复方苦蛇黄洗剂质量标准

Quality Standard of Fufang Kushehuang Lotion

目的:建立复方苦蛇黄洗剂的质量标准。方法:采用薄层色谱(TLC)法对制剂中的苦参、蛇床子、黄柏进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中苦参碱的含量。结果:TLC显色清晰且阴性对照无干扰,苦参碱在0.308～3.080μg与峰面积积分值呈良好的线性关系(r=0.999 8),平均回收率为99.52%,RSD 0.55%。结论:所建标准可用于复方苦蛇黄洗剂的质量控制。

Objective： To develop a method for quality control of Fufang Kushehuang Lotion.Method： Radix Sophorae Flavescens,Cnidium monnier and Cortex Phellodendri were identified by TLC.HPLC was used for determination of matrine.Result： The chromatographic spots were identified without interference of negative control.Matrine had a good linearity within the range of 0.308-3.080 μg（r = 0.999 8） with average recovery of 99.52%（RSD 0.55%）.Conclusion： This standard is used for quality control of Fufang Kushehuang Lotion.