Instant traditional Chinese medicine preparation and preparation method thereof

Abstract

The application relates to the technical field of traditional Chinese medicine preparations, in particular to a fast-dissolving traditional Chinese medicine preparation and a preparation method thereof. The preparation method of the fast-dissolving traditional Chinese medicine preparation comprises the following steps: step 1, preparing co-occluded yiyi oil; step 2, preparing an extract; step 3, preparing a pericarpium citri reticulatae-folium lotei extract; step 4, mixing the co-occluded yiyi oil, the pericarpium citri reticulatae-folium lotei extract and the extract, uniformly stirring, adding a composite disintegrating agent, a flavoring agent and a cosolvent, uniformly stirring, granulating, drying, and obtaining the fast-dissolving traditional Chinese medicine preparation. The fast-dissolving traditional Chinese medicine preparation prepared by the application can be quickly dissolved by being soaked in warm water, takes astragalus and atractylodes as the core of spleen-invigorating and qi-boosting medicinal materials, is matched with dampness-dispelling and qi-regulating components, effectively alleviates symptoms such as abdominal distension and diarrhea, and is suitable for diseases such as functional indigestion.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a fast-dissolving traditional Chinese medicine preparation and its preparation method. Background Technology

[0002] In Traditional Chinese Medicine (TCM) theory, spleen deficiency with dampness is a common syndrome, often manifesting as abdominal distension, loose stools, fatigue, and other symptoms. It corresponds to diseases such as functional dyspepsia and diarrhea-predominant irritable bowel syndrome, requiring intervention with TCM preparations that tonify the spleen, replenish qi, dispel dampness, and harmonize the middle jiao. Traditional TCM preparations suffer from drawbacks such as slow dissolution, inconvenience of administration, and incomplete release of active ingredients, limiting their application. While existing fast-dissolving TCM preparations attempt to improve solubility, they still have shortcomings. Some products use single extraction processes, leading to easy loss of volatile oils and other active ingredients, resulting in poor stability. Enzymatic hydrolysis techniques often use single enzymes, making it difficult to efficiently break down the cell wall structure of medicinal materials, resulting in low extraction rates of active ingredients. Furthermore, unreasonable combinations of functional excipients make it difficult to balance disintegration speed and component stability, affecting efficacy and user experience. Therefore, there is an urgent need to develop a fast-dissolving TCM preparation and its preparation method that achieves rapid dissolution, full retention of active ingredients, and stable efficacy, meeting the clinical needs for convenient medication and efficient treatment, and promoting the modernization of TCM preparations. Summary of the Invention

[0003] To address the technical problems mentioned in the background section, this application provides a fast-dissolving traditional Chinese medicine preparation and its preparation method.

[0004] This application provides a method for preparing an instant-dissolving traditional Chinese medicine preparation, using the following technical solution:

[0005] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0006] Step 1: Take coix seed, crush and sieve it, add 8-10 times the amount of purified water, and extract it by low temperature steam distillation for 2-4 hours. Collect the distillate and set aside the coix seed residue after distillation. Add volatile oil stabilizer to the distillate, stir evenly, and dry to obtain coix seed oil inclusion complex.

[0007] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, crush and sieve, add purified water, stir evenly to obtain a mixture, add compound enzyme to the mixture, enzymatically hydrolyze for 2-4 hours, raise the temperature to inactivate the enzyme after enzymatic hydrolysis, use ultrasound-assisted extraction 2-3 times, combine the extracts, concentrate under reduced pressure to obtain extract.

[0008] Step 3: Mix dried tangerine peel and lotus leaf, crush and sieve, add ethanol, extract by ultrasonication, filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract;

[0009] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, stir evenly to obtain a premix, add compound disintegrant, flavoring agent and solubilizer to the premix, stir evenly, granulate, and dry to a moisture content ≤5% to obtain an instant-dissolving traditional Chinese medicine preparation.

[0010] Preferably, the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, Citrus reticulata peel and lotus leaf is 20-30:15-25:18-30:20-40:8-15:10-20.

