A brain-nourishing capsule and its preparation method

Abstract

This invention provides a Naoluotong capsule and its preparation method, belonging to the field of pharmaceutical technology. The Naoluotong capsule comprises the following components in parts by weight: 40-60 parts of Salvia miltiorrhiza extract, 40-60 parts of Ligusticum chuanxiong extract, 40-60 parts of Astragalus membranaceus extract, 40-60 parts of tolperidone hydrochloride, 5-15 parts of methyl hesperidin, 1-4 parts of vitamin B6, 12-25 parts of polyvinylpyrrolidone K30, 13-25 parts of polyethylene glycol 400, 32-42 parts of corn starch, 3-7 parts of magnesium stearate, and 200-250 parts of an ethanol aqueous solution with a volume concentration of 70-80%. The Naoluotong capsule prepared by this invention has a short disintegration time, good stability, and a high tolperidone hydrochloride content.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a brain-nourishing capsule and its preparation method. Background Technology

[0002] Naoluotong Capsules are a traditional Chinese medicine primarily used to treat symptoms caused by cerebrovascular diseases, such as headaches, dizziness, and memory loss. It is composed of various Chinese herbal ingredients, with specific formulas typically including herbs that promote blood circulation and remove blood stasis, such as Danshen, Chuanxiong, and Chishao.

[0003] Naoluotong capsules are primarily used to treat symptoms caused by cerebrovascular diseases, such as headaches, dizziness, and memory loss. To ensure rapid relief of these symptoms, the drug needs to be released and absorbed within a short timeframe. Furthermore, the absorption rate and bioavailability of Naoluotong capsules are closely related to their disintegration time; a faster disintegration time helps improve bioavailability, ensuring patients receive an adequate dose of the drug.

[0004] Patent CN104906119A discloses a brain-nourishing capsule and its preparation method. This method involves first encapsulating unstable components with an inclusion agent to obtain a core, then adding various extracts for further encapsulation to obtain a master capsule, and finally adding excipients for granulation. Experiments revealed that the product's disintegration time is unsatisfactory.

[0005] Patent CN105727065 A discloses a brain-nourishing capsule and its preparation method. The capsule is characterized by using 250 parts of Coix seed, 500 parts of Salvia miltiorrhiza, 500 parts of Ligusticum chuanxiong, and 500 parts of Astragalus membranaceus. The extract is obtained using supercritical carbon dioxide extraction, followed by vacuum drying. The extract is then pulverized into a nano-dry paste using a high-energy nano-impact mill. Functional excipients are added to produce the brain-nourishing capsule, resulting in a significantly shortened disintegration time. However, the labeled amount of tolperone hydrochloride per capsule is low, while tolperone hydrochloride is an important component of the brain-nourishing capsule and directly affects its efficacy. Furthermore, traditional Chinese medicine emphasizes the interaction of various components; components in a formula may have antagonistic or adverse effects on the body.

[0006] Therefore, there is an urgent need for a brain-nourishing capsule and its preparation method. Summary of the Invention

[0007] The purpose of this invention is to provide a brain-nourishing capsule and its preparation method.

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] A brain-nourishing capsule comprises the following components in parts by weight: 40-60 parts of Salvia miltiorrhiza extract, 40-60 parts of Ligusticum chuanxiong extract, 40-60 parts of Astragalus membranaceus extract, 40-60 parts of tolperidone hydrochloride, 5-15 parts of methyl hesperidin, 1-4 parts of vitamin B6, 12-25 parts of polyvinylpyrrolidone K30, 13-25 parts of polyethylene glycol 400, 32-42 parts of corn starch, 3-7 parts of magnesium stearate, and 200-250 parts of an aqueous ethanol solution with a volume concentration of 70-80%.

[0010] Further, the weight ratio of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch is (15-19):(20-23):(35-38).

[0011] In this invention, the addition of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch in the above weight ratio can improve the disintegration time of Naoluotong capsules. These three excipients, through their respective properties, work synergistically to ensure rapid disintegration of the capsules upon contact with liquid, thereby improving the drug release rate and bioavailability. Simultaneously, under these conditions, Naoluotong capsules can maintain ideal dissolution rates when stored at high temperatures.

