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

Abstract

The invention discloses a traditional Chinese medicine composition for treating primary hypertension and a preparation method and application thereof. The traditional Chinese medicine composition is mainly prepared from the following raw material medicines in parts by weight: 20-60 parts of raw astragalus membranaceus, 10-20 parts of morinda officinalis, 10-20 parts of fried stiff silkworm, 10-20 parts of semen plantaginis, 10-30 parts of gastrodia elata, 10-20 parts of rhizoma alismatis and 10-20 parts of earthworm. The traditional Chinese medicine composition has the advantages that the traditional Chinese medicines are compatible to jointly achieve the effects of tonifying the spleen and kidney, resolving dampness and calming the liver, can effectively reduce blood pressure and improve uncomfortable symptoms, and is remarkable in curative effect when being used for treating primary hypertension with spleen and kidney deficiency, intermingled phlegm-dampness and internal movement of liver-wind as main pathogenesis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine. More specifically, it relates to a traditional Chinese medicine composition for treating essential hypertension, its preparation method and application. Background Art

[0002] Essential hypertension refers to the situation where, without taking medications, the clinic blood pressure measured 3 times on different days reaches 160 / 90 mmHg or higher. The average value of home blood pressure measurement or the average daytime value of ambulatory blood pressure monitoring ≥ 135 / 85 mmHg can also be diagnosed as hypertension. Referring to the hypertension diagnosis criteria formulated in the "Chinese Guidelines for the Prevention and Treatment of Hypertension" (2024): A blood pressure level of 120 - 139 / 80 - 89 mmHg is defined as normal high - value blood pressure, and a blood pressure level of 160 - 159 / 90 - 99 mmHg is defined as grade 1 hypertension. Essential hypertension is a common and frequently - occurring disease that can damage the arterial blood vessels of target organs such as the heart, brain, and kidneys, increasing the risk of cardiovascular and cerebrovascular diseases. It is a major risk factor for diseases such as stroke, heart failure, myocardial infarction, and chronic renal failure. Currently, there is a controversy both at home and abroad regarding whether to immediately initiate antihypertensive drug treatment for patients with normal high - value blood pressure and low - risk patients with grade 1 hypertension. The mainstream view is that there is currently no western medicine that can clearly benefit patients with normal high - value blood pressure. The "Chinese Guidelines for the Prevention and Treatment of Hypertension" (2024 revised edition) recommends that low - risk patients with grade 1 hypertension and low - to - medium - risk patients with normal high - value blood pressure do not necessarily need to immediately initiate antihypertensive drug treatment. The results of the national hypertension sampling survey conducted from 2012 to 2015 showed that the crude detection rate of normal high - value blood pressure in the population aged 18 and above was 39.1%, and the weighted rate was 41.3%. Based on this, it is estimated that 440 million people in China have blood pressure in the normal high - value range. A survey showed that among people over 60 years old with baseline blood pressure of <120 / 80 mmHg, 120 - 129 / 80 - 84 mmHg, and 130 - 139 / 85 - 89 mmHg, the incidence of hypertension after 10 years was 12%, 45%, and 64% respectively.

[0003] Hypertension lifestyle intervention includes maintaining a healthy diet, regular exercise, smoking cessation, alcohol restriction, less salt intake, etc. Antihypertensive drugs are divided into six categories, including diuretics, β - receptor blockers, calcium channel antagonists (CCB), angiotensin - converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), and sacubitril / valsartan (ARNI). Oral antihypertensive drugs can better control blood pressure, but there are many adverse reactions. For example, diuretics can cause hypokalemia, hyperglycemia, etc., β - receptor blockers can lead to dyspnea, arrhythmia, CCBs can cause tachycardia, dizziness and headache, and ACEIs can cause irritating dry cough. For patients with essential hypertension, especially those with normal high - value blood pressure and grade 1 hypertension, who are not suitable for direct treatment with western medicine for the time being, traditional Chinese medicine can be selected to treat this type of hypertension.

[0004] Therefore, it is very necessary to develop a traditional Chinese medicine with no adverse reactions that can effectively and steadily lower blood pressure, gently lower blood pressure, and lastingly lower blood pressure. Summary of the Invention

[0005] In view of the above technical problems, the first object of the present invention is to provide a new traditional Chinese medicine composition for treating primary hypertension. This traditional Chinese medicine composition has very good effects in treating primary hypertension, can improve clinical symptoms such as headache and dizziness related to primary hypertension, improve multiple cardiovascular metabolic factors such as blood lipids, blood sugar, and uric acid, reduce damage to target organs such as the heart, brain, and kidneys, and improve the quality of life.

[0006] The second object of the present invention is to provide a preparation method of the above traditional Chinese medicine composition.

[0007] The third object of the present invention is to provide a traditional Chinese medicine preparation using the above traditional Chinese medicine composition as an effective active ingredient.

[0008] The fourth object of the present invention is to provide the application of the above traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of drugs for treating primary hypertension.

[0009] To achieve the above objects, the present invention adopts the following technical solutions:

[0010] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating primary hypertension. The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 20 - 60 parts of raw Astragalus membranaceus, 10 - 20 parts of Morinda officinalis, 10 - 20 parts of stir-fried Bombyx batryticatus, 10 - 20 parts of Plantago asiatica, 10 - 30 parts of Gastrodia elata, 10 - 20 parts of Alisma orientale, 10 - 20 parts of Pheretima aspergillum.

[0011] In the prescription of the present invention, the functions and effects of each component are as follows:

[0012] Raw Astragalus membranaceus: Sweet, slightly warm; it acts on the spleen and lung meridians. It has the effects of invigorating qi and consolidating the exterior, inducing diuresis and alleviating edema, and expelling toxins and promoting granulation. It is used for qi deficiency with weakness, spontaneous sweating, etc., qi deficiency edema, dysuria, and chronic ulceration that does not heal. Pharmacological research shows that raw Astragalus membranaceus has the effects of enhancing immunity, antioxidation, scavenging free radicals, delaying aging, anti-fatigue, improving the endurance of the body and anti-stress ability, protecting the cardiovascular and cerebrovascular systems, improving myocardial ischemia, and lowering blood pressure. Astragalus polysaccharide can improve the immune function of the body.

