Preparation method of yulanjiangjiang capsule pharmaceutical composition

Abstract

The application provides a preparation method of Yu Lan Jiangtang capsule pharmaceutical composition. Traditional Chinese medicinal materials such as Huangqi and Sangye are crushed into coarse powder, then betaine-malic acid aqueous solution is added, ultrasonic extraction is carried out, filtration is carried out, and extract A and residue A are obtained; then ethanol solution is used for heating reflux extraction on the residue A, sieving is carried out, and extract B is obtained; then the extract A and the extract B are combined, ethanol is added, and cold storage is carried out, and finally, thick paste is concentrated; various pharmaceutical adjuvants can be added to the thick paste to prepare corresponding pharmaceutical preparations. The process can solve the problems of low baicalin content and many water-soluble impurities in the traditional process, the product quality is stable, the indexes meet the regulations, and the process is suitable for actual production.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a method for preparing a pharmaceutical composition for Yulan hypoglycemic capsules. Background Technology

[0002] Yulan Hypoglycemic Capsules are a product of Guizhou Jianxing Pharmaceutical Co., Ltd. They have the effects of clearing heat and nourishing yin, promoting body fluid production and quenching thirst. They are mainly used to improve diabetes mellitus, type 2 diabetes, and its complications caused by yin deficiency and internal heat. The formula consists of 620g of Scutellaria baicalensis, 285g of mulberry leaves, 260g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Phyllostachys nigra root, and 93g of Celosia argentea. The preparation method is as follows: 30g of mulberry leaves are crushed into a fine powder; the remaining mulberry leaves, Scutellaria baicalensis, Arctium lappa, Panax quinquefolius, Scutellaria barbata, Phyllostachys nigra root, and Celosia argentea are decocted twice with water, the first time for 2 hours and the second time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.17-1.20 (80℃). The above fine powder is added, mixed well, dried, crushed into a fine powder, sieved, mixed well, and filled into capsules to obtain the final product.

[0003] However, the above-mentioned decoction extraction process has the following shortcomings: in actual production, the extract contains a large number of water-soluble impurities, and the measured extraction yield of baicalin, as the main active ingredient, is low, which will affect the quality of the medicine. Therefore, in order to ensure the quality of the medicine and achieve better efficacy, it is necessary to improve the traditional process. Summary of the Invention

[0004] The purpose of this invention is to provide a method for preparing a pharmaceutical composition for Yulan hypoglycemic capsules. This method employs an ultrasound-assisted extraction process using a low-co-solubility solvent combined with heating and reflux extraction, followed by alcohol precipitation and refrigeration. This method solves the problems of traditional processes, such as the high amount of water-soluble impurities, low baicalin yield, and low baicalin content in the finished product, thereby improving the quality of the drug.

[0005] This invention is achieved through the following technical solution: The present invention discloses a method for preparing a Yulan hypoglycemic capsule pharmaceutical composition, which comprises 620 parts of Scutellaria baicalensis, 285 parts of mulberry leaf, 260 parts of Arctium lappa fruit, 180 parts of Panax quinquefolius, 170 parts of Scutellaria barbata, 120 parts of Pseudolarix amabilis root, and 93 parts of Celosia argentea fruit. The preparation method includes the following steps: S1. Take Scutellaria baicalensis, mulberry leaf, burdock seed, Panax quinquefolius, Scutellaria barbata, false bamboo root, and Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 4-8 times the amount of 25% betaine-malic acid aqueous solution, and extract by ultrasonic (200-250w) for 1-3 hours. Filter to obtain extract A and residue A. S2, add the residue A to a 50%-80% ethanol solution at a material-to-liquid ratio of 1g:10-20ml, heat and reflux for 1-3 hours, and pass the solution through a 200-mesh sieve to obtain extract B; S3, combine extract A and extract B, add ethanol to the alcohol content to 60%-80%, refrigerate for 12-36 hours, separate the supernatant and precipitate, distill the supernatant to recover ethanol, and concentrate into a thick paste. S4. Add the above-obtained thick paste to pharmaceutically acceptable excipients and mix evenly to prepare the corresponding pharmaceutical preparation.

[0006] Preferably, step S1 of the present invention specifically involves: taking Scutellaria baicalensis, mulberry leaves, burdock seeds, Panax ginseng, Scutellaria barbata, Pseudobulbus buergerianum root, and Celosia argentea according to the formula ratio, mixing them, pulverizing them into coarse powder (20-50 mesh), adding 6 times the amount of 25% betaine-malic acid aqueous solution, ultrasonically extracting (200-250W) for 2 hours, and filtering to obtain extract A and residue A.

[0007] Preferably, the molar ratio of betaine to malic acid in this invention is 1-2:1.

[0008] More preferably, the molar ratio of betaine to malic acid in the present invention is 1-1.5:1.