[0012] Furthermore, the preparation method of the tanshinone extract includes the following steps:

[0013] (1) Grind the danshen into powder with a fineness of less than 80 mesh to obtain danshen powder;

[0014] (2) Mix the danshen powder and water to obtain danshen fermentation material. Add compound bacteria to the danshen fermentation material. The compound bacteria include animal bifidobacterium, long bifidobacterium and helvetica lactobacillus. Ferment at 38-40℃ for 10-12 hours, sterilize, and obtain danshen fermentation product.

[0015] (3) The fermentation product of Salvia miltiorrhiza was filtered and spray-dried to obtain Salvia miltiorrhiza extract.

[0016] Further, mix danshen powder and water in a weight ratio of 1:(10-12).

[0017] Furthermore, the dosage of the animal bifidobacterium is 10. 5 -10 6 CFU / mL of fermented danshen feed; the dosage of Bifidobacterium longum was 10. 7 -10 8 CFU / mL of fermented tanshinone; the dosage of Lactobacillus helveticus was 10. 6 -10 7 CFU / mL Danshen fermented feed.

[0018] Furthermore, the tanshinone fermentation product was filtered using a 0.22μm filter membrane.

[0019] Furthermore, the preparation method of Astragalus extract includes the following steps:

[0020] (1) Grind Astragalus membranaceus into powder smaller than 80 mesh to obtain Astragalus membranaceus powder;

[0021] (2) Mix Astragalus powder and water to obtain Astragalus fermented material; add Lactobacillus acidophilus to the Astragalus fermented material, the amount of Lactobacillus acidophilus is 10 6 -10 7 CFU / mL Astragalus membranaceus fermented feed; ferment at 38-40℃ for 3-5 hours, sterilize, and then add Lactobacillus casei at a dosage of 10... 8 -10 9 Fermented Astragalus membranaceus slurry at CFU / mL was fermented at 38-40℃ for 6-8 hours, then sterilized. Finally, Bifidobacterium bifidum was added at a dosage of 10 CFU / mL. 7 -10 8 Fermented Astragalus membranaceus slurry at CFU / mL was fermented at 38-40℃ for 4-6 hours, then sterilized to obtain the Astragalus membranaceus fermentation product.

[0022] (3) The fermentation product of Astragalus membranaceus was filtered through a 0.22 μm filter membrane and spray-dried to obtain Astragalus membranaceus extract.

[0023] Further, mix Astragalus powder and water in a weight ratio of 1:(10-12).

[0024] In experiments, it was found that the labeled amount of tolperone hydrochloride in Naoluotong capsules after long-term storage was less than 90%. Analysis suggests this may be due to the reaction of components in the herbal extract with tolperone hydrochloride, as well as the effects of adsorption and encapsulation after long-term storage, leading to a decrease in the labeled amount. This invention, using a specific enzyme for fermentation to prepare Naoluotong capsules, can improve the stability of the tolperone hydrochloride content in Naoluotong capsules after long-term storage. Analysis shows that fermentation degrades substances in the extract that react with tolperone hydrochloride, while the newly generated substances reduce the adsorption and encapsulation of tolperone hydrochloride, ensuring its free concentration in solution.

[0025] Further, the composition includes the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Ligusticum chuanxiong extract, 50 parts of tolperidone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus membranaceus extract, 2 parts of vitamin B6, 18 parts of polyvinylpyrrolidone K30, 22 parts of polyethylene glycol 400, 36 parts of corn starch, 5 parts of magnesium stearate, and 220 parts of 75 (v / v)% aqueous ethanol solution.

[0026] This invention also provides a method for preparing Naoluotong capsules, comprising the following steps: mixing danshen extract, chuanxiong extract and astragalus extract, pulverizing to less than 60 mesh, mixing evenly, adding topiperone hydrochloride, methyl hesperidin, vitamin B6, polyvinylpyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding ethanol aqueous solution, wet granulation, drying, and filling into capsules to obtain Naoluotong capsules.

