A traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations and reducing pulse pressure difference, and its preparation method and application

Abstract

The present invention belongs to the field of medical science and relates to a traditional Chinese medicine, specifically to a traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference, as well as its preparation method and application. The formula of the composition is: Astragalus membranaceus, Phellodendron amurense, Scutellaria baicalensis, Angelica sinensis, Magnolia officinalis, Panax ginseng, Cimicifuga foetida, Gastrodia elata, Pinellia ternata, Amomum villosum, Asarum sieboldii, Psoralea corylifolia, Atractylodes lancea stir-fried with bran, Atractylodes macrocephala, Citrus reticulata, Poria cocos, Bupleurum chinense, and roasted Glycyrrhiza uralensis. The traditional Chinese medicine of the present invention treats senile hypertension from the perspective of upward flaring of qi deficiency and yin fire by supplementing primordial qi, promoting the spleen to consolidate and astringe, reducing yin fire, absorbing floating yang, ascending the clear and descending the turbid. It can reduce blood pressure, stabilize blood pressure fluctuations, reduce pulse pressure difference, improve unstable blood pressure, reduce the use of western medicine antihypertensive drugs, with significant curative effects and few safety problems.

Description

Technical Field

[0001] The present invention belongs to the field of medical science, and relates to a traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference, and a preparation method and application thereof. Background Art

[0002] Senile hypertension is clinically common. Its clinical characteristics are multiple and complex symptoms, high systolic blood pressure, increased pulse pressure difference, increased blood pressure variability, and unstable blood pressure fluctuations. Its pathogenesis is complex and involves multiple factors. It is more likely to cause serious damage to target organs such as the heart, brain, and kidneys, and is likely to lead to stroke precursors, cerebral infarction, and cerebral hemorrhage, with a relatively high fatality rate and disability rate. It has become an important public health problem threatening the lives and health of the elderly population. The main treatment of modern medicine for senile hypertension is blood pressure lowering, but it has poor effects on large blood pressure fluctuations and increased pulse pressure difference.

[0003] At present, the treatment of senile hypertension in traditional Chinese medicine mostly focuses on treating from the aspects of internal movement of liver wind, deficiency of both yin and yang, etc. Although certain curative effects can be achieved, there are still problems such as poor blood pressure lowering effect, large blood pressure variability, large blood pressure fluctuations, and low blood pressure, which are not conducive to the long-term prognosis of patients. Summary of the Invention

[0004] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference.

[0005] The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference.

[0006] The present invention also provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of antihypertensive drugs.

[0007] The technical solution adopted by the present invention to achieve the above object is as follows:

[0008] The present invention provides a traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference, which comprises the following raw materials in parts by weight: 15 - 45 g of Astragalus membranaceus, 9 - 45 g of Phellodendron amurense, 6 - 15 g of Scutellaria baicalensis, 6 - 15 g of Angelica sinensis, 6 - 15 g of Magnolia officinalis, 10 - 20 g of Panax ginseng, 6 - 15 g of Cimicifuga foetida, 6 - 15 g of Gastrodia elata, 6 - 15 g of Pinellia ternata, 10 - 20 g of Amomum villosum, 1 - 6 g of Asarum heterotropoides, 10 - 20 g of Psoralea corylifolia, 6 - 15 g of Atractylodes lancea stir-fried with bran, 10 - 20 g of Atractylodes macrocephala, 6 - 15 g of Citrus reticulata, 6 - 15 g of Poria cocos, 6 - 15 g of Bupleurum chinense, 10 - 20 g of roasted Glycyrrhiza uralensis.

[0009] Most preferably, the formula of the traditional Chinese medicine composition provided by the present invention is: raw medicinal materials including the following components, by weight: 24 g of Astragalus membranaceus, 21 g of Phellodendron amurense, 9 g of Scutellaria baicalensis, 9 g of Angelica sinensis, 9 g of Magnolia officinalis, 12 g of Panax ginseng, 9 g of Cimicifuga foetida, 6 g of Gastrodia elata, 9 g of Pinellia ternata, 15 g of Amomum villosum, 3 g of Asarum sieboldii, 12 g of Psoralea corylifolia salted, 9 g of Atractylodes lancea stir-fried with bran, 15 g of Atractylodes macrocephala, 9 g of Citrus reticulata, 6 g of Poria cocos, 9 g of Bupleurum chinense, 15 g of Glycyrrhiza glabra roasted.

[0010] The traditional Chinese medicine composition provided by the present invention may further include 6 - 15 g of dried ginger by weight.

[0011] The traditional Chinese medicine composition provided by the present invention may further include 6 - 18 g of Artemisia capillaris and 6 - 15 g of Ligusticum wallichii by weight.

[0012] The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition, including the following steps: Weigh the raw medicinal materials according to the weight for each dose, soak them in warm water for 180 - 360 minutes, add water to submerge the raw medicinal materials by about 1 - 2 cm, decoct the raw medicinal materials twice, for the first decoction, boil for 60 - 90 minutes after boiling, for the second decoction, boil for 60 minutes after boiling, and then combine the two decoctions.

[0013] The present invention also provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of antihypertensive drugs.

[0014] The usage and dosage of the composition provided by the present invention: Decoct in water for oral administration. Weigh the raw medicinal materials according to the weight for each dose, soak them in warm water for 180 - 360 minutes, add water to submerge the raw medicinal materials by about 1 - 2 cm, decoct the raw medicinal materials twice, for the first decoction, boil for about 60 minutes after boiling, for the second decoction, boil for about 60 minutes after boiling, combine the two decoctions to get a total of 400 ml. In the initial stage of treatment, it can be combined with the conventional antihypertensive western medicine valsartan for treatment. Warmly take 200 ml each time, 2 hours after breakfast and dinner, one dose per day.

[0015] Combined with previous clinical and experimental studies, the present invention proposes that "deficiency of primordial qi and upward flaring of yin-fire" is the key and characteristic pathogenesis leading to senile hypertension, thus presenting a series of symptoms such as "dizziness due to cerebral arteriosclerosis, large blood pressure fluctuations, unstable blood pressure, stroke precursors", such as: dizziness of the head and eyes, bitter taste or dryness in the mouth, irritability and anger, fatigue, listlessness of the body and limbs, lack of qi and disinclination to speak, insomnia, poor appetite, dizziness and about to fall, unsteady gait, head shaking and limb tremors, dryness and pain in the throat, numbness and tremors of the limbs, large blood pressure fluctuations, unstable blood pressure, loose stools, pale and swollen tongue, greasy tongue coating, slow and soggy or string-like pulse, etc.