[0013] Morinda officinalis: Sweet, pungent, slightly warm; it acts on the kidney and liver meridians. It has the effects of tonifying the kidney yang, strengthening the bones and muscles, and dispelling wind and dampness. It is mainly used for soreness and weakness of the waist and knees, impotence and premature ejaculation, rheumatic pain, weakness of the bones and muscles, and wind-cold-damp arthralgia. Pharmacological research shows that Morinda officinalis has the effects of anti-aging, enhancing the body's immunity, promoting hematopoiesis, antidepressant, anti-tumor, anti-inflammatory, and analgesic.

[0014] Plantago: sweet, cold. Enters the liver, kidney, lung, and small intestine meridians. It has the effects of clearing heat and promoting diuresis, dispelling dampness and relieving stranguria, improving eyesight and removing phlegm. It is mainly used to treat urinary dysfunction, stranguria and leukorrhea, edema caused by damp-heat, urinary tract infection, red and swollen eyes, and cough caused by phlegm and heat. Pharmacological studies have shown that Plantago has rich pharmacological activities such as anti-inflammatory, antioxidant, anti-platelet aggregation, anti-aging, anti-anxiety, fatigue relief, sedation and hypnosis, immunomodulation, and neuroprotection.

[0015] Alisma: sweet, light, cold. Enters the kidney and bladder meridians. Has the effects of promoting diuresis and removing dampness, removing turbidity and reducing lipids, and relieving heat. Indications: edema, dysuria, stranguria, leucorrhea, and hyperlipidemia. Pharmacological studies have shown that Alisma has the effects of diuresis, anti-inflammatory, liver protection, blood pressure reduction, lipid reduction, anti-oxidation, regulating sugar and lipid metabolism, and inhibiting kidney stones.

[0016] Gastrodia elata: sweet, neutral, enters the liver meridian. It has the effects of calming wind and stopping spasms, calming liver yang, and dispelling wind and unblocking collaterals. It is used to treat epilepsy, convulsions, dizziness, headaches, limb numbness, rheumatic pain and other diseases caused by internal liver wind. Pharmacological studies have shown that Gastrodia elata has antihypertensive, antilipidemic, anti-oxidative stress, anti-inflammatory, brain protection, anti-epileptic, anti-dizziness, analgesic and other effects.

[0017] Bombyx batryticatus: salty, pungent, neutral in nature, enters the liver, lung, and stomach meridians, can dispel wind and enter the heart, lung, liver, and spleen meridians, and has the effects of dispelling wind and stopping spasms, resolving phlegm and dispersing knots, clearing away heat and detoxifying. It is used to treat diseases such as liver wind with phlegm, epilepsy and convulsions, acute convulsions in children, and wind-heat headaches. Pharmacological studies have shown that Bombyx batryticatus has sedative, anti-inflammatory, antibacterial, immunomodulatory and anti-tumor effects.

[0018] Earthworm: salty, cold, enters the liver, spleen, and bladder meridians, can clear away heat, relieve asthma, promote diuresis, and dredge collaterals. It is used to treat febrile convulsions, rheumatic pain, hemiplegia, lung heat cough and asthma, and heat-induced urinary retention. Pharmacological studies have shown that earthworms have thrombolytic, anticoagulant, antihypertensive, anti-inflammatory, antipyretic, sedative, and blood pressure-lowering effects.

[0019] Hypertension belongs to the disease categories of "dizziness" and "headache" in traditional Chinese medicine according to its clinical symptoms. Clinically, symptoms such as dizziness, headache, irritable mood, and numbness of limbs can be seen. The location of the disease of hypertension is in the brain orifices, and it is closely related to the heart, liver, spleen, and kidney. The pathological changes are mainly the imbalance of qi, blood, yin, and yang in the heart, liver, spleen, and kidney. The pathological factors are nothing but wind, fire, phlegm, stasis, and deficiency, belonging to the syndrome of deficiency in origin and excess in superficiality. For patients with unclear hypertension symptoms and those in the early stage of essential hypertension, from the perspective of "preventive treatment of disease", timely syndrome differentiation and intervention are the keys to preventing disease before its occurrence, preventing the progression of the disease once it occurs, and preventing recurrence after recovery. Spleen-kidney yang deficiency is the root of the disease, and phlegm-dampness is the pathological product as the superficiality. "Dizziness is not caused without phlegm", the spleen is the source of phlegm production, and the spleen is in charge of transportation and transformation. Bad habits such as mental factors, addiction to tobacco and alcohol, air conditioning and cold baths, lack of exercise, preference for fatty, sweet, thick, and greasy foods, preference for cold drinks and raw and cold foods, overwork, and staying up late consume the yang qi of the spleen and kidney. When the spleen fails to transport and transform, the distribution and metabolism of water and beverages are obstructed, and then dizziness occurs. Kidney deficiency leads to heavy head and high shaking, and insufficient marrow in the brain leads to dizziness and tinnitus. If the congenital primordial yang is insufficient and the fire of the gate of vitality fails to warm and nourish, yang deficiency generates cold, phlegm-dampness is internally generated, blood vessels are stagnated, the blood vessels are not warm, yin pathogens accumulate, collaterals lose nourishment, and internal stirring of virtual wind occurs, then the collaterals contract spasmodically, resulting in dizziness and headache. Hypertension is based on spleen-kidney yang deficiency, with phlegm-dampness mutual binding and liver wind internal stirring as the superficiality. The treatment should be based on the methods of tonifying the spleen and kidney yang, resolving phlegm and removing dampness, and calming the liver wind.