[0027] Furthermore, the drying temperature is 60-65℃, and the drying time is 1-2 hours.

[0028] Compared with the prior art, the advantages and beneficial effects of the present invention are as follows:

[0029] 1. The Naoluotong capsules prepared by this invention have the effects of replenishing qi and promoting blood circulation, and clearing the meridians and collaterals; they also have the effects of dilating blood vessels and increasing cerebral blood flow. Naoluotong capsules can be used for headaches, dizziness, hemiplegia, numbness of limbs, fatigue, and other symptoms caused by qi deficiency and blood stasis in various cerebrovascular diseases such as cerebral thrombosis, cerebral arteriosclerosis, and sequelae of stroke.

[0030] 2. In this invention, the addition of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch in the above weight ratio can improve the disintegration time of Naoluotong capsules. Simultaneously, under these conditions, Naoluotong capsules can maintain ideal dissolution rates when stored at high temperatures.

[0031] 3. The present invention prepares Naoluotong capsules by fermenting tanshinone extract and astragalus extract using specific enzymes, which can improve the stability of the content of tolperidone hydrochloride in Naoluotong capsules after long-term storage. Detailed Implementation

[0032] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] All raw materials used in the following embodiments of the present invention are commercially available products:

[0034] Lactobacillus casei, catalog number: SHBCC D24737. Purchased from Shanghai Center for Microbiological Preservation.

[0035] Bifidobacterium bifidum, catalog number: SHBCC D24408ATCC 35914, purchased from Shanghai Center for Microbiology Preservation.

[0036] Lactobacillus acidophilus, catalog number: CCTCC AB 2010208. Purchased from the China Center for Type Culture Collection.

[0037] Bifidobacterium animalis, ID: SHBCC D24407AS 1.1852.

[0038] Lactobacillus helveticus, purchased from the China Center for Type Culture Collection, catalog number: CCTCAB2010205.

[0039] Bifidobacterium longum, purchased from Shanghai Microbiology Preservation Center, catalog number: SHBCC D24310.

[0040] Salvia miltiorrhiza extract, a commercially available product, manufactured by Shaanxi Hongze Biotechnology Co., Ltd., with a specification of 10:1.

[0041] Ligusticum chuanxiong extract, a commercially available product, manufactured by Xi'an Tongjiang Biotechnology Co., Ltd., specification 10:1.

[0042] Astragalus extract, a commercially available product, manufactured by Shanyang Lianfeng Biotechnology Co., Ltd., specification 10:1.

[0043] Tolperidone hydrochloride, CAS: 3644-61-9.

[0044] Methylhesperidin, CAS: 11013-97-1.

[0045] Polyvinylpyrrolidone K30, from Gongbike New Material Technology (Shanghai) Co., Ltd.

[0046] Polyethylene glycol 400, Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0047] Corn starch, Shanxi Jinyang Pharmaceutical Excipients Co., Ltd., CAS: 9005-25-8.

[0048] Example 1

[0049] This embodiment provides a Naoluotong capsule, comprising the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Ligusticum chuanxiong extract, 50 parts of tolperidone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus membranaceus extract, 2 parts of vitamin B6, 18 parts of polyvinylpyrrolidone K30, 22 parts of polyethylene glycol 400, 36 parts of corn starch, 5 parts of magnesium stearate, and 220 parts of 75% (v / v, volume concentration) ethanol aqueous solution.

[0050] The preparation method of the tanshinone extract includes the following steps:

[0051] (1) Grind the danshen into powder with a fineness of less than 80 mesh to obtain danshen powder;

[0052] (2) Mix danshen powder and water at a weight ratio of 1:11 to obtain danshen fermentation material. Add compound bacteria to the danshen fermentation material. The compound bacteria include Bifidobacterium animalis, Bifidobacterium longum and Lactobacillus helveticus. The amount of Bifidobacterium animalis is 10. 5 CFU / mL of fermented danshen feed; the dosage of Bifidobacterium longum was 10. 8 CFU / mL of fermented tanshinone; the dosage of Lactobacillus helveticus was 10. 6 CFU / mL of tanshinone fermentation material was fermented at 39℃ for 11 hours, then sterilized to obtain tanshinone fermentation product.

