Traditional Chinese medicine composition for treating hypertension

Abstract

The invention discloses a traditional Chinese medicine composition for treating hypertension, which is prepared from the following components in parts by mass: 6 to 12 parts of rhizoma gastrodiae, 9 to 15 parts of fried semen ziziphi spinosae, 6 to 12 parts of radix achyranthis bidentatae, 10 to 20 parts of nacre mother of pearl, 10 to 20 parts of poria with hostwood, 5 to 11 parts of fried radix paeoniae alba, 3 to 9 parts of bupleurum chinense, 3 to 9 parts of fried fructus aurantii and 2 to 8 parts of honey-fried licorice root. The traditional Chinese medicine composition can effectively reduce the blood pressure level of yin deficiency and yang excess type 1-grade low-middle-risk hypertension patients, improve the traditional Chinese medicine syndromes and improve the life quality, and has good safety.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for treating hypertension. Background Art

[0002] Essential Hypertension (EH) is a chronic disease affecting a global scale, mainly characterized by elevated systemic arterial blood pressure. Both the acute and slow progression phases of EH can lead to damage to multiple target organs such as the heart, brain, kidneys, and blood vessels, and it is a "silent killer" threatening the health of residents. The results of a global hypertension prevalence survey and analysis [1] released by the World Health Organization showed that as of 2019, the number of hypertensive patients globally was 1.3 billion; the survey data in China in 2015 [2] showed that there were 245 million hypertensive patients, only counting residents over 18 years old, and another piece of data indicated that 435 million residents were in the prehypertensive state, and the detection rate was only 39.1%, which means that more than half of the adults were in the prehypertensive state; however, the control rate and treatment rate of EH were only 16.8% and 45.8% respectively, at a low level. In 2017, data statistics showed that the number of deaths in China due to high blood pressure reached 2.54 million [3]; it can be seen that the prevention and treatment of hypertension are urgent.

[0003] Grade 1 low- and medium-risk hypertension refers to blood pressure levels at grade 1, with no or 1-2 risk factors, belonging to the pre-disease stage of hypertension. According to the guidelines, such hypertensive patients can maintain a healthy lifestyle for several weeks by dynamically monitoring blood pressure and target organ damage. If the blood pressure does not reach the standard, then start antihypertensive western medicine treatment. However, because of the low blood pressure level, this type of hypertension is easily ignored by the general population; and the intervention of lifestyle has poor patient compliance, and the indication for taking western medicine does not meet the requirements of the guidelines, resulting in poor blood pressure control efficacy and gradually developing into grade 2 or 3 hypertension. At the same time, most patients have symptoms such as dizziness, headache, soreness and tinnitus in the waist, chest tightness and palpitations, and insomnia to varying degrees, which not only exacerbate hypertension but also greatly affect the quality of life. Therefore, actively exploring a feasible and complete treatment management plan for grade 1 low- and medium-risk hypertension is of inestimable significance for improving the quality of life and happiness index of residents and the medical cause in China. Summary of the Invention

[0004] The main object of the present invention is to provide a traditional Chinese medicine composition for treating hypertension.

[0005] The technical solution adopted by the present invention to solve its technical problems is:

[0006] A traditional Chinese medicine composition for treating hypertension, by mass, includes:

[0007] 6 to 12 parts of Gastrodia elata, 9 to 15 parts of stir-fried Semen Ziziphi Spinosae, 6 to 12 parts of Radix Achyranthis Bidentatae, 10 to 20 parts of Concha Margaritifera Usta, 10 to 20 parts of Poria cum Radice Pini, 5 to 11 parts of stir-fried Radix Paeoniae Alba, 3 to 9 parts of Radix Bupleuri, 3 to 9 parts of stir-fried Fructus Aurantii Immaturus, and 2 to 8 parts of honey-fried Licorice Root.

[0008] In a preferred embodiment, the traditional Chinese medicine composition for treating hypertension, by mass parts, comprises:

[0009] 9 parts of Gastrodia elata, 12 parts of stir-fried Semen Ziziphi Spinosae, 9 parts of Radix Achyranthis Bidentatae, 15 parts of Concha Margaritifera Usta, 15 parts of Poria cum Radice Pini, 8 parts of stir-fried Radix Paeoniae Alba, 6 parts of Radix Bupleuri, 6 parts of stir-fried Fructus Aurantii Immaturus, and 5 parts of honey-fried Licorice Root.

[0010] In the present invention, each dose of the traditional Chinese medicine composition is equivalent to 54 g to 116 g of the raw medicinal materials.

[0011] In the present invention, the preparation method of the traditional Chinese medicine composition for treating hypertension comprises the following steps: weighing each component according to the above mass ratio, and cleaning according to the characteristics of each raw medicinal material; decocting the above traditional Chinese medicine composition with water to obtain a first decoction; separating the remaining part after separating the first decoction, including the remaining medicinal residues and the residual medicinal liquid, adding water again for decocting to obtain a second decoction; combining the first decoction and the second decoction to obtain the product.

[0012] In the present invention, the above traditional Chinese medicine composition is boiled with strong fire until boiling, and then decocted with slow fire for 25 - 35 min.

[0013] In the present invention, the amount of water added for decocting can be 2 - 10 times the volume of the traditional Chinese medicine. The volume of the obtained first decoction is 200 - 350 mL per dose; the volume of the second decoction is 200 - 350 mL per dose; each dose of the above traditional Chinese medicine composition is equivalent to 54 g to 116 g of the raw medicinal materials.

[0014] The present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a drug for treating hypertension.

[0015] Furthermore, the hypertension is yin deficiency and yang hyperactivity type grade 1 low to medium risk hypertension.

[0016] Furthermore, the dosage form of the drug is an oral preparation.

[0017] Furthermore, the oral preparation includes mixture, granule, tablet, pill or capsule.

[0018] The formula basis of the traditional Chinese medicine composition (named Anjiang Prescription) for treating hypertension in the present invention

[0019] 1. Formula basis

[0020] Regarding the diagnosis and treatment of hypertension with the syndrome of yin deficiency and yang hyperactivity, Tu Qiming et al. believe that "yang killing and yin storing" is closely related to the occurrence and development of yin deficiency and yang hyperactivity, and it should be treated by "balancing yin and yang"; Zhang Jiyue et al. applied the method of nourishing yin and suppressing yang to hypertension with yin deficiency and yang hyperactivity, and its antihypertensive effect is remarkable; Wang Fan's research shows that warm acupuncture combined with acupuncture has a certain antihypertensive effect on hypertension of the yin deficiency and yang hyperactivity type.

[0021] Grade 1 low- and medium-risk hypertension belongs to the early stage of hypertension. The applicant believes that "the abnormal ascending and descending of visceral qi" is the essential pathogenesis of grade 1 low- and medium-risk hypertension with the syndrome of yin deficiency and yang hyperactivity. Considering that modern people are long-term in a highly stressful social environment, overthinking leads to the depletion of yin blood secretly, insufficient heart yin, and the loss of nourishment of the mind; hyperactivity of liver yang, the mother disease affecting the child, and the heart fire is also exuberant. The two yangs fight each other, yang hyperactivity transforms into wind, the fire qi attacks the heart, and the heart blood becomes more deficient; the liver exuberance invades the spleen, the spleen qi fails to ascend, dampness accumulates internally, phlegm turbidity is also generated, the child disease affecting the mother, phlegm turbidity disturbs the mind, or disturbs the clear orifices, the turbid qi reverses upward, and hypertension occurs; the disease location is in the three viscera of "heart, liver, and spleen", and the nature of the disease is mainly deficiency in origin and excess in superficiality. Excess is the reversal of turbid qi, including yang hyperactivity transforming into wind and liver wind accompanied by phlegm, deficiency is the internal deficiency of heart yin, combined with spleen deficiency and dampness exuberance. Therefore, based on "nourishing the heart and calming the mind, suppressing liver wind", the self-made "Anjiang Prescription" is used to treat grade 1 low- and medium-risk hypertension with the syndrome of yin deficiency and yang hyperactivity. The whole prescription combines "Tianma Gouteng Decoction, Suanzaoren Decoction, and Minor Bupleurum Decoction" to exert the effects of "nourishing the heart and calming the mind, suppressing liver yang, and tonifying the spleen and removing dampness". "Materia Medica Q&A" records: "The liver stores ministerial fire, which means the unity of wood and fire." Therefore, the prescription contains "Minor Bupleurum Decoction" to relieve the ministerial fire of Shaoyang and promote the smooth flow of the triple energizer. The "triple energizer" is the track for the operation of qi movement, which is used to consolidate the curative effect. The antihypertensive effect of Anjiang Prescription has been verified clinically, and the symptoms of dizziness, headache, insomnia, palpitation, etc. of patients can be effectively relieved, greatly improving the quality of life.

