Traditional Chinese medicine composition for treating hypertension as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating hypertension and a preparation method and application thereof. The traditional Chinese medicine composition takes uncaria rhynchophylla as a main medicine, pubescent holly root, selfheal, coptis chinensis, parasitic loranthus and eucommia ulmoides as auxiliary medicines, and kudzu vine root as a carrying medicine. One or more of rauvolfia verticillate, fiveleaf gynostemma herb, cassia twig and other medicines can be added in a targeted manner according to the diagnosis and examination results of individual cases. The traditional Chinese medicine composition has the effects of calming liver, calming endogenous wind, tonifying liver and kidney, clearing heat and activating blood, is used for treating liver-yang hyperactivity and liver-wind upward disturbance syndromes, and is suitable for patients with headache, dizziness, dysphoria, insomnia and dreaminess, red eyes, swelling pain, soreness and weakness of waist and knees, weakness of muscles and bones and hypertension in modern medicine. The traditional Chinese medicine composition can be used as or used for preparing medicines for treating hypertension (Zhuang medicine name: blood pressure throat).

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating hypertension, and a preparation method and application thereof. Background Art

[0002] Zhuang medicine theory believes that hypertension belongs to "blood pressure throat", and according to its pathological characteristics and clinical symptoms, hypertension is classified as "Dragon Road disease". The etiology and pathogenesis are mainly due to the obstruction of blood circulation due to the obstruction of Dragon Road, resulting in qi stagnation and blood stasis; the obstruction of Dragon Road network operation, the Dragon Vein is fumigated and burned, the rise and fall are abnormal, wind and fire are generated internally, and phlegm and blood stasis are blocked, which induces headaches, dizziness and other symptoms.

[0003] The prevention and treatment of hypertension in Zhuang medicine prioritizes "detoxification and tonifying deficiency", with "unblocking and calming chaos, and unblocking the dragon road" as the key points. Flexible detoxification is the main method of medication, and "Dragon Road medicine" is the first choice. Commonly used Zhuang medicines include Uncaria rhynchophylla, Ilex tomentosa, Viscum album, Eucommia ulmoides, Pueraria root, Rauwolfia paniculata, Gynostemma pentaphyllum, Cassia twig, Panax notoginseng, Millettia reticulata, Houttuynia cordata, Agrimoniae, Thunbergia fortunei, and Platycladus orientalis leaves. Their effects cover clearing heat and detoxifying, regulating qi and tonifying deficiency, astringing and stopping bleeding, and promoting blood circulation and tonifying blood.

[0004] At present, the treatment of hypertension is mainly oral antihypertensive drugs, but long-term use of drugs can cause some side effects in patients, such as diuretics can cause electrolyte disorders, angiotensin-converting enzyme inhibitors can cause irritating dry coughs, etc. There is currently no specific treatment for hypertension. The mainstream treatment drugs in Western medicine have different shortcomings and even produce side effects, causing more serious diseases. There are Chinese medicine prescriptions such as Zhengan Xifeng Decoction and Tianma Gou Teng Decoction for the treatment of hypertension, each with its own efficacy and shortcomings. However, there is currently no definite and effective prescription for the treatment of hypertension with Zhuang medicine.

[0005] Therefore, based on the theory of Zhuang medicine, providing a Zhuang medicine composition that can be used for the treatment of hypertension with clear effects and few adverse reactions is the current key research direction for those skilled in the art. Summary of the invention

[0006] In order to solve the above technical problems existing in the prior art, the present invention provides a Chinese medicine composition for treating hypertension and its preparation method and application. Specifically, it is achieved through the following technical solutions:

[0007] A traditional Chinese medicine composition for treating hypertension comprises the following raw materials: Uncaria rhynchophylla, Ilex pubescens, Prunella vulgaris, Coptis chinensis, Morus alba, Eucommia ulmoides and Pueraria root.

[0008] Further, the weight proportions of the raw materials are: 3-20 parts of Uncaria rhynchophylla, 9-30 parts of Ilex pubescens, 9-20 parts of Prunella vulgaris, 2-10 parts of Coptis chinensis, 6-30 parts of Loranthus parasiticus, 6-20 parts of Pueraria root, and 6-20 parts of Eucommia ulmoides. Preferably, the weight proportions of the raw materials are: 12 parts of Uncaria rhynchophylla, 20 parts of Ilex pubescens, 9 parts of Prunella vulgaris, 5 parts of Coptis chinensis, 10 parts of Loranthus parasiticus, 10 parts of Eucommia ulmoides, and 10 parts of Pueraria root.

[0009] Furthermore, personalized treatment can be carried out according to the diagnosis and examination results of individual cases, and other drugs can be selectively added to adjust the effect in a targeted manner. Other drugs that can be added include one or more of Rauwolfia, Gynostemma pentaphyllum, and Cassia twig.

