Application of traditional Chinese medicine composition in preparation of medicine for treating hyperlipidemia
Through the extraction and preparation of the Chinese medicinal composition of gypsum, rehmannia root, ophiopogon japonicus, anemarrhena asphodeloides and Achyranthes bidentata, the problem of large side effects of Western medicine is solved, and efficient and mild hyperlipidemia treatment and prevention effects are achieved. The Chinese medicinal composition is suitable for the preparation of hyperlipidemia.
Patent Information
- Application Number
- CN202510789169.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-13
- Publication Date
- 2025-09-26
AI Technical Summary
Among the existing treatments for hyperlipidemia, Western medicines such as statins may cause side effects such as liver damage and muscle soreness. Traditional Chinese medicine treatments are mildly effective in regulating hyperlipidemia but lack systematic research and are particularly unsuitable for patients who require long-term conditioning.
A Chinese medicinal composition of gypsum, rehmannia root, ophiopogon japonicus, anemarrhena asphodeloides and cyperus rotundus is prepared by adding water for reflux extraction, filtering and concentrating, and spray drying into fine powder to prepare pharmaceutically acceptable dosage forms such as oral liquid and pills for the treatment and prevention of hyperlipidemia.
It significantly reduces the levels of TC, TG and LDL-C in hyperlipidemia model rats and golden hamsters, increases HDL-C, reduces the levels of ET-1 and CRP, improves vascular endothelial function, and has a good effect in treating and preventing hyperlipidemia.
Smart Images
Figure BDA0005449680240000061 
Figure BDA0005449680240000081 
Figure BDA0005449680240000091
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of traditional Chinese medicine, relates to a new use of a traditional Chinese medicine composition, and particularly relates to the use of the traditional Chinese medicine composition in the preparation of a drug for hyperlipidemia. Background Art
[0002] Hyperlipidemia refers to a metabolic disease characterized by abnormally elevated levels of lipids (such as cholesterol and triglycerides) in the blood. Hyperlipidemia with an unknown cause (primary hyperlipidemia) is relatively common, while hyperlipidemia with a clear etiology (secondary hyperlipidemia) is usually caused by primary aldosteronism.
[0003] Treatment of hyperlipidemia may involve lifestyle changes, such as dietary adjustments, weight loss, exercise, or combined with medication. A variety of medications are effective for both the initial treatment and subsequent management of hyperlipidemia. These include lipid-lowering drugs that primarily lower plasma cholesterol, including bile acid sequestrants such as cholestyramine and colestipol, and HMG-CoA reductase inhibitors (statins). Clinically used drugs include lovastatin, simvastatin, pravastatin, and fovastatin.
[0004] Hyperlipidemia can also be treated with medications and traditional Chinese medicine (TCM). Hyperlipidemia falls under the TCM categories of "phlegm turbidity," "blood stasis," and "fat turbidity." TCM treatment focuses on holistic conditioning and syndrome differentiation. Its advantages lie in its milder properties and fewer side effects compared to some Western medications (such as statins, which can cause liver damage and muscle aches), making it particularly suitable for patients requiring long-term conditioning. Summary of the Invention
[0005] To solve the above technical problems, the present invention provides a use of a traditional Chinese medicine composition in the preparation of a remedy for hyperlipidemia, wherein the traditional Chinese medicine composition is prepared from gypsum, rehmannia root, ophiopogon japonicus, rhizoma anemarrhenae, and achyranthes bidentata. The use can be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.
[0006] The traditional Chinese medicine composition comprises: 1-100 parts of gypsum, 1-100 parts of rehmannia root, 1-100 parts of ophiopogon japonicus, 1-100 parts of anemarrhena rhizome, and 1-100 parts of achyranthes bidentata.
[0007] Furthermore, the traditional Chinese medicine composition comprises: 10 to 80 parts of gypsum, 10 to 80 parts of rehmannia root, 10 to 80 parts of ophiopogon japonicus, 10 to 80 parts of anemarrhena rhizome, and 10 to 80 parts of achyranthes bidentata.
