醋酸氯己定乳膏的质量标准研究

Study on Quality Standard of Chlorhexidine Acetate Cream

目的：为建立醋酸氯己定乳膏的质量标准提供参考。方法：增订醋酸氯己定乳膏中冰片的薄层色谱鉴别;建立高效液相色谱法测定醋酸氯己定含量的方法。结果：冰片薄层色谱斑点清晰,可用于鉴别;醋酸氯己定质量浓度在10.02-160.30μg/ml范围内与峰面积呈良好的线性关系（r=0.999 7）;精密度、稳定性、重复性试验的RSD均〈1.0%;回收率为100.9%,RSD为1.9%（n=9）。结论：该方法方便、快捷、重复性好,可作为醋酸氯己定乳膏的质量控制方法。

OBJECTIVE：To improve the standard of the quality control of Chlorhexidine acetate cream.METHODS：Thin layer chromatography（TLC） was used to identify the borneol from Chlorhexidine acetate cream;HPLC was used to determine the content of chlorhexidine acetate.RESULTS：The spots of borneol in TLC were clear and could be used for identification.The quality concentration of chlorhexidine acetate showed a good linear relationship in the range of 10.02-160.30 μg/ml（r=0.999 7）;RSDs of precision,stability,and reproduciblity tests were all lower than 1.0%;average recovery was 100.9%（RSD=1.9%,n=9）.CONCLUSIONS：The method is convenient,reproducible,and can be used for the quality control of Chlorhexidine acetate cream.