摘要
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：０．２％冰醋酸（３：２，ｖ／ｖ）为流动相，检测波长为２２９ ｎｍ，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、Ｃ_ｍａｘ、Ｔ_ｍａｘ、Ｔ_１／２、ＭＲＴ等均无显著性差异（Ｐ＞０．０５），证明两种制剂生物等效。
A high performance liquid chromatography was established for the determination of gliclazide in healthy human serum. Using gliclazide as internal standard, methyl alcohol containing 0.2% acetic acid (3:1,v/v) as the mobile phase,229 um as detective wavelength and applying Hypersil ODS-2 column at 30C, this method is accurate, convenient and credible, especially for one-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 the two preparations are bioequivalent (P>0.05) through ANOVA and two one-sided test procedures.The relative bioavailability is 106.74% and the pharmacokinetic parameters, including k, T_1/2, C_max, T_max and MRT, have no prominent difference (P>0.05).
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第1期52-54,共3页
The Chinese Journal of Clinical Pharmacology