[0016] "Qi deficiency and Yin fire rushing up" is the main pathogenesis of hypertension and complications in the elderly: elderly patients, old and weak, spleen dysfunction, deficiency of vital energy, manifested as fatigue, fatigue, limb laziness, lack of breath and laziness, poor appetite. Water and grain essence cannot be transformed, gathered into phlegm and dampness, and phlegm turbidity blocks the middle, spleen and stomach ascending and descending disorder, clear yang does not rise, turbid yin offends, and dizziness, lack of breath and laziness. Deficiency of spleen and stomach vital energy, sinking of vital energy, Yin fire rushing up, head orifice failure to nourish, then it is dizziness, bitter mouth or dry mouth, Yin fire rushing up causes impatience and irritability, unstable blood pressure, large blood pressure fluctuations, and apoplexy. Therefore, it is believed that "Qi deficiency and Yin fire rushing up" is the key and characteristic pathogenesis of hypertension in the elderly. So the Chinese medicine of the present invention treats hypertension in the elderly from Qi deficiency and Yin fire rushing up by replenishing vital energy, transporting spleen and consolidating, reducing Yin fire, collecting floating yang, raising clear and lowering turbidity.

[0017] The prescription of the Chinese medicine of the present invention is based on:

[0018] (I) Formula analysis:

[0019] Astragalus is sweet and warm in nature. The New Compendium of Materia Medica believes that "Astragalus is a holy medicine for replenishing qi". The Compendium of Materia Medica says: (Astragalus) rises and floats... Raw use can purge fire, and roasted use can replenish the middle"; Ginseng is sweet, bitter and warm, enters the spleen and lung meridians, greatly replenishes vital energy, replenishes the spleen and lungs; Atractylodes macrocephala tastes sweet, bitter and warm in nature, enters the spleen and stomach meridians, and "Ben Jing Chong Yuan" says: "If you want to replenish the spleen, use Atractylodes macrocephala". Therefore, the Chinese medicine of the present invention adds Astragalus, ginseng and Atractylodes macrocephala to play the effect of replenishing qi and strengthening the spleen.

[0020] Atractylodes is pungent, fragrant, bitter and warm, enters the spleen and stomach meridians, and is an important medicine for drying dampness, moving the spleen and resolving phlegm; Pinellia is pungent and warm, dries dampness and resolves phlegm, eliminates lumps and resolves knots, and the "New Compendium of Materia Medica" believes that it is "very effective in treating phlegm and saliva"; Magnolia officinalis is bitter, pungent and warm, dries dampness and resolves phlegm, relieves qi and eliminates fullness; Tangerine peel is pungent in taste and warm in nature, regulates qi and harmonizes the stomach, dries dampness and resolves phlegm; Poria cocos is sweet, mild and flat, and is an important medicine for diuresis and dehumidification. "Compendium of Materia Medica" says: "When dampness stagnates spleen yang, it cannot be relieved without the strong fragrance of Atractylodes lancea." Therefore, the Chinese medicine of the present invention adds Atractylodes lancea, Pinellia ternata, Tangerine peel, and Magnolia officinalis to aromatically wake up the spleen, dry dampness and resolve phlegm, and Poria cocos is diuretic and infiltrates dampness, so that damp phlegm can be removed and the spleen can be healthy and operated.

[0021] Bupleurum enters the liver and gallbladder meridians and promotes the qi of Shaoyang; Cimicifuga enters the spleen and stomach meridians and promotes the qi of Yangming. Together, they help Huangqi promote the qi of Qingyang. Blood is the mother of qi, so Angelica sinensis is added to nourish blood and nourish the body. Amomum villosum is pungent and warm, invigorates the spleen and stomach, absorbs qi and returns it to the kidney, and places the fire under the earth; Phellodendron chinense is bitter and cold, clears and drains the false fire, and guides the Yin fire that rushes upward to descend; Roasted Licorice root is sweet and warm, replenishes the earth and suppresses the fire, and the three together play the effect of collecting the floating Yang. Scutellaria baicalensis is bitter and cold, and helps Huangbai clear the Yin fire that rushes upward. Asarum is pungent and warm, and is good at moving around, and can dredge blood stasis. Gastrodia elata is sweet and flat, enters the liver meridian, calms the liver and suppresses yang, and stops wind and spasms. Psoralea corylifolia replenishes the yang qi of the spleen and kidney, which can prevent Scutellaria baicalensis and Phellodendron chinense from being too bitter and cold and damaging the spleen and stomach.

