苯丙醇胺控释混悬剂在健康志愿者的生物利用度

BIOAVAILABILITY OF A CONTROLLED-RELEASE SUSPENSION OF PHENYLPROPANOLAMINE IN HEALTHY VOLUNTEERS

摘要: 研究建立了HPLC测定苯丙醇胺(PPA)体内血药浓度的方法,比较了10名正常受试者单剂量口服苯丙醇胺控释混悬剂(含PPA 150mg)与等剂量的普通PPA片的生物利用度,结果两者AU_0～∞无显著性差异P>0.4,相对生物利用度F=102.6%。

Abstract: A high- performance liquid chromatographic analysis ofphenylpropanolamine (PPA) in human plasma is presented. Using direct UV detectionthe method is sufficiently sensitive to 25 ng/ml for PPA. Single-dose pharmacokineticsof PPA in 10 healthy volunteers taking controlled release suspension (C) or tablet (T),each containing 150 mg PPA was compared. The study described here has shown thatthe (C) AUC_0～∞/(T) AUC_0～∞ = 1.02(P>0.4). The controlled-release product ofPPA is equivalent to PPA tablet.