[0022] 2. Analysis of the formula

[0023] The drug composition of Anjiang Prescription: Gastrodia elata, stir-fried Ziziphus jujuba seed, Concha margaritifera usta, Poria cum Radix Pini, stir-fried Paeonia lactiflora, Achyranthes bidentata, Bupleurum chinense, stir-fried Fructus Aurantii, and roasted Licorice.

[0024] 2.1 Gastrodia elata and stir-fried Ziziphus jujuba seed are the monarch drugs

[0025] "When the liver is deficient, it becomes weak... then wind moves internally." Yang hyperactivity transforms into wind, liver wind stirs internally, and blood pressure rises. Gastrodia elata can "settle the internal wind in the liver and gallbladder", also known as Dingfengcao. "Secret Collection of the Orchid Chamber" states: "For internal wind caused by wind deficiency, only Gastrodia elata can treat it." Therefore, Gastrodia elata is the monarch drug, which can not only extinguish the generated liver wind but also suppress the hyperactive liver yang; moreover, Gastrodia elata is a product that is both a medicine and a food. "Compendium of Materia Medica" says: "Among the superior tonics, Gastrodia elata ranks first... Taking it can prolong life." The research period of this project is 12 weeks, and it is suitable for long-term use.

[0026] Ye Tianshi said that sour jujube seed "has an acidic taste and benefits the blood, and when the blood circulates smoothly, the wind subsides". In this formula, sour jujube seed is the monarch drug, nourishing the heart blood and liver blood. When the earth qi stagnates and restricts the wood qi, the stagnant wood qi should be soothed. Therefore, bupleurum is used in combination to soothe the wood, and the sweet and slow-roasted licorice is used as an assistant. Most patients with hypertension due to yin deficiency and yang hyperactivity are accompanied by restlessness and poor sleep, which is caused by the disharmony between the heart and the kidney. Sour jujube seed, as the "fruit of the liver", has a red skin color and enters the heart; its pulp is yellow and enters the spleen, ultimately belonging to the three organs of the liver, spleen, and heart. "Compendium of Materia Medica Speculation" states that "when the heart obtains it, it is at peace, when the liver obtains it, the soul is stored, and when the spleen obtains it, thoughts are calmed", achieving the effect of nourishing the heart and calming the mind.

[0027] 2.2 Concha Margaritifera Usta, Poria cum Radice Pini, and stir-fried Paeonia Lactiflora are ministerial drugs

[0028] (1) Concha Margaritifera Usta

[0029] Concha Margaritifera Usta is a salty, cold, and heavy drug. "Fu Qingzhu's Male Medicine" states that Concha Margaritifera Usta "enters the liver first". Therefore, Concha Margaritifera Usta is used to assist in calming the liver yang and reducing turbidity.

[0030] (2) Poria cum Radice Pini

[0031] Poria cum Radice Pini has a neutral qi and a sweet taste. Its neutral qi benefits the lung. When the lung qi descends, the heart qi descends and intersects. Its sweet taste invigorates the spleen. When the spleen qi ascends, the kidney qi ascends and intersects. When combined with the monarch drug sour jujube seed, it treats restlessness and insomnia due to the disharmony between the heart and the kidney. Also, Poria cum Radice Pini "treats dizziness and restlessness due to heart deficiency. Without this, one cannot be at peace". When liver wind stirs internally and phlegm turbidity is generated, disturbing the mind, Poria cum Radice Pini nourishes the heart blood to harmonize the heart qi and can also tonify the spleen yin.

[0032] (3) Stir-fried Paeonia Lactiflora

[0033] Paeonia Lactiflora has a constricting property. It can harmonize the qi and blood of the liver and spleen, constrict the internal yin qi of the body, and also constrict rebellious qi. Zhu Danxi said: "Paeonia Lactiflora inhibits the growing qi... Use it stir-fried with wine". Therefore, stir-fried Paeonia Lactiflora is selected as the ministerial drug in the formula to nourish yin blood and regulate qi and blood to nourish and protect the liver yang, so as to protect the effect of reducing turbidity.

[0034] 2.3 Achyranthes Bidentata, Bupleurum Chinense, stir-fried Fructus Aurantii, and roasted licorice are adjuvant and guiding drugs

[0035] (1) Radix Achyranthis Bidentatae

[0036] Radix Achyranthis Bidentatae is sour, bitter, sweet, and neutral. Its sour and bitter properties can purge and descend excessive qi and blood, guiding the blood downward. "Supplementary Records of Famous Physicians" states that Achyranthes Bidentatae: "Guides its qi and blood downward and also guides the floating and excessive fire downward". Hypertension is due to liver yang hyperactivity. Therefore, Radix Achyranthis Bidentatae is effectively used for its property of "descending downward" to calm the liver and reduce rebellion. "Compendium of Materia Medica for Easy Reading" states that Radix Achyranthis Bidentatae "resembles a branch, with sufficient downward power". Also, the internal condition of this disease is "excessiveness above and deficiency below". "Treatise on Blood Syndromes" states: "Radix Achyranthis Bidentatae has the function of guiding fire back to its origin". Therefore, Radix Achyranthis Bidentatae is used in the formula to calm the liver and reduce rebellion, guide the dragon back to the sea, so that the turbid qi descends and the blood pressure immediately drops. Therefore, clinically, it can be observed that the blood pressure of patients drops three days after taking the medicine.

[0037] (2) Bupleurum Chinense and stir-fried Fructus Aurantii

[0038] Bupleurum can elevate the "descending of the ministerial fire of the Sanjiao Meridian". "The Sanjiao Meridian is responsible for the qi of the whole body". When the liver wood stagnates, the Shaoyang Meridian stagnates, so the "ministerial fire flares up". When the ministerial fire rebels upward, the Sanjiao Meridian "will surely descend and not rise". Therefore, Bupleurum is used to regulate the qi mechanism. "The Classic of Difficult Issues Explained" states: "The meridian of the Sanjiao... generates the spleen and stomach and transforms water and grains", and it can also assist the qi transformation function of the spleen and stomach. Also, "New Compilation of Materia Medica" says that "for those with initial onset of fire due to yin deficiency, use Bupleurum sparingly to guide various yin-nourishing herbs directly into the liver and kidneys". Since patients with grade 1 low to medium-risk yin deficiency and yang hyperactivity type hypertension are in the early stage of the disease, Bupleurum in the formula can also nourish the yin of the liver and kidneys. Stir-fried Fructus Aurantii regulates the spleen and stomach, relieves the stagnation of phlegm turbidity in the spleen and stomach, and mainly promotes the descending of turbidity. The combination of Fructus Aurantii and Bupleurum, with one ascending and one descending, jointly regulates the liver and spleen.

[0039] (3) Prepared Licorice Root

[0040] Huang Yuanyu said that licorice root "belongs to the qi between water and fire... a spiritual pill for regulating qi and blood". Prepared Licorice Root is used in the formula to enhance its function of strengthening the spleen and stomach. The spleen and stomach are the centers of the ascending and descending of qi mechanism, and the reverse flow of clear and turbid qi is closely related to the spleen and stomach. Therefore, properly using Prepared Licorice Root can assist various herbs in exerting the effects of ascending clear and descending turbid qi. "Shennong's Classic of Materia Medica" states that "taking it for a long time can make the body light and prolong life", which is the best choice for this formula.

[0041] In summary, the entire formula of Anjiang Prescription can achieve the effects of "nourishing the heart and calming the mind, suppressing liver yang, strengthening the spleen and removing dampness", ultimately relieving the pathological state of yin deficiency and yang hyperactivity, restoring the balance between yin and yang, reducing blood pressure, and eliminating the disease.

[0042] 3. Modern Pharmacological Research

[0043] (1) Gastrodia elata: The most widely studied currently is gastrodin, which is mostly used in diseases related to the heart and brain. In terms of cardiovascular diseases, the active ingredients in Gastrodia elata can dilate microvessels, dilate small arteries, and reduce peripheral vascular resistance to achieve the effect of lowering blood pressure; Dai R et al.

