Traditional Chinese medicine compound composition for treating pure diastolic hypertension and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine treatment of hypertension, in particular to a traditional Chinese medicine compound composition for treating pure diastolic hypertension and a preparation method thereof. The traditional Chinese medicine compound composition is prepared from the following raw material medicines in parts by mass: 30-180 parts of calcined nacre mother of pearl, 20-180 parts of uncaria, 15-90 parts of raw gardenia, 10-60 parts of radix scrophulariae, 30-180 parts of kudzu vine root, 10-60 parts of chrysanthemum and 10-60 parts of fried sophora flower. The traditional Chinese medicine compound composition disclosed by the invention has a remarkable antihypertensive curative effect on hypertensive patients with pure diastolic pressure rise, and can obviously improve heart and liver fire hyperactivity syndromes such as dizziness, blurred vision, bitter mouth and vexation, emotion restlessness, facial flushing and the like of the hypertensive patients at the same time. Through clinical verification, the traditional Chinese medicine composition has the advantages of stable curative effect, small side effect and lasting effect, is particularly suitable for standardized treatment of middle-aged and young early-stage hypertension patients, and provides a safe and reliable traditional Chinese medicine solution for pure diastolic pressure rise.

Description

Technical Field

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

[0002] Isolated Diastolic Hypertension (IDH) is a special type of hypertension, characterized by normal systolic blood pressure (<140 mmHg) and abnormally elevated diastolic blood pressure (≥90 mmHg). Epidemiological investigations show that IDH has a relatively high incidence in the middle-aged and young population, with the peak age range concentrated in the 35 - 49-year-old stage, accounting for approximately 10% - 15% of primary hypertension cases. Its pathological mechanism exhibits characteristics of multi-system interaction: firstly, abnormal hemorheology, manifested as increased blood viscosity and slowed blood flow velocity; secondly, over-activation of the sympathetic nervous system, leading to increased peripheral arteriolar tension and vasoconstriction; thirdly, changes in cardiac function, including increased heart rate and increased end-diastolic volume load of the heart. Since the large arteries of middle-aged and young patients have relatively good elasticity and can effectively buffer pressure during cardiac systole, the systolic blood pressure remains normal; while during diastole, due to the combined action of the aforementioned pathological factors, the diastolic blood pressure is significantly elevated. The key to clinical treatment lies in improving hemorheology, regulating autonomic nerve function, and eliminating risk factors, including multiple modifiable factors such as mental stress, unhealthy lifestyle, and metabolic abnormalities. It should be noted that IDH is not a benign condition, and studies have confirmed that it is also an independent risk factor for cardiovascular and cerebrovascular events and target organ damage.

[0003] Currently, Western medicine treatment for IDH faces multiple dilemmas: for patients with a diastolic blood pressure of 90 - 94 mmHg, lifestyle intervention is usually recommended first. However, practice has shown that simple lifestyle intervention has defects such as poor compliance (only 23% of patients can continuously reach the standard) and a long onset period (an average of 6 - 9 months); when it progresses to the stage where the diastolic blood pressure ≥95 mmHg, drug treatment needs to be initiated, mainly using single-drug treatments with drugs such as β-blockers, diuretics, and angiotensin-converting enzyme inhibitors (ACEI) / angiotensin receptor blockers (ARB). However, the adverse reactions of these drugs are particularly prominent in the middle-aged and young population: β-blockers are prone to causing fatigue, decreased exercise tolerance, and sexual dysfunction; diuretics may cause electrolyte disorders, hyperuricemia, and abnormal glucose and lipid metabolism; ACEI drugs are often accompanied by adverse reactions such as intractable dry cough. A more prominent contradiction is that existing chemical drugs mostly have a single-target action mechanism and are difficult to simultaneously intervene in complex multi-dimensional and multi-target pathological links such as autonomic nerve imbalance, hemodynamic disorders, and endothelial function disorders in IDH. Moreover, the combined drug treatment plan not only doubles the incidence of adverse reactions but also brings an economic burden of increased annual treatment costs, forming a major bottleneck in clinical treatment.

