山苓祛斑凝胶剂提取物质量标准研究

Quality Standards Control of the Shanling Quban Gels

目的：建立山苓祛斑凝胶的质量标准。方法：运用HPLC法测定祛斑凝胶提取物中尿囊素、阿魏酸含量作为评价指标，流动相分别为乙腈-0．085％磷酸-水（5：95）、（17：83），流速为0．5mL／min、1mL／min，柱温30℃，检测波长为224nm、316nm。结果：尿囊素、阿魏酸线性范围0．368-2．208μg、0．424-2．544μg，精密度RSD0．55％、0．92％，稳定性RSD1.4％、1．5％，重复性RSD 0.95％、0．55％。祛斑凝胶剂中尿囊素、阿魏酸含量分别为11．2mg／g、4．5mg／g。结论：该方法重复性好，质量可控，可为该凝胶制剂进行中试、生产提供参考。

Objective Study on establish quality standards of Shanling Quban gels. Methods The content of allantoin and ferulic acid was used as the index to optimize the extraction process by HPLC analysis. Results Allantoin and ferulic acid showed a good linear relationship in the range of 0. 368 - 2. 208μg, 0. 424 - 2. 544μg with an average recovery of RSD 1.4% , 1.5% , Repeatability RSD 0. 95%, 0. 55%. and precision of RSD 0.55% , 0.92% , respectively. Average extracting amount of allantoin and ferulie acid in the Shanling Quban gels was 11.2mg/g and 4. 5mg/g. Coneluslon This method is simple and appropriate for quality control of Quban gels and provide a reference for industrial production of this preparation.