Naoluotong capsule and preparation method thereof

Abstract

The invention provides a Naoluotong capsule and a preparation method thereof, and belongs to the technical field of medicines. The Naoluotong capsule is prepared from the following components in parts by weight: 40 to 60 parts of radix salviae miltiorrhizae extract, 40 to 60 parts of rhizoma chuanxiong extract, 40 to 60 parts of radix astragali seu hedysari extract, 40 to 60 parts of tolperidone hydrochloride, 5 to 15 parts of methyl hesperidin, 1 to 4 parts of vitamin B6, 12 to 25 parts of polyvinylpyrrolidone K30, 13 to 25 parts of polyethylene glycol 400, 32 to 42 parts of corn starch, 3 to 7 parts of magnesium stearate and 200 to 250 parts of ethanol aqueous solution with the volume concentration of 70 to 80 percent. The Naoluotong capsule prepared by the invention is short in disintegration time, good in stability and high in tolperidone hydrochloride content.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines, and particularly relates to a Naoluotong capsule and a preparation method thereof. Background Art

[0002] Naoluotong Capsule is a Chinese patent medicine, mainly used to treat symptoms caused by cerebrovascular diseases, such as headache, dizziness, memory loss, etc. It is composed of a variety of Chinese medicinal ingredients, and the specific formula generally contains blood-activating and blood-stasis-removing herbs such as Danshen, Chuanxiong, and Red Peony Root.

[0003] Naoluotong Capsules are mainly used to treat symptoms caused by cerebrovascular diseases, such as headaches, dizziness, memory loss, etc. In order to ensure that these symptoms can be relieved quickly, the drug needs to be released and absorbed in a shorter period of time. In addition, the absorption rate and bioavailability of Naoluotong Capsules are closely related to their disintegration time. A faster disintegration time helps to improve bioavailability and ensure that patients can get enough drug doses.

[0004] Patent CN104906119A discloses a Naoluotong capsule and its preparation method, which first includes encapsulating unstable components with an inclusion agent to obtain a core pill, then adding various extracts for further inclusion to obtain a mother pill, and finally adding auxiliary materials for granulation. Experiments have found that the disintegration time limit of this product is not ideal.

[0005] Patent CN105727065 A discloses a Naoluotong capsule and its preparation method, characterized in that 250 parts of coix seed, 500 parts of salvia miltiorrhiza, 500 parts of chuanxiong, and 500 parts of astragalus are extracted by supercritical carbon dioxide extraction, dried under reduced pressure, crushed into nano dry paste by high-energy nano impact mill, and functional excipients are added to make Naoluotong capsule, and the disintegration time is significantly shortened, but the product contains a low labeled amount of tolperisone hydrochloride per capsule, and tolperisone hydrochloride is an important component in Naoluotong capsule, which has a direct impact on the efficacy. In addition, the treatment of traditional Chinese medicine pays attention to the interaction of each component, and the components in the prescription have antagonism or adverse effects on the body.

[0006] Therefore, there is an urgent need for a Naoluotong capsule and a preparation method thereof. Summary of the invention

[0007] The purpose of the present invention is to provide a Naoluotong capsule and a preparation method thereof.

[0008] In order to achieve the above object, the present invention provides the following technical solutions:

[0009] A Naoluotong capsule comprises the following components in parts by weight: 40-60 parts of salvia miltiorrhiza extract, 40-60 parts of chuanxiong extract, 40-60 parts of astragalus extract, 40-60 parts of tolperisone 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 ethanol aqueous solution with a volume concentration of 70-80%.

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

[0011] In the present invention, when polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are added at the above weight ratio, the disintegration time of Naoluotong capsule can be improved. These three excipients work synergistically through their respective characteristics to ensure that the capsule disintegrates rapidly after contacting the liquid, thereby improving the release rate and bioavailability of the drug. At the same time, under this condition, the present invention can maintain an ideal dissolution when storing Naoluotong capsule under high temperature conditions.

[0012] Furthermore, the preparation method of the Salvia miltiorrhiza extract comprises the following steps:

[0013] (1) crushing salvia miltiorrhiza to less than 80 meshes to obtain salvia miltiorrhiza powder;

[0014] (2) mixing salvia miltiorrhiza powder and water to obtain salvia miltiorrhiza fermentation material, adding composite bacteria to the salvia miltiorrhiza fermentation material, the composite bacteria including animal bifidobacterium, long bifidobacterium and helveticus, fermenting at 38-40° C. for 10-12 hours, sterilizing, and obtaining a salvia miltiorrhiza fermentation product;

[0015] (3) filtering the salvia miltiorrhiza fermentation product, spray drying it, and obtaining the salvia miltiorrhiza extract.

