林可霉素甲硝唑凝胶的制备及质量控制

Preparation and Quality Control of Lincomycin and Metronidazole Gel

目的:制备林可霉素甲硝唑凝胶并建立其质量控制方法。方法:以甘油、卡波姆-940等为辅料制备凝胶;采用高效液相色谱法和紫外分光光度法分别测定其中主药含量。结果:所制备凝胶性状、鉴别等均符合2005年版《中国药典》相关规定;林可霉素、甲硝唑检测浓度的线性范围分别为248.00～1033.34(r=0.9999)、2.29～22.90μg.mL-1(r=1.0000),平均回收率分别为101.10%(RSD=1.54%)、100.47%(RSD=0.62%)。结论:本制剂制备工艺简便可行,质量稳定可控。

OBJECTIVE： To prepare lincomycin and metronidazole gel and to establish its quality control method.METHODS： Lincomycin and metronidazole gel was prepared with glycerol, carbomer-940 etc as excipients, with content determination performed using HPLC and ultraviolet spectrophotometry. RESULTS： The prepared gel fitted the description of China Pharmacopeia （2005 edition） in property, identification etc. The linear ranges of lincomycin and metronidazole were 248.00～ 1 033.34μg · mL^-1（r = 0.999 9） and 2.29～22.90μg · mL^-1（r = 1.000 0）, and the average recoveries of which were 101.10% （RSD = 1.54% ） and 100.47% （RSD = 0.62% ） . CONCLUSION： The established technique of this preparation is simple and feasible, and its quality is stable and controllable.