CN104398921A - 一种预防心脏支架手术后再狭窄的药物组合物及制备方法 - Google Patents

一种预防心脏支架手术后再狭窄的药物组合物及制备方法 Download PDF

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CN104398921A
CN104398921A CN201410735653.4A CN201410735653A CN104398921A CN 104398921 A CN104398921 A CN 104398921A CN 201410735653 A CN201410735653 A CN 201410735653A CN 104398921 A CN104398921 A CN 104398921A
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王政乾
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Abstract

本发明的目的在于公开一种预防心脏支架手术后再狭窄的药物组合物及其制备方法，本发明的目的还在于公开该组合物的制备方法。本发明药物组合物的原料药组成比例为：制成该药的原料药的组成及重量份为：桃仁100—220份，红参60—160份，制何首乌80—120份，当归80—120份，麦芽50—100份，茯苓50—100份，山楂30—100份，远志30—100份，合欢皮30—100份，女贞子30—100份，桑椹30—100份、延胡索20—120份、丹参20—90份，柴胡10—90份，白芍10—80份，枳壳30—90份，甘草20—100份。本发明药物可以加入常规辅料，按照常规工艺，制成临床可接受的片剂、胶囊剂。

Description

一种预防心脏支架手术后再狭窄的药物组合物及制备方法
技术领域
本发明涉及一种药物组合物及制备方法，具体的说，涉及一种预防心脏支架手术后再狭窄的药物组合物及制备方法。
背景技术
心脏支架手术自诞生以来，就被医学界视为一个治病救人的良方。在近20年的时间里，心脏支架以其创伤小、痛苦小、安全系数高而备受患者和医生青睐。对于急性心梗患者来说，心脏支架的出现，为他们的生命提供了强大的保障。相对于需要全身麻醉、开胸的心脏冠状动脉支架手术来说，心脏支架手术治疗的过程可谓简单便捷。患者仅仅需要在局部麻醉的情况下穿刺血管，使导管在血管中前行，到达冠状动脉开口处，用特殊的传送系统将支架输送到需要安放的部位，撑开已经被堵塞的血管，保持血流的畅通。病人一般在手术后24小时就可以下床。
心脏支架植入人体后，会有一定几率出现再度狭窄。普通支架再狭窄的几率为30％左右。为对抗再狭窄，出现了药物涂层支架，药物涂层有效地将血管再狭窄的几率降低至5％。但是，药物涂层又会引发新的问题。由于植入心脏支架会在一定程度上损伤血管内壁，而药物涂层则会延迟破损内壁的自我修复过程，因此会导致血栓形成。但是，药物涂层又会引发新的问题。由于植入心脏支架会在一定程度上损伤血管内壁，而药物涂层则会延迟破损内壁的自我修复过程，因此会导致血栓形成。研究表明，药物涂层支架会造成3%的血栓形成率，一旦形成血栓，很容易出现急性心梗。而这些症状的严重困扰,造成精神和心理的压力,严重影响生活质量。
祖国医学博大精深，通过组方配伍，在预防心脏支架手术后再狭窄的治疗的研究还刚开始，尚无疗效确定的药物。
发明内容
本发明的目的在于公开一种预防心脏支架手术后再狭窄的药物组合物，本发明的目的还在于公开该组合物的制备方法。
本发明所涉及的一种预防心脏支架手术后再狭窄的药物组合物，它主要是由原料药 桃仁，红参，制何首乌，当归，麦芽，茯苓，山楂，远志、合欢皮，女贞子、桑椹，延胡索、丹参，柴胡、白芍、枳壳 ，甘草。
君药桃仁活血通瘀，臣药红参补气，制何首乌、当归补心血， 麦芽、茯苓和山楂补脾益胃，远志、合欢皮养心安神，女贞子、桑椹滋阴补血生津，共为佐药，延胡索、丹参活血通络，柴胡、白芍、枳壳舒肝理气，甘草调和诸药全方合用，诸药合用共奏活血祛瘀、益气通脉之功效。
本发明用于临床常见的气虚血瘀型的心脏支架后遗症患者，症见憋气，胸痛，乏力，少寐多梦，舌红赤少苔，脉虚弦数。
本发明的中药组合物及其药物组分的用量也是经过发明人进行大量摸索总结得出的。
所述的一种预防心脏支架手术后再狭窄的药物组合物的组成及重量份为：桃仁100—220份，红参60—160份，制何首乌80—120份，当归80—120份，麦芽50—100份，茯苓50—100份，山楂30—100份，远志30—100份，合欢皮30—100份，女贞子30—100份，桑椹30—100份、延胡索20—120份、丹参20—90份，柴胡10—90份，白芍10—80份，枳壳30—90份，甘草20—100份。