[0011] Preferably, the amount of volatile oil stabilizer added in step 1 is 5-8% of the mass of the distillate.

[0012] Preferably, the volatile oil stabilizer in step 1 is composed of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10-12:5-8.

[0013] Preferably, the amount of compound enzyme added in step 2 is 0.3-1% of the mass of the mixture.

[0014] Preferably, the complex enzyme in step 2 is composed of mannanase, xylanase and arabinofuranase in a mass ratio of 10-12:3-5:1-3.

[0015] Preferably, the enzymatic hydrolysis conditions in step 2 are: enzymatic hydrolysis for 2-4 hours at a temperature of 40-45℃ and a pH of 5.0-6.0.

[0016] Preferably, in step 4, the composite disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2-3:1-1.2.

[0017] Preferably, in step 4, the mass ratio of the premix, compound disintegrant, flavoring agent and cosolvent is 100-120:2-4:0.1-0.3:3-6.

[0018] Another aspect of this application provides a fast-dissolving traditional Chinese medicine preparation, which is prepared by the above method.

[0019] In summary, this application has the following beneficial effects:

[0020] This application utilizes a compound formula of ingredients for synergistic effects, tailored to the needs of Traditional Chinese Medicine (TCM) diagnosis: the combination of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, Citrus reticulata peel, and Nelumbo nucifera leaf follows the TCM theory of "tonifying Qi and strengthening the spleen, and promoting diuresis and eliminating dampness," with the combined herbs forming a synergistic pharmacological effect. Astragalus membranaceus, as the chief ingredient, tonifies Qi and raises Yang; Atractylodes macrocephala, as the assistant ingredient, strengthens the spleen and dries dampness; Poria cocos and Coix lacryma-jobi promote diuresis and eliminate dampness; Citrus reticulata peel regulates Qi and harmonizes the middle Jiao to prevent cloying; and Nelumbo nucifera leaf clears heat, promotes diuresis, and aids digestion. This formula not only tonifies Qi and strengthens the body's foundation but also specifically addresses issues such as fatigue, abdominal distension, and loose stools caused by spleen deficiency and dampness. It is suitable for a wide range of people, and the ingredients are all medicinal and edible or commonly used Chinese herbs, ensuring high safety. The formula utilizes a combination of three enzymes—mannanase, xylanase, and arabinofuranosylase—to synergistically break down the cell wall structure of Chinese herbs and directionally degrade anti-nutritional components, achieving a dual improvement in the extraction efficiency and purity of effective components, far superior to the effects of a single enzyme. The cell walls and intercellular matrix of medicinal herbs such as Astragalus membranaceus, Atractylodes macrocephala, and Poria cocos are rich in mannan, xylan, and complex polysaccharides with arabinofuranose side chains. These components form a dense physical barrier, hindering the release of active ingredients (such as astragaloside A, Poria cocos polysaccharide, and atractylodes macrocephala lactone III). Mannanase can only decompose mannan, xylanase can only break the xylan backbone, while arabinofuranase can specifically remove the arabinofuranose side chains in xylan and hemicellulose. When these three are combined, arabinofuranase first removes the polysaccharide side chains, opening the action channels for xylanase and mannanase. The latter two enzymes then degrade the xylan backbone and mannan, respectively, completely destroying the rigid structure of the cell wall and fully exposing the active ingredients within the cell.

