多家复方丹参片质量测定

Many compound prescription salvia miltiorrhiza piece quality determination

目的：以丹参酮ⅡA的含量为标准对四个厂家的复方丹参片进行质量考察.方法：采用转蓝法测定崩解时限.以HPLC检测丹参酮ⅡA的累积溶出百分率,提取威布尔分布溶出参数进行统计学处理.结果：统计学结果表明四个厂家复方丹参片的崩解时限差异显著（p〈0.01）,溶出度差异显著（p〈0.01）.结论：为了保证临床使用疗效,有必要将溶出度检测纳入到质量检测体系中.

Objective： By salvia miltiorrhiza alkone ⅡThe A content carries on the quality inspection for the standard to four facto- ry compound prescription salvia miltiorrhiza pieces. Methods：Uses transfers the blue method determination disintegration time limit. By HPLC examination salvia miltiorrhiza alkone Ⅱ The A accumulation dissolves the percentage, withdraws the Weibull distribution to dissolve the parameter to carry on statistics processing. Results：Statistics result indicated four factory compound prescription salvia mihiorrhiza piece disintegration time limit difference remarkable （p〈0.01）, dissolves the difference obviously （p〈0. 01）. Condusion：In order to guarcntee clinical use curative effect,it is necessary to dissolve the examination to integrate to the quality exami- nation system in.