Karlsson S, Lührmann B, Bahner M L, Schulz H U
Int J Clin Pharmacol Ther Toxicol. 1987 Jun;25(6):342-6.
In a randomized cross-over study, theophylline serum levels were compared over a 12-h dosing interval after repeated administration of Euphyllin retard and PulmiDur to 18 healthy male volunteers. Although both preparations are sustained-release formulations they differ in the systems used and in the state of hydration of theophylline. Two tablets each of Euphyllin retard or one tablet PulmiDur plus one tablet PulmiDur forte were administered in an identical dosing scheme always before food intake. The mean value curves of theophylline serum levels obtained at steady state clearly demonstrate the marked sustained-release properties of both preparations. The relative bioavailability of Euphyllin retard vs. PulmiDur calculated from the individual ratios of the dose adjusted AUCs was 96(83-111)%, results being given as geometric mean and 95% confidence limits. Hence Euphyllin retard is equivalent to PulmiDur with regard to the extent of absorption.
在一项随机交叉研究中，对18名健康男性志愿者重复给予优菲林缓释片（Euphyllin retard）和普尔米杜（PulmiDur）后，在12小时给药间隔内比较了茶碱血清水平。尽管两种制剂均为缓释制剂，但它们在所用系统和茶碱的水合状态方面存在差异。优菲林缓释片每次两片或一片普尔米杜加一片普尔米杜加强片，均按照相同的给药方案在进食前服用。稳态时获得的茶碱血清水平平均值曲线清楚地显示了两种制剂显著的缓释特性。根据剂量调整后的AUC个体比值计算得出，优菲林缓释片相对于普尔米杜的相对生物利用度为96(83 - 111)%，结果以几何平均值和95%置信区间表示。因此，就吸收程度而言，优菲林缓释片与普尔米杜等效。
