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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 revise the quality standard of emollient ointment. Methods According to “Chinese Pharmacopoeia” 2015 edition related identification method to improve the main components of emollient ointment identification, the use of p-dimethylaminobenzaldehyde (DMAB) colorimetric determination of the main drug urea content, and its conditions were investigated. Results Emollient ointment in the main component of urea, progesterone identification reaction was positive. The linear range of determination of urea was 0.203-1.002 mg / m L, and the regression equation was y = 0.811 1x + 0.005 3 (r = 0.999 0). The average recoveries were 99.50% and RSD = 1.49% (n = 9). Compared with the original standard method, more stringent control of the quality of hospital preparations. Conclusion The method is simple, sensitive and accurate. It can effectively control the quality of emollient ointment.