Traditional Chinese medicine composition capable of reducing transaminase increase and preparation method of traditional Chinese medicine composition

Through the compound combination of Bupleurum, Pueraria root, Chuanqiong and wolfberry and liposome wrapping technology, the efficacy and absorption rate of traditional Chinese medicine compositions in liver protection and quenching wine was solved, and the effect of significantly reducing the increase of aminotransferase was achieved, and the effect of the traditional Chinese medicine compositions was improved.

CN120267614APending Publication Date: 2025-07-08SHANGRAO SHAJIANG HIGH TECH BIOLOGY CO LTD
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Patent Information

Application Number
CN202510661734.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-22
Publication Date
2025-07-08

AI Technical Summary

Technical Problem

The existing traditional Chinese medicine compositions fail to fully consider the drug compatibility relationship in protecting the liver and quenching alcohol, resulting in enhanced efficacy and increased side effects, low extraction rate of active ingredient and poor absorption capacity, especially in people with long-term or excessive drinking.

Method used

Through the compound combination of Bupleurum, Pueraria root, Chuanqin and wolfberry, combined with low-temperature extraction, modification of active ingredients and customized liposome wrapping technology, the absorption rate and drug activity of active ingredients are improved, and a traditional Chinese medicine composition with reduced aminotransferase increase is prepared.

Benefits of technology

实现了加速肝细胞修复、减少炎症反应、促进胆碱代谢,显著降低转氨酶升高,提高了有效成分的药物活性和吸收率,增强了护肝解酒效果。

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The invention discloses a traditional Chinese medicine composition capable of reducing transaminase increase and a preparation method of the traditional Chinese medicine composition, and belongs to a medicine for protecting the liver and dispelling the effects of alcohol, which is prepared by utilizing traditional Chinese medicine compound compatibility and extraction and wrapping technologies. Comprising the following steps: drying and crushing radix bupleuri, radix puerariae, ligusticum chuanxiong hort and fructus lycii to obtain traditional Chinese medicine powder; the traditional Chinese medicine powder is subjected to ultrasonic extraction to obtain a dissolution solution; sequentially carrying out centrifugation, filtration, evaporation, drying and modification treatment on the dissolution liquid to obtain modified effective component micro powder; the modified effective component micro powder, glyceryl monostearate, tricaprylin and an ethanol solution with the mass fraction of 70% are mixed and then evaporated to obtain a lipid membrane; mixing soybean lecithin, Tween 80 and deionized water to obtain a compound emulsifier; the compound emulsifier and the lipid membrane are mixed and then sequentially subjected to drying and pulse ultrasound to obtain the traditional Chinese medicine composition capable of reducing transaminase increase.
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Description

Technical Field

[0001] The present invention belongs to the field of preparing drugs for protecting the liver and relieving alcohol intoxication by using the combination and purification of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with the function of reducing elevated transaminases and its preparation method. Background Art

[0002] In today's society, with the popularization of the drinking culture, the incidence of alcoholic liver disease has been increasing year by year and has become one of the global public health problems. Long-term or excessive drinking can directly damage liver cells, leading to an increased metabolic burden on the liver, and further causing elevated transaminases (such as ALT, AST), which is an early sign of abnormal liver function. If not intervened in time, it may further develop into alcoholic fatty liver, hepatitis, cirrhosis, or even liver cancer. In addition, acetaldehyde produced by alcohol metabolism is highly toxic and can exacerbate oxidative stress and inflammatory responses, accelerating liver damage.

[0003] Currently, the mainstream means of protecting the liver and relieving alcohol intoxication mainly include: Western medicine treatment such as polyene phosphatidylcholine for repairing liver cells, silymarin for antioxidant, and N-acetylcysteine for promoting detoxification; conditioning with traditional Chinese patent medicines (such as Hugan tablets, pueraria extract, hovenia dulcis, etc.) to protect the liver and reduce enzymes through multiple targets and accelerate alcohol metabolism; nutritional support (supplementing B vitamins and high-quality protein) and lifestyle adjustments (regular work and rest, moderate exercise); and alcohol-relieving auxiliary products (such as acetaldehyde dehydrogenase preparations, electrolyte beverages) to relieve discomfort after drinking. For severe liver damage, medical monitoring and targeted treatment are required. Overall, protecting the liver and relieving alcohol intoxication requires comprehensive intervention, emphasizing both prevention and repair.

[0004] Traditional Chinese patent medicines have the advantages of multiple targets and overall conditioning in protecting the liver and relieving alcohol intoxication. Their natural ingredients can not only promote alcohol metabolism, reduce the toxicity of acetaldehyde, but also have anti-inflammatory and antioxidant effects, and repair liver cell damage. At the same time, they have fewer side effects and are suitable for long-term conditioning. Compared with the single-point action of Western medicine, traditional Chinese patent medicines achieve "treating both the symptoms and the root causes" through compound compatibility. They can not only relieve alcohol and protect the liver, but also improve liver function indicators, and some drugs have both preventive and therapeutic effects, providing a more gentle and comprehensive liver protection plan for drinkers.

