初匀速法测定复方替硝唑凝胶的有效期  

Studying on term of Validity of Compound tinidazole gelatin by initial average rate method

作　　者：胡志林[1] 张华[2] 王晓义[1] 

机构地区：[1]石河子大学医学院第一附属医院 [2]石河子大学药学院,新疆石河子832000

出　　处：《农垦医学》2006年第1期12-14,共3页Journal of Nongken Medicine

摘　　要：目的:用化学动力学方法预测复方替硝唑凝胶的有效期,为评价其质量提供依据。方法:采用RP-HPLC法测定凝胶中有效成分水杨酸的含量,初匀速法及光加速试验法预测有效期,结果:复方替硝唑凝胶在室温25℃条件下较稳定,初匀速法预测有效期为1.5年,经4000LX光照0,5,10天后,主药含量无明显变化。结论:初匀速法预测复方替硝唑凝胶的有效期方法简单,RP-HPLC法测定复方制剂中有效成分水杨酸的含量,结果准确、可靠。Objective： To predict the term of validity for Compound tinidazole gelatin and provide the evidences for its quality control by chemistry kinetics method.Methods： Determining the content of salicylic acid in gelatin by RP- HPLC method,and term of validity by initial average rate method and acceleration test by light. Results： Compound tinidazole gelatin is stable at room temperature（25℃ ）, term of validity is 1.5 year and the change of the content of primary （hug is minimal under the 4001x acceleration test of light after 0,5, 10 days. Conclusions：Initial average rate methods is simple, the resuits of RP- HPLC method for determination of salicylic acid in gel is accurate and reliable.

关 键 词：复方替硝唑凝胶 初匀速法 有效期 

分 类 号：R96[医药卫生—药理学]