A kind of compound earthworm capsule traditional Chinese medicine extract powder and preparation method thereof

Abstract

The present invention belongs to the field of medicine, and in particular to a kind of compound earthworm capsule Chinese medicine extract powder and preparation method thereof, comprising the following steps: 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 Chinese medicine extract powder is as follows: 160 parts by weight of Astragalus are spread on a plate, sterilized with moist heat at 121°C for 30-60min in a Chinese medicine sterilizer, dried for 2-4h, and crushed with 60 mesh for standby use. Add 70% ethanol of 3 times the total weight of the extracted medicinal materials, first soak Chuanxiong alone, and then continue to soak Achyranthes and 1 / 3 of the Astragalus. Decoction to reflux for 2h, add 70% ethanol of 3 times the total weight of the extracted medicinal materials again, decoct and reflux for 2h, first concentrate the second decoction, and then concentrate the first decoction to an extract specific gravity of 1.1-1.2. Add Astragalus powder, mix, vacuum belt dry, and crush with a 60-mesh sieve. Compared with the existing preparation method of compound earthworm capsule traditional Chinese medicine extract powder, the present invention greatly shortens the production cycle, maximizes the content retention rate, ensures the quality of the product, and the overall process is easier to apply and produce and easier to promote.

Description

Technical Field

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

[0002] Compound Earth Dragon Capsules have the properties of dispersing blood stasis, dredging the meridians, and invigorating Qi and activating blood circulation. They are used for Qi deficiency and blood stasis during the meridian recovery phase of ischemic stroke, with symptoms including hemiplegia, paralysis of the mouth and tongue, slurred speech or aphasia, hemiplegic numbness, fatigue, palpitations, shortness of breath, drooling, and spontaneous sweating.

[0003] Chuanxiong: The dried rhizome of the Umbelliferae plant Ligusticum chuanxiong Hort., which 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 the legume plant Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., 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 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, etc., which has the effects of dispersing blood stasis, nourishing the liver and kidneys, and strengthening the tendons and bones.

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

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

[0008] The quality standard for Compound Earth Dragon Capsules is set forth in the National Drug Standard WS3-569(Z-114)-2002(Z) issued by the State Drug Administration. The formula comprises 2000g of fresh earth dragon, 280g of Chuanxiong, 240g of Astragalus, and 160g of Achyranthes. The extract powder is prepared as follows: 160g of Astragalus is soaked in 70% ethanol for one hour, filtered, and the ethanol solution is set aside. The medicinal residue is gradually heated to 60°C, the ethanol evaporated, and the mixture is dried at 105°C for approximately four hours, pulverized, and passed through a 60-mesh sieve for later use. The Chuanxiong, Achyranthes, and the remaining Astragalus are then extracted twice with 70% ethanol (the ethanol solution is prepared by adding 95% ethanol), each for two hours. The ethanol solutions are then combined, the ethanol recovered, and concentrated to a relative density of approximately 1.3 (at 70°C). The Astragalus powder is then added, mixed, dried, pulverized, and passed through a 60-mesh sieve.

[0009] According to production experience, it was found that the content of astragaloside IV in the preparation process of astragalus powder was relatively low, and there was a certain safety risk in the production process of evaporating the medicinal 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. In addition, 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 the expansion and strengthening of the product.

[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 traditional 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 traditional 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 minutes, dry it for 2-4 hours, and crush it into 60 mesh size powder for later use to obtain Astragalus membranaceus powder.

