尿素乳膏的质量标准研究

Study on the Quality Standard for Urea Cream

摘要: 目的制定尿素乳膏的质量标准，进一步控制该制剂的产品质量。方法参照中国药典2015年版对尿素乳膏中主要成分尿素进行定性鉴别，同时采用DMAB显色法测定其含量。结果尿素乳膏中尿素鉴别反应呈阳性，尿素含量在0.036 78~0.085 81 mg·ml^-1（r=0.999 5）内与吸光度值呈良好的线性关系，平均加样回收率为98.19%，RSD=0.24%（n=9）。结论该法操作简单，准确可靠，能有效控制院内制剂尿素乳膏的质量。

Abstract: OBJECTIVE To establish and improve the quality standard of Urea cream. METHODS The effective constituent of Urea cream were qualitative identified according to the methods in Chinese Pharmacopoeia (2015 edition) and its content was determined by DMAB color-test. RESULTS The qualitative identifications of urea were specific. The liner range of urea was 0.036 78-0.085 81 mg·ml^-1(r=0.999 5), its average recovery were 98.19% and RSD was 0.24%(n=9). CONCLUSION The method is simple and practical, the result is accurate and reliable and it can be used to control the quality of Urea cream.