A traditional Chinese medicine preparation for preventing and treating frostbite and a preparation process thereof

Abstract

The present application belongs to the technical field of Chinese medicine preparation, and particularly relates to a Chinese medicine preparation for preventing and treating frostbite and a preparation process thereof. The raw medicine and weight parts of the Chinese medicine preparation are as follows: Herba Epimedii 20-40 parts, Herba Rhizomatis 10-20 parts, Angelica sinensis 10-20 parts, Ramulus Cinnamomi 10-15 parts, Radix Ginseng 10-20 parts, and Zingiber officinale 8-12 parts. The Chinese medicine preparation is prepared according to the following process: the above raw medicine is weighed according to the weight parts, crushed to 40-60 meshes, extracted by a water-alcohol mixture, and filtered to remove the residue; the collected filtrate is vacuum dried to prepare a dry paste powder; the dry paste powder is mixed with a filler, a binder and cocoa powder, and then wetted to prepare a soft material which is compressed into chewable tablets. The present application improves the water / alcohol extraction method of the prior art, increases the content of icariin, total flavonoids, polysaccharides and triterpenoid saponins, and improves the cure rate of frostbite.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of Chinese medicine preparation, and particularly relates to a Chinese medicine preparation for preventing and treating frostbite and a preparation process thereof. BACKGROUND

[0002] Frostbite often occurs in cold regions, and is a symptom of body chilling. In the process of real production and life, effective anti-frostbite drugs are needed. A Chinese medicine formula for preventing and treating frostbite has been developed in the past research, and the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Cassia twig 12 parts, dried ginger 10 parts, ginseng 15 parts, and auxiliary materials. The mechanism of treating frostbite is as follows: cold coagulation of the skin, blood vessels not being unobstructed, and yang qi being injured. The treatment method is to warm yang and dispel cold, dredge the channels and invigorate qi. Therefore, Herba Epimedii and Herba Rhizomatis are used as the monarch drug to warm yang and dispel cold, Angelica and Cassia twig are used as the ministerial drug to dredge the channels and dispel cold, ginseng is used as the assistant to promote qi and blood, and dried ginger is used to warm the middle and dispel cold, return yang and dredge the vessels, and guide the drugs to the disease site. The above-mentioned Chinese medicine formula can achieve the functions of warming yang, dispelling cold, dredging the channels and invigorating qi. After a course of treatment, the cure rate is 51.9%, and the total effective rate is 91.7%. The cure rate needs to be further improved.

[0003] When the preparation process of Chinese medicine is different, the content of effective components in the Chinese medicine preparation is different, which also affects the treatment effect. Therefore, in order to improve the content of effective components, a better preparation process is developed, which is a powerful measure to improve the cure rate. SUMMARY

[0004] In order to solve the above technical problems, the present application provides a Chinese medicine preparation for preventing and treating frostbite and a preparation process thereof. The water / alcohol extraction method of the prior art is improved, the content of effective components is improved, and the cure rate of frostbite is improved.

[0005] The purpose of the present application is to provide a preparation process of a Chinese medicine preparation for preventing and treating frostbite, and the raw materials and weight parts are as follows: Herba Epimedii 20-40 parts, Herba Rhizomatis 10-20 parts, Angelica 10-20 parts, Cassia twig 10-15 parts, ginseng 10-20 parts, and dried ginger 8-12 parts.

[0006] The preparation process comprises the following steps:

[0007] The above-mentioned raw materials are weighed according to the weight ratio, crushed to 40-60 meshes, extracted with a water / alcohol mixture, and the drug residue is filtered out. The collected filtrate is vacuum dried to prepare a dry paste powder.

[0008] The dry paste powder is added with a filler equivalent to 24-26% of the mass fraction of the dry paste powder, a binder equivalent to 2.5-4% of the mass fraction of the dry paste powder, and cocoa powder equivalent to 1-1.5% of the mass fraction of the dry paste powder, mixed, wetted to prepare a soft material, and compressed to prepare chewable tablets. The chewable tablets are the Chinese medicine preparation for preventing and treating frostbite.

