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

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating hypertension and a preparation method and application thereof. The composition is prepared from the following raw material medicines in parts by weight: 10 to 15 parts of radix scrophulariae, 5 to 10 parts of herba epimedii, 5 to 10 parts of wine-prepared fructus corni, 5 to 10 parts of radix cyathulae and 10 to 15 parts of uncaria. According to the traditional Chinese medicine composition provided by the invention, the five raw material medicines are compatible, the whole formula is simple and special in effect, and the traditional Chinese medicine composition can nourish kidney yin, replenish essence and fill marrow to strengthen kidney water, warm kidney and strengthen yang to nourish life fire, and jointly play the roles of tonifying yin and yang and nourishing yin and yang, so that yin and yang in the kidney can be recovered, and qi and blood circulation is ordered; the invention provides the clinical curative effect of the traditional Chinese medicine composition on treating hypertension yin-yang deficiency syndrome, the result proves that the traditional Chinese medicine composition has obvious clinical curative effect on hypertension with yin-yang deficiency syndrome, yin not containing yang and yin deficiency syndrome, has the characteristics of few medicines, low cost and high effect compared with similar medicines, and has the advantages of simple preparation method, strong controllability and wide popularization prospect.

Description

Technical Field

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

[0002] Essential hypertension, namely hypertensive disease, is a chronic disease with elevated arterial pressure caused by vascular neuroregulation disorders. Its greatest harm lies in causing long-term excessive pressure on blood vessels throughout the body, resulting in brittle damage to blood vessels, and ultimately leading to blood vessel rupture and blockage. The persistence of hypertensive disease can cause damage to target organs such as the heart, brain, kidneys, and retina, such as various cardiovascular and cerebrovascular diseases, kidney diseases, fundus diseases, and nervous system diseases. "Report on Cardiovascular Health and Diseases in China 2019" shows that the number of hypertensive patients in China has reached 245 million. The prevalence rate of hypertensive disease is 27.9% (weighted rate is 23.2%), the awareness rate is 51.6%, the treatment rate is 45.8%, and the control rate is 16.8%. Moreover, there is a trend of increasing prevalence year by year and gradually younger onset age. The treatment of hypertensive disease with antihypertensive western medicine has certain limitations and obvious side effects. Compared with western medicine, traditional Chinese medicine not only has a better therapeutic effect, can comprehensively regulate the body at multiple levels, multiple links, and multiple targets, but also can significantly improve the discomfort symptoms of patients, improve the quality of life, and has good compliance, and has become the main means for treating hypertensive disease.

[0003] Throughout the literature of traditional Chinese medicine, there is a lack of special discussions on hypertensive disease, and the name of hypertensive disease has never been mentioned. However, this disease has long been recognized. According to its main clinical manifestations and the situation of disease evolution, from the perspective of the distribution of diseases, it can be classified into the categories of "vertigo", "headache", "head wind" and other diseases in traditional Chinese medicine. Among them, the description and theoretical analysis of "vertigo" are closest to modern medical hypertensive disease. It is mostly caused by factors such as emotional discomfort, improper diet, kidney deficiency due to advanced age, and physical weakness after illness. The pathological nature is mostly deficiency in origin and excess in superficiality, with liver and kidney yin deficiency as the root, and hyperactivity of wind-yang, qi and blood disorder, and phlegm turbidity accumulation as the superficiality. The treatment should nourish the kidney yin and warm the kidney yang.

