Preparation method of ginseng and poria cocos intestine-strengthening pharmaceutical composition

Abstract

The invention discloses a preparation method of a ginseng and poria cocos intestine-strengthening pharmaceutical composition. The method comprises the following steps: taking radix pseudostellariae, bran-fried rhizoma atractylodis macrocephalae, poria cocos, semen coicis, Chinese yam, fried hawthorn, radix puerariae, fried medicated leaven, hairyvein agrimony and honey-fried licorice root according to a formula ratio, crushing into powder, adding an ethanol solution with a certain concentration, carrying out dynamic ultrahigh-pressure micro-jet assisted ultrasonic extraction, collecting an extracting solution, and carrying out vacuum concentration to obtain an extract; and adding pharmaceutically acceptable auxiliary materials to prepare a corresponding medicinal preparation. Compared with a traditional water decoction extraction process, the total polysaccharide yield and the extract yield obtained through the extraction process are greatly improved, the problem that the total polysaccharide content extracted through an existing process is low is solved, the product quality is improved, and the taking dosage of a patient can be reduced.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a method for preparing a ginseng and poria cocos strengthening intestinal medicine composition. Background Art

[0002] The combination of Shenling Guchang has the functions of strengthening the spleen and raising clearness, removing dampness and stopping diarrhea. Traditional Chinese medicine believes that diarrhea is caused by dysfunction of the spleen and stomach transportation and transformation, abnormal small intestine reception and large intestine conduction function, resulting in unclear clear and turbid stools, mixed downward movement, and a type of clinical disease characterized by increased frequency of defecation, loose stools or incomplete digestion, and even watery diarrhea. Professor Zhou Sufang, a member of the invention team, and others found in their long-term clinical work that because Guizhou is located in the southwest, it belongs to the subtropical humid monsoon climate zone, with more precipitation and higher relative humidity, mainly due to long-term residence in wetlands, combined with modern people's irregular eating habits leading to eating disorders, staying up late leading to improper work and rest, and other bad living habits, the main pathogenesis of the disease can be summarized as spleen and stomach deficiency and cold or spleen dysfunction, cold and dampness blocking the spleen. "Suwen·Zangqi Fashilun" says: "People with spleen disease feel heavy...If the spleen is weak, the abdomen will be full and the intestines will rumble, and the food will be indigestible and diarrhea will occur." Based on this, Professor Zhou Sufang's team believes that the occurrence of diarrhea is mainly due to the spleen being weak first, and then the internal generation of water and dampness, which affect each other and combine to form diarrhea. Ming Li Zhongzi proposed nine methods for treating diarrhea, mainly based on mild infiltration, lifting, dredging, cooling, sour contraction, sweet and slow, warming the kidney, drying the spleen, and consolidating, which provided important guidance for the treatment of diarrhea in later generations. When diagnosing and treating this disease in the clinic, Professor Zhou Sufang's team mainly focused on strengthening the spleen and replenishing qi to restore the root, while taking into account the infiltration of dampness and the treatment of diarrhea to treat the symptoms, and treating both the symptoms and the root. The self-made prescription Shenling Guchang Granules can achieve good clinical efficacy in treating diarrhea.

[0003] In the formula, Radix Pseudostellariae has the function of protecting the intestines, the Atractylodes macrocephala polysaccharide in Atractylodes macrocephala has the function of repairing the intestinal mucosa, and Poria cocos strengthens the spleen and eliminates dampness. The three can be used together to strengthen the spleen and replenish qi, penetrate dampness and stop diarrhea, and they are all monarch drugs; Chinese yam and braised coix seed have the function of strengthening the spleen and eliminating dampness, and Herba Agrimoniae is specialized in replenishing deficiency and stopping diarrhea, and they are all minister drugs; charred hawthorn, Jianqu, and stewed Pueraria root have the function of strengthening the spleen and replenishing qi, promoting qi and harmonizing the stomach, and they are used together as adjuvant drugs; licorice harmonizes the medicinal properties; all the drugs are used together to play the effect of strengthening the spleen and raising the clear, eliminating dampness and stopping diarrhea. It has been clinically proven that for patients with spleen deficiency and dampness, the combination of Shenling Guchang is based on the principle of strengthening the spleen and removing dampness, which is in line with the pathological characteristics of diarrhea "spleen deficiency and dampness", and the effect is better.

[0004] At present, the preparation process of the Shenling Guchang composition adopts the traditional water decoction extraction, or water decoction extraction followed by alcohol precipitation. In actual production, the paste yield is low, the extraction yield of effective components such as total polysaccharides is low, and long-term high-temperature decoction may lead to loss of effective components. The process is relatively backward, the extraction efficiency is low, and the drug dosage is large. Therefore, it is necessary to improve the existing process.