[0016] Further, the salvia miltiorrhiza powder and water were mixed in a weight ratio of 1:(10-12).

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

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

[0019] Furthermore, the preparation method of the astragalus extract comprises the following steps:

[0020] (1) crushing the astragalus to less than 80 meshes to obtain astragalus powder;

[0021] (2) mixing astragalus powder and water to obtain an astragalus fermented material; adding Lactobacillus acidophilus to the astragalus fermented material, wherein the amount of Lactobacillus acidophilus is 10 6 -10 7 CFU / mL Astragalus fermentation material; ferment at 38-40℃ for 3-5h, sterilize, and continue to add Lactobacillus casei, the amount of Lactobacillus casei is 10 8 -10 9 CFU / mL Astragalus fermentation material, ferment at 38-40℃ for 6-8h, sterilize, and finally add Bifidobacterium bifidum. The dosage of Bifidobacterium bifidum is 10 7 -10 8 CFU / mL Astragalus fermentation material, ferment at 38-40℃ for 4-6h, sterilize to obtain Astragalus fermentation product,

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

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

[0024] In the experiment, it was found that the labeled amount of Tolperisone Hydrochloride in Naoluotong Capsules after long-term storage was less than 90%. Analysis showed that the components in the Chinese medicine extract reacted to Tolperisone Hydrochloride, as well as adsorption and embedding effects after long-term storage, resulting in a decrease in the labeled amount. The Naoluotong Capsules prepared by fermentation using a specific enzyme can improve the stability of the content of Tolperisone Hydrochloride in Naoluotong Capsules after long-term storage. Analysis showed that the substances in the extract that reacted with Tolperisone Hydrochloride were degraded by fermentation, and the newly generated substances could reduce the adsorption and embedding of Tolperisone Hydrochloride, ensuring its free concentration in the solution.

[0025] Further, the invention comprises the following components in parts by weight: 50 parts of salvia miltiorrhiza extract, 50 parts of chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of astragalus extract, 2 parts of vitamin B6, 18 parts of polyvinyl pyrrolidone K30, 22 parts of polyethylene glycol 400, 36 parts of corn starch, 5 parts of magnesium stearate and 220 parts of 75 (v / v)% ethanol aqueous solution.

[0026] The present invention also provides a preparation method of Naoluotong capsules, comprising the following steps: mixing salvia miltiorrhiza extract, chuanxiong extract and astragalus extract, crushing to less than 60 meshes, mixing evenly, adding tolperisone hydrochloride, methyl hesperidin, vitamin B6, polyvinyl pyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, and finally adding ethanol aqueous solution, using wet granulation, drying, and filling into capsules to obtain Naoluotong capsules.

[0027] Furthermore, the drying temperature is 60-65° C., and the drying time is 1-2 h.

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

[0029] 1. The Naoluotong capsule prepared by the present invention has the effects of invigorating qi and activating blood circulation, promoting blood circulation and activating collaterals; it has the effects of dilating blood vessels and increasing cerebral blood flow. Naoluotong capsule can be used for headache, dizziness, hemiplegia, numbness of limbs, fatigue and other symptoms caused by qi deficiency and blood stasis syndrome of various cerebrovascular diseases such as cerebral thrombosis, cerebral arteriosclerosis, and sequelae of stroke.

[0030] 2. When polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are added in the above weight ratio, the disintegration time of Naoluotong capsule can be improved. At the same time, under this condition, Naoluotong capsule can maintain an ideal dissolution rate when stored under high temperature conditions.

[0031] 3. The present invention uses a specific enzyme to ferment and prepare the Naoluotong capsules prepared from the Danshen extract and the Astragalus extract, thereby improving the stability of the content of Tolperisone Hydrochloride in the Naoluotong capsules after long-term storage. DETAILED DESCRIPTION

[0032] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] The raw materials used in the following examples of the present invention are all commercially available products:

[0034] Lactobacillus casei, number: SHBCC D24737, was purchased from Shanghai Collection of Microorganisms. Bifidobacterium bifidum, number: SHBCC D24408 ATCC 35914, was purchased from Shanghai Collection of Microorganisms.

[0035] Lactobacillus acidophilus, number: CCTCC AB 2010208. was purchased from China Center for Type Culture Collection.