[0020] The compatibility significance of the traditional Chinese medicine composition of the present invention lies in: essential hypertension mostly belongs to the syndrome of deficiency in origin and excess in superficiality, and both the origin and superficiality should be treated, with consolidating the origin as the main. Morinda officinalis is sweet, pungent, and slightly warm, tonifying the kidney yang, expelling wind and removing dampness. Astragalus membranaceus is warm in nature, good at tonifying the qi of the lung and spleen, and helping the growth of spleen yang. The two together are the monarch drugs, tonifying the yang of the spleen and kidney. When spleen-kidney yang deficiency occurs, the transportation and metabolism of water and fluids are abnormal, water and dampness accumulate and coagulate, forming phlegm-dampness. Plantago asiatica is sweet and cold, entering the kidney, lung, and small intestine meridians, having the effects of eliminating phlegm, clearing heat, and promoting diuresis. Alisma orientale is sweet, light, and cold, belonging to the kidney and bladder meridians, and can promote diuresis and percolate dampness, transform turbidity and reduce lipid. The two together are the minister drugs to promote diuresis and percolate dampness. Due to insufficient spleen and kidney, the brain marrow loses nourishment, and internal stirring of virtual wind occurs. Therefore, Gastrodia elata, Bombyx batryticatus, and Pheretima aspergillum are used as adjuvant drugs. Gastrodia elata is sweet and flat, entering the liver meridian, having the effects of calming endogenous wind and stopping convulsions, suppressing liver yang. Bombyx batryticatus and Pheretima aspergillum can also calm endogenous wind and stop convulsions. The combination of the three has the effect of calming endogenous wind. The compatibility of all the drugs plays the role of tonifying the spleen and kidney, resolving dampness and calming the liver, and treating essential hypertension with insufficient spleen and kidney, phlegm-dampness mutual binding, and liver wind internal stirring.

[0021] Exemplarily, the traditional Chinese medicine composition is mainly made of the following raw materials in parts by weight: 30 parts of raw Astragalus membranaceus, 15 parts of Morinda officinalis, 10 parts of stir-fried Bombyx batryticatus, 15 parts of Plantago asiatica, 20 parts of Gastrodia elata, 15 parts of Alisma orientale, and 10 parts of Pheretima aspergillum.

[0022] Exemplarily, the traditional Chinese medicine composition is mainly made of the following raw materials in parts by weight: 60 parts of raw Astragalus membranaceus, 15 parts of Morinda officinalis, 10 parts of stir-fried Bombyx batryticatus, 15 parts of Plantago asiatica, 30 parts of Gastrodia elata, 20 parts of Alisma orientale, and 10 parts of Pheretima aspergillum.

[0023] Exemplarily, the traditional Chinese medicine composition is mainly made from the following raw materials by weight: 40 parts of Astragalus membranaceus, 15 parts of Morinda officinalis, 10 parts of stir-fried Bombyx batryticatus, 15 parts of Plantago asiatica, 30 parts of Gastrodia elata, 15 parts of Alisma orientale, and 10 parts of Pheretima aspergillum.

[0024] The raw materials of the above traditional Chinese medicine composition of the present invention form a basic formula. In specific embodiments, it can be adjusted based on the clinical symptoms on the basis of the above traditional Chinese medicine composition to achieve the purpose of improving certain other clinical symptoms while treating hypertension, further enhancing the adaptability of the composition of the present invention and improving the treatment effect. These adjusted formulas based on the basic formula of the present invention are also within the protection scope of this application.

[0025] Second, the present invention provides a preparation method of a traditional Chinese medicine composition for treating essential hypertension, characterized in that the preparation method includes:

[0026] (1) Weigh Astragalus membranaceus, Morinda officinalis, stir-fried Bombyx batryticatus, Plantago asiatica, Gastrodia elata, Alisma orientale, and Pheretima aspergillum according to the prescription amount, and soak them in water for 20 - 30 minutes;

[0027] (2) Decoct with slow fire until it boils and then continue to decoct for 20 - 30 minutes, decocting twice in total;

[0028] (3) Combine the two decoction liquids, filter, and obtain the product.

[0029] Further, for the convenience of storage and for making various dosage forms, the above preparation method further includes the step of concentrating the filtrate obtained by filtering in step (3) into an extract.

[0030] Furthermore, the extract can be further dried into powder.

[0031] Third, the present invention provides a traditional Chinese medicine preparation for treating essential hypertension, and the active ingredient of the traditional Chinese medicine preparation is the above traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above preparation method.

[0032] According to actual needs, the traditional Chinese medicine preparation may further include pharmaceutically acceptable excipients, including but not limited to disintegrants, lubricants, adhesives, etc., and various preparations are made according to conventional preparation processes, such as decoctions, granules, pills, capsules, tablets, powders, ointments, or oral liquids and other dosage forms.

[0033] Fourth, the present invention further provides the application of the above traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of any one of the following drugs:

[0034] (1) Application in the preparation of drugs for treating essential hypertension;

[0035] (2) Application in the preparation of drugs for treating essential hypertension of yang deficiency and phlegm-dampness type;

[0036] (3) Use in the preparation of a medicament for treating high-normal blood pressure or grade 1 hypertension.

[0037] In addition, unless otherwise specified, each raw material drug of the traditional Chinese medicine composition of the present invention can be obtained through commercial purchase. Any range described in the present invention includes the end values and any numerical value between the end values, and the traditional Chinese medicine composition of any sub-range constituted by any numerical value between the end values or the end values can achieve the purpose of treating essential hypertension.

[0038] The beneficial effects of the present invention are as follows:

[0039] The various drugs in the present invention are combined to play the functions of invigorating the spleen and tonifying the kidney, resolving dampness and calming the liver, and can effectively treat yang-deficiency phlegm-damp type essential hypertension with the main pathogenesis of spleen-kidney deficiency, mutual binding of phlegm and dampness, and stirring of liver wind. In addition, the traditional Chinese medicine composition of the present invention not only improves the clinical symptoms such as headache and dizziness related to essential hypertension and improves the quality of life, but also has the effects of steadily reducing blood pressure, gently reducing blood pressure, and persistently reducing blood pressure, and improves multiple cardiovascular metabolic factors such as blood lipids, blood sugar, and uric acid, and reduces the damage to target organs such as the heart, brain, and kidney. Detailed implementation manners

[0040] In order to more clearly illustrate the present invention, the present invention will be further described below in conjunction with preferred embodiments. Those skilled in the art should understand that the content specifically described below is illustrative rather than restrictive, and should not be used to limit the protection scope of the present invention.

[0041] Example 1

[0042] 30 grams of astragalus membranaceus, 15 grams of morinda officinalis, 10 grams of stir-fried bombyx batryticatus, 15 grams of plantago asiatica, 20 grams of gastrodia elata, 15 grams of alisma orientale, 10 g of pheretima aspergillum. Mix the above raw material drugs together, place them in a casserole, add water to cover the drug surface, soak for 20 - 30 minutes, and then decoct with slow fire. After boiling, continue to decoct for 30 minutes. Decoct twice in total, combine the two decoction liquids and filter to obtain the decoction.

