康瘫丸的质量标准

Quality Standard for Kangtan Pills

目的:建立康瘫丸的质量标准。方法:用薄层色谱法对康瘫丸中的黄芪、赤芍、羌活、当归进行定性鉴别;HPLC法测定制剂中芍药苷含量;检测波长230 nm,流速1.0 ml·min^(-1)。结果:薄层色谱斑点清晰,芍药苷在21.6～216.0μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9),平均回收率为99.5%,RSD为1.15%(n=6)。结论:本方法简便、准确,可控制该制剂的质量。

Objective： To establish the quality standard for kangtan pills. Method： Radix Astragali,Radix Paeoniae Rubra,Rh/zorna Et Radix Notopterygii ,Radix Angelicae Sinensis were identified by TLC. The content of paeoniflorin was determined by HPLC. The detective wavelength was 230 nm, the flow rate was 1.0 ml.min^ - 1. Result： The spots in TLC were clear and distinguished well. The lin- ear range of Paeoniflorin was 21.6-216. 0 μg.ml^-1 （r = 0. 999 9 ）. The average recovery was 99.5%, RSD = 1.15% （n = 6 ）. Conclu- sion： The method is simple and accurate,it can be used for quality control of kangtan pills.