注射用盐酸吉西他滨细菌内毒素检查法的可行性研究

Research on the Feasibility of Bacterial Endotoxin Test for Gemcitabine Hydrochloride for Injection

目的考察注射用盐酸吉西他滨的细菌内毒素检查方法的可行性。方法按《中国药典》2010年版二部收载的细菌内毒素检查方法进行试验。结果将注射用盐酸吉西他滨稀释液的pH值调成近中性时,对鲎试剂的凝集反应无抑制作用。结论用细菌内毒素检查法替代家兔热原法控制注射用盐酸吉西他滨的质量是可行的。

Objective To test the bacterial endotoxin in gemcitabine hydrochloride for injection. Methods Bacterial endotoxin test of the Chinese pharmacopoeia was used. Results The test showed that inhibitory effect was not shown when the pH value of gemcitabine hydrochloride dilution was adjusted nearly neutral. Conclusion Bacterial endotoxin test can be alternative to rabbit method for pyrogen monitoring of gemcitabine hydrochloride for injection.