[0022] (II) Modern pharmacological research

[0023] Modern pharmacological studies have shown that astragalus can enhance the physiological metabolism of cells and has the effects of enhancing immunity, anti-fatigue, anti-myocardial ischemia, and anti-aging. Ginsenosides have the effect of protecting against myocardial ischemia-reperfusion injury and can significantly reduce the myocardial infarction area and myocardial enzymes. Ginsenoside Rg1 can inhibit apoptosis, inflammatory responses, and regulate energy metabolism through multiple pathways such as inhibiting excessive mitochondrial autophagy, downregulating the nuclear factor-κB pathway, and RhoA signaling pathway. The index component of atractylodes macrocephala, atractylenolide, has the effect of inhibiting platelet aggregation, and its mechanism may be related to regulating the MAPK and PI3K-Akt signaling pathways during platelet activation. The index compounds of atractylodes macrocephala, atractylenolide components and atractylodes macrocephala polysaccharides, have significant anti-inflammatory activities. Atractylenolide I and III can significantly inhibit the production of TNF-α, IL-1β, and IL-6 by M1 macrophages and increase the protein expression levels of arginase-1, CCL22, and transforming growth factor-β. Atractylodes lancea can directly act on gastrointestinal smooth muscle to achieve a dual regulatory effect on gastrointestinal motility, and its acetone extract can significantly promote gastrointestinal motility. The decoction of magnolia officinalis has an inhibitory effect on the isolated heart, and the water-soluble substance of the tincture of magnolia flower has a hypotensive effect. Pinellia ternata has a significant anti-inflammatory effect, and its mechanism may be that pinellia ternata has a glucocorticoid-like effect. Pinellia ternata also has an antioxidant effect. In vitro antioxidant experiments of pinellia ternata polysaccharide show that it has scavenging effects on oxygen free radicals and DPPH. Tangerine peel can relieve gastrointestinal smooth muscle spasm, inhibit gastrointestinal smooth muscle, reduce the tonicity of the isolated intestinal tract of animals, and counteract the spastic contraction of intestinal smooth muscle caused by acetylcholine. The volatile oil of tangerine peel can promote gastric juice secretion and help digestion. Poria cocos has an anti-inflammatory effect and has good curative effects on both acute and chronic inflammations. Poria cocos also has the effects of reducing blood sugar, weight loss, and regulating blood lipids. Bupleurum chinense has a wide range of central inhibitory effects, such as sedation, tranquility, analgesia, antipyretic, and antitussive effects. The active ingredient in bupleurum chinense, saikosaponin, has the effect of regulating blood lipids and can prevent atherosclerosis. The active ingredient of cimicifuga foetida, cimicifugoside, can inhibit the heart, slow down the heart rate, and lower blood pressure. Angelica sinensis has an anti-inflammatory effect and can inhibit the release of inflammatory mediators such as interleukin-6 (IL-6), nitric oxide (NO), tumor necrosis factor-α (TNF-α), IL-1β, and prostaglandin E2 (PGE2). Angelica sinensis has obvious curative effects on patients with cardiovascular and cerebrovascular diseases and can better prevent and treat diseases such as hyperlipidemia, hypertension, and atherosclerosis. Amomum villosum has a gastrointestinal protective effect, can resist gastric ulcers, affect gastrointestinal motility and the bioelectricity of gastrointestinal cells. In addition, amomum villosum also has certain effects of reducing blood sugar and weight loss. Phellodendron amurense has a significant anti-inflammatory effect and can inhibit the activation of NF-κB by degrading and phosphorylating the inhibitor protein of nuclear factor κB. Phellodendron amurense also has an antioxidant effect, and its antioxidant activity is proportional to the concentration of its extract. The ethanol extract of phellodendron amurense shows better antioxidant effects. Honey-fried licorice has pharmacological effects such as analgesia, antitussive and antiasthmatic, anti-arrhythmia, anti-inflammatory, and immunomodulation.Scutellaria baicalensis can play roles in anti - inflammation, antioxidant, anti - colon cancer, anti - immunity and kidney protection through mechanisms such as inhibiting the expression of inflammatory factors and free radicals, inducing apoptosis, and reducing the expression level of Bax protein. Asarum sieboldii not only has pharmacological activities such as analgesia, anti - inflammation, relieving cough and asthma, but also has effects such as antiviral, antibacterial, sedative, antioxidant, antidepressant, blood pressure lowering, and inhibiting cancer cells. Gastrodia elata has pharmacological effects on the nervous system such as sedation, analgesia, anti - convulsion, and memory improvement. Gastrodia elata has certain pharmacological activities on blood vessels, heart, blood pressure, etc., has significant anticoagulant and antithrombotic effects, and can also stimulate angiogenesis, which is beneficial to the treatment of ischemic cardiovascular diseases and atherosclerosis. In addition, Gastrodia elata can lower the blood pressure of spontaneously hypertensive rats. Psoralea corylifolia has multiple pharmacological effects such as anti - osteoporosis, neuroprotection, anti - tumor, estrogen - like, and anti - inflammation.

[0024] The beneficial effects of the traditional Chinese medicine provided by the present invention for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure are as follows:

[0025] 1) The traditional Chinese medicine of the present invention combines traditional Chinese and Western medicine for treatment. By tonifying primordial qi, promoting the spleen to secure and hold, reducing yin fire, receiving and absorbing floating yang, ascending the clear and descending the turbid, it treats senile hypertension from the syndrome of qi deficiency and upward - rushing yin fire. It can lower blood pressure, stabilize blood pressure fluctuations, reduce pulse pressure, improve unstable blood pressure, reduce the use of Western medicine antihypertensive drugs, has significant curative effects, and has few safety problems. It can significantly improve symptoms such as dizziness, bitter or dry mouth, irritability, unsteady gait, fatigue, listlessness of the body and limbs, lack of qi and disinclination to talk, poor appetite, dizziness, and lack of qi and disinclination to talk. It can significantly improve unstable blood pressure, stroke precursors, reduce the 24 - hour blood pressure variability coefficient, reduce blood pressure variability, stabilize blood pressure fluctuations, reduce pulse pressure, and thus can have a certain preventive effect on cerebral infarction and cerebral hemorrhage.

[0026] 2) Treating senile hypertension from the syndrome of qi deficiency and yin fire not only has definite therapeutic effects, but also has sufficient theoretical bases in traditional Chinese medicine and modern medicine, providing new ideas and drugs for the integrated traditional Chinese and Western medicine treatment of senile hypertension.

[0027] 3) Reasonably selecting Chinese herbal medicines has the characteristics of relieving patients' symptoms and reducing the side effects of Western medicines. Detailed implementation mode

[0028] The beneficial effects of the traditional Chinese medicine of the present invention are further illustrated below through clinical trial data and specific examples. Clinical trial:

[0029] Objective: To mainly observe the effects of Guben Jiangya Decoction on the curative effect and related indexes of senile hypertension.

[0030] I. Case selection

[0031] (I) Diagnostic criteria

[0032] 1. Western medicine diagnostic criteria

[0033] 1) Diagnostic criteria for senile hypertension

[0034] According to the latest "2019 Chinese Guidelines for the Management of Senile Hypertension" in 2019, for those aged ≥ 65 years old, without the use of antihypertensive drugs, if the systolic blood pressure (SBP) ≥ 140 mmHg (1 mmHg = 0.133 kPa) and / or diastolic blood pressure (DBP) ≥ 90 mmHg in three non - consecutive measurements, it can be diagnosed as senile hypertension. For the elderly who have been clearly diagnosed with hypertension and are receiving antihypertensive drug treatment, even if the blood pressure is < 140 / 90 mmHg, they should also be diagnosed as senile hypertension. The grading method of senile hypertension is the same as that of general adults. As shown in the table:

[0035] Table 1 Definition and classification of blood pressure levels in the elderly

[0036]

[0037]

[0038] Note: When the systolic blood pressure and diastolic blood pressure belong to different levels, the higher level shall prevail. Isolated systolic hypertension is classified according to the systolic blood pressure level.

