抗妇炎软胶囊质量标准研究

摘要

Aim To establish a quality standard for kangfuyan soft capsules so as to control its quality efficiently and effectively. Methods Chinese medical plants Kushen Lianqiao and Huangbai were identified by TLC. Contents of matrine were determined by HPLC. Results The method of TLC was reliable .accurate, and specific. Matrine showed good linear relationship in the range between 0. 52 and 2.60 μg and regression equation was A = 835 294C -74 818( r =0. 999 8 ),with a mean recovery rate of 97. 48％ ( RSD being 1. 18％ ).Conclusion The quality of kangfuyan soft capsules could be controlled by the standard.%目的 建立抗妇炎软胶囊的质量控制标准.方法 采用薄层色谱法对抗妇炎软胶囊中连翘、黄柏、苦参进行定性鉴别,采用高效液相色谱法测定主要成分苦参碱的含量.结果 供试品溶液色谱中,在与连翘、黄柏、苦参所含有效成分对照品色谱相应位置上显相同颜色的斑点;苦参碱在0.52～2.60 μg范围内与峰面积呈良好线性关系,回归方程为A =835 294C-74 818(r=0.999 8),平均回收率为97.48%,RSD=1.18%(n=6).结论 该方法简便可靠,快速准确,结果稳定,重复性好.可作为抗妇炎软胶囊的质量控制方法之一.