[0008] Preferably, the traditional Chinese medicine composition comprises: 10-60 parts of gypsum, 10-80 parts of rehmannia root, 10-50 parts of ophiopogon japonicus, 10-20 parts of anemarrhena asphodeloides, and 10-20 parts of achyranthes bidentata.
[0009] Preferably, the traditional Chinese medicine composition comprises: 30-35 parts of gypsum, 50-55 parts of rehmannia root, 15-18 parts of ophiopogon japonicus, 12-15 parts of anemarrhena rhizome, and 12-15 parts of achyranthes bidentata.
[0010] The above composition can be directly ground into powder and mixed by raw materials, or can be an extract or other form prepared by conventional means. The raw materials used can also be used in the form of direct grinding into powder, extract, or other processed forms.
[0011] Specifically, the pharmaceutical dosage forms for treating hyperlipidemia provided by the present invention include oral dosage forms, injection dosage forms or external dosage forms.
[0012] The dosage forms of the drugs of the present invention are prepared by weighing the raw materials in proportion, adding pharmaceutically acceptable excipients or additives, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc., and preparing them according to conventional production methods in the pharmaceutical field to prepare conventional pharmaceutically acceptable dosage forms, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.
[0013] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows: gypsum, rehmannia root, ophiopogon japonicus, anemarrhena asphodeloides, and cyperus rotundus are extracted by reflux with water, filtered, the filtrate is concentrated to an extract, dried, crushed into fine powder, and mixed to obtain spray-dried fine powder.
[0014] More preferably, the preparation method of the aforementioned drug is as follows: add 6 times the amount of water to the five medicinal materials of gypsum, Rehmannia, Ophiopogon japonicus, Anemarrhena asphodeloides, and Achyranthes bidentata, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70°C), spray dry, grind into fine powder, mix to obtain spray-dried fine powder, add an appropriate amount of dextrin and 5g of stevioside, and granulate to obtain the product.
[0015] The present invention also proposes the use of a traditional Chinese medicine composition in the preparation of a medicine for treating atherosclerosis or improving vascular endothelial function. The traditional Chinese medicine composition is prepared from the following components by weight: 1 to 100 parts of gypsum, 1 to 100 parts of rehmannia root, 1 to 100 parts of ophiopogon japonicus, 1 to 100 parts of anemarrhena asphodeloides, and 1 to 100 parts of achyranthes bidentata.
[0016] Furthermore, the traditional Chinese medicine composition comprises: 10 to 80 parts of gypsum, 10 to 80 parts of rehmannia root, 10 to 80 parts of ophiopogon japonicus, 10 to 80 parts of anemarrhena rhizome, and 10 to 80 parts of achyranthes bidentata.
[0017] Preferably, the traditional Chinese medicine composition comprises: 10-60 parts of gypsum, 10-80 parts of rehmannia root, 10-50 parts of ophiopogon japonicus, 10-20 parts of anemarrhena asphodeloides, and 10-20 parts of achyranthes bidentata.
[0018] Preferably, the traditional Chinese medicine composition comprises: 30-35 parts of gypsum, 50-55 parts of rehmannia root, 15-18 parts of ophiopogon japonicus, 12-15 parts of anemarrhena rhizome, and 12-15 parts of achyranthes bidentata.
[0019] The composition of the present invention can significantly reduce the contents of TC, TG and LDL-C in hyperlipidemia model rats, increase the level of HDL-C, and reduce the contents of ET-1 and CRP in hyperlipidemia golden hamsters, and has a good therapeutic effect on hyperlipidemia. DETAILED DESCRIPTION
[0020] The present application aims to provide an application of a Chinese medicine composition in the preparation of a drug for treating or preventing hyperlipidemia. In order to enable those skilled in the art to more clearly understand the technical solution of the present application, the technical solution of the present application will be described in detail below in conjunction with specific examples. If the specific conditions are not specified in the following experiments, they are all carried out according to conventional conditions or the conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, for which the manufacturer is not specified, are all conventional products that can be obtained commercially. The experimental methods for which the detailed conditions are not specified are carried out in accordance with conventional test methods or in accordance with the operating instructions recommended by the supplier.
[0021] It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those of ordinary skill in the art to which this application belongs. The following examples are intended only to further illustrate the technical solutions of the present application and are not intended to limit the scope of protection of the present application.