[0010] Furthermore, the weight proportions of the raw materials are: 3-20 parts of Uncaria rhynchophylla, 9-30 parts of Ilex pubescens, 9-20 parts of Prunella vulgaris, 2-10 parts of Coptis chinensis, 6-30 parts of Morus alba, 6-20 parts of Eucommia ulmoides, 6-20 parts of Pueraria root, 10-30 parts of Rauwolfia lappa, 6-15 parts of Gynostemma pentaphyllum, and 3-15 parts of Cassia twig.

[0011] The Chinese medicine composition of the present application has the effects of calming the liver and calming the wind, nourishing the liver and kidney, clearing away heat and activating blood circulation. It is used for liver yang hyperactivity and liver wind disturbance syndrome. It is suitable for headache, dizziness, irritability, insomnia and dreaminess, red and swollen eyes, sore waist and knees, weak tendons and bones, and hypertension in modern medicine with the above symptoms. It can be used as or in the preparation of drugs for treating hypertension (Zhuang medical name: blood pressure throat).

[0012] The above-mentioned Zhuang medicine composition can be added with auxiliary materials to prepare granules. The prepared granules have 10g per bag, and each gram of granules contains about 2.5g of medicinal pieces.

[0013] The granules are prepared by the following method: (1) soaking the Chinese herbal medicine slices in water and then decocting them three times, adding 12 times of water for the first time and 10 times of water for the second and third times, each time for 1 hour, filtering and combining the filtrate; (2) concentrating the filtrate to a thick paste with a relative density of 1.25 to 1.30 (60° C.); (3) adding appropriate amounts of stevioside and dextrin, mixing, granulating and drying to obtain the granules.

[0014] The Chinese medicine composition can be used to prepare a decoction. Furthermore, the prepared decoction is obtained by decocting the Chinese medicine pieces with water.

[0015] The pharmaceutically acceptable excipients mentioned in the present invention include the excipients listed in the Handbook of Pharmaceutical Excipients (American Pharmaceutical Association, October 1986), the Handbook of Pharmaceutical Excipients (Original Fourth Edition) published by Chemical Industry Press, or the Complete Collection of Pharmaceutical Excipients (Sichuan Publishing Group, Sichuan Science and Technology Press, January 2006), but are not limited to these excipients.

[0016] This prescription is designed for treating hypertension in Zhuang medicine. It aims to calm the liver and calm the wind, nourish the liver and kidney, and clear away heat and activate blood circulation. Uncaria rhynchophylla is the main drug (similar to the monarch drug in traditional Chinese medicine); Coptis chinensis, Ilex pubescens, Prunella vulgaris, Eucommia ulmoides, and Morus alba are the auxiliary drugs (similar to the minister drugs in traditional Chinese medicine); and Pueraria root is the supporting drug (similar to the adjuvant and guiding drugs in traditional Chinese medicine, the same below).

[0017] The Uncaria rhynchophylla in the prescription is the dried hooked stems and branches of Uncaria rhynchophylla (Miq.) Miq.ex Havil. of the Rubiaceae family. It is sweet in taste and cool in nature. It enters the liver and pericardium meridians and has the effects of clearing away heat and calming the liver, calming wind and calming convulsions. It is mainly used to treat internal liver wind movement, epilepsy convulsions, high fever convulsions, headache and dizziness. Modern studies have shown that total alkaloids of Uncaria rhynchophylla can lower blood pressure by reducing peripheral resistance and cardiac output. It is suitable for hypertension caused by hyperactivity of liver yang and liver wind disturbance, so it is the main drug.

[0018] The holly in the prescription is the dried root of Ilexpubescens Hook.etArn. of the Aquifoliaceae family. It is bitter in taste and cold in nature. It enters the lung, liver, and large intestine meridians and has the effects of clearing away heat and detoxifying, promoting blood circulation and unblocking collaterals. Modern research has confirmed that holly has the effects of lowering blood pressure, resisting arrhythmia, increasing coronary flow, inhibiting platelet aggregation, and resisting thrombosis. It is used to treat chest pain, coronary artery sclerosis, acute myocardial infarction, hypertension, arrhythmia, hemiplegia caused by stroke, thromboangiitis obliterans, uveitis, central retinitis, and other diseases. The injection, capsule, and tablet made from the root extract of holly are often used in the treatment of cardiovascular and cerebrovascular diseases and various inflammations. It is a cardiovascular and cerebrovascular drug developed earlier in my country.

[0019] The herb Prunella vulgaris in the prescription is the dried fruit spike of the Lamiaceae plant Prunella vulgaris L. It is pungent and bitter in taste, cold in nature, and enters the liver and gallbladder meridians. It has the effects of clearing the liver and purging fire, improving eyesight, dispersing stagnation and reducing swelling. It is mainly used to treat headaches, dizziness, red and swollen eyes, and night pain in the eyes. Modern pharmacological studies have shown that herb Prunella vulgaris has the effect of lowering blood pressure, and is used in modern clinical practice to treat hypertension.

[0020] The coptis root in the prescription is the dried rhizome of the plant Coptis chinensis Franch. of the Ranunculaceae family. It is bitter in taste and cold in nature. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians and has the effects of clearing away heat and dampness, purging fire and detoxifying. It is used for hyperactivity of heart fire, restlessness and insomnia, damp-heat fullness, vomiting and acid regurgitation, high fever and coma, etc. Modern pharmacological studies have shown that coptis root has positive inotropic effects and negative frequency effects, and can lower blood pressure, resist arrhythmia, and resist myocardial ischemia, etc.

