CN104306905A - 一种治疗高血压中药组合物及其制备方法 - Google Patents

一种治疗高血压中药组合物及其制备方法 Download PDF

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CN104306905A
CN104306905A CN201410673179.7A CN201410673179A CN104306905A CN 104306905 A CN104306905 A CN 104306905A CN 201410673179 A CN201410673179 A CN 201410673179A CN 104306905 A CN104306905 A CN 104306905A
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苏少中
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Abstract

本发明涉及一种治疗高血压中药组合物及其制备方法，该中药组合物由如下重量配比的原料组成：芡实22～26份、鸡血藤16～20份、扶芳藤16～20份、蒲黄8～12份、大黄13～17份、丹参10～14份、地骨皮10～14份、沙棘8～12份、半夏6～10份、乌药6～10份、白芷10～14份、香附6～10份、陈皮8～12份、泽泻13～17份、木通4～8份、牡蛎4～8份、莪术6～10份、白僵蚕4～8份、柴胡10～14份、丝瓜藤7～11份、五灵脂4～8份、水蛭4～8份。本发明具有疗效显著，副作用小，制备简单，成本低的优点。

Description

一种治疗高血压中药组合物及其制备方法
技术领域
本发明涉及一种治疗高血压中药组合物及其制备方法，属于医药制剂技术领域。
背景技术
高血压是全球最为常见的心血管疾病之一，对人类健康的造成很大威胁。高血压病的后期可引起其它脏器的损害包括心、脑、肾的损害，严重者可以引起中风，甚至导致死亡。近年来高血压的发病率呈上升趋势，发病年龄也逐渐降低。高血压是一种常见病、多发病、危害大、死亡率高，是目前造成人类心脑血管疾病死亡的主要原因之一。近年来，高血压疾病已经引起众多医学家的重视，成为疾病研究领域的热点。
高血压病属中医“头痛”“ 眩晕”“ 肝阳”“ 肝风”等范畴。《内经》“髓海不足，脑转耳鸣”“诸风掉眩，皆属于肝”等论述，”当人步入中老年时，脏腑功能衰退，尤其是肾精不足，肝失柔顺，脾失健运，心失所主。其基本病机是阴阳失衡，与肝、肾的阴阳盛衰关系密切，多为本虚标实，实为肝气郁结，肝风、肝阳上扰；虚为肾阴亏损，肝火失于滋养，致肝阳偏亢，病久则阴伤气损，导致气阴两虚和阴阳两虚。一般认为，病位在肝，根源在肾。阴虚阳亢的体质是本病的基本病理，本虚标实、虚实夹杂为其主要病机特点。从辨证而言，易患体质应该以阴虚体质、湿热体质、瘀血体质，以及痰湿体质为主。高血压病的中医辨证分型有多种，主要分为以下证型：血脉瘀阻型、痰湿内蕴型、肝阳上亢型、阴虚阳亢型、肝肾阴虚型、肾精亏虚型。中医药在治疗此类疾病采用辨证论治进行治疗，气虚血瘀型予以益气健脾、活血化瘀法；痰湿壅阻型予以利湿化痰、通腑降浊法；肝阳上亢型予以平抑肝阳、清肝泻火法；肝肾阴虚型予以滋阴补肾、养血柔肝法；阴阳两虚型予以阴阳双补法。
目前常用的降压西药有卡托普利、硝苯地平、氢氯噻嗪等药物，这些药物疗效确切，服用方便，但副作用大、价格昂贵、必须长期服药，而且容易产生抗药性而出现反复发作的缺点，由于传统中医药具有强调整体观念、协调阴阳、标本兼治、毒副作用小等优点，它不仅可以有效控制血压，还可以预防并发症及保护脏器，起到标本兼职的目的。但是，目前临床上缺乏有效的降压中成药。
发明内容
本发明的目的在于提供一种治疗高血压的中药组合物及其制备方法，该中药组合物在治疗高血压疾病方面，具有治疗效果显著、副作用小的优点。
