格列齐特片剂的生物利用度研究

为比较研制的格列齐特片剂相对进口格列齐特片剂的生物利用度,建立了格列齐特的体内HPLC分析方法：格列吡嗪为内标,甲醇：0.25冰醋酸（3:2,v/v)为流动相,检测波长为229nm,血浆处理采用乙醚一步萃取法,准确可靠。统计分析结果表明两种制剂的生物利用度无显著性差异（P＞0.05),相对生物利用度为106.74%,药代动力学参数k、Cmax、Tmax、T1／2、MRT等均无显著性差异（P＞0.05),证明两种制剂生物等效。

Pharmacokinetic and Relative Bioavailability of Gliclazide Tablets By High Performance Liquid Chromatography

A high performance liquid chromatography was established for thedetermination of gliclazide in healthy human serum. Using gliclazide as internal standard,methyl alcohol containing 0.2% acetic acid (32,v/v) as the mobile phase ,229 nm asdetective wavelength and applying Hypersil ODS-2 column at 30, this method is accurate, convenient and credible, especially forone-step extraction by diethyl ether. In comparison of two types of gliclazide tablets,one is domestic, the other is imported (Diamicron(r)). Statistical results showed that thetwo preparations are bioequivalent (P>0.05) through ANOVA and two one-sided testprocedures.The relative bioavailability is 106.74% and the pharmacokinetic parameters,including k, T1/2, Cmax, Tmax and MRT, have no prominent difference (P>0.05).