[0004] In contrast, traditional Chinese medicine (TCM) demonstrates irreplaceable systematic regulation advantages in the field of IDH prevention and treatment. TCM compound prescriptions are characterized by multiple components, multiple targets, and overall regulation. This overall regulation property precisely corresponds to the multi-factor pathogenesis of IDH, enabling simultaneous regulation of autonomic nerve function, improvement of hemorheology, protection of vascular endothelium, and with relatively minor side effects of natural medicine components. Therefore, developing TCM compound preparations targeting the pathological characteristics of IDH not only conforms to the theoretical essence of "treatment based on syndrome differentiation" in TCM but also meets the urgent clinical need for safe and effective treatment regimens, possessing important clinical application value and development prospects. Summary of the Invention

[0005] Based on the above, the present invention provides a TCM compound composition for treating isolated diastolic hypertension and its preparation method. In view of the multi-target pathological characteristics of isolated diastolic hypertension and the limitations of existing treatment regimens, the present invention innovatively constructs a trinity TCM compound system of "calming the liver and suppressing yang - clearing the heart and purging fire - nourishing yin and dredging collaterals". Through the scientific compatibility of monarch, minister, assistant, and envoy herbs, the dual treatment goals of blood pressure regulation and syndrome improvement are achieved, especially suitable for the precise intervention of IDH patients with the syndrome type of hyperactivity of heart and liver fire.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] One technical solution of the present invention is a TCM compound composition for treating isolated diastolic hypertension, which is prepared from the following raw materials in parts by mass: 30 - 180 parts of calcined nacre, 20 - 180 parts of uncaria rhynchophylla, 15 - 90 parts of gardenia jasminoides Ellis, 10 - 60 parts of scrophularia ningpoensis Hemsl, 30 - 180 parts of pueraria lobata (Willd.) Ohwi, 10 - 60 parts of flos chrysanthemi, and 10 - 60 parts of stir-fried sophora japonica L.

[0008] Another technical solution of the present invention is a preparation method of the above TCM compound composition for treating isolated diastolic hypertension, comprising the following steps:

[0009] According to the parts by mass, decoct the calcined nacre with water to obtain filtrate 1;

[0010] According to the parts by mass, decoct the uncaria rhynchophylla with water to obtain filtrate 2;

[0011] Decoct the remaining raw materials except for the calcined nacre and uncaria rhynchophylla with water to obtain filtrate 3;

[0012] Combine filtrate 1, filtrate 2, and filtrate 3, and successively filter, concentrate, precipitate by alcohol sedimentation, and then concentrate again to obtain an extract.

[0013] Another technical solution of the present invention is a drug for treating isolated diastolic hypertension, the active ingredient of which is the above TCM compound composition for treating isolated diastolic hypertension.

[0014] The present invention discloses the following technical effects:

[0015] The present invention provides a traditional Chinese medicine compound composition containing the compatibility of calcined nacre and uncaria rhynchophylla, which has a significant antihypertensive effect on patients with isolated diastolic hypertension. At the same time, it can significantly improve the syndromes of hyperactivity of heart-fire and liver-fire in hypertensive patients, such as dizziness, blurred vision, bitter taste in the mouth, restlessness, and flushing of the face. The curative effect on isolated diastolic hypertension (syndrome of hyperactivity of heart-fire and liver-fire) is definite, and long-term use has small toxic and side effects, and the medication is safe and reliable. Detailed implementation manners

[0016] The various exemplary implementation manners of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics, and implementation manners of the present invention.

[0017] It should be understood that the terms used in the present invention are only for describing specific implementation manners and are not used to limit the present invention. In addition, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0018] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0019] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific implementation manners of the present invention specification, which are obvious to those skilled in the art. Other implementation manners obtained from the specification of the present invention are obvious to those skilled in the art. The specification and examples of the present invention are only exemplary.

[0020] Regarding the terms "comprising", "including", "having", "containing", etc. used herein, they are all open-ended terms, that is, they are intended to include but not limited to.