[0022] Example 1 Preparation of Chinese medicine composition
[0023] Take 932.50g of gypsum, 1515.63g of Rehmannia root, 466.25g of Ophiopogon japonicus, 350.00g of Anemarrhena asphodeloides and 350.00g of Achyranthes bidentata, add 6 times the amount of water, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70°C), spray dry, grind into fine powder, mix together to obtain a spray-dried fine powder Chinese medicine composition intermediate, add an appropriate amount of dextrin and 5g of stevioside, granulate, and make 1000g.
[0024] Experimental Example 2 Effect of Chinese herbal composition on hyperlipidemia rats
[0025] 1. Experimental Materials
[0026] 1.1 Animals
[0027] Male SPF Sprague-Dawley rats weighing 200–220 g were purchased and fed adaptively for the experiments. They were purchased from Sibeifu (Suzhou) Biotechnology Co., Ltd., license number: SCXK(Su)2022-0006. A high-fat diet consisting of 84% basal feed, 10% lard, 1% cholesterol, and 5% egg yolk powder was purchased from Beijing Huafukang Biotechnology Co., Ltd. and stored at 4°C.
[0028] 1.2 Drugs and reagents
[0029] The intermediate of the Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.;
[0030] Fluvastatin capsules, Zhejiang Hisun Pharmaceutical Co., Ltd., specification: 40 mg / capsule, batch number: 20240627;
[0031] Chloral hydrate, Sangon Biotech (Shanghai) Co., Ltd., specification: 250 g / bottle, batch number: KB14BA0021;
[0032] Total cholesterol (TC) kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., specification: 50T / box, batch number: 141324013;
[0033] Triglyceride (TG) kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., specification: 50T / box, batch number: 141324011;
[0034] Low-density lipoprotein cholesterol (LDL-C) kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., specification: 50T / box, batch number: 141324015;
[0035] High-density lipoprotein cholesterol (HDL-C) kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., specification: 50T / box, batch number: 141324016;
[0036] 1.3 Instruments
[0037] BSA224S-CW electronic balance, Sartorius; TC3K body weight scale, G&G; 5840 refrigerated centrifuge, Eppendorf; BCD-216SZ refrigerator, Haier; BS-240VET small animal blood biochemical analyzer, Mindray, USA; Flexstation 3 microplate reader, Meigu Molecular, USA.
[0038] 2. Dosage design
[0039] The daily dosage of the traditional Chinese medicine composition is 57.83g of crude drug per day. Based on the body surface area conversion method, the equivalent dose for rats is 57.83g of crude drug per 60kg x 6.2 = 5.98g of crude drug per kg, which is considered the medium dose. Using a 0.5:1:2 dosing regimen, the low dose is 2.99g of crude drug per kg and the high dose is 11.96g of crude drug per kg. The clinical daily dosage of fluvastatin capsules is 20mg, which translates to an equivalent dose of 2.07mg for rats.
[0040] 3. Experimental Methods
[0041] 3.1 Modeling and grouping
[0042] Ten male SPF-grade Sprague-Dawley rats were randomly selected as the normal control group, and the remaining rats served as the modeling group. The normal control group rats were fed a standard diet, while the modeling group rats were fed a high-fat diet. Both rats had free access to water. Four weeks later, blood was collected from the rats' tail veins to measure serum TC and TG levels. After successful modeling, the modeling group rats were randomly divided into a model group, a positive drug (fluvastatin) group, and high-, medium-, and low-dose groups of the Chinese medicine composition, with 10 rats in each group.
[0043] 3.2 Administration
[0044] Rats in the normal control and model groups were given double-distilled water. Rats in the positive drug group were gavaged with fluvastatin solution. Rats in the high-, medium-, and low-dose groups of the Chinese medicine composition were given the corresponding concentrations of the Chinese medicine composition solution once daily for four consecutive weeks, with a gavage volume of 10 mL / kg. During the administration process, except for the normal control group, which received ordinary feed, all other groups continued to be fed a high-fat diet.
