| 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） |
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| 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. |
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