【摘要】 目的:建立人血清中苯酰甲硝唑体内代谢产物--甲硝唑的反相高效液相色谱分析方法,比较苯酰甲硝唑分散片和苯酰甲硝唑胶囊生物等效性。方法:采用Eurosphex-100 C18柱,以乙腈-KH2PO4(0．01 mol·L-1)(22:78,v／v)为流动相,替硝唑作内标,紫外检测波长为318 nm,测定血清中甲硝唑的血药浓度。结果:血清中甲硝唑的浓度在0．1-20．0μg·ml-1范围内线性关系良好,r=0．999 9(n=8)。受试制剂及参比制剂的Cmax分别为(10．475±2．135)和(10．118±2．116),Tmax分别为(4．000±1．414)和(4．667±1．138)h,t1／2分别为(11．247±2．264)和(10．800±2．000)h,根据AUC0→t计算受试制剂的相对生物利用度为(100．9±20．2)％。结论:本方法操作简便、灵敏度高、重现性好,可用于血清中甲硝唑浓度的测定。苯酰甲硝唑分散片和苯酰甲硝唑胶囊具有生物等效性。更多还原

【Abstract】 Objective: To develop a RP-HPLC method for the blood concentration of metronidazole which was the metabolite of benzometronidazole and compare the bioequivalence between dispersible tablets and capsules of benzoylmetronidazole. Method: Euros-phex-100 C18 column was used,the mobile phase was constituted by acetonitrile -0.01 mol·L-1 potassium dihydrogen phosphate buffer (22:78,v/v). The detection wavelength was 318 run. Result; The standard curve was linear within a concentration range of 0. 1 -20.0μg·mT-1 with r = 0.999 9(n=8).The main pharmacokinetic parameters Cmax, Tmax t1/2 were (10.475±2.135)μg·ml-1, (4.000±1.414)h and(11.247±2.264)h for the reference tablets,also (10.118±2.116)μg·ml-1, (4.667±1.138) h and ( 10. 800±2.000) h for the test tablets respectively, the relative bioavalability of the test tablets was ( 100. 9±20. 2 ) %. Conclusion: This method is simple, sensitive, accurate and fine reproducible for determination of serum concentration in metronidazole. The results of statistical analysis demonstrated that the two preparations of benzoylmetronidazole are bioequivalent.更多还原