Traditional chinese medicine composition for reducing blood pressure and preparation method therefor and pharmaceutical use thereof

Abstract

Provided is a traditional Chinese medicine composition for reducing blood pressure, which is prepared from the following active pharmaceutical ingredients in parts by weight: 20-35 parts of Uncaria rhynchophylla, 15-30 parts of Laggera pterodonta, 10- 30 parts of Rubus sachalinensis, 15-30 parts of Chinese yam, 10-15 parts of Erigeron breviscapus, and 5-15 parts of Tetrapanax papyrifer. The preparation method comprises: crushing part of the active pharmaceutical ingredients into medicinal powder, preparing medicinal juice from the remaining active pharmaceutical ingredients, uniformly mixing the pharmaceutical juice with the pharmaceutical powder, forming the mixture into strips, kneading into pills, and air-drying. Also provided is use of the traditional Chinese medicine composition in preparing a drug for preventing and treating hypertension diseases.

Description

A traditional Chinese medicine composition for lowering blood pressure, its preparation method and pharmaceutical use Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a blood pressure lowering traditional Chinese medicine composition and a preparation method thereof. Background Art

[0002] Hypertension is a common clinical cardiovascular disease that threatens human health and is a major cause of cardiovascular and cerebrovascular disease and mortality. Long-term hypertension can cause severe damage to target organs such as the heart, brain, kidneys, and blood vessels. The etiology of hypertension is complex and is often related to genetics, the environment, medications, lifestyle, stress, and age. In recent years, with socioeconomic development and changes in lifestyle, the prevalence of hypertension has gradually increased, but its awareness, treatment, and control rates remain unsatisfactory. This not only endangers human health and quality of life, but also imposes a significant economic burden on individuals, families, and society. Therefore, the prevention and treatment of hypertension is urgent.

[0003] Hypertension falls under the categories of "dizziness" and "headache" in Traditional Chinese Medicine. Dizziness can be localized to the liver and kidneys, representing a syndrome of underlying deficiency and superficial excess. The underlying deficiency is liver and kidney yin deficiency, while the superficial excess is hyperactivity of liver yang and blood stasis blocking the collaterals. Liver yang transforming into wind and blood stasis transforming into wind both fall under the rubric of internal wind-qi movement, and therefore their pathogenesis can be summarized as "deficiency, stasis, and wind." Early-stage hypertension is often caused by emotional factors, leading to dysfunctional liver qi circulation and hyperactivity of liver yang, resulting in elevated blood pressure. Mid-stage hypertension is often associated with qi deficiency and phlegm turbidity, which generate phlegm, and the obstruction of phlegm turbidity is closely related to atherosclerotic lesions caused by hypertension. Mid-stage hypertension is also associated with deficiency of both the heart and spleen. Late-stage hypertension is often associated with liver and kidney yin deficiency, and treatment should focus on regulating the balance of yin and yang in the internal organs. Therefore, hyperactive liver fire and internal accumulation of phlegm heat are the fundamental pathogenesis of the superficial syndrome of hypertension.

[0004] Traditionally, the treatment of hypertension has been based on conservative treatment with Western medicine alone. However, Western medicine alone not only fails to meet the patient's blood pressure lowering requirements, but also has many side effects and unsatisfactory safety due to long-term oral administration. Compared with Western medicine, traditional Chinese medicine and natural medicine have many advantages in treating hypertension. However, existing Chinese medicine treatments still have shortcomings such as slow onset, poor efficacy, long treatment cycles, and even the need to combine other Western medicines. These treatments impose heavy economic and physical and psychological burdens on patients, reduce patient compliance, and are difficult to expand and promote. Therefore, the present invention provides a Chinese medicine composition for lowering blood pressure that is fast-acting and has a short treatment cycle. Summary of the Invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition for lowering blood pressure and a preparation method thereof to solve the problems existing in the above-mentioned prior art. The Chinese medicine composition has a therapeutic effect of more than 90% on hypertension, which makes up for the shortcomings of existing Chinese medicines such as slow effect, poor efficacy, and long cycle, and provides a practical new drug for the efficient treatment of patients with hypertension.

