维生素E乳膏的质量标准提高研究

Study on the improvement of quality standard for vitamin E creams

目的 完善维生素E乳膏的质量标准。方法 参照《中国药典》(2015年版)进行维生素E乳膏微生物限度检查的方法学研究,采用HPLC法测定维生素E乳膏中维生素E的含量,色谱柱Inertsil ODS(250 mm×4.6 mm,5μm),流动相为100%甲醇,检测波长284 nm,流速1.0 ml/min。结果 采用常规平皿法进行维生素E乳膏的微生物限度检查,微生物计数检查5种试验菌的回收比值均为0.5~2.0,控制菌检查中铜绿假单胞菌及金黄色葡萄球菌均可检出。含量测定维生素E在0.54~2.7 mg/ml(r=0.999 8,n=5)内线性关系良好,平均回收率为99.91%,RSD为1.38%(n=9)。结论 HPLC法操作简便,专属性高,重复性好,可作为维生素E乳膏的质量控制方法。

Objective To optimize and improve the quality standard for vitamin E creams.Methods Methodological study on microbial limit test of vitamin E creams reference to the microbial limit test of Chinese Pharmacopoeia(2015 Edition).The content of Vitamin E was determined by HPLC on a column of Inertsil ODS(250 mm× 4.6 mm,5 μm).The mobile phase was 100% methanol with flow rate of 1.0 ml/min,and the detecting wavelength was at 284 nm.Results The microbial limit of vitamin E creams could be examined by routine method.The recovery ratios of the five experimental bacteria examined by microbial count were within 0.5-2.0,Staphylococcus aureus and Pseudomonas aeruginosa can be detected in control bacteria.The linear range of vitamin E was 0.54-2.7 mg/ml(r=0.999 8,n=5),the average recovery was 99.91%,RSD was 1.38%(n=9).Conclusion The HPLC method is simple,highly and reproducible,and can be used as a quality control method for vitamin E creams.