| 摘要: |
| 目的：比较自制的盐酸尼卡地平缓释微丸（NIC-SP）与普通市售盐酸尼卡地平片剂、进口缓释尼卡地平胶囊(Perdipine LA)的药代动力学及生物利用度。方法：采用拉丁方试验设计，将志愿者6人随机分为3组，交叉口服NIC-SP、普通市售片剂和Perdipine LA，以普通片剂和Perdipine LA为对照制剂，计算NIC-SP的相对生物利用度。结果：NIC-SP相对于Perdipine LA的生物利用度为116.09％；两种制剂的AUC及体内平均驻留时间（MRT）有显著性差异(P<0.05)；达峰时间，峰浓度，消除速率常数和吸收速率常数均没有显著性差异(P>0.05)。NIC-SP和Perdipine LA相对于普通片剂的生物利用度分别为86.53％和74.54％。结论：NIC-SP体内缓释效果优于进口的Perdipine LA，达到设计要求。 |
| 关键词: 盐酸尼卡地平 迟效制剂 药代动力学 生物利用度 |
| DOI： |
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| 基金项目: |
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| Study on pharmacokinetics and bioavailability of nicardipine hydrochloride sustained-release pellets |
| 孙其荣,张国庆,钟延强,刘善奎 |
| () |
| Abstract: |
| Objective： To compare the pharmacokinetics and bioavailability of nicardipine hydrochloride sustained-release pellets (NIC-SP) with common market tablets and imported sustained-release capsules (Perdipine LA). Methods: Latin test was employed in the single oral administration of NIC-SP, common market tablets and Perdipine LA with 6 volunteers. The relative bioavailabilities of NIC-SP against market tablet and Perdipine LA were calculated. Results: The bioavailability of NIC-SP against Perdipine LA is 116.09%. The bioavailabilities of NIC-SP and Perdipine LA against market tablet is 86.53%and 74.54%, respectively. There were significant differences between AUC, MRT of NIC-SP and Perdipine LA (P<0.05), while tmax,cmax,ke and ka of them did not show significant difference(P>0.05). Conclusion: The sustained effect of NIC-SP is better than the Perdipine LA in vivo. |
| Key words: nicardipine hydrochloride sustained-release pellets pharmacokinetics bioavailability |