[0021] The mistletoe in the prescription is the dried leaves, stems and branches of Taxillus chinensis (DC.) Danser, a plant of the family Loranthaceae. It tastes bitter and sweet, is neutral in nature, and enters the liver and kidney meridians. It has the functions of removing rheumatism, nourishing the liver and kidney, strengthening the tendons and bones, and calming the fetus. It is used to treat dizziness, sore waist and knees, weak tendons and bones, hemiplegia, wind-cold-dampness arthralgia, etc. When used together with Ilex pubescens, Prunella vulgaris, Coptis chinensis, and Eucommia ulmoides, it can enhance the effects of clearing heat and cooling the liver, and nourishing the liver and kidney.

[0022] The eucommia in the prescription is the dried bark of Eucommia ulmoides Oliv., a plant of the Eucommia family. It is sweet and warm in nature. It enters the liver and kidney meridians and has the effects of nourishing the liver and kidney, strengthening the tendons and bones, and calming the fetus. It is used to treat liver and kidney deficiency, sore waist and knees, weak tendons and bones, dizziness, etc. Modern studies have shown that eucommia extracts and their decoctions have a lasting antihypertensive effect on animals.

[0023] The kudzu root in the prescription is the dried root of Pueraria lobata (Willd.) Ohwi, a plant of the leguminous family. It is sweet and spicy, cool in nature, and enters the spleen, stomach, and lung meridians. It has the effects of relieving muscle and fever, promoting the production of body fluid, and promoting blood circulation. Modern pharmacological studies have shown that kudzu root can dilate blood vessels, stabilize and lower blood pressure, and prevent atherosclerosis. Kudzu root can promote blood circulation, relieve spasms and relieve pain, and is the main drug in the prescription.

[0024] The above medicines are used together to calm the liver and calm the wind, nourish the liver and kidney, clear away heat and activate blood circulation. It is used to treat high blood pressure and throat caused by hyperactivity of liver yang and liver wind (Western medical name: hypertension). It is also suitable for hypertension in modern medicine if there are symptoms such as dizziness, headache, irritability, insomnia, red and painful eyes, sore waist and knees, and weak tendons and bones caused by liver and kidney deficiency and liver wind.

[0025] Compared with the prior art, the technical effects created by the present invention are embodied in:

[0026] The present invention has a scientific prescription and a reasonable ratio. In the prescription, Uncaria rhynchophylla is the main drug, Ilex pubescens, Herba Prunellae, Rhizoma Coptis, Herba Viscumae, Eucommia barbata are auxiliary drugs, and Radix Puerariae is a leading drug. The various medicinal flavors act synergistically to jointly play the role of treating dizziness, headache, irritability, insomnia and dreaminess, red and swollen eyes, soreness of waist and knees, weakness of tendons and bones caused by hypertension, and long-term use is safe. In the present invention, Uncaria rhynchophylla is sweet and cold and enters the liver, clears heat and calms the liver, relieves wind and relieves spasms, and calms the mind, and is the main drug. Ilex pubescens is bitter and cool in nature, clears heat and reduces fire, cools blood and detoxifies, so as to break its hyperyang, and also activates blood circulation and calms the mind; Herba Prunellae enters the liver meridian, clears the liver and reduces fire, so as to help level and reduce liver yang, and disperse depression; Rhizoma Coptis chinensis enters the heart, liver, and gallbladder meridians, is bitter in taste, cold in nature, clears heat and dries dampness, and purges fire and detoxifies. The three help the main drug to clear heat, cool the liver and relieve wind; Eucommia barbata and Herba Viscumae tonify the liver and kidney, strengthen tendons and bones to treat the root cause, and are auxiliary drugs. Pueraria root is sweet, spicy and cool, relieves muscles and reduces fever, and nourishes the liver by promoting the production of body fluids. It is a drug for nourishing the liver. The combination of various drugs can be used to treat toxicity and deficiency, with the liver as the main treatment. The heart, liver and kidney are treated together, with the liver as the main treatment. Together, they can calm the liver and calm the wind, clear away heat and activate blood circulation, and nourish the liver and kidney. DETAILED DESCRIPTION

[0027] The technical solution of the present invention is further defined below in conjunction with specific implementation methods, but the scope of protection required is not limited to the description.

[0028] Example 1

[0029] (1) Weigh 12 kg of Uncaria rhynchophylla, 20 kg of Ilex pubescens, 9 kg of Prunella vulgaris, 5 kg of Coptis chinensis, 10 kg of Morus alba, 10 kg of Pueraria root, and 10 kg of Eucommia ulmoides, soak in water, and then decoct three times, adding 12 times of water for the first time, and 10 times of water for the second and third times, each time for 1 hour, filter, and combine the filtrate;

[0030] (2) The filtrate is concentrated to a thick paste with a relative density of 1.25 to 1.30 (60°C);

[0031] (3) Add appropriate amount of stevioside and dextrin, mix well, granulate and dry to obtain the prepared granules, each gram of granules contains about 2.5 g of the medicinal material.