[33] found that the extract of Gastrodia elata can enhance nitric oxide and its activity in endothelial cells and regulate vascular tension to treat hypertension; there are research reports that the expression of a certain active ingredient in Gastrodia elata is related to inflammation and intestinal flora.

[0044] (2) Stir-fried Semen Ziziphi Spinosae: Semen Ziziphi Spinosae can regulate the nerves to soothe the mind, improve cognition, control heart rate, have anti-tumor effects, and protect the liver, etc.; Zhao Kui et al. summarized and reviewed that Semen Ziziphi Spinosae Decoction can regulate the circadian rhythm to treat insomnia, which is related to the regulation of gene and neurotransmitter expression.

[0045] (3) Concha Margaritifera Usta: Concha Margaritifera Usta is heavy in nature and can calm the mind and suppress liver yang, with effects such as anti-anxiety and sedation; there are also studies showing that Concha Margaritifera Usta can be used in diseases such as hypertension, insomnia, and neurasthenia; Li Jiao et al. found that the meat protein in the shell of pearl oyster can inhibit angiotensin-converting enzyme and can be used to treat hypertension; in addition, Concha Margaritifera Usta can extract trace protein peptides, which have effects such as whitening, antioxidant, blood pressure lowering, and immune regulation.

[0046] (4) Poria cum Radix Pini: Research shows that Poria cum Radix Pini has the effect of regulating the intestinal microbial community. Pan Lin et al. observed through clinical trials that the Anshen Tie containing Poria cum Radix Pini can improve the sleep quality of heart failure patients.

[0047] (5) Stir-fried White Peony Root: Wang Wei found through a randomized controlled study that Danggui Shaoyao Decoction can play a hypotensive role by improving arterial elasticity, and it is reliable in terms of safety. Yao Zhuangxian et al. pointed out that White Peony Root can regulate blood lipids, protect the cardiovascular system, reduce proteinuria and other functions.

[0048] (6) Radix Achyranthis Bidentatae: Modern medical research shows that the active ingredients of Radix Achyranthis Bidentatae can increase the absorption of other drugs and improve the bioavailability of drugs; Deng Linhua et al. summarized that the main effect of Radix Achyranthis Bidentatae in the treatment of hypertension is to guide blood downward; Geniposide is one of the active ingredients of Radix Achyranthis Bidentatae, which has the effects of inhibiting cardiac hypertrophy, reducing blood sugar, anti-atherosclerosis, etc.; Wang Li extracted the components of the Danggui-Radix Achyranthis Bidentatae decoction for animal experimental research and found that its active ingredients can play a hypotensive role by improving vasomotor function.

[0049] (7) Bupleurum chinense DC.: Bupleurum chinense DC. is widely used in the diagnosis and treatment of the heart, brain, lungs, spleen and stomach. It contains more than 200 chemical substances, and the most important component is flavonoids, which can protect the heart through various effects; Wang Senshen et al. found through research that Bupleurum chinense DC.-Scutellaria baicalensis Georgi can achieve hypotensive efficacy through multiple targets, proving the advantages of traditional Chinese medicine in multi-target and multi-pathway hypotensive effects.

[0050] (8) Stir-fried Fructus Aurantii: The current research mechanisms of Fructus Aurantii developed include antioxidant, regulating gastrointestinal motility, regulating intestinal flora, immune regulation, etc.; Master Lü Renhe uses Fructus Aurantii to regulate the qi movement of the spleen and stomach, because Fructus Aurantii can regulate gastrointestinal motility and reduce gastrointestinal resistance.

[0051] (9) Prepared Licorice Root: It has the reputation of being the king of traditional Chinese medicines. It can harmonize various medicines, warm the middle-jiao and replenish deficiency, tonify qi and promote yang, and can also clear heat and detoxify. Du Kangjia et al. found through research that Prepared Licorice Root can treat hypotension, and its key mechanism is to regulate vascular endothelial cells, regulate inflammation, and regulate energy metabolism.

[0052] In traditional Chinese medicine, there is no disease name of "hypertension". It is often classified into the categories of "headache, dizziness" etc. according to the symptom manifestations. Traditional Chinese medicine emphasizes the overall concept and syndrome differentiation and treatment. Therefore, differentiating the "pathogenesis" is extremely important. The diseased zang-fu organs involved in hypertension are the "liver, heart, spleen, kidney". The yin-yang hyperactivity and yin-yang imbalance of the zang-fu organs are the key to its pathogenesis; however, at each stage of the development of hypertension, the yin-yang imbalance of each zang-fu organ is often different. In the early stage, it is mainly the "liver", in the middle stage, it involves the "heart, spleen", and in the late stage, it affects the "kidney". Therefore, differentiating the pathogenesis characteristics at different stages of hypertension, combining syndrome and disease, and fundamentally adjusting the pathogenesis state of hypertension can achieve the purpose of effectively reducing blood pressure and improving the prognosis.

[0053] Grade 1 low- to medium-risk hypertension belongs to the early stage of hypertension. Considering the accelerating pace of modern social life and the increasing social pressure, long-term excessive thinking leads to the depletion of yin-blood, hyperactivity of liver-yang, the mother disease affecting the child, and excessive heart-fire. The combination of two yangs causes yang hyperactivity to transform into wind. The liver exuberance invades the spleen, resulting in spleen deficiency and failure to ascend, the generation of phlegm-dampness. The liver-wind is accompanied by phlegm, disturbing the clear orifices, and thus causing hypertension. It is differentiated as the syndrome of "yin deficiency and yang hyperactivity", and the essence of the pathogenesis is the "abnormal ascending and descending of qi movement". The disease location is mainly in the "liver, heart, and spleen", and in the long term, it affects the kidney. The nature of the disease is mainly deficiency in origin and excess in superficiality. The excess is the upward reversal of phlegm-turbidity disturbing the clear orifices, manifested as "yang hyperactivity transforming into wind, liver-wind accompanied by phlegm", or disturbing the mind internally. The deficiency is yin deficiency internally, combined with spleen deficiency and dampness exuberance.

[0054] Based on this pathogenesis, the treatment principle is to treat both the symptoms and the root cause. The specific treatment method is to "nourish the heart and soothe the mind, suppress liver-yang, strengthen the spleen and remove dampness". Therefore, the "Anjiang Formula" is created by integrating "Gastrodia and Uncaria Decoction, Semen Ziziphi Spinosae Decoction, and Minor Bupleurum Decoction". Good clinical efficacy has been obtained in small-sample observations. To further clarify the effectiveness and safety of the "Anjiang Formula" in treating grade 1 low- to medium-risk hypertension with the syndrome of yin deficiency and yang hyperactivity, this randomized controlled study is set up to observe the effects of the Anjiang Formula on efficacy indicators such as blood pressure, TCM syndrome scores, and Du's hypertension quality of life scores in patients with grade 1 low- to medium-risk hypertension with the syndrome of yin deficiency and yang hyperactivity, as well as the occurrence of adverse reactions, in order to provide clinical evidence for the treatment of grade 1 low- to medium-risk hypertension with traditional Chinese medicine.

[0055] This invention uses the major treatment method of "nourishing the heart and soothe the mind, suppressing liver-wind" to treat hypertension with the syndrome of yin deficiency and yang hyperactivity, breaking new ground and not being restricted to the "Liver-Suppressing and Wind-Extinguishing Decoction". It is believed that for patients with grade 1 low- to medium-risk hypertension with the syndrome of yin deficiency and yang hyperactivity, it is "yin deficiency of the heart and liver, and hyperactivity of liver-yang", mainly involving the three viscera of the heart, liver, and spleen, with abnormal ascending and descending of qi movement in the zang-fu organs, thus generating pathological products of "wind, fire, phlegm, and deficiency", which are mixed in the body and cause hypertension. Therefore, the treatment is to suppress liver-wind to reduce turbidity, using "Gastrodia elata" as the monarch drug to calm the wind of the liver and gallbladder, and cooperating with "Radix Bupleuri and Fructus Aurantii" to soothe the liver qi and regulate the triple energizer; combining with Semen Ziziphi Spinosae to nourish the heart-blood and soothe the mind, and using "Paeonia lactiflora preparata" to tonify the liver and nourish blood. Since this yang hyperactivity is false yang, "Achyranthes bidentata" is used to guide fire back to its origin and effectively exert the antihypertensive effect, and attention is paid to the importance of regulating qi movement in the middle earth spleen and stomach, selecting drugs to strengthen the spleen and resolve dampness-turbidity. This formula reverses the pathological state of yin deficiency and yang hyperactivity by protecting the origin of qi movement's ascending and descending; then assisted by drugs that regulate qi and blood and astringe yin, and starting from the origin of blood pressure generation, the antihypertensive effect is stable and lasting. The whole formula treats both the symptoms and the root cause, not only balancing yin and yang, but also paying attention to the generation and dispersion of qi, blood, and body fluids. There is ascending in descending and descending in ascending, each returning to its proper position, "the clear yang ascending to the sky, the turbid yin descending to the earth... can grow, transform, harvest, and store, cycle after cycle", and the functions of the zang-fu organs can operate normally, and the blood pressure will naturally drop. Detailed implementation methods

[0056] Example 1

[0057] Gastrodia elata 9g, Stir-fried Semen Ziziphi Spinosae 12g, Radix Achyranthis Bidentatae 9g, Concha Margaritifera Usta 15g, Poria 15g, Stir-fried Radix Paeoniae Alba 8g, Bupleurum chinense DC. 6g, Stir-fried Fructus Aurantii 6g, Honey-fried Licorice Root 5g.

