肝素钠细菌内毒素检查法的建立

目的: 建立肝素钠原料药的细菌内毒素检查方法.方法: 通过干扰评价试验,证明肝素钠对细菌内毒素检查有抑制作用,使用稀释剂(I)适当补充二价阳离子,对样品作适当稀释,以消除其干扰抑制作用.结果: 补充适量的二价阳离子可以消除干扰作用.结论: 肝素钠原料药可以建立细菌内毒素检查法.

Development of Bacterial Endotoxin Test for Heparin Sodium

Objective: to develop the bacterial endotoxin test for heparin sodium rmateial.Method: The heparin sodium inhibied bacterial endotoxin test through interference test was proved. Proclotting enzyme cannot be activated to cause coacervation reaction due to the binding of heparin sodium with divalent cation in the TAL. The use of buffer was offered to properly supple divalent cation and dilue the sample to eliminate the inhibition.Result: The test showed that proper amount of divalent cation added can eliminate the interference. Conclusion: bacterial endotoxin test can be developed for heparin sodium material.