[0005] The present invention adopts dynamic ultra-high pressure micro-jet combined with ultrasound to extract the Shenling Guchang pharmaceutical composition. After optimizing the extraction process, an in-hospital preparation is made. The yield of total polysaccharides and the yield of extract are greatly improved, which solves the problem of low content of effective ingredients such as total polysaccharides, improves product quality, and can reduce the dosage taken by patients. Summary of the invention

[0006] The purpose of the present invention is to provide a method for preparing a Shenling Guchang pharmaceutical composition. The active ingredients of the Shenling Guchang pharmaceutical composition are extracted mainly by dynamic ultrahigh pressure microfluidics combined with ultrasound. After the extraction process is optimized, the yield of total polysaccharides is increased to 2.77%, and the yield of extract is increased to 28.9%, which solves the problem of low yield of total polysaccharides and extract in the existing process, improves product quality, and can reduce the dosage taken by patients.

[0007] The present invention is achieved through the following technical solutions:

[0008] The preparation method of the Shenling Guchang pharmaceutical composition of the present invention comprises the following steps:

[0009] S1, according to the formula, take Radix Pseudostellariae Radix, Rhizoma Atractylodis Macrocephalae Rhizoma, Poria, Semen Coicis, Rhizoma Dioscoreae, Rhizoma Hawthorne, Radix Puerariae, Rhizoma Dioscoreae, Herba Agrimoniae, and Radix Glycyrrhizae, grind, sieve, and mix to obtain a mixed powder;

[0010] S2, adding ethanol solution to the mixed powder at a material-liquid mass-volume ratio of 1:8-16, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization for 1-3 times, with a microfluidization pressure of 80-100 MPa;

[0011] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50-60°C, each time for 30-60 minutes, and combining the extracts;

[0012] S4, concentrating the extract under reduced pressure to an extract with a relative density of 1.20-1.23 at 50° C., and adding pharmaceutically acceptable excipients to prepare a corresponding pharmaceutical preparation.

[0013] Preferably, the method for preparing the Shenling Guchang pharmaceutical composition of the present invention comprises the following steps:

[0014] S1, according to the formula, take Radix Pseudostellariae Radix, Rhizoma Atractylodis Macrocephalae Rhizoma, Poria, Semen Coicis, Rhizoma Dioscoreae, Rhizoma Hawthorne, Radix Puerariae, Rhizoma Dioscoreae, Herba Agrimoniae, and Radix Glycyrrhizae, grind, sieve, and mix to obtain a mixed powder;

[0015] S2, adding ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0016] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 45 min, and combining the extracts;

[0017] S4, concentrating the extract under reduced pressure to an extract with a relative density of 1.20 at 50° C., and adding pharmaceutically acceptable excipients to prepare a corresponding pharmaceutical preparation.

[0018] The mesh number of the crushing and screening in step S1 of the present invention is: 20-80 mesh.

[0019] Preferably, the pulverizing and sieving mesh number in step S1 of the present invention is: 65 mesh.

[0020] The ethanol concentration in step S2 of the present invention is: 40-80% ethanol.

[0021] Preferably, the ethanol concentration in step S2 of the present invention is: 55-65% ethanol.

[0022] Further preferably, the ethanol concentration in step S2 of the present invention is: 55% ethanol.

[0023] The conditions for reduced pressure concentration in the present invention are: vacuum degree is 0.06-0.08Mpa.

[0024] Preferably, the conditions for the reduced pressure concentration of the present invention are: the vacuum degree is 0.07Mpa.

[0025] The pharmaceutical preparations of the present invention include, but are not limited to, granules, capsules, tablets, powders, and oral liquids.

[0026] Compared with the prior art, the present invention has the following advantages:

[0027] 1. The preparation method of the present invention has remarkable extraction effect of total polysaccharides and other effective ingredients. Through single factor and orthogonal experiments, it was found that under the conditions of ethanol concentration of 55%, material-liquid mass volume ratio of 1:12, microjet pressure of 100MPa, extraction temperature of 55°C, extraction time of 45min, and extraction times of 2 times, the extract yield reached 28.9%, and the total polysaccharide yield reached 2.77%, which doubled the total polysaccharide yield obtained by traditional water decoction extraction process. The problem of low total polysaccharide content is solved, the product quality is improved, and the dosage for patients can be reduced.

[0028] 2. The process of the present invention is stable and feasible. Through verification of three batches of samples prepared by the optimal preparation process, the average total polysaccharide yield was measured to be 2.77%, with an RSD of 1.46%; the average extract yield was 28.9%, indicating that the extraction process is stable, feasible, and suitable for industrial production. DETAILED DESCRIPTION

[0029] The technical solution of the present invention is further described in detail below through specific embodiments.

[0030] Example 1 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0031] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0032] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0033] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 55°C, each time for 45 min, and combining the extracts;

[0034] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of soluble starch and 0.1 times the amount of aspartame are added, granulated and dried to prepare granules (5 g / bag).