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

[0007] The invention provides a traditional Chinese medicine composition for lowering blood pressure. The composition comprises the following raw materials in parts by weight: 20-35 parts of Uncaria rhynchophylla, 15-30 parts of Psoralea corylifolia, 10-30 parts of Rubus sakhalinus, 15-30 parts of Dioscorea opposita, 10-15 parts of Erigeron breviscapus and 5-15 parts of Smilax china.

[0008] Furthermore, the invention comprises the following raw materials in parts by weight: 27 parts of Uncaria rhynchophylla, 30 parts of Psoralea corylifolia, 10 parts of Rubus sakhalinensis, 30 parts of Dioscorea opposita, 15 parts of Erigeron breviscapus and 8 parts of Smilax glabra.

[0009] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0010] Weigh the raw materials according to the ratio, crush part of the raw materials into powder, and make the remaining raw materials into juice, mix the juice and powder evenly, roll them into strips, make them into pills, and dry them.

[0011] Furthermore, some of the raw materials include Uncaria rhynchophylla, Chinese yam and Smilax glabra; and the medicinal juice is prepared by decocting Rhizoma Coptidis, Rubus kushicheni and Erigeron breviscapus.

[0012] Furthermore, the decoction method is as follows: adding 2 times the volume of water to the raw material and soaking it for 1 hour, decocting it with slow fire for 1.5 hours, collecting the decoction, adding water again and decocting it with slow fire for 1 hour, combining the decoctions to obtain the medicinal juice.

[0013] Furthermore, before the medicinal juice and the medicinal powder are evenly mixed, honey in an amount of 2 times its weight is added to the medicinal juice for preparation.

[0014] The present invention also provides an application of the traditional Chinese medicine composition in preparing medicines for preventing and treating hypertension.

[0015] Furthermore, the hypertensive disease includes hypertension and liver-fire hyperactivity disease.

[0016] Furthermore, the dosage form of the drug includes pills.

[0017] Furthermore, the medicine also includes pharmaceutically acceptable excipients.

[0018] The prescription of the Chinese medicine composition of the present invention is as follows:

[0019] Uncaria rhynchophylla has a sweet and cooling nature and enters the Liver and Pericardium meridians. Its medicinal effects are sweet, mild, and slightly cold, with a light, penetrating nature. It primarily enters the Liver and Pericardium meridians. It calms Liver Yang, calms Liver Wind, clears Liver Heat, and disperses Liver Heat. It is primarily used to treat dizziness and vertigo caused by hyperactivity of Yang, headaches and swelling due to Liver Heat, and epilepsy and convulsions. Deer Ear Lin has a pungent, bitter, and cold nature and enters the Lung meridian. It has antitussive and expectorant effects, clears heat and detoxifies, and has anti-inflammatory, antibacterial, and anti-tumor effects. Both herbs work synergistically to calm the Liver and dispel dampness, clear heat and dispel wind, and relieve cough and expectoration, serving as the monarch herb. Rubus kuyeliensis is bitter, astringent and neutral in nature; it enters the heart, spleen and large intestine meridians; it has the effects of clearing the lungs and stopping bleeding, dispelling wind and clearing heat, detoxifying and stopping dysentery; Chinese yam is sweet and warm in taste, cool and moist in nature; it enters the lungs, spleen and kidney meridians; it treats diarrhea due to spleen deficiency, asthma and cough due to lung deficiency, spermatorrhea due to kidney deficiency, and chronic dysentery, and has the effects of tonifying the spleen and stomach, promoting fluid production and benefiting the lungs, tonifying the kidneys and astringing essence, clearing the heart and calming the mind, tonifying the middle and replenishing qi, helping the five internal organs, and strengthening the bones and muscles; Rubus kuyeliensis and Chinese yam work together as ministers, together playing the role of dispelling wind and clearing heat, dispersing swelling and removing blood stasis, transforming dampness and relieving heat, and calming the mind and tranquilizing the mind. Erigeron breviscapus (Erigeron breviscapus) has a pungent, slightly bitter flavor and a warm nature. It enters the Heart and Liver meridians, promoting blood circulation, dredging the meridians, alleviating pain, and dispelling wind and cold. Tongcao (Tongcao) has a sweet, light flavor and a slightly cold nature. It enters the Lung and Stomach meridians, clearing heat and promoting urination, as well as promoting ventilation and lactation. Erigeron breviscapus and Tongcao work synergistically to promote blood circulation, dissipate stasis, promote ventilation and urination, and dredge the meridians. They can assist the main herb in soothing the liver and relieving fever, dispelling dampness and promoting qi, and relieving cough and expectoration. The entire formula is mild in flavor, and the herbs are harmoniously balanced, effectively lowering blood pressure and addressing the symptoms associated with hypertension: headaches, dizziness, palpitations, coughs, and fatigue.