[0009] It should be noted that the wet soft material preparation and the compression into chewable tablets all adopt the conventional process in the art, and no innovation point is involved, so the process conditions are not described in detail, but it should be noted that the same "wet soft material preparation and compression into chewable tablets" process is adopted for all the examples and controls of the present application, and the interference of these processes on the experimental results is excluded.

[0010] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the water-alcohol mixed solution is an ethanol solution with a volume fraction of 50% to 52%, and the solvent is water meeting the pharmaceutical standard, such as drinking water, purified water, water for injection or sterile water for injection. Preferably, the volume fraction of the ethanol solution is 50%, 51% or 52%.

[0011] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the dry powder is added with a filler corresponding to 25% of the mass fraction of the dry powder, a binder corresponding to 3% of the mass fraction of the dry powder, and cocoa powder corresponding to 1% of the mass fraction of the dry powder.

[0012] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and the weight parts are as follows: Herba Epimedii 30 parts, Herba Cuspariae 15 parts, Angelica sinensis 15 parts, Ramulus Cinnamomi 12 parts, Zingiber officinale 10 parts, and Radix Ginseng 15 parts.

[0013] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the cosolvent is added within 1h to 2h after the start of the water-alcohol mixed solution extraction, and the cosolvent is L-threonine, and the amount of L-threonine is 0.1% to 0.5% of the mass of the water-alcohol mixed solution. L-threonine is soluble in water but not in ethanol, so when it encounters both water and ethanol in the water-alcohol mixed solution, the affinity of L-threonine changes, and a high affinity is generated between L-threonine and the raw materials, thereby promoting the dissolution of icariin, total flavonoids, polysaccharides and triterpenoid saponins.

[0014] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the water-alcohol mixed solution extraction refers to the static extraction for 6h to 10h with the water-alcohol mixed solution corresponding to 8 times to 10 times the total weight of the raw materials.

[0015] Preferably, in the preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite, the temperature of the vacuum drying is -20℃ to -10℃, and the vacuum degree is -0.06MPa to -0.04MPa. Preferably, the temperature of the vacuum drying is -20℃, and the vacuum degree is -0.04MPa; the temperature of the vacuum drying is -15℃, and the vacuum degree is -0.05MPa, or the temperature of the vacuum drying is -10℃, and the vacuum degree is -0.06MPa.

[0016] Preferably, the above-mentioned traditional Chinese medicine preparation for preventing frostbite, the filling agent is starch paste with mass fraction of 10% to 12%, and the preparation process of the starch paste is as follows: starch and water are mixed according to the mass ratio of 1:10 to 12, and boiled to be viscous, for example, boiled for 10 to 20 minutes.

[0017] Preferably, the above-mentioned traditional Chinese medicine preparation for preventing frostbite, the binder is sodium carboxymethyl cellulose.

[0018] The traditional Chinese medicine preparation for preventing frostbite of the present application has the following prevention scheme: 2g at a time, twice a day, and 2 weeks as a course of treatment.

[0019] Compared with the prior art, the present application has the following beneficial effects:

[0020] The raw materials and weight parts of the traditional Chinese medicine preparation of the present application are as follows: 20 to 40 parts of Herba Epimedii, 10 to 20 parts of Herba Rhizomatis, 10 to 20 parts of Angelica sinensis, 10 to 15 parts of Ramulus Cinnamomi, 10 to 20 parts of Radix Ginseng, and 8 to 12 parts of Zingiberis. Among them, Herba Epimedii and Herba Rhizomatis are the monarch drugs for warming yang and dispelling cold; Angelica sinensis and Ramulus Cinnamomi are the minister drugs for dredging meridians and dispelling cold; Radix Ginseng is the assistant drug for promoting qi and blood circulation; and Zingiberis is the guide drug for guiding all the drugs to the diseased parts. Experiments prove that the traditional Chinese medicine preparation prepared by the preparation process of the present application has the effects of warming yang, promoting qi, dredging meridians and dispelling cold; it is suitable for workers in cold environments, and can enhance the body's resistance to cold and improve the anti-freezing function of the limbs. In addition, the preparation process of the present application clearly defines the amounts of the filling agent, the binder and the cocoa powder, and the prepared traditional Chinese medicine preparation has improved efficacy compared with the existing frostbite medicine. The chewable tablets of the present application can be chewed and swallowed, and the taking method is simple.

