细菌内毒素检查法与家兔法同步检测丹参川芎嗪注射液热原的比较

Comparison of pyrogen test of danshen ligustrazine injection by simultaneous use of bacteria endotoxin test and rabbits test

目的考察细菌内毒素检查法和家兔法对丹参川芎嗪注射液检查的可行性。方法采用《中国药典》2010年版一部附录细菌内毒素检查法,对家兔试验进行比较试验。结果丹参川芎嗪注射液稀释至160倍时,用灵敏度为0.06 EU/ml的鲎试剂进行实验,干扰消失。家兔热原检查法与细菌内毒素检查法相吻合。结论采用细菌内毒素检查法和家兔检查法检测丹参川芎嗪注射液热原均可行。

Objective To investigate the feasibility of bacteria endotoxin test and rabbits test for pyrogen examination of danshen ligustrazine injection. Methods The bacteria endotoxin test in Chinese Pharmacopoeia 2010 version ap- pendix was used to pyrogen test on danshen ligustrazine injection. The different results of rabbits pyrogen test of dan- shen ligustrazine injection were compared with bacteria endotoxin test. Results The interference on bacterial endotoxin test can be excluded when danshen ligustrazine injection was diluted at 160 times. The samples were no showed inter- ferential efforts on danshen ligustrazine injection. Conclusion Both bacteria endotoxin test and rabbits test are feasible in pyrogen test of danshen ligustrazine injection.