[0014] 2) Add 3 times the total weight of the extracted herbs in 70% ethanol to the extraction tank. Soak Chuanxiong alone first, then continue soaking Achyranthes and 1 / 3 of the prescribed amount of Astragalus. Boil until refluxed for 2 hours. Add 3 times the total weight of the extracted herbs in 70% ethanol again, boil and reflux for 2 hours. Concentrate the second decoction first, then the first decoction, to an extract with a specific gravity of 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 membranaceus 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 in the present invention is to sterilize and dry the astragalus slices with wet heat, and then crush them. The process is simple, safe, and easy to operate, and it retains the active ingredients of the astragalus medicinal material to the greatest extent. The standard preparation method is to take 2 / 3 of the prescribed amount of astragalus, soak it in 70% ethanol for 1 hour, filter it, and set aside the ethanol solution; gradually heat the residue to 60°C, evaporate the ethanol, dry it at 105°C for about 4 hours, crush it, pass it through a 60-mesh sieve, and set aside. Its production cycle is longer, and the gradual heating of the residue to 60°C and the evaporation of ethanol process poses an unsafe risk of ethanol being flammable and explosive. At the same time, the retention rate of astragaloside IV, the active ingredient of astragalus, is low.

[0021] The extraction process selected by the present invention is to add 70% ethanol, which is three times the total weight of the extracted medicinal materials, to an extraction tank, first soak Chuanxiong alone, and then continue to soak Achyranthes and 1 / 3 of the amount of Astragalus. The mixture is decocted to reflux for 2 hours, and then 70% ethanol, which is three times the total weight of the extracted medicinal materials, is added again, and refluxed for 2 hours. The second decoction is first concentrated, and then the first decoction is concentrated to an extract with a specific gravity of 1.1-1.2 (thermal measurement). Compared with the standard preparation method, Chuanxiong, Achyranthes and the remaining Astragalus are extracted twice with 70% ethanol (the above ethanol solution is prepared by adding 95% ethanol), each for 2 hours, and the ethanol solution is combined, the ethanol is recovered and concentrated to a relative density of about 1.3 (70°C). The effective retention rate of ferulic acid content is greatly improved, greatly improving the quality of the product. The specific gravity is reduced to 1.1-1.2, which can be fully mixed with the 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 drying time is 24 hours, and the drying and crushing time of the whole batch of materials is 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 material active ingredients, as well as the retention rate of active ingredients in each process. The results are shown in the following table:

[0024]

[0025] As shown in the table above, the overall production cycle of this method is 57 hours, with a retention rate of 78.14% for astragaloside IV and 23.02% for ferulic acid from the time of adding the raw materials to the output of the Chinese herbal extract powder. In contrast, the standard process has a production cycle of 118 hours, with a retention rate of 34.07% for astragaloside IV and 8.97% for ferulic acid from the time of adding the raw materials to the output of the Chinese herbal extract powder. This demonstrates that the present invention has a short production cycle and a high retention rate of active ingredients.

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

[0027] Samples prepared using the standard process and the preferred preparation method of the present invention were prepared into Chinese medicinal extract powders. The extract powders were then filled into capsules, pressed into plates, and packaged to obtain the samples. Accelerated stability testing was conducted under the following conditions: a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5% for 6 months. Samples were collected and tested at the 0th, 3rd, and 6th month of the test.

[0028]

[0029] Note: The method for determining the content of astragaloside IV is based on the method for determining the content of astragaloside IV in the Quality Standard of Astragalus in the 2020 edition of the Chinese Pharmacopoeia (pages 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 0 months, the astragaloside content, ferulic acid content and moisture content are higher; and the standard process samples and the samples prepared by the method of the present invention have basically the same decrease in astragaloside content, both of which are about 3%, and the decrease in ferulic acid content is basically the same, both of which are about 36.4%, and the moisture content is basically unchanged.

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

[0033] In order to better reflect the advanced nature 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 are more stable than those prepared by other patented processes, and the obtained products have strong anti-moisture absorption ability, strong stability and stable therapeutic effect.

