克林霉素凝胶的制备及质量控制

Preparation and Quality Control of Clindamycin Gel

目的:制备克林霉素凝胶并建立其质量控制方法。方法:以盐酸克林霉素为主药,卡波姆-934、丙二醇等为辅料制备凝胶;采用高效液相色谱法测定盐酸克林霉素的含量。结果:所制凝胶质地均匀,粘稠度适中;盐酸克林霉素检测浓度线性范围为20～80μg/ml,平均回收率为99.50%,RSD=1.05%。结论:该制剂性质稳定,质量易控。

OBJECTIVE ： To prepare clindamycin gel and to establish its quality control. METHODS： Hydrochloride clindamycin was used as the principal agent, carbomer-934, propylene glycol as preservatives to prepare clindamycin gel; HPLC method was adopted to determine the content of clindamycin. RESULTS： The prepared gel showed fine consistency and moderate viscosity; The detected concentration of clindamycin was linear in the range of 20～80μg/ml, the average recovery rate was 99.50%, RSD = 1.05%.CONCLUSION： This preparation is stable in quality and the quality control is feasible and reliable.