替硝唑果胶骨架型结肠定位缓释片在犬体内药动学研究  

The pharmacokinetics study of tinidazole pectin matrics colon-specific sustained-release tablets in dogs

作　　者：刘福强[1] 王艳萍[1] 赵楠[1] 王相阳[2] 崔海珍[3] 

机构地区：[1]解放军第208医院,吉林长春130062 [2]天士力集团公司药物研究院,天津300142 [3]延边大学药学院,吉林延吉133000

出　　处：《药学实践杂志》2010年第5期363-365,368,共4页Journal of Pharmaceutical Practice

摘　　要：目的研究替硝唑果胶骨架型结肠定位缓释片在犬体内药动学。方法采用双周期交叉试验设计,6只健康Beagle犬分别服用受试制剂或参比制剂,用HPLC法测定Beagle犬血浆中药物浓度。结果受试、参比制剂在犬体内的血药浓度变化符合二室模型,其主要药动学参数:Tmax分别为(7.0±0.92)和(2.0±0.31)h;Cmax分别为(66.97±5.9)和(112.2±7.4)μg/L;AUC0-t分别为(1 243.88±25.67)和(1 523.84±27.89)mg.h/L;AUC0-∞分别为(1 277.18±30.58)和(1 548.67±20.89)mg.h/L,受试制剂的相对生物利用度为82.47%。结论本法准确、灵敏,适用于替硝唑果胶骨架型结肠定位缓释片的药动学研究。Objective To develop a method to study the pharmacokinetics of tinidazole pectin matrics colon-specific sustainedrelease tablets in dogs. Methods The plasma concentrations were determined by HPLC. Two-period cross over self-control trail was con- ducted to 6 Beagle dogs which were administrated a single dose of the oral test tablets and reference tablets. Results The pharmacokinetics of two preparations fitted to two-compartment model. The main pharmacokinetic parameters ： Tmax were （ 7.0 ±0. 92 ） and （ 2.0 ±0. 31） h;Cmax were （66.97±5.9）and（112.2 ±7.4） μg./L;AUC0-t were （1 243.88 ±25.67）and（1 523.84 ±27.89） mg · h/L;AUC0-∞were （1 277.18 ± 30.58）and（ 1 548.67 ± 20.89） mg · h/L and test tablets showed a relative bioavailability of 82.47%. Conclusion The method was accurate and sensitive which was suitable for Tinidazole pectin matrics pharmacokinetics study.

关 键 词：替硝唑 果胶 骨架片 结肠定位缓释片 

分 类 号：R945[医药卫生—微生物与生化药学]