盐酸多西环素注射液的稳定性研究.pdfVIP

2007, 37(09) : 815818 Veterinary Science in China : S 859. 796 : A :2007) 1 1 2 吴俊伟 , 唐建华 , 姜 波 ( 1. , 402460; 2. , 402460) : 为确定盐酸多西环素注射液的有效期和包装运输条件, 高效液相色谱法测定多西环素的含量 变化, 评价制剂对温度和光照的稳定性温度加速试验采用经典恒温法, 考察温度为657585 和95 , 每 一温度设5 个不同的采样时间点, 根据动力学和Arrhenius 指数定律计算稳定性的相关参数光照试验分 裸露组和包装组, 在照度(4 500 500) lx 条件下放置10 d, 于第5 d 和第10 d 检测样品温度加速试验表明 多西环素的分解反应为一级动力学反应, k25 为5. 319 7 10- 6 / h, 25 时t0. 9 为2. 26 年光照试验表明盐 酸多西环素注射液对光照敏感, 裸露组的药物含量H 值和颜色均有明显变化; 稳定性试验结果表明盐酸 多西环素注射液在25 避光条件下的有效期可暂定为24 个月 : 盐酸多西环素; 经典恒温法; 稳定性; 有效期 Studies on stability of doxycycline hydrochloride injection 1 1 2 WU Junw ei , T ANG Jianhua , JIANG Bo (1. Dep artment of Veterinary Medicine, Southwest University , Chongqing 402460, China; 2. Chongqing F angtong nimal P harmaceutical Co. , L td, Chongqing 402460, China) Abstract: T o establish ex iration time and suitable ackage and trans ort conditions for doxycycline hydrochloride injection, the changes of doxycycline w ith tem erature and illumination w ere determined by high erformance liquid chromatogra hy( HPLC) w ith U V detector. Tem eratureaccelerated tests by the classic homeothermia method w ere erformed at 65 , 75 , 85 and 95 , res ectively, w ith 5 different time oints in each tem erature. Stability arameters were com uted by reaction kinetic equation and A r rhenius ex onential law . Illumination tests including ex osure grou and ackage grou w ere carried out by lace for 10 days at illumination level of( 4 500 500) lx and the sam les w ere determined on day 5 and 10. Results of tem eratureaccelerated tests indicated that the rate rocess of doxycycline degradation in doxy