复方奥硝唑凝胶的研制与质量控制

目的:制备复方奥硝唑凝胶,并进行质量控制。方法:以0．6％卡波姆-940为基质,奥硝唑和西咪替丁为主药制备凝胶;采 用紫外分光光度法直接测定2组分含量,并考察成品稳定性。结果:所得凝胶外观、成形及涂展性良好;奥硝唑、西咪替丁的检测浓 度线性范围均为0．5-32μg／ml,平均回收率分别为100．58％、100．59％,相对标准差分别为1．17％、1．61％;稳定性考察结果符合 《中国药典》2000年版的规定。结论:复方奥硝唑凝胶配方合理,制备工艺简单,质量可靠,性质稳定。

Preparation and Quality Control of Compound Ornidazole Gel

OBJECTIVE: To prepare compound ornidazole gel and conduct its quality control. METHODS: The gel was prepared with 0.6% carbopol - 940 as base and with ornidazole and cimetidine as main ingredients. Contents of 2 constituents were determined directely by UV - spectrophotometry. The stability of the finished product was investigated as well. RE-SULTS:The gel obtained was good in appearance, shaping and spreading. The linear ranges for ornidazole and cimetidine were all 0.5-32uuuuuuuuuug/ ml. The average recovery rates of ornidazole and cimetidine were 100.58% (RSD= 1.17%) and 100.59% (RSD=1.61%), respectively. The stability investigation results were in line with the requirement of Chinese Pharmacopeia 2000 version. CONCLUSION:The formula of compound gel is reasonable; its preparation technics is simple and the quality is reliable; and which meets the requirements of clinical medication.