复方阿司匹林/双嘧达莫缓释片的生物等效性研究

Bioequivalent Study of Aspirin-Dipyridomole Sustained-Release Compound Tablets

目的 考察复方阿司匹林 /双嘧达莫缓释片生物等效性。方法 采用高效液相色谱法 ,对受试样品 (复方阿司匹林 /双嘧达莫缓释片 )及国外参比制剂Aggrenox (复方阿司匹林 /双嘧达莫缓释胶囊 )进行了家犬生物利用度对照研究。采用交叉实验设计 ,对 6条健康家犬体内血药复方阿司匹林 /双嘧达莫缓释片浓度进行实际测定 ,采用三因素方差分析及双单侧检验进行生物等效性研究。结果 自制复方阿司匹林 /双嘧达莫缓释体内外相关 ,并与参比制剂生物等效。结论 研制的复方阿司匹林 /双嘧达莫缓释片具有一定的开发价值。

Aim To study the bioequivalence of aspirin-dipyridomole compound sustained-release tablets.Methods The bioavailability of the test preparation and foreign reference preparation in the dogs were determined and assessed by HPLC.In the crossover experiment designed study,the plasma in the six dogs was determined and the bioequivalence was assessed by 6 factors analysis of variance and two or one side test.Results The results showed that the relativity between the release extent in vitro and absorption percent in vivo were good.The aspirin-dipyridomole sustained-release tablets were no distinct discrepancy in the absorption comparing to the foreign reference preparation.Conclusion The preparation and reference preparation have the same absorption extent.