复方连翘皮康乳膏质量标准研究

Study on the Quality Control of Lianqiaopikang Ointment

目的建立复方连翘皮康乳膏的质量控制方法。方法采用TLC法对复方连翘皮康乳膏中大黄、威灵仙和地塞米松进行定性鉴别,以HPLC法测定其主要活性成分大黄素、大黄酚和地塞米松的含量。结果薄层鉴别,供试品色谱中大黄素、大黄酚、地塞米松在与对照品和对照药材色谱相应位置上显相同颜色的斑点,阴性无干扰;大黄素和大黄酚在1～80μg/ml范围内线性良好,平均回收率分别为100.83%、101.70%,RSD分别为3.03%、3.51%。地塞米松在5～80μg/ml范围内线性良好,平均回收率为100.36%,RSD为1.54%。结论 TLC鉴别和HPLC含量测定方法操作简便、结果准确、重复性好,能有效控制复方连翘皮康乳膏的质量。

Objective To study the quality control of Lianqiaopikang Ointment.Methods TLC was used to identify Rheum officinale Baill,Radix et rhizome Clematidis and dexamethasone.HPLC system was used to determine the content of emodin,chrysophanol and dexamethasone in Lianqiaopikang Ointment.Results The spots of emodin,chrysophanol and dexamethasone of the test sample were consistent with the control.The linear range of emodin and chrysophanol was both 1-80 μg/ml,r=0.9999.The average recovery was 100.83% and 101.70%,respectively,and the relative deviation（RSD） was 3.03% and 3.51%,respectively.The linear range of dexamethasone was 5-80 μg/ml,and the average recovery rate was 100.36%,RSD was 1.54%.Conclusion The methods of TLC and HPLC used in this study are simple and accurate for quality control of Lianqiaopikang Ointment.