[0004] There are few reports on pure traditional Chinese medicine preparations for treating the syndrome of deficiency of both kidney yin and yang, yin failing to nourish yang, and partial yin deficiency in hypertensive nephropathy. Currently, although western medicine antihypertensive drugs with clear pharmacological effects and evidence-based medicine evidence can achieve satisfactory antihypertensive effects, due to their relatively single treatment methods, mostly symptomatic treatments, with an emphasis on the pursuit of antihypertensive effects and neglect of the overall condition of the body and the unique clinical characteristics of hypertension, almost all antihypertensive drugs will cause varying degrees of damage to the body (especially the elderly). For example, diuretics can have adverse effects on blood lipids, blood sugar, and blood potassium; β-blockers affect their antihypertensive efficacy due to the low renin activity in the elderly and have adverse effects on the respiratory, cardiac functions, and blood lipids of the elderly; the disadvantage of calcium channel blockers is that blood pressure is not stable enough and the long-term efficacy is not yet definite, etc., and they are not suitable for long-term use in the elderly. In addition, since the manifestation of symptoms reflects the essence of the imbalance between blood supply and demand in important organs in hypertension, in a sense, the improvement of symptoms is more practically significant than simply lowering blood pressure. However, western medicine antihypertensive drugs are often ineffective in improving clinical symptoms, and the discomfort symptoms caused by their side effects can further reduce the quality of life of patients and even interrupt treatment. Traditional Chinese medicine, starting from the overall concept and syndrome differentiation and treatment, not only emphasizes the heterogeneity and individualized treatment of hypertensive patients but also gives play to the comprehensive regulation of traditional Chinese medicine through multiple levels, multiple links, and multiple targets, enabling hypertensive patients to obtain greater benefits in terms of improving symptoms, enhancing the quality of life, alleviating or reversing end-stage organ damage, and preventing the occurrence of serious complications. Summary of the Invention

[0005] Aiming at the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating hypertension; this traditional Chinese medicine composition is for treating the syndrome of deficiency of both kidney yin and yang in hypertension. Through the compatibility of 5 raw medicinal materials, the whole prescription is simple and powerful. It can not only nourish kidney yin, supplement essence and marrow to strengthen kidney water but also warm the kidney and assist yang to nourish the life gate fire, jointly achieving the effects of tonifying both yin and yang, nourishing yin and cultivating yang. In this way, the yin and yang in the kidney can return to normal and qi and blood can circulate in an orderly manner.

[0006] The present invention further provides a preparation method of the above-mentioned traditional Chinese medicine composition.

[0007] Another object of the present invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for treating the syndrome of deficiency of both kidney yin and yang in hypertension.

[0008] The technical solution adopted by the present invention to achieve the above object is as follows: The present invention provides a traditional Chinese medicine composition for treating hypertension, which is composed of the following raw medicinal materials in parts by weight: 10 - 15 parts of Scrophulariae Radix, 5 - 10 parts of Epimedii Folium, 5 - 10 parts of Corni Fructus, 5 - 10 parts of Cyathulae Radix, and 10 - 15 parts of Uncariae Ramulus cum Uncis.

[0009] Most preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Scrophulariae Radix, 8 parts of Epimedii Folium, 8 parts of Corni Fructus, 8 parts of Cyathulae Radix, and 12 parts of Uncariae Ramulus cum Uncis.

[0010] The present invention also provides a preparation method of the above traditional Chinese medicine composition, comprising the following steps: (1) Take Scrophulariae Radix, Epimedii Folium, Corni Fructus, Cyathulae Radix, and Uncariae Ramulus cum Uncis and mix them. Decoct the mixed raw materials twice with water, filter, and combine the filtrates; (2) Concentrate the filtrate under reduced pressure, filter, add water and stir evenly, filter, sterilize, and fill into containers to obtain the product.

[0011] Preferably, in step (1), the specific process of decocting twice is as follows: For the first time, add 12 times the amount of water of the mixed raw materials and decoct for 1.5 hours; for the second time, add 8 times the amount of water of the mixed raw materials and decoct for 1.5 hours.

[0012] Preferably, in step (2), the conditions for reduced pressure concentration are: 65 - 70 °C, -0.06 - -0.08 MPa; the filtrate is concentrated under reduced pressure to a relative density of 1.05 - 1.10 at 60 °C.

[0013] The present invention also provides the application of the above traditional Chinese medicine composition in the preparation of a drug for treating the syndrome of deficiency of both yin and yang in hypertension.

[0014] Under the guidance of the theory of compatibility of traditional Chinese medicine, in combination with the basic pathogenesis and pathological characteristics of the syndrome of deficiency of both yin and yang, yin failing to nourish yang, and partial yin deficiency syndrome in hypertension, a traditional Chinese medicine compound of Scrophulariae Radix, Epimedii Folium, Corni Fructus, Cyathulae Radix, and Uncariae Ramulus cum Uncis for treating the syndrome of deficiency of both yin and yang in hypertension is screened out, which has the effects of tonifying both yin and yang, nourishing yin and cultivating yang. Modern pharmacological research also shows that the composition provided by the present invention can reduce blood pressure, improve the vasodilatory function of blood vessels and other pharmacological effects. The present invention optimizes the extraction process and prepares an effective traditional Chinese medicine preparation for treating the syndrome of deficiency of both yin and yang in hypertension according to the principle of "design based on the mechanism of action of hypertension and comprehensive multi-target intervention". Compared with chemical drugs, it has multiple curative effects such as reducing blood pressure, inhibiting the thickening of blood vessel walls, inhibiting the activation of RAAS and the sympathetic nervous system, and improving the vasodilatory function of blood vessels, can better improve the discomfort symptoms of patients, improve the quality of life, and has good compliance.