[0021] In the first aspect of the present invention, a traditional Chinese medicine compound composition for treating isolated diastolic hypertension is provided, which is made from the following raw materials in parts by mass: 30-180 parts of calcined nacre, 20-180 parts of uncaria rhynchophylla, 15-90 parts of raw gardenia fruit, 10-60 parts of scrophularia ningpoensis, 30-180 parts of kudzu root, 10-60 parts of chrysanthemum, and 10-60 parts of stir-fried sophora japonica flower.

[0022] In some embodiments of the present invention, it is made from the following raw materials in parts by mass: 30 parts of calcined nacre, 20 parts of uncaria rhynchophylla, 15 parts of raw gardenia fruit, 10 parts of scrophularia ningpoensis, 30 parts of kudzu root, 10 parts of chrysanthemum, and 10 parts of stir-fried sophora japonica flower.

[0023] In some embodiments of the present invention, it is made from the following raw materials in parts by mass: 60 parts of calcined nacre, 60 parts of uncaria rhynchophylla, 20 parts of raw gardenia fruit, 20 parts of scrophularia ningpoensis, 60 parts of kudzu root, 20 parts of chrysanthemum, and 20 parts of stir-fried sophora japonica flower.

[0024] In some embodiments of the present invention, it is made from the following raw materials in parts by mass: 180 parts of calcined nacre, 180 parts of uncaria rhynchophylla, 90 parts of raw gardenia fruit, 60 parts of scrophularia ningpoensis, 180 parts of kudzu root, 60 parts of chrysanthemum, and 60 parts of stir-fried sophora japonica flower.

[0025] The traditional Chinese medicine has obvious advantages in the treatment of isolated diastolic hypertension due to its multi-target and multi-pharmacodynamic synergistic effects. It can act synergistically and improve the elevated diastolic blood pressure and hyperactivity of the sympathetic nervous system. The clinical manifestations of isolated diastolic hypertension are related to diseases such as "vertigo" and "headache" in traditional Chinese medicine. The inventors of the present invention innovatively proposed the pathogenesis theory system of "excessive heart and liver fire" for isolated diastolic hypertension, believing that the disease location is mainly in the heart, liver, and spleen, "starting from liver depression and spleen deficiency, becoming a disease due to liver depression transforming into fire and fire damaging yin, and occurring due to yin deficiency and yang hyperactivity, phlegm-heat disturbing the heart". Guided by this pathogenesis theory, prescriptions and medications are made, and it is proposed to soothe the liver and suppress yang, clear the heart and relieve vexation to treat isolated diastolic hypertension, and a traditional Chinese medicine compound is formed based on clinical experience, which can effectively reduce diastolic blood pressure, control heart rate, and relieve related symptoms, with quite good clinical efficacy.

