核黄素磷酸钠注射液细菌内毒素检查法的研究

Establishment of the Quality Standurd for Bacterial Endotoxixs Test of Riboflavin Sodium Phosphate Injection

目的：考察核黄素磷酸钠注射液细菌内毒素检查方法．方法：按《中国药典》2005年版二部，制定本品细菌内毒素限值，并研究核黄素磷酸钠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．结论：本品可采用细菌内毒素检查法，并建立了本品细菌内毒素检查法质量标准。

Object： To establish the quality standurd for the bacterial endotoxins test of Riboflavin Sodium Phosphate Injection to replace the test for pyrogens. Method： The limit of bacterial endotoxins in this product was defined according to CP2005, The interfereacc to bac-terial endotoxins test by the injection was also done to confinm whether this product is suitable for this test. Results： The bacterial endoxin limit of Riboflavin Sodium Phosphate injection is 7.5 EU . mg^-1. Conclusion This product is suitable for bacterial endotoxins test and the bacterial endotoxins test method for this product was established.