[0037] The preferred preparation method of the present invention greatly shortens the production cycle compared to traditional standard processes, 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 significantly improves, 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 per unit material is about 90min, and the drying and crushing time of the whole batch of materials is only 40h, compared to the traditional reduced pressure oven drying unit material drying 24h, and the whole batch material drying and crushing is a production cycle of about 96h that is significantly shortened, and the ferulic acid content retention rate is significantly 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 word "about" or "approximately" is used, it means within 10% of a given value or range, suitably within 5%, and particularly within 1%. Alternatively, for a person of ordinary skill in the art, the term "about" or "approximately" means within an acceptable standard error range of the mean. Whenever a number having a value of N is disclosed, any number having 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 this does not necessarily mean that there are any adverse limitations on the present application. The present application has been described in detail herein, and specific embodiments thereof have been disclosed. 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. 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 traditional Chinese medicine sterilizer at 121 degrees Celsius for 30 minutes, dried for 2 hours, and crushed with a 60-mesh sieve for later use. 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added to an extraction tank. First, soak the Chuanxiong alone, and then soak the Achyranthes and the remaining Astragalus. Decoction is continued until refluxed for 2 hours, and 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added again. Decoction is continued for 2 hours, and the second decoction is concentrated first, and then the first decoction is concentrated to an extract specific gravity of 1.16 (thermal measurement). The above-mentioned Astragalus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve to obtain the product.

[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. 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 traditional Chinese medicine sterilizer at 121 degrees Celsius for 50 minutes, dried for 4 hours, and crushed with a 60-mesh sieve for later use. 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added to an extraction tank. First, soak the Chuanxiong alone, and then soak the Achyranthes and the remaining Astragalus. Decoction is continued until refluxed for 2 hours, and 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added again. Decoction and reflux are continued for 2 hours. The second decoction is first concentrated, and then the first decoction is concentrated to an extract specific gravity of 1.2 (thermal measurement). The above-mentioned Astragalus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve to obtain the product.

[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. 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 traditional Chinese medicine sterilizer at 121 degrees Celsius for 40 minutes, dried for 3 hours, and crushed with a 60-mesh sieve for later use. 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added to an extraction tank. First, soak the Chuanxiong alone, and then continue to soak the Achyranthes and the remaining Astragalus. Decoction is continued until refluxed for 2 hours, and 70% ethanol, which is 3 times the total weight of the extracted medicinal materials, is added again. Decoction and reflux are continued for 2 hours. First, the second decoction is concentrated, and then the first decoction is concentrated to an extract specific gravity of 1.15 (thermal measurement). The above-mentioned Astragalus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve to obtain the product.

[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. 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 traditional Chinese medicine sterilizer at 121 degrees Celsius for 30 minutes, dried for 4 hours, and crushed with a 60-mesh sieve for later use. 70% ethanol, which is three times the total weight of the extracted medicinal materials, is added to an extraction tank. First, soak the Chuanxiong alone, and then soak the Achyranthes and the remaining Astragalus. Decoction is continued until refluxed for 2 hours, and 70% ethanol, which is three times the total weight of the extracted medicinal materials, is added again. Decoction is continued for 2 hours, and the second decoction is concentrated first, and then the first decoction is concentrated to an extract specific gravity of 1.1 (thermal measurement). The above-mentioned Astragalus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve to obtain the product.

Claims

1. A method for preparing the medicinal extract powder in compound earthworm capsules, characterized in that: The steps include: The invention comprises the following medicinal materials: 280 parts by weight of Chuanxiong rhizome, 240 parts by weight of Astragalus root, and 160 parts by weight of Achyranthes bidentata root; 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 traditional Chinese medicine sterilizer at 121°C for 30-60 minutes, dried for 2-4 hours, and crushed with a 60-mesh sieve to obtain astragalus 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 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, the second decoction is concentrated first, and the first decoction is concentrated again until the specific gravity of the extract under thermal measurement is 1.1-1.2; the above-mentioned astragalus powder is added, mixed for 5 minutes, vacuum belt dried, and crushed with a 60-mesh sieve to obtain a ferulic acid retention rate of 23.02% and an astragaloside retention rate of 34.07%.

2. A medicinal extract powder in a compound earthworm capsule, characterized in that: The preparation method according to claim 1 is used to prepare the product.

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