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1、中国兽医科学2007,37(09):815818VeterinaryScienceinChina中图分类号:S859.796文献标识码:A文章编号:16734696(2007)09081504盐酸多西环素注射液的稳定性研究112吴俊伟,唐建华,姜波(1.西南大学动物医学系,重庆402460;2.重庆方通动物药业有限公司,重庆402460)摘要:为确定盐酸多西环素注射液的有效期和包装运输条件,以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
2、65、75、85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(4500500)lx条件下放置10d,于第5d和第10d检测样品。温度加速试验表明-6多西环素的分解反应为一级动力学反应,k25为5.319710/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、pH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。关键词:盐酸多西环
3、素;经典恒温法;稳定性;有效期Studiesonstabilityofdoxycyclinehydrochlorideinjection112WUJunwei,TANGJianhua,JIANGBo(1.DepartmentofVeterinaryMedicine,SouthwestUniversity,Chongqing402460,China;2.ChongqingFangtongAnimalPharmaceuticalCo.,Ltd,Chongqing402460,China)Abstract:Toesta
4、blishexpirationtimeandsuitablepackageandtransportconditionsfordoxycyclinehydrochlorideinjection,thechangesofdoxycyclinewithtemperatureandilluminationweredeterminedbyhighperformanceliquidchromatography(HPLC)withUVdetector.Temperatureacceleratedtestsbytheclassicho
5、meothermiamethodwereperformedat65,75,85and95,respectively,with5differenttimepointsineachtemperature.StabilityparameterswerecomputedbyreactionkineticequationandArrheniusexponentiallaw.Illuminationtestsincludingexposuregroupandpackagegroupwerecarriedoutbyplace
6、for10daysatilluminationlevelof(4500500)lxandthesamplesweredeterminedonday5and10.Resultsoftemperatureacceleratedtestsindicatedthattherateprocessofdoxycyclinedegradationindoxy-6cyclinehydrochlorideinjectionwasafirstorderkineticswithk25of5.319710/handt0.9of2.2
7、6years.Resultsoftheilluminationtestsindicatedthatthedoxycyclinehydrochlorideinjectionwasinstableforlightbecausecontentsofdoxycycline,pHvaluesandcolorintheexposuregroupchangedmarkedlyinthepackagegroup.Thestabilitytestsdemonstratedthattheexpirationtimeofthedoxycycl
8、inehydrochlorideinjectionwas24monthsat25,awayfromlight.Keywords:doxycyclinehydrochloride;classichomeothermiamethod;stability;expirationtime盐酸多西环素(doxycycli
