CN107753738A - 一种中药组合物在制备治疗肺动脉高压的药物中的应用 - Google Patents
一种中药组合物在制备治疗肺动脉高压的药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在制备治疗肺动脉高压的药物中的应用。本发明中药组合物主要由黄芪、人参、丹参等11味中药组成，临床实验研究显示，该中药组合物可以有效治疗肺动脉高压。
Description
技术领域
本发明涉及一种中药组合物的新用途，具体地说，本发明涉及一种中药组合物在制备治疗肺动脉高压的药物中的应用。
背景技术
肺动脉高压是指静息时肺动脉平均压＞3.33kPa(25mmHg)或运动时＞4kPa(30mmHg)者。由于肺血管阻力为肺动脉平均压和肺静脉平均压之差与肺血流量之比，即肺动脉平均压为肺静脉平均压加上肺血管阻力与肺血流量乘积之和，因此凡引起肺静脉压、肺血流量和肺血管阻力增高的因素均可引起肺动脉高压。肺动脉高压是多种病因导致的，以肺动脉压力和肺血管阻力增加为本质，以肺血管受累为起点，以右心衰竭为终点的一组病理生理综合症。
世界卫生组织（WHO）根据肺动脉高压的发病机制将其分为五类：1、原发性肺动脉高压；2、家族性肺动脉高压；3.伴随相关疾病的肺动脉高压:①胶原血管疾病；②左向右分流型先天性心脏病；③门脉高压；④HIV感染；⑤药物和中毒:减肥药、菜籽油、L一色氨酸、甲基苯丙胺、可卡因；⑥其他:甲状腺疾病、Ⅰ型糖原累积病、戈谢病、遗传出血性毛细血管扩张、血红蛋白病、骨髓增生异常、脾切除；4.伴随明显的静脉或毛细血管病变的肺动脉高压:肺静脉阻塞性疾病，多发性肺毛细血管瘤。5.新生儿持续性肺高压。
肺动脉高压的病因可能是多种因素的，先天性肺小动脉发育不全、多因素肺血管挛缩，反复发作的肺小动脉血栓栓塞或羊水栓塞、缺氧、自身免疫、遗传基因、进服某些减肥或者避孕药、肝硬化及门脉高压症使血管活性物质灭活能力降低等都可能为病因。病理检查示肌型肺小动脉内膜增生，可致血栓形成、纤维化，中层退化或萎缩，导致管腔完全或部分堵塞，在血管闭塞的近端，肌型小动脉亦可有中层增生或纤维坏死，肺动脉总干及其分支扩大，右心室肥厚（陈灏珠.实用内科学.人民卫生出版社.1997年7月第10版）。
肺动脉高压的治疗主要包括：（一）病因治疗；（二）一般治疗：1、适当的运动；2、吸氧；3、利尿剂；4、洋地黄；5、抗凝药物；（三）肺动脉扩张治疗：1、钙通道阻滞剂；2、前列环素类药物；3、内皮素受体拮抗剂；4、其他，NO等；5、联合用药；（四）房隔造口术；（五）肺或心肺抑制（龚方戚.肺动脉高压的研究进展.临床儿科杂志.2005年第23卷第3期.）。
目前肺动脉高压没有特效治愈方法。治疗目标是延迟或者阻止病程进展，如果可能则诱导疾病逆转。肺动脉高压一般采用西药治疗，不良反应相对较多，而中医药在治疗肺动脉高压中具有独特的优势，值得临床推广应用。
本发明是在中国专利ZL 02146573.8的基础上进行的改进发明，在此全文引用该专利文件记载的内容。中国专利ZL 02146573.8未记载该中药组合物在治疗肺动脉高压的应用，本发明提供了一种中药组合物在制备治疗肺动脉高压的药物中的新应用。
发明内容
本发明目的是提供一种中药组合物在制备治疗肺动脉高压的药物中的应用。
本发明所述中药组合物由如下重量份的原料药制成：
黄芪 150-450份、附子40-120份、人参或党参75-225份、丹参75-225份、葶苈子50-150份、香加皮或南五加皮60-180份、泽泻75-225份、玉竹25-75份、桂枝30-90份、红花30-90份、陈皮25-75份。
优选地，该中药组合物由如下重量份的原料药制成：
黄芪450份、附子40份、人参或党参225份、丹参75份、葶苈子150份、香加皮或南五加皮60份、泽泻225份、玉竹25份、桂枝90份、红花30份、陈皮75份。
或：
黄芪150份、附子120份、人参或党参75份、丹参225份、葶苈子50份、香加皮或南五加皮180份、泽泻75份、玉竹75份、桂枝30份、红花90份、陈皮25份。
或：
黄芪250份、附子112.5份、人参或党参200份、丹参120份、葶苈子135份、香加皮或南五加皮150份、泽泻200份、玉竹60份、桂枝75份、红花75份、陈皮60份。
本发明还提供了上述中药组合物的活性成分由下列成分组成：
（1）将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮用7-9倍量70%乙醇提取，滤过，浓缩提取液至在60℃热测时相对密度为1.25-1.30的清膏；
（2）水蒸汽蒸馏法提取桂枝、陈皮的挥发油；
