注射用盐酸吉西他滨细菌内毒素检查方法的研究

Study on the Test Method of Bacterial Endotoxin in Gemcitabine Hydrochloride for Injection

目的:建立注射用盐酸吉西他滨的细菌内毒素检查方法。方法:根据《中国药典》2010年版细菌内毒素检查法,采用2个不同厂家的鲎试剂对注射用盐酸吉西他滨通过调节pH值及稀释等方法进行干扰试验和细菌内毒素检查。结果:样品溶液稀释为3.5mg/ml、pH值调节至7.0时对检查无干扰;细菌内毒素限值确定为0.10EU/mg。结论:注射用盐酸吉西他滨采用细菌内毒素检查法代替热原检查法可行。

OBJECTIVE：To establish a method for testing the bacterial endotoxin in Gemcitabine hydrochloride for injection.METHODS：According to the bacterial endotoxin test stated on Chinese Pharmacopeia（2010 edition）,interference test and bacterial endotoxin test were carried out by using TAL from 2 manufacturers to adjust the pH value of Gemcitabine hydrochloride for injection and dilute Gemcitabine hydrochloride for injection.RESULTS：No interference was found in the bacterial endotoxin test after Gemcitabine hydrochloride for injection was diluted at 3.5mg/ml with pH value of 7.0.The endotoxin limit of it was 0.10 EU/mg.CONCLUSION：It is feasible for bacterial endotoxin test instead of pyrogen test of Gemcitabine hydrochloride for injection.