论文部分内容阅读
目的:建立注射用炎琥宁细菌内毒素检查方法。方法:按《中国药典》2010年版(二部)附录收载的细菌内毒素检查方法,用不同厂家的鲎试剂对不同批号的样品分别进行干扰试验。结果:注射用炎琥宁稀释至质量浓度为0.17mg.mL-1的供试品溶液时对试验无干扰作用。结论:细菌内毒素检查方法可用于注射用炎琥宁的热原检查。
Objective: To establish a method of bacterial endotoxin test for injection of mesylate. Methods: According to the bacterial endotoxin test method contained in the Appendix of Chinese Pharmacopoeia (2010 Edition) (Part 2), interference test was carried out on samples of different batches with different reagents from different manufacturers. Results: The injection of melatonin diluted to the mass concentration of 0.17mg.mL-1 for the test solution without interference on the test. Conclusion: Bacterial endotoxin test can be used for pyrogen test of injection of mesylate.