柑柏止痒浴液的质量标准研究

Study on Quality Standard of Ganbai Zhiyang Lotion

目的：建立柑柏止痒浴液的质量标准。方法：采用薄层色谱（TLC）法对处方中薄荷脑和黄柏进行定性鉴别；采用高效液相色谱法测定黄柏中盐酸小檗碱的含量：色谱柱为Agilent Eclipse Plus C18（100mm×4．6mm，5μm），流动相为甲醇．0．03mol／ml乙酸铵溶液（45：55，V／V），检测波长为346nm。结果：TLC图专属性强，阴性对照无干扰。盐酸小檗碱的质量浓度在1～200μg／ml范围内与峰面积积分值呈良好的线性关系（r=0．9998）；精密度、稳定性、重复性试验的RSD〈2％；平均加样回收率为100．28％，RSD：1．58％（n=6）。结论：所建标准可用于柑柏止痒浴液的质量控制。

OBJECTIVE： To establish the quality standard of Ganbai zhiyang lotion. METHODS： Menthol and Phellodendron chinense were identified by TLC. The content of berberine hydrochloride in P chinense was determined by HPLC. The determination was performed on Agilent Eclipse Plus C18 （100 mm×4.6mm,5μm） column with mobile phase consisted of methanol-0.03 mol/ml ammonium acetate（45： 55, V/V）. The detection wavelength was set at 346 nm. RESULTS： TLC identification method exhibited good specificities without interference from negative samples. The linear range berberine hydrochloride were 1-200 μg/ml（r= 0.999 8） ; RSDs of precision, stability and reproducibility tests were all lower than 2% ; average recovery was 100.28% （RSD= 1.58% ,n=6）. CONCLUSIONS： The established standard can be used for the quality control of Ganbai zhiyang lotion.