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目的研究精氨洛芬(非甾体抗炎药)片剂与颗粒剂在中国健康志愿者体内的生物等效性。方法20名健康男性受试者分别随机交叉口服精氨洛芬片(试验制剂)及其颗粒(参比制剂)0.4 g,用HPLC-UV法测定给药后不同时间点的血浆布洛芬浓度;用DAS程序对试验数据进行统计处理,评价2种制剂的生物等效性。结果试验制剂和参比制剂的药代动力学参数如下:Cmax分别为(50.60±9.12)、(50.53±8.58)mg.L-1,tmax分别为(0.51±0.20)、(0.34±0.11)h,AUC0-t分别为(118.63±21.42)、(115.75±20.23)mg.h.L-1,AUC0-∞分别为(121.18±22.18)、(118.55±21.83)mg.h.L-1。试验制剂与参比制剂AUC0-t之比和Cmax之比的90%可信区间分别为97.5%～107.6%和93.3%～107.2%。结论试验制剂和参比制剂吸收程度等效(AUC0-t,AUC0-∞和Cmax均生物等效性);但吸收速度不等效(tmax不等效)。
Objective To study the bioequivalence of amiloride (NSAID) tablets and granule in Chinese healthy volunteers. Methods Twenty healthy male subjects were randomized to oral administration of 0.4 mg of armpitofen tablets (test preparation) and their granules (reference preparation) respectively. The plasma concentrations of ibuprofen at different time points after administration were measured by HPLC-UV. The experimental data were statistically processed using the DAS program to evaluate the bioequivalence of the two formulations. Results The pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (50.6 ± 9.12), (50.53 ± 8.58) mg.L-1, tmax were (0.51 ± 0.20), (0.34 ± 0.11) h AUC0-t were (118.63 ± 21.42) and (115.75 ± 20.23) mg.hL-1, respectively, and AUC0-∞ were (121.18 ± 22.18) and (118.55 ± 21.83) mg.hL-1, respectively. The 90% confidence interval for the ratio of test preparation to reference preparation AUC0-t and Cmax was 97.5% -107.6% and 93.3% -107.2%, respectively. Conclusions The test preparation and the reference preparation have equivalent degree of absorption (AUC0-t, AUC0-∞ and Cmax are bioequivalent); however, the absorption rate is not equivalent (tmax is not equivalent).