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目的:对两种双氯灭痛缓释片进行相对生物利用度的测定.方法:18名健康志愿者交叉服用两种双氯灭痛缓释片后,用高效液相色谱法测定不同时间的血药浓度,检测波长280nm,测定方法的线性范围为3~2000ng/ml(r=0.9998).高中低3个浓度的回收率为97.40%~95.02%.结果:由测定结果可以看出两种缓稀片的AUC、FI、MRT均无统计学差异.平均相对生物利用度为96.75%.结论:试验片与对照片具生物等效性.
OBJECTIVE: To determine the relative bioavailability of two diclofenac sustained-release tablets.Methods: Eighteen healthy volunteers were treated with two sustained release tablets of diclofenac sodium and determined by HPLC at different times. The detection wavelength The linear range of the determination method was 3 ~ 2000ng / ml (r = 0.9998) .The recoveries of high, medium and low concentrations were 97.40% ~ 95.02% .Results: The results showed that the AUC, FI and MRT were not statistically different.The average relative bioavailability was 96.75% .Conclusion: The test piece is bioequivalent to the control.