CN105412680A - 一种药物制剂在制备治疗崩漏的中药中的应用 - Google Patents

一种药物制剂在制备治疗崩漏的中药中的应用 Download PDF

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CN105412680A
CN105412680A CN201610020134.9A CN201610020134A CN105412680A CN 105412680 A CN105412680 A CN 105412680A CN 201610020134 A CN201610020134 A CN 201610020134A CN 105412680 A CN105412680 A CN 105412680A
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刘学键
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Abstract

本发明公开了一种药物制剂在制备治疗崩漏的中药中的应用，涉及中医药技术领域。其以高粱壳、槐花、陈艾、月季花、续断为原料制得。本发明中的药物制剂对崩漏患者的疗效显著，且无副作用，疗效巩固。

Description

一种药物制剂在制备治疗崩漏的中药中的应用
本申请是申请人王雪雁提出的发明专利申请（发明名称为：一种治疗崩漏的药物制剂，申请号为：2014100476200，申请日为：2014年2月11日）的分案申请。
技术领域
本发明涉及一种药物制剂在制备治疗崩漏的中药中的应用，属于中药技术领域。
背景技术
崩漏系指经血非时暴下不止或淋漓不尽者，亦称“崩中漏下”。一般以月经出血量多的称“崩”；出血量少或淋漓不净的为“漏”，二者可以相互转化，崩久可演变成漏，漏久可演变成崩，临床上统称为“崩漏”。崩漏的发病机理是脏腑气血功能失调，冲任损伤不能制约经血，从胞宫非时妄行，与肝、脾、肾三脏密切相关，不外乎肝不藏血，血热妄行，脾不统血(气不摄血)，血不归经，肾虚亏损，冲任失调等。
发明内容
本发明的目的在于提供一种治疗崩漏的药物组合物。该药物组合物是在祖传秘方的基础上改进而得，具有疗显著、花费低的优点，经数十年临床应用后确定其是一种治疗崩漏的特效药物。
本发明的目的是这样实现的：
一种治疗崩漏的药物制剂，由如下重量份的中药材制备而成：高粱壳32-50份、槐花32-50份、陈艾18-22份、月季花25-30份、续断8-12份。
在一个最优选的实施例中，所述的治疗崩漏的药物制剂，由如下重量份的中药材制备而成：高粱壳37-43份、槐花39-42份、陈艾20份、月季花28份、续断10份。
进一步优选地，所述的治疗崩漏的药物制剂是口服制剂。
再进一步优选地，所述的治疗崩漏的药物制剂是口服液、颗粒剂、片剂和胶囊剂。
通过临床应用研究发现，由上述中药材制备而成的药物组合物在治疗崩漏患者方面获得了满意的疗效。因此，本发明的第二个目的在于提供一种医药新用途，即上述的药物制剂在制备治疗崩漏的中药中的应用。
将上述各中药材制备成本发明的中药制剂的制备方法，包括如下步骤：称取清洗干净且干燥的高粱壳32-50份、槐花32-50份、陈艾18-22份、月季花25-30份和续断8-12份,合并，加水煎煮两次，合并煎液，减压浓缩至70℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至70℃时相对密度为1.10-1.20并回收乙醇得浓缩液。将浓缩液加水及辅料配制成口服液，或者将该浓缩液真空干燥（60℃以下）成干膏，粉碎，加药用辅料，制成40目颗粒粉剂并包装。
与现有技术相比，本发明具有如下优点和显著地进步：（1）疗效好；崩漏患者采用本发明的药物治疗后，月经恢复正常，经期＜7天，经量恢复正常，贫血得以纠正，临床症状基本消失，停药后连续3个月经周期未复发，标本兼治，无副作用，疗效巩固；并且，大量试验研究显示，绝大部分崩漏症患者服用本发明药物2个经周期即出现明显疗效；（2）治疗成本低，安全性高；由于本发明的药物由采用价格较低的传统中药材制备而成，治疗费用低，基本无毒副作用，患者用药更安全。
具体实施方式
