CN115300573B - Traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, preparation method thereof and ready-to-drink beverage - Google Patents
Traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, preparation method thereof and ready-to-drink beverage Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract
The invention provides a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia. On the basis of the preparation and conversion drink formula in the running series, the invention enriches, separates, extracts and purifies the effective parts of the medicinal materials, screens the components of the extracts, and combines different extracts into a new prescription, thereby developing the Chinese patent medicine with definite medicinal effect substance basis, clear medicinal action mechanism and accurate clinical indication. Meanwhile, the new prescription is free from adding sucrose, has unique taste, keeps 0 sucrose and 0 fat, and is suitable for the vast population. Through pharmacodynamic comparison research, the effect of the traditional Chinese medicine composition is obviously better than that of a control group, and the traditional Chinese medicine composition can promote gastrointestinal motility and inhibit gastric acid secretion, has definite pharmacological effects on the aspects of treating functional dyspepsia caused by incoordination between spleen and stomach, qi movement retardation and the like, and has obvious effects.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, a preparation method thereof and a preparation method of a ready-to-drink beverage.
Background
Along with the rapid development of Chinese economy, the living standard of people is gradually improved, the living rhythm is faster and faster, and the modern people are easy to suffer from digestive system diseases due to living pressure, working pressure, poor eating habits and mental stress. Wherein, the functional dyspepsia is the most common disease of the digestive system, the incidence rate is obviously increased in recent years, the functional dyspepsia patients account for about 50% of the outpatient quantity of spleen and stomach diseases in China, the symptoms are discomfort symptoms such as upper abdominal pain, upper abdominal distention, early satiety, eructation, inappetence, nausea and vomiting, and the disease is continuous, repeatedly and discontinuously attacks and is not easy to cure thoroughly. At present, western medicine has no special medicine for treating the disease, and the disease is considered to be in the stomach through dialectical treatment, and is closely related to two viscera of liver and spleen. Therefore, the traditional Chinese medicine is used for searching a novel traditional Chinese medicine preparation for treating incoordination between spleen and stomach and liver qi stagnation, the traditional Chinese medicine preparation has the advantages of being common to doctors and patients, safe, nontoxic and small in side effect, has good effects in relieving the course of disease, reducing recurrence, maintaining the stability of the illness state and improving the quality of life, and is easily accepted by the patients.
The prior art has the defects of relatively backward process, limited extraction components, low content of effective components, slower drug action, sucrose in the preparation method, large dosage, poor compliance, poor pertinence, undefined indication and the like, and is not suitable for special people.
Disclosure of Invention
In view of the above, the technical problem to be solved by the invention is to provide a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, a preparation method thereof and a ready-to-use drink.
The invention provides a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, which consists of 2-44 parts by mass of traditional Chinese medicine extract A, 2-32 parts by mass of traditional Chinese medicine extract B, 2-18 parts by mass of traditional Chinese medicine extract C and 1-10 parts by mass of traditional Chinese medicine extract D;
the preparation method of the traditional Chinese medicine extract A comprises the following steps:
a) Pulverizing rhizoma Dioscoreae and Poria, soaking in water, and performing enzymolysis leaching to obtain leaching solution;
neutralizing the obtained leaching solution, and heating for extraction to obtain an extracting solution;
concentrating, drying and pulverizing the extract to obtain medicinal powder a;
b) Mixing the hawthorn powder with ethanol water solution, and drying the hawthorn powder after reflux extraction to obtain treated hawthorn extract powder;
Mixing the treated hawthorn extract powder with water, and sequentially carrying out enzymolysis, ultrasonic treatment, centrifugation and drying to obtain medicinal powder b;
the mass ratio of the Chinese yam, the poria cocos and the hawthorn is 6-10:4-8:8-12
c) Mixing the powder a and the powder b to obtain a traditional Chinese medicine extract A;
the preparation method of the traditional Chinese medicine extract B comprises the following steps:
extracting fructus crataegi with rapid solvent extraction to obtain extractive solution, concentrating and lyophilizing to obtain Chinese medicinal extract B;
the preparation method of the traditional Chinese medicine extract C comprises the following steps:
mixing rhizoma Dioscoreae and water, and flash extracting to obtain extractive solution;
mixing the extract with ethanol, regulating pH, standing, and concentrating to obtain concentrated solution;
lyophilizing the concentrated solution to obtain a Chinese medicinal extract C;
the preparation method of the traditional Chinese medicine extract D comprises the following steps:
mixing Poria with ethanol solution, and reflux extracting under heating to obtain extractive solution;
concentrating the extract, and freeze-drying to obtain the traditional Chinese medicine extract D.
Preferably, the traditional Chinese medicine composition comprises 14 parts by mass of traditional Chinese medicine extract A, 6 parts by mass of traditional Chinese medicine extract B, 2 parts by mass of traditional Chinese medicine extract C and 5 parts by mass of traditional Chinese medicine extract D.