[0045] 3.3 Index detection
[0046] The rats were fasted but not watered for 16 h the day before sampling. One h after the last administration, the rats were anesthetized with 10% chloral hydrate and blood was collected from the abdominal aorta. The blood was allowed to stand at room temperature for 0.5 h and then centrifuged at 3000 r / min for 10 min. The supernatant was collected and serum TC, TG, HDL-C and LDL-C were detected using a small animal blood biochemical analyzer.
[0047] 3.4 Data Analysis
[0048] All quantifiable data were expressed as x ± SD, and data were compared between groups using analysis of variance and T test. p < 0.05 indicated statistically significant differences.
[0049] 4. Experimental results
[0050] As shown in Table 1, compared with the normal control group, serum TC, TG, and LDL-C levels in the model group rats were significantly increased, while HDL-C levels were significantly decreased (p < 0.001), indicating successful model establishment. Compared with the model group, serum TC, TG, and LDL-C levels in the high-, medium-, and low-dose groups of the Chinese herbal composition were all lower (p < 0.01, 0.05). Furthermore, HDL-C levels were significantly increased in each dose group (p < 0.01, 0.05). This suggests that the Chinese herbal composition has a significant lipid-lowering effect.
[0051] Table 1 Blood lipid levels of rats in each group (mmol / L)
[0052]
[0053] Note: Compared with the normal control group, ### P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.
[0054] Experimental Example 3 Effect of Chinese herbal medicine composition on hyperlipidemic golden hamsters
[0055] 1. Experimental Materials
[0056] 1.1 Animals
[0057] SPF-grade male golden hamsters weighing 90–120 g were purchased and fed adaptively for the experiment. They were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., license number: SCXK(Beijing)2021-0011. A high-fat diet consisting of 84.8% basal feed, 15% lard, and 0.2% cholesterol was purchased from Beijing Huafukang Biotechnology Co., Ltd. and stored at 4°C.
[0058] 1.2 Medication
[0059] The intermediate of the Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.;
[0060] Fluvastatin capsules, Zhejiang Hisun Pharmaceutical Co., Ltd., specification: 40 mg / capsule, batch number: 20240627;
[0061] Chloral hydrate, Sangon Biotech (Shanghai) Co., Ltd., specification: 250 g / bottle, batch number: KB14BA0021;
[0062] Hamster endothelin 1 (ET-1) ELISA kit, Hefei Lyle Biotechnology Co., Ltd., specification: 96T, batch number: 202412;
[0063] Hamster C-reactive protein (CRP) ELISA kit, Beijing Zhongke Quality Inspection Biotechnology Co., Ltd., specification: 96T, batch number: 202501.
[0064] 1.3 Instruments
[0065] BSA224S-CW electronic balance, Sartorius; TC3K weight scale, G&G; CENTRFUGE5840 refrigerated centrifuge, Eppendorf; BCD-216SZ refrigerator, Haier; Flexstation3 microplate reader, Meigu Molecular.
[0066] 2. Dosage design
[0067] The daily dosage of the traditional Chinese medicine composition is 57.83g of crude drug per day. Based on the body surface area conversion method, the equivalent dose for a golden hamster is 57.83g of crude drug per 60kg * 7.4 = 7.13g of crude drug per kg, which is considered the medium dose. Using a 0.5:1:2 dosing regimen, the low dose is 3.57g of crude drug per kg and the high dose is 14.26g of crude drug per kg. The clinical daily dosage of fluvastatin capsules is 20mg, which translates to an equivalent dose of 2.47mg for rats.
[0068] 3. Experimental Methods
[0069] 3.1 Grouping and Dosing
[0070] SPF-grade male golden hamsters were randomly divided into a normal group, a model group, a positive drug (fluvastatin) group, and a high-, medium-, and low-dose group of a Chinese medicine composition, with 10 hamsters in each group. The normal group hamsters were given a normal diet, and the other hamster groups were given a high-fat diet. After 2 weeks, the corresponding drugs were gavaged at the same time. The normal control group and the model group hamsters were given double-distilled water, the fluvastatin group was gavaged with a fluvastatin solution, and the high-, medium-, and low-dose groups of the Chinese medicine composition were given a Chinese medicine composition solution of corresponding concentrations. The drugs were administered once a day for 4 consecutive weeks. During the administration process, except for the normal control group hamsters who were given a normal diet, the other groups continued to be fed with a high-fat diet.
