Wallemacq Pierre E, Capron Arnaud, Vanbinst Roger, Boeckmans Eric, Gillard Jean, Favier Bertrand
Clinical Chemistry Department, University Hospital St. Luc, Université Catholique de Louvain, 10 Hippocrate Avenue, B-1200 Brussels, Belgium.
Am J Health Syst Pharm. 2006 Mar 15;63(6):547-56. doi: 10.2146/ajhp050197.
The permeability of 13 different gloves to 13 cytotoxic agents under controlled dynamic conditions is described.
Thirteen cytotoxic agents were prepared at the highest concentrations normally encountered by pharmacy personnel. Four glove types--neoprene, natural rubber latex, nitrile, and vinyl--were exposed to the cytotoxic agents for 15, 30, and 60 minutes. Tests were conducted using the middle finger of each glove. Linearity, reproducibility, and sensitivity were evaluated for each drug tested. Assays were run using liquid chromatographic tandem mass spectrometry (LC/MS/MS) and high-performance liquid chromatography with ultraviolet light (HPLC-UV). Permeability testing was conducted using an original system designed to evaluate dynamic constraints, such as rubbing, stretching, and tension.
Linearity by LC/MS/MS and HPLC-UV was confirmed at concentrations up to 1000 ng/mL for all drugs. Most glove materials were permeable at rates below ASTM recommendations over the one-hour testing period. Vinyl was the most permeable material. Carmustine permeated the widest variety of materials. Due to the high sensitivity of the analytic methods, all materials displayed low but significant permeability for at least one drug after one hour. Higher resistance to permeation was recorded for all neoprene, some natural rubber latex, and one nitrile glove.
Neoprene, natural rubber latex, and nitrile gloves displayed the highest resistance to permeation of the 13 cytotoxic agents studied. Additional factors, such as duration of exposure, glove thickness, and drug liposolubility and molecular weight, also affected permeability.
描述13种不同手套在可控动态条件下对13种细胞毒性药物的渗透性。
以药剂人员通常遇到的最高浓度配制13种细胞毒性药物。将氯丁橡胶、天然橡胶乳胶、腈类和乙烯基4种手套类型暴露于细胞毒性药物中15、30和60分钟。使用每只手套的中指进行测试。对每种测试药物评估线性、重现性和灵敏度。使用液相色谱串联质谱法(LC/MS/MS)和带紫外光的高效液相色谱法(HPLC-UV)进行测定。渗透性测试使用专门设计的系统进行,该系统可评估诸如摩擦、拉伸和张力等动态因素。
对于所有药物,LC/MS/MS和HPLC-UV在浓度高达1000 ng/mL时均证实具有线性。在一小时的测试期内,大多数手套材料的渗透率低于ASTM建议值。乙烯基是渗透性最强的材料。卡莫司汀能渗透多种材料。由于分析方法的高灵敏度,所有材料在一小时后对至少一种药物均表现出低但显著的渗透性。所有氯丁橡胶手套、部分天然橡胶乳胶手套和一副腈类手套对渗透的抵抗力更高。
氯丁橡胶、天然橡胶乳胶和腈类手套对所研究的13种细胞毒性药物表现出最高的抗渗透性。其他因素,如暴露持续时间、手套厚度、药物脂溶性和分子量,也会影响渗透性。