[0035] Example 2 Preparation method of Shenling Guchang pharmaceutical composition

[0036] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0037] S2, adding 60% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 80 MPa;

[0038] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 30 min, and combining the extracts;

[0039] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 6 times the amount of soluble starch and 0.2 times the amount of aspartame are added, granulated and dried to prepare granules (5 g / bag).

[0040] Example 3 Preparation method of Shenling Guchang pharmaceutical composition

[0041] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0042] S2, adding 65% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 90 MPa;

[0043] S3, extracting the drug solution treated by microfluidization twice by ultrasonic extraction at 60°C, each time for 60 min, and combining the extracts;

[0044] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 8 times the amount of soluble starch and 0.1 times the amount of aspartame are added, granulated and dried to prepare granules (3 g / bag).

[0045] Example 4 Preparation method of Shenling Guchang pharmaceutical composition

[0046] S1, according to the formula ratio, weigh 10g of Radix Pseudostellariae, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Rhizoma Dioscoreae, 10g of Rhizoma Hawthorne, 10g of Radix Puerariae, 10g of Rhizoma Dioscoreae, 15g of Herba Agrimoniae, and 6g of Radix Glycyrrhizae, grind them through an 80-mesh sieve, mix them evenly, and obtain a mixed powder for later use;

[0047] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:8, mixing thoroughly, and treating with dynamic ultrahigh pressure microfluidization for 3 times, with a microfluidization pressure of 100 MPa;

[0048] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 55°C, each time for 45 min, and combining the extracts;

[0049] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.23 at 50°C, 5 times the amount of soluble starch and 0.2 times the amount of sodium carboxymethyl starch are added, mixed evenly, granulated and dried to prepare granules (5 g / bag).

[0050] Example 5 Preparation method of Shenling Guchang pharmaceutical composition

[0051] S1, according to the formula ratio, weigh 10g of Radix Pseudostellariae, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Rhizoma Dioscoreae, 10g of Rhizoma Hawthorne, 10g of Radix Puerariae, 10g of Rhizoma Dioscoreae, 15g of Herba Agrimoniae, and 6g of Radix Glycyrrhizae, grind them through a 20-mesh sieve, mix them evenly, and obtain a mixed powder for later use;

[0052] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:16, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0053] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 55°C, each time for 45 min, and combining the extracts;

[0054] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.23 at 50°C, 5 times the amount of soluble starch and 0.2 times the amount of sodium carboxymethyl starch are added, mixed evenly, granulated and dried to prepare granules (5 g / bag).

[0055] Example 6 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0056] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0057] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 80 MPa;

[0058] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 30 min, and combining the extracts;

[0059] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of soluble starch and 0.2 times the amount of sodium carboxymethyl starch are added, mixed evenly, granulated and dried to prepare a granular preparation.

[0060] Example 7 Preparation method of Shenling Guchang pharmaceutical composition

[0061] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0062] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 90 MPa;

[0063] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 55°C, each time for 45 min, and combining the extracts;

[0064] S4, concentrating the extract under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, drying, adding ethanol and wet granulating to obtain an extract.

[0065] Example 8 Preparation method of Shenling Guchang pharmaceutical composition

[0066] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0067] S2, adding 55% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0068] S3, extracting the drug solution treated by microfluidization twice by ultrasonic extraction at 60°C, each time for 60 min, and combining the extracts;

[0069] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of soluble starch is added, the mixture is mixed evenly, the mixture is dried, the mixture is crushed, 0.2 times the amount of magnesium stearate is added, the mixture is mixed evenly, and the mixture is put into capsule shells to obtain capsules.

[0070] Example 9 Preparation method of Shenling Guchang pharmaceutical composition

[0071] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0072] S2, adding 60% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 80 MPa;

[0073] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 55°C, each time for 60 min, and combining the extracts;

[0074] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 4 times the amount of poly starch and 0.2 times the amount of dextrin are added, and tablets are made.

[0075] Example 10 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0076] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0077] S2, adding 60% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 90 MPa;

[0078] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 60°C, each time for 30 min, and combining the extracts;

[0079] S4, concentrate the extract under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, dilute the extract with water, add 0.2 times amount of sodium benzoate, stir and mix thoroughly, and then adjust the volume to 500 mL to obtain an oral solution.

[0080] Example 11 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0081] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0082] S2, adding 60% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0083] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 45 min, and combining the extracts;

[0084] S4, concentrate the extract under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, dilute the extract with water, add 10 g of sodium benzoate, stir well to mix, and then adjust the volume to 1000 mL to obtain an oral solution.

[0085] Example 12 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0086] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0087] S2, adding 65% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 80 MPa;

[0088] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 60°C, each time for 45 min, and combining the extracts;

[0089] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of soluble starch is added, the mixture is mixed evenly, the mixture is dried, the mixture is crushed, 0.2 times the amount of magnesium stearate is added, the mixture is mixed evenly, and the mixture is put into capsule shells to obtain capsules.

