight of the mixed material I and pectinase 0.015 times the total weight of the mixed material I in the enzymolysis tank, after the addition, mixing all the materials and adding lactic acid to adjust the pH to 4.5, then enzymolyzing all the materials at a temperature of 40° C. for 50 hours, stirring continuously in the middle, after the enzymolysis is completed, adding cellulase 0.02 times the total weight of the mixed material I to the enzymolysis tank, and then enzymolyzing at 45° C. for 40 hours, stirring continuously in the middle, after the enzymolysis is completed again, heating the enzymolysis solution to boil and inactivate the enzyme for 10 minutes, centrifuging at 3000 r / min for 15 minutes, and finally taking the supernatant to obtain the Chinese medicine extract I;

[0041] Preparation of Chinese medicine extract II:

[0042] 10 parts by weight of Forsythia suspensa leaves, 1 part by weight of Ganoderma lucidum, 1 part by weight of Apricot kernel, 1 part by weight of Taraxacum officinale, 1 part by weight of Mint, 1 part by weight of Lilium bark, and 1 part by weight of Lilium bark were accurately weighed, and Chinese medicine extract II was prepared according to the preparation method of Chinese medicine extract I.

[0043] 2. Bacteria activation:

[0044] Use an inoculation loop to pick up Lactobacillus acidophilus strains and place them in a sterilized activation medium. After streaking on the medium, invert the plate and culture at 36° C. for 36 hours to obtain activated Lactobacillus acidophilus.

[0045] 3. Prepare seed solution

[0046] (1) inoculating the activated Lactobacillus acidophilus strain into a sterile seed culture medium, and shaking culture at 37° C. for 23 h at a rotation speed of 120 r / min to serve as a primary seed solution;

[0047] (2) The first-level seed solution was taken at an inoculation volume of 6 vol%, inoculated into the expansion culture medium, and cultured statically in an incubator at 36° C. for 12 h to serve as the second-level seed solution.

[0048] 4. Seed tank fermentation

[0049] The secondary seed liquid was added into the seed tank at a ratio of 8 vol%, and the tank pressure during the fermentation process of the seed tank was controlled at 0.02 MPa, the compressed air flow rate was controlled at 4 L / min, the rotation speed was controlled at 200 rpm, the ventilation ratio was 1:0.8, and the culture was carried out at 35°C for 16 hours to obtain the tertiary seed liquid;

[0050] The components of the culture medium for seed culture medium, expansion culture medium and seed tank are the same, which are:

[0051] Each 1L of culture medium includes: 42g millet, 8g wheat bran, 20g glucose, 0.6g magnesium sulfate, 2.2g yeast extract, 3g peptone, 0.06g VB1, 0.3g K2HPO4, 0.8g KH2PO4, 1g white sugar, 0.01g VB6, and the rest is water; adjust its pH to 5.8 and sterilize at 121℃ for 30 minutes.

[0052] The number of Lactobacillus acidophilus in the third-grade seed solution was 1×10 9 Pieces / ml.

[0053] 5. Preparation of fermented Chinese medicine preparations

[0054] (1) Preparation of fermentation medium containing Chinese medicine extract I

[0055] The formula of each 1L fermentation medium is: 42g millet, 8g wheat bran, 20g glucose, 0.6g magnesium sulfate, 2.2g yeast extract, 3g peptone, 0.06g VB1, 0.3g K2HPO4, 0.8g KH2PO4, 1g white sugar, 0.01g VB6, and the rest is Chinese medicine extract I; adjust the pH to 5.8 and sterilize at 121℃ for 30 minutes.