[0021] This application utilizes a compound of hydroxypropyl-β-cyclodextrin and micronized silica gel to prepare a volatile oil stabilizer. This stabilizer effectively avoids the drawbacks of Coix seed volatile oil, such as easy volatility, easy oxidation, and poor water solubility. While hydroxypropyl-β-cyclodextrin alone can form oil inclusion complexes through inclusion, these complexes are prone to absorbing moisture and clumping, affecting subsequent granulation and product stability. Micronized silica gel, with its high specific surface area and strong adsorption capacity, when compounded with hydroxypropyl-β-cyclodextrin, can both encapsulate the volatile oil through the hydrophobic cavities of hydroxypropyl-β-cyclodextrin, isolating it from oxygen and moisture and reducing evaporation loss, and adsorb free moisture on the surface of the inclusion complex through the micronized silica gel, preventing moisture absorption and adhesion. Simultaneously, it improves the fluidity of the inclusion complex, facilitating uniform mixing with extracts and other extracts. The combination of crospovidone and low-substituted hydroxypropyl cellulose (LSC) allows for rapid dissolution in water. Crospovidone exhibits strong water absorption and swelling properties, enabling it to disintegrate quickly. However, when used alone, it tends to form a gel layer after disintegration, affecting the uniformity of dissolution. LSC, on the other hand, rapidly absorbs liquid through capillary action, promoting particle dispersion and leaving no gel residue after disintegration. The combination of crospovidone's swelling and disintegration with LSC's capillary dispersibility creates a synergistic effect. Combined with the solubilizer sodium dodecyl sulfate, this traditional Chinese medicine preparation dissolves rapidly in warm water with no significant particle residue. Detailed Implementation

[0022] The present application will be further described in detail below with reference to the embodiments.

[0023] The mannanase (enzyme activity: 30000u / g) used in the examples and comparative examples of this application was purchased from Henan Kangzhiwang Biotechnology Co., Ltd.; xylanase (enzyme activity: 100000u / g) was purchased from Hefei Shengrun Biological Products Co., Ltd.; arabinofuranoside was purchased from Jiangsu Caiwei Biotechnology Co., Ltd.; low-substituted hydroxypropyl cellulose (food grade) was purchased from Jiangsu Caiwei Biotechnology Co., Ltd.; hydroxypropyl-β-cyclodextrin (model: whshuer) was purchased from Wuhan Shuer Biotechnology Co., Ltd.; micronized silica gel (pharmaceutical grade) was purchased from Shaanxi Mingcheng Pharmaceutical Co., Ltd.; and crospovidone (pharmaceutical grade) was purchased from Shaanxi Yangyuanshen Biotechnology Co., Ltd.

[0024] Examples 1-3 provide a fast-dissolving traditional Chinese medicine preparation and its preparation method.

[0025] Example 1

[0026] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0027] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10:5. The amount of volatile oil stabilizer added is 5% of the mass of the distillate.

[0028] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Enzymatically hydrolyze the mixture for 2 hours at 40℃ and pH 5.0. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice at 200W and 40kHz for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to a paste with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 10:3:1.

[0029] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0030] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0031] Example 2

[0032] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0033] Step 1: Grind Job's tears into powder and pass it through a 60-mesh sieve. Add 9 times the amount of purified water and extract using low-temperature steam distillation at 65℃ for 3 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 400 rpm for 15 minutes. After stirring evenly, dry at 50℃ for 9 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 11:7. The amount of volatile oil stabilizer added is 7% of the mass of the distillate.

[0034] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 60-mesh sieve, add purified water, and stir evenly at 200 rpm to obtain a mixture. Add 0.5% of the mixture mass of compound enzyme to the mixture, control the material-liquid mass ratio at 1.5:20, and perform enzymatic hydrolysis for 3 hours at 42℃ and pH 5.5. After enzymatic hydrolysis, raise the temperature to 80℃ and inactivate the enzyme for 18 minutes. Perform ultrasonic-assisted extraction 3 times with an ultrasonic power of 250W and an ultrasonic frequency of 50kHz, each extraction lasting 35 minutes. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.20 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 11:4:2.

[0035] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 60-mesh sieve, add 9 times the volume of 75% ethanol, and extract by ultrasonic extraction at 150W power and 50kHz frequency for 30 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 25:20:25:30:12:15.

[0036] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 150 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 150 rpm until homogeneous. Granulate and dry at 55°C until the moisture content is 3% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 110:3:0.1:4. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2.5:1.1.