[0026] The traditional Chinese medicine compound composition for treating simple diastolic hypertension of the present invention is targeted at the basic pathogenesis of simple diastolic hypertension patients with liver depression and spleen deficiency, liver depression transforming into fire, excessive fire injuring yin, yin deficiency and yang hyperactivity, and phlegm-heat disturbing the heart, and establishes the therapeutic principles and methods of suppressing liver yang and clearing the heart and relieving vexation. In "Plain Questions: The Great Treatise on the Most Essential Questions", it is said that "all wind-induced dizziness and vertigo pertain to the liver". The dizziness and headache caused by hypertension are mostly attributed to the liver yang transforming into wind. Zhang Xichun in "Medical Records of Combining Traditional Chinese and Western Medicine" emphasized the method of "suppressing liver wind", and created Zhengan Xifeng Decoction by combining minerals with nourishing yin herbs. This formula follows this idea, using calcined mother-of-pearl and uncaria as the monarch drugs to directly reduce liver yang; compatibility with gardenia and sophora flower to clear the fire of the liver and heart, which implicitly conforms to Liu Wansu's theory of "extreme heat generating wind"; scrophularia nourishes yin in accordance with the principle of "strengthening water to control yang", and kudzu root ascends the clear qi and relaxes the muscles following the treatment method of "stiff neck and back" in "Treatise on Febrile Diseases", and the overall compatibility conforms to the pathogenesis of liver yang hyperactivity combined with fire transforming and injuring yin. In the formula, calcined mother-of-pearl is heavy and can suppress yang. "Compendium of Materia Medica" states that it "calms the mind... stops spermatorrhea and leukorrhagia". After calcination, calcium ions are released, enhancing the power of suppressing and subsiding; uncaria is light and clear in nature. "New Compilation of Materia Medica" says that it "suppresses liver wind without being dry", and combines with mother-of-pearl, hardness and softness assisting each other, to achieve the effect of suppressing liver wind and extinguishing wind together. Raw gardenia clears the fire of the triple energizer. In "Danxi's Heart Method", it is used to treat headache due to fire stagnation; stir-fried sophora flower cools the liver and purges heat. "Medicinal Properties Interpretation" says that it "purgates the excess heat in the blood aspect of the liver". The two work together to clear the liver and reduce blood pressure. The dosage of kudzu root is particularly heavy, ascending the clear yang of the spleen and stomach to relieve the spasm of the liver. Scrophularia nourishes yin and reduces fire. "Correct Meaning of Materia Medica" praises it as "soft, moistening and nourishing fluid", restricting the dryness of heavy drugs; chrysanthemum clears and benefits the head and eyes. "Explanation of Shennong's Classic of Materia Medica" says that it "specially treats wind in the liver wood". Together with kudzu root, it guides the medicine upward; and the sedimentation of mother-of-pearl is combined with the light rising of uncaria and chrysanthemum, conforming to the ascending nature of liver wood without over-suppressing. In the whole formula, among the cold and cool compatibility, kudzu root with pungent and dispersing property is used as an adjuvant to prevent the stagnation of liver qi due to ice. All the herbs are combined to achieve the effects of suppressing liver yang and clearing the heart and relieving vexation.

[0027] In some embodiments of the present invention, the dosage form is granule, oral liquid, paste, capsule or tablet.

[0028] Clinically verified, the traditional Chinese medicine compound composition of the present invention has the advantages of stable curative effect, small side effects and long-lasting action, and is especially suitable for the standardized treatment of young and middle-aged patients with early hypertension, providing a safe and reliable traditional Chinese medicine solution for simple diastolic blood pressure elevation.

[0029] The second aspect of the present invention provides a preparation method of the above-mentioned traditional Chinese medicine compound composition for treating simple diastolic hypertension, including the following steps:

[0030] According to parts by mass, decoct calcined mother-of-pearl with water to obtain filtrate 1;

[0031] According to parts by mass, decoct uncaria with water to obtain filtrate 2;

[0032] Decoct the remaining raw materials except calcined mother-of-pearl and uncaria with water to obtain filtrate 3;

[0033] Combine filtrate 1, filtrate 2, and filtrate 3, and successively perform filtration, concentration, alcohol precipitation to remove precipitate, and then concentration to obtain an extract.

[0034] In a preferred embodiment of the present invention, the preparation method of the paste of the traditional Chinese medicine compound composition for treating isolated diastolic hypertension includes the following steps: Weigh calcined nacre according to weight, add water and decoct twice, combine the decoction liquids to obtain filtrate 1; Weigh uncaria rhynchophylla slices according to weight, add water and decoct twice, combine the decoction liquids to obtain filtrate 2; Weigh raw gardenia jasminoides, scrophularia ningpoensis, pueraria lobata, chrysanthemum morifolium, and stir-fried sophora japonica slices according to weight, add water and decoct twice, combine the decoction liquids to obtain filtrate 3; Combine filtrate 1, filtrate 2, and filtrate 3, then filter and concentrate the filtrate, perform alcohol precipitation treatment on the concentrated filtrate, filter off the precipitate, recycle the filtrate after filtering off the precipitate and concentrate it to a relative density of 1.30 - 1.36 at 80°C to obtain an extract. The obtained extract can be prepared into oral liquid, granule, capsule, paste, or tablet dosage forms as needed.

[0035] In a further preferred embodiment of the present invention, the alcohol precipitation treatment uses ethanol with a volume concentration of 85%.

