利巴韦林注射液细菌内毒素检查法质量标准的建立

Establishment of the Quality standurd for bacterial endotoxins test of ribavirin injection

目的 建立利巴韦林注射液细菌内毒素检查法质量标准以替代热原检查法。方法 按中国药典 2 0 0 0年版二部 ,制定本品细菌内毒素限值 ,并研究利巴韦林注射液对细菌内毒素检查试验的干扰情况 ,以确定本品是否适用细菌内毒素检查法。结果 3 .33mg .mL- 1 的供试品稀释液对试验无干扰作用。结论 本品可采用细菌内毒素检查法 。

OBJECTIVE To establish the quality standurd for the bacterial endotoxins test of ribavirin injection to replace the test for pyrogens. METHOD The limit of bacterial endotoxins in this product was defined according to CP2000,The interfereace to bacterial endotoxins test by eptifibatide injection was also done to confinm whether this product is suitable for this test.RESULTS ribavirin injection neither inhibits nor enhances the test at the concentration of 3.33mg·mL -1 .CONCLUSION This product is suitable for bacterial endotoxins test and the bacterial endotoxins test method for this product was established.