CN103055164B - Traditional Chinese medicine composition for treating isolated diastolic hypertension - Google Patents
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Abstract
Description
技术领域 technical field
本发明涉及一种中药组合物,具体涉及一种治疗单纯舒张期高血压的中药组合物。 The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating simple diastolic hypertension. the
背景技术 Background technique
单纯舒张期高血压(IDH)是指收缩压(SBP)<140mmHg和舒张压(DBP)≥90 mmHg的高血压病,是高血压病的一个亚型。研究发现,收缩压随年龄增长而上升,而舒张压在男性60岁左右,女性70岁左右达高峰,此后缓慢下降。因此,随着年龄的增长单纯收缩期高血压(ISH)比例显著增高、单纯舒张期高血压比例显著降低。 Isolated diastolic hypertension (IDH) refers to hypertension with systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) ≥ 90 mmHg, which is a subtype of hypertension. The study found that systolic blood pressure rises with age, while diastolic blood pressure reaches a peak around 60 years old for men and 70 years old for women, and then slowly declines. Therefore, the proportion of isolated systolic hypertension (ISH) increased significantly and the proportion of isolated diastolic hypertension decreased significantly with age. the
IDH的好发人群是年轻人、男性、肥胖、睡眠呼吸障碍者,尤其是存在吸烟、酗酒、缺乏锻炼等不良生活习惯者。 IDH is most likely to occur in the young, male, obese, and sleep-disordered persons, especially those with unhealthy living habits such as smoking, alcoholism, and lack of exercise. the
许多研究证实收缩压和舒张压均为脑卒中和冠心病独立危险因素。英国对42万人进行的前瞻性观察研究证明,舒张压与脑卒中呈十分明确的线性相关,即使在正常范围内舒张压与脑卒中亦呈明确正相关,舒张压每增加10mmHg,脑卒中发生率增加56%,冠心病发生率增加37%。因此,舒张期高血压的危害不容小觑。 Many studies have confirmed that both systolic and diastolic blood pressure are independent risk factors for stroke and coronary heart disease. A prospective observational study conducted on 420,000 people in the United Kingdom proved that there is a very clear linear correlation between diastolic blood pressure and stroke. Even within the normal range, there is a clear positive correlation between diastolic blood pressure and stroke. The incidence of coronary heart disease increased by 56%, and the incidence of coronary heart disease increased by 37%. Therefore, the hazards of diastolic hypertension should not be underestimated. the
发明内容 Contents of the invention
本发明提供了一种治疗单纯舒张期高血压的中药组合物。 The invention provides a traditional Chinese medicine composition for treating simple diastolic hypertension. the
本发明目的是通过如下技术方案实现的: The object of the invention is achieved through the following technical solutions:
本发明中药组合物原料药组成为: Chinese medicine composition crude drug of the present invention consists of:
钩藤5-30重量份 生杜仲5-15重量份 桑寄生5-15重量份 川牛膝5-20 重量份 天麻1-15重量份 5-30 parts by weight of Uncaria 5-15 parts by weight of Eucommia ulmoides 5-15 parts by weight of Sangjisi 5-20 parts by weight of Chuan Achyranthes bidentata 1-15 parts by weight of Gastrodia elata
本发明中药组合物原料药组成优选 为: The composition of the Chinese medicine composition raw material of the present invention is preferably:
钩藤15-30重量份 生杜仲10-15重量份 桑寄生8-12重量份 川牛膝10-15重量份 天麻5-10重量份 15-30 parts by weight of Uncaria 10-15 parts by weight of Eucommia ulmoides 8-12 parts by weight of Sangjisi 10-15 parts by weight of Achyranthes sichuanensis Gastrodia 5-10 parts by weight
本发明中药组合物原料药组成优选 为: The composition of the Chinese medicine composition raw material of the present invention is preferably:
钩藤12重量份 生杜仲10重量份 桑寄生10重量份 川牛膝12重量份 天麻8重量份 12 parts by weight of Uncaria, 10 parts by weight of Eucommia ulmoides, 10 parts by weight of Sangjisheng, 12 parts by weight of Achyranthes bidentata, 8 parts by weight of Gastrodia elata
本发明中药组合物原料药组成优选 为: The composition of the Chinese medicine composition raw material of the present invention is preferably:
钩藤14重量份 生杜仲9重量份 桑寄生9重量份 川牛膝14重量份 天麻6重量份 Uncaria 14 parts by weight Raw Eucommia 9 parts by weight Sangjisi 9 parts by weight Achyranthes bidentata 14 parts by weight Gastrodia elata 6 parts by weight
