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目的:研究氢溴酸加兰他敏缓释微丸胶囊在家犬体内单剂量的生物利用度。方法:采用双周期交叉试验,取家犬6只随机分成2组,分别灌胃给予氢溴酸加兰他敏缓释微丸胶囊和氢溴酸加兰他敏胶囊进行双周期交叉试验,于给药后不同时点取血样,采用高效液相色谱法测定血药浓度及计算相关药动学参数。结果:单剂量给药后,缓释微丸胶囊和胶囊的AUC分别为(1867.24±321.05)、(1604.60±289.17)ng·h·mL-1,tmax分别为(5.42±2.24)、(0.73±0.62)h,Cmax分别为(89.62±11.23)、(162.82±15.35)ng·mL-1,t1/2分别为(8.93±1.82)、(7.58±1.21)h;缓释微丸胶囊的相对生物利用度为116.36%。结论:氢溴酸加兰他敏缓释微丸胶囊具有明显的缓释性,与氢溴酸加兰他敏胶囊具有生物等效性。
OBJECTIVE: To study the single dose bioavailability of galantamine hydrobromide sustained-release pellets in dogs. Methods: Six-week cross-over test was conducted. Six dogs were randomly divided into two groups. The two groups were given galantamine hydrobromide sustained-release pellets and galanthamine hydrobromide capsules orally. Blood samples were taken at different time points after administration, and plasma concentrations were determined by HPLC and related pharmacokinetic parameters were calculated. RESULTS: After single-dose administration, the AUC of sustained-release pellets and capsules were (1867.24 ± 321.05) and (1604.60 ± 289.17) ng · h · mL-1, respectively, and the tmax values were 5.42 ± 2.24 and 0.73 ± 0.62) h and Cmax were (89.62 ± 11.23) and (162.82 ± 15.35) ng · mL-1, respectively, with t1 / 2 being (8.93 ± 1.82) and (7.58 ± 1.21) Utilization was 116.36%. CONCLUSION: Galantamine hydrobromide sustained-release pellets have obvious sustained-release properties and are bioequivalent to galantamine hydrobromide capsules.