[0037] Example 3

[0038] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0039] Step 1: Grind Job's tears into powder and pass it through an 80-mesh sieve. Add 10 times the amount of purified water and extract using low-temperature steam distillation at 70℃ for 4 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 500 rpm for 20 minutes. After stirring evenly, dry at 60℃ for 10 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 12:8. The amount of volatile oil stabilizer added is 8% of the mass of the distillate.

[0040] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through an 80-mesh sieve, add purified water, stir at 300 rpm until homogeneous, and add 1% of the mixture mass of the compound enzyme to the mixture, controlling the material-liquid mass ratio to 2:30. Under the conditions of 45℃ and pH 6.0, perform enzymatic hydrolysis for 4 hours. After enzymatic hydrolysis, raise the temperature to 90℃ and inactivate the enzyme for 20 minutes. Perform ultrasonic-assisted extraction 3 times, with an ultrasonic power of 300W and an ultrasonic frequency of 60kHz, for 40 minutes each time. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.25 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 12:5:3.

[0041] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through an 80-mesh sieve, add 10 times the volume of 80% ethanol, and extract by ultrasonic extraction at 200W power and 60kHz frequency for 40 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 30:25:30:40:15:20.

[0042] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 200 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 200 rpm until homogeneous. Granulate and dry at 60°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 120:4:0.3:6. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 3:1.2.

[0043] Comparative Example 1

[0044] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0045] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add hydroxypropyl-β-cyclodextrin to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The amount of hydroxypropyl-β-cyclodextrin added is 5% of the mass of the distillate.

[0046] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Enzymatically hydrolyze the mixture for 2 hours at 40℃ and pH 5.0. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice at 200W and 40kHz for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to a paste with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 10:3:1.

[0047] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0048] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0049] Comparative Example 2

[0050] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0051] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10:5. The amount of volatile oil stabilizer added is 5% of the mass of the distillate.

[0052] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, and stir evenly at 100 rpm to obtain a mixture. Add 0.3% of the mixture mass of compound enzyme to the mixture, control the material-liquid mass ratio at 1:10, and perform enzymatic hydrolysis for 2 hours at 40℃ and pH 5.0. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice, with an ultrasonic power of 200W and an ultrasonic frequency of 40kHz, for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.15 at 60℃. The compound enzyme consists of xylanase and arabinofuranosides in a mass ratio of 3:1.

[0053] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0054] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0055] Comparative Example 3

[0056] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0057] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10:5. The amount of volatile oil stabilizer added is 5% of the mass of the distillate.

[0058] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Under the conditions of 40℃ and pH 5.0, perform enzymatic hydrolysis for 2 hours. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice, with an ultrasonic power of 200W and an ultrasonic frequency of 40kHz, for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase and arabinofuranosides in a mass ratio of 10:1.

[0059] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0060] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0061] Comparative Example 4

[0062] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0063] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10:5. The amount of volatile oil stabilizer added is 5% of the mass of the distillate.

[0064] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Enzymatically hydrolyze for 2 hours at 40℃ and pH 5.0. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Use ultrasound-assisted extraction twice, with an ultrasound power of 200W and an ultrasound frequency of 40kHz, for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase and xylanase in a mass ratio of 10:3.

[0065] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0066] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0067] Comparative Example 5

[0068] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0069] Step 1: Grind Job's tears into powder and pass it through a 40-mesh sieve. Add 8 times the amount of purified water and extract using low-temperature steam distillation at 60℃ for 2 hours. Collect the distillate and set aside the Job's tears residue. Add a volatile oil stabilizer to the distillate and stir at 300 rpm for 10 minutes. After stirring evenly, dry at 40℃ for 8 hours to obtain Job's tears oil inclusion complex. The volatile oil stabilizer consists of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10:5. The amount of volatile oil stabilizer added is 5% of the mass of the distillate.

[0070] Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Enzymatically hydrolyze the mixture for 2 hours at 40℃ and pH 5.0. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice at 200W and 40kHz for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to a paste with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 10:3:1.