[0090] Example 13 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0091] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0092] S2, adding 65% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 90 MPa;

[0093] S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 60 min, and combining the extracts;

[0094] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.07 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of soluble starch is added, the mixture is mixed evenly, the mixture is dried, the mixture is crushed, 0.2 times the amount of magnesium stearate is added, the mixture is mixed evenly, and the mixture is put into capsule shells to obtain capsules.

[0095] Example 14 Preparation method of Shenling intestinal strengthening pharmaceutical composition

[0096] S1, according to the formula ratio, weigh 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea Oppositae, 10g of Stir-fried Hawthorn, 10g of Puerariae Radix, 10g of Stir-fried Shenqu, 15g of Agrimoniae Herba, and 6g of Roasted Licorice Root, grind through a 65-mesh sieve, mix well, and obtain a mixed powder for later use;

[0097] S2, adding 65% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa;

[0098] S3, extracting the drug solution treated by microfluidization twice by ultrasonic extraction at 60°C, each time for 60 min, and combining the extracts;

[0099] S4, decompressing and concentrating the extract to an extract with a relative density of 1.20 at 50° C., adding 5 times the amount of poly starch and 0.2 times the amount of dextrin, and pressing to prepare tablets.

[0100] Example 15 Preparation method of Shenling Guchang pharmaceutical composition

[0101] S1, according to the formula ratio, weigh 10g of Radix Pseudostellariae, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Rhizoma Dioscoreae, 10g of Rhizoma Hawthorne, 10g of Radix Puerariae, 10g of Rhizoma Dioscoreae, 15g of Herba Agrimoniae, and 6g of Radix Glycyrrhizae, grind them through a 50-mesh sieve, mix them evenly, and obtain a mixed powder for later use;

[0102] S2, adding 50% ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:14, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 90 MPa;

[0103] S3, extracting the drug solution treated by microfluidization twice by ultrasonic extraction at 60°C, each time for 60 min, and combining the extracts;

[0104] S4, the extract is concentrated under reduced pressure (vacuum degree is 0.08 MPa) to an extract with a relative density of 1.20 at 50°C, 5 times the amount of poly starch and 0.2 times the amount of dextrin are added, and tablets are made.

[0105] In order to further verify the feasibility of the present invention, the inventor conducted a series of experiments, as follows:

[0106] 1. Process investigation of the Shenling Guchang drug composition

[0107] The Shenling intestinal strengthening drug composition is composed of 10g of Pseudostellariae Radix, 10g of bran-fried Atractylodes macrocephala, 10g of Poria cocos, 20g of Coix seeds, 20g of Chinese yam, 10g of fried hawthorn, 10g of Pueraria root, 10g of fried Shenqu, 15g of Agrimoniae, and 6g of roasted Licorice root. The production process currently adopted is: add water and boil three times, the first time for 2 hours, the second time for 1.5 hours, and the third time for 1 hour, filter in batches, combine the filtrate and concentrate it to a clear paste with a relative density of about 1.10 (20°C), add ethanol for wet granulation, and dry to obtain the product.

[0108] The research team of the present invention found that when the traditional water decoction was used for extraction, the total polysaccharide yield was 1.22% and the extract yield was 17.1%, both of which were relatively low, and there were many water-soluble impurities, which affected the product quality. Therefore, the team of the present invention improved the traditional extraction process and optimized the preparation process of the Chinese medicine Shenling Guchang pharmaceutical composition. After consulting a large amount of literature and combining with actual production, the present invention chooses to use dynamic ultra-high pressure micro-jet assisted ultrasound to extract the main medicinal ingredients in the Shenling Guchang pharmaceutical composition. Since Prince, Atractylodes and Poria are used as the main medicines in the prescription, their medicinal ingredients are mainly polysaccharides, so the present invention chooses to use the total polysaccharide yield and the extract yield as evaluation indicators to investigate the preparation process of the Shenling Guchang pharmaceutical composition.

[0109] 1 Single factor test

[0110] Take 10g of Pseudostellaria baicalensis, 10g of Atractylodes macrocephala with bran, 10g of Poria cocos, 20g of Coix seed, 20g of Dioscorea opposita, 10g of stir-fried Hawthorn, 10g of Pueraria root, 10g of stir-fried Shenqu, 15g of Herba Agrimoniae, and 6g of roasted Licorice root, grind them into a sieve (65 mesh), add a certain concentration of ethanol solution, use dynamic ultra-high pressure microfluidization treatment twice, and then perform ultrasonic extraction. In this experiment, factors such as ethanol concentration, microfluidization pressure, material-liquid ratio, extraction temperature, and extraction time are the main factors affecting the total polysaccharide yield and extract yield of the active ingredient of the Shenling Guchang pharmaceutical composition.

