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建立头孢克罗在人血浆及尿中的HPLC快速测定方法,选用分析柱为Hypersil C18(4.6x200mm,5m),流动相采用甲醇:四氢呋喃:水(1L水中含庚烷磺酸钠0.5g、三乙胺7.5ml。磷酸6ml,pH2.5)为23∶4∶73,流速1.0ml/min;检测波长265nm。选择8名男性健康志愿者单剂量口服500mg,应用所建方法研究其在健康人体内的药代动力学。研究结果表明:血药浓度在0.10~25.0g/ml范围内线性良好(=0.9999),尿药浓度在1~250g/ml范围内线性良好(=0.9999),方法的日内及日间精密度均小于10%,回收率也符合体内药物分析的要求。测得希刻劳胶囊的Cmax为13.17±4.76g/ml;Tmax为0.62±0.20h;t1/2为0.63±0.20h;AUC0为18.30±3.62h/(g·ml)。
The HPLC method for determination of cefaclor in human plasma and urine was established. The analytical column was Hypersil C18 (4.6 × 200 mm, 5m). The mobile phase consisted of methanol: tetrahydrofuran: water (0.5g heptane sulfonate in 1L water) , Triethylamine 7.5ml. Phosphoric acid 6ml, pH2.5) 23:4:73, flow rate 1.0ml / min; detection wavelength 265nm. Eight healthy male volunteers were selected to take 500 mg orally. The pharmacokinetics of the drug in healthy volunteers were studied using the established method. The results showed that the linearity was good (= 0.9999) in the range of 0.10-25.0 g / ml, the linearity was good in the range of 1-250 g / ml (= 0.9999) Intra-day and intra-day precision were less than 10%, the recovery rate also in line with the requirements of in vivo drug analysis. The measured Cmax of Xijiaole capsule was 13.17 ± 4.76g / ml; Tmax was 0.62 ± 0.20h; t1 / 2 was 0.63 ± 0.20h; AUC0 was 18.30 ± 3.62h / (G · ml).