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建立了高效液相色谱-荧光检测法测定Beagle犬血浆中的氢溴酸加兰他敏,并考察其缓释片在Beagle犬体内的药动学。采用Venusil XBP-C18色谱柱,以甲醇-25 mmol/L磷酸二氢钠溶液(含0.2%三乙胺,用磷酸调至pH 3.5)(84︰16)为流动相,激发波长290 nm,发射波长320 nm。加兰他敏在1～300 ng/ml范围内线性关系良好。提取回收率分别为(75.56±2.44)%、(86.63±5.14)%和(88.22±1.13)%。采用单剂量双周期交叉试验,6只Beagle犬分别口服给予氢溴酸加兰他敏缓释片和氢溴酸加兰他敏普通片,主要药动学参数分别为:t1/2(25.20±5.46)h和(12.52±8.38)h,tmax(1.17±0.41)和(0.63±0.14)h,cmax(39.03±11.13)和(94.91±15.75)ng/ml,MRT0→t(20.63±1.27)和(10.11±4.06)h。可见氢溴酸加兰他敏缓释片在Beagle犬体内具有明显的缓释特征。
A high performance liquid chromatography-fluorescence detection method was established for the determination of galantamine hydrobromide in Beagle dog’s plasma and the pharmacokinetics of its sustained release tablets in Beagle dogs. Venusil XBP-C18 column was used with a mobile phase of methanol-25 mmol / L sodium dihydrogen phosphate solution (containing 0.2% triethylamine and phosphoric acid to pH 3.5) (84︰16) Wavelength 320 nm. Galantamine had good linearity in the range of 1 to 300 ng / ml. The extraction recoveries were (75.56 ± 2.44)%, (86.63 ± 5.14)% and (88.22 ± 1.13)%, respectively. The single-dose two-cycle crossover test was conducted in six Beagle dogs. The main pharmacokinetic parameters of galantamine hydrobromide sustained-release tablets and galantamine hydrobromide tablets were: t1 / 2 (25.20 ± 5.46) h and (12.52 ± 8.38) h, tmax (1.17 ± 0.41) and (0.63 ± 0.14) h, cmax (39.03 ± 11.13) and (94.91 ± 15.75) ng / (10.11 ± 4.06) h. Visible Gallatonate hydrobromide sustained release tablets in Beagle dogs with sustained release characteristics.