近年來注射劑的安全性問題引起了社會(huì)各界的廣泛關(guān)注，注射用輔料引發(fā)的類過敏反應(yīng)是導(dǎo)致注射劑臨床使用安全隱患的主要原因之一，而目前尚未建立完善的可用于評(píng)價(jià)注射用輔料類過敏反應(yīng)的非臨床研究方法。對(duì)近年來國內(nèi)外在該方面的研究進(jìn)展做一綜述，旨在為注射用輔料類過敏反應(yīng)非臨床評(píng)價(jià)方法的發(fā)展提供一些幫助和啟示。

The safety issues of injection have evoked more public concern recently. Pseudoallergy induced by injective excipient is one of the main causes. However, non-clinical evaluation methods for this have not yet developed well. This paper reviewed the progress in this field in order to get more recognition for non-clinical evaluation of pseudoallergy induced by injective excipient.

科技部“十一五”國家科技支撐計(jì)劃重點(diǎn)項(xiàng)目——藥用新輔料臨床前安全性評(píng)價(jià)及藥品與包裝材料的相容性安全研究（2008BAI55B03）