[0021] Epimedrkoreanoside and total flavonoids are the main effective components of Herba Epimedii, and polysaccharides and triterpenoid saponins are the main effective components of Herba Rhizomatis. As the monarch drugs of the traditional Chinese medicine preparation of the present application, the extraction rates of the effective components of Herba Epimedii and Herba Rhizomatis are the key to the anti-freezing effect. The traditional Chinese medicine preparation of the present application at least includes the following effective components: epimedrkoreanoside, total flavonoids, polysaccharides and triterpenoid saponins. In addition, the present application tests the contents of epimedrkoreanoside, total flavonoids, polysaccharides and triterpenoid saponins under different preparation processes, and finally determines the best scheme as adding the cosolvent L-threonine with an amount of 0.3% of the mass of the water-alcohol mixed solution. Experiments prove that the preparation process of the present application can efficiently extract the effective components of epimedrkoreanoside, total flavonoids, polysaccharides and triterpenoid saponins, and improve the frostbite cure rate. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 The flow chart of the preparation process of the traditional Chinese medicine preparation for preventing frostbite of the present application. DETAILED DESCRIPTION

[0023] To enable those skilled in the art to better understand and implement the technical solutions of the present invention, the present invention will be further described below in conjunction with specific embodiments and accompanying drawings.

[0024] The inventive concept of this invention is as follows:

[0025] Different preparation processes result in varying levels of active ingredients in traditional Chinese medicine (TCM) preparations, thus affecting therapeutic efficacy. Therefore, developing superior preparation processes aimed at increasing the content of active ingredients is a powerful measure to improve cure rates.

[0026] The preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite of the present invention is as follows: Figure 1 The raw materials and their weight parts for the traditional Chinese medicine preparation for preventing frostbite are as follows: Epimedium 20-40 parts, Curculigo orchioides 10-20 parts, Angelica sinensis 10-20 parts, Cinnamomum cassia 10-15 parts, Panax ginseng 10-20 parts, and dried ginger 8-12 parts.

[0027] The preparation process includes the following steps:

[0028] Weigh the above raw materials according to the weight ratio, pulverize them to 40-60 mesh, extract them with a water-alcohol mixture, filter out the residue, and vacuum dry the collected filtrate to make a dry ointment powder.

[0029] Add 24%–26% filler, 2.5%–4% binder, and 1%–1.5% cocoa powder (by mass fraction of dry ointment) to the dry ointment powder, mix, wet process to form a soft material, and press into chewable tablets to obtain a traditional Chinese medicine preparation for preventing and treating frostbite.

[0030] The traditional Chinese medicine preparation prepared by the process of this invention has the effects of warming yang and promoting qi circulation, clearing the meridians and dispelling cold; it is suitable for workers in cold environments, and can enhance the body's cold resistance and improve the frostbite resistance of limbs. In addition, the preparation process of this invention clarifies the dosage of fillers, binders and cocoa powder, and the prepared traditional Chinese medicine preparation has improved efficacy compared with the existing frostbite medicines.

[0031] It should be noted that the raw materials used in the traditional Chinese medicine preparations prepared by this invention are pharmaceutical grade, and their main medicinal effects are as follows: the fillers, binders and cocoa powder can be pharmaceutical grade or food grade, and are mainly used as excipients.

[0032] The technical solution and technical effects of the present invention will be illustrated below with some specific embodiments and experiments.

