CAJ | 학술논문

目的：对注射用盐酸吉西他滨的细菌内毒素检查方法进行探讨，建立其细菌内毒素检查方法。方法按《中国药典》2010版附录ⅪE细菌内毒素检查方法进行。结果在验证条件下，注射用盐酸吉西他滨可以采用稀释方法排除干扰。结论可以采用此法对本品的细菌内毒素进行检查。
목적：대주사용염산길서타빈적세균내독소검사방법진행탐토，건립기세균내독소검사방법。방법안《중국약전》2010판부록ⅪE세균내독소검사방법진행。결과재험증조건하，주사용염산길서타빈가이채용희석방법배제간우。결론가이채용차법대본품적세균내독소진행검사。
Objective Research and establish bacterial endotoxin test method of Gemcitabine Hydrochloride for Injection. Methods The test method was developed according to the bacterial endotoxin method of Appendix XI E in 2010 Edition of Chinese Pharmacopeia VolumeⅡ. Results In the validation conditions, the dilution method can be used to eliminate the interference in the test of Gemcitabine Hydrochloride for Injection. Conclusion This method can be used to test the bacterial endotoxin in Gemcitabine Hydrochloride for Injection.