头孢克洛缓释片的研制及人体药物动力学研究  

Preparation and Pharmacokinetics of Cefaclor Sustained-release Tablets

作　　者：尹莉芳[1] 屠锡德[1] 徐伟[2] 

机构地区：[1]中国药科大学药剂教研室,江苏南京210009 [2]福建中医学院药学系,福建福州350003

出　　处：《中国医药工业杂志》2005年第8期478-480,共3页Chinese Journal of Pharmaceuticals

摘　　要：以HPMC为阻滞剂制备头孢克洛缓释片,并测定体外释放度和人体内血药浓度。结果表明,单剂量口服375mg头孢克洛自制缓释片和参比制剂(商品名CeclorCD)后的tmax、Cmax、AUC0-τ和MRT分别为(1.42±0.20)和(1.25±0.27)h、(3.58±0.30)和(3.42±0.28)μg/ml、(12.31±1.8)和(11.65±1.26)μg·h·ml-1、(2.77±0.27)和(2.66±0.23)h。统计结果显示,AUC0-τ无显著性差异(P>0.05),表明两制剂生物等效。HPMC was used as blocking agent for the preparation of cefaclor sustained-release tablets. The in vitro release of the product and the drug concentration in plasma were determined. After a single oral dosage of 375mg cefaclor sustained-release tablets and Ceclor CD, tmax （h）, Cmax （μg·ml^-1）, AUC0-τ （μg·h·ml^-1） and MRT（h） were （1.42 ± 0.20） and （1.25 ± 0.27）, （3.58± 0.30） and （3.42± 0.28）, （12.31 ± 1.8） and （11.65 ± 1.26）, （2.77 ± 0.27） and （2.66± 0.23）, respectively.The results showed that AUC0-τ had no significant difference （P 〉 0.05） and this two preparations were bioequivalent.

关 键 词：头孢克洛 缓释片 药物动力学 生物等效性 

分 类 号：R944.9[医药卫生—药剂学] R978.11[医药卫生—药学]