本发明中药组合物原料药组成优选 为: The composition of the Chinese medicine composition raw material of the present invention is preferably:
钩藤11 重量份 生杜仲11重量份 桑寄生11重量份 川牛膝12重量份 天麻8重量份 11 parts by weight of Uncaria, 11 parts by weight of Eucommia ulmoides, 11 parts by weight of Sangjisheng, 12 parts by weight of Achyranthes sichuanensis, 8 parts by weight of Gastrodia elata
本发明中药组合物加入常规辅料,按照常规工艺,制成片剂、胶囊剂、散剂、软胶囊剂、滴丸、蜜丸、丸剂、颗粒剂、蜜炼膏剂、缓释制剂、速释制剂、控释制剂、口服液体制剂、冻干粉针剂或注射制剂。 The traditional Chinese medicine composition of the present invention is added conventional adjuvant materials, according to the conventional process, is made into tablet, capsule, powder, soft capsule, dripping pill, honeyed pill, pill, granule, honey refining ointment, slow-release preparation, quick-release preparation, Controlled-release preparations, oral liquid preparations, lyophilized powder preparations or injection preparations. the
本发明中药组合物由生杜仲、桑寄生、川牛膝、天麻、钩藤组成。生杜仲长于补肝肾、强筋骨以治本,为君药。臣以桑寄生,主入肝、肾经,功用平补肝肾,以增君药之功;二药合用,对肝肾不足型高血压的腰膝酸软、耳鸣健忘患者尤宜。钩藤,功用平抑肝阳,亦为臣药,为治疗肝阳偏亢头痛头晕的主药。佐以川牛膝一则补益肝肾,一则引上亢之肝阳下行,标本兼治;天麻平抑肝阳以治标,同时是头痛的引经药,为使药。诸药合用,标本兼治,阴阳调和,可平稳降压。 The traditional Chinese medicine composition of the present invention is composed of Eucommia ulmoides, Sangjisheng, Achyranthes bidentata, Gastrodia elata and Uncaria. Eucommia ulmoides is good at invigorating the liver and kidney, strengthening the bones and muscles to cure the root cause, and is the king medicine. The subject is Sangjisheng, which mainly enters the liver and kidney meridians, and its function is to nourish the liver and kidney, so as to increase the power of the monarch medicine; the combination of the two medicines is especially suitable for patients with weak waist and knees, tinnitus and forgetfulness of liver and kidney deficiency hypertension. Uncaria, the function of calming liver yang, is also a ministerial drug, and is the main drug for treating headache and dizziness due to hyperactivity of liver yang. Accompanied by Chuan Achyranthes bidentata, one is to nourish the liver and kidney, and the other is to guide the hyperactive liver-yang to descend, and treat both the symptoms and root causes; Gastrodia elata calms the liver-yang to treat the symptoms, and it is also a meridian-leading medicine for headaches. Combination of various medicines can treat both symptoms and root causes, harmonize yin and yang, and can stably lower blood pressure. the
本发明中药组合物治疗单纯舒张压期高血压效果显著且无副作用。 The traditional Chinese medicine composition of the invention has remarkable effect in treating hypertension in simple diastolic period and has no side effect. the
下面实验和实施例用于进一步说明但不限于本发明。 The following experiments and examples are used to further illustrate but not limit the present invention. the
实验例一:临床实验 Experimental Example 1: Clinical Experiment
1 资料与方法 1 Materials and methods
1.1一般资料 1.1 General Information
所有病例均来源于广州荔湾区中医医院及广州市中医医院2003年12月~2006年10月门诊和住院患者。根据诊断标准、纳入标准、排除标准共纳入单纯舒张期高血压患者90例。按照随机数字的方法随机分为试验组和对照组。试验组67例,男性22例,女性45例,年龄64.42±12.43岁,病程4.60±4.92年。对照组30例,男性17例,女性13例,年龄74.13±10.00岁,病程7.18±5.81年。两组资料经统计学处理差异无显著性(p>0.05),具有可比性。 All the cases were from outpatients and inpatients of Guangzhou Liwan District Hospital of Traditional Chinese Medicine and Guangzhou Hospital of Traditional Chinese Medicine from December 2003 to October 2006. A total of 90 patients with isolated diastolic hypertension were included according to the diagnostic criteria, inclusion criteria, and exclusion criteria. According to the random number method, they were randomly divided into the experimental group and the control group. The test group consisted of 67 cases, including 22 males and 45 females, aged 64.42±12.43 years, and the course of disease was 4.60±4.92 years. The control group consisted of 30 cases, including 17 males and 13 females, aged 74.13±10.00 years old, and the course of disease was 7.18±5.81 years. There was no significant difference between the two groups of data after statistical processing (p>0.05), and they were comparable. the