本发明治疗高血压的中药组合物，它是由如下重量配比的原料药组成：芡实22～26份、鸡血藤16～20份、扶芳藤16～20份、蒲黄8～12份、大黄13～17份、丹参10～14份、地骨皮10～14份、沙棘8～12份、半夏6～10份、乌药6～10份、白芷10～14份、香附6～10份、陈皮8～12份、泽泻13～17份、木通4～8份、牡蛎4～8份、莪术6～10份、白僵蚕4～8份、柴胡10～14份、丝瓜藤7～11份、五灵脂4～8份、水蛭4～8份。
其中，较优原料组方配比为：芡实24份、鸡血藤18份、扶芳藤18份、蒲黄10份、大黄15份、丹参12份、地骨皮12份、沙棘10份、半夏8份、乌药8份、白芷12份、香附8份、陈皮10份、泽泻15份、木通6份、牡蛎6份、莪术8份、白僵蚕6份、柴胡12份、丝瓜藤9份、五灵脂6份、水蛭6份。
本方所治的高血压是由血脉瘀阻，夹痰湿内蕴所致。方中芡实、柴胡、香附，能益气健脾、疏肝活血；与鸡血藤、大黄、乌药、沙棘、扶芳藤、丝瓜藤、莪术、五灵脂，水蛭药物相配，诸药合用具有活血散瘀、舒筋通脉的功效；配以半夏、陈皮燥湿化痰；泽泻、蒲黄、木通能利水、渗湿、通淋；白芷活血排脓，生肌止痛；地骨皮清热，凉血；牡蛎平肝潜阳；白僵蚕祛风止痛。诸药相配，共奏补气活血、散瘀止痛、燥湿化痰的功效。
本发明技术方案是一种用于治疗高血压的中药组合物的制备方法，所述的制备方法具体是由以下步骤制备而成： 
⑴将鸡血藤、扶芳藤、蒲黄、大黄、半夏、乌药、白芷、白僵蚕、五灵脂、水蛭粉碎成100目细粉，备用； 
⑵再将芡实、丹参、地骨皮、沙棘、香附、陈皮、泽泻、木通、牡蛎、莪术、柴胡、丝瓜藤药材合并，并加与药材重量比为9倍量的水，煎煮2次，每次1h，滤过，合并滤液，减压浓缩干燥，并粉碎成干膏粉，备用；
⑶取上述步骤⑴中的药粉，步骤⑵中的干膏粉，混合均匀后，即得中药混合物，再加入药剂学上常用的辅料制成各种不同口服制剂，即得。
本发明技术方案制成的口服制剂可以是颗粒剂、片剂、或硬胶囊剂。
颗粒剂：将所得中药混合物，与适量的糊精、蔗糖，混匀，制粒，干燥，制成颗粒剂。
片剂：将所得中药混合物，与适量淀粉、糊精混匀，制粒，压制成片剂。
硬胶囊剂：将所得中药混合物，加入适宜的辅料，制粒，装胶囊，制成硬胶囊剂。
本发明与现有技术相比所具有的有益效果是：本发明是在传统中医理论和临床经验指导下，精选出各原料药及其配比，利用诸位药物相互配伍组合，互为补充，发挥协同作用，进一步提高药物的疗效。本发明的中药组合物具有疗效显著，副作用小的优点，且制备工艺简单，易于工业化生产。经临床验证，本发明的中药组合物在治疗高血压的总有效率可达92.3%以上。
具体实施方式
以下是本发明内容的具体实施例，用于阐述本申请文件中所要解决技术问题的技术方案，有助于本领域技术人员理解本发明内容，但本发明技术方案的实现并不限于这些实施例。
实施例1
⑴将鸡血藤18g、扶芳藤18g、蒲黄10g、大黄15g、半夏8g、乌药8g、白芷12g、白僵蚕6g、五灵脂6g、水蛭6g粉碎成100目细粉，备用； 
⑵再将芡实24g、丹参12g、地骨皮12g、沙棘10g、香附8g、陈皮10g、泽泻15g、木通6g、牡蛎6g、莪术8g、柴胡12g、丝瓜藤9g药材合并，并加与药材重量比为9倍量的水，煎煮2次，每次1h，滤过，合并滤液，减压浓缩干燥，并粉碎成干膏粉，备用；
⑶取上述步骤⑴中的药粉，步骤⑵中的干膏粉，混合均匀后，即得中药混合物，与适量的糊精、 蔗糖，混匀，制粒，干燥，制成1000g颗粒剂。
实施例2
 ⑴将鸡血藤20g、扶芳藤16g、蒲黄8g、大黄17g、半夏10g、乌药6g、白芷10g、白僵蚕8g、五灵脂4g、水蛭8g粉碎成100目细粉； 
⑵再将芡实22g、丹参14g、地骨皮10g、沙棘12g、香附10g、陈皮8g、泽泻13g、木通8g、牡蛎4g、莪术10g、柴胡10g、丝瓜藤11g药材合并，并加与药材重量比为9倍量的水，煎煮2次，每次1h，滤过，合并滤液，减压浓缩干燥，并粉碎成干膏粉，备用；