[0043] Administration method: Decoction, one dose per day, decocted in water for oral administration, once in the morning and once in the evening, and 28 days is a course of treatment.

[0044] Example 2

[0045] 60 grams of astragalus membranaceus, 15 grams of morinda officinalis, 10 grams of stir-fried bombyx batryticatus, 15 grams of plantago asiatica, 30 grams of gastrodia elata, 20 grams of alisma orientale, 10 g of pheretima aspergillum. The preparation and administration method are as in Example 1.

[0046] Example 3

[0047] 40 grams of astragalus membranaceus, 15 grams of morinda officinalis, 10 grams of stir-fried bombyx batryticatus, 15 grams of plantago asiatica, 30 grams of gastrodia elata, 15 grams of alisma orientale, 10 g of pheretima aspergillum. The preparation and administration method are as in Example 1.

[0048] Example 4 Clinical Research

[0049] 1 Research Method

[0050] 1.1 Research Purpose

[0051] To conduct a prospective self - before - and - after control study to explore the clinical timeliness and safety of the traditional Chinese medicine composition of the present invention in the treatment of patients with primary hypertension (normal high - value blood pressure, grade 1 hypertension) of yang deficiency and phlegm - dampness type.

[0052] 1.2 Research Subjects

[0053] 1.2.1 Source of Cases

[0054] The research population comes from patients with hypertension of yang deficiency and phlegm - dampness type who have long visited the cardiovascular outpatient department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences.

[0055] 1.2.2 Diagnostic Criteria

[0056] Western Medicine Diagnostic Criteria

[0057] Refer to the "Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revised Edition)" to formulate the blood pressure level classification criteria:

[0058] For the western medicine diagnostic criteria of primary hypertension, the blood pressure level is classified as normal high - value blood pressure: 120 - 139 mmHg and (or) 80 - 89 mmHg, and grade 1 hypertension: 140 - 159 mmHg and (or) 90 - 99 mmHg.

[0059] Traditional Chinese Medicine Diagnostic Criteria

[0060] For the traditional Chinese medicine syndrome differentiation and typing, refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and clinical experience. The diagnostic criteria for the syndrome of yang deficiency and phlegm - dampness in traditional Chinese medicine are as follows:

[0061] Main symptoms: dizziness, headache, head feeling like being wrapped, chest tightness, vomiting of phlegm, soreness and weakness of the waist and knees, fear of cold and cold limbs.

[0062] Secondary symptoms: palpitations, insomnia, tastelessness in the mouth, poor appetite, shortness of breath, frequent urination at night. The tongue is pale and plump with a greasy coating, and the pulse is deep and slippery. When patients present with dizziness and headache symptoms, accompanied by 2 main symptoms and 2 secondary symptoms, they can be identified according to the characteristics of the tongue and pulse for differentiation.

[0063] 1.2.3 Inclusion Criteria

[0064] (1) Meeting the western medicine diagnostic criteria for primary hypertension;

[0065] (2) Meeting the diagnostic criteria for the syndrome of yang deficiency and phlegm abundance in traditional Chinese medicine;

[0066] (3) Aged 18 - 59 years old, regardless of gender;

[0067] (4) Patients with normal high blood pressure who have never taken antihypertensive drugs, or who have taken antihypertensive drugs in the past but have stopped taking them for more than two weeks, and the measured blood pressure values still meet the above diagnostic criteria;

[0068] (5) The subjects are aware of and sign the informed consent form.

[0069] 1.2.4 Exclusion criteria

[0070] (1) Secondary hypertension;

[0071] (2) Blood pressure levels classified as grade 2 or grade 3;

[0072] (3) Dizziness and headache caused by non-essential hypertension;

[0073] (4) Those with severe primary diseases involving the heart, brain, liver, kidneys, and blood system, etc.;

[0074] (5) Women who are planning pregnancy, pregnant, or lactating;

[0075] (6) Those with contraindications to the drugs used in this study;

[0076] (7) Those who have participated in other clinical trials within the past 3 months;

[0077] (8) Patients with mental abnormalities and those who are unwilling to cooperate.

[0078] 1.2.5 Case exclusion and dropout criteria

[0079] (1) Those who cannot complete the treatment process or are lost to follow-up for various reasons;

[0080] (2) If trial participants (such as volunteers, patients, etc.) request to withdraw from the trial, their wishes should be respected, the relevant trial operations should be stopped immediately, and corresponding follow-up measures should be taken;

[0081] (3) Deterioration of health: The health of the subjects deteriorates during the clinical trial, affecting normal work and life.

[0082] 1.3 Research methods

[0083] 1.3.1 Treatment plan

[0084] (1) Basic treatment: The basic treatment mainly focuses on health education and lifestyle intervention, and the basic treatment is formulated with reference to the "2024 Revised Edition of the Chinese Guidelines for the Prevention and Treatment of Hypertension":

[0085] Health education to help patients understand the diagnosis, hazards, and treatment of hypertension;

[0086] It is recommended to have a low-salt and low-fat diet, abstain from smoking and alcohol, and have regular sleep;

[0087] Try to maintain a healthy and stable mood and promptly eliminate bad moods;

[0088] Exercise appropriately and control your weight.

[0089] (2) Treatment medication: The hypertensive patients were given the traditional Chinese medicine composition of this application for treatment, and the treatment course was 8 weeks.

[0090] Drug composition: 30 grams of Astragalus membranaceus, 15 grams of Morinda officinalis, 10 grams of stir-fried Bombyx batryticatus, 15 grams of Plantago asiatica, 20 grams of Gastrodia elata, 15 grams of Alisma orientale, 10 grams of Pheretima aspergillum. All the medicinal materials were sourced from the outpatient dispensing pharmacy of Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Decoct with water for oral administration, 200 ml each time, taken twice a day, morning and evening.

[0091] (3) Western medicine basic treatment: During the research and observation period, patients with grade 1 hypertension continued to take western medicine according to their own conditions. The western medicine included but was not limited to: Amlodipine besylate tablets, Nifedipine sustained-release tablets, Nifedipine controlled-release tablets, Valsartan tablets, Losartan tablets, Irbesartan tablets, Captopril tablets, Metoprolol tablets, Metoprolol tartrate, Carvedilol tablets.