[0032] Example 2

[0033] (1) Weigh 3 kg of Uncaria rhynchophylla, 30 kg of Ilex pubescens, 20 kg of Prunella vulgaris, 10 kg of Coptis chinensis, 30 kg of Morus alba, 20 kg of Pueraria root, and 20 kg of Eucommia ulmoides, soak in water, and then decoct three times, adding 12 times of water for the first time, and 10 times of water for the second and third times, each time for 1 hour, filter, and combine the filtrate;

[0034] (2) The filtrate is concentrated to a thick paste with a relative density of 1.25 to 1.30 (60°C);

[0035] (3) Add appropriate amount of stevioside and dextrin, mix well, granulate and dry to obtain the prepared granules, each gram of granules contains about 2.5 g of the medicinal material.

[0036] Example 3

[0037] (1) Weigh 20 kg of Uncaria rhynchophylla, 9 kg of Ilex pubescens, 9 kg of Prunella vulgaris, 2 kg of Coptis chinensis, 6 kg of Morus alba, 6 kg of Pueraria root, and 6 kg of Eucommia ulmoides, soak them in water and then boil them three times, adding 12 times of water for the first time and 10 times of water for the second and third times, each time for 1 hour, filter, and combine the filtrate;

[0038] (2) The filtrate is concentrated to a thick paste with a relative density of 1.25 to 1.30 (60°C);

[0039] (3) Add appropriate amount of stevioside and dextrin, mix well, granulate and dry to obtain the prepared granules, each gram of granules contains about 2.5 g of the medicinal material.

[0040] Example 4

[0041] Weigh 12g of Uncaria rhynchophylla, 20g of Ilex pubescens, 9g of Prunella vulgaris, 5g of Coptis chinensis, 10g of Morus alba, 10g of Puerariae lobata, and 10g of Eucommia ulmoides, place them in a casserole, add water to cover the surface of the medicine by 2-3 cm, soak for 20-30 minutes, boil over high heat, then boil over low heat for 10-15 minutes, filter out the first liquid, then add appropriate amount of water, boil again according to the above method, filter out the second liquid. Combine the two decoctions to about 300 ml.

[0042] Example 5

[0043] Weigh 12g of Uncaria rhynchophylla, 20g of Ilex pubescens, 9g of Prunella vulgaris, 5g of Coptis chinensis, 10g of Morus alba, 10g of Pueraria root, 10g of Eucommia ulmoides, and 20g of Rauwolfia oleifera, place them in a casserole, add water to cover the surface of the medicine by 2-3 cm, soak for 20-30 minutes, boil over high heat, then boil over low heat for 10-15 minutes, filter out the first liquid, then add appropriate amount of water, boil again according to the above method, filter out the second liquid. Combine the two liquids to about 300 ml.

[0044] Example 6

[0045] Weigh 12g of Uncaria rhynchophylla, 20g of Ilex pubescens, 9g of Prunella vulgaris, 5g of Coptis chinensis, 10g of Morus alba, 10g of Pueraria root, 10g of Eucommia barbata, 20g of Rauwolfia truncatum, 10g of Gynostemma pentaphyllum, and 9g of Cinnamomum cassia, put them in a casserole, add water to cover the surface of the medicine by 2-3 cm, soak for 20-30 minutes, boil over high heat, then boil over low heat for 10-15 minutes, filter out the first liquid, then add appropriate amount of water, boil again according to the above method, filter out the second liquid. Combine the two liquids to about 300 ml.

[0046] Pharmacodynamics experiment of the Chinese medicine composition of the present application

[0047] 1. Purpose of the test

[0048] According to the functional characteristics and therapeutic scope of the Chinese medicine composition granules of the present application, and combined with the characteristics of hypertension, experimental research was conducted from the two aspects of lowering blood pressure and promoting blood circulation and removing blood stasis, so as to provide pharmacodynamic experimental data support for its clinical application.

[0049] II. Experimental Animals and Test Drugs

[0050] 1. Experimental animals

[0051] SPF WKY rats, body weight 180-250g, male; SPF spontaneously hypertensive (SHR) rats, body weight 180-220g, male; both were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., animal license number is SCXK (Beijing) 2021-0006. Breeding conditions: room temperature 24-26℃, humidity 60%; animal use license number is SYXK Gui 2022-000.

[0052] (II) Main experimental instruments and reagents

[0053] 1. Instruments: CODA small animal blood pressure assessment system, Kent Company, USA; Multiskan microplate reader, Thermo Company; BCE224i-1CCN analytical balance, Beijing Sartorius Scientific Instrument Co., Ltd.; TDL-5-A high-speed centrifuge, Shanghai Anting Scientific Instrument Factory; constant temperature water bath, Shanghai Senxin Experimental Instrument Co., Ltd.