所述的一种预防心脏支架手术后再狭窄的药物组合物的进一步的组成及重量份为：桃仁100—200份，红参80—140份，制何首乌90—110份，当归90—110份，麦芽60—90份，茯苓60—90份，山楂40—90份，远志40—90份，合欢皮40—90份，女贞子40—90份，桑椹40—90份、延胡索30—100份、丹参30—80份，柴胡30—80份，白芍20—60份，枳壳40—80份，甘草30—80份。
所述的一种预防心脏支架手术后再狭窄的药物组合物的优选的组成及重量份为：桃仁180份，红参100份，制何首乌100份，当归100份，麦芽80份，茯苓80份，山楂60份，远志50份，合欢皮50份，女贞子50份，桑椹60份、延胡索60份、丹参60份，柴胡40份，白芍30份，枳壳40份，甘草80份。
所述的一种预防心脏支架手术后再狭窄的药物组合物的优选的组成及重量份为：桃仁150份，红参80份，制何首乌90份，当归90份，麦芽60份，茯苓60份，山楂50份，远志50份，合欢皮60份，女贞子40份，桑椹40份、延胡索30份、丹参80份，柴胡30份，白芍20份，枳壳60份，甘草60份。
所述的一种预防心脏支架手术后再狭窄的药物组合物的优选的组成及重量份为：桃仁120份，红参90份，制何首乌100份，当归100份，麦芽90份，茯苓70份，山楂60份，远志60份，合欢皮60份，女贞子40份，桑椹60份、延胡索80份、丹参70份，柴胡50份，白芍40份，枳壳70份，甘草60份。
总之，本发明组成君、臣、佐、使俱全，配伍严谨，相辅相成，共奏诸药合用共奏活血祛瘀、益气通脉之功效。
本发明药物可以加入常规辅料，按照常规工艺，制成临床可接受的片剂、颗粒剂、丸剂、胶囊剂、口服液体制剂等。
本发明药物的制备的片剂或胶囊剂的方法包括如下步骤：
红参，茯苓以上两味粉碎成细粉，过筛，其余十五味水煎，浓缩，50%醇沉，过滤后，滤液浓缩,二者混匀，制颗粒，干燥，装胶囊或压片。
本发明药物的制备方法优选包括如下步骤：红参，茯苓以上两味粉碎成细粉，过筛。其余十五味水煎2次，每次30分钟，浓缩，50%醇沉，过滤后，滤液浓缩，喷雾干燥，混匀，制颗粒，干燥，制成胶囊或片剂。
具体实施方式
以下实施例用于说明本发明，但不用来限制本发明的范围。
实施例1 
1、处方：
桃仁180g，红参100g，制何首乌100g，当归100g，麦芽80g，茯苓80g，山楂60g，远志50g，合欢皮50g，女贞子50g，桑椹60g、延胡索60g、丹参60g，柴胡40g，白芍30g，枳壳40g，甘草80g。
2. 制法：
红参，茯苓以上两味粉碎成细粉，过筛。其余十五味水煎2次，每次30分钟，浓缩，50%醇沉，过滤后，滤液浓缩，喷雾干燥，混匀，制颗粒，干燥，制成胶囊或片剂。
实施例2 
1、处方：
桃仁150g，红参80g，制何首乌90g，当归90g，麦芽60g，茯苓60g，山楂50g，远志50g，合欢皮60g，女贞子40g，桑椹40g、延胡索30g、丹参80g，柴胡30g，白芍20g，枳壳60g，甘草60g。
2. 制法：
红参，茯苓以上两味粉碎成细粉，过筛。其余十五味水煎2次，每次30分钟，浓缩，50%醇沉，过滤后，滤液浓缩，喷雾干燥，混匀，制颗粒，干燥，制成胶囊或片剂。
实施例3
1、处方：
桃仁120g，红参90g，制何首乌100g，当归100g，麦芽90g，茯苓70g，山楂60g，远志60g，合欢皮60g，女贞子40g，桑椹60g、延胡索80g、丹参70g，柴胡50g，白芍40g，枳壳70g，甘草60g。
2、工艺：
红参，茯苓以上两味粉碎成细粉，过筛。其余十五味水煎2次，每次30分钟，浓缩，50%醇沉，过滤后，滤液浓缩，喷雾干燥，混匀，制颗粒，干燥，制成胶囊或片剂。
实施例4   临床实验：心安胶囊对预防心脏支架手术后再狭窄的临床观察
【试验药品】
受试药物：心安胶囊：0.30g/粒，由实施例1制得，用前用蒸馏水配成所需的浓度的混悬液。
【入选病例】
40例患者，均为支架术治疗后冠心病患者。按治疗方法的不同分为治疗组与对照组，各20例。患者均经冠脉造影检查证实病变狭窄血管均经支架纠正。
2、治疗与观察方法：
   两组患者支架放置成功后均常规口服拜阿司匹林，氯吡格雷，他汀类药物。对照组: 为单纯西药组; 治疗组: 常规西药治疗的基础上加用心安胶囊，每日3次，每次2粒。
3、疗效评定：
  用药8个月后复查冠状动脉造影，再狭窄: 经冠状动脉造影证实的血管再次狭窄，通常较多使用的定义是介入治疗术后残余狭窄。
4、统计学分析：
本实验所得数据采用SPSS10.0版统计软件进行分析，组键比较采用t检验。
5、结果见表1：
表1两组再狭窄发生情况
从表1可见, 治疗组较对照组再狭窄发生率显著减少，两组比较有显著性差异 ( P<0.05)。
。

