目的：研究不同類別及廠家的聚山梨酯80直接刺激肥大細(xì)胞RBL-2H3脫顆粒的作用，為建立完善的注射用輔料引發(fā)類過敏反應(yīng)的篩選評(píng)價(jià)體系提供依據(jù)。方法：以不同劑量的聚山梨酯80處理RBL-2H3細(xì)胞，測(cè)定β-氨基己糖苷酶釋放量，并通過MTT法進(jìn)一步研究有脫顆粒作用的受試物對(duì)RBL-2H3細(xì)胞的毒性作用。結(jié)果：8種聚山梨酯80樣品具有不同程度的直接刺激RBL-2H3細(xì)胞脫顆粒的作用，且呈濃度依賴性，其中上海試劑采購供應(yīng)站提供的受試物作用極強(qiáng)，威爾制藥口服級(jí)受試物作用較強(qiáng)，威爾制藥A、威爾制藥B、威爾制藥注射級(jí)、威爾制藥4個(gè)受試物作用相近，2個(gè)進(jìn)口品種的作用略弱。在產(chǎn)生直接刺激RBL-2H3細(xì)胞脫顆粒作用的濃度下，上海試劑采購供應(yīng)站的聚山梨酯80有明顯的細(xì)胞毒性，并呈濃度依賴性。結(jié)論：聚山梨酯80能夠直接刺激RBL-2H3細(xì)胞脫顆粒，其作用強(qiáng)度不同反映了產(chǎn)品的質(zhì)量差異；上海試劑采購供應(yīng)站提供的聚山梨酯80直接刺激RBL-2H3細(xì)胞脫顆粒的作用可能由其細(xì)胞毒性引起。

Objective: To study directive effects of multiple kinds of injective excipients on the degranualation in rat mast cell line RBL-2H3 and to provide some indications for establishing a screening and evaluating method for pseudoallergy induced by different Tween 80. Methods: RBL-2H3 cells were cultured and treated with varying dose of Tween 80, and then the amount of releasing β-hexosaminidase was detected. MTT assay was demonstrated to determine the cytotoxicity of injective excipients which causing RBL-2H3 cells degranulation. Results: All of eight different Tween 80 products directly induced RBL-2H3 cells degranulation in a concentration-dependent manner while the degree of this effect was varying (Shanghai > Weier (oral) > Weier (A) = Weier (B) = Weier (injective) = Weier > Nof = Croda). Tween 80 (Shanghai) showed cytotoxicity effect in a concentration-dependent manner. Conclusion: Tween 80 can induce RBL-2H3 cells degranulation directly, and the degree of effect is related to the different quality among these products. Cell degranulation induced by Tween 80 (Shanghai) dues to its cytotoxicity.

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）