摘要
目的建立高效液相色谱-串联质谱(HPLC-MS/MS)测定血浆中格列吡嗪的方法,研究格列吡嗪控释片在Beagle犬体内药动学和相对生物利用度。方法 8只Beagle犬双周期随机交叉单剂量口服10 mg受试格列吡嗪控释片和市售格列吡嗪控释片,HPLC-MS/MS测定血药浓度,计算两者的药动学参数及相对生物利用度,并进行生物等效性评价。结果单次口服10 mg格列吡嗪控释片受试制剂和参比制剂的主要药动学参数AUC0-32h分别为2940.3±947.1,3195.5±1294.3μg/L·h;Cmax分别为298.85±153.24,282.51±122.37μg/L;Tmax分别为6.8±1.8,8.0±4.0 h;平均滞留时间(MRT0-32h)分别为12.5±2.9,11.9±2.5 h;终末半衰期(t1/2z)分别为12.4±7.0,7.2±5.7 h。结论两种制剂具有生物等效性。
Objective To establish an HPLC-MS/MS method for determination of glipizide in plasma and study thein vivo pharmacokinetics and the relative bioavailability of Glipizide Controlled Release Tablets in Beagle dogs.Methods A double periodic, random crossover study was conducted in eight Beagle dogs： the test tablets or referencetablets were administered orally to dogs at the single dose of 10 mg. The glipizide concentration in plasma wasdetected by HPLC-MS/MS. The pharmacokinetic parameters and bioequivalence of the two formulations were alsostudied. Results The main pharmacokinetic parameters of the test tablets or reference tablets were as follows： A UC0.32h were2940.3 ±947.1 and 3195.5± 1294.3 μg/L.h; Cmax were 298.85±153.24 and 282.51 ± 122.37μg/L; Tmxwere 6.8± 1.8and 8.0±4.0 h; MRT0.32h were 12.5±2.9 and 11.9±2.5 h： tl/zzwere 12.4±7.0 and 7.2±5.7 h. Conclusion Theresults of statistical analysis showed that two formulations were bioequivalent.
出处
《食品与药品》
CAS
2015年第5期305-308,共4页
Food and Drug