[0036] The third aspect of the present invention provides a drug for treating isolated diastolic hypertension, and the active ingredient is the above-mentioned traditional Chinese medicine compound composition for treating isolated diastolic hypertension.

[0037] The technical solutions of the present invention, unless otherwise specified, are all conventional solutions in the art, and the reagents or raw materials used, unless otherwise specified, are all purchased from commercial channels or are publicly available.

[0038] The following combines examples to detail the technical solutions provided by the present invention, but they cannot be understood as limiting the protection scope of the present invention.

[0039] Example 1

[0040] A traditional Chinese medicine compound composition for treating isolated diastolic hypertension, the raw materials are composed of 30 g of calcined nacre, 20 g of uncaria rhynchophylla, 15 g of raw gardenia jasminoides, 10 g of scrophularia ningpoensis, 30 g of pueraria lobata, 10 g of chrysanthemum morifolium, and 10 g of stir-fried sophora japonica.

[0041] The preparation method of the decoction of the above-mentioned traditional Chinese medicine compound composition for treating isolated diastolic hypertension is the following steps:

[0042] Put the calcined nacre into a decocting earthenware pot, add 500 ml of water, bring to a boil over high heat, and then simmer with the lid open for 30 minutes; add the raw gardenia, scrophularia, kudzu root, chrysanthemum, and stir-fried sophora flower slices, supplement the water to 500 ml, bring to a boil over high heat, and then simmer with the lid open for 20 minutes; then add the uncaria slice, supplement the water to 500 ml, bring to a boil over high heat, and then simmer with the lid open for 10 minutes, and filter the decoction; then supplement the water to 500 ml, bring to a boil over high heat, and then simmer with the lid open for 20 minutes, and filter the decoction; combine the two decoctions to obtain the water decoction of the traditional Chinese medicine compound composition for treating simple diastolic hypertension.

[0043] Example 2

[0044] A traditional Chinese medicine compound composition for treating simple diastolic hypertension, the raw materials are composed of 60 g of calcined nacre, 60 g of uncaria, 20 g of raw gardenia, 20 g of scrophularia, 60 g of kudzu root, 20 g of chrysanthemum, and 20 g of stir-fried sophora flower;

[0045] The preparation method of the ointment of the above-mentioned traditional Chinese medicine compound composition for treating simple diastolic hypertension is the following steps:

[0046] Weigh the calcined nacre according to the above weight, add water for two decoctions (the amount of water added for each decoction is 500 ml, first bring to a boil over high heat for each decoction, and then simmer over low heat for 30 minutes), combine the two obtained decoctions to obtain filtrate 1.

[0047] Weigh the uncaria slice according to the above weight, add water for two decoctions (the amount of water added for each decoction is 500 ml, first bring to a boil over high heat for each decoction, and then simmer over low heat for 10 minutes), combine the two obtained decoctions to obtain filtrate 2.

[0048] Weigh the raw gardenia, scrophularia, kudzu root, chrysanthemum, and stir-fried sophora flower slices according to the weight, add water for two decoctions (the amount of water added for each decoction is 500 ml, first bring to a boil over high heat for each decoction, and then simmer over low heat for 30 minutes), combine the two obtained decoctions to obtain filtrate 3.

[0049] After combining filtrate 1, filtrate 2, and filtrate 3, filter them, concentrate the obtained filtrate, the concentration temperature is 60 °C (any temperature between 50 and 70 °C is acceptable), and concentrate to a relative density of 1.10 (any value between 1.05 and 1.15 is acceptable) mg / cm 3 to obtain a concentrated solution, and perform alcohol precipitation treatment on the concentrated solution (specifically: add an ethanol-aqueous solution with a volume concentration of 85% to the concentrated solution, add it to the concentrated solution according to the volume ratio of ethanol-aqueous solution: concentrated solution of 5:1, stir and dissolve at 60 °C for 120 minutes), then filter off the precipitate, and recover the obtained filtrate and concentrate it at 80 °C to a relative density of 1.33 (any value between 1.30 and 1.36 is acceptable) mg / cm 3 to obtain an extract.

