【摘要】 地红霉素属国家二类新药 ,为满足地红霉素质量控制之需要 ,我们参照 WHO基准品的建立指导原则 ,定义“1mg地红霉素 (C42 H78N2 O1 4 ) =10 0 0地红霉素单位 (u)”。采用正反高效液相色谱法 ,首先确定地红霉素的化学纯度 ,再根据地红霉素的效价定义 ,确定地红霉素的效价。建立了首批国家地红霉素标准品更多还原

【Abstract】 According to the guidline of WHO for the establishment of drug reference substance, the national reference standard of dirithromycin, which belongs to the national second class new drug, has been defined that 1mg dirithomycin (C 42H 78N 2O 14) has a potency of 1000 units, and the potency units of the national reference standard is 979 unit/mg.更多还原