[0071] Step 3: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0072] Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, and stir at 100 rpm until homogeneous to obtain a premix. Add crospovidone, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, crospovidone, mannitol and sodium lauryl sulfate is 100:2:0.1:3.

[0073] Comparative Example 6

[0074] A method for preparing an instant-dissolving traditional Chinese medicine preparation includes the following preparation steps:

[0075] Step 1: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and Coix lacryma-jobi, pulverize and pass through a 40-mesh sieve, add purified water, stir at 100 rpm until homogeneous, and add 0.3% (by weight) of the compound enzyme to the mixture, controlling the material-to-liquid mass ratio to 1:10. Under the conditions of 40℃ and pH 5.0, perform enzymatic hydrolysis for 2 hours. After enzymatic hydrolysis, raise the temperature to 70℃ and inactivate the enzyme for 15 minutes. Perform ultrasonic-assisted extraction twice, with an ultrasonic power of 200W and an ultrasonic frequency of 40kHz, for 30 minutes each time. Combine the extracts and concentrate under reduced pressure to an extract with a relative density of 1.15 at 60℃. The compound enzyme consists of mannanase, xylanase and arabinofuranosides in a mass ratio of 10:3:1.

[0076] Step 2: Mix dried tangerine peel and lotus leaf, pulverize and pass through a 40-mesh sieve, add 8 times the volume of 70% ethanol, and extract by ultrasonic extraction at 100W power and 40kHz frequency for 20 minutes. Filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract. Control the mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, dried tangerine peel and lotus leaf to be 20:15:18:20:8:10.

[0077] Step 3: Mix the tangerine peel-lotus leaf extract and the extract, and stir at 100 rpm until homogeneous to obtain a premix. Add the compound disintegrant, mannitol and sodium lauryl sulfate to the premix, and stir at 100 rpm until homogeneous. Granulate and dry at 50°C until the moisture content is 5% to obtain an instant-dissolving traditional Chinese medicine preparation. The mass ratio of the premix, compound disintegrant, mannitol and sodium lauryl sulfate is 100:2:0.1:3. The compound disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2:1.

[0078] Performance testing

[0079] The performance of the fast-dissolving traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-6 of this application was tested, as follows:

[0080] The fast-dissolving traditional Chinese medicine preparation prepared in this application can be used to treat spleen deficiency and dampness syndrome, especially suitable for digestive symptoms such as loss of appetite, abdominal distension and loose stools, worsening abdominal distension after meals, and heaviness in the limbs; systemic symptoms such as fatigue, sallow complexion, white and greasy tongue coating, and weak and slow pulse; and concurrent symptoms such as mild edema (eyelids / lower limbs), phlegm-damp cough (thick and sticky phlegm that is difficult to cough up), and summer-dampness related discomfort (dizziness and chest tightness in summer).

[0081] The instant-dissolving traditional Chinese medicine preparations (each tablet weighing 5g) prepared in Examples 1-3 and Comparative Examples 1-6 were dissolved in 30ml of distilled water at 50℃. The mixtures were stirred on a constant-temperature magnetic stirrer at a stirring speed of 500rpm, and the time required for the instant-dissolving traditional Chinese medicine preparations to be completely dissolved was recorded.

[0082] 180 patients meeting the above-mentioned symptoms were selected and randomly divided into 9 groups according to the severity of their condition. The efficacy of the instantaneous traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-6 was determined. Patients took the medicine twice a day for 14 consecutive days, with a total daily dose of 10g. The improvement rate was calculated by "(pre-treatment score - post-treatment score) ÷ pre-treatment score × 100%". Significant effect: improvement rate ≥ 60% (core symptoms such as abdominal distension and loose stools basically disappeared, and concurrent symptoms were significantly reduced); Effective: improvement rate 30%-59% (core symptoms were reduced, and concurrent symptoms were somewhat relieved); Ineffective: improvement rate < 30% (symptoms did not improve or worsened).