[0005] Patent CN115212241A discloses a high-purity phthalide-containing ligusticum chuanxiong extract, its preparation method, and its application in anti-liver fibrosis. Through research, the present invention discovers a phthalide-containing extract from ligusticum chuanxiong. Compared with the active extracts separated by other traditional extraction processes of ligusticum chuanxiong, this phthalide-containing extract can play a more significant role in antioxidant damage, relieve excessive collagen deposition, reduce the levels of serum alanine aminotransferase, aspartate aminotransferase, total bile acid, alkaline phosphatase, total bilirubin, liver malondialdehyde, and hydroxyproline, and increase the levels of superoxide dismutase, etc., thereby playing a more excellent anti-liver fibrosis role. Further analysis of its active ingredients lays a foundation for the practical application of ligusticum chuanxiong in the prevention and treatment of liver fibrosis, especially cholestatic liver fibrosis.

[0006] Although the single traditional Chinese medicine extract in the above patent can reduce transaminase to a certain extent and achieve the therapeutic effect of protecting the liver, it does not consider that the compatibility relationship between traditional Chinese medicines can enhance the curative effect and reduce the side effects of drugs.

[0007] Patent CN104274582B discloses a pharmaceutical composition for protecting the liver. The pharmaceutical composition is composed of active ingredients and pharmaceutically acceptable excipients. It is characterized in that the active ingredients are made from the following raw materials in parts by weight: Ligustrum lucidum 1.5 - 2.5 parts, Schisandra chinensis 0.5 - 1.5 parts, Epimedium brevicornu 1 - 1.5 parts, Polygonum cuspidatum 2 - 3 parts, Human placenta 1 - 1.5 parts, Acanthopanax senticosus 1 - 2 parts, Astragalus membranaceus 1 - 1.5 parts, Cortex Moutan 1 - 2 parts, Isatis indigotica 1 - 2 parts, Scutellaria baicalensis 0.5 - 1.5 parts, Taxillus chinensis 0.5 - 1.5 parts, Bupleurum chinense 0.5 - 1.5 parts. The function of the pharmaceutical composition of the present invention is to nourish the liver and kidney, clear heat and detoxify, regulate qi and blood. At the same time, the drug has an inhibitory effect on hepatitis B virus, reduces transaminase, and enhances the body's immune function. The prescription has extremely small side effects and obvious therapeutic effects, providing an ideal drug for patients with liver injury.

[0008] Although the pharmaceutical composition in the above patent can achieve a certain therapeutic effect in liver protection, it does not consider that the simple extraction method has a low extraction rate of active ingredients in the drug, and the absorption ability of long-term or excessive alcohol drinkers to the drug is generally poor. Most active ingredients are absorbed in the intestine, and the gastric environment of the human body will cause certain damage to the active ingredients, resulting in a reduction in the therapeutic effect and an increase in potential side effects under the same dose.

[0009] Therefore, it is of great significance to study a traditional Chinese medicine composition with the function of reducing elevated transaminase, which enhances the curative effect and reduces the side effects of drugs through compatibility, and encapsulates the traditional Chinese medicine extract to improve the absorption rate of active ingredients. Summary of the Invention

[0010] In view of the deficiencies of the prior art, the present invention prepares a traditional Chinese medicine formulation with the functions of protecting the liver and relieving alcoholism from Bupleurum chinense, Pueraria lobata, Chuanxiong rhizome, and Lycium barbarum by traditional Chinese medicine compound compatibility, then extracts the active ingredients in the traditional Chinese medicine formulation through a more effective extraction scheme, and finally modifies the active ingredients and combines with a customized liposome encapsulation technology to solve the problems in the background technology. Specifically, the technical solution of the present invention includes the following contents:

[0011] A preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase, the preparation method comprising the following steps:

[0012] Mix glyceryl monostearate, glyceryl trioctanoate, modified active ingredient micropowder and an ethanol solution with a mass fraction of 70%, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion liquid;

[0013] The dispersion solution was rotary evaporated at 40 °C and 100 rpm for 1 h using a rotary evaporator to obtain a lipid film;

[0014] Soybean lecithin, Tween 80 and deionized water were mixed and placed in a water bath at 60 °C, and stirred at 100 rpm for 10 min using a stirrer to obtain a composite emulsifier;

[0015] The lipid film and the composite emulsifier were mixed and placed in a water bath at 35 °C, and stirred at 100 rpm for 30 min using a stirrer to obtain an emulsified lipid film;

[0016] The emulsified lipid film was treated with pulsed ultrasound to obtain liposomes;

[0017] The liposomes were dried by microwave vacuum drying to obtain a traditional Chinese medicine composition.

[0018] Furthermore, the preparation method of the modified active ingredient micropowder includes the following steps:

[0019] 3 - 5 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Ligusticum chuanxiong, and 6 - 10 parts by weight of Lycium barbarum were mixed and rinsed with purified water for 10 min to remove surface impurities to obtain a traditional Chinese medicine formulation;

[0020] The traditional Chinese medicine formulation was dried at 60 °C for 4 h using a dryer and then pulverized through an 80 - mesh sieve using a pulverizer to obtain traditional Chinese medicine powder;

[0021] 1 part by weight of the traditional Chinese medicine powder and 10 parts by weight of an ethanol solution with a mass fraction of 70% were mixed and stirred at 100 rpm for 2 min using a stirrer to obtain a powder mixture solution;

[0022] The powder mixture solution was subjected to ultrasonic extraction three times to obtain a dissolution solution;

