论文部分内容阅读
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。
Objective To investigate the pharmacokinetics of glipizide double-permeable pump in Beagle dogs and evaluate its bioequivalence and in vitro and in vivo correlation. Methods UPLC / MS / MS method was established for the determination of glipizide Beagle dog plasma samples. The glipizide controlled release tablets Beagle dog pharmacokinetic study. Results The determination of glipizide UPLC / MS / MS method was established. The method was sensitive and fast. The relative bioavailability of glipizide in homemade glipizide controlled-release tablets was (85.37 ± 26.69)%. Conclusion The test preparation and reference preparation are not equivalent, but the correlation is good in vitro and in vivo.