金槐冠心滴丸制备工艺及质量标准的研究.pdf

陕西中医学院
硕士学位论文
金槐冠心滴丸制备工艺及质量标准研究
姓名:苏卓
申请学位级别:硕士
专业:中药学
指导教师:王昌利
20100401
1
摘要

金槐冠心滴丸是利用固体分散技术制备而成的一种“固态液体制剂”,它是在金
槐冠心片基础上制成的,处方由穿山龙、雪胆、槐米三位药材组成,提取三位药材中
作用于心血管系统的有效成分制成本品,该滴丸是防治冠心病的有效制剂。
金槐冠心滴丸中对穿山龙、雪胆、槐米三位药材的提取工艺进行了考察。采用正
交设计对各位药材的提取工艺参数进行了考察,最终确定出最佳的工艺参数。为了提
高每粒滴丸中有效成分的含量,减少服用量,本实验中对提取物进行了纯化考察,考
察了不同大孔树脂对三位药材提取物的吸附和解析能力影响的大小,最终得到了穿山
龙、雪胆、槐米三位药材的提取物,该过程工艺可行、质量稳定。
为了给患者提供高效、速效、长效、服用剂量小、服用方便的药物,因此对金槐
冠心片进行了剂型改良。本实验中采用了单因素及正交设计实验设计来考察滴丸的制
备工艺,通过主、客观指标的考察最终也确定了滴丸的制备条件。
在金槐冠心滴丸的质量标准研究中,我们对滴丸的制法、鉴别、检查、含量测定
等方面进行了研究,并且制订了限度,为给患者提供质量稳定的药物提供了保障。
通过本文的研究,有望给患者提供一个高效、速效、长效、服用剂量小、服用方
便并且疗效突出的药物,同时也符合对中药新剂型的创新性探索以及中药剂型研发的
要求。

关键词:金槐冠心滴丸;制备工艺;大孔吸附树脂;质量标准









2
study on preparation process and quality standards of Jinhuai
Guanxin Dropping Pill
Abstract

Jinhuai Guanxin Dropping Pill is a Solid liquid preparations which was
made by using Preparation of solid dispersion. It is made on the basis of the
Jinhuai Guanxin Tablets,It posed of three ingredients Chinese herbal
medicines that is Dioscorea nipponica makino、Hemsleya and sopHora bud. It
is make up with three kinds of medicinal active ingredients,and it is a
effective preparation to Coronary heart disease.
Jinhuai Guanxin Dropping Pill Study on the extraction process of Dioscorea
nipponica makino、Hemsleya and sopHora bud,Orthogonal design of the parameters
of the extraction process you herbs were investigated, eventually determine
the best process order to improve the content of active
ingredients, reduce the dose,that Each Dropping Pill carried out an
experiments on purified extracts investigated. The experiments carried out
on purified extracts investigated to investigate the influence of different
macroporous resin adsorption of the three herbs extracts and analytical
ability . Finally got the three extracts of medicinal herbs of Dioscorea
nipponica makino、Hemsleya and sopHora. The process technology i