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目的:建立白癜风搽剂(补骨脂、乌梅、白芷、肉桂)的质量标准。方法:采用TLC法鉴别白癜风搽剂中补骨脂、乌梅、白芷及肉桂;用HPLC法同时对制剂中补骨脂素、异补骨脂素进行含量测定。结果:薄层色谱中,供试品溶液色谱在与对照药材或对照品相应位置上出现相同颜色的斑点。高效液相色谱中,补骨脂素在2.0～101.3μg·ml~(-1)浓度范围内线性关系良好(r =0.999 8),平均回收率为99.3%(RSD=0.6%,n=6);异补骨脂素在2.3～114.3μg·ml~(-1)浓度范围内线性关系良好(r= 0.999 9,n=5),平均回收率为99.2%(RSD=0.7%,n=6)。结论:该含量测定方法简便,快速,精密度高,准确度高,可用于该制剂的质量控制。
Objective: To establish vitiligo liniment (psoralen, plum, Angelica, cinnamon) quality standards. Methods: The TLC method was used to identify psoralen, plum, Angelica dahurica and Cinnamon in vitiligo liniment. Meanwhile, the content of psoralen and isopsoralen in the preparations was determined by HPLC. Results: Thin layer chromatography, the test solution chromatography with the reference substance or reference substance at the corresponding position of the same color spots. In HPLC, psoralen showed good linearity (r = 0.999 8) at a concentration range of 2.0 ~ 101.3μg · ml ~ (-1) with an average recovery of 99.3% (RSD = 0.6%, n = 6 ). The average recovery of isopsoralen was 99.2% (RSD = 0.7%, n = 5) in the range of 2.3 ~ 114.3μg · ml ~ (-1) 6). Conclusion: The determination of content is simple, rapid, high precision, high accuracy, can be used for the quality control of the preparation.