目的建立同时测定人血浆和尿中哌拉西林／他唑巴坦浓度的高效液相色谱方法、方法血浆样品经乙腈沉淀蛋白，二氯甲烷二次提取去杂质，用水相进样，尿液直接稀释，采用梯度洗脱的方式同时测定哌拉西林／他唑巴坦，经CAPCELL PAK C18柱分离，220nm波长检测。结果哌拉西林／他唑巴坦的血浆样品线性范围分别为0．5～400mg·L^-1（哌拉西林）和0．5—100mg·L^-1（他唑巴坦），尿样线性范围分别为2．5～2000mg·L^-1（哌拉西林）和2．5～500mg·L^-1（他唑巴坦），低、中、高3个浓度的提取回收率分别为85．3％～92.9％（哌拉西林）和87．6％～90．8％（他唑巴坦），日内、日间相对标准偏差均低于10％。结论本方法准确性好、操作简单，可满足药动学研究的要求.
Biapenem, a new parenteral carbapenem, has been widely used for treating bacterial infections. A simple, effective and accurate method based on solid-phase extraction （SPE） and HPLC was developed for the quantitative determination of biapenem in human plasma. Stability and feasibility of the method was validated through a series of experiments. Using Vitamin B6 as an internal standard, analyte was separated on a Capcell Pak C18 column after SPE on Oasis hydrophilic-lipophilic balance （HLB） cartridge. The mobile phase was comprised of 0.05 mol/L NaH2PO4 （pH 5.7） and methanol （98：2, v/v） at a flow rate of 1.0 mL/min. Ultraviolet absorbance was measured at 300 nm. The calibration curve was linear in the concentration range of 0.04-50.00 μg/mL, and the lower limit of quantification was as low as 0.04 μg/mL. Recovery rates of biapenem at 0.10, 5.00, and 25.00 μg/mL were about 70%. The validated method has been successfully applied for quantifying biapenem in human samples and a pharmacokinetic study of 12 healthy volunteers who received three different doses （150, 300 and 600 mg） of biapenem by intravenous infusion. Our method has featured good accuracy and precision, and the processed sample was stable. Therefore, it can be propagated for clinical use.