[0050] Example 3

[0051] A traditional Chinese medicine compound composition for treating simple diastolic hypertension, which is composed of 180 g of calcined nacre, 180 g of uncaria rhynchophylla, 90 g of raw gardenia jasminoides, 60 g of scrophularia ningpoensis, 180 g of pueraria lobata, 60 g of chrysanthemum morifolium, and 60 g of stir-fried sophora japonica;

[0052] The preparation method of the paste of the above traditional Chinese medicine compound composition for treating simple diastolic hypertension is the same as that in Example 2.

[0053] Effect Example 1

[0054] (1) Select patients with simple diastolic hypertension (syndrome of hyperactivity of heart-fire and liver-fire) who met the inclusion criteria and were treated in the Department of Cardiology of Jiangsu Hospital of Integrated Traditional Chinese and Western Medicine from November 2022 to January 2025 as the research objects. They were randomly divided into a traditional Chinese medicine group and a control group according to the coin-tossing random grouping method. Finally, 30 cases in the traditional Chinese medicine group and 27 cases in the control group completed the observation study.

[0055] (2) Treatment methods

[0056] Control group: Given metoprolol sustained-release tablets, 47.5 mg·d -1 , or bisoprolol, 5 mg·d -1 , taken once a day.

[0057] Traditional Chinese medicine group: Given the traditional Chinese medicine compound decoction of Example 1, decocted to 100 ml, 1 dose per day (the raw material dosage recorded in Example 1 is 1 dose), taken twice a day, in the morning and evening.

[0058] The observation and treatment courses for both groups were 4 weeks.

[0059] (3) Observation indicators and methods

[0060] ① Blood pressure situation

[0061] Clinic blood pressure: The patient rested for at least 15 minutes in a resting state, and the blood pressure of both upper arms was measured 3 times using an electronic sphygmomanometer. The average value of the 3 blood pressure readings was taken, and the higher blood pressure on both sides was recorded. Home blood pressure monitoring: The patient measured blood pressure at home every day according to the provided blood pressure monitoring record sheet. Before measurement, the patient rested for at least 15 minutes, and the blood pressure of the higher side arm was measured using an electronic sphygmomanometer and recorded in the issued blood pressure monitoring record form, which was brought back during the follow-up visit and the values were recorded by the doctor.

[0062] ② Efficacy criteria for traditional Chinese medicine syndromes

[0063] The integral method was adopted. For the main symptoms, scores of 0, 2, 4, and 6 were given according to the absence, mildness, moderate severity, and severe severity of the symptoms respectively. For the secondary symptoms, scores of 0, 1, 2, and 3 were given according to the absence, mildness, moderate severity, and severe severity of the symptoms respectively.

[0064] Efficacy index = (total score before treatment - total score after treatment) ÷ total score before treatment.

[0065] The curative effect was judged according to the following criteria: Marked effect: The symptoms were significantly improved, and the syndrome integral was reduced by ≥70% compared with that before treatment; Effective: The symptoms were improved, and the syndrome integral was reduced by ≥30% and <70% compared with that before treatment; Ineffective: The symptoms were not improved, and the syndrome integral was reduced by <30% compared with that before treatment.

[0066] ③ Safety indicators

[0067] Blood routine, liver and kidney functions: They were measured before the start of treatment and at the 4th week after treatment respectively, and used as safety evaluation indicators.

[0068] Results and analysis

[0069] The collected data were statistically analyzed using SPSS 21 statistical software. Measurement data were expressed as mean ± standard deviation ( ), paired sample t-test was used for within-group comparison, and independent sample t-test was used for between-group comparison. Count data were expressed as rate and constituent ratio, and χ 2 test was used. P < 0.05 was considered statistically significant.

[0070] (1) The traditional Chinese medicine compound composition of the present invention can significantly reduce the diastolic blood pressure of patients with isolated diastolic hypertension

[0071] The diastolic blood pressure of patients in the traditional Chinese medicine group and the control group decreased significantly after treatment compared with that before treatment, and the differences were all statistically significant (P < 0.01); In the between-group comparison, there was no statistically significant difference between the diastolic blood pressure of the traditional Chinese medicine group and the control group (P > 0.05). The results showed that the traditional Chinese medicine compound composition of the present invention had a good antihypertensive effect on the diastolic blood pressure of patients with isolated diastolic hypertension (Table 1).

