CN108096433A - 治疗老年性冠心病气虚血瘀证的中药胶囊及其制备方法 - Google Patents
治疗老年性冠心病气虚血瘀证的中药胶囊及其制备方法 Download PDFInfo
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- CN108096433A CN108096433A CN201711495211.7A CN201711495211A CN108096433A CN 108096433 A CN108096433 A CN 108096433A CN 201711495211 A CN201711495211 A CN 201711495211A CN 108096433 A CN108096433 A CN 108096433A
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Abstract
本发明公开了一种治疗老年性冠心病气虚血瘀证的中药胶囊及其制备方法，它是由中药原料人参、黄芪、当归、生地、白芍、川芎、红花、桃仁、柴胡、升麻、枳壳、瓜蒌壳、薤白、制乳香、制没药、丹参、血竭、水蛭、三七粉、甘草制备而得，本发明的技术方案制备的补气通痹胶囊治疗老年性冠心病气虚血瘀证具有良好的补气养心，活血通脉之功效。临床上用于老年性冠心病气虚血瘀证疗效确切，且安全性好。
Description
技术领域
本发明涉及中药技术领域，特别是涉及一种治疗老年性冠心病气虚血瘀证的中药胶囊及其制备方法。
背景技术
随着人口老龄化，冠心病发病率逐年增高，胸痹气虚血瘀证成为冠心病最为常见的证型，单纯的活血化瘀法疗效较差，而补气活血以推动血液运行为治则的方法往往取得满意疗效。胸痹指胸阳不振，气血痹阻而言。临床常见胸闷痛，短气，喘息不得卧等症状。相当于现代医学的冠心病心绞痛。已成为严重的公共卫生学问题和临床研究的热点问题。中医药治疗老年性冠心病气虚血瘀证具有一定疗效已被临床广泛证实，因此，研发一种用于治疗老年性冠心病气虚血瘀证的中药制剂是十分有前景的。
发明内容
本发明所要解决的技术问题是提供一种具有补气养心，活血通脉之功效，且疗效确切的用于治疗老年性冠心病气虚血瘀证的中药胶囊及其制备方法。
为了解决上述技术问题，本发明采用如下的技术方案：按照重量份计算，本发明治疗老年性冠心病气虚血瘀证的中药胶囊是由中药原料人参12～18g、黄芪15～20g、当归5～6g、生地12～18g、白芍12～18g、川芎8～12g、红花8～12g、桃仁8～12g、柴胡8～12g、升麻3～7g、枳壳8～12g、瓜蒌壳8～12g、薤白8～12g、制乳香8～12g、制没药8～12g、丹参8～12g、血竭2～5g、水蛭8～12g、三七粉2～5g、甘草2～5g制备而成。
优选为：按照重量份计算，它是由中药原料人参15g、黄芪18g、当归6g、生地15g、白芍15g、川芎10g、红花10g、桃仁10g、柴胡10g、升麻5g、枳壳10g、瓜蒌壳10g、薤白10g、制乳香10g、制没药10g、丹参10g、血竭3g、水蛭10g、三七粉3g、甘草3g制备而成。
前述治疗老年性冠心病气虚血瘀证的中药胶囊的制备方法：将人参12～18g、黄芪15～20g、当归5～6g、生地12～18g、白芍12～18g、川芎8～12g、红花8～12g、桃仁8～12g、柴胡8～12g、升麻3～7g、枳壳8～12g、瓜蒌壳8～12g、薤白8～12g、制乳香8～12g、制没药8～12g、丹参8～12g、血竭2～5g、水蛭8～12g、三七粉2～5g、甘草2～5g加水浸泡3小时后，煎煮二次，每次加6倍量水，每次1.5小时，合并煎液，滤过，取滤液于-0.08Mpa、75℃的条件下减压浓缩至相对密度为1.35-1.39(80℃)的稠膏，取稠膏在-0.08Mpa、50℃、1000W微波减压干燥，粉碎，混匀，装入胶囊，制成1000粒，即得。
