Application of traditional Chinese medicine composition in preparation of hypertension medicine

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicine for treating hypertension, which is characterized in that the traditional Chinese medicine composition is prepared from gypsum, rehmannia, ophiopogon root, rhizoma anemarrhenae and achyranthes root. The composition disclosed by the invention can be used for remarkably reducing systolic pressure of spontaneously hypertensive rats and reducing blood pressure rise of the rats caused by feeding of high-fat feed, so that the traditional Chinese medicine composition has a relatively good treatment effect on hypertension.

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 hypertension. Background Art

[0002] Hypertension is defined as a persistent elevation in resting systolic or diastolic blood pressure (systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥80 mmHg). Hypertension of unknown etiology (primary hypertension) is relatively common, while hypertension with a clear etiology (secondary hypertension) is usually caused by primary aldosteronism.

[0003] For patients with hypertension, lifestyle modification and medication are the most commonly used treatments. The basic principles of medication include prioritizing the use of long-acting antihypertensive medications, controlling 24-hour blood pressure, and adjusting medications and dosages as needed. If hypertension is left uncontrolled for a long time, it can lead to more serious complications, even fatal consequences such as stroke and cerebral infarction.

[0004] While Western medicine can quickly lower blood pressure, it's less effective in relieving accompanying symptoms like dizziness, headaches, and insomnia. Some patients may experience symptoms persisting even though their blood pressure is within target. Traditional Chinese medicine compound preparations not only lower blood pressure but also delay arteriosclerosis and reverse target organ damage through lipid-lowering, antioxidant, and endothelial function-improving mechanisms. Their long-term protective effects on the heart, brain, and kidneys are superior to those of Western medicine alone. 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 drug for hypertension, wherein the traditional Chinese medicine composition is prepared from gypsum, rehmannia root, ophiopogon root, rhizoma anemarrhenae, and achyranthes root. 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 hypertension drugs 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 drug for treating hypercholesterolemia or hyperglycemia. 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 systolic blood pressure of spontaneously hypertensive rats and reduce the increase in blood pressure of rats fed with a high-fat diet, indicating that the traditional Chinese medicine composition has a good therapeutic effect on hypertension. DETAILED DESCRIPTION

[0020] The present application aims to provide a kind of application of Chinese medicine composition in the preparation of treatment or prevention hypertension medicine.In order to make those skilled in the art understand the technical scheme of the present application more clearly, the technical scheme of the present application will be described in detail below in conjunction with specific examples.If the following experiments are not specified in specific conditions, 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, which are not specified by the manufacturer, are all conventional products that can be obtained commercially.The experimental methods for which the detailed conditions are not specified are carried out according to conventional test methods or according to 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 the whole to obtain a spray-dried fine powder to obtain a traditional Chinese medicine composition intermediate, add an appropriate amount of dextrin and 5g of stevioside, granulate, and make 1000g.

[0024] Experimental Example 2 Effect on Spontaneously Hypertensive Rat Model

[0025] 1. Experimental Materials

[0026] Animals: Wistar rats, SPF grade, male, 6 in total, weighing 180-200 g. Spontaneously hypertensive rats (SHR), SPF grade, male, 34 in total, weighing 180-200 g were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd.

[0027] Drug: Telmisartan, Jiangsu Yabang Epson Pharmaceutical Co., Ltd., batch number: 2302035.

[0028] Instruments: electronic balance, Sartorius, Germany, model: BS224S; weight scale, G&G brand, China, model: TC3K; NIBP biological multi-channel noninvasive pressure measurement system, Ede Instrument, model: MedLab U / 8C.

[0029] 2. Dosage design

[0030] The daily dose of telmisartan for humans is 35 mg, and the clinical dose for adults (calculated based on 60 kg) is 0.58 mg / kg. The calculated equivalent dose for rats is 3.6 mg / kg.

[0031] The daily dose of the Chinese medicine composition is 57.83g, and the clinical dose for an adult (60kg) is 0.96g / kg. The calculated rat equivalent dose is 5.98g / kg. Using this dose as the median dose, and using a 0.5:1:2 dose ratio, the low, medium, and high doses of the Chinese medicine composition are 2.99, 5.98, and 11.95g of crude drug / kg, respectively.

[0032] 3. Experimental Methods

[0033] 60 male Wistar rats were used as blank control group, and 30 male SHR rats were randomly divided into 5 groups according to body weight, namely: model control group, telmisartan group (positive drug), low, medium and high dose groups of the present composition, 6 in each group.Blank control group: conventional feeding, double distilled water (10ml / kg) gavage.Model group: conventional feeding, double distilled water (10ml / kg) gavage.Telmisartan group: conventional feeding, telmisartan (3.6mg / kg) suspension gavage, continuous administration for 8 weeks.The low (2.99g / kg), medium (5.98g / kg), and high dose (11.95g / kg) groups of the present composition: conventional feeding, composition intermediate solution gavage.Continuous administration for 8 weeks.

[0034] Detection indicators: The biological signal acquisition system observation system was used to measure the rat tail artery blood pressure before the experiment, 2 weeks later, 4 weeks later, 5 weeks later, and at the end of the experiment (6 weeks). The systolic blood pressure of the same rat was measured 3 times each time. The fluctuation of the value should not exceed 10 mmHg. The average value was taken and recorded.