[0039] 2. TCM diagnostic criteria

[0040] 1) Diagnostic criteria for dizziness

[0041] Formulated according to the "Diagnostic and Therapeutic Criteria for TCM Syndromes", "Guiding Principles for Clinical Research of New Chinese Medicines" and "Internal Medicine of Traditional Chinese Medicine" promulgated by the State Administration of Traditional Chinese Medicine of China:

[0042] ① Dizziness and vertigo, with visual rotation. In mild cases, it stops when closing the eyes. In severe cases, it is like sitting in a car or boat, and in extremely severe cases, the patient may even fall down.

[0043] ② It may be accompanied by nausea, vomiting, nystagmus, tinnitus, deafness, sweating, pale complexion, etc.

[0044] ③ It has a chronic onset with gradual aggravation, or an acute onset, or repeated attacks.

[0045] ④ Measuring blood pressure, checking hemoglobin, red blood cell count, electrocardiogram, electro - audiometry, brainstem evoked potential, electronystagmogram, cervical spine X - ray film, transcranial Doppler, etc. are helpful for a clear diagnosis. CT and magnetic resonance examinations can be done if conditions permit.

[0046] ⑤ It should be noted that this test is to explore dizziness caused by hypertension, and tumors, nervous system diseases, severe blood diseases, etc. should be excluded.

[0047] 2) Diagnostic criteria for the TCM syndrome types of qi deficiency and dampness excess, primordial qi deficiency, upward disturbance of wind - yang, and upward flaring of yin - fire

[0048] According to the Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes and the National Standard of the People's Republic of China - Traditional Chinese Medical Clinical Diagnosis and Treatment Terms - Syndromes Section, the diagnostic criteria for qi deficiency with dampness preponderance, primordial qi deficiency, upward disturbance of wind-yang, and upward flaring of yin-fire syndromes are formulated as follows:

[0049] Dizziness, tinnitus, lassitude of the body and limbs, lack of qi and disinclination to speak, poor appetite, flushed face, red eyes, restlessness and irritability, head shaking and limb tremors, numbness of the limbs, bitter taste in the mouth, dryness of the mouth and throat, insomnia, loose stools, pale and plump tongue, greasy tongue coating, soggy and slow or string-like pulse, etc.

[0050] 3) Grading and Quantification Criteria for Traditional Chinese Medical Symptoms

[0051] Formulated with reference to the Guidelines for Clinical Research of New Traditional Chinese Medicines:

[0052]

[0053]

[0054]

[0055]

[0056] (II) Inclusion Criteria for Cases

[0057] 1. Meeting the criteria for qi deficiency with dampness preponderance, primordial qi deficiency, upward disturbance of wind-yang, and upward flaring of yin-fire syndromes.

[0058] 2. Meeting the diagnostic criteria for traditional Chinese medical headache or dizziness and the diagnostic criteria for senile hypertension in Western medicine.

[0059] 3. Age ≥ 65 years old.

[0060] 4. Signing the informed consent form.

[0061] (III) Exclusion Criteria for Cases

[0062] 1. Not meeting the diagnostic criteria for qi deficiency with dampness preponderance, upward disturbance of wind-yang, and upward flaring of yin-fire syndromes.

[0063] 2. Secondary hypertension, such as hypertension caused by renal parenchymal diseases and renal vascular stenosis, pheochromocytoma, primary aldosteronism, etc., and hypertension caused by taking drugs such as ephedrine.

[0064] 4. Those with a history of hypertension but whose blood pressure has been normal without taking medicine in the past 3 months.

[0065] 6. Age below 65 years old,

[0066] 7. Those allergic to the ingredients contained in the observed drugs; those with contraindications to angiotensin II receptor inhibitor (ARB) drugs; those who cannot be followed up regularly.

[0067] 8. The patient is in a critical condition and it is difficult to make an accurate evaluation of the effectiveness and safety of treatment.

[0068] (IV) Criteria for termination of observation of cases

[0069] 1. The treatment is over.

[0070] 2. The treatment plan needs to be changed due to changes in the patient's condition, such as serious adverse reactions or worsening of the condition.

[0071] 3. Patients with poor compliance who go against the observer's wishes.

[0072] 2. Observation and treatment methods

[0073] 1. Grouping and treatment

[0074] By collecting cases of elderly patients with hypertension who visited the outpatient clinic or ward of the Department of Cardiology of Shandong Provincial Hospital of Traditional Chinese Medicine from June 2020 to October 2022. Randomly divided into an experimental group and a control group, a basic information table of elderly hypertension was formulated, and information was collected. The content of both samples was preset to 40 cases.

[0075] The statistical analysis of the TCM clinical symptoms of the above 80 patients showed that 66 cases (83%) had dizziness, 44 cases (55%) had tinnitus, 50 cases (63%) had fatigue and limb laziness, 43 cases (54%) had shortness of breath and laziness to speak, 54 cases (68%) had poor appetite, 52 cases (65%) had flushed face, 45 cases (56%) had red eyes, 58 cases (73%) had irritability, 37 cases (46%) had head shaking and limb tremors. %), 45 cases (56%) had limb numbness, 54 cases (68%) had bitter taste in the mouth, 56 cases (70%) had dry mouth and throat, 66 cases (83%) had insomnia, 48 cases (60%) had loose stools, 44 cases (55%) had pale and fat tongue, and 68 cases (85%) had greasy tongue coating, indicating that the above-mentioned elderly hypertensive patients do have symptoms of spleen deficiency and dampness, wind-yang disturbance, and yin-fire rushing up, which can be used to verify the efficacy of the Chinese medicine of the present invention.

[0076] The treatment plans for the experimental group and the control group are as follows:

[0077] Basic treatment: diet adjustment and exercise therapy.

[0078] Control group: basic treatment + oral antihypertensive drugs: valsartan 80 mg qd (Diovan).

