摘要
目的:比较不同厂家生产的六味地黄丸中丹皮酚和马钱苷含量差异以及体外溶出度的差异。方法:采用HPLC方法测定丹皮酚和马钱苷的含量,采用溶出度测定法进行六味地黄丸体外溶出度的研究。结果:不同厂家生产的六味地黄丸浓缩丸中丹皮酚和马钱苷的含量均有显著性差异,RSD值分别为11%和33%(n=5)。丹皮酚和马钱苷的体外溶出度参数之间有显著性差异(P<0.05)。结论:为达到临床疗效的一致性,有必要对中成药的原料药材进行严格的质量控制,对制剂工艺过程进行标准化研究。
AIM： To compare the quality of Liuwei Dihuang Pill produced by different pharmaceutical compa- nies by determining the content and the in vitro dissolution of paeonol and loganin of Liuwei Dihuang Pill. METH- ODS ： The HPLC method was used for the assay of paeonol and loganin in Liuwei Dihuang Pill. The standard disso- lution test was used to investigate the in vitro dissolution of paeonol and loganin. RESULTS： The content of pae- onol and loganin from different manufacturers differed significantly. Six products differed significantly from one an- other in their in vitro dissolution （P 〈 0.05）. CONCLUSION ： In order to get the similar clinical effect, it is nec- essary to control the quality of the Chinese herbs strictly and develop the technology standardization research about the preparation.
出处
《中成药》
CAS
CSCD
北大核心
2009年第6期882-886,共5页
Chinese Traditional Patent Medicine
基金
上海市浦东新区科技发展基金项目(PKM2008-07)
上海市教委重点学科资助(J50302)
关键词
六味地黄丸
丹皮酚
马钱苷
溶出度
工艺标准化
Liuwei Dihuang Pill
paeonol
loganin
dissolution
technology standardization
作者简介
作者简介：鲜洁晨（1983-），男，硕士研究生，研究方向：中药制剂制备工艺标准化。
通讯作者：张宁，研究员，博士生导师。Tel：（021）51322384