（3）附子、丹参、玉竹、红花加6-10倍量水煎煮2次，每次2小时，合并提取液，滤过；桂枝、陈皮提油后的水溶液滤过，备用，提油后的药材残渣再加6-10倍量水煎煮1小时，滤过，合并水溶液；将上述所得的各种水溶液合并，浓缩至相对密度为1.25-1.30清膏，搅拌中加入乙醇，至醇浓度70%，静置，滤过，滤液浓缩至在60℃热测时相对密度为1.25-1.30的清膏；
步骤（1）所得的醇提清膏，步骤（2）所得挥发油与步骤（3）所得的水提清膏共同构成本发明中药组合物的活性成分。
本发明还公开了含有上述中药组合物作为活性组分的药物制剂为胶囊剂、片剂、丸剂、口服液、或注射液。
本发明中药组合物中，作为活性组分的原料药的拉丁名及其加工方法来自《中药大辞典》（1977年7月，第一版，上海科学技术出版社）和《中国药典》（2005年版，化学工业出版社）。
本发明中药组合物还可以按常规的制剂工艺，例如，范碧亭《中药药剂学》（上海科学出版社1997年12月第1版）记载的制备工艺，制成药剂学可接受的任意常规剂型，例如胶囊剂、片剂、丸剂、口服液、注射液等。
本发明的应用中，所述中药组合物为胶囊剂、片剂、丸剂、口服液或注射剂制剂中的一种，为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。为使上述剂型能够实现中药药剂学，需在制备这些剂型时加入药学可接受的其它辅料（范碧亭《中药药剂学》，上海科学出版社1997年12月第1版中各剂型记载的辅料）。
本发明胶囊剂优选通过以下制备方法制成：（1）将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮按照比例量称取加8倍量70%乙醇回流提取2次，第一次3小时，第二次2小时，合并提取液，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)的清膏，备用；
（2）桂枝、陈皮按照比例蒸馏提取挥发油，提油后的水溶液滤过，备用，残渣再加8倍量水煎煮1小时，滤过，合并水煎液，备用；
（3）附子、丹参、玉竹、红花加水9倍量煎煮2次，每次2小时，合并提取液，滤过，与步骤（2）中桂枝、陈皮水煎液合并，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，搅拌中加入乙醇，至醇浓度70%，4℃以下静置24小时，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，与步骤（1）的醇提清膏混合，65-70℃烘干；
（4）将步骤（3）所得干膏混合粉碎成100目粉，加70%乙醇适量制粒，喷入桂枝、陈皮挥发油，混匀，装胶囊，即得。
本发明中药组合物的用量，按活性组分原料药总重量计，为4-20克/日，可每日服用一次，优选为分2-4次服用，还优选为6-12克/日，分2-4次服用，更优选为7.59克/日，分3次服用。
为阐明本发明中药组合物治疗肺动脉高压的活性，用按实施例1方法所制得的药物（以下称本发明药物）进行了下列实验。
1 资料与方法
1.1一般资料 全部病例均选自河北以岭医院住院患者，共计102例，随机分为治疗组和对照组，每组51例。治疗组男23例，女28例，年龄18-75岁之间，平均 (55.23±7.05)岁；肺动脉高压类型分布：动脉性30例，静脉性6例，与呼吸系统疾病或缺氧相关性13例，慢性血栓和（或）栓塞性2例。对照组男26例，女25例；平均年龄(56.02±8.11)岁，；肺动脉高压类型分布：动脉性28例，静脉性6例，与呼吸系统疾病或缺氧相关性16例，慢性血栓和（或）栓塞性1例。两组在性别、年龄以及病种分布方面经统计学处理无显著性差异(P>0.05)，具有可比性。
1.2病例选择 入选标准：（1）年龄18-75岁，性别不限；（2）符合1989年第三届全国肺心病心功能专题会议制定的诊断标准：在海平面水平呼吸空气，静息状态下肺动脉收缩压(PASP)>30mmHg，肺动脉平均压（PAPm）>20mmHg，或者运动状态下PAPm>30mmHg。排除标准：（1）合并心血管、肝、肾和造血系统等原发性疾病；（2）过敏体质，对多种药物有过敏史者；（3）妊娠期或哺乳期妇女。
1.3治疗方法 对照组采用西地那非治疗，0.3g/次，3次/天。治疗组在对照组用药基础上加用本发明药物治疗，4粒/次，3次/天。疗程均为4周。
1.4观察指标：观察治疗前后静息状态下PASP和PAPm的变化。
1.5统计学处理 采用SPSS13.0统计软件进行数据处理，计量资料以均数±标准差（±s）表示，采用t检验，计数资料采用x 2检验。
2 结果