Claims (8)

1.一种预防心脏支架手术后再狭窄的药物组合物，其特征在于：制成该药的原料药的组成及重量份为：桃仁100—220份，红参60—160份，制何首乌80—120份，当归80—120份，麦芽50—100份，茯苓50—100份，山楂30—100份，远志30—100份，合欢皮30—100份，女贞子30—100份，桑椹30—100份、延胡索20—120份、丹参20—90份，柴胡10—90份，白芍10—80份，枳壳30—90份，甘草20—100份。
2.根据权利要求1所述的一种预防心脏支架手术后再狭窄的药物组合物，其特征在于：制成该药的原料药的组成及重量份为：桃仁100—200份，红参80—140份，制何首乌90—110份，当归90—110份，麦芽60—90份，茯苓60—90份，山楂40—90份，远志40—90份，合欢皮40—90份，女贞子40—90份，桑椹40—90份、延胡索30—100份、丹参30—80份，柴胡30—80份，白芍20—60份，枳壳40—80份，甘草30—80份。
3.根据权利要求2所述的一种预防心脏支架手术后再狭窄的药物组合物，其特征在于：制成该药的原料药的组成及重量份为：桃仁180份，红参100份，制何首乌100份，当归100份，麦芽80份，茯苓80份，山楂60份，远志50份，合欢皮50份，女贞子50份，桑椹60份、延胡索60份、丹参60份，柴胡40份，白芍30份，枳壳40份，甘草80份。
4.根据权利要求2所述的一种预防心脏支架手术后再狭窄的药物组合物，其特征在于：制成该药的原料药的组成及重量份为：桃仁150份，红参80份，制何首乌90份，当归90份，麦芽60份，茯苓60份，山楂50份，远志50份，合欢皮60份，女贞子40份，桑椹40份、延胡索30份、丹参80份，柴胡30份，白芍20份，枳壳60份，甘草60份。
5.根据权利要求2所述的一种预防心脏支架手术后再狭窄的药物组合物，其特征在于：制成该药的原料药的组成及重量份为：桃仁120份，红参90份，制何首乌100份，当归100份，麦芽90份，茯苓70份，山楂60份，远志60份，合欢皮60份，女贞子40份，桑椹60份、延胡索80份、丹参70份，柴胡50份，白芍40份，枳壳70份，甘草60份。
6.如权利要求1—5任一所述的药物组合物的制备方法，其特征在于：红参，茯苓以上两味粉碎成细粉，过筛，其余十五味水煎，浓缩，50%醇沉，过滤后，滤液浓缩，二者混匀，制颗粒，干燥，装胶囊或压片。
7. 如权利要求6所述的药物组合物的制备方法，其特征在于：红参，茯苓以上两味粉碎成细粉，过筛。
8.其余十五味水煎2次，每次30分钟，浓缩，50%醇沉，过滤后，滤液浓缩，喷雾干燥，混匀，制颗粒，干燥，制成胶囊或片剂。
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