[0058] First, stir evenly, then add 300 ml of water and soak for half an hour, then boil over high heat, and then turn to low heat and decoct for about half an hour. Filter, add another 300 m of water to the residue, decoct for half an hour, pour out the filtrate, and mix the two filtrates to obtain the daily dosage. Take it in two doses daily.

[0059] Example 2

[0060] Gastrodia elata 6g, Stir-fried Semen Ziziphi Spinosae 15g, Radix Achyranthis Bidentatae 6g, Concha Margaritifera Usta 20g, Poria 10g, Stir-fried Radix Paeoniae Alba 10g, Bupleurum chinense DC. 3g, Stir-fried Fructus Aurantii 9g, Honey-fried Licorice Root 2g.

[0061] First, stir evenly, then add 300 ml of water and soak for half an hour, then boil over high heat, and then turn to low heat and decoct for about half an hour. Filter, add another 300 m of water to the residue, decoct for half an hour, pour out the filtrate, and mix the two filtrates to obtain the daily dosage.

[0062] Example 3

[0063] Gastrodia elata 12g, Stir-fried Semen Ziziphi Spinosae 10g, Radix Achyranthis Bidentatae 12g, Concha Margaritifera Usta 10g, Poria 20g, Stir-fried Radix Paeoniae Alba 5g, Bupleurum chinense DC. 9g, Stir-fried Fructus Aurantii 3g, Honey-fried Licorice Root 8g.

[0064] First, stir evenly, then add 300 ml of water and soak for half an hour, then boil over high heat, and then turn to low heat and decoct for about half an hour. Filter, add another 300 m of water to the residue, decoct for half an hour, pour out the filtrate, and mix the two filtrates to obtain the daily dosage.

[0065] Taking the formula of Example 1 as an example

[0066] 1. Distribution and completion of cases

[0067] A total of 70 subjects were included, including 35 in the experimental group and 35 in the control group. During the study, 1 subject in the experimental group was excluded because they could not adhere to regular Chinese medicine intake, and 1 subject was excluded because they often traveled out of town and could not return for follow-up visits on time, and there was no family blood pressure data. In the control group, 3 subjects dropped out due to poor compliance and inability to follow up on time. Finally, 65 effective cases were collected, including 33 in the experimental group and 32 in the control group. The total dropout rate was 7.14%. No adverse reactions or adverse events occurred during the study.

[0068] 2. Analysis of basic conditions

[0069] 2.1 Gender comparison

[0070] As shown in Table 2-1, gender belongs to count data, and the row * column χ 2Test: P = 0.675 > 0.05. Therefore, there is no statistical difference in gender between the two groups, and they are comparable.

[0071] Table 2-1 Comparison of gender between two groups of subjects (cases, n)

[0072]

[0073] 2.2 Comparison of age

[0074] As shown in Table 2-2, age is measurement data. After normality test, the ages of both groups conform to normal distribution. The age of the experimental group is 45.85 ± 11.98 years old, and the age of the control group is 45.34 ± 9.94 years old. After t-test, P = 0.854 > 0.05. Therefore, there is no statistical difference in age between the two groups, and they are comparable.

[0075] Table 2-2 Comparison of age between two groups of subjects (years, )

[0076]

[0077] 2.3 Comparison of BMI and waist circumference

[0078] As shown in Table 2-3, BMI is measurement data. After normality test, the BMIs of both groups conform to normal distribution. The BMI of the experimental group is 25.87 ± 1.63 kg / m 2 , and the BMI of the control group is 25.54 ± 1.64 kg / m 2 . After t-test, P = 0.419 > 0.05. Therefore, there is no statistical difference in BMI between the two groups, and they are comparable.

[0079] As shown in Table 2-4, waist circumference is measurement data. After normality test, the waist circumferences of both groups conform to normal distribution. The waist circumference of the experimental group is 83.21 ± 5.68 cm, and the waist circumference of the control group is 82.06 ± 6.72 cm. The waist circumferences of the two groups are compared between groups. After t-test, P = 0.459 > 0.05. Therefore, there is no statistical difference in waist circumference between the two groups, and they are comparable.

[0080] Table 2-3 Comparison of BMI between two groups of subjects (kg / m 2 , )

[0081]

[0082] Table 2-4 Comparison of waist circumference between two groups of subjects (cm, )

[0083]

[0084] 2.4 Comparison of smoking history, drinking history, and family history of cardiovascular disease

[0085] As shown in Table 2-5, smoking history, drinking history, and family history of cardiovascular disease belong to count data. In the experimental group, there were 9 cases with a combined smoking history, 8 cases with a drinking history, and 9 cases with a family history of cardiovascular disease; in the control group, there were 6 cases with a combined smoking history, 8 cases with a drinking history, and 10 cases with a family history of cardiovascular disease. The smoking history, drinking history, and family history of cardiovascular disease were compared between groups respectively. After performing a *-by-* chi-square 2 test, the P values were 0.415, 0.943, and 0.724 (all P>0.05). Therefore, there were no statistically significant differences in the smoking history, drinking history, and family history of cardiovascular disease between the two groups, and they were comparable.

[0086] As shown in Table 2-6, smoking history, drinking history, and family history of cardiovascular disease are all risk factors for cardiovascular disease. After performing a *-by-* chi-square 2 test, P = 0.751>0.05. Therefore, there were no statistically significant differences in the combined risk factors for cardiovascular disease between the two groups, and they were comparable.

[0087] Table 2-5 Comparison of smoking history, drinking history, and family history of cardiovascular disease between two groups of subjects

[0088]

[0089] Table 2-6 Comparison of smoking history, drinking history, and family history of cardiovascular disease between two groups of subjects (cases, n)

[0090]

[0091] Treatment method: A prospective, randomized controlled clinical research design was adopted. The above 70 first-level low-to-moderate-risk hypertensive patients who met the inclusion and exclusion criteria were used as the research subjects and randomly divided into a control group and an experimental group, with 35 cases in each group. On the basis of lifestyle intervention, the experimental group was additionally given oral administration of Anjiang Formula, 2 bags per day; the treatment courses of both groups were 12 weeks. By observing the basic conditions, main efficacy indicators (clinic blood pressure), secondary efficacy indicators (home self-measured blood pressure, ambulatory blood pressure (ABPM) (24-hour average blood pressure, daytime average blood pressure, nighttime average blood pressure), traditional Chinese medicine syndrome score, and Du's hypertensive quality of life score) of the two groups at week 0 and week 12, and recording the adverse reactions and adverse events that occurred during the research period, the collected data were statistically analyzed using SPSS 23.0 software.

[0092] Control group: Given lifestyle intervention, formulated with reference to the "Chinese Guidelines for the Prevention and Treatment of Hypertension":

[0093] Experimental group: On the basis of the above lifestyle intervention, oral administration of the traditional Chinese medicine formula in Example 1 was additionally given.

[0094] Administration method: All Chinese medicinal materials are Chinese herbs uniformly purchased by the Pharmacy Department of Xiamen Traditional Chinese Medicine Hospital and decocted uniformly by the Decoction Room of Xiamen Traditional Chinese Medicine Hospital. In Example 1, each dose is decocted into 2 bags, 1 bag each time, 2 times a day. One bag is taken warm one hour before noon nap and one hour before bedtime at night, and taken continuously for 12 weeks.