Preferably, in the preparation method of the traditional Chinese medicine composition A, in the step a), the enzyme used for enzymolysis leaching is selected from plant complex enzymes, and the plant complex enzymes are selected from cellulase, neutral protease and pectinase with the mass ratio of (1:2-4:2-4);
The enzymolysis temperature is 40-60 ℃, the pH is 4-6, and the time is 70-110 min;
the enzyme amount used in enzymolysis is 3-8% of the mass of the medicinal material;
after neutralization, heating to 70-90 ℃ and extracting for 80-100 minutes.
Preferably, in the preparation method of the traditional Chinese medicine composition A, in the step b), the volume fraction of the ethanol water solution is 90-100%;
the volume ratio of the haw powder to the ethanol water solution is 1:2-8;
the mass ratio of the treated hawthorn extract powder to water is 1:20-40;
the enzyme for enzymolysis is cellulase; the addition amount of the cellulase accounts for 4g of the mixed liquid of the hawthorn extract powder and water in mass and volume ratio: 50-150 ml; the enzymolysis temperature is 40-80 ℃, the pH is 4-6, and the enzymolysis time is 50-70 min;
the ultrasonic treatment time is 5-9 min.
Preferably, in the preparation method of the traditional Chinese medicine extract B, the extractant of the rapid solvent extraction method is selected from ethanol solution with the volume concentration of 40-60%, the extraction temperature is 70-90 ℃, and the pressure is 0.6-0.9 MPa.
Preferably, in the preparation method of the traditional Chinese medicine extract C, the mass ratio of the Chinese yam to the water is 1:30-50, the voltage of the flash extraction is 80-120V, the time of the flash extraction is 1-3 min,
In the mixed solution obtained by mixing the extracting solution with ethanol, the volume concentration of the ethanol is 50-90%;
the pH is regulated to 4.0-6.0, and the standing time is 12-48 h.
Preferably, in the preparation method of the traditional Chinese medicine extract D, the volume fraction of the ethanol solution is 90-100%, the mass ratio of the poria cocos to the ethanol solution is 4:8-12, and the times of heating reflux extraction are 2-4 times, and each time is 20-40 min.
The invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating and/or preventing functional dyspepsia and/or chronic gastritis.
The invention also provides a preparation method of the Chinese medicinal composition.
Preferably, the preparation beverage further comprises pharmaceutically acceptable auxiliary materials.
Compared with the prior art, the invention provides a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, which consists of 2-44 parts by mass of traditional Chinese medicine extract A, 2-32 parts by mass of traditional Chinese medicine extract B, 2-18 parts by mass of traditional Chinese medicine extract C and 1-10 parts by mass of traditional Chinese medicine extract D; the preparation method of the traditional Chinese medicine extract A comprises the following steps: a) Pulverizing rhizoma Dioscoreae and Poria, soaking in water, and performing enzymolysis leaching to obtain leaching solution; neutralizing the obtained leaching solution, and heating for extraction to obtain an extracting solution; concentrating, drying and pulverizing the extract to obtain medicinal powder a; b) Mixing the hawthorn powder with ethanol water solution, carrying out reflux extraction, and drying the extract to obtain treated hawthorn extract powder; mixing the treated hawthorn extract powder with water, and sequentially carrying out enzymolysis, ultrasonic treatment, centrifugation and drying to obtain medicinal powder b; the mass ratio of the Chinese yam to the poria cocos to the hawthorn is 6-10:4-8:8-12; c) Mixing powder a and powder b to obtain extract A; the preparation method of the traditional Chinese medicine extract B comprises the following steps: mixing hawthorns and diatomite, extracting in an extraction tank to obtain an extract, concentrating and freeze-drying the extract to obtain an extract B; the preparation method of the traditional Chinese medicine extract C comprises the following steps: flash extracting rhizoma Dioscoreae to obtain extractive solution; mixing the extract with ethanol, regulating pH, standing, and concentrating to obtain concentrated solution; lyophilizing the concentrated solution to obtain a Chinese medicinal extract C; the preparation method of the traditional Chinese medicine extract D comprises the following steps: mixing Poria with ethanol solution, and reflux extracting under heating to obtain extractive solution; concentrating the extract, and freeze-drying to obtain the traditional Chinese medicine extract D.
On the basis of the preparation and conversion drink formula in the running series, the invention enriches, separates, extracts and purifies the effective parts of the medicinal materials, screens the components of the extracts, and combines different extracts into a new prescription, thereby developing the Chinese patent medicine with definite medicinal effect substance basis, clear medicinal action mechanism and accurate clinical indication. Meanwhile, the new prescription is free from adding sucrose, has unique taste, keeps 0 sucrose and 0 fat, and is suitable for the vast population.
Through pharmacodynamic comparison research, the effect of the traditional Chinese medicine composition is obviously better than that of a control group, and the traditional Chinese medicine composition can promote gastrointestinal motility and inhibit gastric acid secretion, has definite pharmacological effects on the aspects of treating functional dyspepsia caused by incoordination between spleen and stomach, qi movement retardation and the like, and has obvious effects.