[0079] Experimental group: basic treatment + oral antihypertensive drugs: valsartan 80mg qd (Diovan) + Guben Jiangya Decoction treatment.

[0080] Ordinary patients in the experimental group took this Chinese medicine.

[0081] Guben Jiangya Decoction: Astragalus membranaceus 24g, Ginseng 12g, Cimicifuga foetida 9g, Bupleurum chinense 9g, Atractylodes macrocephala 15g, Atractylodes lancea stir-fried with bran 12g, Magnolia officinalis 9g, Amomum villosum 15g, Pinellia ternata 9g, Gastrodia elata 6g, Angelica sinensis 9g, Scutellaria baicalensis 9g, Phellodendron amurense 21g, Poria cocos 6g, Citrus reticulata 9g, Psoralea corylifolia salted 12g, Asarum sieboldii 3g, Licorice roasted 15g. For patients with spleen and stomach yang deficiency, the optional raw material drug Dry Ginger can be added on the basis of Formula 1 to warm and tonify the middle energizer. Valsartan can be taken in combination in the early stage. Warmly taken 1 hour after breakfast and dinner, 100 ml each time, one dose per day.

[0082] Course of treatment: Two weeks is a course of treatment, and two courses of treatment are carried out.

[0083] (2) Observation items and related indicators

[0084] 1. Safety indicators

[0085] 1) General physical examination items.

[0086] 2) Routine blood, urine, and stool examinations. Check once before and after treatment.

[0087] 3) Liver and kidney functions, blood biochemical examinations. Check once before and after treatment.

[0088] 4) Possible adverse reactions.

[0089] 2. Antihypertensive efficacy indicators and evaluation criteria

[0090] The antihypertensive efficacy is determined by the change in systolic blood pressure. Measure the 24-hour ambulatory blood pressure once before and after the trial. According to the measured ambulatory blood pressure values, calculate the 24-hour average systolic blood pressure (24h SBP), 24-hour average diastolic blood pressure (24h DBP), 24-hour systolic blood pressure standard deviation (24h SSD), and 24-hour diastolic blood pressure standard deviation (24h DSD) respectively. The evaluation criteria for blood pressure efficacy are as follows:

[0091] 1) Marked effect: The blood pressure value drops by 10 mmHg or more and reaches the normal range; or although the blood pressure value has not dropped to normal, it has dropped by 20 mmHg or more.

[0092] 2) Effective: The blood pressure value drops by less than 10 mmHg but reaches the normal range; or drops by 10 - 19 mmHg but does not reach the normal range.

[0093] 3) Ineffective: Does not meet the above criteria.

[0094] 3. Physical and chemical indicators

[0095] Electrocardiogram examination and echocardiogram examination tests.

[0096] 4. Reduction and discontinuation rate of antihypertensive drugs

[0097] Calculation formula: (Dose before treatment - Dose after treatment) / Dose before treatment * 100%

[0098] 5. Coefficient of variation (CV) of blood pressure in 24 hours

[0099] Calculation formula: 24h SBP-CV = 24h SSD / 24h SBP * 100%

[0100] 24h DBP-CV = 24h DSD / 24h DBP * 100%

[0101] 6. Therapeutic effect of traditional Chinese medicine symptoms

[0102] Dizziness, tinnitus, fatigue, listlessness, shortness of breath, poor appetite, flushed face, irritability, head shaking and limb tremors, limb numbness, bitter taste in the mouth, dry mouth and throat, insomnia, loose stools, pale and swollen tongue, greasy tongue coating, slow and rolling or string-like pulse, etc.

[0103] The changes of traditional Chinese medicine symptoms are scored according to the traditional Chinese medicine symptom scoring method. The grading and quantification of traditional Chinese medicine symptoms are scored according to the above-mentioned grading and quantification standards of traditional Chinese medicine symptoms. Normal is 0 point, mild is 2 points, moderate is 4 points, and severe is 6 points.

[0104] 1) Total therapeutic effect and judgment criteria of traditional Chinese medicine symptoms

[0105] Formulated according to the relevant regulations in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", and the total therapeutic effect of traditional Chinese medicine syndromes is judged according to the scoring method.

[0106] ① Clinical cure: All or basically all the original symptoms and signs disappear, and the total score decreases by > 95%;

[0107] ② Marked effect: All the original symptoms basically disappear, and the total score decreases by > 70%;

[0108] ③ Effective: The original symptoms are significantly relieved, and the total score decreases by > 30% and < 70%;

[0109] ④ Ineffective: The original symptoms have no obvious improvement, or the symptoms are aggravated compared with before, and the total score decreases by < 30%.

[0110] Note: Calculation formula = {(Score before treatment - Score after treatment) / Score before treatment} × 100%

[0111] 2) Therapeutic effect and judgment criteria of single traditional Chinese medicine symptoms (refer to the above)

[0112] ① Clinical cure: All or basically all the original symptoms and signs disappear, and the total score decreases by > 95%;

[0113] ② Marked effect: All the original symptoms basically disappear, and the total score decreases by > 70%;

[0114] ③Effective: The original symptoms were significantly reduced, and the total score decreased by > 30% and < 70%.

[0115] ④Ineffective: The original symptoms did not improve significantly, or the symptoms worsened compared with before, and the total score decreased by < 30%.

[0116] (III) Statistical methods

[0117] The obtained data were statistically processed using spss 25.0 software. Analysis of variance was used for measurement data, independent t-tests were used between groups, and paired t-tests were used within groups before and after treatment. is expressed as; chi-square tests were used for count data, and Ridit analysis was used for ranked data. 2

[0118] III. Clinical data

[0119] (I) General information

[0120] A total of 80 cases were selected, all from the cardiac medicine ward and outpatient clinic of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Among them, there were 40 cases in the experimental group and 40 cases in the control group. The gender composition, age, and course of disease of the two groups are shown in Tables 2 and 3.

[0121] Table 2 Gender composition of the two groups

[0122]

[0123] Note: Chi-square tests were used for comparison between the two groups, *p < 0.05, **p < 0.01.

[0124] Table 3 Age and course of disease of the two groups

[0125]

[0126] Note: Independent t-tests were used for comparison between groups, *p < 0.05, **p < 0.01.