[0092] (4) Use of other drugs:

[0093] During the observation period, if patients had other concurrent diseases, they could continue to take the relevant western medicine for treatment.

[0094] 1.3.2 Treatment course

[0095] 4 weeks was one treatment course, and the treatment cycle was 2 treatment courses, for a total of 8 weeks.

[0096] 1.3.3 Observation indicators and efficacy evaluation criteria

[0097] (1) General clinical data (recorded at the time of enrollment)

[0098] Gender, age, disease duration, past history, allergy history, medication history, smoking history, drinking history.

[0099] (2) Efficacy observation indicators:

[0100] At 0 week, 2 weeks, 4 weeks, and 8 weeks, the following indicators were observed:

[0101] Main indicators: Clinic blood pressure, TCM syndrome score;

[0102] Secondary indicators: 24-hour ambulatory blood pressure, score of the Dou's Quality of Life Scale for Hypertension, total cholesterol CH0, triglyceride TG, low-density lipoprotein LDL-C;

[0103] Two weeks after the end of treatment, the following indicator was observed:

[0104] Home self-measured blood pressure.

[0105] (4) Clinical efficacy determination criteria

[0106] All subjects took a sitting position to measure blood pressure in a quiet state. They rested for about 10 minutes before measuring blood pressure. The measurement method was to measure the blood pressure of the right arm three times and take the average blood pressure of the three measurements. The evaluation of the antihypertensive effect was based on the "Guiding Principles for Clinical Research of New Chinese Medicines" (Revised Edition in 2002), which was as follows:

[0107] Marked effect: Any one of the following four conditions was satisfied

[0108] 1. The diastolic blood pressure decreased by ≥10 mmHg and reached the normal range;

[0109] 2. The systolic blood pressure decreased by ≥20 mmHg and reached the normal range;

[0110] 3. The diastolic blood pressure decreased by ≥20 mmHg, but still did not reach the normal level;

[0111] 4. The systolic blood pressure decreased by ≥30 mmHg, but still did not reach the normal level;

[0112] Effective: Any one of the following four conditions was satisfied

[0113] 1. The diastolic blood pressure decreased by <10 mmHg, but had reached the normal range;

[0114] 2. The systolic blood pressure decreased by <20 mmHg, but had reached the normal range;

[0115] 3. 10 mmHg ≤ the decrease in diastolic blood pressure ≤ 19 mmHg, but still did not reach the normal range;

[0116] 4. The systolic blood pressure decreased by ≥20 mmHg, but still did not reach the normal range;

[0117] Ineffective: Those who did not meet the above criteria;

[0118] The total effective rate of traditional Chinese medicine / western medicine was: (the number of cases with marked effect + effective cases) / total number of cases × 100%.

[0119] Evaluation criteria for the curative effect of traditional Chinese medicine syndromes

[0120] According to the "Guiding Principles for Clinical Research of New Chinese Medicines" in 2002. Specifically as follows:

[0121] Marked effect: The main symptoms and secondary symptoms were significantly relieved, and at the same time, the degree of reduction in the syndrome score was 70% and above;

[0122] Effective: The main symptoms and secondary symptoms were relieved, and at the same time, the degree of reduction in the syndrome score was 30% and above, but below 70%;

[0123] Ineffective: The main symptoms and secondary symptoms were not relieved or were aggravated, and at the same time, the degree of reduction in the syndrome score was below 30%.

[0124] Note: Calculation formula: therapeutic index = [(score before treatment - score after treatment) / score before treatment] × 100%.

[0125] 1.3.4 Scoring criteria for the Duchenne Hypertension Quality of Life Scale

[0126] Patients fill in the scale truthfully according to the presence and severity of symptoms. The sum of the scores of each item is the total score of the scale. The higher the score, the better the patient's quality of life.

[0127] 1.3.5 Safety evaluation criteria

[0128] Level 1: During the test, there were no abnormalities in the routine blood and urine tests, liver and kidney function tests, and no adverse reactions;

[0129] Level 2: During the test, there were no abnormalities in the two blood and urine routine tests and liver and kidney function tests. There were mild adverse reactions, but no special treatment was required.

[0130] Level 3: Mild abnormalities in blood and urine routine tests and liver and kidney function tests twice during the trial, moderate adverse reactions, requiring timely treatment;

[0131] Level 4: During the trial, severe abnormalities were found in routine blood and urine tests twice, liver and kidney function tests, and severe adverse reactions occurred, requiring termination of the trial.

[0132] 2 Research results

[0133] 2.1 General Condition of Included Patients

[0134] A total of 60 patients were included in this study, of which 1 dropped out due to failure to take Chinese medicine continuously and 1 was lost to follow-up. The final number of cases that completed the study was 58.

[0135] 2.1.1 Gender

[0136] Of the 58 patients included, 38 were male and 20 were female, with a male:female ratio of ≈2:1. See Table 1.

[0137] Table 1 Gender distribution of patients

[0138]

[0139] 2.1.2 Age

[0140] Among the 58 patients included in this study, their age ranged from 26 to 59 years old, with an average age of 42.33±6.59 years old, of which 36 patients were aged 18 years old ≤ 44 years old, accounting for 62.07%, and 22 patients were aged 45 years old ≤ 59 years old, accounting for 37.93%. See Table 2.

[0141] Table 2 Distribution of patients' age range

[0142]

[0143] 2.1.3 Family genetic history and smoking and drinking history

[0144] Among the 58 patients included in the study, 30 had a genetic history of hypertension, accounting for 51.7%, 35 were smokers, accounting for 60.3%, and 38 were drinkers, accounting for 65.5%. See Table 3.

[0145] Table 3 Distribution of family genetic history, smoking history and drinking history

[0146]

[0147] 2.1.4 Number of patients with high normal blood pressure and newly diagnosed grade 1 hypertension

[0148] Among the 58 patients included in the study, 38 had high normal blood pressure, accounting for 65.52%, and 20 had grade 1 hypertension, accounting for 34.48%. See Table 4.

[0149] Table 4 Distribution of high normal blood pressure and grade 1 hypertension

[0150]

[0151] 2.1.5 Use of western medicine in patients with grade 1 hypertension

[0152] Twenty patients with grade 1 hypertension among the 58 patients included in the study were analyzed. The use of western medicine before and after treatment was compared. After adding traditional Chinese medicine treatment, the dosage of western medicine decreased compared with that before treatment. See Table 5.