Detailed Description
The invention provides a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, which consists of 2-44 parts by mass of traditional Chinese medicine extract A, 2-32 parts by mass of traditional Chinese medicine extract B, 2-18 parts by mass of traditional Chinese medicine extract C and 1-10 parts by mass of traditional Chinese medicine extract D;
the preparation method of the traditional Chinese medicine extract A comprises the following steps:
a) Pulverizing rhizoma Dioscoreae and Poria, soaking in water, and performing enzymolysis leaching to obtain leaching solution;
Neutralizing the obtained leaching solution, and heating for extraction to obtain an extracting solution;
concentrating, drying and pulverizing the extract to obtain medicinal powder a;
b) Mixing the hawthorn powder with ethanol water solution, carrying out reflux extraction, and drying the extract to obtain treated hawthorn extract powder;
mixing the treated hawthorn extract powder with water, and sequentially carrying out enzymolysis, ultrasonic treatment, centrifugation and drying to obtain medicinal powder b;
the mass ratio of the Chinese yam to the poria cocos to the hawthorn is 6-10:4-8:8-12;
c) Mixing powder a and powder b to obtain extract A;
the preparation method of the traditional Chinese medicine extract B comprises the following steps:
extracting fructus crataegi with rapid solvent extraction to obtain extractive solution, concentrating and lyophilizing to obtain extract B;
the preparation method of the traditional Chinese medicine extract C comprises the following steps:
flash extracting rhizoma Dioscoreae to obtain extractive solution;
mixing the extract with ethanol, regulating pH, standing, and concentrating to obtain concentrated solution;
lyophilizing the concentrated solution to obtain a Chinese medicinal extract C;
the preparation method of the traditional Chinese medicine extract D comprises the following steps:
mixing Poria with ethanol solution, and reflux extracting under heating to obtain extractive solution;
concentrating the extract, and freeze-drying to obtain the traditional Chinese medicine extract D.
The traditional Chinese medicine composition for treating and/or preventing functional dyspepsia provided by the invention consists of a traditional Chinese medicine extract A, a traditional Chinese medicine extract B, a traditional Chinese medicine extract C and a traditional Chinese medicine extract D.
Wherein the traditional Chinese medicine extract A is prepared according to the following method:
a) Pulverizing rhizoma Dioscoreae and Poria, soaking in water, and performing enzymolysis leaching to obtain leaching solution;
neutralizing the obtained leaching solution, and heating for extraction to obtain an extracting solution;
concentrating, drying and pulverizing the extract to obtain medicinal powder a;
b) Mixing the hawthorn powder with ethanol water solution, and drying the hawthorn powder after reflux extraction to obtain treated hawthorn extract powder;
mixing the treated hawthorn extract powder with water, and sequentially carrying out enzymolysis, ultrasonic treatment, centrifugation and drying to obtain medicinal powder b;
the mass ratio of the Chinese yam to the poria cocos to the hawthorn is 6-10:4-8:8-12;
c) Mixing powder a and powder b to obtain extract A.
Specifically, the present invention first prepares powder a and powder b.
The preparation method of the medicine powder a comprises the following steps:
pulverizing rhizoma Dioscoreae and Poria, soaking in water to obtain a mixture; wherein the mass ratio of the total mass of the Chinese yam and the poria cocos to the water is 1:5-10. The soaking time is 20-40 min.
Then, adding enzyme into the mixture for enzymolysis, wherein the enzyme is selected from plant complex enzyme, and the plant complex enzyme is selected from cellulase, neutral protease and pectinase with the mass ratio of (1:2-4:2-4).
The enzymolysis temperature is 40-60 ℃, the pH is 4-6, and the time is 70-110 min;
the enzyme amount used in enzymolysis is 3-8% of the mass of the medicinal material;
and neutralizing the enzymatic hydrolysate after enzymatic hydrolysis until the pH value is 6.0-8.0. And then heating the neutralized enzymolysis liquid to 70-90 ℃ and extracting for 80-100 min to obtain an extracting liquid.
Concentrating the extracting solution to obtain fluid extract with relative density of 1.20-1.25, drying under reduced pressure, pulverizing the dry extract, and obtaining medicinal powder a.
The preparation method of the medicine powder b comprises the following steps:
drying fructus crataegi, and pulverizing to obtain fructus crataegi powder. Then mixing the haw powder with ethanol water solution for reflux extraction to obtain extract. Wherein the volume fraction of the ethanol water solution is 90-100%; the volume ratio of the haw powder to the ethanol water solution is 1:2-8. Repeatedly reflux-extracting to obtain supernatant with colorless color to remove fat, pigment, alcohol-soluble polysaccharide and small molecule impurity.
And drying the hawthorn powder subjected to reflux extraction to obtain the processed hawthorn extract powder.
Mixing the haw extracted powder with water for enzymolysis to obtain enzymolysis liquid. Wherein the enzyme used for enzymolysis is cellulase. The addition amount of the enzyme is 4g of the mixed liquid of the hawthorn extract powder and water in mass and volume ratio: 50-150 ml; the enzymolysis temperature is 60 ℃, the pH is 5, and the enzymolysis time is 60min.
And then carrying out ultrasonic treatment on the enzymolysis liquid to obtain an ultrasonic extract. The time of the ultrasonic treatment is 7min.