[0053] (3) The fermentation product of Salvia miltiorrhiza was filtered through a 0.22 μm filter membrane and spray-dried to obtain Salvia miltiorrhiza extract.

[0054] The preparation method of Astragalus extract includes the following steps:

[0055] (1) Grind Astragalus membranaceus into powder smaller than 80 mesh to obtain Astragalus membranaceus powder;

[0056] (2) Mix Astragalus powder and water at a weight ratio of 1:11 to obtain Astragalus fermented feed; add Lactobacillus acidophilus to the Astragalus fermented feed, the amount of Lactobacillus acidophilus is 10 7 CFU / mL Astragalus membranaceus fermented feed; fermented at 39℃ for 4 hours, sterilized, and then Lactobacillus casei was added at a dosage of 10... 8 Astragalus membranaceus fermented feed was fermented at 39℃ for 7 hours, then sterilized. Finally, Bifidobacterium bifidum was added at a dosage of 10 CFU / mL. 8 Astragalus fermentation material was fermented at CFU / mL at 39℃ for 5 hours, then sterilized to obtain the Astragalus fermentation product.

[0057] (3) The fermentation product of Astragalus membranaceus was filtered through a 0.22 μm filter membrane and spray-dried to obtain Astragalus membranaceus extract.

[0058] The preparation method of the Naoluotong capsules includes the following steps: mixing danshen extract, chuanxiong extract and astragalus extract, pulverizing to less than 60 mesh, mixing evenly, adding topiperone hydrochloride, methyl hesperidin, vitamin B6, polyvinylpyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding ethanol aqueous solution, wet granulation, drying at 62℃ for 1.5h, and filling into capsules to obtain Naoluotong capsules.

[0059] Example 2

[0060] This embodiment provides a Naoluotong capsule, comprising the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Ligusticum chuanxiong extract, 50 parts of tolperidone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus membranaceus extract, 2 parts of vitamin B6, 15 parts of polyvinylpyrrolidone K30, 23 parts of polyethylene glycol 400, 35 parts of corn starch, 5 parts of magnesium stearate, and 220 parts of 75 (v / v)% ethanol aqueous solution.

[0061] The preparation method of the tanshinone extract includes the following steps:

[0062] (1) Grind the danshen into powder with a fineness of less than 80 mesh to obtain danshen powder;

[0063] (2) Mix danshen powder and water at a weight ratio of 1:10 to obtain danshen fermentation material. Add compound bacteria to the danshen fermentation material. The compound bacteria include Bifidobacterium animalis, Bifidobacterium longum and Lactobacillus helveticus. The amount of Bifidobacterium animalis is 10. 6 CFU / mL of fermented danshen feed; the dosage of Bifidobacterium longum was 10. 7 CFU / mL of fermented tanshinone; the dosage of Lactobacillus helveticus was 10. 6 CFU / mL of tanshinone fermentation material was fermented at 38℃ for 12 hours, then sterilized to obtain tanshinone fermentation product.

[0064] (3) The fermentation product of Salvia miltiorrhiza was filtered through a 0.22 μm filter membrane and spray-dried to obtain Salvia miltiorrhiza extract.

[0065] The preparation method of Astragalus extract includes the following steps:

[0066] (1) Grind Astragalus membranaceus into powder smaller than 80 mesh to obtain Astragalus membranaceus powder;

[0067] (2) Mix Astragalus powder and water at a weight ratio of 1:12 to obtain Astragalus fermented feed; add Lactobacillus acidophilus to the Astragalus fermented feed, the amount of Lactobacillus acidophilus is 10 6 CFU / mL Astragalus membranaceus fermented feed; fermented at 40℃ for 5 hours, sterilized, and then Lactobacillus casei was added at a dosage of 10... 8 Astragalus membranaceus fermented feed was fermented at 40℃ for 8 hours, sterilized, and finally Bifidobacterium bifidum was added at a dosage of 10 CFU / mL. 7 Astragalus fermentation material was fermented at CFU / mL at 40℃ for 4 hours, then sterilized to obtain the Astragalus fermentation product.

