目的 建立HPLC法測定人血清中氯吡格雷及其羧酸代謝物SR26334，研究硫酸氫氯吡格雷片在PCI術(shù)后患者體內(nèi)的藥動學(xué)情況。方法 采用CLC-ODS色譜柱（250 mm×4.6 mm，5 μm）；流動相：乙腈–0.1%甲酸溶液（60：40）；檢測波長：235 nm；體積流量：1.0 mL/min；柱溫：40℃；進樣體積10 μL。收集到7例PCI術(shù)后口服硫酸氫氯吡格雷片75 mg/d超過7 d的患者，在當天早上服藥后0、0.5、1、1.5、2、3、4、6、8、12、16、24 h從靜脈采血，檢測氯吡格雷和SR26334的血藥濃度，制備平均藥時曲線，使用DSA 2.0計算氯吡格雷和SR26334的藥動學(xué)參數(shù)。結(jié)果 氯吡格雷、SR26334在0.2~8 μg/mL線性關(guān)系良好，定量限均為0.2 μg/mL。絕對、相對回收率均大于80%，日內(nèi)、日間精密度RSD值均小于5%。氯吡格雷、SR26334的C_max、t_max、t_1/2分別為（65±0.57）、（0.77±0.22）μg/mL，（3.02±0.69）、（2.88±0.48）h，（7.66±3.65）、（8.52±3.37）h。結(jié)論 本方法簡便、快速，適用于硫酸氫氯吡格雷片血藥濃度的臨床監(jiān)測。

Objective To establish an HPLC method for the determination of clopidogrel and its carboxylic acid (SR26334) in human serum, and study pharmacokinetics of Clopidogrel Sulfate Tablets in patients after PCI. Methods HPLC-UV method was adopted on CLC-ODS column (250 mm×4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1% formic acid solution (60:40). The detection wavelengths were 235 nm. The flow rate was 1 mL/min, and the column temperature was set at 40℃ with injection volume of 10 μL. Seven cases administered with Clopidogrel Bisulfate Tablets 75 mg/d more than 7 d after PCI were collected. After taking drugs in the morning, the blood samples were collected from venous blood after 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h, and the blood concentrations of clopidogrel and SR26334 were detected. The average time curve was prepared. The pharmacokinetic parameters of clopidogrel and SR26334 were calculated by DSA soft. Results A good linearity was shown in the concentration ranges of 0.2 — 8 μg/mL for clopidogrel and SR26334 with quantitative limits of 0.2 μg/mL. The absolute recovery and relative recoveries were all above 80%. The inter-day or intra-day precisions were less than 5%. C_max, t_max, and t_1/2 for clopidogrel and SR26334 were (65 ±0.57), (0.77 ±0.22) μg/mL, (3.02 ±0.69), (2.88 ±0.48) h, and (7.66 ±3.65), (8.52 ±3.37) h, respectively. Conclusion This method is simple and quick, which is suitable for clinical monitoring for the serum concentration of Clopidogrel Bisulfate Tablets.