复方替硝唑溶液制备工艺影响因素考察及其稳定性研究  

Study on Influencing Factors of Preparation of Compound Tinidazole Solution and its Stability

作　　者：龚亚 李敏 曹健 GONG Ya;LI Min;CAO Jian(Dept.of Pharmacy,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]陆军军医大学第二附属医院药剂科,重庆400037

出　　处：《中国医院用药评价与分析》2020年第11期1343-1346,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:考察温度和时间对复方替硝唑溶液制备的影响并探讨其稳定性。方法:采用高效液相色谱法测定替硝唑溶液、醋酸氯己定溶液及混合溶液中替硝唑和醋酸氯己定含量随温度和时间的变化情况,考察时间和温度对制备工艺的影响。采用经典恒温加热法,测定加速试验前后复方替硝唑溶液中替硝唑和醋酸氯己定的含量,根据Arrhenius指数定律,预测复方替硝唑溶液在室温(25℃)下的有效期。结果:工艺中采用热水助溶的方式对替硝唑有影响,对醋酸氯己定几乎无影响,且醋酸氯己定的存在对替硝唑的降解具有协同作用。复方替硝唑溶液中替硝唑t(0.9)^(25℃)为2.81年,醋酸氯己定稳定性高于替硝唑。结论:制备工艺方面,建议替硝唑在60℃以下单独溶解。复方替硝唑溶液在室温下贮存期为2.81年。OBJECTIVE: To investigate the effects of temperature and time on the preparation of compound tinidazole solution and to predict its stability. METHODS: Tinidazole solution,chlorhexidine acetate solution and mixed solution were sampled with temperature and time. The samples were determined by high performance liquid chromatography( HPLC) to investigate the effects of temperature and time on the preparation process. The contents of tinidazole and chlorhexidine acetate in compound tinidazole solution before and after the accelerated test were determined by classical thermostatic heating method. The shelf life of compound tinidazole solution at room temperature( 25 ℃) was predicted according to Arrhenius theory. RESULTS: Hot water for solubilization in the preparation process had an effect on tinidazole,yet almost no effect on chlorhexidine acetate,and chlorhexidine acetate had a synergic effect on the degradation of tinidazole. The t0.925℃ of tinidazole in compound tinidazole solution was 2. 81 years,and the stability of chlorhexidine acetate was higher than that of tinidazole. CONCLUSIONS: In the preparation process,tinidazole is recommended to be dissolved separately below 60 ℃ . The shelf life of compound tinidazole solution at room temperature was 2. 81 years.

关 键 词：复方替硝唑溶液 制备工艺 稳定性预测 经典恒温法 

分 类 号：R943[医药卫生—药剂学]