[0054] 2. Reagents: serum aldosterone (ALD), angiotensin I (Ang I), angiotensin II (Ang II), angiotensin converting enzyme (ACE), renin activity (PRA) kits, norepinephrine (NE), epinephrine (AD) and nitric oxide (NO) ELISA kits, all provided by Shanghai Fanke Industrial Co., Ltd.

[0055] (III) Test drugs and groups

[0056] 1. Drug under test

[0057] Sangshun Decoction Granules (i.e., the Chinese medicine composition granules of the present application, with the same formulation ratio as in Example 1) are provided by Guangxi International Zhuang Medicine Hospital. Its clinical usage and dosage is oral, 1 bag at a time, 3 times a day; the specification is 10g of granules per bag (each gram of granules contains 2.5g of decoction pieces); the finished product is packaged in aluminum-plastic composite film bags and stored at room temperature and dry conditions. During the test, distilled water is used to prepare the required dosing concentration. Positive control drug: Captopril tablets, specification is 12.5mg / tablet, produced by Shanghai Sanofi Pharmaceuticals Co., Ltd.; Compound Danshen tablets, specification is 0.32g / tablet (equivalent to 0.6g of decoction pieces), produced by Guangzhou Baiyunshan Hutchison Whampoa Chinese Medicine Co., Ltd.

[0058] 3. Experimental Methods

[0059] The Chinese medicine composition of the present application is derived from a clinical experience prescription, has the effects of calming the liver and calming wind, nourishing the liver and kidney, and clearing away heat and activating blood circulation, and is used for liver yang hyperactivity, liver wind disturbance syndrome, headache, dizziness, irritability, insomnia, red and swollen eyes, sore waist and knees, weak tendons and bones, and hypertension in modern medicine. According to the functional characteristics and main treatment range of the drug, experimental research on its ability to lower blood pressure and activate blood circulation and remove blood stasis is carried out.

[0060] (I) Dose setting

[0061] Three dose groups were set for each test drug, and the drug dose was expressed in g / kg (amount of decoction pieces / animal body weight). According to the "Methodology of Pharmacological Research of Traditional Chinese Medicine", the dose conversion is calculated based on the body surface area ratio. Based on the adult clinical decoction piece amount of 76g / day, the equivalent dose for rats (200g) and adults is 7.0g / kg. Among them, the small dose is set as 1 / 2 times the equivalent dose, the medium dose is the equivalent dose, and the large dose is 2 times the equivalent dose. The dose of the positive control drug is calculated based on the body surface area ratio to be equivalent to the adult dose.

[0062] (II) Dosage method and frequency

[0063] Each experiment was conducted by intragastric administration, with the dosage of 10 ml / kg for rats, once a day for 4 weeks.

[0064] 3. Statistical methods

[0065] All data were expressed as x±s, and the t-test was performed between groups using SPSS13.0 statistical software, and variance analysis was performed to compare the differences between groups. P<0.05 was considered statistically significant.

[0066] (IV) Main steps

[0067] 1. Effect of the Chinese medicine composition granules of the present application on the renin-angiotensin-aldosterone system of SHR rats

[0068] Fifty 13-week-old male SHR rats were selected and randomly divided into 5 groups after adaptive feeding for 1 week: model group, captopril group and high, medium and low dose (14.0, 7.0, 3.5 g / kg) groups of the Chinese medicine composition granules of the present application, 10 rats in each group; 10 WKY rats were used as the normal control group. Each group of rats was given the corresponding drug by gavage at 10 ml / kg body weight, and the normal control group and the model group were given the corresponding volume of distilled water once a day for 4 consecutive weeks. The tail artery blood pressure of the rats was measured by a small animal blood pressure assessment system before gavage and 4 weeks after administration. The rats were required to be awake during the measurement, and the measurement was repeated 3 times each time, and the average value was taken. 1h after the last administration, the rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital, and blood was collected from the abdominal aorta and placed in a serum tube for standby use. The ELISA method was used to detect the serum PRA, ALD, AngⅠ, AngⅡ, and ACE levels.

[0069] The results are shown in Table 1. Before administration, compared with the normal control group, the blood pressure of rats in the model group, captopril group and the high, medium and low dose groups of the Chinese medicine composition granules of the present application was higher. After 4 weeks of administration, compared with the normal control group, the blood pressure of rats in the model group was still higher, and the difference was statistically significant (P < 0.01), indicating that SHR rats have been in a relatively stable state of hypertension. After 4 weeks of administration, compared with the model group, the blood pressure levels of rats in the captopril group and the high and medium dose groups of the Chinese medicine composition granules of the present application were significantly reduced, and the difference was statistically significant (P < 0.05, P < 0.01). The results show that the Chinese medicine composition granules of the present application have a therapeutic effect on hypertension.

[0070] The results are shown in Table 2. Compared with the normal control group, the serum PRA, ALD, AngⅠ, and AngⅡ levels of the model group rats increased, and the ACE level decreased, and the difference was statistically significant (P < 0.01), indicating that the renin-angiotensin-aldosterone system of SHR rats was damaged. Compared with the model group, the serum PRA, ALD, AngⅠ, and AngⅡ levels of the captopril group and the high and medium dose groups of the Chinese medicine composition granules of the present application were reduced, and the difference was statistically significant (P < 0.05, P < 0.01), indicating that the Chinese medicine composition granules of the present application can protect the damaged renin-angiotensin-aldosterone system of SHR rats.