[0036] Bifidobacterium animalis, number: SHBCC D24407AS1.1852, was purchased from China Center for Type Culture Collection.

[0037] Lactobacillus helveticus was purchased from China Center for Type Culture Collection, with the number: CCTCCAB2010205.

[0038] Bifidobacterium longum was purchased from Shanghai Collection of Microorganisms Center, with the number: SHBCC D24310.

[0039] Salvia miltiorrhiza extract, commercially available product, Shaanxi Hongze Bioengineering Co., Ltd., specification 10:1.

[0040] Chuanxiong extract, commercially available product, Xi'an Tongjiang Biotechnology Co., Ltd., specification 10:1.

[0041] Astragalus extract, commercially available product, Shanyang Lianfeng Biotechnology Co., Ltd., specification 10:1.

[0042] Tolperisone hydrochloride, CAS: 3644-61-9.

[0043] Methyl hesperidin, CAS: 11013-97-1.

[0044] Polyvinylpyrrolidone K30, Topbike New Materials Technology (Shanghai) Co., Ltd.

[0045] Polyethylene glycol 400, Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0046] Corn starch, Shanxi Jinyang Pharmaceutical Excipients Co., Ltd., CAS: 9005-25-8.

[0047] Example 1

[0048] The present embodiment provides a Naoluotong capsule, comprising the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus 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.

[0049] The preparation method of the Salvia miltiorrhiza extract comprises the following steps:

[0050] (1) crushing salvia miltiorrhiza to less than 80 meshes to obtain salvia miltiorrhiza powder;

[0051] (2) mixing salvia miltiorrhiza powder and water in a weight ratio of 1:11 to obtain salvia miltiorrhiza fermentation material, adding composite bacteria to the salvia miltiorrhiza fermentation material, the composite bacteria comprising animal bifidobacterium, long bifidobacterium and helveticus, the amount of animal bifidobacterium being 105 CFU / mL Danshen fermented material; the dosage of Bifidobacterium longum is 10 8 CFU / mL Danshen fermented material; the dosage of Lactobacillus helveticus is 10 6 CFU / mL of Danshen fermented material; fermented at 39°C for 11h, sterilized, and obtained Danshen fermented product;

[0052] (3) The salvia miltiorrhiza fermentation product was filtered using a 0.22 μm filter membrane and spray-dried to obtain a salvia miltiorrhiza extract.

[0053] The preparation method of the astragalus extract comprises the following steps:

[0054] (1) crushing the astragalus to less than 80 meshes to obtain astragalus powder;

[0055] (2) Mixing astragalus powder and water in a weight ratio of 1:11 to obtain an astragalus fermented material; adding Lactobacillus acidophilus to the astragalus fermented material, wherein the amount of Lactobacillus acidophilus is 10 7 CFU / mL Astragalus fermentation material; ferment at 39℃ for 4h, sterilize, and continue to add Lactobacillus casei, the amount of Lactobacillus casei is 10 8 CFU / mL Astragalus fermentation material, fermented at 39℃ for 7h, sterilized, and finally added Bifidobacterium bifidum, the dosage of Bifidobacterium bifidum was 10 8 CFU / mL Astragalus fermentation material, fermented at 39℃ for 5h, sterilized, and obtained Astragalus fermentation product,

[0056] (3) The fermented product of Astragalus membranaceus was filtered using a 0.22 μm filter membrane and spray-dried to obtain an Astragalus membranaceus extract.

[0057] The preparation method of the Naoluotong capsule comprises the following steps: mixing a salvia miltiorrhiza extract, a chuanxiong extract and an astragalus extract, crushing to less than 60 meshes, mixing evenly, adding tolperisone hydrochloride, methyl hesperidin, vitamin B6, polyvinyl pyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding an ethanol aqueous solution, using a wet granulation method, drying at a drying temperature of 62° C. and a drying time of 1.5 hours, and filling into capsules to obtain the Naoluotong capsules.

[0058] Example 2

[0059] The present embodiment provides a Naoluotong capsule, comprising the following components in parts by weight: 50 parts of Salvia miltiorrhiza extract, 50 parts of Chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of Astragalus extract, 2 parts of vitamin B6, 15 parts of polyvinyl pyrrolidone 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.