[0009] More preferably, the molar ratio of betaine to malic acid in this invention is 1:1.

[0010] Preferably, step S2 of the present invention specifically involves: adding the residue A to a 60%-80% ethanol solution at a material-to-liquid ratio of 1g:14-16ml, heating and refluxing for 1.5-2.5h, and passing the solution through a 200-mesh sieve to obtain extract B.

[0011] In a further preferred embodiment, step S2 of the present invention specifically involves: adding the residue A to a 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heating and refluxing for 2 hours, and then passing the solution through a 200-mesh sieve to obtain extract B.

[0012] Preferably, step S3 of the present invention specifically involves: combining extract A and extract B, adding ethanol to a concentration of 65%-75%, refrigerating for 24-36 hours, separating the supernatant from the precipitate, distilling the supernatant to recover the ethanol, and concentrating it into a thick paste.

[0013] More preferably, step S3 of the present invention specifically involves: combining extract A and extract B, adding ethanol to a concentration of 70%, refrigerating for 24 hours, separating the supernatant from the precipitate, distilling the supernatant to recover the ethanol, and concentrating it into a thick paste.

[0014] The pharmaceutical preparations described in this invention include, but are not limited to, capsules.

[0015] The pharmaceutical preparation may also be a tablet, granule, or oral liquid.

[0016] Compared with the prior art, the present invention has the following advantages: 1. The method of this invention can significantly improve the extraction rate of baicalin in the Yulan hypoglycemic capsule pharmaceutical composition, and the effect is remarkable. Using an ultrasound-assisted low-co-soluble solvent combined with heating reflux, the extraction rate of baicalin reached 40.77%, solving the problem of low baicalin yield in traditional processes. Furthermore, the extract was subjected to alcohol precipitation and refrigeration to remove water-soluble impurities, solving the problem of excessive water-soluble impurities affecting drug quality in traditional processes.

[0017] 2. The method of this invention can improve product quality. By using an ultrasound-assisted low-co-solubility solvent combined with heating and reflux, followed by alcohol precipitation and cold storage technology, the baicalin content in the product is 30.32 mg / capsule, which is significantly higher than the baicalin content of 21.49 mg / capsule obtained by the traditional extraction process.

[0018] 3. The process of this invention is stable and feasible, and is suitable for actual large-scale production. Detailed Implementation

[0019] The technical solution of the present invention will be further described in detail below through specific embodiments.

[0020] Example 1: Preparation of the pharmaceutical composition for Yulan hypoglycemic capsules (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch to the above-obtained thick paste, granulate, pass through a 12-mesh sieve, dry at 50-60℃, pulverize, and encapsulate to obtain capsules, 0.3g / capsule.

[0021] Example 2: Preparation of the pharmaceutical composition for Yulan hypoglycemic capsules (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1.5:1) aqueous solution, and extract by ultrasonic extraction at 200W for 1h. Filter to obtain extract A and residue A; (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:8ml, heat and reflux for 1 h, and pass the solution through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch to the above-obtained thick paste, granulate, pass through a 12-mesh sieve, dry at 50-60℃, pulverize, and encapsulate to obtain capsules, 0.3g / capsule.

[0022] Example 3: Preparation of the pharmaceutical composition for Yulan hypoglycemic capsules (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (2:1) aqueous solution, and extract by ultrasonic extraction at 300W for 3h. Filter to obtain extract A and residue A; (2) Add the residue A to 60% ethanol solution at a material-to-liquid ratio of 1g:10ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch to the above-obtained thick paste, granulate, pass through a 12-mesh sieve, dry at 50-60℃, pulverize, and encapsulate to obtain capsules, 0.3g / capsule.

[0023] Example 4: Preparation method of the pharmaceutical composition of Yulan hypoglycemic capsules (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 4 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract by ultrasonic extraction at 300W for 1.5h. Filter to obtain extract A and residue A; (2) Add the residue A to 50% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 12 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch to the above-obtained thick paste, granulate, pass through a 12-mesh sieve, dry at 50-60℃, pulverize, and encapsulate to obtain capsules, 0.3g / capsule.

[0024] Example 5: Preparation method of Yulan hypoglycemic capsule pharmaceutical composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 8 times the amount of 25% betaine-malic acid (3:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:10ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 36 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch to the above-obtained thick paste, granulate, pass through a 12-mesh sieve, dry at 50-60℃, pulverize, and encapsulate to obtain capsules, 0.3g / capsule.

[0025] Example 6 Preparation of the Yulan Hypoglycemic Granules Pharmaceutical Composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add appropriate amounts of soluble starch, microcrystalline cellulose and silicon dioxide to the above-obtained thick paste, granulate, dry, granulate, sieve and package to obtain granules, 6g / bag.