[0056] (2) Preparation of fermented Chinese medicine mixture

[0057] The third-grade seed liquid was inoculated into a fermentation tank at an inoculation rate of 9 vol%, and the tank pressure of the fermentation tank was controlled at 0.02 MPa, the compressed air flow rate was controlled at 20 L / min, the rotation speed was controlled at 150 rpm, and the ventilation ratio was controlled at 1:0.5 during the fermentation process; the fermentation was carried out at 35° C. for 16 hours to obtain a fermented Chinese medicine mixture;

[0058] (3) Preparation of fermented Chinese medicine preparations

[0059] First, the fermented Chinese medicine mixture of step (2) is sterilized under high pressure at 121° C. for 30 min to inactivate the bacteria, and then the fermented Chinese medicine mixture is filtered, and the filtrate is centrifuged at 3500 r / min for 15 min to obtain a supernatant. Finally, the supernatant is mixed with the Chinese medicine extract II obtained in step 1 to obtain the fermented Chinese medicine preparation of the present invention, and the final crude drug content in the preparation is 0.4 g per 1 mL.

[0060] 6. Preparation of fermented Chinese medicine preparations

[0061] (1) When the dosage form of the Chinese medicine preparation of the present invention is granules, the preparation method thereof comprises the following steps:

[0062] First, the fermented Chinese medicine preparation described in step 5 is concentrated at 60° C. to a paste with a relative density of 1.25, and then the paste is spread on a drying plate, the spread amount is set to 5.5 kg / plate, the material temperature is set to 90° C., the hysteresis temperature is 1° C., the vacuum degree is -0.08 MPa, and microwave vacuum drying is performed to obtain a dry paste powder; then, 5% of the total weight of L-arabinose, 10% of oat bran powder and 5% of soy protein isolate are added to the dry paste powder, and the powder is placed in a granulator to prepare granules, and the granules are packaged at 0.5 g / granule to obtain granules.

[0063] (2) When the dosage form of the Chinese medicine preparation of the present invention is a tablet, the preparation method thereof comprises the following steps:

[0064] The dry powder prepared in step (1) is added with 5% of the total mass of microcrystalline cellulose, 10% of sorbitol, 1% of magnesium stearate and 1% of silicon dioxide, mixed evenly, and placed in a tablet press to make tablets, each weighing 0.5 g.

[0065] (3) When the dosage form of the Chinese medicine preparation of the present invention is an oral liquid, the preparation method thereof comprises the following steps:

[0066] The fermented Chinese medicine preparation prepared in step 5 is added with 7% honey, 0.4% citric acid, 1.5% sucrose and 0.4% stevioside in terms of the total weight thereof to prepare a mixed solution, which is first homogenized at a temperature of 70° C. and a homogenization pressure of 10 MPa; the homogenized mixed solution is then instantaneously sterilized at 130° C. and then filled into a 10 ml bottle under a vacuum aseptic environment; and the finished product after the filling is stored at room temperature after passing the inspection.

[0067] Example 2

[0068] Preparation method of traditional Chinese medicine preparation for upper respiratory tract allergic cough

[0069] 1. Preparation of Chinese medicine extract:

[0070] Preparation of Chinese herbal medicine extract Ⅰ:

[0071] (1) accurately weighing 13 parts by weight of Platycodon grandiflorum, 13 parts by weight of honeysuckle, 3 parts by weight of dried orange peel, 3 parts by weight of houttuynia cordata, and 3 parts by weight of reed root, respectively, and grinding them through an 80-mesh sieve, then mixing all the materials and grinding them into powder to prepare a mixed material I;

[0072] (2) placing the mixed material I obtained in step (1) in an enzymolysis tank, and adding distilled water 5 times the total weight of the mixed material I and pectinase 0.02 times the total weight of the mixed material I in the enzymolysis tank, after the addition is completed, all the materials are mixed and lactic acid is added to adjust the pH to 5.0, and then all the materials are enzymolyzed at a temperature of 50° C. for 55 hours, stirring continuously in the middle, and after the enzymolysis is completed, 0.025 times the total weight of cellulase of the mixed material I is added to the enzymolysis tank, and then enzymolyzed at 48° C. for 45 hours, stirring continuously in the middle, and after the enzymolysis is completed again, the enzymolysis solution is heated and boiled to inactivate the enzyme for 10 minutes, centrifuged at 3000 r / min for 15 minutes, and finally the supernatant is taken to obtain the Chinese medicine extract I;

