当归多糖铁胃内滞留缓释片在犬体内的药物动力学研究

Study on the pharmacokinetics of Angelica sinensis polysaccharideiron complex floating sustained-release tablets in Beagle dogs

目的:制备当归多糖铁胃内滞留缓释片(APIC-FSRT),考察其在犬体内的药物动力学。方法:以丙烯酸树脂Ⅱ、羟丙基甲基纤维素、聚维酮等为辅料,全粉末直接压片,制备了1 d给药2次的当归多糖铁缓释片,建立火焰原子吸收光谱法测定血清中药物浓度,采用DAS 2.0统计软件估算Beagle犬服用对照组(力蜚能组)和受试试剂后的各个药动学参数,进行统计学分析。结果:所得胃滞留缓释片在犬体内药动学参数为AUC(0-t)(6.024±0.950)mg.h.L-1,MRT(7.395±0.530)h,Cmax(1.026±0.332)mg.L-1,缓释片与力蜚能组比较,相对生物利用度为:134%。结论:当归多糖铁胃内滞留缓释片制备工艺简单,缓释效果明显,与受试制剂比有显著差异。

Objective：To prepare Angelica sinensis polysaccharide-iron complex floating sustained-release tablets（APIC FSRT） and to evaluate its pharmacokinetics in Beagle dogs.Methods：The tablets were prepared using acrylic resinⅡ,HPMC,PVP and so on as excipients.And the tablet was prepared by direct compression.The serum drug concentration in Beagle dogs was measured by AAS.The parameters of control groups and APIC groups in Beagle dogs were evaluated and analyzed statistically by DAS 2.0 software.Results：The pharmacokinetic parameters of APIC in dogs showed that the AUC（0-t）（6.024±0.950） mg·h·L-1,MRT（7.395±0.530）h,Cmax（1.026±0.332） mg·L-1,the relative bioavailability of the tablets was 134%.Conclusion：The study was found to be effective in the process of Angelica sinensis polysaccharide-iron complex floating sustained-release tablets.The tablets produced a relatively flat serum drug concentration in vivo compared with the control groups