[0015] The beneficial effects of the present invention are as follows: (1) The traditional Chinese medicine composition provided by the present invention is formulated with 5 raw materials, with a simple formula and strong efficacy. It can not only nourish kidney yin, replenish essence and marrow to strengthen kidney water, but also warm the kidney and boost yang to nourish the vital fire, jointly achieving the effects of tonifying both yin and yang, nourishing yin and cultivating yang. In this way, the yin and yang in the kidney can return to normal, and qi and blood can circulate orderly; (2)The present invention provides the clinical efficacy of this traditional Chinese medicine composition in the treatment of hypertension with syndrome of deficiency of both yin and yang. The results prove that it has significant clinical efficacy in treating hypertension with syndrome of deficiency of both yin and yang, deficiency of yin failing to nourish yang, and relatively yin deficiency syndrome. Compared with similar drugs, it has the characteristics of fewer herbs, lower cost and higher efficacy, and the preparation method is simple and highly controllable, with broad prospects for promotion. Detailed implementation mode

[0016] The technical solution of the present invention will be further explained and illustrated through specific examples below.

[0017] Example 1 The traditional Chinese medicine composition is a medicament prepared from the following raw materials in parts by weight (in grams), and the composition is: 12 parts of Scrophulariae Radix, 8 parts of Epimedii Folium, 8 parts of Corni Fructus, 8 parts of Cyathulae Radix, and 12 parts of Uncariae Ramulus cum Uncis.

[0018] The specific preparation method is as follows: Take Scrophulariae Radix, Epimedii Folium, Corni Fructus, Cyathulae Radix, and Uncariae Ramulus cum Uncis, decoct twice with water. For the first time, add 12 times the amount of water and decoct for 1.5 hours; for the second time, add 8 times the amount of water and decoct for 1.5 hours. Filter, combine the filtrates, concentrate the filtrates under reduced pressure (65 - 70 °C, -0.06 - -0.08 MPa) to a relative density of 1.05 - 1.10 (60 °C), filter, add water to 1000 mL, stir well, filter, sterilize, and fill into containers to obtain the product.

[0019] Example 2 The traditional Chinese medicine composition is a medicament prepared from the following raw materials in parts by weight (in grams), and the composition is: 10 parts of Scrophulariae Radix, 5 parts of Epimedii Folium, 5 parts of Corni Fructus, 5 parts of Cyathulae Radix, and 10 parts of Uncariae Ramulus cum Uncis.

[0020] The preparation method is the same as that of Example 1.

[0021] Example 3 The traditional Chinese medicine composition is a medicament prepared from the following raw materials in parts by weight (in grams), and the composition is: 15 parts of Scrophulariae Radix, 10 parts of Epimedii Folium, 10 parts of Corni Fructus, 10 parts of Cyathulae Radix, and 15 parts of Uncariae Ramulus cum Uncis.

[0022] Effect Example 1 Clinical trial (I)Clinical study on the treatment of hypertension with syndrome of deficiency of both yin and yang by the composition provided in the examples of the present invention 1. Case source and method 1.1 Case source All cases were from outpatients with hypertension with syndrome of deficiency of both yin and yang in the Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine from 2015 to 2021.

[0023] 1.2 Western medicine diagnostic criteria Referring to the "Chinese Guidelines for the Prevention and Treatment of Hypertension (2010 Edition)", the diagnosis can be confirmed if, in the absence of taking antihypertensive drugs, the systolic blood pressure is ≥140 mmHg and / or the diastolic blood pressure is ≥90 mmHg in at least 3 non-simultaneous standard brachial artery blood pressure measurements, and secondary hypertension is excluded; specifically as shown in Table 1.

