摘要:
目的： 采用高效液相色谱法测定Beagle犬体内盐酸伪麻黄碱血药浓度,并对其药动学参数、相对生物利用度及体内外的相关性作初步研究。 方法： Beagle犬6只,单次口服西替伪麻缓释片2片．用HPLC法,采用DiamonsilTMC18色谱柱（5μm,250×4．6mm）,0．05mol/L的磷酸二氢钠溶液-甲醇（75：25）,以磷酸调节pH3．0为流动相,盐酸苯丙醇胺为内标,检测波长213nm,测定血浆中的药物浓度。 结果： 盐酸伪麻黄碱的相对生物利用度为（95．9±2．3）%,单次口服西替伪麻缓释片药动学参数分别为MRT=8．21h,Tpeak=4h,Cmax=2008．7ng/mL。 结论： 经统计数据分析自制片与对照片药动学过程相似,生物利用度等效,并且自制片体内外累积释放有着良好的相关性。
Abstract:
Objective: To study the pharmacokinetics of cetirizine/pseudoephedrine sustained release tablets in Beagle dogs. Methods: Pseudoephedrine concentrations in serum were assayed by HPLC with DiamonsilTM C18（250×4.6 mm,5μm） column, 0.05mol/L sodium dihydrogen phosphate-mathanol（75:25）,pH adjusted to 3.0 with phosphoric acid as mobile phase,and detec- tion wavelength of 213nm.The pharmacokinetic parameters were researched after single admininstration of cetirizine/pseudoephedrine sustained release tablets in 6 Beagle dogs. Results: The pharmacokinetic parameters cetirizine/pseudoephedrine sustained release tablets were followed:MRT=8.21 h,Tpeak=4h,Cmax=200 8.7ng/mL.The relative hioavailabihy of cetirizine/pseudoephedrine sustained release tablets was（95.9±2.3）%. Conclusion: The pharmacokinetic profile of cetirizine/pseudoephedrine sustained release tablets was similar to the reference tablets.The self-made one was bioequivalent to Zycted-D 12h tablets,and its released profile in vivo/in vitro was correlation.
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