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目的:以硝苯地平为模型药物,利用脉冲控释的原理,对Beagle犬体内药动学进行探讨。方法:以Beagle犬为试验对象进行药动学研究。建立一种具有较高灵敏度和精密度的高效液相-紫外检测法测定血浆中硝苯地平的浓度。试验组给予脉冲控释片组,对照组给予普通片。采用交叉试验设计,测定Beagle犬在空腹状态下服用脉冲控释片和普通片的体内药-时曲线。采用3P97药动学软件对血药浓度-时间数据进行分析,并求出系列药动学参数。结果:药动学研究表明,定时脉冲片的tlag、tmax和MRT与普通片相比差异有极显著性。结论:硝苯地平定时脉冲片可在体内,延迟释药,其释药行为与普通片差异有显著性。
OBJECTIVE: To study the pharmacokinetics of Beagle dogs with nifedipine as a model drug by using the principle of pulse controlled release. Methods: Beagle dogs were used as experimental subjects for pharmacokinetic study. To establish a HPLC method with high sensitivity and precision for the determination of nifedipine in plasma. The experimental group given pulse controlled release tablets group, the control group given ordinary tablets. A crossover design was used to determine the in vivo drug-time curve of Beagle dogs taking pulse-controlled and normal tablets in the fasting state. 3P97 pharmacokinetic software was used to analyze plasma concentration-time data and to obtain a series of pharmacokinetic parameters. Results: Pharmacokinetic studies showed that there was a significant difference in tlag, tmax and MRT between time-pulsed films and ordinary films. Conclusion: Nifedipine time-lapse tablets can delay the release of drugs in vivo, and the release behavior of nifedipine is obviously different from that of ordinary tablets.