[0073] Preparation of Chinese medicine extract II:

[0074] 13 parts by weight of Forsythia suspensa leaves, 3 parts by weight of Ganoderma lucidum, 3 parts by weight of Apricot kernel, 3 parts by weight of Taraxacum officinale, 2 parts by weight of Peppermint, 3 parts by weight of Lily, and 3 parts by weight of Lilium were accurately weighed, and then Chinese medicine extract II was prepared according to the preparation method of Chinese medicine extract I.

[0075] 2. Bacteria activation:

[0076] Use an inoculation loop to pick up Lactobacillus acidophilus strains and place them in a sterilized activation medium. After streaking on the medium, invert the plate and culture at 37° C. for 36 hours to obtain activated Lactobacillus acidophilus.

[0077] 3. Prepare seed solution

[0078] (1) inoculating the activated Lactobacillus acidophilus strain into a sterile seed culture medium, and shaking culture at 37° C. for 24 h at a rotation speed of 120 r / min to serve as a primary seed solution;

[0079] (2) Take the first-level seed solution at an inoculation volume of 7 vol% and inoculate it into the expansion culture medium. Incubate it in an incubator at 37°C for 20 hours to serve as the second-level seed solution.

[0080] 4. Seed tank fermentation

[0081] The secondary seed liquid was added into the seed tank at a ratio of 9%. During the fermentation process of the seed tank, the tank pressure was controlled at 0.04 MPa, the compressed air flow was controlled at 14 L / min, the rotation speed was controlled at 220 rpm, the ventilation ratio was 1:0.8, and the culture was carried out at 36°C for 20 hours to obtain the tertiary seed liquid;

[0082] The components of the culture medium for seed culture medium, expansion culture medium and seed tank are the same, which are:

[0083] Each 1L of culture medium includes: 45g millet, 10g wheat bran, 22g glucose, 0.7g magnesium sulfate, 2.5g yeast extract, 4g peptone, 0.08g VB1, 0.4g K2HPO4, 1g KH2PO4, 2g white sugar, 0.01g VB6, and the rest is water; adjust its pH to 6.0 and sterilize at 121℃ for 35 minutes.

[0084] The number of Lactobacillus acidophilus in the third-grade seed liquid was 1.5×10 9 Pieces / ml.

[0085] 5. Preparation of fermented Chinese medicine preparations

[0086] (1) Preparation of fermentation medium containing Chinese medicine extract I

[0087] The formula of each 1L fermentation medium is: 45g millet, 10g wheat bran, 22g glucose, 0.7g magnesium sulfate, 2.5g yeast extract, 4g peptone, 0.08g VB1, 0.4g K2HPO4, 1g KH2PO4, 2g white sugar, 0.01g VB6, and the rest is Chinese medicine extract I; adjust its pH to 6.0 and sterilize at 121℃ for 35 minutes.

[0088] (2) Preparation of fermented Chinese medicine mixture

[0089] The third-grade seed liquid is added to the fermentation tank at a ratio of 10%, and the tank pressure of the fermentation tank is controlled at 0.04MPa, the compressed air flow rate is controlled at 50L / min, the rotation speed is controlled at 180rpm, and the ventilation ratio is controlled at 1:0.6 during the fermentation process; the fermentation is carried out at 37°C for 20 hours to obtain a fermented Chinese medicine mixture;

[0090] (3) Preparation of fermented Chinese medicine preparations

[0091] First, the fermented Chinese medicine mixture of step (2) is sterilized under high pressure at 121° C. for 30 min to inactivate the bacteria, and then the fermented Chinese medicine mixture is filtered, and the filtrate is centrifuged at 3500 r / min for 15 min to obtain a supernatant. Finally, the supernatant is mixed with the Chinese medicine extract II obtained in step 1 to obtain the fermented Chinese medicine preparation of the present invention, and the final crude drug content in the preparation is 0.5 g of crude drug per 1 mL.