[0026] Example 7 Preparation of the Yulan Hypoglycemic Granules Pharmaceutical Composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea according to the formula ratio, mix them, pulverize them into coarse powder (20-50 mesh), add 4 times the amount of 25% betaine-malic acid (2:1) aqueous solution, and extract them by ultrasonic extraction at 400W for 1.5h. Filter to obtain extract A and residue A. (2) Add the residue A to 60% ethanol solution at a material-to-liquid ratio of 1g:8ml, heat and reflux for 3 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 12 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add appropriate amounts of soluble starch, microcrystalline cellulose and silicon dioxide to the above-obtained thick paste, granulate, dry, granulate, sieve and package to obtain granules, 6g / bag.

[0027] Example 8 Preparation of the Yulan Hypoglycemic Granules Pharmaceutical Composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, pulverize them into coarse powder (20-50 mesh), add 8 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract by ultrasonic extraction at 250W for 0.5h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:6ml, heat and reflux for 1 h, and pass the solution through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add appropriate amounts of soluble starch, microcrystalline cellulose and silicon dioxide to the above-obtained thick paste, granulate, dry, granulate, sieve and package to obtain granules, 6g / bag.

[0028] Example 9 Preparation of the Yulan Hypoglycemic Granules Pharmaceutical Composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (3:1) aqueous solution, and extract by ultrasonic extraction at 250W for 1h. Filter to obtain extract A and residue A. (2) Add the residue A to 50% ethanol solution at a material-to-liquid ratio of 1g:10ml, heat and reflux for 3 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 36 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add appropriate amounts of soluble starch, microcrystalline cellulose and silicon dioxide to the above-obtained thick paste, granulate, dry, granulate, sieve and package to obtain granules, 6g / bag.

[0029] Example 10 Preparation of the Yulan Hypoglycemic Granules Pharmaceutical Composition (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 200W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:20ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add appropriate amounts of soluble starch, microcrystalline cellulose and silicon dioxide to the above-obtained thick paste, granulate, dry, granulate, sieve and package to obtain granules, 6g / bag.

[0030] Example 11 Preparation of the pharmaceutical composition for Magnolia officinalis hypoglycemic tablets (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch and dextrin to the above-obtained thick paste, compress it into tablets, 0.45g / tablet.

[0031] Example 12 Preparation of the pharmaceutical composition for Magnolia officinalis hypoglycemic tablets (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, pulverize them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 400W for 1.5h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to 60% alcohol content, refrigerate for 36 hours, separate, take the supernatant, distill to recover ethanol, and concentrate into a thick paste. (4) Add an appropriate amount of starch and dextrin to the obtained thick paste, compress it into tablets, 0.45g / tablet.

[0032] Example 13 Preparation of the pharmaceutical composition for Yulan hypoglycemic tablets (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, pulverize them into coarse powder (20-50 mesh), add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract by ultrasonic extraction at 500W for 0.5h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heat and reflux for 1 h, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 24 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch and dextrin to the obtained thick paste, compress it into tablets, 0.45g / tablet.

[0033] Example 14 Preparation of the pharmaceutical composition for Yulan hypoglycemic tablets (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 8 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 70% ethanol solution at a material-to-liquid ratio of 1g:20ml, heat and reflux for 3 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 36 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch and dextrin to the obtained thick paste, compress it into tablets, 0.45g / tablet.

[0034] Example 15 Preparation of the pharmaceutical composition for Yulan hypoglycemic tablets (1) Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea according to the formula ratio, mix them, grind them into coarse powder (20-50 mesh), add 4 times the amount of 25% betaine-malic acid (2:1) aqueous solution, and extract with ultrasound at 250W for 2h. Filter to obtain extract A and residue A. (2) Add the residue A to 40% ethanol solution at a material-to-liquid ratio of 1g:10ml, heat and reflux for 2 hours to extract, and pass the liquid through a 200-mesh sieve to obtain extract B; (3) Combine extract A and extract B, add ethanol to a concentration of 70%, refrigerate for 12 hours, separate the supernatant from the precipitate, distill the supernatant to recover the ethanol, and concentrate it into a thick paste. (4) Add an appropriate amount of starch and dextrin to the obtained thick paste, compress it into tablets, 0.45g / tablet.

[0035] To further verify the feasibility and effectiveness of the technical solution of this invention, a series of verification experiments were conducted, as follows: I. Process Investigation of Yulan Hypoglycemic Capsules Yulan hypoglycemic capsules are composed of 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Bambusa textilis root, and 93g of Celosia argentea.

[0036] Traditional process: Take 30g of mulberry leaves and grind them into a fine powder; add water and decoct the remaining mulberry leaves with six other medicinal materials, including Scutellaria baicalensis, Arctium lappa, Panax ginseng, Scutellaria barbata, Pseudolarix amabilis root, and Celosia argentea, twice, for 2 hours the first time and 1.5 hours the second time. Combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.17-1.20 (80℃). Add the above fine powder, mix well, dry, grind into a fine powder, sieve, mix well, and fill into capsules to obtain the final product.

