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目的建立人血浆头孢丙烯检测的高效液相色谱方法,研究头孢丙烯分散片的人体药动学。方法血浆经高氯酸沉淀,采用ZORBAX Eclipse XDB-C8色谱柱;流动相为乙腈-0.1%三氟乙酸-水(15:40∶45),流速为1.0 mL.min-1;检测波长282 nm。10名健康志愿者单剂量口服500 mg头孢丙烯分散片后,不同时间点抽取静脉血。用该方法检测血浆中头孢丙烯浓度,用DAS程序计算药动学参数。结果头孢丙烯浓度在0.10～20.00 mg.L-1内线性关系良好(r=0.999 9);高、中、低3个浓度的相对回收率分别为(99.20±4.41)%,(98.07±3.94)%和(100.07±1.69)%;日内RSD分别为5.28%,5.19%和1.97%,日间RSD分别为4.38%,3.95%和1.33%。头孢丙烯在人体内符合一级吸收的一室模型,Cmax为(8.79±1.09)mg.L-1,t1/2(ke)为(1.06±0.29)h。结论本方法简便、快速、准确可靠,可满足药动学研究的要求。
Objective To establish a HPLC method for the determination of cefprozil in human plasma and study the pharmacokinetics of cefprozil dispersible tablets. Methods The plasma was precipitated with perchloric acid using ZORBAX Eclipse XDB-C8 column. The mobile phase was acetonitrile-0.1% trifluoroacetic acid-water (15:40:45) and the flow rate was 1.0 mL.min-1. . Ten healthy volunteers were given a single oral dose of 500 mg cefprozil dispersible tablets, venous blood was drawn at different time points. The concentration of cefprozil in plasma was measured by this method and the pharmacokinetic parameters were calculated using the DAS program. Results The linear correlation between cefprozil concentration and the concentration of cefprozil was 0.10-20.00 mg.L-1 (r = 0.999 9), the relative recoveries were (99.20 ± 4.41)%, (98.07 ± 3.94) % And (100.07 ± 1.69)% respectively. The intraday RSD were 5.28%, 5.19% and 1.97%, respectively. The daytime RSD were 4.38%, 3.95% and 1.33% respectively. Cmax was (8.79 ± 1.09) mg.L-1 and t1 / 2 (ke) was 1.06 ± 0.29 h in the one-compartment model of cefprozil in the human body. Conclusion The method is simple, rapid, accurate and reliable, which can meet the requirements of pharmacokinetic studies.