And finally, centrifuging the ultrasonic extract, collecting supernatant, concentrating, and finally drying to obtain medicinal powder b.
Mixing the powder a and the powder b to obtain the traditional Chinese medicine extract A.
The preparation method of the traditional Chinese medicine extract B comprises the following steps:
extracting fructus crataegi with rapid solvent extraction to obtain extractive solution, concentrating and lyophilizing to obtain Chinese medicinal extract B;
wherein the extractant is selected from ethanol solution with volume concentration of 50%, the extraction temperature is 80 ℃, and the pressure is 0.8MPa.
Concentrating under reduced pressure and lyophilizing to obtain Chinese medicinal extract B.
The preparation method of the traditional Chinese medicine extract C comprises the following steps:
flash extracting rhizoma Dioscoreae to obtain extractive solution;
mixing the extract with ethanol, regulating pH, standing, and concentrating to obtain concentrated solution;
And freeze-drying the concentrated solution to obtain the traditional Chinese medicine extract C.
Specifically, the mass ratio of the yam to the water is 1:30-50, the voltage of the flash extraction is 80-120V, the time of the flash extraction is 1-3 min,
the volume concentration of ethanol in the mixed solution obtained by mixing the extracting solution with ethanol is 70%;
the pH was adjusted to 5.0 and the rest time was 24h.
The preparation method of the traditional Chinese medicine extract D comprises the following steps:
mixing Poria with ethanol solution, and reflux extracting under heating to obtain extractive solution;
concentrating the extract, and freeze-drying to obtain the traditional Chinese medicine extract D.
Specifically, the volume fraction of the ethanol solution is 95%, the mass ratio of the poria cocos to the ethanol solution is 4:10, and the times of heating reflux extraction are 3 times and 30 minutes each time.
Finally, the traditional Chinese medicine extract A, the traditional Chinese medicine extract B, the traditional Chinese medicine extract C and the traditional Chinese medicine extract D are mixed to obtain the traditional Chinese medicine composition for treating and/or preventing functional dyspepsia.
The invention provides a traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, which consists of 2-44 parts by mass of traditional Chinese medicine extract A, 2-32 parts by mass of traditional Chinese medicine extract B, 2-18 parts by mass of traditional Chinese medicine extract C and 1-10 parts by mass of traditional Chinese medicine extract D;
The traditional Chinese medicine composition for treating and/or preventing functional dyspepsia comprises 2-44 parts by mass of traditional Chinese medicine extract A, preferably 2, 5, 10, 15, 20, 25, 30, 35, 40, 44 or any value between 2 and 44 parts.
The traditional Chinese medicine composition for treating and/or preventing functional dyspepsia also comprises 2-32 parts by mass of traditional Chinese medicine extract B, preferably 2, 5, 10, 15, 20, 25, 30, 32 or any value between 2 and 32 parts.
The traditional Chinese medicine composition for treating and/or preventing functional dyspepsia also comprises 2-18 parts by mass of traditional Chinese medicine extract C, preferably 2, 4, 6, 8, 10, 12, 14, 16, 18 or any value between 2 and 18 parts.
In some specific embodiments of the invention, the traditional Chinese medicine composition for treating and/or preventing functional dyspepsia comprises 14 parts by mass of traditional Chinese medicine extract A, 6 parts by mass of traditional Chinese medicine extract B, 2 parts by mass of traditional Chinese medicine extract C and 5 parts by mass of traditional Chinese medicine extract D.
The invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating and/or preventing functional dyspepsia and/or chronic gastritis.
The invention also provides a preparation method of the Chinese medicinal composition. The preparation method comprises the step of preparing the drink, and further comprises pharmaceutically acceptable auxiliary materials.
Based on the compatibility principle of traditional Chinese medicine formulas, the invention is based on the treatment of functional dyspepsia caused by incoordination between spleen and stomach, takes hawthorn with functions of promoting digestion, invigorating stomach, promoting qi and removing blood stasis as a monarch drug, and the hawthorn is good in eliminating greasy meat food retention, helping digestion, removing greasy food and strengthening spleen and stomach. The Chinese yam and the poria cocos are used as ministerial drugs, and the Chinese yam is used for tonifying qi and yin, tonifying spleen, lung and kidney, securing essence and stopping leukorrhagia. Poria is sweet and light in nature, and has effects of tonifying deficiency, entering spleen, kidney and heart channels, promoting diuresis, invigorating spleen and calming heart. The traditional Chinese medicine compatibility principle is followed, all medicinal materials are extracted, separated and purified in a modern scientific mode, extract components are screened to form a new prescription, and a new prescription with definite material base and more definite and obvious curative effect is obtained.
In order to further understand the present invention, the following examples are provided for illustrating the traditional Chinese medicine composition for treating and/or preventing functional dyspepsia, the preparation method thereof and the ready-to-drink beverage, and the scope of the present invention is not limited by the following examples.
