舒血宁注射液细菌内毒素检查法的建立

Establishment of bacterial endotoxin test for shuxuening injection

目的建立舒血宁注射液的细菌内毒素检查的方法。方法按《中国药典》2000年版(二部)附录收载的细菌内毒素检查方法及指导原则进行实验。结果将舒血宁注射液经4倍稀释可消除干扰因素,用标示灵敏度为0.25EU/mL的鲎试剂检测细菌内毒素是有效的。结论可以用细菌内毒素检查法代替家兔法来控制舒血宁注射液的质量。

OBJECTIVE To establish the method of checking bacterial endotoxin in shuxuening injection.METHODS Bacterial endotoxin test procedure and guideline in Chinese Pharmacopoeia were used. RESULTS The test showed that the interference elements can be excluded by diluting shuxuening injection 4 times, and it is effective that endotoxin can be tested by amebocyte lysate with accuracy of 0.25EU/mL.CONCLUSION Bacterial endotoxin test can be used in place of rabbit method for pyrogen monitoring of shuxuening injection.