本发明在临床观察中针对冠心病气虚血瘀证取得满意效果。方中黄芪、人参，补益心气，勃发心气运血之力为君药；川芎为血中之气药，《别录》日：川芎主“心腹坚痛”。配丹参养血活血，行气止痛共为臣药；生地、白芍、当归养血活血，红花、桃仁、乳香、没药、血竭、水蛭、三七活血行血、化瘀止痛共为佐药，以求瘀去而正气自伸，心脉通而血运自畅；瓜蒌、薤白、升麻、柴胡宽胸理气.调理气机。全方以补为主、以行为通、通补兼施，使补而不壅塞，通而不伤正气，使心气得充，瘀血尽散，血脉得养，气血畅通，则胸痹心痛自止。
本发明的药材质量标准如下：
1.人参 质量标准参见《中国药典》2010版“人参”项下规定。
2.黄芪 质量标准参见《中国药典》2010版“黄芪”项下规定。
3.当归 质量标准参见《中国药典》2010版“当归”项下规定。
4.生地 质量标准参见《中国药典》2010版“生地”项下规定。
5.白芍 质量标准参见《中国药典》2010版“白芍”项下规定。
6.川芎 质量标准参见《中国药典》2010版“川芎”项下规定。
7.红花 质量标准参见《中国药典》2010版“红花”项下规定。
8.桃仁 质量标准参见《中国药典》2010版“桃仁”项下规定。
9.柴胡 质量标准参见《中国药典》2010版“柴胡”项下规定
10.升麻 质量标准参见《中国药典》2010版“升麻”项下规定。
11.枳壳 质量标准参见《中国药典》2010版“枳壳”项下规定。
12.瓜蒌壳 质量标准参见《中国药典》2010版“瓜蒌壳”项下规定。
13.薤白 质量标准参见《中国药典》2010版“薤白”项下规定。
14.制乳香 质量标准参见《中国药典》2010版“制乳香”项下规定。
15.制没药 质量标准参见《中国药典》2010版“制没药”项下规定。
16.丹参 质量标准参见《中国药典》2010版“丹参”项下规定。
17.血竭 质量标准参见《中国药典》2010版“血竭”项下规定。
18.水蛭 质量标准参见《中国药典》2010版“水蛭”项下规定。
19.三七粉 质量标准参见《中国药典》2010版“三七粉”项下规定
20.甘草 质量标准参见《中国药典》2010版“甘草”项下规定。
本发明的产品名称：补气通痹胶囊。
功效：补气养心，活血通脉。
用法：3～5粒/次，3次/日，温开水送服。
本发明的临床试验：
1临床资料
1.1一般资料 所有病例均为胸痹气虚血瘀证诊断标准患者。
1.2诊断标准 诊断标准西医诊断标准参照中华医学会心血管病学分会《慢性稳定性心绞痛诊断与治疗指南》(2007年)，中医诊断标准参照《中药新药治疗冠心病心绞痛临床研究指导原则》所制定的辨证标准。纳入病例具有胸痹主症，符合中医气虚血瘀症及冠心病心绞痛诊断。
1.3纳入标准 (1)符合胸痹气虚血瘀证；(2)年龄40～70岁；(3)患者或家属均签署书面知情同意书。(4)自愿作为受试对象，并能接受试验药物剂型，保证完成疗程者。
1.4排除标准 (1)急性冠状动脉综合征；(2)活动性心肌炎或心包炎；(3)NYHA功能分级Ⅵ级者；(4)计划行心外手术；(5)合并肝肾损害及内分泌、造血系统等严重原发病；(6)精神病患者不愿意合作者；(7)妊娠哺乳妇女，过敏体质及对多种药物过敏者；(8)凡能增加死亡率的因素患者：如心源性休克、严重室性心律失常、完全性房室传导阻滞、梗阻性心肌病、缩窄性心包炎、肺栓塞、有明显的感染者，以及没有控制的高血压等。
1.5终止研究标准 (1)实验中未能坚持按医嘱用药或自行换用其他药物治疗者；(2)实验中胸痹气虚血瘀证加重不能继续治疗者；(3)出现严重不良事件；(4)临床试验过程中出现严重的其他并发疾病者。
