Compound earthworm capsule traditional Chinese medicine extract powder and preparation method thereof

Abstract

The invention belongs to the field of medicine, and particularly relates to compound earthworm capsule traditional Chinese medicine extract powder and a preparation method thereof.The preparation method comprises the following steps that 280 parts by weight of ligusticum wallichii, 240 parts by weight of astragalus membranaceus and 160 parts by weight of achyranthes bidentata are prepared, and the preparation method of the traditional Chinese medicine extract powder comprises the steps that 160 parts by weight of astragalus membranaceus is taken to be laid on a tray, subjected to 121 DEG C moist heat sterilization in a traditional Chinese medicine sterilization cabinet for 30-60 min, dried for 2-4 h and smashed to be 60 meshes for use; adding 70% ethanol which is 3 times of the total weight of the extracted medicinal materials, independently soaking the ligusticum wallichii, and continuously soaking the radix achyranthis bidentatae and 1 / 3 of the astragalus membranaceus; adding 70% ethanol which is 3 times of the total weight of the extracted medicinal materials, decocting and refluxing for 2 hours, firstly concentrating the secondary decoction, and then concentrating the primary decoction until the specific gravity of the extract is 1.1-1.2; adding radix astragali powder, mixing, carrying out vacuum belt type drying, and crushing with a 60-mesh sieve; compared with an existing preparation method of the compound earthworm capsule traditional Chinese medicine extract powder, the preparation method has the advantages that the production period is greatly shortened, the content retention rate is improved to the maximum extent, the product quality is guaranteed, and the whole process is easier to apply and produce and is easier to popularize.

Description

Technical Field

[0001] The invention relates to a compound earthworm capsule Chinese medicine extract powder and a preparation method thereof, belonging to the field of medical technology. Technical Background

[0002] Compound earthworm capsule has the functions of removing blood stasis, unblocking meridians, replenishing qi and activating blood circulation. It is used for the syndrome of qi deficiency and blood stasis in the meridian recovery period of ischemic stroke, with symptoms such as hemiplegia, crooked mouth and tongue, slurred speech or aphasia, numbness on one side of the body, fatigue, palpitations, shortness of breath, drooling, spontaneous sweating, etc.

[0003] Chuanxiong: The dried rhizome of Ligusticum chuanxiong Hort. of the Apiaceae family, mainly contains ligustilide, ligustrazine, neutral oil, ferulic acid and other ingredients. It has the effects of dilating blood vessels and reducing peripheral arterial blood flow resistance, increasing cerebral blood flow, inhibiting platelet activity, improving microcirculation, and having analgesic, sedative, antispasmodic, anti-inflammatory, and tocolytic effects, and has a good effect on sudden deafness.

[0004] Astragalus: The dried root of Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family mainly contains monosaccharides, polysaccharides, proteins, astragaloside I-VIII and other ingredients. It has the effects of invigorating Qi and removing blood stasis, unblocking meridians, enhancing immunity, enhancing the ability of viruses to induce interferon, enhancing the body's tolerance to hypoxia and stress, promoting body metabolism, improving cardiac function, lowering blood pressure, protecting the liver, regulating blood sugar, antibacterial and antiviral, and has a tendency to reduce the scope of cerebral ischemia.

[0005] Achyranthes bidentata: The dried root of Achyranthes bidentata Blume, a plant of the Amaranthaceae family, mainly contains saponins, triterpenoid saponins and their hydrolysis products (oleanolic acid, glucuronic acid, etc.), ecdysterone, inokosterone and the immune-active Achyranthes bidentata peptidoglycan ABAB, which has the effects of dispersing blood stasis, nourishing the liver and kidneys, and strengthening the tendons and bones.

[0006] The active ingredient ferulic acid in the traditional Chinese medicine extract powder of Compound Dilong Capsule has the effects of anti-platelet aggregation, inhibiting the release of platelet 5-hydroxytryptamine, inhibiting the production of platelet thromboxane a2 (TXA2), enhancing the activity of prostaglandins, and having analgesic and relieving vasospasm effects. It is the basic raw material for the production of medicines used to treat cardiovascular and cerebrovascular diseases and leukocytopenia.