[0033] In the following examples and experiments, the reagents used are commercially available unless otherwise specified, and the methods used are conventional techniques in the art. The cocoa powder used is natural cocoa powder, purchased from Shandong Xinghongsheng Biological Technology Co., Ltd., with a particle size of 200 mesh and an effective substance content of 99%. The starch used is corn starch, with a particle size of 100 mesh and an effective substance content of 99%, purchased from Henan Fengwei Biological Technology Co., Ltd. The carboxymethylcellulose sodium has a particle size of 5 μm. The sucrose powder has a particle size of 100 nm. The magnesium stearate has a particle size of 15 μm.

[0034] In the following examples and experiments, the same "wet soft material preparation and compression into chewable tablets" process is used to exclude the interference of these processes on the experimental results.

[0035] In the following examples and experiments, the water used is purified water.

[0036] Example 1

[0037] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Cuspariae 15 parts, Angelica sinensis 15 parts, Ramulus Cinnamomi 12 parts, Zingiber officinale 10 parts, and Radix Ginseng 15 parts.

[0038] The traditional Chinese medicine preparation is prepared according to the following process:

[0039] The above raw materials are weighed according to the weight ratio, pulverized to 40 mesh, extracted with a water-alcohol mixture, and the dregs are filtered out. The collected filtrate is vacuum dried to prepare a dry paste powder. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixture is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixture extraction refers to static extraction for 6 h with 8 times the total weight of the raw materials of the water-alcohol mixture.

[0040] To the dry paste powder, 24% of the mass fraction of the dry paste powder of the filler, 2.5% of the mass fraction of the dry paste powder of the binder, and 1% of the mass fraction of the dry paste powder of the cocoa powder are added, mixed uniformly, wet soft material is prepared, and chewable tablets are compressed. The filler is a starch paste with a mass fraction of 10%. The filler is a starch paste with a mass fraction of 10%, and the preparation process is as follows: the starch and water are mixed according to a mass ratio of 1:10, boiled for 10 min, and become viscous. The binder is carboxymethylcellulose sodium.

[0041] The preparation process parameters of Example 1 are changed to obtain the preparation processes of other examples, and the relevant settings are shown in Table 1.

[0042] Table 1 Preparation process parameter settings

[0043]

[0044]

[0045] Note: "-" means no such item.

[0046] For the convenience of detailed understanding of the preparation process of other embodiments, the method of other embodiments will also be specifically described below.

[0047] Example 2

[0048] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Cinnamomum 12 parts, Dried Ginger 10 parts, Ginseng 15 parts.

[0049] The traditional Chinese medicine preparation is prepared according to the following process:

[0050] The above raw materials are weighed according to the weight ratio, crushed to 60 mesh, extracted with a water-alcohol mixed solution, the drug residue is filtered out, and the collected filtrate is vacuum dried to prepare a dry paste powder; the vacuum drying temperature is -10°C, and the vacuum degree is -0.06MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixed solution extraction refers to static extraction for 6h with 8 times the total weight of the raw materials of the water-alcohol mixed solution.

[0051] To the dry paste powder, add a filler corresponding to 24% of the mass fraction of the dry paste powder, a binder corresponding to 2.5% of the mass fraction of the dry paste powder, and cocoa powder corresponding to 1% of the mass fraction of the dry paste powder, mix well, wet the soft material, and press into chewable tablets. The filler is a starch paste with a mass fraction of 10%. The filler is a starch paste with a mass fraction of 10%, and the preparation process is as follows: mix the starch and water according to a mass ratio of 1:10, boil for 10min, and become viscous. The binder is sodium carboxymethyl cellulose.

[0052] Example 3

[0053] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Cinnamomum 12 parts, Dried Ginger 10 parts, Ginseng 15 parts.

[0054] The traditional Chinese medicine preparation is prepared according to the following process:

[0055] The above raw materials are weighed according to the weight ratio, crushed to 40 mesh, extracted with a water-alcohol mixed solution, the drug residue is filtered out, and the collected filtrate is vacuum dried to prepare a dry paste powder; the vacuum drying temperature is -10°C, and the vacuum degree is -0.06MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixed solution extraction refers to static extraction for 6h with 10 times the total weight of the raw materials of the water-alcohol mixed solution.

