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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。
Objective: To take gliclazide tablets (Tianxin (Gliclazide Tablets, 80mg / tablet) produced by Tianjin Xinxin Pharmaceutical Factory as reference substance, to investigate the effect of Gliclazide produced by Taiwan Weida Chemical Co., The relative bioavailability and pharmacokinetic parameters of tablets (Lai grams of tablets, 80mg / tablet) .Methods: A single oral dose of self-control method was used. The blood samples were pretreated and determined by high performance liquid chromatography. Results: The results of CRFB program showed that Tc = 91.92 ± 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, relative bioavailability F = 119.41 ± 23.92% .Conclusion: The relative bioavailability of Lek pancreatic tablets is in line with the guidance of clinical study of new drugs Principles Compilation "requirement.