[0153] Table 5 Use of western medicine in patients with grade 1 hypertension

[0154]

[0155] 2.2 Efficacy analysis

[0156] 2.2.1 Total scores of traditional Chinese medicine syndromes

[0157] The total scores of traditional Chinese medicine syndromes of 58 patients before and after treatment were compared. After normal distribution test, the total scores of traditional Chinese medicine syndromes before and after treatment did not conform to normal distribution. Paired sample rank sum test was used. The results showed that the total scores of traditional Chinese medicine syndromes after intervention were lower than those before intervention, and the difference in the total scores of traditional Chinese medicine syndromes before and after treatment was statistically significant (P < 0.01). See Table 6.

[0158] Table 6 Comparison of total scores of traditional Chinese medicine syndromes before and after intervention

[0159]

[0160] 2.2.2 Efficacy of Traditional Chinese Medicine Syndrome Scores

[0161] The efficacy of the total scores of traditional Chinese medicine syndromes was analyzed in the 58 included patients. After 2 months of treatment, 6 cases showed marked improvement (10.34%), 46 cases were effective (79.31%), and 6 cases were ineffective (10.34%). The total effective rate was 89.65%. See Table 7.

[0162] Table 7 Evaluation of the Efficacy of the Total Scores of Traditional Chinese Medicine Syndromes after Intervention

[0163]

[0164] 2.2.3 Clinic Blood Pressure of Patients with High-Normal Blood Pressure

[0165] The systolic blood pressure of the clinic blood pressure of patients with high-normal blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment was analyzed by pre-post comparison. After the normality test, the systolic blood pressure of the clinic blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment conformed to the normal distribution. The paired sample t-test was used. The results showed that the blood pressure after treatment was lower than that before treatment. After 6 weeks of treatment, the blood pressure decreased significantly. The difference in the systolic blood pressure of the clinic blood pressure before and after treatment was statistically significant (P < 0.01). See Table 8.

[0166] Table 8 Comparison of the Systolic Blood Pressure of the Clinic Blood Pressure before Intervention, 2 Weeks after, 4 Weeks after, and 8 Weeks after

[0167]

[0168] The diastolic blood pressure of the clinic blood pressure of patients with high-normal blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment was analyzed by pre-post comparison. After the normality test, the diastolic blood pressure of the clinic blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment conformed to the normal distribution. The paired sample t-test was used. The results showed that after 2 weeks of treatment, the decrease in diastolic blood pressure was not obvious, and the difference was not statistically significant (P > 0.01). After 4 weeks, 6 weeks, and 8 weeks of treatment, the diastolic blood pressure decreased successively. The decrease in diastolic blood pressure was more obvious at the 6th week. The difference in the diastolic blood pressure of the clinic blood pressure before and after treatment was statistically significant (P < 0.01). See Table 9.

[0169] Table 9 Comparison of the Diastolic Blood Pressure of the Clinic Blood Pressure before Intervention, 2 Weeks after, 4 Weeks after, and 8 Weeks after

[0170]

[0171] The systolic blood pressure of the office blood pressure before treatment and 8 weeks after treatment in patients with high normal blood pressure was analyzed by pre - and post - comparison. After normality test, the systolic blood pressure of the office blood pressure before treatment and 8 weeks after treatment conformed to the normal distribution. Paired - sample t - test was used. The results showed that the systolic blood pressure of the office blood pressure 8 weeks after treatment was lower than that before treatment, and the difference in the systolic blood pressure of the office blood pressure before and after treatment was statistically significant (P < 0.01). See Table 10.

[0172] Table 10 Comparison of systolic blood pressure of office blood pressure before and after intervention

[0173]

[0174] The diastolic blood pressure of the office blood pressure before treatment and 8 weeks after treatment in patients with high normal blood pressure was analyzed by pre - and post - comparison. After normality test, the diastolic blood pressure of the office blood pressure before treatment and 8 weeks after treatment conformed to the normal distribution. Paired - sample t - test was used. The results showed that the diastolic blood pressure of the office blood pressure 8 weeks after treatment was lower than that before treatment, and the difference in the diastolic blood pressure of the office blood pressure before and after treatment was statistically significant (P < 0.01). See Table 11.

[0175] Table 11 Diastolic blood pressure of office blood pressure before and after intervention

[0176]

[0177] 2.2.4 Office blood pressure of patients with newly - diagnosed grade 1 hypertension

[0178] The systolic blood pressure of the office blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment in patients with newly - diagnosed grade 1 hypertension was analyzed by pre - and post - comparison. After normality test, the systolic blood pressure of the office blood pressure before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, and 8 weeks after treatment conformed to the normal distribution. Paired - sample t - test was used. The results showed that the blood pressure after treatment was lower than that before treatment. After 6 weeks of treatment, the blood pressure decreased significantly. The difference in the systolic blood pressure of the office blood pressure before and after treatment was statistically significant (P < 0.01). See Table 12.

[0179] Table 12 Comparison of systolic blood pressure of office blood pressure before, 2 weeks after, 4 weeks after, and 8 weeks after intervention

[0180]

[0181] The diastolic blood pressure of the clinic of patients with newly diagnosed stage 1 hypertension was compared before treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 6 weeks of treatment, and after 8 weeks of treatment. After normal distribution test, the diastolic blood pressure of the clinic before treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 6 weeks of treatment, and after 8 weeks of treatment conformed to the normal distribution. Paired-sample t-test was used. The results showed that from 2 to 4 weeks of treatment, the decrease in diastolic blood pressure was not obvious, and the difference was not statistically significant (P>0.01). The diastolic blood pressure decreased successively after 2 weeks, 6 weeks, and 8 weeks of treatment. The decrease in diastolic blood pressure was more obvious at 6 weeks. The difference in diastolic blood pressure of the clinic before and after treatment was statistically significant (P<0.01). See Table 13.