[0023] The dissolution solution was centrifuged at 4000 rpm for 10 min using a centrifuge, and the supernatant was taken and filtered through a 0.45 - μm microporous membrane to obtain an extraction solution;

[0024] The extraction solution was rotary evaporated at 60 °C and 100 rpm for 2 h using a rotary evaporator to obtain the active ingredient;

[0025] 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% were mixed and placed in a water bath at 35 °C, and stirred at 100 rpm for 24 h using a stirrer to obtain a suspension;

[0026] The suspension was filtered through a 0.45 - μm microporous membrane to obtain a modified solution;

[0027] The modified solution was rotary evaporated at 40 °C and 100 rpm for 1 h using a rotary evaporator to obtain the modified active ingredient;

[0028] The modified active ingredient was microwave vacuum dried and then ground through a 400-mesh sieve to obtain the modified active ingredient micropowder.

[0029] Furthermore, the powder mixture solution was ultrasonically extracted using an ultrasonic extractor. The extraction conditions included an ultrasonic temperature of 40 - 60 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min, and the interval time between each ultrasonic extraction was 10 min.

[0030] Furthermore, the modified active ingredient was microwave vacuum dried using a microwave vacuum dryer. The drying conditions included a power of 1 kW, a vacuum degree of 15 Pa, and a drying time of 40 min.

[0031] Furthermore, the microwave vacuum drying conditions of the modified active ingredient included a power of 1 kW, a vacuum degree of 15 Pa, and a drying time of 40 min.

[0032] Furthermore, the mass ratio of glyceryl monostearate: glyceryl tricaprylate: modified active ingredient micropowder: ethanol solution with a mass fraction of 70% was 5:2:1:10.

[0033] Furthermore, the mass ratio of soy lecithin: Tween 80: deionized water was 3:1:1.

[0034] Furthermore, the mass ratio of the lipid membrane: composite emulsifier was 8:1.

[0035] Furthermore, the pulsed ultrasound conditions for the emulsified lipid membrane included a power of 200 W, a pulse frequency of on for 2 s / off for 2 s, a process temperature of 0 - 40 °C, and an ultrasound time of 10 min.

[0036] Furthermore, the liposome was microwave vacuum dried using a microwave vacuum dryer. The drying conditions included a power of 1 kW, a vacuum degree of 10 Pa, and a drying time of 1 h.

[0037] Application of a traditional Chinese medicine composition with the effect of reducing elevated transaminase in the field of protecting the liver and relieving hangover. The traditional Chinese medicine composition for this application is a solid powder preparation.

[0038] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0039] (1) Through the compatibility of traditional Chinese medicine compounds, the present invention creatively combines Bupleurum chinense, Pueraria lobata, Chuanxiong rhizome, and Lycium barbarum, enabling it to achieve a series of effects of treating both the symptoms and the root causes, such as accelerating the repair of liver cells, increasing hepatic blood flow, reducing inflammatory reactions, and promoting choline metabolism, thus achieving the effect of reducing elevated transaminase.

[0040] (2) Through technologies such as low-temperature extraction and low-temperature drying, the present invention more efficiently extracts the active ingredients from Bupleurum chinense, Pueraria lobata, Chuanxiong rhizome, and Lycium barbarum, and fully ensures the drug activity of the active ingredients during the extraction process, improving the utilization rate of medicinal materials.

[0041] (3) By modifying functional groups such as hydroxyl groups in the active ingredients, the present invention increases the liposolubility of the active ingredients. Combining with the customized liposome encapsulation technology, the active ingredients are fully protected, and the absorption rate of the active ingredients is improved. Specific embodiments

[0042] The technical solutions of the present invention will be clearly and completely described below through the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts belong to the scope of protection of the present invention.

[0043] Unless otherwise specified, the raw materials and reagents used in the present invention below are all commercially available products or can be prepared by known methods.

[0044] Glycerol monostearate, glyceryl trioctanoate, soy lecithin, Tween 80, palmitic acid, and lipase were purchased from Sinopharm Chemical Reagent Co., Ltd.

[0045] Immobilized lipase was purchased from Shangke Biopharmaceuticals (Shanghai) Co., Ltd.

[0046] Preparation Example 1:

[0047] The preparation of traditional Chinese medicine powder includes the following process:

[0048] Put 5 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Chuanxiong rhizome, and 10 parts by weight of Lycium barbarum in a bamboo sieve, rinse with purified water for 10 min, then pour into a ceramic pot, and put it in a dryer to dry at 60 °C for 4 h, take it out, pour it into a pulverizer and pulverize until it can pass through an 80-mesh sieve to obtain traditional Chinese medicine powder.

[0049] Preparation Example 2:

[0050] The preparation of traditional Chinese medicine powder includes the following process:

[0051] Put 3 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Chuanxiong rhizome, and 10 parts by weight of Lycium barbarum in a bamboo sieve, rinse with purified water for 10 min, then pour into a ceramic pot, and put it in a dryer to dry at 60 °C for 4 h, take it out, pour it into a pulverizer and pulverize until it can pass through an 80-mesh sieve to obtain traditional Chinese medicine powder.