[0020] The present invention discloses the following technical effects:

[0021] The present invention provides a traditional Chinese medicine composition for treating hyperactive liver fire syndrome in hypertension. The composition includes Uncaria rhynchophylla, Rhizoma Coptidis, Rubus kusnezoffii, Dioscorea opposita, Erigeron breviscapus, and Smilax glabra. Through reasonable compatibility, the whole formula uses Uncaria rhynchophylla and Rhizoma Coptidis as monarch drugs, Rubus kusnezoffii and Dioscorea opposita as minister drugs, and Erigeron breviscapus and Smilax glabra as adjuvant drugs, conforming to the "monarch, minister, adjuvant, and adjuvant" compatibility treatment principle, and synergistically achieves the effects of soothing the liver and relieving fever, eliminating dampness and promoting qi circulation, and relieving cough and expectoration. The present invention also improves the drug preparation process by batch-forming the drug raw materials into powders and juices, which are then mixed to form pills, thereby significantly improving the drug efficacy. The pills prepared by this method can significantly improve hyperactive liver fire syndrome in hypertension and quickly and efficiently lower blood pressure, overcoming the shortcomings of existing traditional Chinese medicines such as slow onset of action, poor efficacy, and long cycle time. The present invention provides a practical new drug for the efficient treatment of patients with hypertension. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] FIG1 is a statistical diagram showing the difference in the total symptom score reduction of each group of patients before and after treatment; Note: “*” indicates a significant difference compared with Examples 1-3, *P<0.05. DETAILED DESCRIPTION

[0024] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0025] It should be understood that the terms described herein are intended only to describe particular embodiments and are not intended to limit the present invention. In addition, for numerical ranges herein, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. The intermediate value within any stated value or stated range, and each smaller range between any other stated value or intermediate value within the stated range, is also encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the scope.

[0026] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein may also be used in the practice 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 associated with the documents. In the event of any conflict with any incorporated document, the contents of this specification shall prevail.

[0027] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from the description of the invention. The description and examples are intended to be illustrative only.

[0028] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0029] Example 1

[0030] A traditional Chinese medicine composition for lowering blood pressure comprises the following raw materials in parts by weight: 20 parts of Uncaria rhynchophylla, 25 parts of Psoralea corylifolia, 20 parts of Rubus sakhalinensis, 15 parts of Dioscorea opposita, 12 parts of Erigeron breviscapus, and 5 parts of Smilax glabra.

