药物流产后孕妇血浆中米非司酮浓度的监测

Plasma Concentration Monitoring of Mifepristone in Pregnancy Women after Medical Abortion

目的:建立米非司酮血药浓度的测定方法,监测药物流产后孕妇血浆中米非司酮浓度的变化情况。方法:选择停经<49d以内,米非司酮配伍米索前列醇行药物流产的早孕妇女28例,于胎囊排出后24、48、72h时抽肘静脉血。血浆样品中米非司酮以正己烷、二氯甲烷的混合液提取后,采用HypersilODS色谱柱分离,流动相为甲醇-乙腈-水(42:28:30),流速为1.0mL.min-1,紫外检测波长为302nm。结果:米非司酮血药浓度在20～5000μg.L-1范围内线性关系良好(r=0.9983),血浆中米非司酮最低检出限为10.0μg.L-1;相对回收率在95.69%～102.25%之间;日内、日间RSD分别为2.82%～3.39%、3.19%～4.76%。28例孕妇在胎囊排出后24、48、72h时血浆中米非司酮浓度分别为(606.68±123.61)、(243.86±50.16)、(92.70±34.21)μg.L-1。结论:本方法操作简单、灵敏度高、实用性强,适合基层计划生育部门监测妊娠流产后孕妇血浆中米非司酮的浓度情况。

OBJECTIVE： To establish a method for the determination of mifepristone concentrations in plasma and monitor the changes of plasma concentrations of mifepristone in pregnancy women （Menopanse for 〈49 days） after medical abortion, METHODS： 28 cases of early pregnancy women who had terminated their pregnancy by administration of mifepristone and misoprostol were detected at the 24 h, 48 h and 72 h after discharging pregnant sac. Plasma samples were extracted with the mixture of n-hexane and dichloromethane. Chromatographic separation was conducted with a Hypersil ODS column with mobile phase consisted of methanol-acetonitrile-water （42：28：30） at a flow rate of 1.0 mL.min^-1. The UV detection wavelength was set at 302 nm. RESULTS： The linear range of mifepristone was 20-5 000 μg· L^-1 （r=0.998 3） ; the minimum detection limit was 10.0 μg· L^-1, The relative recovery was within 95.69% -102.25%. The RSDs of intra-day and inter-day were 2.82% -3.39% and 3.19% -4.76%. Mifepristone concentration of 28 cases in plasma at the 24 h, 48 h and 72 h after discharging pregnant sac were （606.68 ±123.61）μg·L ^-1, （243.86 ± 50.16）μg·L^-1 and （92.70± 34.21）μg·L^-1. CONCLUSION： The method is simple, sensitive and practical. It is suitable for the plasma concentration monitoring of mifepristone in primary family planning department.