Example 1
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 2 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 2 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 2 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 1 part of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 2
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
Taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 2 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 6 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 4 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 3 parts of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 3
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
Adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 2 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 10 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 6 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 5 parts of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 4
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 8 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 2 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 4 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 5 parts of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 5
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
Taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 8 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 8 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 8 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 1 part of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 6
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
Adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 8 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 10 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 2 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 3 parts of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 7
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of functional dyspepsia traditional Chinese medicine extract composition
Taking 14 parts of a functional dyspepsia traditional Chinese medicine composition A, 2 parts of a functional dyspepsia traditional Chinese medicine extract B, 6 parts of a functional dyspepsia traditional Chinese medicine extract C and 3 parts of a functional dyspepsia traditional Chinese medicine extract D, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 8
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 14 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 6 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 2 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 5 parts of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 9
1. A preparation method of a traditional Chinese medicine extract A for treating functional dyspepsia comprises the following steps:
Taking 8 parts of Chinese yam and 6 parts of poria cocos, crushing the two traditional Chinese medicines, adding 60 parts of water, soaking for 30 minutes, adding 0.7 part of plant complex enzyme (the mass ratio is 1:3:3 cellulase (10 ten thousand enzyme activities), neutral protease (5 ten thousand enzyme activities) and pectase (1 ten thousand enzyme activities) to leach for 90 minutes at 48 ℃ and pH value of 5, heating to 80 ℃ after neutralization, extracting for 90 minutes to obtain an extract, concentrating to 1.20 clear paste, drying under reduced pressure, crushing dry paste, and obtaining medicinal powder a.
10 parts of hawthorn is taken, dried to constant weight at 60 ℃, crushed and sieved by a 40-mesh sieve, the hawthorn powder is taken, 5 times of 95% ethanol is added, and the mixture is repeatedly refluxed and extracted to obtain supernatant liquid which is nearly colorless, so that fat, pigment, alcohol-soluble polysaccharide and small molecular impurities are removed. Collecting filter residues, drying to obtain pretreated hawthorn powder, and mixing the pretreated hawthorn powder with deionized water according to a liquid-to-material ratio of 30:1, adding 4% cellulase (powder: cellulase, w/v) into the reaction solution, adjusting pH to 5, controlling temperature at 60deg.C, and performing water bath enzymolysis for 60 min. After the enzymolysis reaction is finished, the mixture is subjected to ultrasonic treatment for 7 minutes, the extracting solution is centrifuged for 10 minutes at 8000rpm/min, the supernatant is collected for concentration, and finally the powder b is obtained by freeze-drying.
Mixing powder a and powder b to obtain extract A.
2. A preparation method of a traditional Chinese medicine extract B for treating functional dyspepsia comprises the following steps:
mixing 5 parts of hawthorn with equal amount of diatomite uniformly, loading into a 100ml extraction tank, filling a proper amount of diatomite into a gap of the extraction tank, sealing the extraction tank, placing the extraction tank and a collecting bottle into an extraction instrument, opening a nitrogen valve, adjusting the partial pressure to 0.8MPa, opening a power supply of the extraction instrument, performing self-inspection on the instrument, cleaning a pipeline of the extraction instrument by using a cleaning solvent after the self-inspection is finished, setting the preheating temperature to 80 ℃, and starting preheating by using the ethanol concentration of 50%; and (3) adjusting the parameters to start extraction for 3 times, 5 minutes each time, and after the circulation is completed for three times, taking the extracting solution in the collecting bottle, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract B.
3. A preparation method of a traditional Chinese medicine extract C for treating functional dyspepsia comprises the following steps:
taking 3 parts of Chinese yam, adding 40 times of water, controlling the voltage to be 100V, performing flash extraction for 2min, adding ethanol into the extract to ensure that the concentration of the ethanol is 70%, regulating the pH of the liquid medicine to be 5.0, standing for 24 hours, recovering the ethanol, concentrating under reduced pressure, and freeze-drying the concentrated solution to obtain the extract C.
4. A preparation method of a traditional Chinese medicine extract D for treating functional dyspepsia comprises the following steps:
adding 10 times of 95% ethanol into 4 parts of Poria, reflux-extracting for three times under heating for 30 min, mixing the three extractive solutions, filtering, mixing, recovering ethanol, concentrating the extractive solution, and lyophilizing the concentrated solution to obtain extract D.
5. Preparation of traditional Chinese medicine extract composition for treating functional dyspepsia
Taking 14 parts of a traditional Chinese medicine composition A for treating functional dyspepsia, 10 parts of a traditional Chinese medicine extract B for treating functional dyspepsia, 4 parts of a traditional Chinese medicine extract C for treating functional dyspepsia and 1 part of a traditional Chinese medicine extract D for treating functional dyspepsia, uniformly mixing, adding a proper amount of lactose, and preparing 1000 tablets.