[0031] The preparation method is as follows:

[0032] After weighing the above raw materials and processing them as required, some of them are crushed, sieved, and mixed to produce a powder to facilitate preparation and fully retain the active ingredients in the prescription. The raw materials for powder production include Uncaria rhynchophylla, Chinese yam, and Smilax glabra. Deer ear forest, Rubus kushicheni, and Erigeron breviscapus are prepared into a medicinal concoction using a traditional decoction method: add 2 times the volume of water to the raw materials, soak for 1 hour, simmer for 1.5 hours, collect the decoction, add water again, simmer for 1 hour, and combine the decoctions to obtain the medicinal concoction. Add 2 times the weight of honey to the concoction for preparation. The prepared concoction and powder are evenly mixed, rolled into strips, and then made into pills. After air drying, the pills are bagged, with each bag containing 5g.

[0033] Example 2

[0034] A traditional Chinese medicine composition for lowering blood pressure comprises the following raw materials in parts by weight: 35 parts of Uncaria rhynchophylla, 15 parts of Psoralea corylifolia, 30 parts of Rubus sakhalinensis, 20 parts of Dioscorea opposita, 10 parts of Erigeron breviscapus, and 15 parts of Smilax glabra.

[0035] The preparation method is the same as that of Example 1.

[0036] Example 3

[0037] A traditional Chinese medicine composition for lowering blood pressure comprises the following raw materials in parts by weight: 27 parts of Uncaria rhynchophylla, 30 parts of Psoralea corylifolia, 10 parts of Rubus sakhalinensis, 30 parts of Dioscorea opposita, 15 parts of Erigeron breviscapus, and 8 parts of Smilax glabra.

[0038] The preparation method is the same as that of Example 1.

[0039] Comparative Example 1

[0040] The same as Example 1, the only difference is that the raw material of deer ear forest is omitted.

[0041] Comparative Example 2

[0042] The same as embodiment 1, the only difference is that the sahelian raspberry is omitted.

[0043] Comparative Example 3

[0044] The same as Example 1, the only difference is that the Chinese medicine composition comprises the following raw materials in parts by weight: 40 parts of Uncaria rhynchophylla, 5 parts of Luerlin, 20 parts of Rubus sakhalinensis, 15 parts of Dioscorea opposita, 22 parts of Erigeron breviscapus, and 25 parts of Smilax china.

[0045] Comparative Example 4

[0046] The same as Example 1, the only difference is that the preparation method of the traditional Chinese medicine composition is a decoction method of a traditional decoction, specifically: weigh Uncaria rhynchophylla, Rhizoma Ceratitis, Rubus kushichen, Dioscorea opposita, Erigeron breviscapus and Scutellaria baicalensis as specified, add 2 times the volume of water thereto, soak for 1 hour, simmer for 1.5 hours, collect the decoction, add water again and simmer for 1 hour, combine the decoctions, cool them, and bag them, 200 mL per bag.

[0047] Clinical validation

[0048] 1 General Information

[0049] All cases were from outpatients who visited the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from January 2021 to January 2023, and were diagnosed with hypertension and hyperactivity of liver fire.

[0050] 2 Diagnostic criteria

[0051] 2.1 Western medicine diagnostic standards

[0052] The diagnostic criteria for hypertension refer to the "Guidelines for the Prevention and Treatment of Hypertension in China" (revised edition in 2018): when blood pressure is measured three times on different days without taking antihypertensive drugs, systolic blood pressure (SBP) ≥ 140 mmHg and / or diastolic blood pressure (DBP) ≥ 90 mmHg.

[0053] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0054] (1) Diagnostic criteria of Traditional Chinese Medicine: According to the diagnostic criteria of vertigo and headache in Traditional Chinese Medicine Internal Medicine: vertigo is a disease characterized by dizziness and lightheadedness. Headache is a disease characterized by conscious pain in the head.

