Drug Test Anal. 2013 May;5(5):380-3. doi: 10.1002/dta.1457. Epub 2013 Jan 21.
Quality assurance of pharmaceutical products is of particular importance and thoroughly controlled. Among these, the preparation of human plasma follows strict guidelines from the point of donor selection to product processing. While various precautions particularly concerning antiviral treatment as well as quality assessment are standard procedure, tests for drug residues are rarely, if at all, conducted with fresh frozen plasma products. With the constantly increasing sensitivity and specificity of modern analytical instruments, the detection of trace amounts of therapeutics in plasma is feasible and can be applied to blood products where considered appropriate. To estimate the prevalence of a selection of commonly prescribed and over-the-counter drugs (including diuretics, beta-receptor blocking agents, contraceptives, β2 -agonists, antibiotics, antidepressants, analgesics, opioids, glucocorticosteroids, benzodiazepines, stimulants, and oral anti-diabetics) as well as cannabinoids in human donor plasma, a total of 100 specimens (61 female, 39 male) collected at the German Red Cross Organization in 2012 was subjected to an established analytical approach. The methodology was based on protein precipitation followed by liquid chromatographic-high resolution/high accuracy mass spectrometric analysis. Following initial test results, confirmatory analyses were conducted with respective reference substances employing a conventional liquid chromatography-triple-quadrupole mass spectrometer (LC-MS/MS) apparatus. Out of one hundred samples, five were found to contain diuretics (four hydrochlorothiazide and one torasemide), five contained beta-receptor blocking agents (four bisoprolol and one metoprolol), one was found with residues of pseudoephedrine (stimulant) and one with drosperinone (contraceptive). Overall, 12% of samples yielded detectable amounts of drug residues at concentrations estimated to levels common to individuals under therapeutic treatment. In addition, six aliquots of different lots of commercially available plasma preparations with solvent-detergent processing were tested. Here, no drug residues of the targeted therapeutics were detected.
药品质量保证尤为重要，需要进行严格的控制。其中，人血浆的制备需要从供体选择到产品加工都遵循严格的指导原则。虽然各种预防措施，特别是抗病毒治疗和质量评估，是标准程序，但很少对新鲜冷冻血浆产品进行药物残留测试。随着现代分析仪器的灵敏度和特异性不断提高，检测血浆中痕量治疗药物是可行的，并可应用于认为合适的血液制品。为了评估 100 份（61 名女性，39 名男性）于 2012 年在德国红十字组织采集的人供体血浆中选定的常用处方和非处方药（包括利尿剂、β受体阻滞剂、避孕药、β2-激动剂、抗生素、抗抑郁药、镇痛药、阿片类药物、糖皮质激素、苯二氮䓬类药物、兴奋剂和口服抗糖尿病药）以及大麻素的流行率，采用建立的分析方法对这些样本进行了分析。该方法基于蛋白沉淀，然后进行液相色谱-高分辨/高精度质谱分析。在初始测试结果之后，使用常规液相色谱-三重四极杆质谱（LC-MS/MS）仪器，采用各自的参考物质对确证分析进行了检测。在一百个样本中，有五个样本含有利尿剂（四个氢氯噻嗪和一个托拉塞米），五个样本含有β受体阻滞剂（四个比索洛尔和一个美托洛尔），一个样本含有伪麻黄碱（兴奋剂）残留，一个样本含有屈螺酮（避孕药）残留。总的来说，12%的样本中检测到药物残留，浓度估计与接受治疗的个体的治疗水平相当。此外，还对六种不同批次的市售经溶剂-去污剂处理的血浆制剂进行了测试。在这些样本中，未检测到目标治疗药物的药物残留。