[0127] (II) Disease conditions and signs

[0128] The blood pressure conditions of the two groups of patients were mainly collected and analyzed. See Table 4.

[0129] Table 4 Comparison of blood pressure between the two groups

[0130]

[0131] Note: Independent t-tests were used for comparison between groups, *p < 0.05, **p < 0.01.

[0132] IV. Research results

[0133] (I) Blood pressure lowering efficacy (see Table 5)

[0134] Comparison of the curative effects of systolic blood pressure and diastolic blood pressure between two groups

[0135]

[0136] Note: Paired t-test was used for within-group comparison, * p < 0.05, ** p < 0.01; independent t-test was used for between-group comparison, △p < 0.05, △△ p < 0.01.

[0137] Table 5 shows that the curative effects of the experimental group and the control group on systolic blood pressure and diastolic blood pressure are significant (p < 0.01) in within-group comparison, and the curative effects of the experimental group on systolic blood pressure and diastolic blood pressure are better than those of the control group (p < 0.05) in between-group comparison.

[0138] Table 6 Comparison of the curative effects of pulse pressure difference between two groups

[0139]

[0140] Note: Paired t-test was used for within-group comparison, *p < 0.05, **p < 0.01; independent t-test was used for between-group comparison, △p < 0.05, △△p < 0.01.

[0141] Table 6 shows that the curative effects of the experimental group and the control group on pulse pressure difference are significant (p < 0.01) in within-group comparison, and the curative effect of the experimental group on reducing pulse pressure difference is better than that of the control group (p < 0.05) in between-group comparison.

[0142] Table 7 Comparison of the antihypertensive curative effects between two groups

[0143]

[0144] Note: There were 40 cases in the experimental group, 20 cases with marked effect, the marked effect rate was 50.0%, 36 cases with effective, and the effective rate was 90.0%, which was better than that of the control group. After Ridit analysis, there was a significant difference (*p < 0.05).

[0145] Table 7 shows that the antihypertensive effective rate of the experimental group reached 90.0%, which was better than that of the control group (p < 0.05).

[0146] (2) 24-hour blood pressure variability coefficient (see Table 8)

[0147] Table 8 Comparison of the curative effects of 24-hour systolic blood pressure and diastolic blood pressure variability between two groups

[0148]

[0149] Note: Paired t-test was used for within-group comparison, *p < 0.05, **p < 0.01; independent t-test was used for between-group comparison, △p < 0.05, △△p < 0.01.

[0150] Table 8 shows that within the group, the experimental group had significant effects on SBP-CV and DBP-CV (p < 0.01), while the control group had a significant effect on SBP-CV (p < 0.01), and there was no significant difference in the effect on DBP-CV. Between-group comparison shows that the effects of the experimental group on SBP-CV and DBP-CV were better than those of the control group (p < 0.01).

[0151] (III) Drug reduction rate (Table 9)

[0152] Table 9 Comparison of valsartan reduction rates between the two groups

[0153]

[0154] Table 9 shows that the valsartan reduction rate in the experimental group was 67.5%, which was better than that of the control group. After Ridit analysis, P < 0.05, indicating a statistically significant difference in the valsartan reduction rates between the experimental group and the control group.

[0155] (IV) Traditional Chinese medicine symptoms

[0156] 1. Total efficacy of traditional Chinese medicine symptoms (see Table 10)

[0157] Table 10 Analysis of the total efficacy of traditional Chinese medicine symptoms in the two groups

[0158]

[0159] Note: As shown in Table 10, the marked efficacy rate of the experimental group was 25%, and the total effective rate was 90%, which was better than that of the control group. After Ridit analysis, there was a significant difference (*p < 0.05).

[0160] 2. Efficacy of single traditional Chinese medicine symptoms (see Table 11)

[0161] Table 11 Comparison of the efficacy of single traditional Chinese medicine symptoms between the two groups

[0162]

[0163] Note: For the comparison of the efficacy between the two groups, the p-values are shown in the above table.

[0164] Table 11 shows that both methods achieved good effects in the treatment of dizziness. After using the traditional Chinese medicine of the present invention, the traditional Chinese medicine symptoms changed significantly compared with the control group. The effective improvement rate for dizziness reached over 90%, and the improvement rates for listlessness, flushing, limb numbness, loose stools, and greasy tongue coating reached over 80%, which were better than those of the control group.

[0165] The above clinical trial results show that the Chinese medicine of the present invention has a definite therapeutic effect on senile hypertension. The Chinese medicine of the present invention can be taken in combination with conventional antihypertensive western medicine in the early stage. In the treatment of 40 elderly patients with hypertension, the blood pressure improvement rate was 50%, and the total effective rate was 90%; the efficacy on blood pressure variability and pulse pressure difference was better than that of the control group; the TCM symptom improvement rate was 13%, and the total effective rate was 90%, which was better than that of the western medicine group alone, and the antihypertensive effect was more obvious.

[0166] Typical Case 1

[0167] The patient, female, Liu, 66 years old, from Lixia District, Jinan City, Shandong Province, visited the cardiology outpatient clinic in 2021 due to "dizziness for more than 3 years and worsening for 6 months."

[0168] Initial visit on 2021-10-30: The patient has had hypertension for 3 years. His blood pressure is relatively stable when he takes valsartan. Recently, his dizziness has worsened due to emotional excitement, which comes and goes, and he is unstable when standing. He occasionally has headaches and tinnitus. He reported that his blood pressure has fluctuated greatly recently, and he has chest tightness, shortness of breath, dry eyes, dry mouth, bitter taste in the morning, fatigue, numbness of the limbs, and occasional unconscious tremors. He is usually anxious and irritable. Stomach bloating, which worsens after eating. Poor appetite, poor sleep, difficulty falling asleep, regular urination, loose stools, 2-3 times a day. The tongue is fat with tooth marks, the tongue is pale, the tongue coating is white and greasy, and the pulse is stringy and slippery. Physical examination: Outpatient BP: 162 / 78mmHg, P: 72 times / min. 24-hour dynamic blood pressure monitoring on October 28, 2021: 24hSBP-CV; 12.6%, 24hDBP-CV: 10.6%; electrocardiogram: 1. Sinus rhythm 2. ST segment depression (I, V5). No obvious abnormalities were found in blood and urine routine tests and liver and kidney function.