[0052] Preparation Example 3:

[0053] Preparation of traditional Chinese medicine powder, including the following process:

[0054] Put 5 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Chuanxiong rhizome and 6 parts by weight of Lycium barbarum in a bamboo sieve, rinse with purified water for 10 min, then pour into a ceramic pot, put it in a dryer and dry at 60 °C for 4 h, take it out, pour into a pulverizer and pulverize until it can pass through an 80-mesh sieve to obtain traditional Chinese medicine powder.

[0055] Preparation Example 4:

[0056] Preparation of traditional Chinese medicine powder, including the following process:

[0057] Put 3 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Chuanxiong rhizome and 6 parts by weight of Lycium barbarum in a bamboo sieve, rinse with purified water for 10 min, then pour into a ceramic pot, put it in a dryer and dry at 60 °C for 4 h, take it out, pour into a pulverizer and pulverize until it can pass through an 80-mesh sieve to obtain traditional Chinese medicine powder.

[0058] Preparation Example 5:

[0059] Preparation of traditional Chinese medicine powder, including the following process:

[0060] Put 10 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata and 8 parts by weight of Chuanxiong rhizome in a bamboo sieve, rinse with purified water for 10 min, then pour into a ceramic pot, put it in a dryer and dry at 60 °C for 4 h, take it out, pour into a pulverizer and pulverize until it can pass through an 80-mesh sieve to obtain traditional Chinese medicine powder.

[0061] Example 1:

[0062] A preparation method of a traditional Chinese medicine composition for reducing elevated transaminase, including the following process:

[0063] Put 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 2 min to obtain a powder mixture solution. Put the powder mixture solution into an ultrasonic extractor, and perform ultrasonic extraction repeatedly at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. Put the dissolution solution into a centrifuge, centrifuge at 4000 rpm for 10 min, take the supernatant, and filter through a microporous membrane with a pore size of 0.45 μm to obtain an extract. Put the extract into a rotary evaporator, and perform rotary evaporation at 60 °C and 100 rpm for 2 h to obtain an active ingredient. Put 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, place it in a water bath at 35 °C, and stir with a stirrer at 100 rpm for 24 h to obtain a suspension. Filter the suspension through a microporous membrane with a pore size of 0.45 μm to obtain a modified solution. Put the modified solution into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. Put the modified active ingredient into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put it into a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. Put 5 parts by weight of glyceryl monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion solution. Put the extract into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a lipid film. Put 3 parts by weight of soybean lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a composite emulsifier. Pour 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier into a beaker, place it in a water bath at 60 °C, and stir with a stirrer at 100 rpm for 30 min to obtain an emulsified lipid film. Put the emulsified lipid film into a temperature-controlled ultrasonic crusher, and perform ultrasonic treatment at a power of 200 W, a process temperature of 0 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. Put the liposomes into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0064] Example 2:

[0065] A preparation method of a traditional Chinese medicine composition for reducing elevated transaminase levels, comprising the following process:

[0066] 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 2 and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker and stirred at 100 rpm for 2 min by a stirrer to obtain a powder mixture solution. The powder mixture solution was placed in an ultrasonic extractor, and ultrasonic extraction was repeatedly carried out at an ultrasonic temperature of 50 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min, for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. The dissolution solution was placed in a centrifuge, centrifuged at 4000 rpm for 10 min, and the supernatant was taken and filtered through a microporous membrane with a pore size of 0.45 μm to obtain an extract. The extract was placed in a rotary evaporator and rotary evaporated at 60 °C and 100 rpm for 2 h to obtain an active ingredient. 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, placed in a water bath at 35 °C, and stirred at 100 rpm by a stirrer for 24 h to obtain a suspension. The suspension was filtered through a microporous membrane with a pore size of 0.45 μm to obtain a modified solution. The modified solution was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. The modified active ingredient was placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put into a grinder for pulverization until it could pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. 5 parts by weight of glyceryl monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker and stirred at 100 rpm by a stirrer for 10 min to obtain a dispersion solution. The extract was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a lipid film. 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water were poured into a beaker and stirred at 100 rpm by a stirrer for 10 min to obtain a composite emulsifier. 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier were poured into a beaker, placed in a water bath at 60 °C, and stirred at 100 rpm by a stirrer for 30 min to obtain an emulsified lipid film. The emulsified lipid film was placed in a temperature-controlled ultrasonic crusher and ultrasonically treated at a power of 200 W, a process temperature of 10 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. The liposomes were placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0067] Example 3:

[0068] A preparation method of a traditional Chinese medicine composition for reducing elevated transaminase levels, comprising the following process:

[0069] Put 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 3 and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 2 min to obtain a powder mixture solution. Put the powder mixture solution into an ultrasonic extractor, and perform ultrasonic extraction repeatedly at an ultrasonic temperature of 50 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. Put the dissolution solution into a centrifuge, centrifuge at 4000 rpm for 10 min, take the supernatant, and filter through a microporous membrane with a pore size of 0.45 μm to obtain an extract. Put the extract into a rotary evaporator, and perform rotary evaporation at 60 °C and 100 rpm for 2 h to obtain an active ingredient. Put 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, place it in a water bath at 35 °C, and stir with a stirrer at 100 rpm for 24 h to obtain a suspension. Filter the suspension through a microporous membrane with a pore size of 0.45 μm to obtain a modified solution. Put the modified solution into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. Put the modified active ingredient into a microwave vacuum dryer, dry it at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put it into a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a micropowder of the modified active ingredient. Put 5 parts by weight of glyceryl monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the micropowder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion solution. Put the extract into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a lipid film. Put 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a composite emulsifier. Pour 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier into a beaker, place it in a water bath at 60 °C, and stir with a stirrer at 100 rpm for 30 min to obtain an emulsified lipid film. Put the emulsified lipid film into a temperature-controlled ultrasonic crusher, and perform ultrasonic treatment at a power of 200 W, a process temperature of 30 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. Put the liposomes into a microwave vacuum dryer, dry them at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0070] Example 4:

