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目的：比较Ａ、Ｂ两厂复方卡托普利片的生物利用度和药代动力学。方法：９名健康志愿者随机交叉口服单剂量３０ｍｇ复方卡托普利片，以对溴苯乙酰基溴（ＰＢＰＢ）为衍生化试剂，采用反相高效液相色谱法。结果：测得Ａ、Ｂ药厂生产的复方卡托普利片剂在血浆中Ｃａｐ浓度达峰时间分别为（０．９４±０．１３）ｈ和（１．００±０．１５）ｈ；达峰浓度Ｃｍａｘ分别为（９２．０３±２７．３６）ｎｇ／ｍｌ、（７４．６７±１９．２９）ｎｇ／ｍｌ；药时曲线下面积（ＡＵＣ）分别为（２５２．７８±６８．１４）ｎｇ／（ｈ·Ｌ）、（２５１．１９±５０．１３）ｎｇ／（ｈ·Ｌ）。血药浓度—时间曲线符合二房室模型。结论：以Ａ厂复方卡托普利片为标准算得Ｂ厂复方卡托普利片中卡托普利的相对生物利用度（Ｆ）为９９．３７％。
OBJECTIVE: To compare the bioavailability and pharmacokinetics of captopril tablets in plants A and B. Methods: Nine healthy volunteers were randomized to receive a single dose of 30 mg captopril tablets at randomized crossover point. P-BPB was used as a derivatization reagent and reversed phase high performance liquid chromatography (RP-HPLC). Results: The Cap concentration of Captopril tablets produced in A and B pharmaceutical factories reached (0.94 ± 0.13) h and (1.00 ± 0.15) h respectively in plasma. The maximal peak concentration (Cmax) were (92.03 ± 27.36) ng / ml and (74.67 ± 19.29) ng / ml, respectively. The AUC values were (252.78 ± 68.14 ) Ng / (h · L), (251.19 ± 50.13) ng / (h · L). Plasma concentration - time curve in line with two-compartment model. CONCLUSION: The relative bioavailability (F) of captopril in Compound C, Captopril tablets in Factory B, calculated on the basis of Compound A captopril tablets in Factory A, is 99.37%.