Kumar Vineet, Kalonia Devendra S
Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, USA.
AAPS PharmSciTech. 2006 Jul 28;7(3):62. doi: 10.1208/pt070362.
The purpose of this study was to investigate the utility of vacuum drying for removing peroxides from polyethylene glycols (PEGs). PEG solutions (PEG 1450 and PEG 20000) containing varying levels of peroxides were prepared by storing under different light and temperature conditions. PEGs containing low and high levels of peroxides were vacuum dried from dilute and concentrated solutions (2.5%, 7.5%, 15%, and 50% wt/vol of PEG 1450 and 2.5%, 7.5%, 15%, and 25% wt/vol of PEG 20000). Ferrous ion oxidation in presence of ferric ion indicator xylenol orange (FOX) colorimetric assay was used to determine the concentration of peroxides. Peroxide content in PEGs increased upon storage. The increase was more pronounced when PEGs were stored at higher temperatures and exposed to light. Vacuum drying at 0.1 mm Hg for 48 hours at 25 degrees C resulted in greater than 90% decrease in the level of peroxides in all cases except when high peroxide containing 25% wt/vol solution of PEG 20000 or 50% wt/vol solution of PEG 1450 were dried. The reduction in the level of peroxides for PEGs dried from high peroxide containing 25% wt/vol solution of PEG 20000 and 50% wt/vol solution of PEG 1450 was found to be 88% and 52%, respectively. Oxidation of methionine in Met-Leu-Phe peptide was significantly reduced when vacuum-dried PEGs were used. Vacuum drying PEG solutions at low pressures is an effective method for the removal of the residual peroxides present in commercially available PEGs.
本研究的目的是探究真空干燥法去除聚乙二醇（PEG）中过氧化物的效用。通过在不同光照和温度条件下储存，制备了含有不同水平过氧化物的PEG溶液（PEG 1450和PEG 20000）。从稀溶液和浓溶液（PEG 1450的2.5%、7.5%、15%和50%重量/体积，PEG 20000的2.5%、7.5%、15%和25%重量/体积）中对含有低水平和高水平过氧化物的PEG进行真空干燥。采用在铁离子指示剂二甲苯酚橙（FOX）比色法存在下的亚铁离子氧化法测定过氧化物浓度。PEG在储存时过氧化物含量增加。当PEG在较高温度下储存并暴露于光照时，这种增加更为明显。在25℃下于0.1 mmHg真空干燥48小时，在所有情况下，除了干燥含有25%重量/体积的PEG 20000或50%重量/体积的PEG 1450的高过氧化物溶液外，过氧化物水平均降低了90%以上。发现从含有25%重量/体积的PEG 20000和50%重量/体积的PEG 1450的高过氧化物溶液中干燥的PEG，其过氧化物水平的降低分别为88%和52%。当使用真空干燥的PEG时，Met-Leu-Phe肽中甲硫氨酸的氧化显著减少。在低压下真空干燥PEG溶液是去除市售PEG中残留过氧化物的有效方法。