2.1静息状态下PASP和PAPm的变化
经统计，两组患者治疗后静息状态下PASP和PAPm均明显低于治疗前（P＜0.05）；治疗组治疗后静息状态下PASP和PAPm均明显低于对照组治疗后（P＜0.05）。结果见表1。
表1 两组患者PASP和PAPm比较（±s）
注：与同组治疗前比较，*P<0.05；与对照组治疗后比较，#P<0.05。
3 结论
本研究在西医常规治疗的基础上，加入本发明药物治疗，在降低静息状态下肺动脉收缩压和肺动脉平均压等方面均优于单纯西医治疗，充分证实本发明药物对肺动脉高压具有显著的临床疗效。
具体实施方式
实施例1：本发明药物胶囊剂的制备
处方：
黄芪450g 附子112.5g 人参225g 丹参225g 葶苈子150g
香加皮180g 泽泻225g 红花90g 玉竹75g 陈皮75g 桂枝90g
制备方法：
（1）按照上述处方将黄芪、葶苈子、泽泻、人参、香加皮加8倍量70%乙醇回流提取2次，第一次3小时，第二次2小时，合并提取液，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)的清膏，备用；
（2）按照处方称取桂枝、陈皮蒸馏提取挥发油，提油后的水溶液滤过，备用，残渣再加8倍量水煎煮1小时，滤过，合并水煎液，备用；
（3）按照处方称取附子、丹参、玉竹、红花加水9倍量煎煮2次，每次2小时，合并提取液，滤过，与步骤（2）中桂枝、陈皮水煎液合并，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，搅拌中加入乙醇，至醇浓度70%，4℃以下静置24小时，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，与步骤（1）的醇提清膏混合，65-70℃烘干；
（4）将步骤（3）所得干膏混合粉碎成100目粉，加70%乙醇适量制粒，喷入桂枝、陈皮挥发油，混匀，装胶囊，制成1000粒，即得。
实施例2：本发明药物片剂的制备
处方：
黄芪150g 附子40g 人参225g 丹参225g 葶苈子50g
香加皮180g 泽泻75g 玉竹75g 桂枝30g 红花90g 陈皮25g
制备方法：
（1）按照上述处方将黄芪、葶苈子、泽泻、人参、香加皮加8倍量70%乙醇回流提取2次，第一次3小时，第二次2小时，合并提取液，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)的清膏，备用；
（2）按照上述处方桂枝、陈皮蒸馏提取挥发油，提油后的水溶液滤过，备用，残渣再加8倍量水煎煮1小时，滤过，合并水煎液，备用；
（3）按照上述处方附子、丹参、玉竹、红花加水9倍量煎煮2次，每次2小时，合并提取液，滤过，与步骤（2）中桂枝、陈皮水煎液合并，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，搅拌中加入乙醇，至醇浓度70%，4℃以下静置24小时，滤过，滤液减压回收乙醇，浓缩至相对密度为1.25-1.30 (60℃热测)清膏，与步骤（1）的醇提清膏混合，65-70℃烘干；
（4）按常规制剂方法制成片剂。
实施例3：本发明药物口服液的制备
处方：
黄芪250g 附子112.5g 党参200g 丹参120g 葶苈子135g
南五加皮150g 泽泻200g 玉竹60g 桂枝75g 红花75g 陈皮60g
制备方法：按常规制剂方法制成口服液。
实施例4：本发明药物滴丸剂的制备
处方：
黄芪250g 附子112.5g 党参200g 丹参120g 葶苈子135g
南五加皮150g 泽泻200g 玉竹60g 桂枝75g 红花75g 陈皮60g
制备方法：按常规制剂方法制成滴丸剂。
实施例5：本发明药物胶囊剂的制备
黄芪450g、附子40g、人参225g、丹参75g、葶苈子150g、香加皮60g、泽泻225g、玉竹25g、桂枝90g、红花30g、陈皮75g
制备方法：按常规制剂方法制成滴丸剂。
实施例6：本发明药物胶囊剂的制备
黄芪150g、附子120g、人参75g、丹参225g、葶苈子50g、香加皮180g、泽泻75g、玉竹75g、桂枝30g、红花90g、陈皮25g
制备方法：按常规制剂方法制成滴丸剂。
实施例7：本发明药物胶囊剂的制备
黄芪250g、附子112.5g、人参200g、丹参120g、葶苈子135g、香加皮150g、泽泻200g、玉竹60g、桂枝75g、红花75g、陈皮60g
制备方法：
（1）按照上述处方将黄芪、葶苈子、泽泻、人参、香加皮加8倍量70%乙醇回流提取2次，第一次3小时，第二次2小时，合并提取液，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.25-1.30的清膏，备用；