[0071] A preparation method of a traditional Chinese medicine composition for reducing elevated transaminase levels, comprising the following process:

[0072] 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 4 and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, and stirred at 100 rpm for 2 min by a stirrer to obtain a powder mixture solution. The powder mixture solution was placed in an ultrasonic extractor, and ultrasonic extraction was repeatedly performed at an ultrasonic temperature of 60 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. The dissolution solution was placed in a centrifuge, centrifuged at 4000 rpm for 10 min, and the supernatant was taken and filtered through a microporous membrane with a pore size of 0.45 μm to obtain an extract. The extract was placed in a rotary evaporator and rotary evaporated at 60 °C and 100 rpm for 2 h to obtain an active ingredient. 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, placed in a water bath at 35 °C, and stirred at 100 rpm by a stirrer for 24 h to obtain a suspension. The suspension was filtered through a microporous membrane with a pore size of 0.45 μm to obtain a modified solution. The modified solution was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. The modified active ingredient was placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put into a grinder for grinding until it could pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. 5 parts by weight of glycerol monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, and stirred at 100 rpm by a stirrer for 10 min to obtain a dispersion solution. The extract was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a lipid membrane. 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water were poured into a beaker, and stirred at 100 rpm by a stirrer for 10 min to obtain a composite emulsifier. 8 parts by weight of the lipid membrane and 1 part by weight of the composite emulsifier were poured into a beaker, placed in a water bath at 60 °C, and stirred at 100 rpm by a stirrer for 30 min to obtain an emulsified lipid membrane. The emulsified lipid membrane was placed in a temperature-controlled ultrasonic crusher, and ultrasonically treated at a power of 200 W, a process temperature of 40 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. The liposomes were placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0073] Comparative Example 1:

[0074] The traditional Chinese medicine powder prepared in Preparation Example 1 in Example 1 was replaced with the traditional Chinese medicine powder prepared in Preparation Example 5, and the remaining conditions were the same as those in Example 1.

[0075] Comparative Example 2:

[0076] A preparation method of a traditional Chinese medicine composition with reduced elevation of transaminase, comprising the following process:

[0077] Pour 1 part by weight of the traditional Chinese medicine powder of Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 2 min to obtain a powder mixture solution. Put the powder mixture solution into an ultrasonic extractor, and perform ultrasonic extraction at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and an ultrasonic time of 30 min to obtain a dissolution solution. Put the dissolution solution into a centrifuge, centrifuge at 4000 rpm for 10 min, take the supernatant, and filter through a 0.45 μm microporous membrane to obtain an extract. Put the extract into a rotary evaporator, and perform rotary evaporation at 60 °C and 100 rpm for 2 h to obtain an active ingredient. Pour 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, place it in a water bath at 35 °C, and stir with a stirrer at 100 rpm for 24 h to obtain a suspension. Filter the suspension through a 0.45 μm microporous membrane to obtain a modified solution. Put the modified solution into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. Put the modified active ingredient into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put it into a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. Pour 5 parts by weight of glycerol monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion solution. Put the extract into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a lipid film. Pour 3 parts by weight of soybean lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a composite emulsifier. Pour 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier into a beaker, place it in a water bath at 60 °C, and stir with a stirrer at 100 rpm for 30 min to obtain an emulsified lipid film. Put the emulsified lipid film into a temperature-controlled ultrasonic crusher, and perform ultrasonic treatment at a power of 200 W, a process temperature of 0 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. Put the liposomes into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain the traditional Chinese medicine composition.

[0078] Comparative Example 3:

[0079] A preparation method of a traditional Chinese medicine composition with reduced elevation of transaminase, comprising the following process:

[0080] Pour 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 6 parts by weight of an ethanol solution with a mass fraction of 70% into a flask, and extract for 2 hours by the ethanol reflux method (heating temperature 80°C), and then filter through a 0.45 μm microporous filter membrane to obtain an extract. Put the extract into a rotary evaporator and rotary evaporate at 60°C and 100 rpm for 2 h to obtain the active ingredient. Pour 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase and 15 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, place it in a water bath at 35°C, and stir with a stirrer at 100 rpm for 24 h to obtain a suspension. Filter the suspension through a 0.45 μm microporous filter membrane to obtain a modified solution. Put the modified solution into a rotary evaporator and rotary evaporate at 40°C and 100 rpm for 1 h to obtain a modified active ingredient. Put the modified active ingredient into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put it into a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. Pour 5 parts by weight of glycerol monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion solution. Put the extract into a rotary evaporator and rotary evaporate at 40°C and 100 rpm for 1 h to obtain a lipid membrane. Pour 3 parts by weight of soybean lecithin, 1 part by weight of Tween 80 and 1 part by weight of deionized water into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a composite emulsifier. Pour 8 parts by weight of the lipid membrane and 1 part by weight of the composite emulsifier into a beaker, place it in a water bath at 60°C, and stir with a stirrer at 100 rpm for 30 min to obtain an emulsified lipid membrane. Put the emulsified lipid membrane into a temperature-controlled ultrasonic crusher, and ultrasonicate at a power of 200 W, a process temperature of 0°C and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. Put the liposomes into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0081] Comparative Example 4:

[0082] A preparation method of a traditional Chinese medicine composition with the effect of reducing elevated transaminase, comprising the following process:

[0083] Pour 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 2 min to obtain a powder mixture solution. Put the powder mixture solution into an ultrasonic extractor, and perform ultrasonic extraction repeatedly at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction to obtain a dissolution solution. Put the dissolution solution into a centrifuge, centrifuge at 4000 rpm for 10 min, take the supernatant, and filter through a 0.45 μm microporous filter membrane to obtain an extract. Put the extract into a rotary evaporator, and perform rotary evaporation at 60 °C and 100 rpm for 2 h to obtain an active ingredient. Put the active ingredient into a microwave vacuum dryer, and dry at a power of 1 kW and a vacuum degree of 15 Pa for 40 min to obtain a traditional Chinese medicine composition.

[0084] Comparative Example 5:

[0085] A preparation method of a traditional Chinese medicine composition with the effect of reducing elevated transaminase levels, comprising the following steps:

[0086] 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% are poured into a beaker, and stirred at 100 rpm for 2 min by a stirrer to obtain a powder mixture solution. The powder mixture solution is placed in an ultrasonic extractor, and ultrasonic extraction is repeatedly carried out at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. The dissolution solution is placed in a centrifuge, centrifuged at 4000 rpm for 10 min, and the supernatant is taken and filtered through a microporous filter membrane with a pore size of 0.45 μm to obtain an extract. The extract is placed in a rotary evaporator and rotary evaporated at 60 °C and 100 rpm for 2 h to obtain an active ingredient. The active ingredient is placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then placed in a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a fine powder of the active ingredient. 5 parts by weight of glycerol monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% are poured into a beaker, and stirred at 100 rpm for 10 min by a stirrer to obtain a dispersion solution. The extract is placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a lipid film. 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water are poured into a beaker, and stirred at 100 rpm for 10 min by a stirrer to obtain a composite emulsifier. 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier are poured into a beaker, and placed in a water bath at 60 °C, and at the same time stirred at 100 rpm by a stirrer for 30 min to obtain an emulsified lipid film. The emulsified lipid film is placed in a temperature-controlled ultrasonic crusher, and ultrasonically treated at a power of 200 W, a process temperature of 0 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. The liposomes are placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0087] Comparative Example 6:

[0088] A preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase, comprising the following process:

[0089] Put 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 2 min to obtain a powder mixture solution. Put the powder mixture solution into an ultrasonic extractor, and perform ultrasonic extraction repeatedly at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. Put the dissolution solution into a centrifuge, centrifuge at 4000 rpm for 10 min, take the supernatant, and filter through a 0.45 μm microporous filter membrane to obtain an extract. Put the extract into a rotary evaporator, and perform rotary evaporation at 60 °C and 100 rpm for 2 h to obtain an active ingredient. Put 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, place it in a water bath at 35 °C, and stir with a stirrer at 100 rpm for 24 h to obtain a suspension. Filter the suspension through a 0.45 μm microporous filter membrane to obtain a modified solution. Put the modified solution into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. Put the modified active ingredient into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put it into a grinder for pulverization until it can pass through a 400-mesh sieve to obtain a fine powder of the modified active ingredient. Put 5 parts by weight of glyceryl monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the fine powder of the modified active ingredient, and 10 parts by weight of an ethanol solution with a mass fraction of 70% into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a dispersion solution. Put the extract into a rotary evaporator, and perform rotary evaporation at 40 °C and 100 rpm for 1 h to obtain a lipid film. Put 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water into a beaker, and stir with a stirrer at 100 rpm for 10 min to obtain a composite emulsifier. Pour 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier into a beaker, place it in a water bath at 60 °C, and stir with a stirrer at 100 rpm for 30 min to obtain an emulsified lipid film. Put the emulsified lipid film into a temperature-controlled ultrasonic crusher, and perform ultrasonic treatment at a power of 200 W, a process temperature of 0 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. Put the liposomes into a microwave vacuum dryer, dry at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0090] Comparative Example 7:

[0091] A preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase levels, comprising the following steps:

[0092] 1 part by weight of the traditional Chinese medicine powder prepared in Preparation Example 1 and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, and stirred at 100 rpm for 2 min by a stirrer to obtain a powder mixture solution. The powder mixture solution was placed in an ultrasonic extractor, and ultrasonic extraction was repeatedly carried out at an ultrasonic temperature of 40 °C, an ultrasonic frequency of 25 kHz, and a single ultrasonic time of 10 min for a total of 3 times, with an interval of 10 min between each ultrasonic extraction, to obtain a dissolution solution. The dissolution solution was placed in a centrifuge, centrifuged at 4000 rpm for 10 min, and the supernatant was taken and filtered through a microporous filter membrane with a pore size of 0.45 μm to obtain an extract. The extract was placed in a rotary evaporator and rotary evaporated at 60 °C and 100 rpm for 2 h to obtain an active ingredient. 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 3 parts by weight of immobilized lipase, and 15 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, placed in a water bath at 35 °C, and stirred at 100 rpm by a stirrer for 24 h to obtain a suspension. The suspension was filtered through a microporous filter membrane with a pore size of 0.45 μm to obtain a modified solution. The modified solution was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient. The modified active ingredient was placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 15 Pa for 40 min, and then put into a grinder for grinding until it could pass through a 400-mesh sieve to obtain a modified active ingredient fine powder. 5 parts by weight of glyceryl monostearate, 2 parts by weight of glyceryl trioctanoate, 1 part by weight of the modified active ingredient fine powder, and 10 parts by weight of an ethanol solution with a mass fraction of 70% were poured into a beaker, and stirred at 100 rpm for 10 min by a stirrer to obtain a dispersion solution. The extract was placed in a rotary evaporator and rotary evaporated at 40 °C and 100 rpm for 1 h to obtain a lipid film. 3 parts by weight of soy lecithin, 1 part by weight of Tween 80, and 1 part by weight of deionized water were poured into a beaker, and stirred at 100 rpm for 10 min by a stirrer to obtain a composite emulsifier. 8 parts by weight of the lipid film and 1 part by weight of the composite emulsifier were poured into a beaker, placed in a water bath at 60 °C, and stirred at 100 rpm by a stirrer for 30 min to obtain an emulsified lipid film. The emulsified lipid film was placed in a temperature-controlled ultrasonic crusher, and ultrasonicated at a power of 200 W, a process temperature of 0 °C, and a pulse frequency of on 2 s / off 2 s for 10 min to obtain liposomes. The liposomes were placed in a microwave vacuum dryer, dried at a power of 1 kW and a vacuum degree of 10 Pa for 1 h to obtain a traditional Chinese medicine composition.

[0093] The traditional Chinese medicine compositions obtained in Examples 1 to 4 and Comparative Examples 1 to 4 were respectively fully dissolved and diluted to 10 times the original with a mixed solution of methanol and water. The diluted solution was filtered through a microporous filter membrane with a pore size of 0.45 μm and then injected into a high-performance liquid system to detect the wavelength and calculate the content of the active ingredient. The results are shown in the following table:

[0094]

[0095] The encapsulation efficiency of the traditional Chinese medicine compositions obtained in Example 1 and Comparative Examples 5-7 was detected by the micro ultrafiltration centrifugation method respectively, and the results are shown in the following table:

[0096] Material source Entrapment efficiency (%) Example 1 92 Comparative Example 5 78 Comparative Example 6 84 Comparative Example 7 81

[0097] A batch of adult male mice weighing between 25 and 30 g were intragastrically administered with the same 52-degree high-proof liquor at 10 mL / kg. After 20 min, blood was taken to detect the concentrations of ALT and AST in the mouse serum. 110 mice with ALT: 150 ± 20 U / L and AST: 300 ± 50 U / L were selected and randomly divided into 11 groups with 10 mice in each group. Subsequently, at the same time every day, the same 52-degree high-proof liquor was intragastrically administered at 10 mL / kg. One group was not treated with other treatments on this basis as the control group, and the remaining 7 groups were respectively administered the traditional Chinese medicine compositions obtained in Example 1-4 and Comparative Examples 1-7 at 4 g / kg 30 min after the mice were intragastrically administered with the liquor. At 10 h after administration on the 10th day of continuous intragastric administration of the liquor, blood was taken to detect the average concentrations of ALT and AST in the serum of each group of mice. The results are shown in the following table:

[0098]

[0099]

[0100] It can be seen from the data of the above two tests that:

[0101] (1) The traditional Chinese medicine compositions of Example 1-4 achieved the effect of significantly reducing the elevation of transaminase through unique traditional Chinese medicine compound compatibility, extraction scheme and encapsulation technology.

[0102] (2) It can be seen from Comparative Example 1 that if the dosage of Bupleurum chinense is excessive, certain toxicity will be produced, and its dosage needs to be controlled, and adding Lycium barbarum through compatibility can reduce the side effects of the traditional Chinese medicine composition.

[0103] (3) It can be seen from Comparative Example 2 that the active ingredients in the traditional Chinese medicine composition are sensitive to temperature, and high temperature will cause the active ingredients to be inactivated. Although the ultrasonic extraction technology has a lower extraction temperature, continuous long-term ultrasonic waves will cause the local temperature to be too high, thus affecting the activity of the active ingredients.

[0104] (4) It can be seen from Comparative Example 3 that the conventional ethanol reflux extraction method has a long extraction time and poor effect, and is not suitable for extracting complex active ingredients sensitive to temperature.

[0105] (5) It can be seen from Comparative Example 4 that if the active ingredients are not encapsulated by liposomes, it may affect the absorption of the active ingredients, thus greatly weakening the effect of the traditional Chinese medicine composition in reducing the elevation of transaminase.

[0106] (6) It can be seen from Comparative Example 5 that if the active ingredient micropowder is not modified, the encapsulation efficiency of the liposome is relatively low, which will affect the efficacy of the traditional Chinese medicine composition in reducing the elevation of transaminase.