[0024] Table 1

[0025] Note: When the patient's systolic blood pressure and diastolic blood pressure belong to different levels, the classification should be based on the higher level of the two; if the patient has a history of hypertension and is currently taking antihypertensive drugs, and the blood pressure is already lower than 140 / 90 mmHg, the patient should also be diagnosed with hypertension.

[0026] 1.3 Traditional Chinese Medicine Diagnostic Criteria The diagnostic criteria for kidney yin and yang deficiency, yin failing to nourish yang, and partial yin deficiency syndromes in hypertension refer to the syndrome differentiation criteria in the "Guiding Principles for Clinical Research of New Chinese Medicines" (2002 Edition) issued by the Ministry of Health: Main symptoms: dizziness, headache, soreness of the waist, weakness of the knees, fear of cold and cold limbs; Secondary symptoms: tinnitus, palpitation, shortness of breath, frequent urination at night; Tongue and pulse: pale red tongue with little coating, deep and thready pulse.

[0027] Syndrome differentiation criteria: meeting the western medicine diagnostic criteria for hypertension, having 2 of the above main symptoms, 2 - 4 of the secondary symptoms, and referring to the tongue and pulse can confirm the diagnosis of kidney yin and yang deficiency and partial yin deficiency syndromes.

[0028] (1) Dizziness 0 points - none; 3 points - dizziness and blurred vision, occurring intermittently; 6 points - spinning of vision, unable to walk; 9 points - on the verge of fainting due to dizziness, unable to stand.

[0029] (2) Headache 0 points - none; 3 points - mild headache, occurring intermittently; 6 points - tolerable headache, persisting without stopping; 9 points - unbearable headache, rushing up to the forehead and top of the head.

[0030] (3) Soreness of the waist 0 points - none; 3 points - soreness of the waist in the morning, which can be relieved by pounding; 6 points - persistent soreness of the waist, aggravated by labor; 9 points - soreness of the waist like being broken, not stopping even at rest.

[0031] (4)Weakness of the knees 0 points - None; 3 points - Slightly aware of weakness and limpness in the knees; 6 points - Lower back soreness, unable to bear heavy objects; 9 points - Limp knees, not wanting to walk.

[0032] (5) Aversion to cold and cold limbs 0 points - None; 3 points - Slight coldness at the extremities of the limbs; 6 points - Cold limbs, need to add clothes and quilts; 9 points - Whole body cold, still feeling not fully relieved even after adding more clothes and quilts.

[0033] (6) Tinnitus 0 points - None; 3 points - Tinnitus occurs intermittently, or only at night or in a quiet environment, and is mild in degree, without accompanying hearing impairment; 6 points - Tinnitus persists, is relatively severe, still present in a noisy environment or accompanied by mild hearing impairment; 9 points - Severe tinnitus, often affecting work and sleep, or accompanied by moderate or above hearing impairment.

[0034] (7) Palpitation 0 points - None; 3 points - Occasionally experiencing slight palpitation; 6 points - Palpitations occur in fits, several times a week; 9 points - Palpitation and uneasiness, several times a day;

[0035] (8) Shortness of breath 0 points - None; 3 points - Shortness of breath after general activities; 6 points - Shortness of breath after slightly strenuous activities; 9 points - Usually feeling short of breath and gasping even without activities.

[0036] (9) Frequent urination at night 0 points - None; 3 points - Urinate once at night; 6 points - Urinate 2 - 3 times at night; 9 points - Urinate more than 3 times at night.

[0037] (10) Tongue manifestation 6 points - Tongue is light red, no other scores; 6 points - Scanty coating on the tongue, no other scores.

[0038] (11) Pulse condition 6 points - Pulse is deep and thready, no other scores.

[0039] 1.4 Inclusion Criteria (1) Meeting the Western medicine diagnostic criteria for hypertension and the TCM syndrome differentiation criteria for kidney yin and yang deficiency, yin failing to nourish yang, and partial yin deficiency syndrome; (2) Having been clearly diagnosed with essential hypertension through the clinical risk stratification of hypertension, with blood pressure remaining unqualified after 3 months of lifestyle improvement or other forms of non-pharmacological treatment, and maintaining at 140 - 159 / 90 - 99 mmHg; (3) Aged between 18 and 85 years old; (4) The patient's duration of clearly diagnosed hypertension must be greater than 3 months.

