来克胰片剂的药物动力学和生物等效性研究  

THE PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF GLICLAZIDE TABLETS

作　　者：王曼丽[1] 郭红英[1] 洪蕾[1] 王汝龙[1] 

机构地区：[1]北京友谊医院,100050

出　　处：《首都医药》1999年第10期24-25,共2页Capital Medicine

摘　　要：目的:以天津市新新制药厂生产的格列齐特片剂(天新(格列齐特片,80mg/片)为对照品,考察台湾卫达化学制药股份有限公司生产的格列齐特片剂(来克胰片,80mg/片)的相对生物利用度和药物动力学参数。方法:采用自身对照法进行单剂量口服给药,血样经预处理后采用高效液相色谱法测定浓度。结果:用CRFB程序处理,来克胰片T1/2=13.92±4.12h,Tmax=4.33±1.87h,MRT=21.41±6.00h,Cmax=9.34×10^(-3)±1.63×10^(-3)mg/ml,AUC=0.1998±0.0832h·mg/ml,相对生物利用度F=119.41±23.92％。结论:来克胰片剂的相对生物利用度符合《新药(西药)临床研究指导原则汇编》的要求。Gliclazide tablet (XINXIN PHARMACEUTICAL FACTORY (TIANJIN )) were adopted as reference standard in study the relative bioavalability and pharmacokinetics of Gliclazide tablet (WEIDA PHARMACEUTICAL IND. (TAIWAN). CO. , LTD. ). METHODS: A crossover self-control study of single dose was conducted on 9 healthy volunteers. Blood drug concentrations were determined by HPLC. RESULTS: The pharmacikinetic parameters of Gliclazide tablet (WEIDA PHARMACEUTICAL IND. (TANWAN).CO. ,LTD. ) were T1/2=13. 92±4. 12h, Tmax = 4. 33±1. 87h,MRT = 21. 41 ± 6. 00h,Cmax = 9. 34 × 10-3 ± 1. 63 × 10-3mg/ml, AUC = 0. 1998 ± 0. 0832h · mg/ml,and a relative bioavalability of 119. 41±23. 92% was obtained. CONCLUSION : The bioavalia-bility data of Gliclazide tablet (WEIDA PHARMACEUTICAL IND, (TAIWAN). CO. .LTD. ) obtained in the study are in compliance with the standard required by Chinese health authority.

关 键 词：来克胰片剂 药物动力学 相对生物利用度 

分 类 号：R977.1[医药卫生—药品] R969.1[医药卫生—药学]