论文部分内容阅读
《中国医院制剂规范》1995年版“细菌内毒素检查法”规定“供试品的内毒素限量应不超过1Eu·ml-1[1]。这一规定是欠妥的。该检查法使用灵敏度(λ)不超过0.5Eu·ml-1的鲎试剂。阳性对照管内装有0.1ml鲎试剂溶解液,并加入2λ内毒素工作标准...
“Chinese Hospital Preparations Code” 1995 edition of the “bacterial endotoxin test” provides that "the test sample endotoxin limit should not exceed 1Eu · ml-1 [1] This provision is defective.This test method uses the sensitivity ( λ) 鲎 Reagent not to exceed 0.5Eu · ml-1. Positive control tube containing 0.1ml 鲎 reagent solution, and add 2λ endotoxin working standard ...