[0095] 3. Analysis of main efficacy indicators

[0096] 3.1 Comparison of clinic blood pressure

[0097] 3.1.1 Comparison of clinic sBP

[0098] As shown in Table 2-7:

[0099] (1) Before treatment: sBP belongs to measurement data. After normal distribution test, both groups conform to normal distribution. The experimental group is 150.67 ± 4.67 mmHg, and the control group is 150.22 ± 5.90 mmHg. After test, P = 0.735 > 0.05. Therefore, there is no statistical difference in sBP between the two groups and they are comparable.

[0100] (2) After treatment: After normal distribution test, both groups conform to normal distribution. The experimental group is 136.00 ± 7.57 mmHg, and the control group is 145.94 ± 6.24 mmHg. It can be seen that the blood pressure values in both groups decreased compared with before treatment, and there was significant statistical significance in within-group comparison (P < 0.001).

[0101] (3) Before and after treatment: After normal distribution test of the differences, neither of them conforms to normal distribution. The experimental group is 14.0 (9.0, 19.0) mmHg, and the control group is 4.00 (2.25, 5.00) mmHg. The decrease range of blood pressure in the experimental group is better than that in the control group. After test, the differences have significant statistical significance (P < 0.001).

[0102] Table 2-7 Comparison of clinic sBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0103]

[0104] 3.1.2 Comparison of clinic dBP

[0105] As shown in Table 2-8:

[0106] (1) Before treatment: dBP belongs to measurement data. After normal distribution test, both groups conform to normal distribution. The experimental group is 88.88 ± 5.50 mmHg, and the control group is 89.78 ± 3.63 mmHg. After test, P = 0.439 > 0.05. Therefore, there is no statistical difference in dBP between the two groups and they are comparable.

[0107] (2) After treatment: After normality test, both groups conformed to normal distribution. The experimental group was 84.82 ± 5.41 mmHg, and the control group was 88.19 ± 4.09 mmHg. It can be seen that the blood pressure values of both groups decreased compared with those before treatment, and there was statistical significance in within-group comparison (P < 0.001).

[0108] (3) Before and after treatment: After normality test of the differences, the experimental group did not conform to normal distribution, which was 4.0 (2.0, 5.5) mmHg; the control group conformed to normal distribution, which was 1.59 ± 2.67 mmHg. The decline amplitude of blood pressure in the experimental group was better than that in the control group. After test, the differences were significantly statistically significant (P < 0.001).

[0109] Table 2-8 Comparison of clinic dBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0110]

[0111] 3.1.3 Comparison of clinic blood pressure curative effects

[0112] As shown in Table 2-9, after 12 weeks of treatment, the effective rate of blood pressure reduction in the experimental group was 78.79%, and that in the control group was 53.13%. After performing *column χ 2 test, P = 0.006 < 0.05, so there was statistical significance in the comparison between the two groups.

[0113] Table 2-9 Comparison of clinic blood pressure curative effects after 12 weeks of treatment

[0114]

[0115] 4. Analysis of secondary efficacy indicators

[0116] 4.1 Comparison of home self-measured blood pressure

[0117] 4.1.1 Comparison of home self-measured sBP

[0118] As shown in Table 2-10:

[0119] (1) Before treatment: sBP belonged to measurement data. After normality test, both groups conformed to normal distribution. The experimental group was 145.97 ± 4.80 mmHg, and the control group was 147.41 ± 6.46 mmHg. After test, P = 0.311 > 0.05, so there was no statistical difference in the comparison of sBP between the two groups, and they were comparable.

[0120] (2) After treatment: After normal distribution test, both groups conformed to normal distribution. The experimental group was 131.24 ± 1.46 mmHg, and the control group was 139.53 ± 1.26 mmHg. It can be seen that the blood pressure values of both groups decreased compared with those before treatment, and the within-group comparison was statistically significant (P < 0.001).

[0121] (3) Before and after treatment: After normal distribution test of the differences, the experimental group conformed to normal distribution, which was 14.73 ± 7.34 mmHg; the control group did not conform to normal distribution, which was 8.0 (7.0, 9.0) mmHg. The blood pressure decrease amplitude of the experimental group was better than that of the control group. After test, the differences were significantly statistically significant (P < 0.001).

[0122] Table 2-10 Comparison of home self-measured sBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0123]

[0124] 4.1.2 Comparison of home self-measured dBP

[0125] As shown in Table 2-11:

[0126] (1) Before treatment: dBP was quantitative data. After normal distribution test, the experimental group conformed to normal distribution, which was 90.58 ± 4.60 mmHg, and the control group did not conform to normal distribution, which was 91.0 (86.25, 95.75) mmHg. After test, P = 0.727 > 0.05. Therefore, there was no statistical difference in dBP between the two groups, and they were comparable.

[0127] (2) After treatment: After normal distribution test, both groups conformed to normal distribution. The experimental group was 82.42 ± 5.56 mmHg, and the control group was 85.28 ± 6.10 mmHg. It can be seen that the blood pressure values of both groups decreased compared with those before treatment, and the within-group comparison was statistically significant (P < 0.001).

[0128] (3) Before and after treatment: After normal distribution test of the differences, the experimental group did not conform to normal distribution, which was 9.0 (6.5, 11.0) mmHg; the control group conformed to normal distribution, which was 5.47 ± 2.44 mmHg. The blood pressure decrease amplitude of the experimental group was better than that of the control group. After test, the differences were significantly statistically significant (P < 0.001).

[0129] Table 2-11 Comparison of home self-measured dBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0130]

[0131] 4.1.3 Comparison of Efficacy of Home Self - measured Blood Pressure

[0132] As shown in Table 2 - 12, after 12 weeks of treatment, the effective rate of controlling home self - measured blood pressure in the experimental group was 75.76%, and that in the control group was 59.38%. After performing the row - column χ 2 test, P = 0.036 < 0.05. Therefore, there was a statistically significant difference between the two groups.

[0133] Table 2 - 12 Comparison of Efficacy of Home Self - measured Blood Pressure in Two Groups of Subjects after 12 - week Treatment

[0134]

[0135] 4.2 24 - hour Ambulatory Blood Pressure Comparison

[0136] 4.2.1 24h - sBP Comparison

[0137] As shown in Table 2 - 13:

[0138] (1) Before treatment: 24h - sBP belongs to measurement data. After normality test, neither group conformed to the normal distribution. The experimental group was 138.0 (135.0, 151.0) mmHg, and the control group was 137.5 (135.25, 149.5) mmHg. After t - test, P = 0.995 > 0.05. Therefore, there was no statistically significant difference in 24h - sBP between the two groups, and they were comparable.

[0139] (2) After treatment: After normality test, neither group conformed to the normal distribution. The experimental group was 128 (125, 134) mmHg, and the control group was 135.5 (131, 145) mmHg. The blood pressure values of both groups decreased compared with before treatment, and there was a statistically significant difference within the group (P < 0.001).

[0140] (3) Before and after treatment: After normality test of the difference values, the experimental group did not conform to the normal distribution, being 10.0 (8.0, 12.0) mmHg; the control group conformed to the normal distribution, being 3.75 ± 2.40 mmHg. The degree of blood pressure decrease in the experimental group was better than that in the control group. After testing, the difference values had a significant statistical significance (P < 0.001).

[0141] Table 2 - 13 Comparison of 24h - sBP in Two Groups of Subjects (mmHg, (Ρ 25 , Ρ 75 ))

[0142]

[0143] Note a: 24h-sBP: 24-hour Average Systolic Blood Pressure.

[0144] 4.2.2 Comparison of 24h-dBP

[0145] As shown in Table 2-14:

[0146] (1) Before treatment: 24h-dBP belongs to measurement data. After normality test, the experimental group conforms to normal distribution, which is 88.27 ± 6.64 mmHg; the control group does not conform to normal distribution, which is 87.5 (77.5, 94.75) mmHg. After test, P = 0.386 > 0.05. Therefore, there is no statistical difference in the comparison of 24h-dBP between the two groups, and they are comparable.

[0147] (2) After treatment: After normality test, both groups do not conform to normal distribution. The experimental group is 80 (76.5, 89.0) mmHg, and the control group is 85.50 (77.00, 91.75) mmHg. It can be seen that the blood pressure values of both groups decreased compared with before treatment, and there is statistical significance in the within-group comparison (P < 0.001).