[0072] Table 1 Comparison of blood pressure between the two groups before and after treatment (mmHg)

[0073]

[0074] Note: **P < 0.01 for within-group comparison

[0075] (2) The curative effect of the traditional Chinese medicine syndrome of the traditional Chinese medicine compound composition of the present invention is significantly better than that of western medicine treatment

[0076] The total effective rate of the traditional Chinese medicine syndrome in the traditional Chinese medicine group was significantly better than that in the control group, and the difference was statistically significant. The results are shown in Table 2:

[0077] Table 2 Comparison of the curative effect of traditional Chinese medicine syndromes between the two groups before and after treatment

[0078] Group Number of cases Marked effect Effective Ineffective Total effective rate / % Traditional Chinese medicine group 30 22 6 2 <![CDATA[93.33 # > Control group 27 8 7 12 55.56

[0079] Note: After χ 2 test, χ 2 = 8.92,# P < 0.01

[0080] Conclusion

[0081] The traditional Chinese medicine compound composition of the present invention has a good antihypertensive effect on patients with isolated diastolic hypertension and can significantly improve the clinical symptoms of patients.

[0082] Effect Example 2

[0083] Patient A, male, 39 years old, had dizziness accompanied by elevated diastolic blood pressure for half a year. Half a year ago, due to dizziness, blood pressure measurement found elevated diastolic blood pressure and normal systolic blood pressure. Usually, the blood pressure was around 128 - 132 / 92 - 110 mmHg, accompanied by dry mouth and bitter taste, fatigue, irritability, flushing, and palpitations. Usually, the work and life pressure were relatively high, the sleep at night was poor, the stool was sticky and uncomfortable, the tongue was red, the tongue body was enlarged, there were tooth marks on the side, the tongue coating was yellow and thick and greasy, and the pulse was stringy and rapid. He had taken metoprolol sustained-release tablets for treatment. After taking the medicine, the diastolic blood pressure could be controlled at 86 - 98 mmHg, but after taking the medicine, he felt severe weakness in the lower limbs and obvious sexual dysfunction, so he stopped taking the medicine by himself. When visiting the doctor, the blood pressure was measured at 132 / 108 mmHg and the heart rate was 92 beats per minute. After taking 28 doses of the traditional Chinese medicine decoction of the first embodiment of the present invention, the blood pressure was stably reduced to 124 - 130 / 82 - 88 mmHg, and symptoms such as dizziness, dry mouth and bitter taste, fatigue, irritability, flushing, and palpitations were all relieved, the red tongue improved, and the tongue coating turned white and slightly greasy.

[0084] Effect Example 3

[0085] Patient A, male, 38 years old, had elevated diastolic blood pressure for more than 2 years. Two years ago, during the physical examination and intermittent self-measurement of blood pressure, it was 130 - 136 / 98 - 112 mmHg. He had taken "indapamide 1.5 mg qd", and after taking the medicine, the uric acid increased, so he stopped taking the medicine by himself. Usually, he had symptoms such as dizziness and irritability. When visiting the doctor, the blood pressure was measured at 138 / 110 mmHg and the heart rate was 94 beats per minute. The edge of the tongue was red, there were tooth marks on the side, the tongue coating was yellow and slightly greasy, and the pulse was stringy and rapid. He took the extract of the traditional Chinese medicine compound composition of the second embodiment of the present invention, 20 ml, twice a day, and took it with 100 ml of warm boiled water. After 4 weeks, the blood pressure dropped to 132 / 86 mmHg. During this period, the blood pressure was measured many times and fluctuated between 126 - 134 / 78 - 90 mmHg, and the discomfort symptoms such as dizziness were significantly relieved.