[0111] 1.1 Effect of ethanol concentration on total polysaccharide yield

[0112] Ethanol with concentrations of 40%, 50%, 60%, 70% and 80% were added to the medicinal material powder at a material-liquid mass volume ratio of 1g:12ml, and the powder was treated twice at a microfluidization pressure of 100MPa and ultrasonically extracted twice at 60°C, each time for 1 hour.

[0113] Results: In the range of 40%-60% ethanol concentration, the total polysaccharide yield increased with the increase of ethanol concentration, and reached the maximum value at 60% ethanol concentration, at which the yield was 2.55%; in the range of 60%-80% ethanol concentration, the total polysaccharide yield decreased slightly with the increase of ethanol concentration. Therefore, the ethanol concentration of 60% was selected.

[0114] 1.2 Effect of solid-liquid ratio on total polysaccharide yield

[0115] 60% ethanol was added to the medicinal material powder at a solid-liquid ratio of 1:8, 1:10, 1:12, 1:14, and 1:16 (g:ml), respectively. The powder was treated twice at a microfluidization pressure of 100 MPa and ultrasonically extracted twice at 60°C, each time for 1 h.

[0116] Results: In the range of 1:8-12 (g:ml) solid-liquid ratio, the total polysaccharide yield increased with the increase of solid-liquid ratio; in the range of 1:12-16 (g:ml) solid-liquid ratio, the total polysaccharide yield tended to be flat. Therefore, the solid-liquid ratio was selected as 1:12 (g:ml).

[0117] 1.3 Effect of microfluidization pressure on total polysaccharide yield

[0118] 60% ethanol was added to the medicinal material powder at a solid-liquid ratio of 1:12 (g:ml), and then the powder was treated twice at microfluidic pressures of 80, 90, 100, 110, and 120 MPa, respectively, and ultrasonic extraction was performed twice at 60°C, each time for 1 h.

[0119] Results: In the microjet pressure range of 80-100MPa, the total polysaccharide yield gradually increased with the increase of microjet pressure; in the microjet pressure range of 100-120MPa, the total polysaccharide yield tended to be flat and slightly decreased. Therefore, the microjet pressure was selected to be 100MPa.

[0120] 1.4 Effect of ultrasonic temperature on total polysaccharide yield

[0121] At a solid-liquid ratio of 1:12 (g:ml), 60% ethanol was added to the medicinal material powder, treated twice under a microfluidization pressure of 100 MPa, and ultrasonically extracted twice at temperatures of 40°C, 50°C, 60°C, 70°C, and 80°C, each time for 1 h.

[0122] Results: In the ultrasonic temperature range of 40-60℃, as the ultrasonic temperature increased, the total polysaccharide yield gradually increased; and when the temperature exceeded 60℃, the total polysaccharide yield gradually decreased. Therefore, the ultrasonic temperature was selected to be 60℃.

[0123] 1.5 Effect of ultrasonic time on total polysaccharide yield

[0124] According to the ethanol concentration, solid-liquid ratio, microjet pressure, and ultrasonic temperature determined in the above experiments, 60% ethanol was added at a solid-liquid ratio of 1:12 (g:ml), treated twice at a microjet pressure of 100 MPa, and ultrasonic extraction was performed at 60°C. The ultrasonic time was 15 min, 30 min, 45 min, 60 min, and 90 min respectively, and extraction was performed twice.

[0125] Results: The total polysaccharide yield increased with the increase of ultrasonic time. After 45 minutes of ultrasonic extraction, the total polysaccharide yield tended to be flat and slightly decreased. Therefore, ultrasonic extraction for 45 minutes was selected.

[0126] 2 Orthogonal experimental design

[0127] According to the above single factor experimental investigation, the effects of the solid-liquid ratio and the number of extractions on the total polysaccharide were not significant, so the solid-liquid ratio was determined to be 1:12 (g:ml) and the number of extractions was 2. Based on the single factor experiment, the effects of ethanol concentration, microjet homogenization pressure, ultrasonic temperature, and ultrasonic time on the total polysaccharide yield were mainly studied. Therefore, this experiment selected ethanol concentration (A), microjet pressure (B), ultrasonic temperature (C), and ultrasonic time (D) as the investigation factors, and used L9 (3 4 ) The process conditions were optimized by the orthogonal test method with four factors and three levels. The total polysaccharide and extract yield were used as evaluation indicators. The factor levels are shown in Table 1, the orthogonal test results are shown in Table 2, and the variance analysis is shown in Tables 3 and 4.

[0128] Table 1 Orthogonal test factor level table

[0129]

[0130] Table 2 Orthogonal test results

[0131]

[0132]

[0133] Table 3 Extract yield results variance analysis

[0134]

[0135] Table 4 Total polysaccharide yield results variance analysis

[0136]

[0137] From the intuitive analysis of Table 2, the order of influence of each factor on the total polysaccharide yield is factor C>A>D>B, and the best extraction process is A1B3C2D2; the order of influence of each factor on the extract yield is factor C>A>B>D, and the best extraction process is A1B3C2D2; therefore, the final optimized extraction process is A1B3C2D2, that is, the selected ethanol concentration is 55%, the microjet pressure is 100MPa, the extraction temperature is 55℃, and the extraction time is 45min.