[0169] In terms of treatment, the principle is to replenish vital energy, move the spleen and consolidate, contain floating yang, reduce yin fire, raise the clear and reduce turbid, and treat from the perspective of qi deficiency and yin fire rushing up, and take the Chinese medicine formula of the present invention (Guben Jiangya Decoction: Astragalus 24g, Ginseng 12g, Cimicifuga 9g, Bupleurum 9g, Atractylodes 15g, Fried Atractylodes 12g, Magnolia Bark 9g, Amomum 15g, Pinellia 9g, Gastrodia 6g, Angelica 9g, Scutellaria 9g, Phellodendron 21g, Poria 6g, Tangerine Peel 9g, Salt Psoralea 12g, Asarum 3g, and Radix Glycyrrhizae 15g).

[0170] Decoction, one dose per day, taken twice a day with warm water in the morning and evening, for 14 days; combined with conventional antihypertensive valsartan capsules (Western medicine Diovan, 80 mg, Beijing Novartis Pharmaceutical Co., Ltd.) 80 mg / d.

[0171] Second diagnosis on November 13, 2021: The patient's dizziness symptoms were alleviated, and the headache and tinnitus disappeared. The physical strength improved significantly compared with before, the symptoms such as bitter taste in the mouth and dry mouth improved, the anxiety was relieved, and now there is still slight abdominal distension after eating, numbness in the limbs, no tremors recently, normal appetite and sleep, loose stools, twice a day, normal urination, pale tongue, enlarged tongue body, thin white coating, and taut, slippery pulse. Continue to cooperate with the conventional antihypertensive western medicine Diovan, reduce the amount of Phellodendron amurense in Guben Jiangya Decoction to 9g, and take it for another 28 doses.

[0172] Third diagnosis on December 20, 2021: The patient's vertigo symptoms basically disappeared, physical strength was okay, no bitter taste in the mouth, dry mouth, limb numbness and tremors, abdominal distension and other symptoms. The patient reported that the blood pressure was stable recently, normal appetite and sleep, normal defecation and urination, pale tongue, enlarged tongue body, flexible rotation, thin white coating, and gentle pulse. Physical examination: Clinic BP: 140 / 70 mmHg; 24-hour ambulatory blood pressure monitoring on December 19, 2021: 24hSBP-CV: 10.23%, 24hDBP-CV: 8.1%; Electrocardiogram: within the normal range. The patient's blood pressure decreased significantly, electrocardiogram was within the normal range, and there were no obvious abnormalities in blood routine, urine routine and liver and kidney functions during the treatment period.

[0173] Typical medical record 2

[0174] Patient Meng, male, 75 years old, from Gaoqing County, Zibo City, Shandong Province, with a history of hypertension for more than 8 years.

[0175] First diagnosis on November 30, 2021: The patient's blood pressure was unstable recently without obvious inducement, dizziness and head distension, occasional stabbing pain in the head, tinnitus, numbness in the limbs and involuntary muscle tremors, palpitation and chest tightness, fatigue, shortness of breath and reluctance to talk, bitter taste in the mouth and dry mouth, abdominal distension, easy to get angry and anxious, normal appetite, poor sleep and easy to wake up, loose stools, twice a day. Enlarged tongue body, yellow and greasy tongue coating, taut, slippery and rapid pulse. Physical examination: Clinic blood pressure 170 / 75 mmHg. 24-hour ambulatory blood pressure monitoring on November 28, 2021: 24hSBP-CV: 17.6%, 24hDBP-CV: 9.7%; There were no obvious abnormalities in blood routine, urine routine and liver and kidney functions.

[0176] In the treatment, it is based on the principle of tonifying vital energy, reducing pathogenic fire of yin, promoting the function of the spleen and astringing, absorbing floating yang, ascending the clear and descending the turbid, and treating from the syndrome of upward flaring of qi deficiency and pathogenic fire of yin. Take the traditional Chinese medicine formula of the present invention (Guben Jiangya Decoction: Astragalus membranaceus 24g, Panax ginseng 12g, Rhizoma Cimicifugae 9g, Bupleurum chinense 9g, Atractylodes macrocephala 15g, Atractylodes lancea stir-fried with bran 12g, Magnolia officinalis 9g, Amomum villosum 15g, Pinellia ternata 9g, Gastrodia elata 6g, Angelica sinensis 9g, Scutellaria baicalensis 9g, Phellodendron amurense 21g, Poria cocos 6g, Citrus reticulata 9g, Psoralea corylifolia salted 12g, Asarum sieboldii 3g, Glycyrrhiza uralensis roasted 15g).

[0177] Decoct in water for oral administration, one dose per day, warm it and take it twice, morning and evening, for 14 days; cooperate with the conventional antihypertensive valsartan capsule (western medicine Diovan, 80mg, Novartis Pharma AG) 80mg / d.

[0178] Second diagnosis on December 14, 2021: Currently, the patient's dizziness symptoms have been relieved, there has been no tinnitus recently, the blood pressure has mostly stabilized at around 145 / 72 mmHg, the palpitation has improved, symptoms such as fatigue and reluctance to talk have improved, the spirit is okay, the numbness of the limbs and muscle tremors have improved, and there are still dry mouth, bitter taste in the mouth, and chest tightness. The appetite is okay, the sleep is okay, the urine is normal, and the stool is unformed, 1-2 times a day. The tongue is pale, the tongue body is enlarged, the tongue coating is yellow, and the pulse is stringy and slippery. Continue to cooperate with the conventional antihypertensive valsartan capsule, add 15g of Artemisia capillaris and 9g of Ligusticum chuanxiong to the above-mentioned Guben Jiangya Decoction, and take it for another 28 doses.

[0179] Third diagnosis on January 15, 2022: Currently, the patient's dizziness symptoms have basically disappeared, the valsartan capsule has been discontinued, there is no head distension or headache, no palpitations or chest tightness, the limbs are slightly numb, there is no muscle tremor, the physical strength is okay, there is no shortness of breath or reluctance to talk, no dry mouth or bitter taste in the mouth, and no stomach distension. The appetite and sleep are okay, and the defecation and urination are normal. The tongue is pale, the tongue body is faintly enlarged and flexible, the tongue coating is thin and white, and the pulse is gentle. Physical examination: Ambulatory blood pressure monitoring on January 12, 2022: 24hSBP-CV: 11.5%, 24hDBP-CV: 6.1%, outpatient BP: 125 / 69 mmHg. Electrocardiogram: Electrocardiogram within the normal range. During the treatment period, there were no obvious abnormalities in blood and urine routine and liver and kidney functions.