[0056] The dry powder is added with a filler equivalent to 24% of the mass fraction of the dry powder, a binder equivalent to 2.5% of the mass fraction of the dry powder, and cocoa powder equivalent to 1% of the mass fraction of the dry powder, and mixed uniformly, wet material is prepared, and compressed into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: starch and water are mixed in a mass ratio of 1:10, boiled for 10 min, and become viscous. The binder is sodium carboxymethyl cellulose.

[0057] Example 4

[0058] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Cuspariae 15 parts, Angelica sinensis 15 parts, Ramulus Cinnamomi 12 parts, Zingiber officinale 10 parts, and Radix Ginseng 15 parts.

[0059] The traditional Chinese medicine preparation is prepared according to the following method:

[0060] The above raw materials are weighed according to the weight ratio, pulverized to 40 mesh, extracted with a water-alcohol mixed solution, and the residue is filtered out. The collected filtrate is dried under vacuum to prepare dry powder; the temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixed solution extraction refers to static extraction with 8 times the total weight of the raw materials of the water-alcohol mixed solution for 8 hours.

[0061] The dry powder is added with a filler equivalent to 24% of the mass fraction of the dry powder, a binder equivalent to 2.5% of the mass fraction of the dry powder, and cocoa powder equivalent to 1% of the mass fraction of the dry powder, and mixed uniformly, wet material is prepared, and compressed into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: starch and water are mixed in a mass ratio of 1:10, boiled for 10 min, and become viscous. The binder is sodium carboxymethyl cellulose.

[0062] Example 5

[0063] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Cuspariae 15 parts, Angelica sinensis 15 parts, Ramulus Cinnamomi 12 parts, Zingiber officinale 10 parts, and Radix Ginseng 15 parts.

[0064] The traditional Chinese medicine preparation is prepared according to the following method:

[0065] The above raw medicine is weighed according to the proportion of weight parts, crushed to 40 meshes, extracted with a water-alcohol mixed solution, and the medicine residue is filtered out. The collected filtrate is dried under vacuum to prepare dry paste powder. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%. The water-alcohol mixed solution extraction refers to the use of 8 times the total weight of the raw medicine of the water-alcohol mixed solution for 6 hours of stationary extraction. The auxiliary solvent, L-threonine, is added at the 1.5th hour after the start of water-alcohol mixed solution extraction. The amount of auxiliary solvent is 0.1% of the mass of the water-alcohol mixed solution.

[0066] The dry paste powder is added with a filler corresponding to 24% of the mass fraction of the dry paste powder, a binder corresponding to 2.5% of the mass fraction of the dry paste powder, and cocoa powder corresponding to 1% of the mass fraction of the dry paste powder. Mix well, wet the soft material, and press into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: mix starch and water according to a mass ratio of 1:10, boil for 10 minutes, and become viscous. The binder is sodium carboxymethyl cellulose.

[0067] Example 6

[0068] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw medicine and the weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica sinensis 15 parts, Cinnamomum cassia 12 parts, Zingiber officinale 10 parts, and Panax ginseng 15 parts.

[0069] The traditional Chinese medicine preparation is prepared by the following method:

[0070] The above raw medicine is weighed according to the proportion of weight parts, crushed to 40 meshes, extracted with a water-alcohol mixed solution, and the medicine residue is filtered out. The collected filtrate is dried under vacuum to prepare dry paste powder. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%. The water-alcohol mixed solution extraction refers to the use of 8 times the total weight of the raw medicine of the water-alcohol mixed solution for 6 hours of stationary extraction. The auxiliary solvent, L-threonine, is added at the 1.5th hour after the start of water-alcohol mixed solution extraction. The amount of auxiliary solvent is 0.1% of the mass of the water-alcohol mixed solution.

