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目的研究阿司匹林双嘧达莫缓释胶囊中双嘧达莫的体内外相关性。方法应用释放度测定法研究阿司匹林双嘧达莫缓释胶囊中双嘧达莫的体外释药行为,用HPLC-UV法测定双嘧达莫在人体内的血药浓度,按Wanger-Nelson公式计算药物吸收百分数,并与相应时间体外累积溶出度线性回归,进行体内外相关性考察。结果双嘧达莫体内药物动力学特征符合单室一级吸收模型,以体内吸收质量百分率(Y)与体外释放质量百分率(X)建立线性回归方程:Y=0.5587X+30.49,r=0.9165。结论阿司匹林双嘧达莫缓释胶囊体外释放质量百分率和体内吸收质量百分率呈显著相关。
Objective To study the in vitro and in vivo correlation of dipyridamole in aspirin and dipyridamole sustained release capsules. Methods The release of dipyridamole in aspirin sustained-release capsules in vitro was determined by the method of determination of release. The concentration of dipyridamole in human plasma was determined by HPLC-UV method and calculated according to Wanger-Nelson formula Drug absorption percentage, and with the corresponding time in vitro cumulative linear regression of dissolution, in vitro and in vivo correlation study. Results The pharmacokinetics of dipyridamole in vivo was in accordance with the single-chamber first-order absorption model. The linear regression equation was established between the mass percent absorption (Y) in vivo and the mass percent release in vitro (X): Y = 0.5587X + 30.49, r = 0.9165. Conclusion Aspirin dipyridamole sustained-release capsules in vitro release mass percentage and in vivo absorption mass percentage was significantly correlated.