[0071] Table 1 Effect of the Chinese medicine composition granules of the present application on rat tail artery blood pressure (mmHg)

[0072]

[0073] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0074] Table 2 Effects of the Chinese medicine composition granules of the present application on the levels of PRA, ALD, AngⅠ, AngⅡ, and ACE (ng / L) in rat serum

[0075]

[0076] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0077] 2. Effect of the Chinese medicine composition granules of the present application on hypertensive rats with liver yang hyperactivity

[0078] Fifty 13-week-old male SHR rats were selected and randomly divided into 5 groups after adaptive feeding for 1 week: model group, captopril group, high, medium and low dose (14.0, 7.0, 3.5g / kg) group of the Chinese medicine composition granules of the present application, 10 rats in each group; 10 WKY rats were used as the normal control group. 50 SHR rats were used to replicate the liver yang hyperactivity hypertension model, and the liver yang hyperactivity hypertension model was replicated by the method of SHR plus oral administration of Chinese medicine aconite decoction. Each group of rats was given the corresponding drug by gavage at 10ml / kg body weight, and the normal control group and model group were given the corresponding volume of distilled water once a day for 4 consecutive weeks. The rat tail artery blood pressure was measured by a small animal blood pressure assessment system before gavage and 4 weeks later. The rats were required to be in a conscious state during the measurement, and the measurement was repeated 3 times each time, and the average value was taken. 1h after the last administration, the rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital, and the rat abdominal aorta blood was drawn and placed in a serum tube for standby use. The levels of serum NE, AD and NO were detected by ELISA.

[0079] The results are shown in Table 3. Before administration, compared with the normal control group, the blood pressure of rats in the model group, captopril group and the high, medium and low dose groups of the Chinese medicine composition granules of the present application was higher. After 4 weeks of administration, compared with the normal control group, the blood pressure of rats in the model group was still higher, and the difference was statistically significant (P < 0.01), indicating that the hypertensive rats with liver yang hyperactivity have been in a relatively stable state of hypertension. Compared with the model group, the blood pressure levels of rats in the captopril group and the high and medium dose groups of the Chinese medicine composition granules of the present application were significantly reduced after 4 weeks of administration, and the difference was statistically significant (P < 0.05, P < 0.01). The results show that the Chinese medicine composition granules of the present application have a therapeutic effect on hypertension of liver yang hyperactivity type.

[0080] The results are shown in Table 4. Compared with the normal control group, the serum NE, AD and NO levels of the rats in the model group were increased, and the difference was statistically significant (P < 0.01), indicating that the soft tissue and blood vessels of the hypertensive rats with liver yang hyperactivity had spasms and insufficient blood supply to the blood vessels; compared with the model group, the serum NE, AD and NO levels of the rats in the captopril group and the high and medium dose groups of the Chinese medicine composition granules were decreased, and the difference was statistically significant (P < 0.05, P < 0.01), indicating that the Chinese medicine composition granules have a therapeutic effect on cervical vertigo caused by hypertension with liver yang hyperactivity, and can improve soft tissue spasm and inflammatory reaction, improve vascular spasm and increase blood supply.

[0081] Table 3 Effect of the Chinese medicine composition granules of the present application on rat tail artery blood pressure (mmHg)

[0082]

[0083]

[0084] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0085] Table 4 Effects of the Chinese medicine composition granules of the present application on NE, AD and NO in rat serum

[0086]

[0087] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0088] 3. Effect of the Chinese medicine composition granules of the present application on blood rheology indexes in rats with acute blood stasis syndrome

[0089] 60 WKY rats weighing 200-250g were randomly divided into normal control group, model group, compound Danshen tablet group and high, medium and low (14.0, 7.0, 3.5g / kg) dose groups of the Chinese medicine composition granules of the present application. The rats were given oral administration once a day, and the normal control group and the model group were given equal volume of distilled water for 28 consecutive days. In the fourth week, except for the normal control group, the animals in the other groups were subcutaneously injected with 0.1% epinephrine 0.08ml / 100g body weight, for a total of 2 injections, once every 4 hours. Two hours after the first injection, the rats were placed in ice water and soaked for 5min, then fasted, and blood was taken from the abdominal aorta the next day, anticoagulated with heparin, and the rats were measured for whole blood viscosity, plasma viscosity, red blood cell index, hematocrit, red blood cell electrophoresis time and other indicators on the fully automatic blood rheology analysis.