[0148] (3) Before and after treatment: After normality test of the differences, both groups also do not conform to normal distribution. The experimental group is 6.0 (6.0, 8.0) mmHg, and the control group is 2.0 (0.25, 4.00) mmHg. The decrease range of blood pressure in the experimental group is better than that in the control group. After test, the differences have significant statistical significance (P < 0.001).

[0149] Table 2-14 Comparison of 24h-dBP between two groups of subjects (mmHg, (Ρ 25 , Ρ 75 ))

[0150]

[0151] Note a: 24h-dBP: 24-hour Average Diastolic Blood Pressure.

[0152] 4.2.3 Comparison of d-sBP

[0153] As shown in Table 2-15:

[0154] (1) Before treatment: d-sBP belongs to measurement data. After normality test, both groups conformed to normal distribution. The experimental group was 143.15 ± 8.16 mmHg, and the control group was 143.03 ± 7.90 mmHg. After test, P = 0.952 > 0.05. Therefore, there was no statistical difference in d-sBP between the two groups, and they were comparable.

[0155] (2) After treatment: After normality test, the experimental group did not conform to normal distribution, being 129 (125.5, 135.5) mmHg, and the control group conformed to normal distribution, being 139.78 ± 9.36 mmHg. It can be seen that the blood pressure values of both groups decreased compared with before treatment, and there was statistical significance in within-group comparison (P < 0.001).

[0156] (3) Before and after treatment: After normality test of the differences, neither conformed to normal distribution. The experimental group was 11.0 (9.0, 13.0) mmHg, and the control group was 5.0 (3.0, 6.0) mmHg. The decline range of blood pressure in the experimental group was better than that in the control group. After test, the differences had significant statistical significance (P < 0.001).

[0157] Table 2-15 Comparison of d-sBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0158]

[0159]

[0160] Note a: d-sBP: Daytime mean Systolic Blood Pressure.

[0161] 4.2.4 Comparison of d-dBP

[0162] As shown in Table 2-16:

[0163] (1) Before treatment: d-dBP belongs to measurement data. After normality test, both groups conformed to normal distribution. The experimental group was 89.52 ± 6.65 mmHg, and the control group was 88.38 ± 5.65 mmHg. After test, P = 0.460 > 0.05. Therefore, there was no statistical difference in d-dBP between the two groups, and they were comparable.

[0164] (2) After treatment: After normality test, both groups also conformed to normal distribution. The experimental group was 83.85 ± 6.34 mmHg, and the control group was 85.81 ± 7.46 mmHg. It can be seen that the blood pressure values of both groups decreased compared with before treatment, and there was statistical significance in within-group comparison (P < 0.001).

[0165] (3) Before and after treatment: After the difference was tested for normality, it was found that both were normal. The difference in the experimental group was 5.67 ± 3.11 mmHg, and that in the control group was 2.56 ± 3.16 mmHg. The degree of blood pressure decrease in the experimental group was better than that in the control group. After testing, the difference was statistically significant (P < 0.001).

[0166] Table 2-16 Comparison of d-dBP between two groups of subjects (mmHg, )

[0167]

[0168] Note a: d-dBP: Daytime mean Diastolic Blood Pressure.

[0169] 4.2.5 Comparison of n-sBP

[0170] As shown in Table 2-17:

[0171] (1) Before treatment: n-sBP was quantitative data. After testing for normality, it was found that both groups conformed to a normal distribution. The n-sBP in the experimental group was 133.73 ± 6.54 mmHg, and that in the control group was 135.03 ± 8.57 mmHg. After testing, P = 0.492 > 0.05. Therefore, there was no statistical difference in n-sBP between the two groups, and they were comparable.

[0172] (2) After treatment: After testing for normality, it was found that n-sBP after treatment also conformed to a normal distribution. The n-sBP in the experimental group was 123.67 ± 5.15 mmHg, and that in the control group was 133.13 ± 9.11 mmHg. It can be seen that the blood pressure values of both groups decreased compared with those before treatment, and the within-group comparison was statistically significant (P < 0.001).

[0173] (3) Before and after treatment: After the difference was tested for normality, it was found that neither conformed to a normal distribution. The difference in the experimental group was 9 (8, 12) mmHg, and that in the control group was -1.5 (-3.0, 2.0) mmHg. The degree of blood pressure decrease in the experimental group was better than that in the control group. After testing, the difference was statistically significant (P < 0.001).

[0174] Table 2-17 Comparison of n-sBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0175]

[0176] Note a: n-sBP: Nighttime mean Systolic Blood Pressure.

[0177] 4.2.6 Comparison of n-dBP

[0178] As shown in Table 2-18:

[0179] (1) Before treatment: n-dBP belongs to measurement data. After normality test, both groups conform to normal distribution. The experimental group is 81.42±7.64 mmHg, and the control group is 81.44±8.34 mmHg. After test, P = 0.995 > 0.05. Therefore, there is no statistical difference in the comparison of n-dBP between the two groups, and they are comparable.

[0180] (2) After treatment: After normality test, the experimental group conforms to normal distribution, which is 77.46±8.21 mmHg, and the control group does not conform to normal distribution, which is 83.5(76.5, 86.7) mmHg. It can be seen that the n-dBP of the experimental group decreased compared with that before treatment, and there was significant statistical significance in the within-group comparison (P < 0.001); while the n-dBP of the control group did not show obvious decrease, and there was no statistical significance in the within-group comparison (P > 0.05).

[0181] (3) Before and after treatment: After normality test of the difference value, the experimental group does not conform to normal distribution, which is 5.0(0.5, 6.5) mmHg, and the control group conforms to normal distribution, which is -0.63±3.62 mmHg. The blood pressure decrease amplitude of the experimental group is better than that of the control group. After test, the difference value has significant statistical significance (P < 0.001).

[0182] Table 2-18 Comparison of n-dBP between two groups of subjects (mmHg, (Ρ 25 ,Ρ 75 ))

[0183]

[0184] Note a: n-dBP: Nighttime mean Diastolic Blood Pressure.

[0185] 4.3 Comparison of TCM syndrome scores

[0186] As shown in Table 2-19:

[0187] (1) Before treatment: TCM syndrome scores belong to measurement data. After normality test, both groups conform to normal distribution. The experimental group is 12.82±2.28 points, and the control group is 13.00±2.19 points. After t-test, P = 0.775 > 0.05. Therefore, there is no statistical difference in the comparison of TCM syndrome scores between the two groups, and they are comparable.

[0188] (2) After treatment: After normal distribution test, both groups conformed to normal distribution. The experimental group scored 6.79 ± 1.52 points, and the control group scored 9.41 ± 2.54 points. Both groups improved compared with before treatment, and the within-group comparison was statistically significant (P < 0.001).

[0189] (3) Before and after treatment: After normal distribution test of the differences, they conformed to normal distribution. The experimental group had a difference of 6.03 ± 2.54 points, and the control group had a difference of 3.59 ± 2.24 points. The improvement degree of the experimental group was better than that of the control group, and the comparison was significantly statistically significant (P < 0.001).

[0190] As shown in Table 2-20, after 12 weeks of treatment, the effective rate of traditional Chinese medicine syndromes in the experimental group was 84.85%, and that in the control group was 56.25%. After performing the *column χ 2 test, P = 0.029 < 0.05. The effective rate of the experimental group was higher than that of the control group, and the comparison was statistically significant.

[0191] Table 2-19 Comparison of traditional Chinese medicine syndrome scores between two groups of subjects (points, )

[0192]

[0193] Table 2-20 Comparison of curative effects of traditional Chinese medicine syndrome scores after 12 weeks of treatment

[0194]

[0195] 4.4 Comparison of quality of life scores in patients with Doi hypertension

[0196] As shown in Table 2-21:

[0197] (1) Before treatment: The quality of life scores of Doi hypertension belonged to measurement data. After normal distribution test, both groups conformed to normal distribution. The experimental group scored 108.00 ± 7.93 points, and the control group scored 108.38 ± 6.84 points. After testing, P = 0.839 > 0.05. Therefore, there was no statistical difference in the quality of life scores of Doi hypertension between the two groups, and they were comparable.

[0198] (2) After treatment: After normal distribution test, both groups conformed to normal distribution. The experimental group scored 128.67 ± 11.39 points, and the control group scored 121.94 ± 7.31 points. Both groups improved compared with before treatment, and the within-group comparison was statistically significant (P < 0.001).

[0199] (3) Before and after treatment: After normal distribution test of the differences, they conformed to normal distribution. The experimental group had a difference of 20.67 ± 7.47 points, and the control group had a difference of 13.56 ± 4.17 points. The improvement degree of the experimental group was better than that of the control group, and the comparison was significantly statistically significant (P < 0.001).