[0092] 6. Preparation of fermented Chinese medicine preparations

[0093] (1) When the dosage form of the Chinese medicine preparation of the present invention is granules, the preparation method thereof comprises the following steps:

[0094] First, the fermented Chinese medicine preparation described in step 5 is concentrated at 65° C. to a paste with a relative density of 1.28, and then the paste is spread on a drying plate, the spread amount is set to 5.5 kg / plate, the material temperature is set to 90° C., the hysteresis temperature is 1° C., the vacuum degree is -0.08 MPa, and microwave vacuum drying is performed to obtain a dry paste powder; then, 8% of the total weight of L-arabinose, 15% of oat bran powder and 8% of soy protein isolate are added to the dry paste powder, and the powder is placed in a granulator to prepare granules, and the granules are packaged at 0.5 g / granule to obtain granules.

[0095] (2) When the dosage form of the Chinese medicine preparation of the present invention is a tablet, the preparation method thereof comprises the following steps:

[0096] The dry paste powder obtained in step (1) is added with 8% of the total mass of microcrystalline cellulose, 15% of sorbitol, 1.5% of magnesium stearate and 1.5% of silicon dioxide, mixed evenly, and placed in a tablet press to tablet, with one tablet weighing 0.5 g.

[0097] (3) When the dosage form of the Chinese medicine preparation of the present invention is an oral liquid, the preparation method thereof comprises the following steps:

[0098] The fermented Chinese medicine preparation prepared in step 5 is added with 8% of the total weight of honey, 0.5% of citric acid, 2% of sucrose and 0.5% of stevioside to prepare a mixed solution, and the mixed solution is first homogenized at a temperature of 72° C. and a homogenization pressure of 13 MPa; the homogenized mixed solution is then instantaneously sterilized at 130° C. and the sterilized mixed solution is filled into a 10 ml bottle under a vacuum aseptic environment; finally, the finished product after the filling is stored at room temperature after passing the inspection.

[0099] Example 3

[0100] Preparation method of traditional Chinese medicine preparation for upper respiratory tract allergic cough

[0101] 1. Preparation of Chinese medicine extract:

[0102] Preparation of Chinese herbal medicine extract Ⅰ

[0103] (1) accurately weighing 15 parts by weight of Platycodon grandiflorum, 15 parts by weight of honeysuckle, 5 parts by weight of dried orange peel, 5 parts by weight of houttuynia cordata, and 5 parts by weight of reed root, respectively, and grinding them through a 100-mesh sieve, and then mixing all the materials and grinding them into powder to prepare a mixed material I;

[0104] (2) placing the mixed material I obtained in step (1) in an enzymolysis tank, and adding distilled water 6 times the total weight of the mixed material I and pectinase 0.025 times the total weight of the mixed material I in the enzymolysis tank, after the addition is completed, all the materials are mixed and lactic acid is added to adjust the pH to 5.5, and then all the materials are enzymolyzed at a temperature of 55° C. for 60 hours, stirring continuously in the middle, after the enzymolysis is completed, 0.03 times the total weight of cellulase of the mixed material I is added to the enzymolysis tank, and then enzymolyzed at 55° C. for 50 hours, stirring continuously in the middle, after the enzymolysis is completed again, the enzymolysis solution is heated and boiled to inactivate the enzyme for 10 minutes, centrifuged at 3000 r / min for 15 minutes, and finally the supernatant is taken to obtain the Chinese medicine extract I;

[0105] Preparation of Chinese herbal medicine extract Ⅱ

[0106] 15 parts by weight of Forsythia suspensa leaves, 5 parts by weight of Ganoderma lucidum, 5 parts by weight of Apricot kernel, 5 parts by weight of Taraxacum officinale, 3 parts by weight of Peppermint, 5 parts by weight of Liquorice and 5 parts by weight of Lilium were accurately weighed and then Chinese medicine extract II was prepared according to the preparation method of Chinese medicine extract I.