[0035] 4. Experimental Results

[0036] The results showed that the systolic blood pressure of spontaneously hypertensive rats detected after one week of pre-feeding was significantly higher than that of the blank control group. Compared with the blank control group, the systolic blood pressure values ​​of the model control group rats increased significantly (P < 0.01). After 2 weeks of administration, compared with the model control group, the systolic blood pressure of the positive drug telmisartan group and the medium and high dose groups of the present composition significantly decreased (P < 0.01, P < 0.01). After four weeks of administration, the systolic blood pressure of the low dose group of the present composition also decreased significantly (P < 0.01). The results are shown in Table 1 and Table 2.

[0037] Table 1 Effects on blood pressure changes in hypertensive rats

[0038]

[0039]

[0040] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0041] Table 2 Effects on blood pressure changes in hypertensive rats

[0042]

[0043] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0044] Experimental Example 3 Effects of high-fat diet on systolic blood pressure in rats with hypertension

[0045] 1. Experimental Materials

[0046] Animals: 60 male Sprague-Dawley rats, SPF grade, weighing 180-220 g, were purchased from Nantong University.

[0047] Drug: Telmisartan, Jiangsu Yabang Epson Pharmaceutical Co., Ltd., batch number: 2302035. Reagents: Blood glucose test kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., size: 50 T / box; total cholesterol test kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., size: 50 T / box; total triglyceride test kit, Shenzhen Mindray Animal Healthcare Technology Co., Ltd., size: 50 T / box.

[0048] Instruments: electronic balance, Sartorius Scientific Instruments, model: BSA224S-CW; refrigerated centrifuge, CENTRFUGE5840, Eppendorf; microplate reader, American Bio-Volume Molecular, model: Flexstation 3; NIBP biological multi-channel non-invasive pressure measurement system, Edelweiss Instruments, model: MedLab U / 8C; small animal blood biochemical analyzer, Mindray, USA, model: BS-240VET.

[0049] 2. Dosage design

[0050] The daily dose of telmisartan for humans is 35 mg, and the clinical dose for adults (calculated based on 60 kg) is 0.58 mg / kg. The calculated equivalent dose for rats is 3.6 mg / kg.

[0051] The daily dose of the Chinese medicine composition is 57.83g of crude drug, and the clinical dose for an adult (60kg) is 0.96g / kg. The calculated rat equivalent dose is 5.98g / kg. Using this dose as the median dose, and using a 0.5:1:2 dose ratio, the low, medium, and high doses of the Chinese medicine composition are 2.99, 5.98, and 11.95g of crude drug / kg, respectively.

[0052] 3. Experimental Methods

[0053] 60 mice were randomly divided into 6 groups according to body weight, namely: blank control group, model control group, telmisartan group (positive drug, 3.6mg / kg), low (2.99g / kg), medium (5.98g / kg), and high dose (11.95g / kg) groups of the present invention's composition, with 10 mice in each group. Except the blank control group, all the other groups were fed a high-fat diet every day, in which the energy supply ratios of fat, sugar, and protein were 42.5%, 40.0%, and 17.5%, respectively. Starting from the 5th week, the blood pressure of rats was monitored by non-invasive tail artery blood pressure measurement every week. After the hypertensive rat model was successfully established, i.e., starting from the 9th week, the model group: high-fat diet, double distilled water (10ml / kg) gavage. Telmisartan group: high-fat diet, telmisartan (3.6mg / kg) suspension gavage, continuous administration for 4 weeks. The low-dose (2.99 g / kg), medium-dose (5.98 g / kg), and high-dose (11.95 g / kg) groups of the present invention's composition were fed a high-fat diet and gavaged with the intermediate solution of the composition. Administration was continued for four weeks. At week 13, the rats were sacrificed and plasma was collected. Test parameters included resting systolic blood pressure, and biochemical indicators of blood glucose, total cholesterol, and total triglycerides.

[0054] 4. Experimental Results

[0055] The results showed that after nine weeks of high-fat diet feeding, SD rats experienced a significant increase in blood pressure. Compared with the blank control group, the systolic blood pressure of the model control group was significantly increased (P < 0.01). Compared with the model control group, after one week of administration, the systolic blood pressure of the positive drug telmisartan group and the low, medium, and high dose groups of the present composition significantly decreased (P < 0.05), while the blood glucose and total cholesterol levels of the telmisartan group and the low, medium, and high dose groups of the present composition significantly increased (P < 0.05, P < 0.01). The results are shown in Tables 3-6.

[0056] Table 3 Effects on blood pressure of high-fat fed rats (weeks 5-7)

[0057]

[0058] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0059] Table 4 Effects on blood pressure of high-fat fed rats (weeks 8-10)

[0060]

[0061]

[0062] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0063] Table 5 Effects on blood pressure of high-fat fed rats (weeks 11-13)

[0064]

[0065] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0066] Table 6 Effects on blood glucose, total cholesterol and total triglycerides in rats fed with high fat diet (weeks 11-13)

[0067]

[0068] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0069] The composition of the present invention can significantly reduce the systolic blood pressure of spontaneously hypertensive rats and reduce the increase in blood pressure of rats caused by high-fat diet. In summary, the composition of the present invention has a positive therapeutic effect on hypertension.

[0070] 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 Chinese medicine composition in the preparation of a drug for hypertension, 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, 10-80 parts of anemarrhena, 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 further includes pharmaceutically acceptable excipients or additives.

8. The use according to claim 7, characterized in that The dosage form of the hypertension drug 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 medicines for treating hypertension include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, gels, sprays, and injections.

10. Use of a Chinese medicine composition in preparing a drug for treating hypercholesterolemia or hyperglycemia, 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.

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