需要说明的是，本发明所采用的药材原料具有如下来源：高粱壳选用禾本科植物高粱的外果皮或种皮。槐花选用豆科植物槐（SophorajaponicaL.）的干燥花朵。陈艾选用菊科多年生草本植物艾的干燥叶。月季花选用为蔷薇科植物月季的干燥花朵。续断选用川续断科多年生草本植物川续断的根。
下面通过实施例进一步说明本发明。本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，在本发明的构思前提下对本发明制备方法的简单改进都属于本发明要求保护的范围。
实施例1中药口服液的制备
称取高粱壳4公斤、槐花4公斤、陈艾2公斤、月季花2.8公斤和续断1公斤合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。
实施例2中药口服液的制备
称取高粱壳4.3公斤、槐花4.2公斤、陈艾2.2公斤、月季花3公斤和续断1.2公斤合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。
实施例3中药颗粒剂的制备
称取高粱壳3.7公斤、槐花3.2公斤、陈艾1.8公斤、月季花2.5公斤和续断1公斤合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL的浸膏，浸膏置不锈钢盘中，真空干燥（60℃以下）成干膏粉碎，加蔗糖粉，制成40目颗粒粉剂并包装，每包20g。
实施例4中药口服液的制备
称取高粱壳5公斤、槐花5公斤、陈艾2公斤、月季花3公斤和续断0.8公斤合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.20，加95%(v/v)乙醇使含醇量达80%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。
实施例5中药方剂对崩漏的疗效研究
31例崩漏患者，年龄18-42岁，平均32.4±5.2岁。病程最短者3个月，最长者2年。所有患者服用中药方剂（高粱壳40g、槐花40g、陈艾20g、月季花28g和续断10g。）水煎服，白糖为引。每日1剂，分早晚两次服用。在每次行经前4-5天服药3剂，连续服3个月。按如下判定标准统计疗效：
显效：月经恢复正常，经期＜7天，经量恢复正常，贫血得以纠正，临床症状基本消失，停药后连续3个月经周期未复发；
有效：月经周期正常，经期＞7天，经量仍稍多，但临床症状有好转；
无效：月经周期、经期仍不正常，症状未见改善或加重。
结果：治愈22例，有效6例，无效3例，总有效率达90.3%。
典型病例
张某，女，24岁，未婚，2006年10月29日初诊。患者月经量多，已持续20天，淋漓不断已有5月余。自述每次月经提前7-10天，月经周期15-20天，量较多，血色红稍暗，伴有小腹坠痛，腰骶酸痛，头痛恶心，双眼干涩，纳差乏力。舌淡红，舌苔薄白，脉沉细数。张某服用中药方剂（高粱壳40g、槐花40g、陈艾20g、月季花28g和续断10g），水煎服，白糖为引。每日1剂，分早晚两次服用。在每次行经前4-5天服药3剂，连续服用2个经周期后出血止，继续服药一个经周期，以巩固其疗效。随访3年未复发。

Claims (3)

1.一种药物制剂在制备治疗崩漏的中药中的应用，其特征在于所述药物制剂由如下重量份的原料制得：高粱壳37-43份、槐花39-42份、陈艾20份、月季花28份、续断10份。
2.如权利要求1所述药物制剂在制备治疗崩漏的中药中的应用，其特征在于所述药物制剂由如下工艺步骤制得：按重量份称取清洗干净且干燥的高粱壳37-43份、槐花39-42份、陈艾20份、月季花28份、续断10份，合并，加水煎煮两次，合并煎液，减压浓缩至70℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至70℃时相对密度为1.10-1.20并回收乙醇得浓缩液；在该浓缩液基础上制备得到临床上常用中药药物剂型。
3.根据权利要求1所述药物制剂在制备治疗崩漏的中药中的应用，其特征在于：所述的药物制剂是口服液、颗粒剂、片剂或胶囊剂。
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