[0083] Table 1 Core Symptom Scoring Table

[0084]

[0085] Table 2 Comparison of dissolution time and clinical trial results among different treatment groups

[0086]

[0087] As shown in Tables 1-2, the fast-dissolving traditional Chinese medicine preparation obtained in this application combines convenience with excellent efficacy. This preparation dissolves rapidly in warm water with no obvious particle residue. The formula uses Astragalus membranaceus and Atractylodes macrocephala, among other spleen-tonifying and qi-boosting herbs, as its core, combined with dampness-removing and qi-regulating components, which aligns with the pathogenesis of spleen deficiency with dampness accumulation. Through enzymatic hydrolysis, ultrasonic extraction, and volatile oil encapsulation technology, the effective components are fully preserved, improving bioavailability. Within a 14-day treatment course, patients showed significant improvement in symptom scores, effectively relieving symptoms such as abdominal distension and loose stools. It is suitable for conditions such as functional dyspepsia, demonstrating significant application value.

[0088] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A method for preparing a fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency with dampness syndrome, characterized in that, The preparation steps include the following: Step 1: Take coix seed, crush and sieve it, add 8-10 times the amount of purified water, and extract it by low temperature steam distillation for 2-4 hours. Collect the distillate and set aside the coix seed residue after distillation. Add volatile oil stabilizer to the distillate, stir evenly, and dry to obtain coix seed oil inclusion complex. Step 2: Mix Astragalus membranaceus, Atractylodes macrocephala, Poria cocos and the distilled Coix lacryma-jobi residue, crush and sieve, add purified water, stir evenly to obtain a mixture, add compound enzyme to the mixture, enzymatically hydrolyze for 2-4 hours, raise the temperature to inactivate the enzyme after enzymatic hydrolysis, use ultrasound-assisted extraction 2-3 times, combine the extracts, concentrate under reduced pressure to obtain extract. Step 3: Mix dried tangerine peel and lotus leaf, crush and sieve, add ethanol, extract by ultrasonication, filter, collect the filtrate, and distill under reduced pressure to obtain dried tangerine peel-lotus leaf extract; Step 4: Mix the coix seed oil inclusion complex, tangerine peel-lotus leaf extract and extract, stir evenly to obtain a premix, add compound disintegrant, flavoring agent and solubilizer to the premix, stir evenly, granulate, and dry to a moisture content ≤5% to obtain a fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome. The mass ratio of Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, Citrus reticulata peel and Nelumbo nucifera leaf is 20-30:15-25:18-30:20-40:8-15:10-20; In step 2, the complex enzyme is composed of mannanase, xylanase and arabinofuranase in a mass ratio of 10-12:3-5:1-3. In step 4, the composite disintegrant is composed of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose in a mass ratio of 2-3:1-1.

2.

2. The method for preparing the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome according to claim 1, characterized in that, In step 1, the amount of volatile oil stabilizer added is 5-8% of the mass of the distillate.

3. The method for preparing the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome according to claim 1, characterized in that, In step 1, the volatile oil stabilizer is composed of hydroxypropyl-β-cyclodextrin and micronized silica gel in a mass ratio of 10-12:5-8.

4. The method for preparing the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome according to claim 1, characterized in that, In step 2, the amount of compound enzyme added is 0.3-1% of the mass of the mixture.

5. The method for preparing the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome according to claim 1, characterized in that, The enzymatic hydrolysis conditions in step 2 are as follows: enzymatic hydrolysis for 2-4 hours at a temperature of 40-45℃ and a pH of 5.0-6.

0.

6. The method for preparing the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome according to claim 1, characterized in that, In step 4, the mass ratio of the premix, compound disintegrant, flavoring agent and solubilizer is 100-120: 2-4: 0.1-0.3: 3-6.

7. A fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome, prepared by the preparation method according to any one of claims 1-6.

8. The use of the fast-dissolving traditional Chinese medicine preparation for treating spleen deficiency and dampness syndrome as described in claim 7 in the preparation of medicines for treating spleen deficiency and dampness syndrome.

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