血塞通包衣脉冲片在家犬体内的药物动力学的研究

In vivo pharmacokinetics of Xuesaitong pulsatile-release tablets in dogs

目的研究自制血塞通包衣脉冲片在家犬体内的药动学及相对生物利用度。方法将6只家犬随机分成2组,分别灌服自制血塞通脉冲片和市售普通片50 mg,1周后2组交叉试验,给药后不同时间点取样,采用高效液相色谱法测定血药浓度,考察自制血塞通脉冲片在家犬体内的脉冲控释效果。结果血塞通包衣脉冲片(体外释药时滞为6 h)在家犬体内的时滞为4.82 h,市售普通片剂的时滞为0.3 h,而Cmax、AUC等两者无明显差异。结论本脉冲片达到设计要求,体内试验满足脉冲释药时滞效果。

Objective To study the in vivo pharmacokinetics and bioavailability of Xuesaitong pulsatile-release tablets. Methods Six dogs were randomly given Xuesaitong pulsatile tablets and conventional tablets 50 mg, and plasma concentrations of Xuesaitong in the dogs were quantified by HPLC. The in vivo pharmaceutical behavior of the tablets was evaluated with lag time, Cmax, and AUC. Results Xuesaitong tablets（lag 6 h in vitro） were released at 4.4 h while the lag time of conventional tablets was 0.2 h in the dogs. No statistical difference was found for Cmax, AUC and so on. Conclusion Pulsatile-release tablets meet the requirements of design.