[0071] The dry paste powder is added with a filler corresponding to 24% of the mass fraction of the dry paste powder, a binder corresponding to 2.5% of the mass fraction of the dry paste powder, and cocoa powder corresponding to 1% of the mass fraction of the dry paste powder. Mix well, wet the soft material, and press into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: mix starch and water according to a mass ratio of 1:10, boil for 10 minutes, and become viscous. The binder is sodium carboxymethyl cellulose.

[0072] Example 7

[0073] A traditional Chinese medicine preparation for preventing and treating frostbite, raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Cassia 12 parts, dried ginger 10 parts, and Ginseng 15 parts.

[0074] The traditional Chinese medicine preparation is prepared by the following method:

[0075] The above raw materials are weighed according to the weight ratio, crushed to 40 mesh, extracted with a water-alcohol mixed solution, and the dregs are filtered out. The collected filtrate is vacuum dried to prepare a dry paste powder. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixed solution extraction refers to the use of a water-alcohol mixed solution equivalent to 8 times the total weight of the raw materials for 6 hours of static extraction. An auxiliary solvent is added at the 2nd hour after the start of water-alcohol mixed solution extraction. The auxiliary solvent is L-threonine, and the amount of auxiliary solvent is 0.1% of the mass of the water-alcohol mixed solution.

[0076] To the dry paste powder, a filler equivalent to 24% of the mass fraction of the dry paste powder, an adhesive equivalent to 2.5% of the mass fraction of the dry paste powder, and cocoa powder equivalent to 1% of the mass fraction of the dry paste powder are added, and mixed uniformly to prepare a soft material by wet method, and then compressed into chewable tablets. The filler is a starch paste with a mass fraction of 10%. The filler is a starch paste with a mass fraction of 10%, and the preparation process is as follows: starch and water are mixed according to a mass ratio of 1:10, and boiled for 10 minutes to become viscous. The adhesive is sodium carboxymethyl cellulose.

[0077] Example 8

[0078] A traditional Chinese medicine preparation for preventing and treating frostbite, raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Cassia 12 parts, dried ginger 10 parts, and Ginseng 15 parts.

[0079] The traditional Chinese medicine preparation is prepared by the following method:

[0080] The above raw materials are weighed according to the weight ratio, crushed to 40 mesh, extracted with a water-alcohol mixed solution, and the dregs are filtered out. The collected filtrate is vacuum dried to prepare a dry paste powder. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixed solution extraction refers to the use of a water-alcohol mixed solution equivalent to 8 times the total weight of the raw materials for 6 hours of static extraction. An auxiliary solvent is added at the 2nd hour after the start of water-alcohol mixed solution extraction. The auxiliary solvent is L-threonine, and the amount of auxiliary solvent is 0.1% of the mass of the water-alcohol mixed solution.

[0081] To the dry powder paste, add a filler equivalent to 24% of the mass fraction of the dry paste, an adhesive equivalent to 2.5% of the mass fraction of the dry paste, and cocoa powder equivalent to 1% of the mass fraction of the dry paste, mix well, wet the material to make soft material, and press into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: mix starch and water in a mass ratio of 1:10, boil for 10 min, and become viscous. The adhesive is sodium carboxymethyl cellulose.

[0082] Example 9

[0083] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Cuspariae 15 parts, Angelica sinensis 15 parts, Ramulus Cinnamomi 12 parts, Zingiber officinale 10 parts, and Radix Ginseng 15 parts.

[0084] The traditional Chinese medicine preparation is prepared by the following method:

[0085] According to the weight ratio, the above-mentioned raw materials are weighed and crushed to 40 mesh. Extract with a water-alcohol mixed solution, filter out the dregs, and collect the filtrate. The filtrate is dried under vacuum to obtain a dry paste. The temperature of vacuum drying is -10°C, and the vacuum degree is -0.06 MPa. The water-alcohol mixed solution is an ethanol solution with a volume fraction of 50%. The water-alcohol mixed solution extraction refers to the use of 8 times the total weight of the raw materials of water-alcohol mixed solution for static extraction for 6 hours. An auxiliary solvent is added at 1.5 hours after the start of water-alcohol mixed solution extraction. The auxiliary solvent is L-threonine, and the amount of auxiliary solvent is 0.5% of the mass of the water-alcohol mixed solution.

