盐酸曲美他嗪缓释片在Beagle犬体内药代动力学研究  

Pharmacokinetic Study of Trimetazidine Dihydrochloride Modified Release Tablets in Beagle Dogs

作　　者：吕艳歌 梁建华 吴金平 宋佳 黄姗芬 李云亮[3] LÜYan-ge;LIANG Jian-hua;WU Jin-ping;SONG Jia;HUANG Shan-fen;LI Yun-liang(Zhengzhou Taifeng Pharmaceutical Co.,Ltd.,Zhengzhou 451162,China;Chuzhou University,Chuzhou 239000,China;Jiangsu University,Zhenjiang 212013,China)

机构地区：[1]郑州泰丰制药有限公司,河南郑州451162 [2]滁州学院,安徽滁州239000 [3]江苏大学,江苏镇江212013

出　　处：《药物生物技术》2023年第2期152-156,共5页Pharmaceutical Biotechnology

基　　金：江苏大学校企合作项目(No.20211045)。

摘　　要：文章建立了一种测定盐酸曲美他嗪血药浓度的HPLC定量分析方法,并研究盐酸曲美他嗪缓释片Beagle犬体内药代动力学特征。以盐酸利多卡因为内标,血浆样品前处理以乙酸乙酯萃取,采用高效液相色谱法(HPLC),流动相为磷酸二氢钾水溶液(pH 3.0)∶甲醇=85∶15(V/V),体积流量为1.0 mL/min;进样量为10μL;检测器为紫外检测器(波长230 mm)。结果显示:犬血浆中曲美他嗪的线性范围为100.9~4036.0μg/L,相关系数(r)为0.9998;日内和日间精密度(RSD)介于2.58%~9.27%之间。盐酸曲美他嗪经Beagle犬口服后,受试制剂与参比制剂相比,半衰期、达峰时间、达峰浓度均无显著性差异。结论:该方法专属性好,灵敏度高,准确度好、提取回收率高和稳定性好,可用于盐酸曲美他嗪缓释片药代动力学研究和生物等效性评价。This paper aim to establish a sensitive and rapid HPLC quantitative analysis method to simultaneously determine Trimetazidine Dihydrochloride Modified Release Tablets in Beagle dog plasma,and to study the pharmacokinetic characteristics of oral administration of Trimetazidine Dihydrochloride Modified Release Tablets in vivo.The analytes and the internal standard,lidocarine hydrochloride,were extracted from plasma samples by ethyl acetate.Testing condition were HPLC mode,flow rate of 1 mL/min,injection volume of 10 L,UV 230 nm detector,phosphate buffer(pH 3.0)-methanol(85∶15)(V/V)mobile phase.The linear range of dihydrochloride in dog plasma was 100.9~4036.0μg/L,the correlation coefficient was 0.9998,and the intra-batch and inter-batch precisions(RSDs)were between 2.58%and 9.27%.After trimetazidine hydrochloride was orally administered to Beagle dogs,there was no significant difference in half-life,peak time,and peak concentration between the test preparation and the reference preparation.This method has good specificity,high sensitivity,good accuracy,high extraction recovery,and good stability.It can be used for the pharmacokinetic and bioequivalence evaluation of Trimetazidine Dihydrochloride Modified Release Tablets.

关 键 词：盐酸曲美他嗪 缓释片 高效液相色谱法 药代动力学 

分 类 号：R917[医药卫生—药物分析学]