[0040] 1.5 Exclusion Criteria (1) Secondary hypertension; (2) Patients with grade 2 or 3 hypertension or isolated systolic hypertension; (3) Pregnant or lactating women; (4) Complicated with mental illness; (5) Having a history of myocardial infarction or obvious stroke within this year; (6) Patients with allergic constitution or multiple drug allergies; (7) Those who have participated in other new drug clinical trials within the past three months; (8) Those who do not meet the hypertension diagnostic criteria after the washout period; (9) Patients with a hypertension duration of less than three months; (10) Complicated with the clinical manifestations of the following organ damage, such as: angina pectoris, myocardial infarction, heart failure, transient ischemic attack (TIA), stroke, hypertensive encephalopathy, retinal hemorrhage, exudates with or without papilledema, serum creatinine greater than 177 μmol / L, arterial dissection, arterial occlusive disease. As long as any one of the above items is present, the patient can be excluded.

[0041] 1.6 Research Plan 1.6.1 Enrolled Population A total of 253 hypertension patients were enrolled.

[0042] 1.6.2 Treatment Plan 1.6.2.1 Treatment Method Composition of the prescription: Scrophulariae Radix 12 g, Epimedii Folium 8 g, Corni Fructus 8 g, Cyathulae Radix 8 g, Uncariae Ramulus cum Uncis 12 g Usage: Decoct in water for oral administration, one dose per day, taken twice, morning and evening.

[0043] 1.6.2.2 Treatment Course The treatment course is 4 weeks. 1.6.3 Observation Indicators 1.6.3.1 Safety Indicators: ① General physical examination items: pulse, respiration, heart rate, blood pressure, body weight, etc., once a week; ② Blood and urine routine examinations, once a month; ③ Liver and kidney functions, once a month; ④ Adverse reactions.

[0044] 1.6.3.2 Efficacy observation indicators: ① Changes in blood pressure: The average value of blood pressure measured on three non - consecutive days before treatment is used as the observed blood pressure; the average value of blood pressure measured on three non - consecutive days in the last week of the treatment course is used as the blood pressure for efficacy evaluation; the patient measures blood pressure 2 times a week during the observation period; ② Traditional Chinese medicine symptom measurement score: Observe the common symptoms of kidney yin and yang deficiency, yin failing to nourish yang, and partial yin deficiency syndromes in hypertension. Ask and record item by item before treatment and after treatment, and judge and score according to the symptom scoring standard. The sum of symptoms of each case is the total score of the syndrome of this case.

[0045] 1.6.4 Efficacy judgment indicators 1.6.4.1 Blood pressure lowering efficacy evaluation criteria (Guiding Principles for Clinical Research of New Chinese Medicines, State Drug Administration of China, 2002): ① Marked effect (1) The diastolic blood pressure drops by more than 10 mmHg and reaches the normal range; (2) Although the diastolic blood pressure has not dropped to the normal range, it has dropped by 20 mmHg or more; (3) The systolic blood pressure drops by more than 30 mmHg compared with that before treatment and reaches the normal range; One of the above must be met.

[0046] ② Effective (1) The diastolic blood pressure drops by less than 10 mmHg but reaches the normal range; (2) The diastolic blood pressure drops by 10 - 19 mmHg compared with that before treatment but does not reach the normal range; (3) The systolic blood pressure drops by more than 30 mmHg compared with that before treatment; One of the above must be met.

[0047] ③ Ineffective (1) Those who do not meet the above criteria; (2) Those who show no effect after taking the medicine for more than 7 days.

[0048] 1.6.4.2 Traditional Chinese medicine efficacy judgment criteria: Syndrome efficacy judgment criteria (refer to the criteria stipulated in Guiding Principles for Clinical Research of New Chinese Medicines compiled by the State Drug Administration of China in 2002) Therapeutic effect index n = [(score before treatment - score after treatment) / score before treatment] × 100% ① Marked effect: All symptoms disappear after treatment, or the therapeutic effect index of traditional Chinese medicine syndromes n ≥ 70%; ② Effective: The therapeutic effect index of traditional Chinese medicine syndromes 30% ≤ n < 70%; ③ Ineffective: The therapeutic effect index of traditional Chinese medicine syndromes n < 30%.

