摘要
目的建立一种简便的格列齐特血药浓度HPLC测定和生物等效性研究测定方法，并使此方法达最佳优化状态。方法18名健康受试者单剂量交叉口服格列齐特供试制剂和参比制剂80mg后，用固相萃取高效液相色谱法测定血浆中格列齐特的浓度。结果本方法在0．125-8．0mg／L浓度范围内线性关系良好．最低可定量浓度为0．02mg／L（信噪比〉3），两制剂间AUC、Cmax、Tmax、t1／2β药动学参数经统计学检验无显著性差异（P〉0．05）．供试制剂的相对生物利用度为（99．95±12．57）％。结论本HPLC方法简单、快速、准确，很好的评价了两种制剂的生物等效性。
Objective To establish a simple HPLC method to determine the Gliclazide hydrochloride in human plasma and to study bioequivalenee, and to optimize this methods. Methods The plasma concentrations of glielazide were determined by HPLC with solide-phase extraction in 18 healthy male volunteers after an oral dose of 80 mg standard or tested formulations in crossways. Results The calibration curve was linear in the range of 0. 125-8.0 mg/L. The minimum detection concentration was 0.02 mg/L. The values of AUC,Cmax,Tmax and t1/2β of two preparations had no significant difference （P〉0.05）. The relative bioavailability was （99.95±12. 57） %. Conclusion The proposed method could be applied to the assay of Glielazide in reverse phase conditions easily and rapidly, and two preparations of Glielazide hydroehloride are bioequivalent.
出处
《江西医学院学报》
CAS
2006年第2期50-52,共3页
Acta Academiae Medicinae Jiangxi
