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目的 建立HPLC UV检测方法测定健康人体内头孢泊肟含量的方法 ,并用该法研究头孢泊肟在健康人体内的药动学。方法 色谱柱为KromasilC1 8(1 50mm× 4 .6mm ,5μm) ,流动相为水 乙腈 三乙胺 (1 0 0 0∶1 36∶5) (以磷酸调节 pH =4.6) ,检测波长 2 54nm。以头孢克罗为内标 ,血样以固相萃取法进行预处理 ,尿样稀释 1 0倍后直接进样。结果 血浆样品线性范围 0 .0 50~ 6 .40 0mg·L- 1 (r =0 .9997) ,尿样线性范围 0 .2~ 2 5 .6mg·L- 1 (r =0 .9999) ,血浆样品萃取回收率均在 79%以上 ,日内、日间的RSD皆小于 1 2 %。应用该法研究 2 0名健康受试者 po 2 0 0mg头孢泊肟酯片剂后的药动学 ,其体内过程符合一室模型 ,其药动学参数为 :tmax为 (3 .0± 0 .4)h ,cmax为 (3 .4± 0 .4)mg·L- 1 ,用梯形法计算所得的AUC0~t为 (1 7.7± 2 .1 )mg·h·L- 1 ,V为 (37± 6)L ,1 2h尿药排泄率为 (47.8± 2 .9) %。结论 此方法准确 ,灵敏 ,适于药物分析 ,其药动学参数 ,为临床合理用药提供理论依据
OBJECTIVE To establish a HPLC UV detection method for the determination of cefpodoxime in healthy volunteers and to study the pharmacokinetics of cefpodoxime in healthy volunteers. Methods The chromatographic column was Kromasil C18 (1 50 mm × 4 .6 mm, 5 μm). The mobile phase consisted of water and acetonitrile (100: 1, 36: 5) adjusted to pH 4.6 with phosphoric acid and detected at 254 nm. Take cefaclor as internal standard, the blood sample was pretreated by solid-phase extraction, and the sample was directly injected after diluted 10 times. Results The linear range of plasma samples was 0.50 ~ 6.040 mg · L- 1 (r = 0.9997). The linear range of urine samples was 0.2-2.5.6 mg · L -1 (r = 0.9999) The recovery rate of plasma samples were all above 79%. The RSDs were less than 12% during the day and the day. The pharmacokinetics of po 200 mg cefpodoxime proxetil tablets in 20 healthy subjects were studied by this method. The in vivo process accorded with the one-compartment model. The pharmacokinetic parameters were as follows: tmax was (3.0 ± 0 .4) h, cmax was (3.4 ± 0.4) mg · L -1. The AUC0 ~ t calculated by trapezoidal method was (1 7.7 ± 2 .1) mg · h · L -1, and V was (37 ± 6) L, urinary excretion rate was (47.8 ± 2 .9)% after 12 hours. Conclusion This method is accurate and sensitive, suitable for drug analysis, pharmacokinetic parameters, to provide a theoretical basis for clinical rational use of drugs