3种头孢地尼在健康人体内的生物等效性研究
发布时间：2018-08-07 14:45
【摘要】：目的建立测定人体血浆中头孢地尼浓度的UPLC-MS/MS方法,评价3种头孢地尼口服药物在健康人体内的生物等效性。方法随机、自身前后三交叉的试验设计。24名健康男性受试者单剂量口服3种头孢地尼100 mg,用UPLC-MS/MS法测定其血药浓度,计算主要药代动力学参数及相对生物利用度,评价3种药物的生物等效性。结果头孢地尼的线性范围为11.50~2300.00ng·m L-1,批内、批间精密度(RSD)均小于10%。受试药物(片剂,分散片)与参比药物(胶囊)的主要药代动力学参数为,tmax分别为(3.00±0.80),(3.20±0.90)和(3.50±0.70)h;Cmax分别为(548.96±184.58),(607.09±236.38)和(570.18±172.37)ng·m L-1;t1/2分别为(2.00±0.30),(1.90±0.40)和(1.90±0.30)h,AUC0-t分别为(2755.35±956.10),(3037.49±1014.42)和(2756.43±804.06)ng·m L-1·h。头孢地尼片和头孢地尼分散片分别以胶囊为对照,相对生物利用度分别为(104.2±37.5)%和(111.8±30.3)%。结论建立的分析方法灵敏、快速、准确。3种头孢地尼在健康人体内的生物等效。
[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，
本文编号：2170360
[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，
本文编号：2170360
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