文章摘要
吴静,王天云,张艳军.雷贝拉唑钠肠溶胶囊Beagle犬体内药动学及生物等效性研究[J].药学与临床研究,2018,26(4):249~252
雷贝拉唑钠肠溶胶囊Beagle犬体内药动学及生物等效性研究
Pharmacokinetics and Bioavailability of Rabeprazole Sodium Enteric-Coated Capsules in Beagle Dogs
投稿时间:2018-04-18  修订日期:2018-08-07
DOI:
中文关键词: HPLC-MS/MS  雷贝拉唑钠  药物动力学  生物等效性
英文关键词: HPLC-MS/MS  Rabeprazole  Pharmacokinetics  Bioequivalence
基金项目:江苏省高职院校青年教师企业实践培训资助项目(2017QYSJPX104)
作者单位E-mail
吴静 江苏护理职业学院 药分教研室 619371151@qq.com 
王天云 徐州医科大学  
张艳军 江苏护理职业学院 药分教研室  
摘要点击次数: 5036
全文下载次数: 1466
中文摘要:
      目的:建立HPLC-MS测定方法分析Beagle犬血浆中雷贝拉唑的含量,并作不同厂家两种雷贝拉唑钠肠溶胶囊的药动学及生物等效性研究。方法:6只Beagle犬随机分为两组,采用单剂量双周期交叉试验,分别口服给予60 mg雷贝拉唑钠肠溶胶囊受试制剂或参比制剂,给药后不同时间点采血,测定血药浓度,利用DAS3.0软件计算药动学参数,并比较两个厂家生产的制剂的生物等效性。结果:Beagle犬单次给予雷贝拉唑钠肠溶胶囊受试制剂和参比制剂后的tmax分别为(3.57±0.91)h和(3.43±0.87)h,Cmax分别为(539.03±129.13)ng·mL-1和(554.90±135.75)ng·mL-1,t1/2分别为(2.20±0.90)h和(2.09±0.78)h,药时曲线下面积AUC(0→24 h)分别为(1341.40±442.03)ng·h·mL-1和(1319.41±402.29)ng·h·mL-1。结论:结果表明不同厂家的两种雷贝拉唑钠肠溶胶囊具有生物等效性。
英文摘要:
      Objective: To develop an HPLC-MS method for the determination of rabeprazole sodium in dog plasma and investigate the pharmacokinetics and bioequivalence of rabeprazole sodium enteric-coated capsules. Method: By a two-cycle crossover trial, 6 beagle dogs were randomly administrated a single crossover dose of test or reference capsules (60 mg). The blood concentrations of rabeprazole sodium at the preset time-points were determined by the established HPLC-MS/MS method. The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations were evaluated. Results: The main pharmacokinetic parameters of the test and reference capsules were as follows: tmax, (3.57±0.91)h and (3.43±0.87)h; Cmax, (539.03±129.13)ng·mL-1 and (554.91±135.75)ng·mL-1; t1/2, (2.20±0.90)h and (2.09±0.78)h; AUC(0→24), (1341.40±442.03)ng·h·mL-1 and (1319.41±402.29)ng·h·mL-1, respectively. Conclusion: The results indicated that the two kinds of rabeprazole sodium enteric-coated capsules were bioequivalent in beagle dogs.
查看全文   查看/发表评论  下载PDF阅读器
关闭