润肤软膏质量标准的改进

Improvement of Quality Control of Runfu Lotion

目的改进并修订润肤软膏的质量标准。方法参照《中国药典》2015年版相关鉴别方法改进了润肤软膏中主要成分的鉴别,采用对二甲氨基苯甲醛(DMAB)显色法测定主药尿素的含量,并对其条件进行考察。结果润肤软膏中主要成分尿素、黄体酮的鉴别反应均呈阳性。尿素含量测定线性范围为0.203~1.002 mg/m L,回归方程为y=0.811 1x+0.005 3(r=0.999 0),平均加样回收率为99.50%,RSD=1.49%(n=9)。与原标准方法比较,更严格可控医院制剂的质量。结论该方法简单、灵敏,准确度高,能有效控制润肤软膏的质量。

OBJECTIVE To improve and establish a method for quality control of Runfu lotion.METHODS The main components were identified according to the methods in Chinese Pharmacopoeia（2015 edition）.The concentration of urea was detected by DMAB color-test.RESULTS All main components could be identified by the developed method.The standard curve for urea was linear over a wide range（0.203-1.002 mg/mL） with correlation coefficient（r^2） 0.999.The average recovery of the method was 99.50%,RSD was 1.49%（n=9）.CONCLUSION Compared with previous method,the improved method could be more satisfied for the requirement of Chinese Pharmacopoeia.