（2）按照处方称取桂枝、陈皮蒸馏提取挥发油，提油后的水溶液滤过，备用，残渣再加8倍量水煎煮1小时，滤过，合并水煎液，备用；
（3）按照处方称取附子、丹参、玉竹、红花加水9倍量煎煮2次，每次2小时，合并提取液，滤过，与步骤（2）中桂枝、陈皮水煎液合并，浓缩至60℃热测相对密度为1.25-1.30的清膏，搅拌中加入乙醇，至醇浓度70%，4℃以下静置24小时，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.25-1.30的清膏，与步骤（1）的醇提清膏混合，65-70℃烘干；
（4）将步骤（3）所得干膏混合粉碎成100目粉，加70%乙醇适量制粒，喷入桂枝、陈皮挥发油，混匀，装胶囊，制成1000粒，即得。
Claims (7)
1.一种中药组合物在制备治疗肺动脉高压的药物中的应用，其特征在于所述中药组合物由如下重量份的原料药制成：
黄芪 150-450份、附子40-120份、人参或党参75-225份、丹参75-225份、葶苈子50-150份、香加皮或南五加皮60-180份、泽泻75-225份、
玉竹25-75份、桂枝30-90份、红花30-90份、陈皮25-75份。
2.如权利要求1所述的应用，其特征在于：所述中药组合物由如下重量份的原料药制成：
黄芪450份、附子40份、人参或党参225份、丹参75份、
葶苈子150份、香加皮或南五加皮60份、泽泻225份、玉竹25份、
桂枝90份、红花30份、陈皮75份。
3.如权利要求1所述的应用，其特征在于：所述中药组合物由如下重量份的原料药制成：
黄芪150份、附子120份、人参或党参75份、丹参225份、
葶苈子50份、香加皮或南五加皮180份、泽泻75份、玉竹75份、
桂枝30份、红花90份、陈皮25份。
4.如权利要求1所述的应用，其特征在于：所述中药组合物由如下重量份的原料药制成：
黄芪250份、附子112.5份、人参或党参200份、丹参120份、
葶苈子135份、香加皮或南五加皮150份、泽泻200份、玉竹60份、
桂枝75份、红花75份、陈皮60份。
5.如权利要求1-4中任一项所述的应用，其特征在于：所述中药组合物的活性成分由下列成分组成：
（1）将黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮用7-9倍量70%乙醇提取，滤过，浓缩提取液至在60℃热测时相对密度为1.25-1.30的清膏；
（2）水蒸汽蒸馏法提取桂枝、陈皮的挥发油；
（3）附子、丹参、玉竹、红花加6-10倍量水煎煮2次，每次2小时，合并提取液，滤过；桂枝、陈皮提油后的水溶液滤过，备用，提油后的药材残渣再加6-10倍量水煎煮1小时，滤过，合并水溶液；将上述所得的各种水溶液合并，浓缩至相对密度为1.25-1.30清膏，搅拌中加入乙醇，至醇浓度70%，静置，滤过，滤液浓缩至在60℃热测时相对密度为1.25-1.30的清膏；
步骤（1）所得的醇提清膏，步骤（2）所得挥发油与步骤（3）所得的水提清膏共同构成本发明中药组合物的活性成分。
6.如权利要求1-4中任一项所述的应用，其特征在于：所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液或注射液。
7.根据权利要求6所述应用，其特征在于中药组合物胶囊剂的制备方法包含以下步骤：
（1）按照比例称取黄芪、葶苈子、泽泻、人参或党参、香加皮或南五加皮，加8倍量70%乙醇回流提取2次，第一次3小时，第二次2小时，合并提取液，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.25-1.30的清膏，备用；
（2）按照比例称取桂枝、陈皮，蒸馏提取挥发油，收集挥发油备用，提油后的水溶液滤过，备用，残渣再加8倍量水煎煮1小时，滤过，合并水煎液，备用；
（3）按照比例称取附子、丹参、玉竹、红花加水9倍量煎煮2次，每次2小时，合并提取液，滤过，与步骤（2）中桂枝、陈皮水煎液合并，浓缩至60℃热测相对密度为1.25-1.30清膏，搅拌中加入乙醇，至醇浓度70%，4℃以下静置24小时，滤过，滤液减压回收乙醇，浓缩至相60℃热测对密度为1.25-1.30清膏，与步骤（1）的醇提清膏混合，65-70℃烘干；
（4）将步骤（3）所得干膏粉碎成100目粉，加70%乙醇适量制粒，喷入桂枝、陈皮挥发油，混匀，装胶囊，即得。
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