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目的建立剖宫产产妇乳汁中枸橼酸芬太尼浓度测定的HPLC方法,并考察剖宫产产妇应用枸橼酸芬太尼镇痛泵镇痛后,芬太尼在乳汁中的分布情况,探讨剖宫产术后新生儿的合理哺乳时间。方法1mL乳汁中加入0.5mol·L-1NaOH200μL碱化,涡旋30s,再加入环己烷5mL,涡旋2min,于2000r·min-1离心20min,静置10min,取上述有机相4mL于另一干净试管中,在N2流下吹干,残渣用流动相350μL溶解,进样量100μL。采用AgillentZorbaxSB-C18柱(4.6mm×250mm,5μm),以0.015mol·L-1磷酸二氢钠-乙腈(60∶40)为流动相,流速为0.7mL·min-1,于200nm波长下检测。结果枸橼酸芬太尼在40～2000μg·L-1内线性关系良好(r=0.9997),方法回收率为85.3%～101.6%,乳汁低、中、高3种浓度的萃取回收率(n=5)分别为62.7%,66.3%,65.6%;RSD(n=5)分别为8.11%,6.72%,4.83%;方法回收率(n=5)分别为86.1%,96.4%,103.7%,日内和日间精密度RSD小于12%。结论本法操作简单,灵敏,准确,重现性好,能满足临床对芬太尼乳药浓度的测定,可用于芬太尼在乳汁中的浓度分布研究。
Objective To establish a HPLC method for the determination of fentanyl citrate in cesarean section maternal milk and investigate the distribution of fentanyl in milk after analgesia with fentanyl citrate fentanyl injection in cesarean section, Explore reasonable neonatal lactation after cesarean section. Methods 1 mL milk was added with 0.5mol·L-1NaOH200μL basified, vortexed for 30s, then added cyclohexane 5mL, vortexed for 2min, centrifuged at 2000r · min-1 for 20min, allowed to stand for 10min, the above organic phase 4mL in another In a clean tube, dry in N2 flow, dissolve the residue with 350 μL of the mobile phase and inject 100 μL into the sample. An Agillent Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) was used with a mobile phase of 0.015 mol·L -1 sodium dihydrogen phosphate-acetonitrile (60:40) at a flow rate of 0.7 mL · min -1 at 200 nm . Results The linearity of fentanyl citrate was 40 ~ 2000μg · L-1 (r = 0.9997), the recoveries were in the range of 85.3% -101.6%. The extraction recoveries of low, middle and high concentrations of milk were = 5) were 62.7%, 66.3%, 65.6%, respectively. RSD (n = 5) was 8.11%, 6.72% and 4.83% respectively. The recoveries were 86.1%, 96.4% and 103.7% RSD of intra-day and inter-day precision of less than 12%. Conclusion This method is simple, sensitive, accurate and reproducible. It can meet the clinical determination of the concentration of fentanyl in milk and can be used to study the concentration distribution of fentanyl in milk.