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红霉素碱肠溶片不便于小儿分剂量服用,我们研制了一种肠溶颗粒新剂型。本文采用微生物法(琼脂打孔法)测定了12名健康志愿者单剂量交叉口服三种不同工艺和辅料制成的红霉素肠溶颗粒(EI、EII、EIII)及一种市售红霉素肠溶片(EIV)各500mg后的血药浓度,经计算机处理:EI、EII和EIII之间各药代动力学参数都较接近(P>0.5),体内吸收(t_(lag)、t_(max)和K_a)均比EIV快(P<0.05),且个体差异小,血峰浓度(C_(max))分别是EIV的1.15、1.30和1.34倍,相对生物利用度(颗粒AUC/片剂AUC)分别为126.3、136.1和133.3％。
Erythromycin alkali enteric-coated inconvenient to take doses of children, we have developed a new form of enteric-coated granules. In this study, 12 healthy volunteers were tested for the erythromycin enteric-coated granules (EI, EII, EIII) and three commercially available erythrocytes The plasma concentrations of 500 mg of EIV were calculated by computer. The pharmacokinetic parameters of EI, EII and EIII were close (P> 0.5), and the in vivo absorption (t_ (lag), t_ (P <0.05), and the individual differences were small and the peak plasma concentrations (C max) were 1.15, 1.30 and 1.34 times that of EIV respectively. The relative bioavailability Agent AUC) were 126.3, 136.1 and 133.3%, respectively.