摘要
目的建立检测注射用盐酸吉西他滨中细菌内毒素的方法。方法参照《中国药典》2010年版细菌内毒素鲎试剂检查法进行优化和检测。结果干扰试验证明,按拟定方法检验,供试品没有干扰;所检测的3批供试品中细菌内毒素含量均符合规定。结论所建立的注射用盐酸吉西他滨中细菌内毒素的检测方法简单可行,可用于该制剂的质量控制。
Objective To establish a procedure to detect the bacterial endotoxin in Gemcitabine Hydrochloride injection. Methods Tachypleus Amebocyte Lysate test were optimized to detect the bacterial endotoxin referring to Chinese Pharmaco- poeia （Edition 2010）. Results The sample did not interfere according to the proposed method test. The bacterial endotoxin de- tection results of three lots of Gemcitabme Hydrochloride injection were all within normal ranges. Conclusion The method for detecting bacterial endotoxin in Gemcitabine Hydrochloride injection is simple and feasible. It can be used in the quality control of Gemcitabine Hydrochloride injection.
出处
《肿瘤药学》
CAS
2013年第4期313-315,共3页
Anti-Tumor Pharmacy
关键词
注射用盐酸吉西他滨
细菌内毒素
干扰试验
Gemcitabine Hydrochloride injection
Bacterial endotoxin
Interference test
