蛋白質在水溶液中容易分解破壞失去活性,故不容易長久保存。乾燥去水之蛋白質製劑為目前主要的保存方法,本計劃擬提出以噴霧乾燥(spray-drying)方式進行蛋白質製劑之保存,噴霧乾燥目前廣泛應用於藥品之製劑流程,可結合乾燥與造粒於單一流程,溫度之控制及保護劑之加入仍為操作重點。本計劃將以抗氧化酵素,包括過氧化氫酵素及胳胱甘過氧化酵素為模型蛋白質。這些酵素為自由基特異性清除劑,對生物體可發揮有效的防禦作用。在肺部,自由基可造成平滑肌收縮及細胞增生,與氧化還原酵素交互作用,並造成基因破壞,導致老化及癌症等,可由外界給予抗氧化酵素以作治療。本研究將著重抗氧化酵素之活性於噴霧乾燥(spray-drying)過程之維持及相關機轉之探討。
本研究中電子光譜化學分析可用於分析蛋白質藥物微脂粒粉末表面之元素組成。此粉末表面組成可反應蛋白質於空氣/液體界面之組成。並可配合掃描式電子顯微鏡(scanning electron microscope)以呈現抗氧化酵素於微脂粒中之葡萄乾狀結構。 Oxygen-mediated free radicals interact with cellular lipids, proteins, carbohydrates, and nucleic acids. Such free radical-mediated injury may result in a long list of diseases. The antioxidant enzymes convert these free radicals to less reactive or non-toxic molecules. The antioxidant enzymes convert these free radicals to less reactive or non-toxic molecules. In this study, we aim to develop stable spray-dried liposome dosage forms of antioxidant enzymes to keep long-term activity. The surface characterization of liposomal antioxidant enzymes using ESCA showed that the proteins were well protected by the lipid components. The SEM image of this formulation demonstrated a rasin-like structure.