Lin C, Lim J, Symchowicz S
J Int Med Res. 1982;10(2):126-8. doi: 10.1177/030006058201000211.
The bioavailability of a single dose of d-pseudoephedrine sulfate administered to male volunteers in repeat action tablet form (60 mg d-pseudoephedrine sulfate in the coat and 60 mg d-pseudoephedrine sulfate in the core) was compared with the bioavailability of an equivalent quantity of the drug given as two 60 mg conventional tablets, one given at 0 hour and the second 6 hours later. There was no significant difference (P less than 0.10) between the conventional tablets and the repeat action tablet formulation in area under the plasma concentration-time curve and the maximum plasma concentration of d-pseudoephedrine. Based on the data, we conclude that the repeat action tablet formulation and the conventional tablet are bioequivalent.
将重复作用片剂形式(外层含60毫克硫酸右美沙芬,核心含60毫克硫酸右美沙芬)的单剂量硫酸右美沙芬给予男性志愿者后的生物利用度,与给予等量药物(两片60毫克常规片剂,一片在0小时服用,另一片在6小时后服用)的生物利用度进行了比较。在硫酸右美沙芬的血浆浓度-时间曲线下面积和最大血浆浓度方面,常规片剂与重复作用片剂制剂之间无显著差异(P小于0.10)。基于这些数据,我们得出结论,重复作用片剂制剂与常规片剂具有生物等效性。