[0068] (3) The fermentation product of Astragalus membranaceus was filtered through a 0.22 μm filter membrane and spray-dried to obtain Astragalus membranaceus extract.

[0069] The preparation method of the Naoluotong capsules includes the following steps: mixing danshen extract, chuanxiong extract and astragalus extract, pulverizing to less than 60 mesh, mixing evenly, adding topiperone hydrochloride, methyl hesperidin, vitamin B6, polyvinylpyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding ethanol aqueous solution, wet granulation, drying at 65℃ for 2 hours, and filling into capsules to obtain Naoluotong capsules.

[0070] Comparative Example 1

[0071] The difference between this comparative example and Example 1 is that the weight ratios of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch are different.

[0072] A brain-nourishing capsule comprises the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Ligusticum chuanxiong extract, 50 parts of tolperidone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus membranaceus extract, 2 parts of vitamin B6, 36 parts of polyvinylpyrrolidone K30, 32 parts of polyethylene glycol 400, 8 parts of corn starch, 5 parts of magnesium stearate, and 220 parts of 75 (v / v)% aqueous ethanol solution.

[0073] Comparative Example 2

[0074] The difference between this comparative example and Example 1 is that polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch were replaced with hydroxypropyl methylcellulose (Shandong Aicai Biotechnology Co., Ltd.), microcrystalline cellulose (Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.), and sodium carboxymethyl cellulose (Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.).

[0075] A brain-nourishing capsule comprises the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Ligusticum chuanxiong extract, 50 parts of tolperidone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus membranaceus extract, 2 parts of vitamin B6, 18 parts of hydroxypropyl methylcellulose, 22 parts of microcrystalline cellulose, 36 parts of sodium carboxymethyl cellulose, 5 parts of magnesium stearate, and 220 parts of 75 (v / v)% aqueous ethanol solution.

[0076] Comparative Example 3

[0077] The difference between this comparative example and Example 1 is that the tanshinone extract is a commercially available product.

[0078] Comparative Example 4

[0079] The difference between this comparative example and Example 1 is that the Astragalus extract is a commercially available product.

[0080] Comparative Example 5

[0081] The difference between this comparative example and Example 1 is that the preparation method of the tanshinone extract includes the following steps:

[0082] (1) Grind the danshen into powder with a fineness of less than 80 mesh to obtain danshen powder;

[0083] (2) Mix danshen powder and water at a weight ratio of 1:11 to obtain danshen fermentation material. Add compound bacteria to the danshen fermentation material. The compound bacteria include Lactobacillus acidophilus, Lactobacillus casei, and Lactobacillus casei. The amount of Lactobacillus acidophilus is 10. 5 CFU / mL of Danshen fermented feed; the dosage of Lactobacillus casei was 10. 8 CFU / mL of Danshen fermented feed; the dosage of Lactobacillus casei was 10. 6 CFU / mL of tanshinone fermentation material was fermented at 39℃ for 11 hours, then sterilized to obtain tanshinone fermentation product.

[0084] (3) The fermentation product of Salvia miltiorrhiza was filtered through a 0.22 μm filter membrane and spray-dried to obtain Salvia miltiorrhiza extract.

[0085] Comparative Example 6

[0086] The difference between this comparative example and Example 1 is that the preparation method of Astragalus extract includes the following steps:

[0087] (1) Grind Astragalus membranaceus into powder smaller than 80 mesh to obtain Astragalus membranaceus powder;

[0088] (2) Mix Astragalus powder and water at a weight ratio of 1:11 to obtain Astragalus fermented feed; add Lactobacillus casei, Bifidobacterium longum and Lactobacillus helveticus to the Astragalus fermented feed, with the amount of Lactobacillus casei being 10 7 CFU / mL Astragalus membranaceus fermented slurry; fermented at 39℃ for 4 hours, sterilized, and then Bifidobacterium longum was added at a dosage of 10 CFU / mL. 8 Astragalus membranaceus fermented feed was fermented at 39℃ for 7 hours, then sterilized. Finally, Lactobacillus helveticus was added at a dosage of 10 CFU / mL. 8 Astragalus fermentation material was fermented at CFU / mL at 39℃ for 5 hours, then sterilized to obtain the Astragalus fermentation product.

