摘要
目的考察注射用盐酸头孢替安与0.9%氯化钠注射液、5%葡萄糖注射液、5%葡萄糖氯化钠注射液配伍的稳定性。方法采用HPLC法,在室温条件下放置0、1、2、4 h,测定样品有关物质及含量的变化,同时观察pH值变化。结果随着放置时间的延长,各样品的主成分含量均下降,总杂质及单个最大杂质均显著增加,杂质个数也明显增多,室温放置4 h后总杂质含量部分超限;各样品在放置4 h后pH值无明显变化。结论室温条件下,注射用盐酸头孢替安在上述3种溶液中均不稳定,应临床使用前配制。
Objective To investigate the compatible stability of cefotiam hydrochloride for injection when mixed with 0.9%NaCl injection,5% glucose injection,and 5% glucose saline injection.Methods Samples were collected at 0,1,2 and 4 h after cefotiam was mixed with 3 infusion injections at room teperature.The contents and related substances were determined by HPLC.The pH value was also determined.Results The content of main components of samples decreased with time.The total impurity and single biggest impurity were significantly increased,so did the number of impurities.The content of total impurity exceeded the limit after 4 h at room teperature.The pH value of each sample changed little after four hours.Conclusion Cefotiam hydrochloride for injection and 3 infusion injections mixed under room temperature are incompatible and should be used promptly.
出处
《解放军药学学报》
CAS
2013年第4期354-356,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
盐酸头孢替安
输液
配伍稳定性
cefotiam hydrochloride
infusion injection
compatible stability
