中国临床药学杂志

目的建立HPLC法测定乳汁中奥硝唑的浓度,并监测产后用药妇女乳汁中奥硝唑含量。方法采用Agilent Eclipse XDB-C18柱(150 mm×4.6 mm,5μm),以甲醇-水(27.5∶72.5)为流动相,甲硝唑为内标,检测波长320 nm,流速1.0m L·min-1,柱温30℃。收集产后使用奥硝唑的妇女乳汁,进行乳药浓度监测。结果乳汁中奥硝唑质量浓度在0.875~54.95 mg·L^-1内线性关系良好,r=0.999 3,乳汁中最低检测限为0.075 mg·L^-1。在低、中、高3种浓度下,平均加样回收率分别为98.54%、101.34%和103.11%。对9位产后用药妇女乳汁中奥硝唑含量监测结果为1.88~10.86 mg·L^-1。结论本研究建立的HPLC法可快速、准确地用于测定乳汁中奥硝唑的浓度。产后用药妇女乳汁中奥硝唑含量较高、且个体差异较大,建议在连续用药期间暂停授乳。

AIM To establish an HPLC method for determination of ornidazole concentration in breast milk and monitor the ornidazole milk concentration after delivery. METHODS The drug was detected by UV detector at wavelength of 320 nm with a Agilent Eclipse XDB-C18 column(150 mm × 4. 6 mm,5 μm). The mixture of methanol and water(27. 5∶ 72. 5) was used as the mobile phase and metronidazole was used as the internal standard. The flow rate was 1. 0 m L·min^-1 and the column temperature was 30 ℃. The breast milk in parturient was collected to monitor ornidazole milk concentration. RESULTS The calibration curve was linear over the range of0. 875-54. 95 mg·L^-1 with good correlation coefficient( r = 0. 999 3) and the measurable limit of detection was0. 075 mg·L^-1. The average sample recoveries were 98. 54%,101. 34% and 103. 11% for low,middle and high concentration of quality control,respectively. The monitoring results of the concentration of ornidazole in the milk of 9 postpartum women were 1. 88-10. 86 mg·L^-1. CONCLUSION This HPLC method of detecting ornidazole milk concentration is quick and precise. The ornidazole milk concentration in parturient has a high level during continuous administration,and milk lactation is not recommended.