复方奥硝唑搽剂的制备与质量控制

Preparation and quality control of compound ornidazole liniment

目的:研制复方奥硝唑搽剂并对其质量进行控制。方法:以奥硝唑和硼酸为主药制备复方搽剂,采用紫外分光光度法和中和法分别直接测定两组分含量,并对该制剂的稳定性进行考察。结果:奥硝唑、硼酸平均回收率分别为99.98%,100.29%,RSD分别为0.49%,0.97%。结论:复方奥硝唑搽剂配方合理、质控方法可行,所得制剂性质稳定,符合中国药典2005年版的规定,可满足临床用药要求。

Objective： To study the preparotion and quality control of compound ornidazole liniment. Methods：Prepared compound liniments with ornidazole and boric acid as principle agents. The contents of these two groups were measured respectively, by UV spectrophotometry and neutralization method. Then the stability of it was examined. Results： The average recoveries of ornidazole and boric were 99. 98% and 100. 29% with the RSD of 0. 49% , 0. 97%. Conclusion ：The compound ornidazole liniment formula was reasonable ; the quality control method was viable ; the outcoming liniment was stable, and in line with the 2005 version of Chinese Pharmacopoeia. It could meet the clinical requirment.