[0007] Astragaloside I, the active ingredient in the Chinese medicine extract powder of Compound Dilong Capsule, has the effects of improving cardiopulmonary function, strengthening heart contractility, dilating blood vessels, lowering blood pressure, and improving skin blood circulation and nutritional status.

[0008] The quality standard of compound earthworm capsule is contained in the national drug standard WS3-569 (Z-114) -2002 (Z) of the State Drug Administration. The prescription is: 2000g of earthworm (fresh), 280g of Chuanxiong, 240g of Astragalus, 160g of Achyranthes, and the preparation method of the medicinal extract powder is as follows: take 160g of Astragalus, soak it in 70% ethanol for 1 hour, filter it, and set aside the ethanol solution; gradually heat the drug residue to 60°C, evaporate the ethanol, bake it at 105°C for about 4 hours, crush it, pass through a 60-mesh sieve, and set aside. Take Chuanxiong, Achyranthes and the remaining Astragalus, add 70% ethanol reflux extraction twice (the above ethanol solution is prepared by adding 95% ethanol), each time for 2 hours, combine the ethanol solution, recover the ethanol and concentrate it to a relative density of about 1.3 (70°C), add the above Astragalus powder, mix well, dry, crush it, and pass through a 60-mesh sieve.

[0009] According to production experience, it was found that the content of astragaloside I in the preparation process of astragalus powder was relatively low, and there was a certain safety risk in the production process of evaporating the residue with ethanol at 60°C; the specific gravity of the extract was too high at 1.3, and it was difficult to mix it with astragalus powder. The material was dried in a reduced pressure oven with a production cycle of about 30 hours, and the retention rate of the active ingredient ferulic acid was low. The production cycle was long and the production efficiency was low, which was not conducive to making the product bigger and stronger.

[0010] In order to solve the above-mentioned production problems and production safety risks, the present invention aims to provide a method for preparing a compound earthworm capsule traditional Chinese medicine extract powder. Summary of the invention

[0011] The purpose of the present invention is to solve at least one of the technical problems existing in the prior art and to provide a compound earthworm capsule Chinese medicine extract powder and a preparation method thereof.

[0012] The technical solution of the present invention is as follows: a method for preparing a compound earthworm capsule Chinese medicine extract powder, comprising the following steps:

[0013] 1) Take 2 / 3 of the prescribed amount of Astragalus membranaceus and spread it on a plate, sterilize it in a traditional Chinese medicine sterilizer at 121°C for 30-60 min, dry it for 2-4 h, crush it into 60 meshes and set aside to obtain Astragalus membranaceus powder;

[0014] 2) Add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, to the extraction tank, soak Chuanxiong alone first, then continue to soak Achyranthes bidentata and 1 / 3 of the prescribed amount of Astragalus. Decoction until reflux for 2 hours, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials again, decoction and reflux for 2 hours, first concentrate the second decoction, then concentrate the first decoction, until the specific gravity of the extract is 1.1-1.2 (thermal measurement);

[0015] 3) Add the above-mentioned Astragalus powder, mix for 5 minutes, dry, and crush through a 60-mesh sieve.

[0016] In the preparation method of the present invention, the step 2) of the medicinal material extraction process is to first soak Chuanxiong alone for 2 hours, then continue to soak Achyranthes bidentata and 1 / 3 of the amount of Astragalus for 2 hours, and then reflux and decoct twice, each time for 2 hours.

[0017] In the preparation method of the present invention, in step 2) the decoction is concentrated, the second decoction is concentrated first, and then the first decoction is concentrated.

[0018] In the preparation method of the present invention, the specific gravity of the extract in step 2) is 1.1-1.2 (thermal measurement).

[0019] In the preparation method of the present invention, the drying process described in step 3) adopts vacuum belt drying.

