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建立了反相高效液相色谱法检测正常人口服尼卡地平片剂后的血药浓度。样品经硼酸缓冲液(pH90)碱化后,用正己烷正丁醇混合溶剂(12∶1,V/V)提取,以C18化学键合硅胶为固定相,乙腈KH2PO4缓冲液(0015mol/L,pH=55)三乙胺为流动相,尼莫地平为内标,在236nm波长定量检测。血药浓度在5~200ng/ml范围内线性良好,最低检测浓度为25ng/ml。日内(n=7)及日间(n=5)测定相对标准偏差分别小于54%和64%,血样测定回收率为928%1008%。用本法监测了10名健康人口服盐酸尼卡地平片剂后不同时间的血药浓度变化,测得血浆中尼卡地平浓度在16±03h达到峰值1098±387ng/ml,T1/2=535±228h,血药浓度曲线下面积为3221±696ng·h/ml。
A reversed-phase high performance liquid chromatography was developed for the determination of plasma concentrations of nicardipine tablets administered to normal humans. The samples were alkalized with boric acid buffer (pH 9.0), extracted with n-hexane n-butanol mixed solvent (12: 1 V / V), and C18 chemically bonded silica gel was used as stationary phase. AcetonitrileKH2PO4 buffer 015mol / L, pH = 5 5) triethylamine as the mobile phase, nimodipine as an internal standard, quantitative detection at a wavelength of 236nm. The linearity was good in the range of 5 ~ 200ng / ml with the lowest detection concentration of 25ng / ml. The relative standard deviations (RSDs) were less than 54% and 64% in day (n = 7) and day (n = 5), respectively. The recovery of blood sample was 928% and 1008% respectively. This method was used to monitor the change of plasma concentration of Nicardipine Hydrochloride Tablets in 10 healthy people at different times. The concentration of nicardipine in plasma reached the peak of 109.8 ± 38.7ng at 16 ± 03h / Ml, T1 / 2 = 535 ± 228h, the area under the plasma concentration curve was 3221 ± 696ng · h / ml.