[0037] The research team of this invention discovered that traditional water decoction extraction, with its high temperature and long time, leads to significant loss of the active ingredient baicalin and a high content of water-soluble impurities. Furthermore, some highly viscous components are also extracted, resulting in a high viscosity of the drug extract, which in turn affects subsequent drying processes. Therefore, the research team improved the traditional extraction process and optimized the preparation process of the traditional Chinese medicine Yulan hypoglycemic capsules. Since Scutellaria baicalensis is the principal ingredient in the Yulan hypoglycemic capsule formula, and its main active ingredient is baicalin, this invention uses baicalin as an indicator to investigate the effect of different extraction methods on the baicalin content.

[0038] 1. Investigation of extraction process Baicalin content determination method: High performance liquid chromatography (HPLC) was used. The baicalin content was determined according to the drug standard of "Yulan Hypoglycemic Capsules" issued by Guizhou Jianxing Pharmaceutical Co., Ltd.

[0039] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase; methanol-water-phosphoric acid (47:53:0.2) was used as the mobile phase; the detection wavelength was 280 nm. The theoretical plate number, calculated based on the baicalin peak, should not be less than 2000.

[0040] Preparation of reference solution: Accurately weigh an appropriate amount of baicalin reference standard, add methanol to prepare a solution containing 70 μg per ml, shake well, and the solution is ready.

[0041] Preparation of the test solution: Take the contents from the volume variation section, grind them finely, take 0.5g, accurately weigh it, place it in a stoppered Erlenmeyer flask, accurately add 25ml of 70% ethanol, weigh it, stopper tightly, sonicate (power 250W, frequency 30KHz) for 30 minutes, cool, replenish the lost weight with 70% ethanol, shake well, filter, accurately measure 2ml of the filtrate, place it in a 50ml volumetric flask, add 70% ethanol to dilute to the mark, shake well, filter, and take the filtrate to obtain the test solution.

[0042] Determination method: Accurately pipette 10 μl of the reference solution and the test solution into the liquid chromatograph and determine the result.

[0043] (1) Decoction method Take 255g of mulberry leaves and the prescribed amounts of six medicinal materials, including Scutellaria baicalensis, Arctium lappa, Panax ginseng, Scutellaria barbata, Pseudolarix amabilis root, and Celosia argentea, add water and decoct twice, the first time for 2 hours and the second time for 1.5 hours. Combine the decoctions, filter, concentrate the filtrate to 50ml, and determine the content of baicalin. The results are shown in Table 1.

[0044] (2) Ultrasonic method Take 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea, mix them, grind them into coarse powder, add 6 times the amount of 70% ethanol solution, and extract by ultrasonic extraction at 200W for 1 hour. Filter, obtain the filtrate, concentrate and make up to 50ml, and determine the content of baicalin. The results are shown in Table 1.

[0045] (3) Ultrasonic method assisted by low co-solvent Take 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea, mix them, grind them into coarse powder, add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution, and extract by ultrasonication for 1h under a power of 200W. Filter to obtain the filtrate, concentrate and make up to 50ml, and determine the content of baicalin. The results are shown in Table 1.

[0046] (4) Enzymatic hydrolysis Take 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea, mix them together, grind them into coarse powder, add 6 times the amount of water and 1% cellulase, and enzymatically hydrolyze them at 50℃ and pH 5.0 for 24 hours. Filter, concentrate the filtrate and make up to 50ml, and determine the content of baicalin. The results are shown in Table 1.

[0047] (5) Heating reflux extraction method Take 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea, mix them, grind them into coarse powder, add 6 times the amount of 70% ethanol solution, heat and reflux for 1 hour, filter, obtain the filtrate, concentrate and make up to 50ml, and determine the content of baicalin. The results are shown in Table 1.

[0048] Experimental results showed that the highest extraction rate of baicalin from the ultrasonic extraction solution assisted by a low eutectic solvent was 30.84%, followed by reflux extraction at 27.19%. Ethanol ultrasonic extraction, enzymatic hydrolysis, and traditional decoction methods yielded relatively lower rates. The table shows that the extraction rate of baicalin using ultrasonic extraction with a low eutectic solvent was significantly higher than that using ethanol ultrasonic extraction, indicating that the low eutectic solvent has a greater impact on the extraction rate of baicalin and is more suitable for extracting the highly polar components of flavonoids in Lanjiangtang capsules. Furthermore, considering that Lanjiangtang capsules contain some alkaloids and other active ingredients, and that reflux extraction is more suitable for alkaloid extraction, with little difference in the extraction rates of baicalin between the two methods, this invention combines ultrasonic extraction assisted by a low eutectic solvent with reflux extraction. Ultrasonic extraction with a low eutectic solvent is used first, followed by further extraction of the residue from the former using reflux extraction. The tentative extraction process is as follows: Weigh out 620g of Scutellaria baicalensis, 285g of mulberry leaves, 180g of Arctium lappa, 180g of Panax quinquefolius, 170g of Scutellaria barbata, 120g of Pseudolarix amabilis root, and 93g of Celosia argentea. Mix them and grind them into coarse powder. Add 6 times the amount of 25% betaine-malic acid (1:1) aqueous solution and extract with ultrasound at 200W for 1h to obtain the first extract and residue. Add the residue to 70% ethanol solution at a material-liquid ratio of 1g:15ml and extract by reflux for 2h. Pass the liquid through a 200-mesh sieve to obtain the second extract. Combine the first and second extracts, concentrate and make up to 50ml, and determine the baicalin content.