[0107] 2. Bacteria activation:

[0108] Use an inoculation loop to pick up Lactobacillus acidophilus strains and place them in a sterilized activation medium. After streaking on the medium, invert the plate and culture at 38° C. for 36 hours to obtain activated Lactobacillus acidophilus.

[0109] 3. Prepare seed solution

[0110] (1) inoculating the activated Lactobacillus acidophilus strain into a sterile seed culture medium, and shaking culture at 37° C. for 25 h at a rotation speed of 120 r / min to serve as a primary seed solution;

[0111] (2) Take the first-level seed solution at an inoculation volume of 8 vol% and inoculate it into the expansion culture medium. Incubate it in an incubator at 38°C for 24 hours to serve as the second-level seed solution.

[0112] 4. Seed tank fermentation

[0113] The secondary seed liquid was added into the seed tank at a ratio of 10 vol%, and the tank pressure during the fermentation process of the seed tank was controlled at 0.05 MPa, the compressed air flow rate was controlled at 18 L / min, the rotation speed was controlled at 250 rpm, the ventilation ratio was 1:1, and the culture was carried out at 37°C for 24 hours to obtain the tertiary seed liquid;

[0114] The components of the culture medium for seed culture medium, expansion culture medium and seed tank are the same, which are:

[0115] Each 1L of culture medium includes: 48g millet, 12g wheat bran, 24g glucose, 0.8g magnesium sulfate, 2.7g yeast extract, 5g peptone, 0.1g VB1, 0.5g K2HPO4, 1.2g KH2PO4, 3g white sugar, 0.02g VB6, and the rest is water; pH 6.2, sterilization at 121℃ for 40 minutes.

[0116] The number of Lactobacillus acidophilus in the third-grade seed solution was 2×10 9 Pieces / ml.

[0117] 5. Preparation of fermented Chinese medicine preparations

[0118] (1) Preparation of fermentation medium containing Chinese medicine extract I

[0119] The formula of each 1L fermentation medium is: 48g millet, 12g wheat bran, 24g glucose, 0.8g magnesium sulfate, 2.7g yeast extract, 5g peptone, 0.1g VB1, 0.5g K2HPO4, 1.2g KH2PO4, 3g white sugar, 0.02g VB6, and the rest is Chinese medicine extract I; adjust its pH to 6.2 and sterilize at 121℃ for 40 minutes.

[0120] (2) Preparation of Chinese medicine fermentation mixture

[0121] The third-grade seed liquid is added to the fermentation tank at a ratio of 12%, and the tank pressure of the fermentation tank is controlled at 0.05MPa, the compressed air flow rate is controlled at 70L / min, the rotation speed is controlled at 200rpm, and the ventilation ratio is controlled at 1:0.7 during the fermentation process; the fermentation is carried out at 38°C for 24 hours to obtain a fermented Chinese medicine mixture;

[0122] (3) Preparation of fermented Chinese medicine preparations

[0123] First, the fermented Chinese medicine mixture of step (2) is sterilized under high pressure at 121° C. for 30 min to inactivate the bacteria, and then the fermented Chinese medicine mixture is filtered, and the filtrate is centrifuged at 3500 r / min for 15 min to obtain a supernatant. Finally, the supernatant is mixed with the Chinese medicine extract II obtained in step 1 to obtain the fermented Chinese medicine preparation of the present invention, and the final crude drug content in the preparation is 0.55 g per 1 mL.