[0049] 1.6.5 Safety assessment criteria: Grade 1: Safe, without any adverse reactions, and no abnormalities in safety index examinations; Grade 2: Relatively safe, with mild adverse reactions, and can continue to administer drugs without any treatment, and no abnormalities in safety index examinations; Grade 3: There are safety problems, with moderate adverse reactions, or mild abnormalities in safety index examinations, and can continue to administer drugs after treatment; Grade 4: Terminate the trial due to severe adverse reactions; or obvious abnormalities in safety index examinations.

[0050] 1.7 Statistical methods Measurement data are analyzed by t-test, count data are analyzed by χ 2 test, and clinical grade data are analyzed by Ridit test. The data are expressed as ±S (mean ± standard deviation). P < 0.05 indicates significant difference, and P < 0.01 indicates very significant difference.

[0051] 2. Results 2.1 Comparison of blood pressure changes in patients with kidney yin-yang deficiency syndrome of hypertension during treatment The onset is relatively fast within 1 - 2 weeks. The systolic blood pressure shows a significant decrease on the 7th day after taking the medicine, with a very significant difference compared with that before treatment (P = 0.001 < 0.01). It drops to a relatively low level at 14 days. The most obvious antihypertensive effect occurs in the first two weeks after taking the medicine (P = 0.000 < 0.01), and then it gradually and steadily decreases without obvious blood pressure fluctuations; the diastolic blood pressure begins to decrease significantly 7 days after taking the medicine. Subsequently, as the medication time continues, the blood pressure continues to decrease to a relatively low level at the end of the fourth week and then basically stabilizes, as shown in Table 2.

[0052] Table 2 Comparison of blood pressure changes in patients with kidney yin-yang deficiency and partial yin deficiency syndromes of hypertension during treatment ( ±S, mmHg)

[0053] Note: After t-test and within-group comparison, compared with that before treatment, * P < 0.05, ** P < 0.01.

[0054] 2.2 Comparison of the total antihypertensive efficacy in patients with kidney yin and yang deficiency and partial yin deficiency of hypertension after intervention with the composition provided by the present invention Among 253 patients, 81 cases (32.02%) showed marked efficacy, 128 cases (50.59%) showed effective, and 44 cases (17.39%) showed ineffective, with the total effective rate of 82.61%.

[0055] 2.3 Efficacy of improving traditional Chinese medicine syndromes 2.3.1 Comparison of the changes in the total scores of traditional Chinese medicine symptoms in patients with kidney yin and yang deficiency and partial yin deficiency of hypertension during the treatment Comparisons within the two groups before and after treatment showed that there were very significant statistical differences when comparing one week of treatment with before treatment (P = 0.000 < 0.01), when comparing two weeks of treatment with one week of treatment (P = 0.000 < 0.01), and when comparing four weeks of treatment with two weeks of treatment (P = 0.000 < 0.01); it shows that the composition formula can significantly reduce the total scores of traditional Chinese medicine clinical symptoms in patients with kidney yin and yang deficiency and partial yin deficiency of hypertension, as shown in Table 3.

[0056] Table 3 Comparison of the changes in the total scores of traditional Chinese medicine symptoms in patients with kidney yin and yang deficiency and partial yin deficiency of hypertension during the treatment ( ±S)

[0057] Note: After t-test, within-group comparison, compared with before treatment, * P <0.05, ** P <0.01.

[0058] 2.3.2 Comparison of the traditional Chinese medicine efficacy indexes in patients with kidney yin and yang deficiency and partial yin deficiency of hypertension after intervention with the above formula Among 253 patients, 89 cases (35.18%) showed marked efficacy, 138 cases (54.55%) showed effective, and 26 cases (10.27%) showed ineffective, with the total effective rate of 89.73%.

[0059] 2.4 Safety evaluation Blood routine, liver and kidney function tests were performed on 253 patients with kidney yin and yang deficiency, yin failing to nourish yang, and partial yin deficiency of hypertension before and after treatment. The results showed that there were no obvious changes in the blood routine and liver and kidney functions of the patients before and after treatment.