2研究方法
2.1治疗方法
2.1.1分组 本研究采用临床随机对照试验的方法，按照就诊的先后顺序，以随机数字表法随机分成补气通痹胶囊治疗组和对照组，进行临床疗效观察。治疗组：100例，对照组：100例。
2.1.2治疗方法 对照组采用文献推荐的治疗方法,予一致的胸痹气虚血瘀证标准治疗,包括硝酸酯类药(硝酸甘油)口服、β受体阻滞剂(倍他乐克)和钙拮抗剂(地尔硫卓)等，同时予抗凝(低分子肝素)抗血小板(阿司匹林)及调脂(他汀类调脂药物)等药物基础治疗。治疗组在对照组治疗基础上，再服用补气通痹胶囊，3～5粒/次，3次/日。4周为1疗程。治疗期间停用其他与本病有关的治疗药物或疗法。
2.2观察指标及评定标准
2.2.1.安全性观测
在用药前及疗程结束时各检测一次，如试验过程中出现试验指标的异常，应复查至正常。
(1)一般体格检查；
(2)三大常规；
(3)肾功能(尿素氮、肌酐)、肝功能(谷丙转氨酶、谷草转氨酶)、血压、心电图；
(4)临床症状体征:胸痛、胸闷、心悸、不宁、气短、乏力、唇色、紫暗症状等改善情况；
(5)随访。
2.2.3评定标准
心绞痛及心电图疗效制定参照1979年中西医结合治疗冠心病、心绞痛、心律失常座谈会《冠心病心绞痛及心电图疗效评定标准》，临床主要症状依据轻重采用1～4分积分法。疗效判定分为，显效：原有症状完全消失，总积分减小≥70％；有效：原有症状明显减轻，总积分减少40％～69％之间；无效：原有症状无明显好转，总积分减少<40％；加重：原有症状治疗后有加重，总积分较治疗前增加10％以上。总疗效判定依据心绞痛、心电图、症状改善的结果综合评定。显效：上述三项均达显效或两项显效，一项有效；有效：一项显效，两项有效，或二项显效，一项无效或三项有效，或一项显效，一项有效，一项无效；无效：未达到上述有效标准；加重：上述三项中有二项加重。
2.3统计分析 所有资料均在计算机上由SPSS 15.0版本软件包进行分析处理，计量资料数据以X±S表示，组间比较用t检验，分类变量资料的统计分析用χ2检验。P＜0.05有统计学意义。
3结果
3.3.1两组心绞痛疗效比较 治疗组100例，显效42例，有效47例，无效5例，加重3例，死亡3例，总有效率89.00％；对照组100例，显效25例，有效41例，无效24例，加重5例，死亡5例，总有效率66.00％；两组心绞痛疗效比较,差异有统计学意义(χ2＝15.17,P<0.01)。
3.3.2两组中医症状疗效比较 治疗组在胸闷、乏力两组症状疗效优于对照组(P<0.05)，心悸、气短症状两组比较无显著性差异(P＞0.05)。
结论：补气通痹胶囊治疗老年性冠心病气虚血瘀证具有良好的补气养心，活血通脉之功效。临床上用于老年性冠心病气虚血瘀证疗效确切,且安全性好。
具体实施方式：
实施例1：原料：人参15g、黄芪18g、当归6g、生地15g、白芍15g、川芎10g、红花10g、桃仁10g、柴胡10g、升麻5g、枳壳10g、瓜蒌壳10g、薤白10g、制乳香10g、制没药10g、丹参10g、血竭3g、水蛭10g、三七粉3g、甘草3g。
制备方法：将人参15g、黄芪18g、当归6g、生地15g、白芍15g、川芎10g、红花10g、桃仁10g、柴胡10g、升麻5g、枳壳10g、瓜蒌壳10g、薤白10g、制乳香10g、制没药10g、丹参10g、血竭3g、水蛭10g、三七粉3g、甘草3g加水浸泡3小时后，煎煮二次，每次加6倍量水，每次1.5小时，合并煎液，滤过，取滤液于-0.08Mpa、75℃的条件下减压浓缩至相对密度为1.35-1.39(80℃)的稠膏，取稠膏在-0.08Mpa、50℃、1000W微波减压干燥，粉碎，混匀，装入胶囊，制成1000粒，即得补气通痹胶囊。
