摘要
目的建立一种高效液相色谱法测定人血浆中吗替麦考酚酸的新方法,以进行吗替麦考酚酯的血药浓度监测。方法采用Phenomenex C18(4.6mm×150mm,5μm)色谱柱;甲醇-10mmol·L-1醋酸铵水溶液(95%水-5%甲醇)为流动相,比例为60:40;流速:1mL·min-1;柱温:25℃;紫外检测波长:250nm。结果当吗替麦考酚酸浓度在0.5～60mg·L-1时,其峰面积与浓度的线性关系良好(r=0.9995);高、中、低3个浓度的绝对回收率分别为93.80%,95.82%和98.14%,相对回收率分别为88.20%,99.50%和101.36%,日内及日间精密度的RSD均小于5%。目前采用此方法已测定20例重症肌无力患者谷浓度血样52份,大多数在1～3.5mg·L-1。临床观察的结果显示,吗替麦考酚酯可以改善患者的临床症状,85%患者的合并用药减少,一些患者有轻度的不良反应,但是所有患者未发生严重的不良反应。结论本方法测定结果准确、方法简便,可用于患者的血药浓度监测。
OBJECTIVE To establish a new HPLC method for the determination ofmycophenolic acid in human plasma, for therapeutic drug monitoring of mycophenolate mofetic（MMF） .METHODS The determination by HPLC was carried out using Phenomenex q8 （4.6 mm×150 mm, 5 μm） column, with mobile phase of methanol-10 nun ammonium acetate in 95% water and 5% methanol （60 ： 40） at a flow rate of 1 mL.min1. The detection wavelength was 250 nmol·L^-1. RESULTS Excellent linear correlation was established within the range of 0.5-60 mg·L^-1 （r=0.999 7）. The absolute recovery of high, middle and low concentrations were 93.80%, 95.82% and 98.14%, respectively, and relative recoveries were 88.20%, 99.50% and 101.36%, respectively.lntra-day RSDs and inter-day RSDs were less than 5%. This HPLC method was used in therapeutic drug monitoring for 52 blood samples of patients. The patient sample concentrations were 1-3.5 mg·L^-1. At the same time, the relationship of concentration, efficacy and adverse drug reaction of MMF was analyzed in 20 patients with myasthenia gravis. At the end of treatment, patients showed clinical improvement in different degrees and the dosage of combined medication in 85% patients was also decreased. No severe side effect was found in all patients. CONCLUSION This method is convenient and accurate, so it could be used in therapeutic drug monitoring of patients.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2009年第8期615-619,共5页
Chinese Pharmaceutical Journal
