格列吡嗪双层渗透泵片在比格犬体内的药动学

目的考察格列吡嗪双层渗透泵片在比格犬体内的药动学过程,评价其生物等效性及体内体外相关性。方法建立格列吡嗪比格犬血浆样品的UPLC/MS/MS测定方法,以市售格列吡嗪控释片(瑞易宁)为参比制剂,对自制格列吡嗪控释片进行了比格犬体内药动学研究。结果建立了测定格列吡嗪UPLC/MS/MS方法,方法灵敏度高,分析速度快。自制格列吡嗪控释片中格列吡嗪的相对生物利用度为(85.37±26.69)%。结论受试制剂和参比制剂生物不等效,但体内外相关性较好。

The pharmacokinetics of glipizide bilayer osmotic pump tablets in Beagle dogs

Objective To investigate the pharmacokinetics of glipizide bilayer osmotic pump tablets and evaluate its bioequivalence and correlation betw een in vitro and in vivo. Methods A UPLC / MS / MS method of glipizide beagle dog plasma samples w as established. A commercially available glipizide controlled release tablet( Rui Yi Ning) w as selected as the reference preparations and the home-made glipizide controlled release tablet w as used to study in vivo pharmacokinetic on beagle dogs. Results The results show ed that w e established a UPLC / MS / MS method for the determination of glipizide,w hich has a high sensitivity and fast analytical speed. The relative bioavailability of home-made tablet w as( 85. 37 ± 26. 69) % compared to the reference preparations. Conclusions Although the tested preparation's bioavailability is not equal to the reference preparation,they demonstrate good in vitro-in vivo correlation.