双氯灭痛缓释片的人体相对生物利用度

The relative bioavailablitity of diclofenac sodium sustained-release tablets in healthy volunteer

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.

AIM: To study the relative bioavailability of diclofenac sodium sustained-re-lease tablets. METHODS: According to cross-over design, each one was orally given sus-tained-release tablets in a single dose in 18 young healthy volunteers,and the plasma concen-tration in different time was determined by RP-HPLC method. HPLC instrument was made by France Gilson. Stationary phase was ODS 5 μm. Mobile phase was methanol-actate buffer solution(67 : 33 V/V). The wavelength was set at 280 nm. The linear range was from 3-2 000 ng/ml and the relevant coefficient was 0. 999 8. The recovery was 97. 40%-95. 02% from high concentration to low concentration. RESULTS :AUC,FI,MRT of 2 products were same statistically and the average relative bioavailability was 96. 75%. CONCLUSION :Two products are bioeqivalence.