[0124] 6. Preparation of fermented Chinese medicine preparations

[0125] (1) When the dosage form of the Chinese medicine preparation of the present invention is granules, the preparation method thereof comprises the following steps:

[0126] First, the fermented Chinese medicine preparation in step 5 is concentrated at 70° C. to a paste with a relative density of 1.29, and then the paste is spread on a drying plate, the spread amount is set to 5.5 kg / plate, the material temperature is set to 90° C., the hysteresis temperature is 1° C., the vacuum degree is -0.08 MPa, and microwave vacuum drying is performed to obtain a dry paste powder; then, 10% of the total weight of L-arabinose, 20% of oat bran powder and 10% of soy protein isolate are added to the dry paste powder, and the powder is placed in a granulator to prepare granules, and the granules are packaged at 0.5 g / granule to obtain granules.

[0127] (2) When the dosage form of the Chinese medicine preparation of the present invention is a tablet, the preparation method thereof comprises the following steps:

[0128] The dry paste powder obtained in step (1) is added with 10% of the total mass of microcrystalline cellulose, 20% of sorbitol, 2% of magnesium stearate and 2% of silicon dioxide, mixed evenly, and placed in a tablet press to tablet, with a tablet weight of 0.5 g.

[0129] (3) When the dosage form of the Chinese medicine preparation of the present invention is an oral liquid, the preparation method thereof comprises the following steps:

[0130] The fermented Chinese medicine preparation prepared in step 5 is added with 9% of honey, 0.6% of citric acid, 2.5% of sucrose and 0.6% of stevioside in terms of the total weight thereof to prepare a mixed solution, which is firstly homogenized at a temperature of 75° C. and a homogenization pressure of 15 MPa; the homogenized mixed solution is then instantaneously sterilized at 130° C. and then filled into a 10 ml bottle under a vacuum aseptic environment; finally, the finished product after filling is stored at room temperature after being inspected and qualified.

[0131] Experimental Example 1

[0132] The fermented Chinese medicine preparation prepared in Example 2 was applied to the study of upper respiratory tract allergic diseases;

[0133] 1. A total of 120 patients with upper respiratory tract allergic cough were selected and randomly divided into experimental group 1, experimental group 2 and control group, with 40 patients in each group. The male-female ratio in each group was the same. There was no significant difference in the general information such as gender, age and course of disease between the two groups, and there was no statistical significance (P﹥0.05).

[0134] 2. Experimental groups:

[0135] Control group: given conventional western medicine treatment, patients took aminophylline 3 mg / kg orally once a day, and were treated with antibiotics according to the actual situation of the patients.

[0136] Experimental group 1: The fermented Chinese medicine oral liquid prepared in Example 2 of the present invention was administered at 10 ml / vial, twice a day.

[0137] Experimental group 2: The Chinese medicine extract I prepared in Example 2 of the present invention was directly mixed with the Chinese medicine extract II without probiotic fermentation to prepare a Chinese medicine oral liquid of 10 ml / vial, twice a day, and the other preparation processes were the same.

[0138] All patients took the medication for 7 days and were followed up for 6 months.

[0139] 3. Treatment results:

[0140] Criteria for judging efficacy:

[0141] Markedly effective: After one week of treatment, the patient's cough and other related clinical symptoms disappeared, and within 6 months of follow-up, the patient did not experience recurrence;

[0142] Effective: After one week of treatment, the patient's cough and other related clinical manifestations almost completely disappeared. During the 6-month follow-up, the patient relapsed 1 to 2 times, but without obvious discomfort.

[0143] Ineffective: After one week of treatment, the patient's cough and other related clinical manifestations did not change at all, and the condition even became more serious.

[0144] SPSS15.0 software was used for statistical analysis. (%, n) represents the results of counting data, t-test; (x±s) represents the results of measurement data, t-test; P<0.05 indicates that the difference is statistically significant. The comparison of the treatment effects is shown in Table 1.

