氨茶碱缓释片的人体生物等效性研究

目的：研究氨茶碱缓释片试验制剂和市售参比制剂在20名健康男性志愿者体内的药动学和相对生物利用度,并进行生物等效性评价。方法：根据双交叉试验方法口服单剂量200mg的两种氨茶碱缓释片,采用HPLC法测定血浆中茶碱的浓度。结果：口服单剂量200mg试验制剂后,t1/2、tmax、cmax、AUC0～36、AUC0～∞分别为（9.13±1.94）h、（3.95±0.56）h、（3.66±0.70）μg/ml、（41.01±7.33）μg.h.ml-1和（44.29±8.60）μg.h.ml-1;参比制剂为（9.85±1.79）h、（4.10±0.53）h、（2.69±0.37）μg/ml、（39.36±6.24）μg.h.ml-1和（43.32±7.36）μg.h.ml-1。氨茶碱缓释片试验制剂相对生物利用度为（105±16.7）%。结论：试验制剂和参比制剂具有生物等效性。

Bioequivalence of aminophylline sustained-release tablets in healthy volunteers

Objective：To study the pharmacokinetics and relative bioavailability of test and reference aminophylline sustained-release tablets in 20 healthy volunteers,and to evaluate the bioequivalence between the two preparations.Methods：A single oral dose of 200 mg of two kinds of aminophylline sustained-release tablets was given according to a crossover design.The plasma concentration of theophylline was determined by HPLC method.Results：After the single oral dose of 200 mg of aminophylline sustained-release tablets,the t1/2,tmax,cmax,AUC0-36 and AUC0-∞ of the test tablets were （9.13±1.94） h,（3.95±0.56） h,（3.66±0.70） μg/ml,（41.01±7.33） μg·h·ml^-1 and （44.29±8.60） μg·h·ml^-1,respectively.For the reference tablets,the parameters were （9.85±1.79） h,（4.10±0.53） h,（2.69±0.37） μg/ml,（39.36±6.24） μg·h·ml^-1 and （43.32±7.36） μg·h·ml^-1,respectively.The relative bioavailability of the test aminophylline sustained-release tablets was （105±16.7）%.Conclusion：The test and reference aminophylline sustained-release tablets are bioequivalent.