⑶取上述步骤⑴中的药粉，步骤⑵中的干膏粉，混合均匀后，即得中药混合物，加入适宜的辅料，制粒，装胶囊，制成1000个硬胶囊剂。 
实施例3
⑴将鸡血藤16g、扶芳藤20g、蒲黄12g、大黄13g、半夏6g、乌药10g、白芷14g、白僵蚕4g、五灵脂8g、水蛭4g粉碎成100目细粉； 
⑵再将芡实26g、丹参10g、地骨皮14g、沙棘8g、香附6g、陈皮12g、泽泻17g、木通4g、牡蛎8g、莪术6g、柴胡14g、丝瓜藤7g药材合并，并加与药材重量比为9倍量的水，煎煮2次，每次1h，滤过，合并滤液，减压浓缩干燥，并粉碎成干膏粉，备用；
⑶取上述步骤⑴中的药粉，步骤⑵中的干膏粉，混合均匀后，即得中药混合物， 与适量淀粉、糊精混匀，制粒，压制成1000个片剂。
为了进一步验证本发明成品制剂的疗效，我们将上述具体实施例1-3中制备的成品颗粒剂、硬胶囊剂及片剂药物进行了相应的临床试验，现将结果报告如下。
临床观察及疗效
1、一般资料  收治168例高血压病患者，均符合《中国高血压防治指南( 2010年) 》中高血压病的诊断标准，即3次不同时间测量血压，舒张压（DBP）90mmHg或收缩压（SBP）140mmHg；中医辨证属《中药新药临床研究指导原则（试行）》的证型；均为原发性高血压病患者；符合知情同意原则；病程均大于3个月；排除继发性高血压及药物引起的高血压，过度肥胖（BMI﹥30，合并有糖尿病，合并有严重的瓣膜性心脏病、心肌病，合并有严重肝、肾功能不良者。采用随机分组法分为4组，其中实施例1组43例，其中男性23例，女性20例，平均年龄(57.3±1.7)岁；实施例2组39例，其中男性21例，女性18例，平均年龄(55.2±1.4)岁；实施例3组45例，其中男性22例，女性23例，平均年龄(54.6±1.6)岁；对照组41例，其中男性22例，女性19例，平均年龄(58.4±1.8)岁；四组病例的年龄、性别及一般资料差异无统计学意义。
2、治疗方法   实施例1组、实施例2组、实施例3组的患者服用本发明实施例1-3组的中药组合物，每日3 次，每次口服3个剂量单位，对照组的患者服用珍菊降压片（华佗国药股份有限公司），每次3片，每日3 次。治疗组和对照组均以三周为一个疗程，连续服用3个疗效。
 3、疗效判定标准按照(《中药新药临床研究指导原则》2002 年版) 血压疗效判定标准。(1) 显效：①舒张压下降＞10mmHg，并达到正常范围；②舒张压虽未降至正常但已下降20mmHg 或以上者。以上两项，达到其一者即为显效。(2) 有效：①舒张压下降＜10mmHg，但已达到正常范围；②舒张压较治疗前下降10 ～19mmHg，但未达到正常范围；③收缩压较治疗前下降＞30mmHg。以上三项，具备其中一项者，即为有效。(3) 无效：未达到有效标准中任意一项者即为无效。
3.1试验结果见表1。
表1各试验组治疗前后血压变化
注：与治疗前后自身比较， **P＜0.01，***P＜0.001；对照组（珍菊降压片）比较，△△P<0.01，△△△P<0.001。
患者服用本发明实施例1-3组的药物3个疗程后，表1实验结果表明，本发明实施例1-3组的患者收缩压和舒张压都有明显的下降，且较治疗前比较，具有统计学意义(***P＜0.001)，且本发明实施例1-3组的总有效率明显高于对照组，差异具有统计学意义(△△△P<0.001)。
表2 各试验组临床效果统计
患者经过3个疗程的药物治疗，实验结果可知，实施例1组、实施例2组、实施例3组的临床总有效率分别为：95.35%、92.31%、93.33%，而对照组的总有效率仅为73.17%。本发明实施例1-3组的中药组合物的治疗效果，明显优于对照组（珍菊降压片）。并且在整个治疗期间未观察到明显的不良反应。由此可知，本发明的中药组合物对治疗高血压具有疗效显著，副作用小的优点。

