芒果苷乳膏质量标准研究

Quality standard of Mangiferin Cream

目的建立芒果苷乳膏的质量控制方法。方法采用TLC法对芒果苷乳膏进行定性鉴别,用HPLC法测定乳膏中芒果苷的含量。按照《中国药典》2010年版一部要求对制剂性状、粒度、最低装量、微生物限度进行检查。结果芒果苷乳膏与对照品在相同位置显相同颜色斑点。HPLC法准确测定3批芒果苷乳膏的含量为分别5.39%、4.87%、5.16%,线性范围为26.5～424.0μg/mL,平均回收率为102.40%(RSD=0.84%,n=6)。其他检查项目均符合要求。结论本文建立芒果苷乳膏定性及定量评价方法,质控方法具有简便、可控、重复性好的优点,能准确评价芒果苷乳膏的质量。

Objective To establish the quality standard of Mangiferin Cream. Methods Qualitative identification was car- fled out by TLC. Content determination was carried out by HPLC, meanwhile characters, grain-size analysis, loading quan- tity and microbial limit were evaluated according to Chinese Pharmacopeia （2010 edition, 1 volume）. Results Mangiferin spots were clear and centralized on thin layer chromatography （TLC）. The linear range and mean recovery of mangiferin were 26.5-424.0 ~g/mL and 102.40% （RSD = 0.g4%, n = 6）, respectively. The contents of three batches of Mangiferin Cream were 5.39%, 4.87% and 5.16%. Other inspection items were met the requirment. Conclusion Qualitative methods are simple, sensitive and specific. The quality standard can be used for the evaluation of Mangiferin Cream.