双嘧达莫缓释微丸体内血药浓度及体外溶出度的相关性研究

目的　测定自制双嘧达莫缓释微丸的血药浓度 ,通过双嘧达莫缓释微丸的体外溶出度实验 ,利用统计学方法研究其体内外参数的相关性并提供质控方法。方法　采用改进的HPLC测定血浆药物浓度 ,释放度实验按中国药典 2 0 0 0年版附录中有关转篮法规定进行 ,以美国HansonResearch全自动溶出测定仪进行操作。结果　以药物累积吸收百分率Y与相应时刻的体外累积释放百分数X建立的一元线性回归方程为 :Y =1 0 .90 0 6 +1 .1 792X (r =0 .90 3 6) (P <0 .0 1 )。结论　自制双嘧达莫缓释微丸的体内外各参数间有显著的相关性

Investigation on release of dipyridamole controlled release pellets in vitro and in vivo and their correlation

OBJECTIVE To determine the plasma levels of dipyr id amole after oral administration and to study in vitro and in vivo correl ation of dipyridamole controlled release pellets.METHOD A ra pid and sensitive RP HPLC assay was modified for the determination of the drug levels in plasma.The dissolution was tested according to Chinese Pharmacopoeia 2 000,using the first methed.RESULTS The linear regressive equ ation was established between the absorption percentage in vivo and the accu mulate dissolution percentage in vitro of dipyridamole as Y=10.900 6+1.179 2X (r=0.9036) (P<0.01) .CONCLUSION The results suggested that there was a significant correlation between the absorption in vivo and the dissolution in vitro of dipyridamole controlled release pellets.