研究背景： 賦形劑是常久以來在製藥時加入成為藥物的一部分之不活化物質，且一般認為它不具藥理活性的。
然而，由於新生兒或嬰兒的肝及腎功能未健全，有愈來愈多證據顯示有些賦形劑的使用對他們也許並不安全，最終導致此成分累積體內及產生毒性。
方法： 透過Medline 2.0 資料庫進行文獻檢索，使用下列搜索詞：drug additive、toxicity；drug additive、poison；excipient、toxicity 以及excipient、poison，搜索期間1860 至2014 年5月。我們分別搜索到不同篇數的相關期刊。這些期刊的摘要一一的檢閱而曾經導致毒性的賦形劑就被記錄，然後我們將前述賦形劑透過相同資料庫與toxicity 進行文獻檢索。最後，我們依不同搜索詞而得到不同數量的期刊，這些期刊的摘要一一的檢閱而曾經導致嚴重毒性或不建議用於新生兒或嬰兒的賦形劑則被記錄。
結果： Benzyl alcohol、propylene glycol 及ethanol 於成人用藥中是安全的賦形劑，可是發現於此族群曾導致嚴重毒性甚至死亡。parabens 及sodium metabisulphite 的使用則尚無定論。
結論： 病危新生兒或嬰兒，尤其正接受多劑量或連續輸液式的藥物治療是高風險群。經常觀察及評估此族群病人藥物使用是用藥安全的重要一環。
Background: Excipients, inactive substances formulated alongside the pharmaceutical compound, have long been added to be part of drugs, and considered inert and pharmacologically inactive. However,as infants have immature hepatic and renal function, there have been more and more evidence suggesting some excipients may not be safe for infants, leading to their accumulation and resultant toxicity.
Methods: Literature retrieval was accessed through Medline 2.0 database (1860 to May 2014) using the search terms: drug additive and toxicity; drug additive and poison; excipient and toxicity; and excipient and poison. We found different numbers of journals respectively. Abstracts of these journals were reviewed, and excipients which had caused toxicity were recorded, and then we matched each excipient discovered with “toxicity,” through search of the same database,and found different numbers of journals related to the assorted matched pairs. Abstracts of these journals were reviewed again, and excipients, which had caused major toxicity or are not recommended for use in infants, were recorded.
Results: Benzyl alcohol, propylene glycol, and ethanol, as safe excipients in medicines for adults,were noted to have induced major toxicity or even death in infants. Parabens and sodium metabisulphite drew inconclusive results.
Conclusion: Critically ill infants, especially those receiving multiple doses or medication by continuous infusion are at great risk. Constant observation and evaluation of medication used in infants is essential for drug safety.