[0020] The preparation process of the astragalus powder selected by the present invention is wet heat sterilization and drying of astragalus slices, and crushing. The process is simple, safe and easy to operate, and the effective ingredients of astragalus medicinal materials are retained to the greatest extent. The standard preparation method is to take 2 / 3 of the prescription amount of astragalus, soak it in 70% ethanol for 1 hour, filter it, and use the ethanol solution for standby; the residue is gradually heated to 60°C, the ethanol is evaporated, and it is baked at 105°C for about 4 hours, crushed, passed through a 60-mesh sieve, and used for standby. Its production cycle is longer and the residue is gradually heated to 60°C. There is an unsafe risk of ethanol being flammable and explosive in the process of evaporating ethanol, and the retention rate of astragaloside IV, the effective ingredient of astragalus, is low.

[0021] The extraction process selected by the present invention is to add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, into the extraction tank, first soak Chuanxiong alone, and then continue to soak Achyranthes and 1 / 3 of the amount of Astragalus. Decoction to reflux for 2h, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, again, decoction and reflux for 2h, first concentrate the second decoction, and then concentrate the first decoction to the extract specific gravity of 1.1-1.2 (thermal measurement). Compared with the standard preparation method, Chuanxiong, Achyranthes and the remaining Astragalus are taken, and 70% ethanol is added to reflux and extract twice (the above ethanol solution is prepared by adding 95% ethanol), each time for 2 hours, the ethanol solution is combined, the ethanol is recovered and concentrated to a relative density of about 1.3 (70°C), and the retention rate of ferulic acid content is effectively divided into a large increase, which greatly improves the quality of the product. And the specific gravity is reduced to 1.1-1.2, which can be fully mixed with Astragalus powder, which is more conducive to ensuring the quality control of the product production process.

[0022] The traditional Chinese medicine extract powder drying process selected by the present invention is vacuum belt drying, the drying time of unit material is about 90 minutes, and the drying and crushing time of the whole batch of materials is only 40 hours. Compared with the traditional reduced pressure oven drying, the unit material is dried for 24 hours, and the whole batch of materials is dried and crushed for about 96 hours. The production cycle is greatly shortened, and the retention rate of ferulic acid content is greatly improved, which greatly improves the quality of the product.

[0023] To further illustrate the above advantages, we took the production of 900,000 batches of compound earth dragon capsules as an example to conduct a comparative study on the key parameter control of key production processes, production cycle and effective ingredients of materials, as well as the retention rate of effective ingredients of materials in each process. The results are shown in the following table:

[0024]

[0025] As can be seen from the above table, the overall production cycle of this method is 57h, and the retention rate of astragaloside IV from feeding to the output of Chinese medicine extract powder is 78.14%, and the retention rate of ferulic acid is 23.02%; while the production cycle of the standard process is 118h; the retention rate of astragaloside IV from feeding to the output of Chinese medicine extract powder is 34.07%, and the retention rate of ferulic acid is 8.97%. That is, the production cycle of the present invention is short, and the retention rate of effective ingredients is high.

[0026] In order to further confirm the stability of the present invention, an accelerated stability experiment was performed.

[0027] The samples prepared by the standard process and the preferred preparation method of the present invention were prepared into Chinese medicine extract powder, which was then filled into capsules, pressed into plates, and packaged to obtain samples. Accelerated stability study was conducted under the conditions of 40°C ± 2°C and 75% ± 5% relative humidity for 6 months. Samples were taken once at the 0th month, the 3rd month, and the 6th month during the test for testing.

[0028]

[0029] Note: The content determination method of astragaloside IV refers to the content determination method of astragaloside IV in the quality standard of Astragalus in the 2020 edition of the Chinese Pharmacopoeia, page P315-P316;

[0030] The method for detecting the content of ferulic acid refers to the method for determining the content of ferulic acid in the quality standard of Compound Earth Dragon Capsules in the National Drug Standard WS3-569(Z-114)-2002(Z) of the State Food and Drug Administration.