[0060] The preparation method of the Salvia miltiorrhiza extract comprises the following steps:

[0061] (1) crushing salvia miltiorrhiza to less than 80 meshes to obtain salvia miltiorrhiza powder;

[0062] (2) mixing salvia miltiorrhiza powder and water in a weight ratio of 1:10 to obtain salvia miltiorrhiza fermentation material, adding composite bacteria to the salvia miltiorrhiza fermentation material, the composite bacteria comprising animal bifidobacterium, long bifidobacterium and helveticus, the amount of animal bifidobacterium being 10 6 CFU / mL Danshen fermented material; the dosage of Bifidobacterium longum is 10 7 CFU / mL Danshen fermented material; the dosage of Lactobacillus helveticus is 10 6 CFU / mL of Danshen fermented material; fermented at 38°C for 12h, sterilized, and obtained Danshen fermented product;

[0063] (3) The salvia miltiorrhiza fermentation product was filtered using a 0.22 μm filter membrane and spray-dried to obtain a salvia miltiorrhiza extract.

[0064] The preparation method of the astragalus extract comprises the following steps:

[0065] (1) crushing the astragalus to less than 80 meshes to obtain astragalus powder;

[0066] (2) Mixing astragalus powder and water in a weight ratio of 1:12 to obtain an astragalus fermented material; adding Lactobacillus acidophilus to the astragalus fermented material, wherein the amount of Lactobacillus acidophilus is 10 6 CFU / mL Astragalus fermentation material; fermentation at 40℃ for 5h, sterilization, and then adding Lactobacillus casei, the dosage of Lactobacillus casei is 10 8 CFU / mL Astragalus fermentation material, fermented at 40℃ for 8h, sterilized, and finally added Bifidobacterium bifidum, the dosage of Bifidobacterium bifidum was 10 7 CFU / mL Astragalus fermentation material, fermented at 40℃ for 4h, sterilized, and obtained Astragalus fermentation product,

[0067] (3) The fermented product of Astragalus membranaceus was filtered using a 0.22 μm filter membrane and spray-dried to obtain an Astragalus membranaceus extract.

[0068] The preparation method of the Naoluotong capsule comprises the following steps: mixing a salvia miltiorrhiza extract, a chuanxiong extract and an astragalus extract, crushing to less than 60 meshes, mixing evenly, adding tolperisone hydrochloride, methyl hesperidin, vitamin B6, polyvinyl pyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding an ethanol aqueous solution, using a wet granulation method, drying at a drying temperature of 65° C. and a drying time of 2 hours, and filling into capsules to obtain the Naoluotong capsules.

[0069] Comparative Example 1

[0070] The difference between this comparative example and Example 1 is that the weight ratios of polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are different.

[0071] A Naoluotong capsule comprises the following components in parts by weight: 50 parts of salvia miltiorrhiza extract, 50 parts of chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of astragalus extract, 2 parts of vitamin B6, 36 parts of polyvinyl pyrrolidone K30, 32 parts of polyethylene glycol 400, 8 parts of corn starch, 5 parts of magnesium stearate and 220 parts of 75 (v / v)% ethanol aqueous solution.

[0072] Comparative Example 2

[0073] The difference between this comparative example and Example 1 is that polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are replaced by 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.).

[0074] A Naoluotong capsule comprises the following components in parts by weight: 50 parts of salvia miltiorrhiza extract, 50 parts of chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of astragalus extract, 2 parts of vitamin B6, 18 parts of hydroxypropyl methylcellulose, 22 parts of microcrystalline cellulose, 36 parts of sodium carboxymethylcellulose, 5 parts of magnesium stearate and 220 parts of 75 (v / v)% ethanol aqueous solution.

[0075] Comparative Example 3

[0076] The difference between this comparative example and Example 1 is that the Salvia miltiorrhiza extract is a commercially available product.

[0077] Comparative Example 4

[0078] The difference between this comparative example and Example 1 is that the astragalus extract is a commercially available product.

[0079] Comparative Example 5

[0080] The difference between this comparative example and Example 1 is that the preparation method of the Salvia miltiorrhiza extract comprises the following steps:

[0081] (1) crushing salvia miltiorrhiza to less than 80 meshes to obtain salvia miltiorrhiza powder;

[0082] (2) mixing salvia miltiorrhiza powder and water in a weight ratio of 1:11 to obtain salvia miltiorrhiza fermentation material, adding composite bacteria to the salvia miltiorrhiza fermentation material, the composite bacteria comprising Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus casei, the amount of Lactobacillus acidophilus being 10 5 CFU / mL Danshen fermented material; the dosage of Lactobacillus casei is 10 8 CFU / mL Danshen fermented material; the dosage of Lactobacillus casei is 106 CFU / mL of Danshen fermented material; fermented at 39°C for 11h, sterilized, and obtained Danshen fermented product;

[0083] (3) The salvia miltiorrhiza fermentation product was filtered using a 0.22 μm filter membrane and spray-dried to obtain a salvia miltiorrhiza extract.