[0200] Table 2-21 Comparison of the quality of life scores of patients with Doi hypertension in two groups (points, )

[0201]

[0202] 5. Safety analysis

[0203] In this study, all subjects underwent measurements of the four major vital signs, blood routine + CRP, liver and kidney functions, urine and feces, and electrocardiogram before and after treatment. No abnormalities were found in all indicators. None of the subjects had adverse reactions or adverse events such as allergies, hypertensive emergencies, and cerebral hemorrhage, and the safety level was grade 1.

[0204] Analysis of research results

[0205] 1. Analysis of basic conditions

[0206] A total of 65 subjects completed the full study in this project, including 33 in the experimental group and 32 in the control group. Before treatment (week 0), data such as the gender, age, BMI, waist circumference, smoking and drinking history, and family history of cardiovascular diseases of all subjects were collected and analyzed statistically. The results showed that most subjects had risk factors such as obesity, smoking history, drinking history, and family history. Grade 1 low-to-moderate-risk hypertension is an early stage of hypertension disease and is still in a critical period where active intervention and prevention of disease progression are possible. Therefore, it is extremely important to combine lifestyle intervention with traditional Chinese medicine treatment for hypertension.

[0207] 2. Analysis of blood pressure efficacy

[0208] (1) Clinic blood pressure efficacy

[0209] Clinic blood pressure is the main efficacy evaluation index in this study, an important evidence for the diagnosis of hypertension in clinical practice, and also the most commonly used method for evaluating the antihypertensive efficacy. The results of this study showed that after 12 weeks of treatment, the blood pressure values of both groups decreased compared with before (P < 0.05). Further calculation of the antihypertensive efficacy showed that the total effective rate of antihypertension in the experimental group was 78.79%, and that in the control group was 53.13%. It can be seen that the antihypertensive efficacy of the experimental group was higher than that of the control group. After testing, the difference was statistically significant (P < 0.05), indicating that Anjiang formula can significantly reduce clinic blood pressure and has a better antihypertensive efficacy than lifestyle intervention.

[0210] (2) Home self-measured blood pressure efficacy

[0211] Home self - measured blood pressure is a way to assist in evaluating the efficacy of blood pressure reduction. Instructing patients to measure their home blood pressure can increase patients' attention to blood pressure and improve compliance. The results of this study showed that after 12 weeks of treatment, the blood pressure values of both groups decreased compared with before (P < 0.05). Further calculating the efficacy of blood pressure reduction, the total effective rate of blood pressure reduction in the experimental group was 75.76%, and that in the control group was 59.38%. It can be seen that the efficacy of blood pressure reduction in the experimental group was higher than that in the control group. After testing, the difference was statistically significant (P < 0.05), suggesting that Anjiang Prescription can reduce home self - measured blood pressure, and its efficacy of blood pressure reduction is better than that of lifestyle intervention.

[0212] (3) Ambulatory blood pressure level

[0213] Clinic blood pressure and home self - measured blood pressure are for one - time blood pressure measurement. To avoid errors caused by factors such as spirit and environment, each subject was given 24 - hour ambulatory blood pressure measurement. And the guidelines suggest that ambulatory blood pressure is of great significance for evaluating grade 1 hypertension, and can observe the fluctuation of blood pressure at night. It is a more accurate method to reflect blood pressure level. Therefore, this research selected 24 - hour average blood pressure, daytime average blood pressure, and nighttime average blood pressure as observation indicators. The results showed that after 12 weeks of treatment, the 24 - hour average blood pressure, daytime average blood pressure, and nighttime average blood pressure of the experimental group at the 12th week decreased compared with before (P < 0.05). The 24 - hour average blood pressure, daytime average blood pressure, and n - sBP of the control group decreased compared with before (P < 0.05), while n - dBP had no obvious change compared with before (P > 0.05). After comparison, the decline amplitude of each blood pressure in the experimental group was better than that in the control group (P < 0.05), suggesting that Anjiang Prescription has a certain blood pressure - lowering effect, and its blood pressure - lowering effect is better than that of lifestyle intervention.

[0214] The above research results all indicate that the efficacy of Anjiang Prescription in reducing blood pressure is satisfactory.

[0215] Modern research suggests that the mechanism of the formation of hypertension with the syndrome of yin deficiency and yang hyperactivity is related to the expression of related factors in the Renin - Angiotensin - Aldosterone (RAAS) system and the hyperactivity of the Sympathetic Nervous System (SNS). The blood pressure - lowering pathway of Achyranthes bidentata in Anjiang Prescription is the RAAS axis; research also found that Gastrodia elata can inhibit the RAAS system; Semen Ziziphi Spinosae can soothe the nerves by regulating the SNS and the hypothalamic - pituitary - adrenal cortex system; as shown in the previous pharmacology, this prescription also has pharmacological effects such as regulating vasomotor, improving inflammation, and regulating intestinal flora. Therefore, Anjiang Prescription achieves comprehensive blood pressure reduction through multiple targets and is an effective traditional Chinese medicine prescription for patients with grade 1 low - to - moderate - risk hypertension, worthy of further promotion.

[0216] 3. Analysis of the efficacy of traditional Chinese medicine syndromes

[0217] The efficacy of traditional Chinese medicine (TCM) syndromes in this study was represented by the scores of TCM syndromes, which is a very commonly used method for evaluating efficacy in TCM research. The results showed that after 12 weeks of treatment, the scores of both groups decreased compared with those before treatment. Further calculating the efficacy of TCM syndromes, the effective rate of the experimental group was 84.85%, and that of the control group was 56.25%. After comparison, P < 0.05, indicating statistical significance, suggesting that the effective rate of improvement in the experimental group was better than that of the control group. This result proved that Anjiang Prescription could effectively improve the discomfort symptoms of patients with grade 1 low- to medium-risk hypertension of yin deficiency and yang hyperactivity syndrome.

[0218] Some studies have shown that the high-sensitivity C-reactive protein in the body of patients with hypertension of yin deficiency and yang hyperactivity syndrome is significantly increased, and the pulse pressure difference of their blood pressure is the highest compared with other syndrome types, suggesting a high cardiovascular risk in patients with yin deficiency and yang hyperactivity; Xie Wenjun et al. found that there was a great correlation between patients with hypertension of yin deficiency and yang hyperactivity syndrome and elevated total cholesterol and BMI. Therefore, it is of great significance to treat hypertension by regulating yin deficiency and yang hyperactivity.

[0219] The formation of grade 1 low- to medium-risk hypertension of yin deficiency and yang hyperactivity type is based on long-term mental stress, changes in dietary structure, etc. Excessive thinking depletes yin blood secretly, forming a state of yin deficiency, mainly "yin deficiency of the heart, liver, and spleen". Liver yang is hyperactive, and the mother disease affects the son, so the heart fire is also hyperactive. Wood restrains earth, forming spleen deficiency. Eating too much fatty and sweet food causes disorders in the ascending and descending of the spleen and stomach, generating phlegm-dampness. The son disease affects the mother, disturbing the mind, and combining to cause diseases. When liver wind combines with phlegm and turbid qi rebels upward, dizziness and headache occur; when heart fire is hyperactive and heart yin is deficient, palpitations and insomnia occur; when the heart and kidney are out of harmony, kidney water is deficient below and kidney yin is insufficient, showing symptoms of kidney yin deficiency such as soreness and weakness of the waist and knees, and feverish sensation in the five centers; spleen deficiency hinders the smooth flow of qi throughout the body, further aggravating the imbalance between yin and yang; and "the kidney qi communicates with the ears", which can also be manifested as tinnitus; "the brain is the sea of marrow" and the kidney dominates marrow, so forgetfulness and insomnia may occur; the combination of wind, fire, phlegm, and deficiency results in hypertension of "liver and heart yin deficiency and liver yang hyperactivity", and the key to treatment should be "nourishing the heart and calming the mind, suppressing liver wind". Suppressing liver wind treats the symptoms, and when phlegm-turbidity subsides, blood pressure also drops. Therefore, it was observed during the research that the blood pressure of those taking Anjiang Prescription orally could drop significantly after three days of taking the medicine; nourishing yin and nourishing blood to regulate blood, nourishing liver yang, adjusting the pathological state from within, consolidating the antihypertensive effect, and achieving stable and long-lasting blood pressure reduction; when the zang-fu organs return to normal ascending and descending, all symptoms will be eliminated.