Claims (5)

1.一种治疗高血压的中药组合物，其特征在于，它是由如下重量配比的原料药组成：芡实22～26份、鸡血藤16～20份、扶芳藤16～20份、蒲黄8～12份、大黄13～17份、丹参10～14份、地骨皮10～14份、沙棘8～12份、半夏6～10份、乌药6～10份、白芷10～14份、香附6～10份、陈皮8～12份、泽泻13～17份、木通4～8份、牡蛎4～8份、莪术6～10份、白僵蚕4～8份、柴胡10～14份、丝瓜藤7～11份、五灵脂4～8份、水蛭4～8份。
2. 如权利要求1所述的中药组合物，其特征在于，它是由如下重量配比的原料药组成：芡实24份、鸡血藤18份、扶芳藤18份、蒲黄10份、大黄15份、丹参12份、地骨皮12份、沙棘10份、半夏8份、乌药8份、白芷12份、香附8份、陈皮10份、泽泻15份、木通6份、牡蛎6份、莪术8份、白僵蚕6份、柴胡12份、丝瓜藤9份、五灵脂6份、水蛭6份。
3. 如权利要求1或2所述的中药组合物的制备方法，其特征在于，所述中药组合物由下述工艺步骤制备而成：
⑴将鸡血藤、扶芳藤、蒲黄、大黄、半夏、乌药、白芷、白僵蚕、五灵脂、水蛭粉碎成100目细粉； 
⑵再将芡实、丹参、地骨皮、沙棘、香附、陈皮、泽泻、木通、牡蛎、莪术、柴胡、丝瓜藤药材合并，并加与药材重量比为9倍量的水，煎煮2次，每次1h，滤过，合并滤液，减压浓缩干燥，并粉碎成干膏粉，备用；
⑶取上述步骤⑴中的药粉，步骤⑵中的干膏粉，混合均匀后，即得中药混合物，再加入药剂学上常用的辅料制成各种不同口服制剂，即得。
4. 如权利要求1或2所述的中药组合物，其特征在于，所述中药组合物可制备成：颗粒剂、硬胶囊剂或片剂。
5.如权利要求1所述的中药组合物在制备治疗高血压药物中的用途。
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