[0084] Comparative Example 6

[0085] The difference between this comparative example and Example 1 is that the preparation method of the astragalus extract comprises the following steps:

[0086] (1) crushing the astragalus to less than 80 meshes to obtain astragalus powder;

[0087] (2) Mixing astragalus powder and water in a weight ratio of 1:11 to obtain an astragalus fermented material; adding Lactobacillus casei, Bifidobacterium longum and Lactobacillus helveticus to the astragalus fermented material, wherein the amount of Lactobacillus casei is 10 7 CFU / mL Astragalus fermentation material; ferment at 39℃ for 4h, sterilize, and continue to add Bifidobacterium longum, the dosage of Bifidobacterium longum is 10 8 CFU / mL Astragalus fermentation material, fermented at 39℃ for 7h, sterilized, and finally added Lactobacillus helveticus. The amount of Lactobacillus helveticus was 10 8 CFU / mL Astragalus fermentation material, fermented at 39℃ for 5h, sterilized, and obtained Astragalus fermentation product,

[0088] (3) The fermented product of Astragalus membranaceus was filtered using a 0.22 μm filter membrane and spray-dried to obtain an Astragalus membranaceus extract.

[0089] Performance Testing

[0090] The performance of the Naoluotong capsules prepared in Examples 1-2 and Comparative Examples 1-6 was tested. Each Naoluotong capsule contained 0.5 g (empty gelatin capsules, purchased from Shaanxi Panlong Yihai Pharmaceutical Co., Ltd., gastric soluble type).

[0091] 1. Disintegration time: Determine according to the Standard Operating Procedure for Disintegration Time (SOP-QC136).

[0092] 2. Determination of Tolperisone Hydrochloride Content: Take the contents of 30 tablets of this product, mix them, weigh them accurately, weigh about 5 portions, weigh them accurately, put them in a 100ml stoppered conical flask, add 100ml of chloroform accurately, weigh them, treat them with ultrasound for 15 minutes, let them cool, weigh them again, make up the lost weight with chloroform, shake them well, filter them, set the filtrate aside, discard the initial filtrate, accurately measure 50ml of the subsequent filtrate, evaporate them 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 solution, 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 28.18ml of Tolperisone Hydrochloride.

[0093] 3. Determination of the content of Tolperisone Hydrochloride in long-term storage: Place the Naoluotong Capsules in a constant temperature and humidity chamber at a temperature of 25±2°C and a relative humidity of 60±10% for 12 months, and then determine the content of Tolperisone Hydrochloride.

[0094] 4. Solubility of Tolperisone Hydrochloride: Refer to the test method of influencing factors in the Chinese Pharmacopoeia 2015 Edition. The test conditions of influencing factors are: at 40℃±2℃, place for 0 days and 10 days respectively, and measure the dissolution.

[0095] The results are shown in Table 1.

[0096] Table 1 Performance test results

[0097]

[0098]

[0099] From the above performance test results, it can be seen that the Naoluotong Capsules of Examples 1-2 have short disintegration time, high solubility, and good storage stability, especially the comprehensive performance of Example 1 is the most outstanding, which is mainly due to the synergistic effect between the components.

[0100] And the comparative example is because it does not adopt the necessary technical scheme, resulting in it being significantly worse than the embodiment in the corresponding performance test. In comparative example 1, the ratios of polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are different. In comparative example 2, polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch are replaced with hypromellose, microcrystalline cellulose and sodium carboxymethyl cellulose. It can be found that the disintegration time becomes longer and the dissolution rate decreases after high temperature storage. In comparative examples 3 and 4, salvia miltiorrhiza extract and astragalus extract are commercially available products, and the stability of the content of tolperisone hydrochloride in Naoluotong capsule after long-term storage decreases. In comparative examples 5 and 6, the strains used to prepare salvia miltiorrhiza extract and astragalus extract are different, and the stability of the content of tolperisone hydrochloride in Naoluotong capsule after long-term storage decreases. The above experimental results further prove the importance of the technical scheme defined in the present invention for its technical effect.

