菌克软膏的制备及质量控制

Preparation and Quality Contrel of Junke Ointment

目的:制备菌克软膏并建立质控标准。方法:采用HPLC法进行定性鉴别并同时测定处方中盐酸林可霉素和硝酸咪康唑的含量。结果:盐酸林可霉素的平均回收率为101.23％,RSD为0.93％;硝酸咪康唑的平均回收率为99.89％,RSD为0.57％。结论:该制剂处方合理,工艺简单,质量可控。

Objective: To prepare Junke ointment and establish a method for quality control. Method: HPLC was used in qualitative analysis and the content determination of lincomycin hydrochloride and miconazole nitrate in Junke ointment. Result: The average recoveries of lincomycin hydrochloride and miconazole were 101. 23% (RSD = 0. 93% ,n = 5 ). 99. 89% (RSD =0.51% , n = 5) respectively. Conclusion: The prescription of Junke ointment was reasonable, the qualitative method was simple and rapid. The quantitative method was sensitive and accurate in the simultaneous determination of two constituents in Junke ointment.