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Preliminary Study on the Potential Utility of GFP as a Biosensor for Drug Stability in Parenteral Solutions

机译：GFP作为非肠道溶液药物稳定性生物传感器的潜在应用的初步研究

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In the health care setting,drugs added to large volume parenteral solutions (LVPS) are routinely administered to improve therapeutic effects and provide a faster clinical response.The development of analytical techniques that permit the detection of incompatibilities between drugs and parenteral solutions is necessary to guarantee their correct association with minimum adverse effects.Green fluorescent protein (GFP) has been used as a biological indicator of sterilization and disinfection processes because it exhibits a high thermal stability and is easily detected using UV light and spectrofluorometry.The response of GFP structure and/or protonation state to physicochemical changes in the solution favors its potential use as a biosensor for drug stability in parenteral solutions.The stability of the diuretic drugs furosemide and aminophylline,individually or combined,added to parenteral solutions of 20% mannitol and 0.9% NaCl was monitored by absorbance and RP-HPLC immediately and after 20 h of storage at room temperature,with and without 1 h exposure to a strong oxidant,H2O2.Changes in GFP fluorescence intensity were evaluated under the same conditions for purified GFP added to aliquots of the drug/LVPS solutions.Results show that GFP fluorescence intensity was proportional to the loss in drug stability over time and thus may potentially be added to a lot sample of a drug/parenteral solution as an immediate on-site test for defective product.
机译：在医疗保健环境中，常规使用添加到大剂量肠胃外溶液（LVPS）中的药物以改善治疗效果并提供更快的临床反应。必须开发分析技术以检测药物与肠胃外溶液之间的不相容性以确保绿色荧光蛋白（GFP）具有很高的热稳定性，易于使用紫外线和分光光度法检测，因此已被用作杀菌和消毒过程的生物学指标.GFP结构和/溶液的质子化或质子化状态有利于其作为非肠道溶液中药物稳定性的生物传感器。利尿剂速尿和氨茶碱的单独或组合的稳定性分别添加至20％甘露醇和0.9％NaCl的非肠道溶液通过吸光度和RP-HPLC进行监测在室温下保存20小时，有和没有暴露于强氧化剂H2O2的情况下，在相同条件下，将纯化的GFP添加到药物/ LVPS溶液的等分试样中，评估GFP荧光强度的变化。结果表明GFP荧光强度与药物稳定性随时间的损失成正比，因此有可能将其添加到很多药物/非肠道溶液样品中，作为对有缺陷产品的即时现场测试。

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