Example 10
Nine groups of extract pharmacodynamics contrast experiment research
1. Effects on gastrointestinal motility in functional dyspepsia rats
1.1 healthy male SPF-class Wistar rats of animal origin 130, about 60 days of day old, and body mass (200+ -20) g, all supplied by Gibbs laboratory animal technology Co., ltd., laboratory animal quality eligibility number: SCXK (Ji) -2021-0001. The animal is fed into SPF-class animal laboratory, the relative humidity is controlled at 30% -60%, the temperature is controlled at 20-24 ℃, the indoor illumination and ventilation are good, and the animal enters the laboratory personnel to wear the sterilized protective clothing. All rats were given regular feed and free water, on average, 1 pad change for 2 days, regular adaptive feeding was performed for 1 week, and rats were included in the experiment without abnormal performance. The experimental process should meet SPF laboratory requirements for animal handling.
1.2 Experimental drugs
0.9% physiological saline, jiangxi Korea pharmaceutical Co., ltd., lot number 210105; pentobarbital: sigma; carbon tetrachloride, tianjin, fine chemical Co., ltd., lot number 210103; absolute ethanol, northwest rukang pharmaceutical co., lot number: 210501; dextran blue, gold technology biology limited, lot number: 210402. positive traditional Chinese medicine group: stomach strengthening vanishing tablet, jiangzhong pharmaceutical group Co., ltd., lot number 210506. Positive western medicine group: mortiered, populus, inc., lot 210321.
1.3 a low-temperature high-speed centrifuge of a test instrument, namely a Beijing medical centrifuge factory, model LD5-2A; microplate reader, manufactured in China Designed in California USA, SMP500-18272-LSIO.
1.4 Experimental methods
1.4.1 animals group Wistar rats were fed adaptively for 1 week and were randomly divided into 10 blank groups according to the random number table method. 120 rats successfully molded are randomly divided into a model group, a positive control traditional Chinese medicine group (immature bitter orange anti-glomus pill), a positive control western medicine group (domperidone) and traditional Chinese medicine compositions I-IX, wherein 10 rats are respectively used in each group.
1.4.2 modeling method FD rat model was made using a compound factor modeling method with moderate tail-clamping stimulation and irregular feeding. Except for blank groups, the other groups were molded according to the "tail clamping stimulation method plus irregular feeding" for 14 days. The tail end of the rat tail is clamped by a long sponge clamp at a position close to 1/3 of the tail end of the rat, so that the rat is struggled but not broken, the rat is irritated and is beaten with other rats (if the rat is scratched, the wound is disinfected by iodophor and infection is prevented), and each group is stimulated for 30min for 2 times per day; during the period, rats normally drink water, are fed on a single day, fasted on two days, and continuously model for 14 days. During the molding, the rats are in short eyes, obviously in group curling, pile, back arch, listlessness, straphilia, reduced feeding, slow response, increased defecation, anus pollution, obvious actions of emaciation, tension, anxiety and the like, which indicate that the molding is successful. The rats in each group were significantly lean and had significantly reduced body mass, also suggesting successful modeling. After the molding is completed, distilled water is given to the model group and the blank group, each process group is subjected to gastric lavage every day, the proper distilled water is added according to the daily dosage to prepare liquid medicine, the positive control traditional Chinese medicine group (immature bitter orange anti-stuffiness pill) is 1g/kg, the positive control western medicine group (domperidone) is 0.1mg/kg, the traditional Chinese medicine compositions I-IX are 1g/kg, and the gastric lavage capacity is 10 mL/(kg.d). For 2 weeks, the rats were weighed 1 time a week, and the stomach-filling amount was adjusted according to the change in body mass.
1.4.3 sample collection and treatment after last administration, no water forbidden for 24 hours, glucan blue 3mL is given for gastric lavage, nutritive semisolid paste mass is weighed before gastric lavage, pentobarbital (45 mg/kg) is anesthetized after 1 hour, abdominal cavity is rapidly opened, the whole stomach is opened, the stomach is cut along a large curve, and the stomach is placed in a test tube filled with distilled water 2mL, carbon tetrachloride 1.5mL and absolute ethyl alcohol 0.5mL for shaking, so that residual pigment in the stomach is fully dissolved in the mixed solution. Centrifuging at 3000r/min for 30min, collecting supernatant, and measuring residual rate of pigment in stomach at 620nm with enzyme-labeled instrument; the small intestines are separated and spread on a sterile square towel for measuring the advancing distance of the small intestines.
Small intestine push rate (%) =push distance of pigment in small intestine/small intestine whole intestine (pylorus to ileocecum) ×100%.
Table 1 changes in small intestine fraction of rats in each group
Note that: comparison with model group, #P<0.05，##P<0.01; comparison with the Positive control traditional Chinese medicine group ΔΔ P<0.01， Δ P<0.05。
2 effects on gastric acid in rats with chronic gastritis model
Wistar rats, 130, each half male and female, weighing 200±20 g, were supplied by vinca, glossary laboratory animal technologies, inc: SCXK (gimbaled) -2016-0003. The animal is fed into SPF-class animal laboratory, the relative humidity is controlled at 30% -60%, the temperature is controlled at 20-24 ℃, the indoor illumination and ventilation are good, and the animal enters the laboratory personnel to wear the sterilized protective clothing. All rats were given regular feed and free water, on average, 1 pad change for 2 days, regular adaptive feeding was performed for 1 week, and rats were included in the experiment without abnormal performance. The experimental process should meet SPF laboratory requirements for animal handling.