[0086] Effect Example 4

[0087] Patient XX, female, 48 years old, with poorly controlled diastolic blood pressure for more than 6 years. The patient has a history of "anxiety disorder" for 8 years. Six years ago, repeated blood pressure measurements revealed elevated diastolic blood pressure, fluctuating between 122-138 / 90-114 mmHg. She had taken antihypertensive drugs such as "metoprolol", "bisoprolol", "amlodipine", "valsartan", and "hydrochlorothiazide", but all were discontinued due to discomfort after taking the drugs. At the time of diagnosis, the blood pressure was 136 / 112 mmHg and the heart rate was 88 beats per minute. She was accompanied by dizziness, blurred vision, occasional mouth ulcers, a feeling of hotness on the face, sweating and palpitations when moving, occasional numbness all over the body, and difficulty falling asleep. The sides of the tongue were red, the tongue coating was thin and slightly yellowish, and the pulse was thready, taut, and rapid. She took 15 ml of the extract of the traditional Chinese medicine compound composition in Example 3 of the present invention twice a day. After taking it for 3 months, the blood pressure steadily decreased to 122-130 / 72-80 mmHg, and the above-mentioned uncomfortable clinical symptoms were significantly relieved and the sleep was improved.

[0088] The above-described embodiments are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A traditional Chinese medicine compound composition for treating isolated diastolic hypertension, characterized in that, It is prepared from the following raw medicinal materials in parts by mass: 30-180 parts of calcined nacre, 20-180 parts of uncaria rhynchophylla, 15-90 parts of gardenia jasminoides Ellis, 10-60 parts of scrophularia ningpoensis Hemsl., 30-180 parts of pueraria lobata (Willd.) Ohwi, 10-60 parts of flos chrysanthemi, and 10-60 parts of stir-fried sophora japonica L..

2. The traditional Chinese medicine compound composition for treating isolated diastolic hypertension according to claim 1, wherein It is prepared from the following raw medicinal materials in parts by mass: 30 parts of calcined nacre, 20 parts of uncaria rhynchophylla, 15 parts of gardenia jasminoides Ellis, 10 parts of scrophularia ningpoensis Hemsl., 30 parts of pueraria lobata (Willd.) Ohwi, 10 parts of flos chrysanthemi, and 10 parts of stir-fried sophora japonica L..

3. The traditional Chinese medicine compound composition for treating simple diastolic hypertension according to claim 1, wherein It is prepared from the following raw medicinal materials in parts by mass: 60 parts of calcined nacre, 60 parts of uncaria rhynchophylla, 20 parts of gardenia jasminoides Ellis, 20 parts of scrophularia ningpoensis Hemsl., 60 parts of pueraria lobata (Willd.) Ohwi, 20 parts of flos chrysanthemi, and 20 parts of stir-fried sophora japonica L..

4. The traditional Chinese medicine compound composition for treating simple diastolic hypertension according to claim 1, wherein, It is prepared from the following raw medicinal materials in parts by mass: 180 parts of calcined nacre, 180 parts of uncaria rhynchophylla, 90 parts of gardenia jasminoides Ellis, 60 parts of scrophularia ningpoensis Hemsl., 180 parts of pueraria lobata (Willd.) Ohwi, 60 parts of flos chrysanthemi, and 60 parts of stir-fried sophora japonica L..

5. The traditional Chinese medicine compound composition for treating simple diastolic hypertension according to claim 1, wherein, The dosage form is granule, oral liquid, paste, capsule or tablet.

6. A preparation method of the traditional Chinese medicine compound composition for treating simple diastolic hypertension according to any one of claims 1 to 5, characterized in that, It includes the following steps: According to the parts by mass, decoct the calcined nacre with water to obtain filtrate 1; According to the parts by mass, decoct the uncaria rhynchophylla with water to obtain filtrate 2; Decoct the remaining raw materials except the calcined nacre and uncaria rhynchophylla with water to obtain filtrate 3; Combine filtrate 1, filtrate 2 and filtrate 3, and successively carry out filtration, concentration, alcohol precipitation to remove the precipitate, and then concentration to obtain an extract.

7. A drug for treating isolated diastolic hypertension, characterized in that, The active ingredient is the traditional Chinese medicine compound composition for treating simple diastolic hypertension described in any one of claims 1-5.

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