[0182] Table 13 Comparison of diastolic blood pressure of the clinic before intervention, after 2 weeks, after 4 weeks, and after 8 weeks

[0183]

[0184] The systolic blood pressure of the clinic of patients with newly diagnosed stage 1 hypertension was compared before treatment and after 8 weeks of treatment. After normal distribution test, the systolic blood pressure of the clinic before treatment and after 8 weeks of treatment conformed to the normal distribution. Paired-sample t-test was used. The results showed that the systolic blood pressure of the clinic after 8 weeks of treatment was lower than that before treatment. The difference in systolic blood pressure of the clinic before and after treatment was statistically significant (P<0.01). See Table 14.

[0185] Table 14 Comparison of systolic blood pressure of the clinic before and after intervention

[0186]

[0187] The diastolic blood pressure of the clinic of patients with newly diagnosed stage 1 hypertension was compared before treatment and after 8 weeks of treatment. After normal distribution test, the diastolic blood pressure of the clinic before treatment and after 8 weeks of treatment conformed to the normal distribution. Paired-sample t-test was used. The results showed that the diastolic blood pressure of the clinic after 8 weeks of treatment was lower than that before treatment. The difference in diastolic blood pressure of the clinic before and after treatment was statistically significant (P<0.01). See Table 15.

[0188] Table 15 Diastolic blood pressure of the clinic before and after intervention

[0189]

[0190] 2.2.5 Home self-measured blood pressure

[0191] Two weeks after the treatment of patients with high normal blood pressure and grade 1 hypertension, follow-up was carried out, and the patients' self-measured blood pressure at home was recorded. The self-measured blood pressure at home after the end of treatment and two weeks after the end of treatment was compared and analyzed. After normal distribution test, the self-measured blood pressure at home after the end of treatment and two weeks after the end of treatment conformed to normal distribution. Paired sample t-test was used. The results showed that the systolic blood pressure of self-measured blood pressure at home two weeks after the end of treatment was lower than that after the end of treatment, and the difference in systolic blood pressure between the self-measured blood pressure at home two weeks after the end of treatment and the systolic blood pressure after the end of treatment was not significant (P>0.01). See Table 16.

[0192] Table 16 Comparison of systolic blood pressure of self-measured blood pressure at home two weeks after the end

[0193]

[0194] Two weeks after the treatment of patients with high normal blood pressure and grade 1 hypertension, follow-up was carried out. The blood pressure after the end of treatment and the self-measured blood pressure at home two weeks after the end of treatment were compared and analyzed. After normal distribution test, the self-measured blood pressure at home after the end of treatment and two weeks after the end of treatment conformed to normal distribution. Paired sample t-test was used. The results showed that the diastolic blood pressure of self-measured blood pressure at home two weeks after the end of treatment was lower than that after the end of treatment, and the difference in diastolic blood pressure between the self-measured blood pressure at home two weeks after the end of treatment and the diastolic blood pressure after the end of treatment was not significant (P>0.01). See Table 17.

[0195] Table 17 Comparison of diastolic blood pressure of self-measured blood pressure at home two weeks after the end

[0196]

[0197] 2.2.6 Analysis of antihypertensive efficacy

[0198] The antihypertensive efficacy of 58 included patients was analyzed. After 2 months of treatment, 14 cases were markedly effective (24.14%), 39 cases were effective (67.24%), 5 cases were ineffective (8.62%), and the total effective rate was 91.38%. See Table 18.

[0199] Table 18 Antihypertensive efficacy after taking medicine

[0200]

[0201] 2.2.7 24-hour ambulatory blood pressure

[0202] The dynamic blood pressure values before and after treatment of the patients were compared and analyzed. After normality test, the dynamic blood pressure values conformed to the normal distribution. Paired sample t-test was used. The results showed that the daytime average SBP, daytime average DBP, nighttime average SBP, nighttime average DBP, 24H average SBP, and 24H average DBP after treatment were lower than those before treatment. There was a statistically significant difference in the daytime average SBP, daytime average DBP, nighttime average SBP, nighttime average DBP, 24H average SBP, and 24H average DBP before and after treatment (P < 0.01). See Table 19.

[0203] Table 19 Comparison of 24-hour ambulatory blood pressure before and after treatment

[0204]

[0205] 2.2.8 24-hour blood pressure coefficient of variation

[0206] The 24-hour blood pressure coefficient of variation of the patients before and after treatment was compared and analyzed. After normality test, the blood pressure coefficient of variation did not conform to the normal distribution. Paired sample rank sum test was used. The results showed that the 24-hour blood pressure coefficient of variation after treatment was lower than that before treatment. There was a statistically significant difference in the 24-hour blood pressure coefficient of variation before and after treatment (P < 0.01). See Table 20.

[0207] Table 20 Comparison of 24-hour blood pressure coefficient of variation before and after treatment

[0208]

[0209] 2.2.9 Total cholesterol (CHO)

[0210] The total cholesterol (CHO) of the patients before and after treatment was compared and analyzed. After normality test, the CHO before and after treatment conformed to the normal distribution. Paired sample t-test was used. The results showed that the CHO after treatment was lower than that before treatment. There was a statistically significant difference in the CHO before and after treatment (P < 0.01). See Table 21.

[0211] Table 21 Comparison of CHO before and after intervention

[0212]

[0213] 2.2.10 Triglyceride (TG)

[0214] The triglyceride (TG) of the patients before and after treatment was compared and analyzed. After normality test, the TG before and after treatment conformed to the normal distribution. Paired sample t-test was used. The results showed that the TG after treatment was lower than that before treatment. There was a statistically significant difference in the TG before and after treatment (P < 0.01). See Table 22.

[0215] Comparison of TG before and after intervention in Table 22

[0216]

[0217] 2.2.1 Low-density lipoprotein (LDL-C)

[0218] The low-density lipoprotein (LDL-C) of the patients before and after treatment was analyzed by pre-post comparison. After normality test, the LDL-C before and after treatment conformed to the normal distribution. Paired sample t-test was used. The results showed that the LDL-C after treatment was lower than that before treatment, and the difference in TG before and after treatment was statistically significant (P < 0.01). See Table 23.

[0219] Comparison of LDL-C before and after intervention in Table 23

[0220]

[0221] 2.1.12 Doose Hypertension Quality of Life Scale

[0222] The scores of the Doose Hypertension Quality of Life Scale of the patients before and after treatment were analyzed by pre-post comparison. After normality test, the scores of the Doose Hypertension Quality of Life Scale did not conform to the normal distribution. Paired sample rank sum test was used. The results showed that the scores of the Doose Hypertension Quality of Life Scale after treatment were higher than those before treatment, and the difference in the scores of the Doose Hypertension Quality of Life Scale before and after treatment was statistically significant (P < 0.01). See Table 24.

