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格列美脲口腔崩解片人体药动学及相对生物利用度
Pharmacokinetics and Relative Bioavailability of Glimepiride Tablets
【摘要】 目的:研究健康受试者口服格列美脲口腔崩解片的人体药动学及相对生物利用度。方法:18名健康志愿者随机交叉单剂量口服格列美脲受试片与对照片4mg,采用柱前衍生化 HPLC-紫外法测定其血药浓度。结果:受试片与对照片的主要药动学参数 tmax 分别为(3.00±0.73)和(3.25±0.85)h,Cmax分别为(313.1±99.3)和(303.2±104.5)μg·L-1,t1/2Ke分别为(7.337±2.190)和(8.239±2.631)h,AUC0-t分别为(1767.2±598.3)和(1714.1±528.3)μg·h·L-1,AUC0-∞分别为(1956.3±598.1)和(1945.4±682.0)μg·h·L-1。受试片的相对生物利用度为100.1%±18.2%。结论:两种片剂具有生物等效性。
【Abstract】 Objective:To study the pharmacokinetics and relative bioavailability of glimepiride tablet.Method:A single oral dose of 4mg of tested and reference glimepiride tablets were given to 18 healthy volunteers in a randomized crossover design.Plasma concen- trations were determined by pre-column derivatization HPLC method.Result:The main pharmacokinetic parameters were:tmax(3.00± 0.73)and(3.25±0.85)h,Cmax(313.1±99.3)and(303.2±104.5)μg.L-1,t1/2Ke(7.337±2.190)and(8.239±2.631)h, AUC0~t(1767.2±598.3)and(1714.1±528.3)μg.h·L-1,AUC0~∞(1956.3±598.1)and(1945.4±682.0)μg·h·L-1 for test- ed and reference tablets,respectively.The relative bioavailability of tesed tablets was 100.1%±18.2%.Conclusion:Two tablets of glimepiride were bioequivalent.
- 【文献出处】 中国药师 ,China Pharmacist , 编辑部邮箱 ,2006年12期
- 【分类号】R96
- 【被引频次】3
- 【下载频次】139