高丽参注射液的细菌内毒素检查法  

Bacterial Endotoxin Testing Method for Gaolishen Injection

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作  者:蒋三员[1] 莫伯雄[1] 余南发[1] 

机构地区:[1]广东省江门市新会区中医院,江门529100

出  处:《中国药师》2004年第4期280-281,共2页China Pharmacist

摘  要:的 :建立高丽参注射液的细菌内毒素检测法。方法 :根据中国药典 2 0 0 0版二部收载的细菌内毒素检查的要求进行实验。结果 :高丽参注射液经稀释后可消除对鲎试剂的干扰 ,用灵敏度为 0 .5EU·ml-1的鲎试剂检测内毒素是有效的 ,并与家兔法的结果一致。结论 :对高丽参注射液可用内毒素检查法替代家兔法的热原检查。Objective: To establish a testing method for bacterial endotoxin in Gaolishen injection. Method: The experiment was made according to the request of endotoxin testing method collected in the China Phamacopeia in 2000. Result: The result showed that the interference factors can be excluded by diluting Gaolishen injection to 4 times, it was effective that endotoxins were tested by amebocyte lysate agent with accuracy of 0.5 EU/ml, and was consistent with rabbit method. Conclusion: The pyrogen test for Gaolishen injection by baterial endotoxin can be used instead of dometic rabbit method.

关 键 词:高丽参注射液 内毒素检查 鲎试剂 

分 类 号:R927.12[医药卫生—药学]

 

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