[0107] (7) It can be seen from Comparative Example 6 that the catalytic effect of lipase on the modification of the active ingredient micropowder is not as good as that of immobilized lipase. Using lipase for catalysis will lead to a decrease in the encapsulation efficiency of the liposome, thereby affecting the efficacy of the traditional Chinese medicine composition in reducing the elevation of transaminase.

[0108] (8) It can be seen from Comparative Example 7 that excessive use of immobilized lipase may cause a reverse hydrolysis reaction, resulting in a decrease in the modification effect of the active ingredient micropowder, thereby affecting the efficacy of the traditional Chinese medicine composition in reducing the elevation of transaminase.

[0109] The above-described embodiments have detailed the technical solutions and beneficial effects of the present invention. It should be understood that the above are only specific embodiments of the present invention and are not used to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed.

Claims

1. A preparation method of a traditional Chinese medicine composition for reducing elevated transaminase, characterized in that, The preparation method comprises the following steps: Mix glycerol monostearate, glyceryl trioctanoate, modified active ingredient micropowder and 10 parts by weight of an ethanol solution with a mass fraction of 70%, and stir at 100 rpm for 10 min to obtain a dispersion solution; Rotate and evaporate the dispersion solution at 40 °C and 100 rpm for 1 h to obtain a lipid film; Mix soybean lecithin, Tween 80 and deionized water, and stir at 100 rpm for 10 min in a water bath environment at 60 °C to obtain a composite emulsifier; Mix the lipid film and the composite emulsifier, and stir at 100 rpm for 30 min in a water bath environment at 60 °C to obtain an emulsified lipid film; Obtain liposomes by pulsed ultrasound of the emulsified lipid film; Obtain a traditional Chinese medicine composition after microwave vacuum drying of the liposomes.

2. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 1, wherein, The preparation method of the modified active ingredient micropowder comprises the following steps: Mix 3 - 5 parts by weight of Bupleurum chinense, 12 parts by weight of Pueraria lobata, 8 parts by weight of Ligusticum chuanxiong, and 6 - 10 parts by weight of Lycium barbarum, and rinse with purified water for 10 min to obtain a traditional Chinese medicine formulation; Dry the traditional Chinese medicine formulation at 60 °C for 4 h, then pulverize and pass through an 80 - mesh sieve to obtain traditional Chinese medicine powder; Mix 1 part by weight of the traditional Chinese medicine powder and 10 parts by weight of an ethanol solution with a mass fraction of 70%, and stir at 100 rpm for 2 min to obtain a medicine powder mixture; Perform ultrasonic extraction on the medicine powder mixture three times to obtain a dissolution solution; Centrifuge the dissolution solution at 4000 rpm for 10 min, take the supernatant and filter it through a 0.45 - μm microporous membrane to obtain an extraction solution; Rotate and evaporate the extraction solution at 60 °C and 100 rpm for 2 h to obtain an active ingredient; Mix 10 parts by weight of the active ingredient, 30 parts by weight of palmitic acid, 1 part by weight of immobilized lipase and 15 parts by weight of an ethanol solution with a mass fraction of 70%, and stir at 100 rpm for 24 h in a water bath environment at 35 °C to obtain a suspension; Filter the suspension through a 0.45 - μm microporous membrane to obtain a modified solution; Rotate and evaporate the modified solution at 40 °C and 100 rpm for 1 h to obtain a modified active ingredient; Perform microwave vacuum drying on the modified active ingredient and then grind it to pass through a 400 - mesh sieve to obtain modified active ingredient micropowder.

3. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 2, wherein, The ultrasonic extraction conditions of the medicine powder mixture include an ultrasonic temperature of 40 - 60 °C, an ultrasonic frequency of 25 kHz, a single - time ultrasonic time of 10 min, and an interval time of 10 min between each ultrasonic extraction.

4. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 2, wherein, The microwave vacuum drying conditions of the modified active ingredient include a power of 1 kW, a vacuum degree of 15 Pa, and a drying time of 40 min.

5. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 1, characterized in that, The mass ratio of glycerol monostearate: glyceryl trioctanoate: modified active ingredient micropowder: ethanol solution with a mass fraction of 70% is 5:2:1:

10.

6. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 1, characterized in that, The mass ratio of soybean lecithin: Tween 80: deionized water is 3:1:

1.

7. The preparation method of a traditional Chinese medicine composition with the effect of reducing elevated transaminase according to claim 1, characterized in that The mass ratio of the lipid film: composite emulsifier is 8:

1.

8. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 1, characterized in that, The pulsed ultrasound conditions of the emulsified lipid film include a power of 200 W, a pulse frequency of on 2 s / off 2 s, a process temperature of 0 - 40 °C, and an ultrasonic time of 10 min.

9. The preparation method of a traditional Chinese medicine composition with the function of reducing elevated transaminase according to claim 1, characterized in that The microwave vacuum drying conditions of the liposomes include a power of 1 kW, a vacuum degree of 10 Pa, and a drying time of 1 h.

10. A traditional Chinese medicine composition prepared by the preparation method according to any one of claims 1 to 9, characterized in that, The traditional Chinese medicine composition for the application is a solid powder preparation.

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