盐酸阿莫罗芬在水溶液中的降解动力学研究  

Study on Degradation Kinetics of Amorolfine Hydrochloride in Aqueous Solution

作　　者：祁少芳 高丽琼[2] 舒文娟[2] 高缘[2] 张建军[3] 

机构地区：[1]浙江震元制药有限公司,浙江绍兴312000 [2]中国药科大学中药制剂教研室,江苏南京210009 [3]中国药科大学药剂教研室,江苏南京210009

出　　处：《药学进展》2010年第11期518-522,共5页Progress in Pharmaceutical Sciences

基　　金："重大新药创制"科技重大专项(No.2009ZX09310-004)

摘　　要：目的:研究盐酸阿莫罗芬在水溶液中的降解动力学。方法:建立HPLC法,测定盐酸阿莫罗芬在不同pH值、不同温度、不同离子强度的缓冲液中的降解动力学参数。结果:盐酸阿莫罗芬在水溶液中的降解呈现伪一级动力学特征,随着温度的增加,其降解速率增大;在37和60℃时,随着pH的增加,盐酸阿莫罗芬的降解速率明显增大(P<0.05),其半衰期和有效期明显减小(P<0.05),而随着离子强度的增大,其降解速率有所减小(P>0.05);在4和25℃时,盐酸阿莫罗芬在不同pH和不同离子强度的缓冲液中相对稳定;盐酸阿莫罗芬降解活化能随着pH的增大而增大。结论:盐酸阿莫罗芬在水溶液中的降解速率与温度、pH值和离子强度有关,其中温度对盐酸阿莫罗芬降解的影响较为明显。Objective： To study the degradation kinetics of amorolfine hydrochloride in aqueous solution. Methods： A HPLC method was established to measure the degradation kinetic parameters of amorolfine hydrochloride in PBS solutions with various pH values and ionic strengths at different temperatures. Results： Degradation of amorolfine hydrochloride in aqueous solution followed the pseudo-first order kinetics and the degradation rate increased with the increase of temperature. At 37 and 60 ℃. The degradation rate of amorolfine hydrochloride increased （ P 〈 0. 05） and its half-time and expiration date decreased （ P 〈 0.05） significandy with the increase of pH value, but the degradation rate decreased with the increase of ionic strength（P 〉0. 05）. Amorolflne hydrochlorlde was relatively stable at the low temperature and the activation energy of its degradation increased with the increase of pH value. Conclusion： Degradation rate of amorolfine hydrochloride in aqueous solution is related with temperature, pH and ionic strength.

关 键 词：盐酸阿莫罗芬 降解速率 温度 PH值 离子强度 

分 类 号：R914[医药卫生—药物化学]