Das S K, Chattaraj S C
Department of Pharmaceutical Technology, Jadavpur University, Calcutta, India.
Arzneimittelforschung. 1990 Jul;40(7):752-4.
A comparative pharmacokinetic study of a new controlled release multiple unit propranolol formulation and a conventional propranolol tablet was carried out in twelve healthy human volunteers in a randomized balanced crossover design. Under a single dosage regimen, subjects were administered either a single capsule containing controlled release propranolol equivalent to 160 mg of the drug or 80 mg of conventional propranolol tablet, twelve hourly. Peak plasma propranolol concentrations were low which occurred later after controlled release administration than after the administration of the conventional tablet. Analysis of the area under the plasma concentration-time curve (AUC) for the two formulations indicate no significant difference of bioavailability despite a prolonged absorption time and maintenance of effective plasma concentration for the controlled release preparation.
在一项随机平衡交叉设计中，对12名健康人类志愿者进行了新型控释多单元普萘洛尔制剂与传统普萘洛尔片剂的比较药代动力学研究。在单一剂量方案下，受试者每12小时服用一粒含相当于160mg药物的控释普萘洛尔胶囊或80mg传统普萘洛尔片剂。控释给药后血浆普萘洛尔峰值浓度较低，且出现时间晚于传统片剂给药后。两种制剂的血浆浓度-时间曲线下面积（AUC）分析表明，尽管控释制剂的吸收时间延长且有效血浆浓度得以维持，但生物利用度无显著差异。
