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目的:探讨噁丙嗪胶囊剂人体药代动力学特征和相对生物利用度。方法:采用随机交叉法单次给予8名受试者噁丙嗪胶囊剂或片剂600mg后,于不同时间取血浆样本,高效液相色谱法测定受试者血浆中药物浓度,运用TopFit药动学软件的非房室模型拟合药时曲线,计算药代动力学参数及相对生物利用度。结果:统计学分析显示,两制剂的t_(1/2)、MRT、Cl和AUC_(0～∞)均无显著性差异(P>0.05)。药一时曲线呈双峰现象,可能与药物的肠肝循环有关。两制剂的达峰浓度Cp_1及Cp_2均差异显著(P<0.05)。结论:胶囊剂相对于片剂的生物利用度为121.06％,胶囊剂的吸收程度优于片剂,有利于临床治疗应用。
Objective: To investigate the pharmacokinetics and relative bioavailability of oxaprozin capsules. Methods: A randomized crossover method was used to treat eight subjects with oxaprozin capsules or tablets 600mg, plasma samples were taken at different times, and plasma concentrations of the drugs in the subjects were measured by high performance liquid chromatography (HPLC) Non-compartmental models of software were fitted to the drug-time curve to calculate pharmacokinetic parameters and relative bioavailability. Results: Statistical analysis showed that t_ (1/2), MRT, Cl and AUC_ (0 ~ ∞) of the two preparations showed no significant difference (P> 0.05). Herbal profile showed a bimodal curve, which may be related to the enterohepatic circulation of the drug. The peak concentrations of Cp_1 and Cp_2 of the two preparations were significantly different (P <0.05). Conclusion: The bioavailability of capsules relative to tablets is 121.06%. Capsules absorb better than tablets, which is beneficial to clinical treatment.