复方氯霉素搽剂的制备与质量控制

目的 制备复方氯霉素搽剂并建立质量控制方法.方法 以甘油等为辅料,以氯霉素、替硝唑为主药制备搽剂,采用双波长分光光度法测定主药含量.结果 所得制剂经鉴别和检查均符合2010年版《中国药典(二部)》相关规定；氯霉素的检测质量浓度线性范围为9.64～28.92 μg/mL(r=0.999 9),平均回收率为99.49％,RSD为0.37％(n=6)；替硝唑的检测质量浓度线性范围为9.42～28.26 μg/mL(r=0.999 9),平均回收率为99.80％,RSD为0.35％(n=6).结论 该制剂制备简单、可行,含量测定方法准确、简便,质量稳定、可控.

Preparation and Quality Control of Compound Chloramphenicol Liniment

Objective To prepare Compound Chloramphenicol Liniment and to establish its quality control standard. Methods The lini- ment was prepared with glycerin as accessory and ehloramphenicol and tinidazole as main ingredients. The content of chloramphenicol and tinidazole were determined by dual wavelength spectrophotometry. Results The identification and test of the preparation were ac- cordance with the relative stipulation stated in the Chinese Pharmacopeia（edition 2010）.The linear range of chloramphenicol was 9.64-28.92 μg/mL（r=0. 999 9）. The average recovery rate of chloramphenicol was 99.49% （n=6） with RSD 0. 37%. The linear range of tinidazole was 9.42-28.26 μg/mL（ r=0. 999 9）. The average recovery rate of tinidazole was 99.80% with RSD0. 35% （n =6）. Conclusion The preparation of Compound Chloramphenicol Liniment is simple and feasible. The content determination method is simple and accurate with stable and controllable quality.