[0031] From the analysis of all the above data, it can be concluded that compared with the samples prepared by the method of the present invention after 6 months, the content of astragaloside I was higher, the content of ferulic acid was higher, and the water content was lower; and the standard process samples and the samples prepared by the method of the present invention were accelerated for 6 months, and the decrease in the content of astragaloside I was basically the same, both were about 3%, and the decrease in the content of ferulic acid was basically the same, both were about 36.4%, and the water content was basically unchanged.

[0032] That is, the samples prepared by the preferred preparation method have higher content and consistent stability than those prepared by the standard process.

[0033] In order to better reflect the advancement of the present invention, the present invention adopts the form of comparative study and conducts comparative study with other samples.

[0034] Comparative experimental results

[0035]

[0036] From the analysis of all the above data, it can be concluded that the samples prepared by the present invention have better stability than the samples prepared by other patented preparation processes, and the obtained products have strong anti-moisture ability, strong stability and stable therapeutic effect.

[0037] The preferred preparation method of the present invention greatly shortens the production cycle compared to the traditional standard process, simplifies the preparation process of astragalus powder, is safe and easy to operate, and retains the effective ingredients of astragalus medicinal materials to the greatest extent; optimizes the extract extraction process, effectively divides into the ferulic acid content retention rate and greatly improves the quality of the product, and is more conducive to ensuring the quality control of the product production process; the preferred Chinese medicine extract powder drying process is vacuum belt drying, the drying time of the unit material is about 90min, and the drying and crushing time of the whole batch of materials is only 40h, compared to the traditional decompression oven drying unit material drying 24h, and the whole batch of materials drying and crushing is a production cycle of about 96h. The retention rate of ferulic acid content is greatly improved, which greatly improves the quality of the product. The overall process is easier to apply production and is easier to promote.

[0038] It should be noted that in the context of the present invention, when or whether the words "about" or "approximately" are used, it means within 10% of a given value or range, appropriately within 5%, and particularly within 1%. Alternatively, for those of ordinary skill in the art, the term "about" or "approximately" means within an acceptable standard error range of the mean value. Whenever a number with a value of N is disclosed, any number with a value of N+ / -1%, N+ / -2%, N+ / -3%, N+ / -5%, N+ / -7%, N+ / -8% or N+ / -10% will be explicitly disclosed, where "+ / -" means plus or minus. DETAILED DESCRIPTION

[0039] The present application is described in detail below by way of examples, but it is not intended that there is any adverse limitation to the present application. The present application has been described in detail herein, and its specific embodiments are also disclosed therein. It will be apparent to those skilled in the art that various changes and modifications can be made to the specific embodiments of the present application without departing from the spirit and scope of the present application.

[0040] Example 1 Preparation method of compound earthworm capsule Chinese medicine extract powder

[0041] 280 parts by weight of Chuanxiong, 240 parts by weight of Astragalus, and 160 parts by weight of Achyranthes, wherein the preparation method of the medicinal extract powder is as follows: 160 parts by weight of Astragalus are spread on a plate, sterilized in a Chinese medicine sterilizer at 121 degrees for 30 minutes, dried for 2 hours, and crushed into 60 meshes for use. Add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, into the extraction tank, soak Chuanxiong alone first, and then continue to soak Achyranthes and the remaining Astragalus. Decoction until reflux for 2 hours, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, again, decoct and reflux for 2 hours, first concentrate the second decoction, and then concentrate the first decoction to an extract specific gravity of 1.16 (thermal measurement). Add the above-mentioned Astragalus powder, mix for 5 minutes, vacuum belt dry, and crush with a 60-mesh sieve to obtain.