2.2 Experimental drugs
Fresh oxgall was taken from the vinca market site-directed slaughterhouse. Acetylsalicylic acid tablet is produced by Hunan Xinhui pharmaceutical Co., ltd., lot number: 20171102. the 45-degree white spirit is produced by Beijing red star Erguotou winery. Other reagents were all of the commercial grade.
2.3 major instrumentation
Low-temperature high-speed centrifuge, beijing medical centrifuge factory, model LD 5-2A; microplate reader, manufactured in China Designed in California USA, model: SMP500-18272-LSIO. Thermostatic water bath, bang xi instrument science and technology limited company, model: HH-4.
2.4 Experimental methods
2.4.1 reagent preparation reagent a: fresh oxgall and glycerol (glycerin) were mixed at a ratio of 1:1 volume. Reagent B: acetylsalicylic acid is prepared into a 3% solution by using 45-degree white spirit.
2.4.2 replication of animal models
10 rats were randomly taken as normal controls according to body weight, and the rest were subjected to gastric lavage and molding: 2 times per week with reagent A at 4 mL/lavage; the stomach was irrigated with reagent B at 10mL/kg 1 time per week. After 5 weeks of molding, 1 rat was examined in a sampling way, and gastric mucosa was examined by a dissecting way and compared with normal animals. And observing whether congestion, edema, defects, bleeding spots and the like are formed in the model animal so as to determine whether the model is established.
2.4.3 grouping and administration of animals
After the molding method is continuously carried out for 6 weeks, the gastric mucosa of the molded animal is observed to be grey white and matt, the extensibility is poor, the surface mucus is less, and the gastric mucosa can be scattered at bleeding points. The normal animal gastric mucosa surface is flat and smooth, is pink, and is attached with a layer of thicker mucus, and has good elasticity. From this, it was shown that the prepared model of chronic gastritis in rats was established, i.e. group administration was performed. The rats after molding were randomly divided into 10 groups. Namely a model group, a positive western medicine group (domperidone), a positive traditional Chinese medicine group (bitter orange and anti-glomus pills) and traditional Chinese medicine compositions I-IX, wherein 10 traditional Chinese medicine compositions are used in each group. The model group and the blank group are fed with distilled water for each process group to be subjected to stomach irrigation every day, the proper distilled water is added according to the daily dosage to prepare liquid medicine, the positive control traditional Chinese medicine group (immature bitter orange anti-stuffiness pill) is 1g/kg, the positive control western medicine group (domperidone) is 0.1mg/kg, the traditional Chinese medicine compositions I-IX are 1g/kg, and the stomach irrigation capacity is 10 mL/(kg.d). For 6 weeks, the rats were weighed 1 time a week, and the stomach-filling amount was adjusted according to the change in body mass. During the administration period, the stomach molding is continued according to the original molding method.
2.5 detection index
After the last administration of specimen collection, rats were fasted for 24h without water. The 3% pentobarbital sodium was intraperitoneally injected into the midline incision of the abdomen of anesthetized animals to ligate the pylorus. The drug was administered 1 time from the duodenum. And (5) suturing the wound. After 5 hours, animals were sacrificed by cervical dislocation and the whole stomach was extracted. The stomach cavity is dissected along the great curve of the stomach, and gastric juice is collected. And the gastric cavity was rinsed 2 times with 4mL of distilled water. The collected gastric juice was centrifuged (3000 r/min,15 min) and the supernatant was taken for gastric juice analysis.
Gastric juice analysis gastric juice is taken for respectively detecting gastric juice free acid and total acidity. (1) gastric acid assay: gastric juice 1mL was taken. 2 drops of methyl orange and phenolphthalein indicator are added respectively, and the mixture is uniformly mixed to form a cherry red color. Titration with 0.01mol/L NaOH standard solution was carried out until the cherry red disappeared and the orange yellow began to appear, the amount of NaOH used was the free acid endpoint amount of gastric juice. Titration was continued until the sum of the amounts of NaOH used to develop the red color was the total acidity end-point amount of gastric juice. The free acid and total acidity were calculated as follows: free acid (mmol/L) =free acidity end-point amount x Na OH concentration x 1000; total acidity (mmol/L) =total acidity endpoint amount x NaOH concentration x 1000.
2.6 experimental results
2.6.1 Effect on gastric acidity in chronic gastritis model
Compared with the blank group, the gastric free acid of the animals in the model group is reduced, and the total acid output is obviously reduced (P < 0.01). Compared with the model group, the positive western medicine group, the positive Chinese medicine group and the Chinese medicine composition I-IX are increased, and have statistical significance (P <0.05 and P < 0.01); compared with the positive traditional Chinese medicine group, the traditional Chinese medicine composition VIII group has statistical significance (P < 0.01) on the total acidity of gastric juice. The result shows that the gastric acid reduction treatment effect of the group VIII of the traditional Chinese medicine composition on the chronic gastritis model is superior to that of the positive traditional Chinese medicine group. See table 2.
