目的 建立注射用益氣復脈（凍干）藥品中氯化丁基橡膠塞用抗氧劑2，6-二叔丁基-4-甲基苯酚（BHT）和硫化劑對-特辛基苯酚的含量測定方法，并對其穩(wěn)定性進行考察。方法 采用ACQUITY UPLC BEH C₁₈柱，以乙腈-0.2%甲酸水為流動相梯度洗脫，體積流量0.3 mL/min，柱溫35℃，檢測波長280 nm。結(jié)果 BHT和對特-辛基苯酚質(zhì)量濃度在0.4～20μg/mL線性關(guān)系良好（r > 0.999）；準確度試驗平均回收率分別為99.3%、101.9%，精密度及耐用性結(jié)果均符合要求；注射用益氣復脈（凍干）穩(wěn)定性考察樣品中BHT和對-特辛基苯酚含量均小于限度值。結(jié)論 所建立的方法準確可靠，可用于注射用益氣復脈（凍干）中BHT和對-特辛基苯酚的含量測定。

Objective To establish a method for the content determination of antioxygen BHT and vulcanizing agent 4-tert-octylphenol in butyl rubber plug of Yiqi Fumai Lyophilized Injection and to investigate the stability of samples. Methods The chromatographic separation was achieved on the ACQUITY UPLC BEH C₁₈column using acetonitrile-0.2% formic acid water as mobile phase gradient elution, the flow rate was 0.3 mL/min, column temperature was 35℃, and the detection wavelength was 280 nm. Results Good linearity(r>0.999)was observed in the standard curves of BHT and 4-tert-octylphenol in the range of 0.4~20 μg/mL. The average recovery of BHT and 4-tert-octylphenol was 99.3% and 101.9%, respectively. The precision and durability results are in line with the requirements; the content of BHT and 4-tert-octylphenol in the study on the stability of Yiqi Fumai Lyophilized Injection sample was below the limit. Conclusion The established method was accurate and reliable and can be used for the determination of BHT and 4-tert-octylphenol in Yiqi Fumai Lyophilized injection.

天津市中藥注射劑關(guān)鍵技術(shù)校企協(xié)同創(chuàng)新實驗室建設項目（17PTSYJC00090）；天津市中藥注射劑新技術(shù)企業(yè)重點實驗室