格列吡嗪片药代动力学及生物利用度研究  

Pharmacokinetics and relative bioavailability of glipizide

作　　者：刘洋波[1] 钟明康[2] 施孝金[2] 张静华[2] 康越 

机构地区：[1]福建省泉州市第一医院药剂科,泉州362000 [2]复旦大学附属华山医院临床药学研究室,上海200040 [3]普强苏州制药有限公司,苏州215000

出　　处：《药学服务与研究》2003年第1期41-43,共3页Pharmaceutical Care and Research

摘　　要：目的 :研究格列吡嗪 (glipizide,Gli)片的药代动力学和相对生物利用度。 方法 :2 0名受试者单剂量口服 Gli片10 mg后 ,在规定时间取血 ,HPL C法测定血药浓度。采用统计矩方法计算药动学参数。结果 :单剂量口服 Gli试验药和参比药后的平均药动学参数分别为 :AU C0～∞ :(5 76 3± 16 13)、(5 5 5 4± 136 5 ) h· ng/ ml;Tmax:(3.0 0± 1.18)、(3.6 0± 1.72 ) h;cmax:(939.5± 2 33.3)、(819.8± 2 13.8) ng/ ml;MRT:(8.0 9± 1.6 6 )、(8.74± 2 .2 8) h;t1 /2 :(4.82 7± 1.2 2 6 )、(5 .12 3± 1.4 2 1)h;相对生物利用度 F0～ 2 4 =(10 4 .8± 15 .4 ) %。 结论 :两种制剂生物等效 ,其药动学参数无显著差异 ,并且与文献报道一致。Objective: To study the pharmacokinetics and relative bioavailability of glipizide tablet. Methods: The glipizide concentrations in sera of 20 subjects were determined by HPLC following an oral single dose of 10 mg. The statistical moment theory was used to calculate the pharmacokinetic parameters. Results: The average pharmacokinetic parameters after oral single dose of the test drug and the reference drug were as follows: AUC 0～∞ :(5 763±1 613) and (5 554±1 365) h·ng/ml; T max :(3.00±1.18) and (3.60±1.72) h; c max :(939.5±233.3) and (819.8±213.8) ng/ml; MRT:(8.09±1.66) and (8.74±2.28) h; t 1/2 :(4.827±1.226) and (5.123±1.421) h respectively;relative bioavailability F 0～24 was (104.8±15.4)%. Conclusion:The two preparations are bioequivalent. There is no significant difference in pharmacokinetic parameters between two preparations. The results are same as those reported in references.

关 键 词：格列吡嗪片 药代动力学 生物利用度 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]