[0055] (2) TCM symptom diagnostic criteria: TCM symptom diagnostic criteria for hypertensive liver fire syndrome, based on the diagnostic criteria for vertigo (essential hypertension) in the "Clinical Diagnosis and Treatment Guidelines for TCM Internal Medicine" and the "TCM Internal Medicine":

[0056] Hyperactivity of liver fire: dizziness, headache, swelling of the head, irritability, flushed face, red eyes, dry mouth, bitter taste in the mouth, insomnia, numbness and tremors of limbs, yellow or red urine, constipation, red tongue with yellow or white fur, and rapid and stringy pulse.

[0057] 3 Inclusion criteria

[0058] (1) Patients with essential hypertension stage 1 or 2 and risk stratification of low risk, intermediate risk, or high risk;

[0059] (2) TCM syndrome diagnosis is consistent with the syndrome of hyperactivity of liver fire and internal accumulation of phlegm and heat;

[0060] (3) Aged 18–70 years and signed the informed consent form;

[0061] (4) Patients with stable coronary heart disease, stable angina, diabetes, or cerebrovascular disease;

[0062] (5) Those who have not taken antihypertensive drugs or whose blood pressure is not well controlled after taking antihypertensive drugs.

[0063] 4 Exclusion criteria

[0064] (1) Those under 18 years of age or over 70 years of age;

[0065] (2) Patients with various secondary hypertension, stage 3 hypertension, or those classified as very high risk in risk stratification;

[0066] (3) Patients who do not meet the TCM diagnosis of liver fire hyperactivity and internal phlegm heat;

[0067] (4) White coat hypertension: Normal blood pressure during ambulatory blood pressure measurement, but high blood pressure during random blood pressure measurement;

[0068] (5) Severe target organ damage, or combined with serious primary diseases of the heart, brain, liver, kidney, and hematopoietic system;

[0069] (6) Pregnant or breastfeeding women;

[0070] (7) Mental illness patients.

[0071] 5 Treatments

[0072] 160 volunteers with liver-fire hypertensive syndrome who met the above criteria were randomly divided into seven experimental groups and one control group. The experimental groups were treated orally with the Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-4, with pills and decoctions taken three times daily, one bag each time, for a course of four weeks. The control group received two nifedipine tablets twice daily (20 mg total).

[0073] 6. Determination of treatment effect

[0074] 6.1 Observation indicators:

[0075] Before treatment and 4 weeks after treatment, the symptom scoring method in the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)" was used to score the main symptoms (dizziness, headache, irritability, heaviness in the head, chest tightness) and secondary symptoms (palpitations, insomnia, dry mouth and bitter taste, poor appetite, tongue and pulse: thick and greasy tongue, slippery pulse) on a scale of 0-3 points, with 0 point indicating no symptoms, 1 point indicating mild symptoms, 2 points indicating moderate symptoms, and 0 point indicating severe symptoms. The higher the total symptom score, the more severe the patient's clinical symptoms.

[0076] 6.2 Criteria for judging antihypertensive efficacy

[0077] (1) Significantly effective: ①DBP decreased by 10 mmHg or more and reached the normal range; ②DBP did not decrease to the normal range, but decreased by 20 mmHg or more. (2) Effective: ①DBP decreased by less than 10 mmHg, but reached the normal range; ②DBP decreased by 10-19 mmHg compared with pre-treatment but did not reach the normal range; ③SBP decreased by 30 mmHg or more compared with pre-treatment. (3) Ineffective: None of the above criteria were met.

[0078] 6.3 TCM Syndrome Efficacy Standards

[0079] (1) Markedly effective: Clinical symptoms significantly improved, with the total symptom score reduced by ≥70% compared to before treatment. (2) Effective: Clinical symptoms alleviated, with the total symptom score reduced by ≥30% compared to before treatment. (3) Ineffective: Clinical symptoms did not significantly improve or worsened, with the total symptom score reduced by <30% compared to before treatment.

[0080] 6.4 Security

[0081] Before and after treatment, patients were given routine blood, urine, and stool tests, liver function tests, kidney function tests, and electrocardiograms, and any abnormalities in the above tests were recorded.