[0180] From the above two implementation cases, it can be seen that in patients with senile hypertension, there are syndromes of "deficiency of primordial qi, qi deficiency and dampness accumulation, upward flaring of yin fire, upward disturbance of wind-yang, and internal stirring of liver wind". The traditional Chinese medicine of the present invention is effective in treatment, tonifying primordial qi and reducing yin fire, promoting the spleen and consolidating and astringing, absorbing the floating yang, ascending the clear and descending the turbid. Treating from the upward flaring of qi deficiency and yin fire is an effective method for treating senile hypertension.

[0181] The traditional Chinese medicine of the present invention is combined with the treatment of traditional Chinese and Western medicine. By tonifying primordial qi, promoting the spleen and consolidating and astringing, reducing yin fire, absorbing the floating yang, ascending the clear and descending the turbid, it treats senile hypertension from the upward flaring of qi deficiency and yin fire. It can reduce blood pressure, reduce the use of western medicine antihypertensive drugs, has significant curative effects, and has few safety problems. It can significantly improve dizziness, bitter taste or dry mouth, irritability, unsteady walking. Symptoms such as fatigue, weakness of the limbs, shortness of breath and reluctance to talk, poor appetite, dizziness, and shortness of breath and reluctance to talk. It can significantly improve unstable blood pressure, stroke precursors, reduce the 24-hour blood pressure variability coefficient, reduce blood pressure variability, and has a certain preventive effect on cerebral infarction and cerebral hemorrhage.

Claims

1. A traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference, characterized in that, It is made from the following raw medicinal materials by weight: 15 - 45 g of Astragalus membranaceus, 9 - 45 g of Phellodendron amurense, 6 - 15 g of Scutellaria baicalensis, 6 - 15 g of Angelica sinensis, 6 - 15 g of Magnolia officinalis, 10 - 20 g of Panax ginseng, 6 - 15 g of Cimicifuga foetida, 6 - 15 g of Gastrodia elata, 6 - 15 g of Pinellia ternata, 10 - 20 g of Amomum villosum, 1 - 6 g of Asarum heterotropoides, 10 - 20 g of Psoralea corylifolia, 6 - 15 g of Atractylodes lancea stir-fried with bran, 10 - 20 g of Atractylodes macrocephala, 6 - 15 g of Citrus reticulata, 6 - 15 g of Poria cocos, 6 - 15 g of Bupleurum chinense, 10 - 20 g of roasted Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw medicinal materials by weight: 24 g of Astragalus membranaceus, 21 g of Phellodendron amurense, 9 g of Scutellaria baicalensis, 9 g of Angelica sinensis, 9 of Magnolia officinalis, 12 g of Panax ginseng, 9 g of Cimicifuga foetida, 6 g of Gastrodia elata, 9 g of Pinellia ternata, 15 g of Amomum villosum, 3 g of Asarum heterotropoides, 12 g of Psoralea corylifolia, 9 g of Atractylodes lancea stir-fried with bran, 15 g of Atractylodes macrocephala, 9 g of Citrus reticulata, 6 g of Poria cocos, 9 g of Bupleurum chinense, 15 g of roasted Glycyrrhiza uralensis.

3. A traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference based on the one described in claim 1, characterized in that, It is made from the following raw medicinal materials by weight: 15 - 45 g of Astragalus membranaceus, 9 - 45 g of Phellodendron amurense, 6 - 15 g of Scutellaria baicalensis, 6 - 15 g of Angelica sinensis, 6 - 15 g of Magnolia officinalis, 10 - 20 g of Panax ginseng, 6 - 15 g of Cimicifuga foetida, 6 - 15 g of Gastrodia elata, 6 - 15 g of Pinellia ternata, 10 - 20 g of Amomum villosum, 1 - 6 g of Asarum heterotropoides, 10 - 20 g of Psoralea corylifolia, 6 - 15 g of Atractylodes lancea stir-fried with bran, 10 - 20 g of Atractylodes macrocephala, 6 - 15 g of Citrus reticulata, 6 - 15 g of Poria cocos, 6 - 15 g of Bupleurum chinense, 10 - 20 g of roasted Glycyrrhiza uralensis, 6 - 15 g of dried ginger.

4. A traditional Chinese medicine composition for treating senile hypertension, stabilizing blood pressure fluctuations, and reducing pulse pressure difference based on the one described in claim 1, characterized in that, It is made from the following raw medicinal materials by weight: 15 - 45 g of Astragalus membranaceus, 9 - 45 g of Phellodendron amurense, 6 - 15 g of Scutellaria baicalensis, 6 - 15 g of Angelica sinensis, 6 - 15 g of Magnolia officinalis, 10 - 20 g of Panax ginseng, 6 - 15 g of Cimicifuga foetida, 6 - 15 g of Gastrodia elata, 6 - 15 g of Pinellia ternata, 10 - 20 g of Amomum villosum, 1 - 6 g of Asarum heterotropoides, 10 - 20 g of Psoralea corylifolia, 6 - 15 g of Atractylodes lancea stir-fried with bran, 10 - 20 g of Atractylodes macrocephala, 6 - 15 g of Citrus reticulata, 6 - 15 g of Poria cocos, 6 - 15 g of Bupleurum chinense, 10 - 20 g of roasted Glycyrrhiza uralensis, 6 - 18 g of Artemisia capillaris, 6 - 15 g of Ligusticum wallichii.

5. A preparation method of the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, It includes the following steps: Weigh the raw medicinal materials for each dose by weight, soak them in warm water for 180 - 360 minutes, add water to submerge the raw medicinal materials by about 1 - 2 cm, decoct the raw medicinal materials twice. For the first decoction, boil for 60 - 90 minutes after boiling, and for the second decoction, boil for 60 minutes. Then combine the two decoctions.

6. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of antihypertensive drugs.

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