摘要
目的:建立盐酸吉西他滨注射液的细菌内毒素检验方法。方法:按照《中国药典》2010年版二部附录细菌内毒素检查法试验和结果判断。结果:盐酸吉西他滨注射液对鲎试剂与内毒素反应不产生干扰的最大浓度为2.5 mg·mL-1,当限值设定为0.05 EU·mg-1时,使用标示灵敏度为0.125 EU·mL-1或灵敏度更高的鲎试剂均可对其进行细菌内毒素检查。结论:建立其细菌内毒素检查法是可行的,可用于其质量控制。
To establish a bacterial endotoxins testing method for Gemcitabine Hydrochloride Injection. Methods：The ex- periment was carried on and the results were judged according to Chinese Pharmacopeia 2010 editionVol. I1. Results： Maximum non disturb concentration of Gemcitabine Hydrochloride Injection for bacterial endotoxins test was 2. 5 mg. mL-1. When the limit was set to 0. 05 EU . mg-1, TAL of 0. 125 EU . mL-1 sensitivity or more sensitive could be feasible. Conclusion： To establish a bacterial endo toxins testing method is feasible for Gemcitabine Hydrochloride Injection.
出处
《中国药品标准》
CAS
2014年第1期39-41,共3页
Drug Standards of China
关键词
盐酸吉西他滨注射液
细菌内毒素
干扰试验
Gemcitabine Hydrochloride Injection
bacterial endotoxins
interfere factors test
