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白癜风搽剂质量标准 被引量:1

Quality Standard for Leukoderma Liniment
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摘要 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 the quality standard for Leukoderma Liniment ( Fructus Psoralen, Fructus Mume, Radix Angelicae Dahuricae, Cortex Cinnamomi ). Method: Fructus Psoralen, Fructus Mume, Radix Angelicae Dahuricae and Cortex Cinnamomi in Leukoderma Liniment were identified by TLC. The contents of psoralen and isopsoralen in Leukoderma Liniment were determined by HPLC. Result: The fructus psoralen, fructus mume, radix angelicae dahuricae and cortex cinamoni could be obviously identified by TLC, the linear ranges of psoralen and isopsorale were at 2.0 - 101.3 μg.ml^-1 and 2.3 - 114.3 μg.ml^-1 , respectively. The average recoveries were 99.3% and 99.2% with RSD 0. 6% and 0.7%, respectively. Conclusion: The method is simple, rapid and accurate, it can be used for quality control of leukoderma liniment.
作者 刘金德 陈冲
出处 《中国药师》 CAS 2007年第3期255-258,共4页 China Pharmacist
关键词 白癜风搽剂 补骨脂素 异补骨脂素 高效液相色谱法 Leukoderma liniment Psoralen Isopsoralen HPLC
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