[0049] Results: The extraction rate of baicalin was determined to be 40.77%. The experimental results indicate that the use of ultrasound-assisted eutectic solvent combined with heating reflux method can significantly improve the extraction rate of baicalin, and the effect is remarkable.

[0050] 2. Optimization of extraction process parameters 2.1 Selection of Low Cosolvent 2.1.1 Selection of Components Under item “1”, the extraction process was tentatively determined, and the effects of the components of choline chloride-urea (1:2), choline chloride-ethylene glycol (1:2), betaine-lactic acid (1:2), betaine-malic acid (1:2), and 25% betaine-malic acid (1:2) aqueous solution on the content of baicalin were investigated.

[0051] The results showed that the extraction rates of baicalin were 32.86%, 30.53%, 33.14%, 37.72%, and 40.15% respectively, using choline chloride-urea, choline chloride-ethylene glycol, betaine-lactic acid, betaine-malic acid, and a 25% betaine-malic acid (1:2) aqueous solution as components. Therefore, the preferred low co-solubility solvent component is the 25% betaine-malic acid (1:2) aqueous solution.

[0052] 2.1.2 Investigation of the molar ratio of betaine to malic acid This experiment investigated the effect of a 25% betaine-malic acid aqueous solution on the extraction rate of baicalin at different molar ratios of betaine to malic acid (3:1, 2.5:1, 2:1, 1.5:1, and 1:1). The results are shown in Table 2.

[0053] Experimental results showed that the extraction rate of baicalin was significantly higher when the molar ratio of betaine to malic acid was 1:1 than when other molar ratios were used. Therefore, a 25% aqueous solution of betaine and malic acid with a molar ratio of 1:1 was chosen as the low co-solvent.

[0054] 2.2 Selection of Ultrasonic Extraction Time Under item "1", the provisional extraction process method was used. This experiment investigated the effects of different ultrasonic times (0.5 h, 1 h, 2 h, 3 h, and 4 h) on the extraction rate of baicalin. The results are shown in Table 3.

[0055] Experimental results showed that the baicalin content was significantly higher when the ultrasonic extraction time was 2 hours than at other extraction times. Therefore, ultrasonic extraction for 2 hours was selected.

[0056] 2.3 Selection of solvent for heating and reflux extraction Under item "1", the provisional extraction process method was determined. This experiment investigated the effect of heating and reflux extraction with different solvents (40%, 50%, 60%, 70%, and 80% ethanol) on the extraction rate of baicalin. The results are shown in Table 4.

[0057] Experimental results showed that the extraction rate of baicalin was significantly higher when the extraction solvent was 70% ethanol solution under reflux than other solvents. Therefore, 70% ethanol was chosen as the extraction solvent under reflux.

[0058] 2.4 Selection of Heating Reflux Extraction Time Under item "1", the provisional extraction process method was used to investigate the effect of different heating reflux extraction times of 1 h, 1.5 h, 2 h, 2.5 h, and 3 h on the extraction rate of baicalin. The results are shown in Table 5.

[0059] Experimental results showed that the yield of baicalin was significantly higher when the extraction time was refluxed for 2 h, 2.5 h, and 3 h than other extraction times. Since the extraction rates were not significantly different among the three times, and considering both cost and extraction efficiency, reflux extraction for 2 h was chosen.

[0060] 2.5 Selection of the feed-to-liquid ratio for heating and reflux extraction Under item "1", the extraction process method is tentatively determined. In this experiment, the effects of different heating reflux extraction solid-liquid ratios of 1 g:6 ml, 1 g:8 ml, 1 g:10 ml, 1 g:15 ml, and 1 g:20 ml on the extraction rate of baicalin were investigated. The results are shown in Table 6.

[0061] The experimental results show that when the solid-liquid ratio of heating reflux extraction is 1:15 and 1:20, the extraction rate of baicalin is significantly higher than other solid-liquid ratios. However, the difference in the effects of the two on the extraction rate of baicalin is not significant. Considering the cost issue, the solid-liquid ratio of 1:15 (g:ml) is selected.

