肝素钙注射液的细菌内毒素检测研究

Study on The Bacterial Endotoxin Test for Heparin Calcium Injection

目的 对肝素钙注射液进行细菌内毒素检查研究 ,建立检查肝素钙注射液中细菌内毒素的试验方法。方法 采用《中国药典》2 0 0 0年版附录细菌内毒素检查法。结果 肝素钙注射液在稀释至 5 0 0倍时检查细菌内毒素可完全排除干扰因素的影响。结论 使用细菌内毒素检查法检查肝素钙注射液中内毒素是可行的 。

OBJECTIVE To establish a method for control on endotoxin in Heparin Calcium Injection. METHOD Using bacterial endotoxin test approved by Chinese Pharmacopoeia (edation 2000).RESULTS The bacterial endotoxins test showing neither inhibition nor enhancement in diluted solution.CONCLUSION These results suggest that the technique of TAL test could be used as an alternative method for the rabbit pyrogen test for Heparin Calcium Injection.