论文部分内容阅读
目的采用HPLC法测定犬血浆中雷诺嗪缓释片的浓度。方法用乙腈沉淀蛋白,离心后取上清液用氮气吹干,流动相溶解后进行HPLC测定。采用DiamonsilTM C18色谱柱(250mm×4.6mm,5μm)、资生堂MG C18色谱柱(150mm×4.6mm,5μm),流动相为乙腈-水相(7mmol·L-1乙酸铵、3.5mmol·L-1乙酸、1‰三乙胺)(50:50);检测波长230nm;流速0.8mL·min-1;柱温30℃;进样量40μL。犬灌胃给药雷诺嗪缓释片剂量为25mg·kg-1,于不同时间取血,依法测定。结果雷诺嗪的线性范围为0.1～20μg·mL-1(r=0.9998,n=5),高、中、低浓度的日内、日间RSD均小于15%,方法回收率为88%～105%。缓释片和普通片的Cmax分别为1.59±1.07、3.48±2.11μg·mL-1。结论所建方法简便、准确,适用于犬血浆中雷诺嗪的测定及雷诺嗪缓释片的人体药物动力学、生物利用度和生物等效性的研究。雷诺嗪普通片口服吸收快、吸收良好,缓释片无突释现象,具明显缓释作用。
Objective To determine the concentration of ranolazine sustained-release tablets in canine plasma by HPLC. Methods The protein was precipitated with acetonitrile, the supernatant was centrifuged and then blown dry with nitrogen. The mobile phase was dissolved and determined by HPLC. The mobile phase consisted of acetonitrile-water (7mmol·L-1 ammonium acetate, 3.5mmol·L-1) with a DiamonsilTM C18 column (250mm × 4.6mm, 5μm) and Shiseido MG C18 (150mm × 4.6mm, Acetic acid, 1 ‰ triethylamine) (50:50); detection wavelength 230nm; flow rate 0.8mL · min-1; column temperature 30 ℃; injection volume 40μL. Canine oral administration of ranolazine sustained-release tablets at a dose of 25mg · kg-1, at different times of blood, measured according to the law. Results The linear range of ranolazine was 0.1 ~ 20μg · mL-1 (r = 0.9998, n = 5). The intra-day and inter-day RSD of high, medium and low concentrations were all less than 15% and the recoveries were 88% -105% . The Cmax of sustained-release tablets and ordinary tablets were 1.59 ± 1.07,3.48 ± 2.11μg · mL-1, respectively. Conclusion The method is simple and accurate and is suitable for the determination of ranolazine in canine plasma and the pharmacokinetics, bioavailability and bioequivalence of ranolazine sustained-release tablets. Ranolazine ordinary tablets oral absorption fast, good absorption, sustained release tablets without burst phenomenon, with significant sustained release.