面部用赛庚啶尿素乳膏的制备及质量控制

摘要

Objective To prepare Cyproheptadine and Urea Facial Cream with urea and cyproheptadine hydrochloride as the main medicines for the facial external use. Methods Peregal O was used as the emulsifier for preparing the cream and the content of urea in the preparation was determined by the UV-visible spectrophotometry. Results The prepared preparation was homogeneous and fine with medium viscosity. The linear range of urea was 20. 0-100. 0 μg/mL,r=0. 999 9 ( n=5 ) and the average recovery rate was 99. 72%,RSD=1. 23%( n=9). Conclusion The preparing process of this preparation is simple and feasible with good stability in character and without irritation,which is an ideal hospital preparation.%目的：制备以尿素和盐酸赛庚啶为主药的面部用赛庚啶尿素乳膏。方法以平平加O为乳化剂制备乳膏，采用紫外－可见分光光度法测定乳膏中尿素的含量。结果所制乳膏剂质地均匀、细腻、黏稠度适中。其尿素质量浓度线性范围为20.0～100.0 μg/mL， r=0.9999( n=5)，平均回收率为99.72%，RSD=1.23%（n=9）。结论该制剂制备工艺简便可行，性质稳定，无刺激性，是理想的医院制剂。