溶液pH、湿度和光照等因素对西他沙星稳定性的影响  

Effects of pH,humidity and light on the stability of sitafloxacin

作　　者：张倢 张璐[1] 邱立朋[2] 程亮[1] 程丽芳[1] 苗得足 陈大为[1,2] 

机构地区：[1]苏州大学药学院,苏州215123 [2]沈阳药科大学药学院,沈阳110016 [3]瑞阳制药有限公司,淄博256100

出　　处：《中国新药杂志》2014年第13期1583-1586,共4页Chinese Journal of New Drugs

基　　金：山东省科技厅科技发展计划(2011GSF21809)

摘　　要：目的:考察溶液pH、湿度和光照等因素对西他沙星稳定性的影响。方法:利用高效液相色谱法测定西他沙星在上述因素下的含量变化,将浓度变化与时间进行线性回归,得到不同pH条件下药物的降解速率方程,根据降解速率常数推断出西他沙星在恒温条件下的最稳定pH。结果:西他沙星在高温条件下稳定性良好;对酸、碱、高湿及光照敏感,该药物的最稳定pH约为5.3。结论:溶液pH、湿度、光照等因素能够显著影响西他沙星的稳定性,这为制剂的研究提供了科学依据。Objective： To investigate the stability of sitafloxacin affected by pH, humidity and illumination. Methods： An improved HPLC method was applied to measure concentrations of sitafloxacin under various conditions of these experimental factors. The degradation rate equations of sitafloxacin at different pH were obtained by linear regression analysis between concentration and time. According to the degradation rate constants, we could deduce the most stable pH value of sitafloxacin at a constant temperature. Results： Sitafloxacin maintained relative stable under high temperature condition; while acid, alkali, high humidity and illumination accelerated its decomposition. The most stable pH value was about 5.3. Conclusion： pH, humidity, light and other factors significantly affect the stability of sitafloxacin, which provides a scientific basis for the research of related preparations.

关 键 词：西他沙星 稳定性 湿度 光照 PHM 

分 类 号：R978.26[医药卫生—药品]