1.2 干预措施 1.2 Interventions
试验组服用本发明中药组合物(按照实施例二制备),每次120ml,每日2次,温水送服。对照组服用怡那林(马来酸依那普利片,每片20mg),每次20mg,每日2次,餐后半小时温开水送服。两组疗程均为1月。 The test group took the traditional Chinese medicine composition of the present invention (prepared according to Example 2), 120ml each time, twice a day, with warm water. The control group took Yinarin (enalapril maleate tablets, 20 mg per tablet), 20 mg each time, twice a day, and took it with warm water half an hour after meals. The course of treatment for both groups was 1 month. the
两组患者治疗期间均予低盐、低脂饮食,停用其他降压、降脂和影响血压的药物,调摄精神,适当活动,避免劳累。 During the treatment period, the patients in the two groups were given a low-salt and low-fat diet, stopped using other antihypertensive, lipid-lowering and blood pressure-affecting drugs, adjusted their spirits, exercised appropriately, and avoided fatigue. the
1.3 观察指标 1.3 Observation indicators
1.3.1 疗效性指标:血压、肾素活性(PRA)、血管紧张素Ⅱ(AⅡ)、醛固酮(ALD)血液流变学、肝功能、血脂。 1.3.1 Efficacy indicators: blood pressure, renin activity (PRA), angiotensin II (AII), aldosterone (ALD), hemorrheology, liver function, and blood lipids. the
1.3.2 安全性指标:血常规、尿常规、不良反应。 1.3.2 Safety indicators: blood routine, urine routine, adverse reactions. the
1.4 统计方法 1.4 Statistical methods
采用SAS8.2统计软件进行分析,等级资料用Wilcoxon检验,计数资料用X2检验,计量资料用t检验。 SAS8.2 statistical software was used for analysis, grade data was tested by Wilcoxon, count data was tested by X2 , and measurement data was tested by t test.
2 结果 2 Results
2.1两组降压的总有效率比较 2.1 Comparison of the total effective rate of blood pressure reduction in the two groups
试验组降压的显效率为86.57%,有效率为11.94%,总有效率为95.52%。对照组降压的显效率为80%,有效率20%,总有效率为100%,两组间降压效果相比无显著性差异,具体见表1。 In the test group, the effective rate of reducing blood pressure was 86.57%, the effective rate was 11.94%, and the total effective rate was 95.52%. The obvious rate of antihypertensive in the control group was 80%, the effective rate was 20%, and the total effective rate was 100%. There was no significant difference in antihypertensive effect between the two groups, as shown in Table 1. the
表1 两组降血压有效率比较(例 %) Table 1 Comparison of effective rates of lowering blood pressure between the two groups (cases %)
注:两组疗效比较无统计学差异(p>0.05)。 Note: There was no significant difference in curative effect between the two groups (p>0.05). the
2.2 两组血液流变学疗效比较 2.2 Comparison of hemorheological curative effect between the two groups
两组患者治疗前血液流变学值比较无显著性差异,具体见表2。试验组治疗后血浆黏度有明显降低,且有统计学差异(p<0.05);两组治疗后组间血液流变学值比较无统计学差异(p>0.05),具体见表3。 There was no significant difference in hemorheology values between the two groups before treatment, see Table 2 for details. After treatment, the plasma viscosity of the experimental group was significantly reduced, and there was a statistical difference (p<0.05); there was no statistical difference in hemorheology between the two groups after treatment (p>0.05), see Table 3 for details. the
表2 两组治疗前血液流变学值比较 Table 2 Comparison of hemorheology values between the two groups before treatment
注:两组治疗前血液流变学的数值未见显著性差异,具有可比性(p>0.05)。 Note: There was no significant difference in the values of blood rheology between the two groups before treatment, and they were comparable (p>0.05). the
表3 两组治疗后组内、组间血流变学疗效比较 Table 3 Comparison of curative effect of hemorheology within and between groups after treatment between the two groups