TABLE 2 influence of gastric acidity in rats with chronic gastritis (x.+ -.s, n=10, mmol/L)
Note that: compared with blank group, #P<0.01; comparison with model group P<0.05，**P<0.01， ***P<0.01; compared with the positive traditional Chinese medicine group, △ P<0.05， △△ P<0.01。
according to the experimental results, the traditional Chinese medicine composition VIII group is superior to the common positive control group on the market in the aspects of small intestine propulsion rate of mice, gastric fluid free acid of rats, gastric fluid total acid and the like, and the traditional Chinese medicine composition VIII group has obvious effect on the aspect of treating functional dyspepsia.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.
Claims (3)
1. The preparation method of the traditional Chinese medicine composition for treating and/or preventing functional dyspepsia is characterized by comprising 2-44 parts by mass of traditional Chinese medicine extract A, 2-32 parts by mass of traditional Chinese medicine extract B, 2-18 parts by mass of traditional Chinese medicine extract C and 1-10 parts by mass of traditional Chinese medicine extract D;
the preparation method of the traditional Chinese medicine extract A comprises the following steps:
a) Pulverizing rhizoma Dioscoreae and Poria, soaking in water, and performing enzymolysis leaching to obtain leaching solution; the enzyme used for enzymolysis leaching is selected from plant complex enzymes, wherein the plant complex enzymes are cellulase, neutral protease and pectase with a mass ratio of 1:2-4:2-4;
Neutralizing the obtained leaching solution, and heating for extraction to obtain an extracting solution;
concentrating, drying and pulverizing the extract to obtain medicinal powder a;
step a), the enzymolysis temperature is 40-60 ℃, the pH is 4-6, and the time is 70-110 min;
the amount of enzyme used for enzymolysis is 3% -8% of the mass of the medicinal material;
heating to 70-90 ℃ after neutralization, and extracting for 80-100 minutes;
b) Mixing the hawthorn powder with ethanol water solution, and drying the hawthorn powder after reflux extraction to obtain treated hawthorn extract powder;
mixing the treated hawthorn extract powder with water, and sequentially carrying out enzymolysis, ultrasonic treatment, centrifugation and drying to obtain medicinal powder b; the enzyme for enzymolysis is cellulase;
the mass ratio of the Chinese yam to the poria cocos to the hawthorn is 6-10:4-8:8-12;
in the step b), the volume fraction of the ethanol water solution is 90-100%;
the volume ratio of the hawthorn powder to the ethanol water solution is 1:2-8;
the mass ratio of the treated hawthorn extract powder to water is 1:20-40;
the addition amount of the cellulase accounts for 4g of the mixed liquid of the hawthorn extract powder and water in mass and volume ratio: 50-150 ml; the enzymolysis temperature is 40-80 ℃, the pH is 4-6, and the enzymolysis time is 50-70 min;
the ultrasonic treatment time is 5-9 min;
c) Mixing the powder a and the powder b to obtain a traditional Chinese medicine extract A;
the preparation method of the traditional Chinese medicine extract B comprises the following steps:
extracting fructus crataegi with rapid solvent extraction to obtain extractive solution, concentrating and lyophilizing to obtain Chinese medicinal extract B;
the extractant of the rapid solvent extraction method is selected from ethanol solution with the volume concentration of 40-60%, the extraction temperature is 70-90 ℃, and the pressure is 0.6-0.9 MPa;
the preparation method of the traditional Chinese medicine extract C comprises the following steps:
mixing rhizoma Dioscoreae and water, and flash extracting to obtain extractive solution;
mixing the extract with ethanol, regulating pH, standing, and concentrating to obtain concentrated solution;
lyophilizing the concentrated solution to obtain a Chinese medicinal extract C;
in the preparation method of the traditional Chinese medicine extract C, the mass ratio of the Chinese yam to the water is 1:30-50, the flash extraction voltage is 80-120V, the flash extraction time is 1-3 min,
in the mixed solution obtained by mixing the extracting solution with ethanol, the volume concentration of the ethanol is 50-90%;
adjusting the pH to 4.0-6.0, and standing for 12-48 h;
the preparation method of the traditional Chinese medicine extract D comprises the following steps:
mixing Poria with ethanol solution, and reflux extracting under heating to obtain extractive solution;
concentrating the extract, and freeze-drying to obtain a traditional Chinese medicine extract D;
In the preparation method of the traditional Chinese medicine extract D, the volume fraction of the ethanol solution is 90-100%, the mass ratio of the poria cocos to the ethanol solution is 4:8-12, the times of heating reflux extraction are 2-4 times, and each time is 20-40 minutes.
2. The preparation method of claim 1, wherein the traditional Chinese medicine composition comprises 14 parts by mass of traditional Chinese medicine extract a, 6 parts by mass of traditional Chinese medicine extract B, 2 parts by mass of traditional Chinese medicine extract C and 5 parts by mass of traditional Chinese medicine extract D.
3. Use of a Chinese medicinal composition prepared by the preparation method according to any one of claims 1-2 in preparing a medicament for treating and/or preventing functional dyspepsia and/or chronic gastritis.
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