[0090] The results are shown in Tables 5 to 6. Compared with the normal control group, the whole blood viscosity, plasma viscosity, red blood cell index, hematocrit, red blood cell electrophoresis time and other indicators of the model group rats increased, and the difference was statistically significant (P < 0.05, P < 0.01), indicating that the acute blood stasis rat model was successfully prepared. Compared with the model group, the high, medium and low dose groups of the Chinese medicine composition granules of the present application can reduce the high, medium and low shear whole blood viscosity, plasma viscosity, red blood cell index, hematocrit, red blood cell electrophoresis time and other indicators of the acute blood stasis rats, and the difference was statistically significant (P < 0.05, P < 0.01), indicating that the Chinese medicine composition granules of the present application have the effect of promoting blood circulation and removing blood stasis.

[0091] Table 5 Effect of the Chinese medicine composition granules of the present application on the blood rheology indexes of rats with acute blood stasis syndrome

[0092]

[0093]

[0094] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0095] Table 6 Effect of the Chinese medicine composition granules of the present application on the blood rheology indexes of rats with acute blood stasis syndrome

[0096]

[0097] Note: The dosage of each dosage group of the Chinese medicine composition granules in this application is calculated based on the amount of decoction pieces. Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0098] IV. Conclusion

[0099] The Chinese medicine composition of the present application has the pharmacological effects of lowering blood pressure and promoting blood circulation and removing blood stasis, and has an obvious therapeutic effect on hypertension caused by hyperactivity of liver yang and liver wind disturbance.

[0100] Typical clinical cases

[0101] Case 1. Lu, female, 53 years old, consultation date July 4, 2022.

[0102] Current medical history: The patient was admitted to the hospital because of "high blood pressure for 2 months". The patient measured blood pressure at home 2 months ago and it was 189 / 112mmHg. He usually had headaches, no dizziness, blurred vision, tinnitus, spinning vision, limb numbness and other symptoms. Subsequently, blood pressure was monitored irregularly, and systolic blood pressure fluctuated around 170mmHg. No special treatment was given. 2 days before admission, blood pressure was measured at a local community hospital and reached 210 / 120mmHg. He had poor sleep for a long time.

[0103] Examination: pulse 83 beats / min, blood pressure 175 / 111 mmHg, coarse breath sounds in both lungs, no dry or wet rales, no enlargement of the heart border, regular heart rhythm, no pathological murmurs in the auscultation area of ​​each valve. Abdominal examination showed no abnormality. No edema in both lower limbs.

[0104] Diagnosis: Hypertension stage 3, extremely high risk.

[0105] Treatment: The Chinese medicine decoction prepared in Example 4 of the present invention is used. Oral administration, once in the morning and once in the evening, after meals, 150 ml each time. 2 weeks is one course of treatment.

[0106] Efficacy: After taking amlodipine besylate tablets, metoprolol succinate sustained-release tablets, and irbesartan tablets to control blood pressure, the patient's blood pressure still fluctuated around 160 / 100 mmHg. After taking 3 doses of the medicine after admission, the patient reported improved sleep and blood pressure was controlled at around 140 / 90 mmHg. Seven doses were given when he was discharged from the hospital. After taking the medicine, he went to the outpatient clinic again to get medicine. The blood pressure measured in the outpatient clinic was 134 / 82 mmHg, and the blood pressure measured at home fluctuated between 110-140 / 70-90 mmHg, and symptoms such as headaches improved. Blood pressure was well controlled during follow-up.

[0107] Case 2. Chen, female, 73 years old, consultation date March 10, 2023.

[0108] Current medical history: The patient was admitted to the hospital because of "high blood pressure for more than 20 years". The patient complained that he had high blood pressure during a physical examination at work for more than 20 years. At that time, the blood pressure was 180 / 110 mmHg. He would feel dizzy after working hard. He went to the local hospital for treatment and was diagnosed with grade 3 hypertension. He was given 5 mg of amlodipine besylate tablets to control blood pressure. The blood pressure was poorly controlled and was controlled at 140-160 / 90-100 mmHg.

[0109] Examination: pulse 83 beats / min, blood pressure 142 / 91 mmHg, coarse breath sounds in both lungs, no dry or wet rales, no enlargement of the heart border, regular heart rhythm, no pathological murmurs in the auscultation area of ​​each valve. Abdominal examination showed no abnormality. No edema in both lower limbs.

[0110] Diagnosis: Hypertension level 3, very high risk

[0111] Treatment: The Chinese medicine decoction prepared by Example 4 of the present invention is taken orally, once in the morning and once in the evening after meals, 150 ml each time.

[0112] Efficacy: The patient's dizziness and other symptoms were significantly improved before discharge, and no recurrence of the above symptoms was reported in the follow-up call. After discharge, blood pressure was controlled at 110-140 / 60-90 mmHg.

[0113] Case 3. Zhou, male, 39 years old, consultation date: April 6, 2023.

[0114] Current medical history: The patient was admitted to the hospital due to "repeated chest tightness and pain for 10 days and elevated blood pressure for 1 day". The patient had chest tightness and chest pain without obvious cause 10 days ago, mainly in the precordial area, paroxysmal, lasting for several minutes each time, which could be relieved by itself. No special treatment was given during this period. When he visited our outpatient clinic, his blood pressure was measured at BP198 / 129mmHg and HR66 times / min.