[0138] 3. Verification of the best preparation process

[0139] Three batches of samples were prepared according to the optimal preparation process obtained from the experiment, and compared with the prior art water decoction extraction process to determine the extract and total polysaccharide yields. The test results are shown in Table 5.

[0140] Table 5 Verification test results

[0141]

[0142]

[0143] Results: According to the optimal preparation process of the present invention, three batches of samples were prepared, and the extract yield was 28.87%, and the total polysaccharide yield reached 2.77%. Compared with the prior art, the total polysaccharide yield of the present invention was nearly doubled, and the extract yield was also greatly improved, with significant extraction effect. The total polysaccharide yield RSD = 1.46%, indicating that the method is stable and feasible.

[0144] 4. Process determination of Shenling Guchang drug composition

[0145] According to the formula ratio, take 10g of Pseudostellariae Radix, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Poria, 20g of Semen Coicis, 20g of Dioscorea opposita, 10g of Stir-fried Hawthorn, 10g of Pueraria lobata, 10g of Stir-fried Shenqu, 15g of Herba Agrimoniae, and 6g of Radix Glycyrrhizae, grind them through a 65-mesh sieve, add 55% ethanol at a material-liquid mass volume ratio of 1:12, treat twice under a microjet pressure of 100MPa, and then extract twice by ultrasonic at 55°C, each time for 45min, combine the extracts, concentrate under reduced pressure to an extract with a relative density of 1.20 (50°C), and then add pharmaceutically acceptable excipients to prepare the corresponding pharmaceutical preparation.

[0146] 2. Clinical efficacy evaluation

[0147] The clinical efficacy and safety of Shenling Guchang Granules prepared in Example 1 of the present application for treating diarrhea (Spleen Deficiency and Dampness Excess Syndrome) were evaluated.

[0148] 2.1 Research subjects

[0149] This trial adopted a retrospective research method and collected 102 outpatient cases from the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from 2018 to 2024.

[0150] 2.2 Diagnostic criteria

[0151] 2.2.1 TCM diagnostic standards: TCM diagnostic standards for diarrhea are formulated with reference to the TCM industry standard of the People’s Republic of China, “TCM Internal Medicine Disease Diagnosis and Efficacy Standards” (ZY / T001.1-94).

[0152] (1) The frequency of bowel movements increases, to more than 3 times a day, with loose or watery stools and increased stool volume.

[0153] (2) Symptoms persist for more than 1 day.

[0154] 2.2.2 TCM syndrome diagnostic criteria: formulated with reference to the “Guidelines for Clinical Research of New Chinese Medicines” (China Medical Science and Technology Press, 2002).

[0155] Spleen deficiency and dampness syndrome:

[0156] Main symptoms: loose stools, unformed stools, and increased frequency of bowel movements;

[0157] Secondary symptoms: incomplete digestion of food, poor appetite, abdominal pain, abdominal distension; pale red tongue with thin white or greasy white coating, and weak or slippery pulse.

[0158] The main symptoms are necessary, and secondary symptoms may be present. The diagnosis can be made by combining the tongue and pulse.

[0159] 2.3 Inclusion criteria

[0160] (1) Meet the above-mentioned TCM diagnostic criteria for diarrhea.

[0161] (2) It meets the TCM diagnosis of spleen deficiency and dampness excess.

[0162] (3) No age limit, both men and women are welcome.

[0163] (4) The information is basically complete, and the records and data are traceable.

[0164] 2.4 Exclusion criteria

[0165] (1) Diarrhea caused by dysentery, cholera, systemic diseases, poisoning, parasitic infection, malignant tumor, etc.

[0166] (2) Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, endocrine system diseases, blood diseases, and immunosuppression.

[0167] (3) Patients who are pregnant.

[0168] (4) Patients with mental illness.

[0169] (5) The researcher believes that the medical records have an impact on the evaluator.

[0170] 3. Treatment options

[0171] The Shenling Guchang Granules obtained by preparing according to Example 1 of the present application are used in dosage: 10 grams each time (two packets), three times a day.

[0172] Treatment course: 7-14 days as one course of treatment.

[0173] 4. Combined medication

[0174] If the subject meets the inclusion criteria and has other diseases that require continued medication in the clinical trial, or if other drugs or treatments are required for treatment, the name of the drug (or treatment), dosage, number of times used, time of use, etc. used should be recorded in detail in the clinical observation form.

[0175] 5. Data Collection Methods

[0176] Design a case observation form, fill it out truthfully, and record in detail the patient's general condition (age, medical history, diagnosis, etc.), TCM syndrome type, four diagnostic data, treatment plan, combined medication and other clinical data.

[0177] 5.1 General Record Items

[0178] Date of first medication use / date of last medication use.