[0042] Example 2 Preparation method of compound earthworm capsule Chinese medicine extract powder

[0043] 280 parts by weight of Chuanxiong, 240 parts by weight of Astragalus, and 160 parts by weight of Achyranthes, wherein the preparation method of the medicinal extract powder is as follows: 160 parts by weight of Astragalus are spread on a plate, sterilized in a Chinese medicine sterilizer at 121 degrees for 50 minutes, dried for 4 hours, and crushed into 60 meshes for use. Add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, to the extraction tank, first soak Chuanxiong alone, and then continue to soak Achyranthes and the remaining Astragalus. Decoction to reflux for 2 hours, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, again, decoct and reflux for 2 hours, first concentrate the second decoction, and then concentrate the first decoction to an extract specific gravity of 1.2 (thermal measurement). Add the above-mentioned Astragalus powder, mix for 5 minutes, vacuum belt dry, and crush with a 60-mesh sieve to obtain.

[0044] Example 3 Preparation method of compound earthworm capsule Chinese medicine extract powder

[0045] 280 parts by weight of Chuanxiong, 240 parts by weight of Astragalus, and 160 parts by weight of Achyranthes, wherein the preparation method of the medicinal extract powder is as follows: take 160 parts by weight of Astragalus, spread it on a plate, sterilize it with wet heat at 121 degrees in a Chinese medicine sterilizer for 40 minutes, dry it for 3 hours, and crush it into 60 meshes for use. Add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, into the extraction tank, soak Chuanxiong alone first, and then continue to soak Achyranthes and the remaining Astragalus. Decoction until reflux for 2 hours, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, again, decoct and reflux for 2 hours, first concentrate the second decoction, and then concentrate the first decoction to an extract specific gravity of 1.15 (thermal measurement). Add the above-mentioned Astragalus powder, mix for 5 minutes, vacuum belt dry, and crush it with a 60-mesh sieve to obtain it.

[0046] Example 4 Preparation method of compound earthworm capsule Chinese medicine extract powder

[0047] 280 parts by weight of Chuanxiong, 240 parts by weight of Astragalus, and 160 parts by weight of Achyranthes, wherein the preparation method of the medicinal extract powder is as follows: take 160 parts by weight of Astragalus, spread it on a plate, sterilize it with wet heat at 121 degrees in a Chinese medicine sterilizer for 30 minutes, dry it for 4 hours, and crush it into 60 meshes for use. Add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, into the extraction tank, soak Chuanxiong alone first, and then continue to soak Achyranthes and the remaining Astragalus. Decoction until reflux for 2 hours, add 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, again, decoct and reflux for 2 hours, first concentrate the second decoction, and then concentrate the first decoction to an extract specific gravity of 1.1 (thermal measurement). Add the above-mentioned Astragalus powder, mix for 5 minutes, vacuum belt dry, and crush it with a 60-mesh sieve to obtain it.

Claims

1. A method for preparing a compound earthworm capsule Chinese medicine extract powder, characterized in that: The steps include: The invention comprises the following medicinal materials: 280 parts by weight of Chuanxiong, 240 parts by weight of Astragalus, and 160 parts by weight of Achyranthes bidentata; The preparation method of the medicinal extract powder is as follows: 160 parts by weight of Astragalus membranaceus is spread on a plate, sterilized with wet heat at 121°C for 30-60 minutes in a traditional Chinese medicine sterilizer, dried for 2-4 hours, and crushed with a 60-mesh sieve to obtain Astragalus membranaceus powder for later use; 70% ethanol in an amount 3 times the total weight of the extracted medicinal materials is added to an extraction tank, and Chuanxiong is first soaked alone, and then Achyranthes bidentata and 80 parts by weight of Astragalus membranaceus are soaked; decocted and refluxed for 2 hours, 70% ethanol in an amount 3 times the total weight of the extracted medicinal materials is added again, and decocted and refluxed for 2 hours, first concentrating the second decoction, and then concentrating the first decoction until the specific gravity of the extract under thermal measurement is 1.1-1.2; the above-mentioned Astragalus membranaceus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve.

2. A compound earthworm capsule Chinese medicine extract powder, characterized in that: The preparation method according to claim 1 is adopted.

Images