格列齐特胶囊人体生物等效性研究  

Bioequivalence of Two Kinds of Gliclazide Capsules in Human

作　　者：傅颖君[1] 钟丽萍[2] 

机构地区：[1]江西医学院临床药理研究所,东西南昌330006 [2]江西医学院图书馆文献检索教研室,江西南昌330006

出　　处：《江西医学院学报》2001年第3期13-15,共3页Acta Academiae Medicinae Jiangxi

摘　　要：目的 :采用高效液相色谱法测定格列齐特的血药浓度 ,进行两种格列齐特胶囊人体生物等效性比较研究。方法 :12位健康男性受试者采用自身交叉给药方案 ,分别单剂量口服 80mg试验品或对照品。结果 :试验品的主要药代动力学参数分别为AUC0～ 36=(10 0 .19± 10 .34) μg/ (ml·h) ,Cmax=(6 .5 9± 0 .5 9) μg/ml,Tpeak=(4 .33± 1.0 7)h ;对照品的参数分别为AUC0～ 36=(10 3 .41± 9.2 5 ) μg/ (ml·h) ,Cmax=(6 .75± 0 .6 0 ) μg/ml,Tpeak=(4 .5 8± 1.0 8)h ,两制剂的AUC0～ 36、Cmax及Tpeak均无显著性差异。试验品相对于对照品的生物利用度为 (96 .99± 6 .6 2 ) %。结论 :两制剂体内过程相仿 。Objective: To compare the bioequivalence of two Gliclazide capsules in human. Methods: 12 healthy men were treated with a single oral dose (80 mg) of Gliclazide capsules (test or control) in a randomized crossover study. The concentration of Gliclazide in serum was determined using HPLC. Results: AUC0-36, Cmax and Tpeak of the test capsules were (100.19±10.34)μg/ml·h, (6.59±0.59)μg/ml, (4.33±1.07) h, respectively, while the control capsules were (103.41±9.25)μg/ml·h, (6.75±0.60)μg/ml, and (4.58±1.08) h, respectively. Each of those parameters was not significantly different between the two capsules. The relative bioavailability of test capsules was 96.99±6.62% to control capsules. Conclusions: Of the two capsules, the pharmacokinetic profiles are similar, and have bioequivalence.

关 键 词：格列齐特 高效液相色谱法 生物等效性 降血糖药 药物代谢动力学 

分 类 号：R977.15[医药卫生—药品]