[0220] Gastrodia elata in Anjiang Prescription is an important herb for suppressing liver wind. Achyranthes bidentata is good at descending, entering the liver and kidney, making qi and fire submerge downward and guiding fire back to its origin. Mother-of-pearl calms the mind and suppresses liver yang, relieving the discomfort symptoms of headache and dizziness, and reducing turbidity to lower blood pressure; Bupleurum chinense promotes the ascending of clear yang, dredges the triple energizer to regulate qi movement; Poria cum Radix Pini and Ziziphus jujuba var. spinosa nourish the heart blood and harmonize the heart qi, combined with Paeonia lactiflora to nourish yin blood, seeking yang in yin, effectively improving the symptoms of palpitations and insomnia. Its sour taste enters the liver, astringing yin to nourish liver yang; Fructus Aurantii has a pungent flavor for promoting qi movement and a bitter flavor for reducing adverse qi. All the herbs work together to assist in regulating the ascending and descending of qi movement, fundamentally relieving the pathological state of yin deficiency and yang hyperactivity, so all symptoms such as soreness and weakness of the waist and knees, feverish sensation in the five centers, and tinnitus can be eliminated.

[0221] 4. Analysis of the Efficacy of Anjiang Prescription on the Quality of Life of Patients with Dooley Hypertension

[0222] The Dooley Hypertension Quality of Life Score is a comprehensive scale for evaluating the quality of life of hypertensive patients. It has a total of 53 items, with 5 levels ranging from none to extremely severe, and the scores range from 4 to 0. The higher the score, the higher the quality of life. The results of this study showed that the scores of both groups increased after treatment (P < 0.05), and the experimental group was better than the control group (P < 0.05), indicating that Anjiang Prescription can effectively improve the quality of life of patients with grade 1 low- to medium-risk hypertension.

[0223] Currently, many studies have shown that the intervention of traditional Chinese medicine can effectively improve the quality of life of hypertensive patients, and the Dooley Hypertension Quality of Life Score is also used as the evaluation scale. The Anjiang Prescription of the present invention has excellent efficacy in improving the quality of life. Because of its overall dialectical view, it fundamentally adjusts the pathological state of yin deficiency and yang hyperactivity. Mother-of-pearl, Poria, and stir-fried Ziziphus jujuba seed in the prescription all have the effect of nourishing the heart and calming the mind, and are quite effective in improving sleep; adding measures to nourish the liver and protect the heart can ensure the production of qi and blood, enabling patients to cope with the troubles in the world, feel happy, and naturally improve the quality of life.

[0224] In summary: 1. A total of 70 patients were enrolled in this research project. Among them, 2 patients dropped out from the experimental group and 3 patients dropped out from the control group. Finally, 65 cases of valid statistical data were obtained, and the total dropout rate was 7.14%. 2. Baseline comparison: There were no statistically significant differences in gender, age, body mass index (BMI), waist circumference, smoking and drinking history, family history of cardiovascular diseases, blood pressure, traditional Chinese medicine syndrome scores, and Du's hypertension quality of life scores between the two groups of patients at week 0 (P>0.05). 3. Comparison of main efficacy indicators: (1) Clinic blood pressure: Compared with week 0, the clinic systolic blood pressure (sBP) and clinic diastolic blood pressure (dBP) of the two groups of patients at week 12 decreased compared with before (P<0.05). The decrease in blood pressure in the experimental group was better than that in the control group (P<0.05). Among them, the antihypertensive effective rate in the experimental group was 78.79%, and the antihypertensive effective rate in the control group was 53.13%. The antihypertensive efficacy of the experimental group was better than that of the control group (P<0.05). 4. Comparison of secondary efficacy indicators: (1) Home self-measured blood pressure: Compared with week 0, the home self-measured sBP and home self-measured dBP of the two groups of patients at week 12 decreased compared with before (P<0.05). The decrease in blood pressure in the experimental group was better than that in the control group (P<0.05). The antihypertensive effective rate in the experimental group was 75.76%, and the antihypertensive effective rate in the control group was 59.38%. The antihypertensive efficacy of the experimental group was better than that of the control group (P<0.05). (2) Ambulatory blood pressure: Compared with week 0, the 24-hour average blood pressure, daytime average blood pressure, and nighttime average blood pressure of the experimental group at week 12 decreased compared with before (P<0.05). The 24-hour average blood pressure, daytime average blood pressure, and nighttime average systolic blood pressure of the control group decreased compared with before (P<0.05), while the nighttime average diastolic blood pressure did not change significantly compared with before (P>0.05); after comparison, the decrease in blood pressure in the experimental group was better than that in the control group (P<0.05). (3) Traditional Chinese medicine syndrome: Compared with week 0, the traditional Chinese medicine syndrome scores of the two groups of patients at week 12 improved, and the improvement degree in the experimental group was better than that in the control group (P<0.05). Among them, the total effective rate in the experimental group was 84.85%, and the total effective rate in the control group was 56.25%. The efficacy of traditional Chinese medicine syndrome in the experimental group was better than that of the control group (P<0.05). (4) Du's hypertension quality of life score: Compared with week 0, the Du's hypertension quality of life scores of the two groups of patients at week 12 increased, and the improvement degree of quality of life in the experimental group was better than that in the control group (P<0.05). 5. In terms of safety: During the research period of this project, no adverse reactions or adverse events occurred in both groups of patients.

[0225] Conclusion: The antihypertensive formula of the present invention can effectively reduce the blood pressure level of patients with grade 1 low-to-moderate-risk hypertension of yin deficiency and yang hyperactivity type, improve traditional Chinese medicine syndromes, and improve the quality of life, with good safety.

[0226] The above are only the preferred embodiments of the present invention, and thus the scope of implementation of the present invention cannot be limited thereby. That is, equivalent changes and modifications made according to the scope of the present invention patent and the content of the specification should still fall within the scope covered by the present invention.

Claims

1. A Chinese medicine composition for treating hypertension, characterized in that: In parts by mass, including: 6-12 parts of Gastrodia elata, 9-15 parts of stir-fried Ziziphus jujuba seeds, 6-12 parts of Polygonum multiflorum, 10-20 parts of mother of pearl, 10-20 parts of Poria, 5-11 parts of stir-fried White Peony Root, 3-9 parts of Northern Bupleurum, 3-9 parts of stir-fried Citrus aurantium and 2-8 parts of roasted Licorice root.

2. A Chinese medicine composition for treating hypertension according to claim 1, characterized in that: The composition comprises, by weight, 9 parts of Gastrodia elata, 12 parts of stir-fried Semen Ziziphi Spinosae, 9 parts of Rhizoma Cyathulae, 15 parts of Mother of Pearl, 15 parts of Poria, 8 parts of stir-fried White Peony Root, 6 parts of Bupleurum chinense, 6 parts of stir-fried Fructus Aurantii Immaturus and 5 parts of roasted Licorice Root.

3. A Chinese medicine composition for treating hypertension according to claim 1, characterized in that: Each dose of the traditional Chinese medicine composition is equivalent to 54g to 116g of the raw material medicine.

4. A method for preparing a Chinese medicine composition for treating hypertension as claimed in claim 1, comprising the following steps: weighing each component according to the above-mentioned mass ratio, and cleaning each raw material medicine according to the characteristics of each raw material medicine; decocting the above-mentioned Chinese medicine composition with water to obtain a primary decoction liquid; separating the remaining part after the primary decoction liquid, including the remaining drug residue and the residual drug liquid, decocting with water again to obtain a secondary decoction liquid; combining the primary decoction liquid and the secondary decoction liquid to obtain.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The Chinese medicine composition is boiled over high heat and then decocted over low heat for 25-35 minutes.

6. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The volume of the first decoction is 200-350 mL per dose; the volume of the second decoction is 200-350 mL per dose; each dose of the traditional Chinese medicine composition is equivalent to 54g-116g of the raw material medicine.

7. Use of the Chinese medicine composition according to any one of claims 1 or 2 in preparing a medicament for treating hypertension.

8. The use according to claim 7, characterized in that: The hypertension is grade 1 low-to-moderate risk hypertension of the Yin deficiency and Yang hyperactivity type.

9. The use according to claim 7, characterized in that: The dosage form of the drug is an oral preparation.

10. The use according to claim 9, characterized in that: The oral preparations include mixtures, granules, tablets, pills or capsules.

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