【摘要】：目的建立測(cè)定人體血漿中頭孢地尼濃度的UPLC-MS/MS方法,評(píng)價(jià)3種頭孢地尼口服藥物在健康人體內(nèi)的生物等效性。方法隨機(jī)、自身前后三交叉的試驗(yàn)設(shè)計(jì)。24名健康男性受試者單劑量口服3種頭孢地尼100 mg,用UPLC-MS/MS法測(cè)定其血藥濃度,計(jì)算主要藥代動(dòng)力學(xué)參數(shù)及相對(duì)生物利用度,評(píng)價(jià)3種藥物的生物等效性。結(jié)果頭孢地尼的線性范圍為11.50~2300.00ng·m L-1,批內(nèi)、批間精密度(RSD)均小于10%。受試藥物(片劑,分散片)與參比藥物(膠囊)的主要藥代動(dòng)力學(xué)參數(shù)為,tmax分別為(3.00±0.80),(3.20±0.90)和(3.50±0.70)h;Cmax分別為(548.96±184.58),(607.09±236.38)和(570.18±172.37)ng·m L-1;t1/2分別為(2.00±0.30),(1.90±0.40)和(1.90±0.30)h,AUC0-t分別為(2755.35±956.10),(3037.49±1014.42)和(2756.43±804.06)ng·m L-1·h。頭孢地尼片和頭孢地尼分散片分別以膠囊為對(duì)照,相對(duì)生物利用度分別為(104.2±37.5)%和(111.8±30.3)%。結(jié)論建立的分析方法靈敏、快速、準(zhǔn)確。3種頭孢地尼在健康人體內(nèi)的生物等效。
[Abstract]:Objective to establish a UPLC-MS/MS method for the determination of cefdinir in human plasma and to evaluate the bioequivalence of three cefdinir oral drugs in healthy volunteers. Methods A randomized, self-crossover trial was designed. 24 healthy male subjects were given a single dose of cefdinir 100mg. Their blood concentrations were measured by UPLC-MS/MS method, and the main pharmacokinetic parameters and relative bioavailability were calculated. To evaluate the bioequivalence of three drugs. Results the linear range of cefdinir was 11.50~2300.00ng ml -1. The intra-and inter-assay precision (RSD) was less than 10%. 鍙楄瘯鑽墿(鐗囧墏,鍒嗘暎鐗，

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