[0082] 7. Efficacy

[0083] 7.1 Comparison of total symptom scores

[0084] After one course of treatment, the treatment results were statistically analyzed. The total symptom scores of the patients in each group before treatment were 23.14-24.37, and there was no statistically significant difference after comparison. The total symptom scores of the patients in each group after treatment were significantly reduced compared with those before treatment. Among them, the efficacy of the drugs in Examples 1-3 was the most significant, which was significantly better than the Chinese medicine drugs in Comparative Examples 1-4 (Figure 1).

[0085] 7.2 Antihypertensive Efficacy Results

[0086] Table 1 Antihypertensive efficacy of each group of patients before and after treatment

[0087] 7.3 TCM Syndrome Efficacy Results

[0088] Table 2 The efficacy of TCM syndromes in each group of patients before and after treatment

[0089] Combining Tables 1 and 2, we can see that the total effective rate for treating hypertension with liver-fire hyperactivity syndrome using the Chinese herbal compositions prepared in Examples 1-3 was as high as 90-95%, higher than that of the Western medicine control group. However, in Comparative Examples 1-4, changes in the types of the principal and auxiliary herbs, adjustments to the compatibility ratios of the entire formula, or changes in the preparation methods all resulted in significantly reduced efficacy. Thus, the Chinese herbal compositions prepared in Examples 1-3 demonstrated significant efficacy in reducing hypertension and improving clinical symptoms.

[0090] 7.4 Security

[0091] Before and after treatment, the urine routine, blood routine, stool routine, liver and kidney function of patients with hypertensive liver fire in each group were checked and no abnormalities were found. No obvious adverse reactions were found in all patients during the treatment.

[0092] The embodiments described above are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by persons skilled in the art should fall within the scope of protection defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for lowering blood pressure, characterized in that, It comprises the following raw materials in parts by weight: 20-35 parts of Uncaria rhynchophylla, 15-30 parts of Ainsliaea acerifolia, 10-30 parts of Rubus sachalinensis, 15-30 parts of Chinese yam, 10-15 parts of Erigeron breviscapus, and 5-15 parts of Tetrapanax papyriferus.

2. The traditional Chinese medicine composition according to claim 1, wherein It comprises the following raw materials in parts by weight: 27 parts of Uncaria rhynchophylla, 30 parts of Ainsliaea acerifolia, 10 parts of Rubus sachalinensis, 30 parts of Chinese yam, 15 parts of Erigeron breviscapus, and 8 parts of Tetrapanax papyriferus.

3. A preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It comprises the following steps: Weigh the raw materials according to the ratio. Part of the raw materials are pulverized into medicinal powder, and the remaining raw materials are made into medicinal juice. The medicinal juice and the medicinal powder are mixed evenly, rolled into strips, made into pills, and dried.

4. The preparation method according to claim 3, characterized in that, The part of the raw materials includes Uncaria rhynchophylla, Chinese yam, and Tetrapanax papyriferus; the medicinal juice is the medicinal juice prepared by decocting Ainsliaea acerifolia, Rubus sachalinensis, and Erigeron breviscapus.

5. The preparation method according to claim 4, characterized in that, The decocting method is: add 2 times the volume of water to the raw materials and soak for 1 h, decoct with slow fire for 1.5 h, collect the decoction, add water again and decoct with slow fire for 1 h, and combine the decoctions to obtain the medicinal juice.

6. The preparation method according to claim 3, characterized in that, Before mixing the medicinal juice and the medicinal powder evenly, add 2 times the weight of honey to the medicinal juice for blending.

7. Use of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a drug for preventing and treating hypertension diseases.

8. The application according to claim 7, wherein The hypertension diseases include hypertension with hyperactivity of liver-fire syndrome diseases.

9. The application according to claim 7, wherein The dosage form of the drug includes pills.

10. The application according to claim 7, wherein The drug also includes pharmaceutically acceptable excipients.

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