[0089] (3) The fermentation product of Astragalus membranaceus was filtered through a 0.22 μm filter membrane and spray-dried to obtain Astragalus membranaceus extract.

[0090] Performance testing

[0091] The performance of the Naoluotong capsules prepared in Examples 1-2 and Comparative Examples 1-6 was tested. Each Naoluotong capsule contained 0.5g of gelatin empty capsules, purchased from Shaanxi Panlong Yihai Pharmaceutical Co., Ltd., gastrointestinal soluble type.

[0092] 1. Disintegration time limit: The test shall be conducted in accordance with the Standard Operating Procedure for Disintegration Time Limit Test (SOP-QC136).

[0093] 2. Determination of totopazol hydrochloride content: Take the contents of 30 capsules of this product, mix well, weigh accurately, take about 5 portions, weigh accurately, place in a 100ml stoppered conical flask, accurately add 100ml of chloroform, weigh, sonicate for 15 minutes, cool, weigh again, replenish the lost weight with chloroform, shake well, filter, keep the filtrate, discard the initial filtrate, accurately measure 50ml of the subsequent filtrate, evaporate to dryness on a water bath, add 20ml of glacial acetic acid and 5ml of mercuric acetate test solution to dissolve the residue, add 1 drop of crystal violet indicator, titrate with perchloric acid titrant (0.1mol / L) until the solution turns green, and correct the titration result with a blank test (each 1ml of perchloric acid titrant (0.1mol / L) is equivalent to 28.18mg of totopazol hydrochloride).

[0094] 3. Determination of totoprone hydrochloride content during long-term storage: Naoluotong capsules were placed in a constant temperature and humidity chamber at 25±2℃ and 60±10% for 12 months, and then the totoprone hydrochloride content was determined.

[0095] 4. Dissolution of tolperone hydrochloride: Refer to the test methods for influencing factors in the 2015 edition of the Chinese Pharmacopoeia. The test conditions for influencing factors are: place at 40℃±2℃ for 0 days and 10 days respectively, and then determine the dissolution rate.

[0096] The results are shown in Table 1.

[0097] Table 1 Performance Test Results

[0098]

[0099] The performance test results above show that the brain-disintegrating capsules of Examples 1-2 have short disintegration time, high dissolution rate, and good storage stability. In particular, the comprehensive performance of Example 1 is the most outstanding, which is mainly due to the synergistic effect between the components.

[0100] The comparative examples, lacking the necessary technical solutions, showed significantly inferior performance compared to the exemplary examples in relevant tests. In Comparative Example 1, the ratios of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch differed. In Comparative Example 2, polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch were replaced with hydroxypropyl methylcellulose, microcrystalline cellulose, and sodium carboxymethyl cellulose. This resulted in a longer disintegration time and a decrease in solubility after high-temperature storage. In Comparative Examples 3 and 4, the tanshinone extract and astragalus extract were commercially available products, and the stability of the tolperone hydrochloride content in the Naoluotong capsules decreased after long-term storage. In Comparative Examples 5 and 6, the different bacterial strains used to prepare the tanshinone extract and astragalus extract led to a decrease in the stability of the tolperone hydrochloride content in the Naoluotong capsules after long-term storage. These experimental results further demonstrate the importance of the technical solutions defined in this invention for its technical effects.

