斑蝥酸钠维生素B6注射液细菌内毒素检查法研究___
Study on bacterial endotoxins test of disodium cantharidinate and vitamin B6 injection
分类号：
出版年·卷·期（页码）：2009,29 (11):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish a method for determination of the bacterial endotoxin test in disodium cantharidinate and vitamin B6 injection. Methods: Inhibition and bacterial endotoxin test was performed with amebcyte lysate manufactured by different companies with different specifications according to the method of bacterial endotoxin test approved by Chinese Pharmacopoeia 2005 edition. Results: The original solution had non-interference with the bacterial endotoxin test.The results of bacteria endotoxin test in six batchs all accorded with the standard of the quality control. Conclusion: The results suggested that bacteria endotoxin test can be used as an alternative method for the rabbit pyrogen test for disodium cantharidinate and vitamin B6 injection. The limits of bacterial endotoxin was 6EU·mg–1.
-----参考文献：---------------------------------------------------------------------------------------
1 ChP(中国药典).2005.VolⅡ（二部）：Appendix(附录) 85
2 specification of Cantharidinate vitamin B6 injection drug（斑蝥酸钠维生素B6注射液药品说明书）
欢迎阅读《药物分析杂志》！您是该文第 2339位读者！