[0086] To the dry paste, add a filler equivalent to 24% of the mass fraction of the dry paste, an adhesive equivalent to 2.5% of the mass fraction of the dry paste, and cocoa powder equivalent to 1% of the mass fraction of the dry paste, mix well, wet the material to make soft material, and press into chewable tablets. The filler is starch paste with a mass fraction of 10%. The filler is starch paste with a mass fraction of 10%, and the preparation process is as follows: mix starch and water in a mass ratio of 1:10, boil for 15 min, and become viscous. The adhesive is sodium carboxymethyl cellulose.

[0087] Experiment 1, effective ingredient test results

[0088] The contents of icariin, total flavonoids, and triterpenoid saponins in the dry paste were tested by high performance liquid chromatography, and the content of polysaccharide was tested by anthrone-sulfuric acid method. The test results are shown in Table 2.

[0089] Table 2 Test results of Example 1 to Example 9

[0090]

[0091] From Table 1 and Table 2, it can be seen that the icariin, total flavone / triterpene saponin content and polysaccharide extraction effect of Example 8 is the best, so the following efficacy experiment is based on the best condition.

[0092] Experiment two, application experiment

[0093] Patient data: 60 patients in each experimental group. In each experimental group, the oldest was 38 years old, the youngest was 18 years old, the average age was 25 years old, the longest course of disease was 5 years, and the shortest was 2 months. All cases were due to high altitude cold injury. The patients were diagnosed by dermatologists as having different parts and different degrees of chilblains, but the skin was not broken, and the blood pressure and heart rate were within the normal range.

[0094] Treatment method: oral chewable tablets, 1g each time, 3 times a day.

[0095] Evaluation criteria for the treatment effect of frostbite:

[0096] Cure: the patient's symptoms disappeared, the signs were normal, and there was no recurrence within 2 months after stopping the drug.

[0097] Effective: the patient's symptoms disappeared, the signs improved, and there was recurrence within 2 months after stopping the drug.

[0098] No effect: compared with before treatment, there was no significant improvement in symptoms and signs.

[0099] The amount of filler, the amount of adhesive and the amount of cocoa powder were changed respectively, and the treatment effect was tested. The treatment results are shown in Table 4.

[0100] Control 1 is as follows:

[0101] A traditional Chinese medicine preparation for preventing and treating frostbite, the raw materials and weight parts are as follows: Herba Epimedii 30 parts, Herba Rhizomatis 15 parts, Angelica sinensis 15 parts, Cinnamomum cassia 12 parts, Zingiber officinale 10 parts, Panax ginseng 15 parts.

[0102] The traditional Chinese medicine preparation is prepared according to the following process:

[0103] The above raw materials are weighed according to the weight ratio, extracted with a water-alcohol mixture, the dregs are filtered out, and the collected filtrate is spray dried to obtain a dry paste powder. The water-alcohol mixture is an ethanol solution with a volume fraction of 50%, and the water-alcohol mixture extraction refers to static extraction for 6h with 8 times the total weight of the raw materials of water-alcohol mixture.

[0104] To the dry paste powder, add corn starch as a filler, which is equivalent to 25% of the mass fraction of the dry paste powder, water as an adhesive, which is equivalent to 3% of the mass fraction of the dry paste powder, sucrose powder as a flavoring agent, which is equivalent to 1% of the mass fraction of the dry paste powder, and magnesium stearate as a lubricant, which is equivalent to 1% of the mass fraction of the dry paste powder, without adding cocoa powder, mix well, wet the material, and press into chewable tablets.

[0105] The amount of filler, adhesive and cocoa powder is shown in Table 3, and the treatment results are shown in Table 4.