[0179] 5.2 Efficacy evaluation indicators

[0180] Clinical symptoms and signs: loose stools, unformed stools, and increased frequency of bowel movements; secondary symptoms: undigested food, poor appetite, abdominal pain, and bloating; pale red tongue with a thin white or greasy coating, and a soft or slippery pulse.

[0181] 5.3 Safety evaluation indicators

[0182] (1) Routine blood test, routine urine test, routine stool test + occult blood test, liver function test (ALT, AST, AKP, GGT, TBIL), renal function test (BuN, Cr), and electrocardiogram.

[0183] (2) Observation of symptoms and signs of adverse events and reactions (see Adverse Reaction Observation for details and requirements).

[0184] 6. Efficacy evaluation criteria

[0185] 6.1 TCM Syndrome Efficacy: Refer to the "Guidelines for Clinical Research of New Chinese Medicines" (China Medical Science and Technology Press, 2002).

[0186] Clinical cure: symptoms and signs disappear or almost disappear, and the integral value decreases by ≥95%.

[0187] Markedly effective: symptoms and signs are significantly improved, 95%>integral value is reduced by ≥70%. Effective: symptoms and signs are improved, 70%>integral value is reduced by ≥30%.

[0188] Ineffective: There is no significant improvement in symptoms and signs, or they may even get worse, and the integral value decreases by less than 30%.

[0189] Calculation formula: (Nimodipine method): [(score before treatment - score after treatment) / score before treatment] × 100%

[0190] 6.2 Efficacy of single symptom

[0191] Aggravation: symptoms become more severe or more numerous than before;

[0192] Unchanged: Symptoms remain unchanged compared to the original symptoms;

[0193] Improvement: Symptoms are improved, reduced, or better compared to the original symptoms; Disappearance: Symptoms change to 0 points compared to the original symptoms.

[0194] 7. Observation of adverse events

[0195] Record the main symptoms and signs of adverse reactions in detail, including the time of occurrence, end time, duration and severity, and analyze whether the cause of the adverse reaction is related to the study drug and the impact of the adverse reaction on the study. Record whether measures have been taken for the adverse event. If measures have been taken, record the specific measures in detail. Record the outcome of the adverse event at the end of the adverse event or the end of the study, and whether the patient withdrew from the trial due to the adverse event.

[0196] Adverse reaction rate = number of adverse reaction cases / total number of cases × 100%

[0197] 8. Statistical Analysis

[0198] Statistical analysis was performed using SAS 9.4 software.

[0199] In descriptive statistical analysis, qualitative indicators are described by percentage or composition ratio; quantitative indicators are described by mean, standard deviation, etc.

[0200] Qualitative data were analyzed using chi-square test, Fisher's exact probability method, Wilcoxon rank sum test, and CMH Z2 test. Quantitative data were analyzed using t test, analysis of variance, Wilcoxon rank sum test, or analysis of covariance.

[0201] If hypothesis testing is used, a two-sided test should be used uniformly, and the test statistic and its corresponding P value should be given, with P ≤ 0.05 being considered statistically significant.

[0202] This study was only for statistical description and no statistical analysis between groups was performed.

[0203] 9. Research Results

[0204] 9.1 Age Segment Analysis

[0205] Among the 102 cases, 85 were <60 years old and 17 were ≥60 years old. The following analysis is grouped by age. This study is only for statistical description and no statistical analysis between groups is performed.

[0206] Table 6 Age groups

[0207]

[0208] 9.2 Clinical symptoms and signs before treatment

[0209] The 102 patients mainly had loose stools, unformed stools, increased bowel movement frequency, and poor appetite. Some patients also had undigested food, abdominal pain, and bloating.

[0210] Table 7 Clinical symptoms and signs before treatment

[0211]

[0212]

[0213] 9.3 Time of medication

[0214] Among the 102 patients, the average duration of medication was 8.49 days, the median duration was 7 days, and the longest duration was 27 days.

[0215] Table 8 Medication time (days)

[0216]

[0217] 9.4 Efficacy Results

[0218] 9.4.1 TCM Syndrome Efficacy

[0219] All 102 patients showed marked efficacy, with a marked efficacy rate of 100%.

[0220] Table 9 Effect of Traditional Chinese Medicine

[0221]

[0222] 9.4.2 Efficacy of single symptom

[0223] The results in Table 10 show that after treatment, the patients' loose stools, unformed stools, increased bowel movement frequency, undigested food, poor appetite, abdominal pain and bloating were improved or disappeared to varying degrees.

[0224] Table 10 Efficacy of single symptom

[0225]

[0226]

[0227] 9.5 Safety Evaluation

[0228] 9.5.1 Adverse Reactions

[0229] No adverse reactions occurred in any of the 102 cases.

[0230] Table 11 Adverse reactions

[0231]

[0232] 9.6 Discussion

[0233] (1) This study retrospectively collected data on 102 patients who used this prescription from 2018 to 2024, with a history of use of more than 5 consecutive years. This study did not conduct statistical analysis and comparison between groups.