[0062] 3. Impurity removal Although the present invention has improved the traditional water decoction extraction process and reduced the water-soluble impurities, there are still some water-soluble impurities in the newly improved method. Therefore, the method of alcohol precipitation and refrigeration for impurity removal is adopted in the present invention. Ethanol is added to the extract until the alcohol content is 70%, and it is refrigerated for 24 h.

[0063] 4. Preparation of the formed preparation Take the extract after alcohol precipitation and refrigeration under item "3" above, separate the supernatant and the precipitate, distill and recover ethanol from the supernatant, concentrate it into a thick paste, add an appropriate amount of starch, granulate, pass through a 12-mesh sieve, dry at 50 - 60 °C, pulverize, and fill into capsules to obtain the capsule preparation (0.3 g / capsule).

[0064] 5. Verification experiment Prepare 3 batches of Yulan Jiangtang Capsule samples according to the optimal process steps obtained from the experiment, and determine the content of baicalin. The test results are shown in Table 7.

[0065] Results: The 3 batches of Yulan Jiangtang Capsule pharmaceutical compositions prepared according to the above determined preparation process, and the content of baicalin reaches 30.32 mg / capsule, which is significantly higher than the content of baicalin in the finished product of 21.49 mg / capsule prepared by the traditional extraction process. It shows that the extraction process is stable and feasible, and the quality of the Yulan Jiangtang Capsule pharmaceutical composition prepared is stable, which is suitable for actual production.

[0066] II. Pharmacodynamic experiment 1 Materials and instruments 1.1 Animals and medicinal materials 48 SPF-grade male SD rats, 4 weeks old, with a body weight of 120 - 140 g, were purchased from Changsha Tianqin Biotechnology Co., Ltd. The license number for the use of experimental animals is: SCXK(Xiang)2024 - 0021. The rats were raised under the conditions of temperature (22 ± 2) °C, relative humidity 50% - 60%, and a 12 h light / dark cycle, with free access to food and water.

[0067] Drugs: Yulan hypoglycemic capsules (Example 1); metformin hydrochloride tablets (Sino-American Shanghai Bristol-Myers Squibb Pharmaceutical Co., Ltd.).

[0068] 1.2 Reagents Streptozotocin (STZ): Sigma-Aldrich (USA); Biochemical reagent kits: TC, TG, LDL-C, HDL-C, BUN, Scr, etc., Nanjing Jiancheng Biotechnology Institute. ELISA kits: IL-6, TNF-α: Shenzhen Xinbosheng Biotechnology Co., Ltd. FINS: Wuhan Yilairuit Biotechnology Co., Ltd.

[0069] 1.3 Instruments Blood glucose meter: Roche (Germany), model ACCU-CHEK. Automated biochemical analyzer: Shenzhen Leidu Life Science & Technology Co., Ltd., model Chemray 240. Multifunctional microplate reader: BioRad Systems, Inc. (USA), model iMark. Centrifuge: Shanghai Xinyan Biotechnology Co., Ltd., model xinyan22-013.

[0070] 2 Methods 2.1 Animal grouping, model establishment, and drug administration Forty-eight SPF-grade male SD rats were randomly divided into a control group (n=8) and a model group (n=40) after acclimatization. The control group was fed a normal diet, while the model group was fed a high-fat, high-sugar diet for 4 weeks to induce insulin resistance. At the end of the feeding period, the model group was fasted for 12 hours and then given a single intraperitoneal injection of streptozotocin (STZ) 30. The control group received an equal volume of citrate buffer. Random blood glucose levels were measured via tail vein sampling 72 hours post-injection and monitored three times over two weeks. A blood glucose level ≥16.7 g / L on all three tests was considered normal. The T2DM model was determined to be successful. Rats with successful modeling were continued to be fed a high-fat, high-sugar diet during the drug administration period.

[0071] Rats with successfully induced type 2 diabetes mellitus (T2DM) were randomly divided into 5 groups, with 8 rats in each group: model group, metformin group, and 180 rats in each group. The low, medium, and high dose groups of Yulan hypoglycemic capsules were 1.8 g / (kg·d), 3.6 g / (kg·d), and 7.2 g / (kg·d), respectively. The control group and model group were administered an equal volume of distilled water by gavage, while the other groups received the corresponding medication. The medication was administered once daily for 8 weeks, with a gavage volume of 1... .

[0072] 2.2 Sample Collection Fasting is permitted for 12 hours after the last dose. Intraperitoneal injection of sodium pentobarbital (30g) Anesthetized, blood was drawn via the abdominal aorta. After the blood was allowed to stand for 30 minutes, it was centrifuged at 3000 rpm for 10 minutes, and the supernatant serum was collected and stored at −80℃.

[0073] 2.3 Rat liver weight and liver index The liver was rinsed with saline solution, the surface moisture was patted dry, and the wet weight of the liver was measured. The liver index was then calculated. .

