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
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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。Abstract: Objective To develop a method to study the pharmacokinetics of tinidazole pectin matrics colon-specific sustained-release tablets in dogs. Methods The plasma concentrations were determined by HPLC.Two-period cross over self-control trail was conducted 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.
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Key words:
- tinidazole /
- pectin /
- matrics tablets /
- colon-specific sustained-release tablets
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