[0234] (2) All 102 patients showed marked efficacy, with a marked efficacy rate of 100%.

[0235] (3) After treatment, the patient’s loose stools, unformed stools, increased frequency of stools, undigested food, poor appetite, abdominal pain, and bloating all improved or disappeared to varying degrees.

[0236] (4) Among the 102 patients, the average duration of medication was 8.49 days, the median duration was 7 days, and the longest duration was 27 days; the recommended course of treatment was 7-14 days.

[0237] (5) All 102 patients were taking concomitant medications.

[0238] (6) Safety analysis: No adverse reactions were found in 102 cases. We will continue to strengthen the collection and evaluation of adverse reactions and the inspection and evaluation of safety evaluation indicators.

[0239] It can be seen that the Shenling Guchang granules obtained by the preparation process of the present application have good clinical efficacy for diarrhea (spleen deficiency and dampness syndrome), and have a certain improvement effect on patients with loose stools, unformed stools, increased frequency, indigestion, poor appetite, abdominal pain, abdominal distension, etc., and have no adverse reactions.

[0240] Although the present invention has been described in detail above by means of general description, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A method for preparing a Shenling intestinal strengthening pharmaceutical composition, the Shenling intestinal strengthening pharmaceutical composition is composed of 10 parts of Pseudostellariae Radix, 10 parts of Atractylodes macrocephalae stir-fried with bran, 10 parts of Poria cocos, 20 parts of Coix seeds, 20 parts of Chinese yam, 10 parts of stir-fried Hawthorn, 10 parts of Pueraria root, 10 parts of stir-fried Shenqu, 15 parts of Agrimoniae, and 6 parts of roasted Licorice root. It is characterized in that The preparation method comprises the following steps: S1, according to the formula, take Radix Pseudostellariae Radix, Rhizoma Atractylodis Macrocephalae Rhizoma, Poria, Semen Coicis, Rhizoma Dioscoreae, Rhizoma Hawthorne, Radix Puerariae, Rhizoma Dioscoreae, Herba Agrimoniae, and Radix Glycyrrhizae, grind, sieve, and mix to obtain a mixed powder; S2, adding ethanol solution to the mixed powder at a material-liquid mass-volume ratio of 1:8-16, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization for 1-3 times, with a microfluidization pressure of 80-100 MPa; S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50-60°C, each time for 30-60 minutes, and combining the extracts; S4, concentrating the extract under reduced pressure to an extract with a relative density of 1.20-1.23 at 50° C., and adding pharmaceutically acceptable excipients to prepare a corresponding pharmaceutical preparation.

2. The preparation method of the Shenling Guchang pharmaceutical composition according to claim 1, It is characterized in that The steps include: S1, according to the formula, take Radix Pseudostellariae Radix, Rhizoma Atractylodis Macrocephalae Rhizoma, Poria, Semen Coicis, Rhizoma Dioscoreae, Rhizoma Hawthorne, Radix Puerariae, Rhizoma Dioscoreae, Herba Agrimoniae, and Radix Glycyrrhizae, grind, sieve, and mix to obtain a mixed powder; S2, adding ethanol solution to the mixed powder at a material-liquid mass volume ratio of 1:12, mixing thoroughly and evenly, and treating with dynamic ultrahigh pressure microfluidization twice, with a microfluidization pressure of 100 MPa; S3, extracting the drug solution treated by microfluidization by ultrasonic extraction twice at 50°C, each time for 45 min, and combining the extracts; S4, concentrating the extract under reduced pressure to an extract with a relative density of 1.20 at 50° C., and adding pharmaceutically acceptable excipients to prepare a corresponding pharmaceutical preparation.

3. The preparation method according to any one of claims 1 or 2, It is characterized in that The mesh size of the crushed and sieved material in step S1 is 20-80 meshes.

4. The preparation method according to claim 3, It is characterized in that The crushing and screening mesh number in step S1 is: 65 mesh.

5. The preparation method according to any one of claims 1 or 2, It is characterized in that The ethanol concentration in step S2 is: 40-80% ethanol.

6. The preparation method according to claim 5, It is characterized in that The ethanol concentration in step S2 is: 55-65% ethanol.

7. The preparation method according to claim 6, It is characterized in that The ethanol concentration in step S2 is: 55% ethanol.

8. The preparation method according to any one of claims 1 or 2, It is characterized in that The conditions for reduced pressure concentration in step S4 are: vacuum degree is 0.06-0.08Mpa.

9. The preparation method according to claim 8, It is characterized in that The ethanol concentration in step S4 is: the vacuum degree is 0.07Mpa.

10. The preparation method according to any one of claims 1 or 2, It is characterized in that The pharmaceutical preparations in step S4 include, but are not limited to, granules, capsules, tablets, powders, and oral liquids.

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