[0115] Examination: Pulse 71 beats / min, blood pressure 209 / 130 mmHg, soft neck, no jugular vein distention, normal carotid artery pulse. Clear breath sounds in both lungs, no dry or wet rales. No bulge in the precordial area, normal heart sounds, no murmurs in the auscultation area of ​​each valve, no pericardial friction sound. Soft abdominal wall, no tenderness or rebound pain.

[0116] Diagnosis: Hypertension stage 3

[0117] Treatment: The Chinese medicine decoction prepared by Example 4 of the present invention is taken orally, once in the morning and once in the evening after meals, 150 ml each time.

[0118] Efficacy: After taking 3 doses of the medicine after admission, symptoms such as chest tightness and chest pain improved compared with before, and blood pressure improved compared with before. The original treatment plan was continued for 4 doses, and the above symptoms improved significantly. The patient was given 7 doses after discharge. Later follow-up reported that symptoms such as chest tightness and chest pain had disappeared. Later telephone follow-up showed that the blood pressure is currently below 140 / 90 mmHg.

[0119] Case 4. Yin, male, 57 years old, consultation date March 14, 2023.

[0120] Current medical history: The patient was admitted to the hospital due to "high blood pressure for 4 years, headache and tinnitus for 2 weeks". The patient reported that a physical examination 4 years ago found that the blood pressure was high, up to 190 / 95mmHg, and there was no dizziness, headache, palpitation, chest tightness and other discomforts at that time. He went to the First Affiliated Hospital of Guangxi Medical University for treatment. After taking antihypertensive drugs (specific details are unknown), the blood pressure can be reduced to normal, and then the antihypertensive drugs were stopped by himself. Tinnitus appeared without obvious cause 2 weeks ago, which was more obvious at night, and the head pain was paroxysmal, mainly in the temporal and occipital regions on both sides. Blood pressure monitoring found that the blood pressure was elevated to 180 / 90mmHg.

[0121] Examination: Pulse 54 beats / min, blood pressure 181 / 96 mmHg, soft neck, no jugular vein distention, normal carotid artery pulse. Coarse breath sounds in both lungs, no dry or wet rales. No bulge in the precordial area, normal heart sounds, no murmurs in the auscultation area of ​​each valve, no pericardial friction sound. The abdominal wall is soft, without tenderness or rebound pain.

[0122] Diagnosis: Hypertension level 3, very high risk

[0123] Treatment: The Chinese medicine decoction prepared by Example 4 of the present invention is taken orally, once in the morning and once in the evening after meals, 150 ml each time.

[0124] Efficacy: After taking 3 doses of the medicine after admission, symptoms such as headache and tinnitus improved compared with before, and blood pressure improved compared with before. The original treatment plan was continued for 3 doses, and the above symptoms improved significantly. Follow-up after discharge reported that headache and tinnitus had not recurred, and blood pressure could be controlled at around 130 / 70 mmHg.

[0125] Finally, it should be pointed out that the above embodiments are only representative examples of the present invention. Obviously, the technical solution of the present invention is not limited to the above embodiments, and there are many variations. All variations that can be directly derived or associated with the content disclosed by ordinary technicians in this field should be considered as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating hypertension, characterized in that: The invention comprises the following raw materials: Uncaria rhynchophylla, Ilex pubescens, Herba Prunellae, Rhizoma Coptidis, Herba Viscume, Eucommia ulmoides and Radix Puerariae.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight proportions of the raw materials are as follows: 3-20 parts of Uncaria rhynchophylla, 9-30 parts of Ilex pubescens, 9-20 parts of Prunella vulgaris, 2-10 parts of Coptis chinensis, 6-30 parts of Morus alba, 6-20 parts of Eucommia ulmoides, and 6-20 parts of Pueraria root.

3. The Chinese medicine composition according to claim 1, characterized in that The weight proportions of the raw materials are as follows: 12 parts of Uncaria rhynchophylla, 20 parts of Ilex pubescens, 9 parts of Prunella vulgaris, 5 parts of Coptis chinensis, 10 parts of Morus alba, 10 parts of Eucommia ulmoides, and 10 parts of Pueraria root.

4. The Chinese medicine composition according to claim 1, characterized in that: It also includes one or more of Rauwolfia ovata, Gynostemma pentaphyllum, and Cassia twig.

5. The Chinese medicine composition according to claim 4, characterized in that: The weight proportions of the raw materials are as follows: 3-20 parts of Uncaria rhynchophylla, 9-30 parts of Ilex pubescens, 9-20 parts of Prunella vulgaris, 2-10 parts of Coptis chinensis, 6-30 parts of Morus alba, 6-20 parts of Eucommia ulmoides, 6-20 parts of Pueraria root, 10-30 parts of Rauwolfia lappa, 6-15 parts of Gynostemma pentaphyllum, and 3-15 parts of Cassia twig.

6. Use of the Chinese medicine composition according to claim 1 as or in the preparation of a drug for treating hypertension.

7. Granules prepared using the Chinese medicine composition according to claim 1.

8. A decoction prepared using the Chinese medicine composition according to claim 1.

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