[0101] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Naoluotong capsule, characterized in that The invention comprises the following components in parts by weight: 40-60 parts of salvia miltiorrhiza extract, 40-60 parts of chuanxiong extract, 40-60 parts of astragalus extract, 40-60 parts of tolperisone hydrochloride, 5-15 parts of methyl hesperidin, 1-4 parts of vitamin B6, 12-25 parts of polyvinyl pyrrolidone 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 ethanol aqueous solution with a volume concentration of 70-80%; The preparation method of the Salvia miltiorrhiza extract comprises the following steps: (1) crushing salvia miltiorrhiza to less than 80 meshes to obtain salvia miltiorrhiza powder; (2) mixing salvia miltiorrhiza powder and water to obtain salvia miltiorrhiza fermentation material, adding composite bacteria to the salvia miltiorrhiza fermentation material, the composite bacteria including animal bifidobacterium, long bifidobacterium and helveticus, fermenting at 38-40° C. for 10-12 hours, sterilizing, and obtaining a salvia miltiorrhiza fermentation product; (3) filtering the salvia miltiorrhiza fermentation product, spray drying it, and obtaining the salvia miltiorrhiza extract.

2. The Naoluotong capsule according to claim 1, characterized in that Mix Danshen powder and water in a weight ratio of 1:(10-12).

3. The Naoluotong capsule according to claim 1, characterized in that The dosage of the animal bifidobacterium is 10 5 -10 6 CFU / mL Danshen fermented material; the dosage of Bifidobacterium longum is 10 7 -10 8 CFU / mL Danshen fermented material; the dosage of Lactobacillus helveticus is 10 6 -10 7 CFU / mL Salvia miltiorrhiza fermented material.

4. The Naoluotong capsule according to claim 1, characterized in that The fermented product of Salvia miltiorrhiza was filtered using a 0.22 μm filter membrane.

5. The Naoluotong capsule according to claim 1, characterized in that: The preparation method of the astragalus extract comprises the following steps: (1) crushing the astragalus to less than 80 meshes to obtain astragalus powder; (2) mixing astragalus powder and water to obtain an astragalus fermented material; adding Lactobacillus acidophilus to the astragalus fermented material, wherein the amount of Lactobacillus acidophilus is 10 6 -10 7 CFU / mL Astragalus fermentation material; ferment at 38-40℃ for 3-5h, sterilize, and continue to add Lactobacillus casei, the amount of Lactobacillus casei is 10 8 -10 9 CFU / mL Astragalus fermentation material, ferment at 38-40℃ for 6-8h, sterilize, and finally add Bifidobacterium bifidum. The dosage of Bifidobacterium bifidum is 10 7 -10 8 CFU / mL Astragalus fermentation material, ferment at 38-40℃ for 4-6h, sterilize to obtain Astragalus fermentation product, (3) The fermented product of Astragalus membranaceus was filtered using a 0.22 μm filter membrane and spray-dried to obtain an Astragalus membranaceus extract.

6. The Naoluotong capsule according to claim 5, characterized in that: Mix astragalus powder and water in a weight ratio of 1:(10-12).

7. The Naoluotong capsule according to claim 5, characterized in that: The weight ratio of polyvinyl pyrrolidone K30, polyethylene glycol 400 and corn starch is (15-19): (20-23): (35-38).

8. The Naoluotong capsule according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 50 parts of salvia miltiorrhiza extract, 50 parts of chuanxiong extract, 50 parts of tolperisone hydrochloride, 10 parts of methyl hesperidin, 50 parts of astragalus extract, 2 parts of vitamin B6, 18 parts of polyvinyl pyrrolidone K30, 22 parts of polyethylene glycol 400, 36 parts of corn starch, 5 parts of magnesium stearate and 220 parts of 75 (v / v)% ethanol aqueous solution.

9. A method for preparing the Naoluotong capsule according to any one of claims 1 to 8, characterized in that: The method comprises the following steps: mixing salvia miltiorrhiza extract, chuanxiong extract and astragalus extract, crushing to less than 60 meshes, mixing evenly, adding tolperisone hydrochloride, methyl hesperidin, vitamin B6, polyvinyl pyrrolidone K30, polyethylene glycol 400, corn starch and magnesium stearate, mixing evenly, finally adding ethanol aqueous solution, using wet granulation, drying, and filling into capsules to obtain Naoluotong capsules.

10. The method for preparing Naoluotong capsule according to claim 9, characterized in that: The drying temperature is 60-65°C and the drying time is 1-2h.

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