[0106] Table 3 Amount of filler, adhesive and cocoa powder

[0107]

[0108] Table 4 Test results of Example 1, Example 8, Example 10 to Example 15 and Control 1

[0109]

[0110]

[0111] From the results of Table 3 and Table 4, it can be seen that compared with Control 1, the traditional Chinese medicine preparation of each embodiment of the present application has a faster effect, and the number of effective cases in one week can reach 25 cases at most, while the number of effective cases in one week of Control 1 is only 13 cases. The cure rate of each embodiment of the present application is high, and the number of cured cases is 35 to 42. During the treatment process, no adverse reactions such as allergy, diarrhea, fatigue, poor appetite, etc. occurred in each traditional Chinese medicine preparation.

[0112] It should be noted that when numerical ranges are involved in the present application, both endpoints of each numerical range and any number between the two endpoints can be selected. Since the same steps and examples are used, the preferred embodiments of the present application are described to prevent redundancy. Although the preferred embodiments of the present application have been described, those skilled in the art can make additional changes and modifications to these embodiments once they understand the basic inventive concept, and these changes and modifications all fall within the scope of the present application.

[0113] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. If these modifications and variations of the present application fall within the scope of the equivalent technology of the present application, the present application also intends to include these modifications and variations.

Claims

1. A preparation process of a traditional Chinese medicine preparation for preventing and treating frostbite, characterized in that, The raw materials and weight parts of the Chinese medicine preparation for preventing and treating frostbite are as follows: Epimedium 20-40 parts, Herba Rhizomatis 10-20 parts, Angelica 10-20 parts, Ramulus Cinnamomi 10-15 parts, Radix Ginseng 10-20 parts, and Rhizoma Zingiberis Recens 8-12 parts; The preparation process comprises the following steps: The raw materials are weighed according to the weight parts, crushed to 40-60 meshes, extracted with a water-alcohol mixed solution, and the residue is filtered out, and the collected filtrate is dried under vacuum to prepare a dry paste powder; the water-alcohol mixed solution is an ethanol solution with a volume fraction of 50-52%; the water-alcohol mixed solution extraction refers to static extraction for 6-10 hours with 8-10 times the weight of the raw materials of the water-alcohol mixed solution; L-threonine is added for solubilization within 1-2 hours after the start of the water-alcohol mixed solution extraction, and the amount of L-threonine is 0.1-0.5% of the mass of the water-alcohol mixed solution; The dry paste powder is added with a filler corresponding to 24-26% of the mass fraction of the dry paste powder, 2.5-4% of a binder, and 1-1.5% of cocoa powder, mixed, wetted to prepare a soft material, and compressed to prepare chewable tablets, thereby obtaining the Chinese medicine preparation for preventing and treating frostbite; The L-threonine is used for promoting the dissolution of icariin, total flavonoids, polysaccharides, and triterpenoid saponins; The temperature of the vacuum drying is -20 to -10℃, and the vacuum degree is -0.06 to -0.04 MPa.

2. The preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite according to claim 1, characterized in that, The dry paste powder is added with a filler corresponding to 24-26% of the mass fraction of the dry paste powder, 2.5-4% of a binder, and 1-1.5% of cocoa powder, mixed, wetted to prepare a soft material, and compressed to prepare chewable tablets, thereby obtaining the Chinese medicine preparation for preventing and treating frostbite; 3. The preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite according to claim 1, characterized in that, The filler is starch paste with a mass fraction of 10-12%, and the binder is sodium carboxymethyl cellulose.

4. The preparation process of the traditional Chinese medicine preparation for preventing and treating frostbite according to claim 1, characterized in that, The raw materials and weight parts are as follows: Epimedium 30 parts, Herba Rhizomatis 15 parts, Angelica 15 parts, Ramulus Cinnamomi 12 parts, Rhizoma Zingiberis Recens 10 parts, and Radix Ginseng 15 parts.

5. A traditional Chinese medicine preparation for preventing and treating frostbite, characterized in that, The Chinese medicine preparation for preventing and treating frostbite is prepared by the preparation process of any one of claims 1-4.

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