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10名健康志愿者随机交叉口服单剂量30mg两种国产卡托普利片后,用对溴苯乙酰基溴(p-BPB)作为化学稳定剂以及衍生化试剂,采用HPLC法测得血浆中药物浓度达峰时间分别在0.57±0.12h(样品)和0.56±0.17h(对照品),峰值(Cmax)分别为289.2±101.3和266.5±83.8ng/ml,药时曲线下面积(AUC0-∞)分别为393.8±63.7(样品)和383.0±49.4ng·h/ml(对照品)。血药浓度-时间曲线符合一级吸收的二房室模型。以常州制药厂复方卡托普利片为标准算得汕头金石制药总厂复方卡托普利片中卡托普利的相对生物利用度(F)为102.8±1.29。
Ten healthy volunteers were randomized to receive a single dose of 30mg of two domestic captopril tablets at randomized crossover points. The pharmacological effects of p-bromophenacyl bromide (p-BPB) as a chemical stabilizer and derivatization reagent were determined by HPLC. The peak time was 0.57 ± 0.12 h (sample) and 0.56 ± 0.17 h (control), the peak values (Cmax) were 289.2 ± 101.3 and 266.5 ± 83.8 ng / Ml, and the area under the curve (AUC0-∞) of the drug were 393.8 ± 63.7 (samples) and 383.0 ± 49.4 ng · h / ml (control), respectively. The plasma concentration-time curve conformed to the two-compartment model of primary absorption. The relative bioavailability (F) of captopril in Compound Captopril tablets of Shantou Jinshi Pharmaceutical Factory was 102.8 ± 1.29 based on the standard of Captopril tablets in Changzhou Pharmaceutical Factory.