[0074] 2.4 Serum Biochemical Indicators in Rats Serum TC, TG, LDL-C, HDL-C, BUN, and Scr levels were detected using a fully automated biochemical analyzer, following the instructions in the kit manual.

[0075] 2.5 Fasting blood glucose (FBG) test After 0, 2, 4, 6, and 8 weeks of drug administration, rats were fasted for 12 hours but allowed free access to water. Fasting blood glucose levels were measured via the tail vein. If the glucometer displayed "H1", it was recorded as 33.3. .

[0076] 2.6 ELISA method for detecting fasting insulin (FINS), IL-6, and TNF-α levels Serum levels of FINS, IL-6, and TNF-α were measured according to the kit instructions.

[0077] 2.7 Statistical Analysis Statistical analysis was performed using statistical software, and data are expressed as mean ± standard deviation. One-way ANOVA was used for comparisons among multiple groups; the least significant difference (LSD) test was used for comparisons between two groups if variances were homogeneous; otherwise, nonparametric tests were used. A p-value < 0.05 was considered statistically significant.

[0078] 3 Results 3.1 Effects of Yulan Hypoglycemic Capsules on the General Condition and Body Weight of Type 2DM Rats The control group rats were in good mental condition, with smooth and shiny fur, normal appetite, water intake, and urine output, and their weight steadily increased over the experimental period. After modeling, the model group rats gradually developed typical symptoms of diabetes, such as polydipsia, polyphagia, polyuria, and slow weight gain, as well as dry and rough fur and lethargy. After 8 weeks of drug administration, the above symptoms of rats in all drug administration groups improved to varying degrees, with more significant improvements observed in the metformin group and the medium and high dose groups of Yulan hypoglycemic capsules.

[0079] As shown in Table 8, in the initial stage of the experiment (week 0 of drug administration), there was no significant difference in the body weight of rats in each group after modeling, but all were lower than the control group (P<0.05). During the drug administration period, the body weight of the control group continued to increase, while the body weight of the model group increased slowly and was lower than that of the control group (P<0.05). After 8 weeks of drug administration, the body weight of the metformin group and the medium and high dose groups of Yulan hypoglycemic capsules were higher than that of the model group (P<0.05).

[0080] 3.2 Effects of Yulan Hypoglycemic Capsules on Liver Quality and Liver Index in T2DM Rats As shown in Table 9, the liver wet weight and liver index of the model group rats were higher than those of the blank group (P<0.05), suggesting that the T2DM model rats have a tendency for liver enlargement and fatty degeneration. After 8 weeks of administration, the liver wet weight and liver index of the metformin group and each dose group of Yulan hypoglycemic capsules were lower than those of the model group (P<0.05).

[0081] 3.3 Effects of Yulan Hypoglycemic Capsules on Fasting Blood Glucose (FBG) in Type 2 Diabetic Rats As shown in Table 10, at week 0 of drug administration, the FBG of rats in all model groups was higher than that in the blank group (P<0.05). During the drug administration period, the FBG of the blank group remained within the normal range (4.5-6.0 mmol / L), while the FBG of the model group remained at a high level (>16.7 mmol / L). With the extension of drug administration time, the FBG of all drug administration groups gradually decreased: after 2 weeks of drug administration, the FBG of the metformin group and the high-dose Yulan hypoglycemic capsule group was lower than that of the model group (P<0.05); after 4-8 weeks of drug administration, the FBG of all drug administration groups was lower than that of the model group (P<0.05), with the FBG decreasing trend being more obvious in the medium and high-dose Yulan hypoglycemic capsule groups.

[0082] 3.4 Effects of Yulan Hypoglycemic Capsules on Serum Lipid Metabolism Indicators in Type 2 Diabetic Rats As shown in Table 11, the serum TC, TG, and LDL-C levels in the model group were higher than those in the blank group (P<0.05), while the HDL-C level was lower than that in the blank group (P<0.05), indicating that there was significant lipid metabolism disorder in the T2DM model rats. After 8 weeks of drug administration, the serum TC, TG, and LDL-C levels in the metformin group and the medium and high dose groups of Yulan hypoglycemic capsules were lower than those in the model group (P<0.05), while the HDL-C level was higher (P<0.05).

[0083] 3.5 Effects of Yulan Hypoglycemic Capsules on Serum Renal Function Indicators in Type 2 Diabetic Rats As shown in Table 12, the serum BUN and Scr levels in the model group were higher than those in the blank group (P<0.05), indicating early renal function damage in the T2DM model rats. After 8 weeks of administration, the serum BUN and Scr levels in the metformin group and each dose group of Yulan hypoglycemic capsules were lower than those in the model group (P<0.05).

