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目的 :比较盐酸维拉帕米脉冲释放片与其片芯在人体的药代动力学特征及生物利用度。 方法 :采用拉丁方设计 ,将志愿者 8人随机分为 3组 ,交叉口服 , 型脉冲片和片芯 ,以片芯为对照制剂 ,考察体内脉冲控释效果。结果 : 型脉冲片在体内的时滞为 4h,而 cmax,AU C等与片芯无明显差异 ,达到设计要求。 结论 :该研究制备的脉冲释放制剂为防治心血管疾病的凌晨发作提供了一个良好的剂型选择。
OBJECTIVE: To compare the pharmacokinetics and bioavailability of verapamil hydrochloride pulsatile release tablets and their cores in the human body. Methods: Using Latin square design, 8 volunteers were randomly divided into 3 groups, crossover oral administration, type pulse tablet and tablet core, tablet core as the control preparation, to examine the effect of pulse controlled release in vivo. Results: The time delay of pulse pulse in the body was 4h, while the values of cmax, AU C and so on were not significantly different from those of the core, which met the design requirements. Conclusion: The pulsatile release preparation prepared in this study provides a good dosage form for the prevention of early morning attacks of cardiovascular diseases.