[0071] 3.2 Index detection
[0072] The hamsters were fasted but not watered for 16 h the day before sampling. One h after the last administration, the hamsters were anesthetized with 10% chloral hydrate and blood was collected from the abdominal aorta. The blood was allowed to stand at room temperature for 0.5 h and then centrifuged at 3000 r / min for 10 min. The supernatant was collected and serum ET-1 and CRP were detected using an enzyme-labeled instrument.
[0073] 3.3 Data Analysis
[0074] All quantifiable data were expressed as x ± SD, and data were compared between groups using analysis of variance and T test. p < 0.05 indicated statistically significant differences.
[0075] 4. Experimental results
[0076] As shown in Table 2, compared with the normal control group, serum ET-1 and CRP levels in the model group were significantly elevated (p < 0.001), indicating successful model establishment. Serum ET-1 and CRP levels were lower in the high-, medium-, and low-dose groups of the Chinese herbal composition than in the model group (p < 0.01, 0.05, respectively). This suggests that the Chinese herbal composition can improve vascular endothelial function and have a preventive effect on the development of atherosclerosis.
[0077] Table 2 ET-1 and CRP levels in golden hamsters in each group
[0078]
[0079]
[0080] Note: Compared with the normal control group, ### P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.
[0081] The above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Those skilled in the art will appreciate that other variations or modifications may be made based on the above description. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.
Claims
1. Use of a traditional Chinese medicine composition in the preparation of a drug for hyperlipidemia, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 1-100 parts of gypsum, 1-100 parts of rehmannia root, 1-100 parts of ophiopogon japonicus, 1-100 parts of anemarrhena rhizome, and 1-100 parts of achyranthes bidentata.
2. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 10-80 parts of gypsum, 10-80 parts of rehmannia root, 10-80 parts of ophiopogon japonicus, 10-80 parts of anemarrhena rhizome, and 10-80 parts of achyranthes bidentata.
3. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 10-60 parts of gypsum, 10-80 parts of rehmannia root, 10-50 parts of ophiopogon japonicus, 10-20 parts of anemarrhena rhizome, and 10-20 parts of achyranthes bidentata.
4. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following components: 30-35 parts of gypsum, 50-55 parts of rehmannia root, 15-18 parts of ophiopogon japonicus, 12-15 parts of anemarrhena rhizome, and 12-15 parts of achyranthes bidentata.
5. The use according to claim 1, characterized in that The preparation method of the Chinese medicine composition is as follows: Gypsum, Rehmannia root, Radix Ophiopogonis, Rhizoma Anemarrhenae and Achyranthes bidentata are extracted by reflux with water, filtered, the filtrate is concentrated to an extract, dried, crushed into fine powder, and mixed to obtain spray-dried fine powder.
6. The use according to claim 1, characterized in that The preparation method of the medicine is as follows: Add 6 times the amount of water to five medicinal materials including gypsum, rehmannia root, ophiopogon, anemarrhena and cyperus, soak for 30 minutes, reflux extraction for 60 minutes, filter, concentrate the filtrate to an extract with a relative density of 1.05-1.10 (60-70°C), spray dry, grind into fine powder, mix to obtain spray-dried fine powder, add appropriate amount of dextrin and 5g of stevioside, and granulate to obtain the product.
7. The use according to any one of claims 1 to 4, characterized in that: The medicine also includes pharmaceutically acceptable excipients or additives.
8. The use according to claim 7, characterized in that The dosage form of the drug for hyperlipidemia includes an oral dosage form, an injection dosage form or an external dosage form.
9. The use according to claim 8, characterized in that The drugs for treating hyperlipidemia include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, gels, sprays, and injections.
10. Use of a Chinese medicine composition in the preparation of a drug for treating atherosclerosis or improving vascular endothelial function, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 1-100 parts of gypsum, 1-100 parts of rehmannia root, 1-100 parts of ophiopogon japonicus, 1-100 parts of anemarrhena rhizome, and 1-100 parts of achyranthes bidentata.