[0060] Typical cases Typical case 1: Ding x, gender: male, age: 64 years old. First visit time: January 12, 2015, main complaint: dizziness and headache for 1 month, aggravated for 1 week. Diagnosis: hypertension, blood pressure is 147 / 92mmHg. The patient had dizziness, headache, insomnia, and night sweats without obvious cause 1 month ago, which aggravated 1 week ago. The patient came to the doctor for further diagnosis and treatment. Current symptoms: dizziness, headache, insomnia, night sweats, good appetite, and regular bowel movements. Pale red tongue with little coating, thin pulse. Previously healthy. Impression: dizziness, kidney yin and yang deficiency. Taking the medicine of the present invention (Example 1) for 2 weeks, the second visit time: January 26, 2015, blood pressure dropped to 139 / 85mmHg, current symptoms: dizziness and headache improved, insomnia and night sweats alleviated, and the appetite was ok, and the bowel movements were regular. Pale red tongue with little coating, thin pulse. After taking the medicine of the present invention (Example 1) for 4 weeks, the third visit time was: February 9, 2015, blood pressure dropped to 131 / 78 mmHg, headache and dizziness symptoms disappeared, and there was no obvious discomfort, appetite and sleep were good, and bowel movements were normal. The tongue was pale red with less white fur, and the pulse was thin. No recurrence has been reported since follow-up.

[0061] Typical case 2: Wang x, gender: female, age: 64 years old. First visit time: January 13, 2015, main complaint: dizziness for 1 week. Diagnosis: hypertension, blood pressure is 148 / 98mmHg. The patient had dizziness due to fatigue 1 week ago, and occasionally had a headache. The patient came to the doctor for further diagnosis and treatment. Current symptoms: dizziness, headache, tinnitus, deafness, afternoon hot flashes, hot palms and soles, poor appetite and sleep, dreamy and easy to wake up, and two bowel movements are normal. Red tongue with white fur and thin pulse. Previously healthy. Impression: dizziness, kidney yin and yang deficiency. Take the medicine of the present invention (Example 1) for 2 weeks, the second visit time: January 27, 2015, blood pressure dropped to 138 / 90mmHg, current symptoms: dizziness, headache, tinnitus, deafness, afternoon hot flashes, hot palms and soles, appetite and sleep are normal, and two bowel movements are normal. Red tongue with white fur and thin pulse. After taking the drug of the present invention (Example 1) for 4 weeks, the third visit time was: February 10, 2015, blood pressure dropped to 133 / 80 mmHg, dizziness was relieved, head pain symptoms disappeared, tinnitus was relieved, and there was no obvious discomfort, appetite and sleep were good, and bowel movements were normal. The tongue was red with white fur and the pulse was thin. No recurrence has been reported in the follow-up so far.

Claims

1. A traditional Chinese medicine composition for treating hypertension, characterized in that, It is composed of the following raw medicinal materials in parts by weight: 10-15 parts of Scrophulariae Radix, 5-10 parts of Epimedii Folium, 5-10 parts of Corni Fructus, 5-10 parts of Cyathulae Radix, 10-15 parts of Uncariae Ramulus Cum Uncis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following raw medicinal materials in parts by weight: 12 parts of Scrophulariae Radix, 8 parts of Epimedii Folium, 8 parts of Corni Fructus, 8 parts of Cyathulae Radix, 12 parts of Uncariae Ramulus Cum Uncis.

3. A preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: (1) Take Scrophulariae Radix, Epimedii Folium, Corni Fructus, Cyathulae Radix, Uncariae Ramulus Cum Uncis and mix them. Decoct the mixed raw medicinal materials twice with water, filter, and combine the filtrates. (2) Concentrate the filtrate under reduced pressure, filter, add water and stir evenly, filter, sterilize, and fill into containers to obtain the product.

4. The preparation method according to claim 3, characterized in that, In step (1), the specific process of decocting twice is as follows: Add 12 times the amount of water of the mixed raw medicinal materials for the first decoction for 1.5 hours, and add 8 times the amount of water of the mixed raw medicinal materials for the second decoction for 1.5 hours.

5. The preparation method according to claim 3 or 4, characterized in that, In step (2), the conditions for concentration under reduced pressure are: 65-70 °C, -0.06 to -0.08 MPa; the filtrate is concentrated under reduced pressure to a relative density of 1.05-1.10 at 60 °C.

6. Use of a traditional Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a drug for treating yin-yang deficiency syndrome of hypertension.

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