实施例2：原料：人参13g、黄芪15g、当归5g、生地13g、白芍13g、川芎9g、红花9g、桃仁9g、柴胡9g、升麻4g、枳壳9g、瓜蒌壳9g、薤白9g、制乳香9g、制没药9g、丹参9g、血竭3g、水蛭9g、三七粉3g、甘草3g。
制备方法：将人参13g、黄芪15g、当归5g、生地13g、白芍13g、川芎9g、红花9g、桃仁9g、柴胡9g、升麻4g、枳壳9g、瓜蒌壳9g、薤白9g、制乳香9g、制没药9g、丹参9g、血竭3g、水蛭9g、三七粉3g、甘草3g加水浸泡3小时后，煎煮二次，每次加6倍量水，每次1.5小时，合并煎液，滤过，取滤液于-0.08Mpa、75℃的条件下减压浓缩至相对密度为1.35-1.39(80℃)的稠膏，取稠膏在-0.08Mpa、50℃、1000W微波减压干燥，粉碎，混匀，装入胶囊，制成1000粒，即得补气通痹胶囊。
实施例3：原料：人参18g、黄芪20g、当归8g、生地18g、白芍18g、川芎12g、红花12g、桃仁12g、柴胡12g、升麻7g、枳壳12g、瓜蒌壳12g、薤白12g、制乳香12g、制没药12g、丹参12g、血竭3g、水蛭12g、三七粉3g、甘草3g。
制备方法：将人参18g、黄芪20g、当归8g、生地18g、白芍18g、川芎12g、红花12g、桃仁12g、柴胡12g、升麻7g、枳壳12g、瓜蒌壳12g、薤白12g、制乳香12g、制没药12g、丹参12g、血竭3g、水蛭12g、三七粉3g、甘草3g加水浸泡3小时后，煎煮二次，每次加6倍量水，每次1.5小时，合并煎液，滤过，取滤液于-0.08Mpa、75℃的条件下减压浓缩至相对密度为1.35-1.39(80℃)的稠膏，取稠膏在-0.08Mpa、50℃、1000W微波减压干燥，粉碎，混匀，装入胶囊，制成1000粒，即得补气通痹胶囊。
Claims (3)
1.一种治疗老年性冠心病气虚血瘀证的中药胶囊，其特征在于：它是由中药原料人参12～18g、黄芪15～20g、当归5～6g、生地12～18g、白芍12～18g、川芎8～12g、红花8～12g、桃仁8～12g、柴胡8～12g、升麻3～7g、枳壳8～12g、瓜蒌壳8～12g、薤白8～12g、制乳香8～12g、制没药8～12g、丹参8～12g、血竭2～5g、水蛭8～12g、三七粉2～5g、甘草2～5g制备而成。
2.根据权利要求1所述治疗老年性冠心病气虚血瘀证的中药胶囊，其特征在于：它是由中药原料人参15g、黄芪18g、当归6g、生地15g、白芍15g、川芎10g、红花10g、桃仁10g、柴胡10g、升麻5g、枳壳10g、瓜蒌壳10g、薤白10g、制乳香10g、制没药10g、丹参10g、血竭3g、水蛭10g、三七粉3g、甘草3g制备而成。
3.权利要求1或2所述治疗老年性冠心病气虚血瘀证的中药胶囊的制备方法，其特征在于：将人参12～18g、黄芪15～20g、当归5～6g、生地12～18g、白芍12～18g、川芎8～12g、红花8～12g、桃仁8～12g、柴胡8～12g、升麻3～7g、枳壳8～12g、瓜蒌壳8～12g、薤白8～12g、制乳香8～12g、制没药8～12g、丹参8～12g、血竭2～5g、水蛭8～12g、三七粉2～5g、甘草2～5g加水浸泡3小时后，煎煮二次，每次加6倍量水，每次1.5小时，合并煎液，滤过，取滤液于-0.08Mpa、75℃的条件下减压浓缩至相对密度为1.35-1.39(80℃)的稠膏，取稠膏在-0.08Mpa、50℃、1000W微波减压干燥，粉碎，混匀，装入胶囊，制成1000粒，即得。
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