[0084] 3.6 Effects of Yulan Hypoglycemic Capsules on Serum Insulin and Insulin Resistance Index in Type 2 Diabetic Rats As shown in Table 13, the serum FINS level in the model group was higher than that in the blank group (P<0.05), and the insulin resistance index (HOMA-IR) was increased (P<0.05), indicating that there was significant insulin resistance in the T2DM model rats. After 8 weeks of administration, the serum FINS level and HOMA-IR in the metformin group and each dose group of Yulan hypoglycemic capsules were lower than those in the model group (P<0.05).

[0085] 3.7 Effects of Yulan Hypoglycemic Capsules on Serum Inflammatory Factors in T2DM Rats As shown in Table 14, the serum IL-6 and TNF-α levels in the model group were higher than those in the blank group (P<0.05), indicating that there was a significant inflammatory response in the T2DM model rats. After 8 weeks of administration, the serum IL-6 and TNF-α levels in the metformin group and each dose group of Yulan hypoglycemic capsules were lower than those in the model group (P<0.05).

[0086] Pharmacodynamic experiments have demonstrated that the Yulan hypoglycemic capsules prepared in this invention can reduce liver index, blood glucose, serum levels (TC, TG, LDL-C), serum renal function indicators, insulin resistance index, and serum inflammatory factor content in T2DM rats.

[0087] Although the present invention has been described in detail above with general descriptions, specific embodiments, and experiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A method for preparing a pharmaceutical composition for Yulan hypoglycemic capsules, wherein the pharmaceutical composition is made from the following traditional Chinese medicine raw materials in parts by weight: 620 parts of Scutellaria baicalensis, 285 parts of mulberry leaf, 260 parts of Arctium lappa fruit, 180 parts of Panax quinquefolius, 170 parts of Scutellaria barbata, 120 parts of Prunus persica root, and 93 parts of Celosia argentea fruit; characterized in that, The preparation method includes the following steps: S1. According to the formula ratio, take Scutellaria baicalensis, mulberry leaf, burdock seed, Panax ginseng, Scutellaria barbata, false bamboo root, and Celosia argentea, mix them, pulverize them into coarse powder, add 4-8 times the amount of 25% betaine-malic acid aqueous solution, and extract by ultrasonication for 1-3 hours. Filter to obtain extract A and residue A; the molar ratio of betaine to malic acid in the betaine-malic acid aqueous solution is 1-2:

1. S2, add the residue A to a 50%-80% ethanol solution at a material-to-liquid ratio of 1g:10-20ml, heat and reflux for 1-3 hours, and pass the solution through a 200-mesh sieve to obtain extract B; S3, combine extract A and extract B, add ethanol to the alcohol content to 60%-80%, refrigerate for 12-36 h, separate the supernatant and precipitate, distill the supernatant to recover ethanol, and concentrate into a thick paste. S4. Add the above-obtained thick paste to pharmaceutically acceptable excipients and mix evenly to prepare the corresponding pharmaceutical preparation.

2. The preparation method according to claim 1, characterized in that, The specific steps of step S1 are as follows: take Scutellaria baicalensis, mulberry leaves, burdock seeds, Panax ginseng, Scutellaria barbata, Pseudobulbus buergerianum root, and Celosia argentea according to the formula ratio, mix them, crush them into coarse powder, add 6 times the amount of 25% betaine-malic acid aqueous solution, ultrasonically extract for 2 hours, and filter to obtain extract A and residue A.

3. The preparation method according to claim 1 or 2, characterized in that, The molar ratio of betaine to malic acid is 1-1.5:

1.

4. The preparation method according to claim 3, characterized in that, The molar ratio of betaine to malic acid is 1:

1.

5. The preparation method according to claim 1, characterized in that, Step S2 specifically involves adding the residue A to a 60%-80% ethanol solution at a material-to-liquid ratio of 1g:14-16ml, heating and refluxing for 1.5-2.5 hours, and then passing the solution through a 200-mesh sieve to obtain extract B.

6. The preparation method according to claim 5, characterized in that, Step S2 specifically involves adding the residue A to a 70% ethanol solution at a material-to-liquid ratio of 1g:15ml, heating and refluxing for 2 hours, and then passing the solution through a 200-mesh sieve to obtain extract B.

7. The preparation method according to claim 1, characterized in that, Step S3 specifically involves: combining extract A and extract B, adding ethanol to a concentration of 65%-75%, refrigerating for 24-36 hours, separating the supernatant from the precipitate, distilling the supernatant to recover the ethanol, and concentrating it into a thick paste.

8. The preparation method according to claim 7, characterized in that, Step S3 specifically involves: combining extract A and extract B, adding ethanol to a concentration of 70%, refrigerating for 24 hours, separating the supernatant from the precipitate, distilling the supernatant to recover the ethanol, and concentrating it into a thick paste.

9. The preparation method according to claim 1, characterized in that, The pharmaceutical preparation is in the form of capsules.

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