注:从表3可以看出试验组治疗后血浆黏度有明显降低(p<0.05),两组间相比无显著性差异(p>0.05)。 Note: It can be seen from Table 3 that the plasma viscosity of the experimental group decreased significantly after treatment (p<0.05), and there was no significant difference between the two groups (p>0.05). the
2.3两组改善血脂疗效比较 2.3 Comparison of curative effect of improving blood lipids between the two groups
两组患者治疗前血脂值比较无显著性差异,具体见表4。对照组治疗后胆固醇、甘油三酯、低密度脂蛋均有明显降低,试验组高密度脂蛋白明显升高,但两组之间相比均无显著性差异(p>0.05),具体见表5。 There was no significant difference in blood lipid values between the two groups before treatment, see Table 4 for details. Cholesterol, triglycerides, and low-density lipoproteins in the control group were significantly reduced after treatment, and high-density lipoproteins in the test group were significantly increased, but there was no significant difference between the two groups (p>0.05), as shown in the table 5. the
表4 两组治疗前血脂值比较 Table 4 Comparison of blood lipid values between the two groups before treatment
注:治疗前两组血脂数值相比无显著性差异,具有可比性(p>0.05)。 Note: There was no significant difference in blood lipid values between the two groups before treatment, and they were comparable (p>0.05). the
表5 两组治疗后组内、组间血脂改善疗效比较 Table 5 Comparison of curative effect of blood lipid improvement within and between groups after treatment between the two groups
注:对照组治疗后胆固醇、甘油三酯、低密度脂蛋均有明显降低,试验组高密度脂蛋白明显升高,但两组之间相比无显著性差异(p>0.05)。 Note: Cholesterol, triglycerides, and low-density lipoproteins in the control group were significantly reduced after treatment, and high-density lipoproteins in the test group were significantly increased, but there was no significant difference between the two groups (p>0.05). the
2.4两组改善高血压三项(PRA、AⅡ、ALD)疗效比较 2.4 Comparison of the curative effect of improving the three items of hypertension (PRA, AⅡ, ALD) between the two groups
两组治疗前PRA、AⅡ、ALD数值无显著性差异,具有可比性(p>0.05),具体见表6。试验组治疗后血管紧张素Ⅱ(AⅡ)的含量明显降低(p<0.01),两组间相比PRA、AⅡ、ALD均未见显著性差异(p>0.05),具体见表7。 There was no significant difference in the values of PRA, AⅡ, and ALD between the two groups before treatment, and they were comparable (p>0.05). See Table 6 for details. After treatment, the content of angiotensin Ⅱ (AⅡ) in the experimental group decreased significantly (p<0.01), and there was no significant difference between the two groups in PRA, AⅡ, and ALD (p>0.05). See Table 7 for details. the
表6 两组治疗前高血压三项值比较 Table 6 Comparison of the three values of hypertension between the two groups before treatment
注:两组治疗前高血压三项值无显著性差异,具有可比性(p>0.05)。 Note: There was no significant difference in the three values of hypertension between the two groups before treatment, and they were comparable (p>0.05). the
表7 两组治疗后高血压三项值组内、组间疗效比较 Table 7 Comparison of curative effect within and between groups of the three values of hypertension after treatment in the two groups
注:试验组治疗后血管紧张素Ⅱ(AⅡ)的含量明显降低(p<0.01),两组间相比PRA、AⅡ、ALD均未见显著性差异(p>0.05)。 Note: The content of angiotensin Ⅱ (AⅡ) in the experimental group decreased significantly after treatment (p<0.01), and there was no significant difference between the two groups in PRA, AⅡ, and ALD (p>0.05). the
2.5 安全性分析 2.5 Security Analysis
2.5.1两组对肝功能影响比较 2.5.1 Comparison of the effects of the two groups on liver function
两组患者治疗前肝功能值比较无显著性差异,具体见表8。试验组治疗后ALT、TBIL、IBIL明显降低(p<0.05),与对照组相比无显著性差异(p>0.05),具体见表9。 There was no significant difference in liver function values between the two groups before treatment, see Table 8 for details. After treatment, ALT, TBIL, and IBIL in the experimental group were significantly reduced (p<0.05), and there was no significant difference compared with the control group (p>0.05). See Table 9 for details. the
表8 两组治疗前肝功能值比较 Table 8 Comparison of liver function values between the two groups before treatment