[0101] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A brain-nourishing capsule, characterized in that, The product comprises the following components in parts by weight: 40-60 parts of Salvia miltiorrhiza extract, 40-60 parts of Ligusticum chuanxiong extract, 40-60 parts of Astragalus membranaceus extract, 40-60 parts of tolperidone hydrochloride, 5-15 parts of methyl hesperidin, 1-4 parts of vitamin B6, 12-25 parts of polyvinylpyrrolidone K30, 13-25 parts of polyethylene glycol 400, 32-42 parts of corn starch, 3-7 parts of magnesium stearate, and 200-250 parts of an aqueous ethanol solution with a volume concentration of 70-80%. The preparation method of the tanshinone extract includes the following steps: (1) Grind the danshen into powder with a fineness of less than 80 mesh to obtain danshen powder; (2) Mix the danshen powder and water to obtain danshen fermentation material. Add compound bacteria to the danshen fermentation material. The compound bacteria include animal bifidobacterium, long bifidobacterium and helvetica lactobacillus. Ferment at 38-40℃ for 10-12 hours, sterilize, and obtain danshen fermentation product. (3) The fermentation product of Salvia miltiorrhiza was filtered and spray-dried to obtain Salvia miltiorrhiza extract; The preparation method of Astragalus extract includes the following steps: (1) Grind Astragalus membranaceus into powder smaller than 80 mesh to obtain Astragalus membranaceus powder; (2) Mix Astragalus powder and water to obtain Astragalus fermented material; add Lactobacillus acidophilus to the Astragalus fermented material, the amount of Lactobacillus acidophilus is 10 6 -10 7 CFU / mL Astragalus membranaceus fermented feed; ferment at 38-40℃ for 3-5 hours, sterilize, and then add Lactobacillus casei at a dosage of 10... 8 -10 9 Fermented Astragalus membranaceus slurry at CFU / mL was fermented at 38-40℃ for 6-8 hours, then sterilized. Finally, Bifidobacterium bifidum was added at a dosage of 10 CFU / mL. 7 -10 8 Fermented Astragalus membranaceus slurry at CFU / mL was fermented at 38-40℃ for 4-6 hours, then sterilized to obtain the Astragalus membranaceus fermentation product. (3) The fermentation product of Astragalus membranaceus was filtered through a 0.22 μm filter membrane and spray-dried to obtain Astragalus membranaceus extract.

2. The Brain-Locking Capsule according to claim 1, characterized in that, Mix danshen powder and water in a weight ratio of 1:(10-12).

3. The Brain-Locking Capsule according to claim 1, characterized in that, The dosage of the animal bifidobacteria is 10. 5 -10 6 CFU / mL of fermented danshen feed; the dosage of Bifidobacterium longum was 10. 7 -10 8 CFU / mL of fermented danshen feed; the dosage of Lactobacillus helveticus was 10. 6 -10 7 CFU / mL Danshen fermented feed.

4. The Brain-Clearing Capsule according to claim 1, characterized in that, The fermentation product of Salvia miltiorrhiza was filtered using a 0.22μm filter membrane.

5. The Brain-Locking Capsule according to claim 1, characterized in that, Mix Astragalus powder and water in a weight ratio of 1:(10-12).

6. The Brain-Locking Capsule according to claim 1, characterized in that, The weight ratio of polyvinylpyrrolidone K30, polyethylene glycol 400, and corn starch is (15-19):(20-23):(35-38).

7. The Brain-Locking Capsule according to claim 1, characterized in that, The product comprises the following components in parts by weight: 50 parts Salvia miltiorrhiza extract, 50 parts Ligusticum chuanxiong extract, 50 parts tolperidone hydrochloride, 10 parts methyl hesperidin, 50 parts Astragalus membranaceus extract, 2 parts vitamin B6, 18 parts polyvinylpyrrolidone K30, 22 parts polyethylene glycol 400, 36 parts corn starch, 5 parts magnesium stearate, and 220 parts 75 (v / v)% aqueous ethanol solution.

8. A method for preparing the Brain-Clearing Capsules according to any one of claims 1-7, characterized in that, The process includes the following steps: mixing salvia miltiorrhiza extract, chuanxiong extract and astragalus extract, pulverizing to less than 60 mesh, mixing evenly, adding topiperone hydrochloride, methyl hesperidin, vitamin B6, polyvinylpyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding ethanol aqueous solution, wet granulation, drying, and filling into capsules to obtain Naoluotong capsules.

9. The method for preparing the Brain-Locking Capsule according to claim 8, characterized in that, The drying temperature is 60-65℃, and the drying time is 1-2 hours.

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