[0145] Table 1 Comparison of treatment effects

[0146] Group n Significant effect efficient invalid Total Effectiveness Control group 40 14 16 10 75％ Experimental Group 1 40 25 13 2 95％ Experimental Group 2 40 16 17 7 82.5％

[0147] As can be seen from the data in Table 1, the total effective rate of experimental group 1 was significantly higher than that of the control group, and the difference was statistically significant (P<0.05). The effect of experimental group 2 without probiotic fermentation on the treatment of upper respiratory tract allergic cough was far inferior to that of experimental group 1, and the patient had no recurrence of the disease within 6 months after taking the fermented Chinese medicine oral liquid of the present invention. In summary, it is shown that the Chinese medicine fermentation preparation of the present invention can significantly improve the clinical manifestations of upper respiratory tract allergic cough and other clinical manifestations of patients, and can also avoid repeated attacks of symptoms and improve the quality of life of patients.

[0148] 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 can easily understand and modify the technical solutions described in the aforementioned embodiments. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to specific details or the described embodiments.

Claims

1. A method for preparing a Chinese medicine preparation for upper respiratory tract allergic cough, characterized in that: The steps include: 1) crushing, mixing and grinding the Chinese medicine raw materials Platycodon grandiflorum, honeysuckle, dried orange peel, houttuynia cordata and rhizome of Phragmites australis in sequence, adding water and pectinase for primary enzymolysis, adding cellulase for secondary enzymolysis after the enzymolysis is completed, and killing enzymes and centrifuging the enzymolysis solution in sequence after the secondary enzymolysis is completed, and taking the supernatant as Chinese medicine extract I; 2) Accurately weigh the remaining Chinese medicinal materials, and prepare Chinese medicinal extract II according to the method described in step 1); 3) using the Chinese medicine extract I in step 1) to prepare a fermentation medium, inoculating probiotics for fermentation, sterilizing and filtering the resulting fermentation product to obtain a filtrate; and mixing the filtrate with the Chinese medicine extract II obtained in step 2) to obtain the fermented Chinese medicine preparation; The raw material components are prepared from: 10-15 parts of platycodon, 10-15 parts of honeysuckle, 10-15 parts of forsythia leaves, 1-5 parts of ganoderma lucidum, 1-5 parts of tangerine peel, 1-5 parts of almond, 1-5 parts of houttuynia, 1-5 parts of dandelion, 1-3 parts of mint, 1-5 parts of liquorice, 1-5 parts of reed root, and 1-5 parts of lily.

2. The preparation method according to claim 1, characterized in that: In the step 1), the weight ratio of the Chinese medicinal material to water is 1:4-6, the weight ratio of the Chinese medicinal material to pectinase is 1:0.015-0.025, and the weight ratio of the Chinese medicinal material to cellulase is 1:0.02-0.

03.

3. The preparation method according to claim 1, characterized in that: In the step 1), the temperature of the first enzymolysis is 40-55°C for 50-60 hours, and the temperature of the second enzymolysis is 45-55°C for 40-50 hours.

4. The preparation method according to claim 1, characterized in that: In the step 3), the probiotics are one or more of Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus faecalis and Lactobacillus bulgaricus.

5. The preparation method according to claim 4, characterized in that: The number of probiotics is 0.9 to 2.4×10 8 Pieces / ml.

6. The preparation method according to claim 1, characterized in that: The composition of the fermentation medium in step 3) is as follows: 1L of fermentation medium includes 42-48g of millet, 8-12g of wheat bran, 20-24g of glucose, 0.6-0.8g of magnesium sulfate, 2.2-2.7g of yeast extract, 3-5g of peptone, 0.06-0.1g of VB1, 0.3-0.5g of K2HPO4, 0.8-1.2g of KH2PO4, 1-3g of white sugar, 0.01-0.02g of VB6, and the rest is Chinese medicine extract I.

7. The preparation method according to claim 1, characterized in that: In step 3), the fermentation temperature is 35-38° C. and the fermentation time is 16-24 hours.