注:两组治疗前肝功能值无显著性差异,具有可比性(p>0.05)。 Note: There was no significant difference in liver function values between the two groups before treatment, and they were comparable (p>0.05). the
表9 两组治疗后组内、组间肝功能疗效比较 Table 9 Comparison of curative effect on liver function within and between groups after treatment between the two groups
注:试验组治疗后ALT、TBIL、IBIL明显降低(p<0.05),与西药组相比无显著性差异(p>0.05)。 Note: After treatment, ALT, TBIL, and IBIL in the experimental group decreased significantly (p<0.05), and there was no significant difference compared with the western medicine group (p>0.05). the
2.5.2不良反应观察 2.5.2 Observation of adverse reactions
两组血、尿常规检验治疗前后均未见明显变化;两组均未发现明显不良反应。 There was no significant change in blood and urine routine tests before and after treatment in the two groups; no obvious adverse reactions were found in the two groups. the
下属实施例均能实现上述实验例的效果。 The following embodiments can all realize the effects of the above-mentioned experimental examples. the
实施例一: Embodiment one:
钩藤12g 生杜仲10g 桑寄生10g 川牛膝12g 天麻8g Uncaria 12g Raw Eucommia 10g Sangjisi 10g Sichuan Achyranthes bidentata 12g Gastrodia elata 8g
上述药物按照常规工艺,加入常规辅料,制成片剂。 The above-mentioned medicines are prepared into tablets by adding conventional auxiliary materials according to conventional processes. the
实施例二: Embodiment two:
钩藤15g 生杜仲10g 桑寄生10g 川牛膝15g 天麻10g Uncaria 15g Raw Eucommia 10g Sangjisi 10g Sichuan Achyranthes bidentata 15g Gastrodia elata 10g
上述药物按照常规工艺,加入常规辅料,制成口服液。 The above-mentioned medicine is prepared into an oral liquid by adding conventional auxiliary materials according to a conventional process. the
实施例三: Embodiment three:
钩藤11g 生杜仲11g 桑寄生11g 川牛膝12g 天麻8g Uncaria 11g Raw Eucommia 11g Sangjisi 11g Sichuan Achyranthes bidentata 12g Gastrodia elata 8g
上述药物按照常规工艺,加入常规辅料,制成颗粒剂。 The above-mentioned medicines are prepared into granules by adding conventional auxiliary materials according to a conventional process. the
实施例四: Embodiment four:
钩藤6g 生杜仲13g 桑寄生14g 川牛膝6g 天麻13g Uncaria 6g Raw Eucommia 13g Sangjisi 14g Sichuan Achyranthes bidentata 6g Gastrodia elata 13g
上述药物按照常规工艺,加入常规辅料,制成注射制剂 。 The above-mentioned drugs are made into injection preparations by adding conventional excipients according to conventional processes. the
实施例五: Embodiment five:
钩藤18g 生杜仲7g 桑寄生7g 川牛膝18g 天麻13g Uncaria 18g Raw Eucommia 7g Sangjisi 7g Sichuan Achyranthes bidentata 18g Gastrodia elata 13g
上述药物按照常规工艺,加入常规辅料,制成缓释制剂制剂 。 The above-mentioned drugs are made into sustained-release preparations by adding conventional excipients according to conventional processes. the
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CN107485686A (en) * | 2017-07-05 | 2017-12-19 | 庞世斌 | It is a kind of to treat the dizzy sick Chinese medicine composition of wind |
CN107260978B (en) * | 2017-08-16 | 2021-04-20 | 河南科技学院 | A kind of traditional Chinese medicine composition for treating hypertension, preparation method and use thereof |
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CN1362241A (en) * | 2001-01-08 | 2002-08-07 | 杨孟君 | Nano gastrodia and sharpleaf gambirplant medicine and its preparation |
CN100464775C (en) * | 2006-12-12 | 2009-03-04 | 魏发荣 | Chinese medicinal oral liquid for treating hypertension |
CN101579482B (en) * | 2008-05-15 | 2011-04-20 | 北京北大维信生物科技有限公司 | Medicinal composition for treating hypertension and preparation method thereof |
CN102258693B (en) * | 2010-05-25 | 2012-10-17 | 湖北神农本草中药饮片有限公司 | Traditional Chinese medicine for treating hypertension |
CN102671000A (en) * | 2012-05-14 | 2012-09-19 | 成都绿迪科技有限公司 | Oral Chinese patent medicine for treating hypertension |
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