[0223] Comparison of scores of Doose Hypertension Quality of Life Scale before and after intervention in Table 24

[0224]

[0225] 3 Safety analysis

[0226] Patient-related safety indicators: vital signs (body temperature, heart rate, respiration, blood pressure), blood routine, urine routine, liver function, and kidney function did not show any abnormalities or special changes during the experiment.

[0227] Classical cases

[0228] Case 1

[0229] Yang, female, 35 years old, visited the doctor due to "dizziness for 1 year, aggravated for 1 month". She had dizziness, occasional headache, a feeling of the head being wrapped, accompanied by fatigue and shallow sleep. Her blood pressure reached a maximum of 139 / 90 mmHg, and self-measured blood pressure was 135 - 145 / 90 - 100 mmHg. She was given the traditional Chinese medicine composition of the present invention: 30 grams of Astragalus membranaceus, 15 grams of Morinda officinalis, 10 grams of Bombyx batryticatus stir-fried, 15 grams of Plantago asiatica, 20 grams of Gastrodia elata, 15 grams of Alisma orientale, and 10 grams of Pheretima. Decoct in water for oral administration, one dose per day, divided into two portions, one portion in the morning and one portion in the evening. After taking the medicine for 1 month, all symptoms were greatly reduced, and blood pressure monitoring showed 120 - 130 / 80 - 85 mmHg.

[0230] Case 2

[0231] Wu, female, 42 years old, visited the doctor due to "dizziness for 1 year, aggravated for 10 days". One year ago, her blood pressure was measured at 138 / 89 mmHg during a physical examination and was not taken seriously. Ten days ago, she had dizziness, and her blood pressure was measured at 136 / 87 mmHg. She had dizziness, headache, fear of cold, insomnia, and slight swelling of the lower extremities. After taking the traditional Chinese medicine composition of the present invention: 60 grams of Astragalus membranaceus, 15 grams of Morinda officinalis, 10 grams of Bombyx batryticatus stir-fried, 15 grams of Plantago asiatica, 30 grams of Gastrodia elata, 20 grams of Alisma orientale, and 10 grams of Pheretima. Decoct in water for oral administration, one dose per day, divided into two portions, one portion in the morning and one portion in the evening. After taking the medicine for 1 month, dizziness and fear of cold disappeared, sleep improved, and blood pressure monitoring showed 110 - 120 / 70 - 85 mmHg.

[0232] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limitations on the implementation manners of the present invention. For those of ordinary skill in the art, based on the above description, other different forms of changes or variations can be made. It is impossible to enumerate all the implementation manners here. Any obvious changes or variations derived from the technical solutions of the present invention still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating primary hypertension, characterized in that, The traditional Chinese medicine composition is mainly prepared from the following raw materials by weight: 20 - 60 parts of astragalus membranaceus, 10 - 20 parts of morinda officinalis, 10 - 20 parts of stir-fried bombyx batryticatus, 10 - 20 parts of plantago asiatica, 10 - 30 parts of gastrodia elata, 10 - 20 parts of alisma orientale, 10 - 20 parts of pheretima aspergillum.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is mainly prepared from the following raw materials by weight: 30 parts of astragalus membranaceus, 15 parts of morinda officinalis, 10 parts of stir-fried bombyx batryticatus, 15 parts of plantago asiatica, 20 parts of gastrodia elata, 15 parts of alisma orientale, 10 parts of pheretima aspergillum.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly prepared from the following raw materials by weight: 60 parts of astragalus membranaceus, 15 parts of morinda officinalis, 10 parts of stir-fried bombyx batryticatus, 15 parts of plantago asiatica, 30 parts of gastrodia elata, 20 parts of alisma orientale, 10 parts of pheretima aspergillum.

4. The traditional Chinese medicine composition according to claim 1, wherein, The traditional Chinese medicine composition is mainly prepared from the following raw materials by weight: 40 parts of astragalus membranaceus, 15 parts of morinda officinalis, 10 parts of stir-fried bombyx batryticatus, 15 parts of plantago asiatica, 30 parts of gastrodia elata, 15 parts of alisma orientale, 10 parts of pheretima aspergillum.

5. The preparation method of the traditional Chinese medicine composition for treating primary hypertension according to any one of claims 1-4, characterized in that, The preparation method includes: (1) Weigh astragalus membranaceus, morinda officinalis, stir-fried bombyx batryticatus, plantago asiatica, gastrodia elata, alisma orientale and pheretima aspergillum according to the prescription amount, and soak them in water for 20 - 30 minutes; (2) Decoct with slow fire until boiling and then continue to decoct for 20 - 30 minutes, decocting twice in total; (3) Combine the two decoction liquids, filter, and obtain the product.

6. The preparation method according to claim 5, characterized in that, The preparation method further includes the step of concentrating the filtrate obtained by filtering in step (3) into an extract; optionally, further drying the extract into powder.

7. A traditional Chinese medicine preparation for treating primary hypertension, characterized in that, The traditional Chinese medicine preparation uses the traditional Chinese medicine composition described in any one of claims 1 - 4, or the traditional Chinese medicine composition prepared by the preparation method described in any one of claims 5 - 6 as the active ingredient.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The traditional Chinese medicine preparation further includes pharmaceutically acceptable excipients.

9. The traditional Chinese medicine preparation according to claim 7, wherein, The dosage form of the traditional Chinese medicine preparation is decoction, granule, pill, capsule, tablet, powder, plaster or oral liquid.

10. Use of the traditional Chinese medicine composition for treating essential hypertension described in any one of claims 1 - 4, or the traditional Chinese medicine composition prepared by the preparation method described in any one of claims 5 - 6, or the traditional Chinese medicine preparation for treating essential hypertension described in any one of claims 7 - 9 in the preparation of any one of the following drugs: (1) Use in the preparation of a drug for treating essential hypertension; (2) Use in the preparation of a drug for treating yang deficiency and phlegm dampness type essential hypertension; (3) Use in the preparation of a drug for treating normal high value blood pressure or grade 1 hypertension.

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