生物制品用辅料蔗糖中颗粒杂质体外补体激活研究  

Study on the complement activation of particle impurity in sucrose for biological products

作　　者：王珏[1] 江颖 肖新月[1] 杨锐[1] 孙会敏[1] WANG Jue;JIANG Ying;XIAO Xinyue;YANG Rui;SUN Huimin(National Institutes for Food and Drug Control,Beijing 100050,China;Evaluation and Verification Center for Medical Equipment and Cosmetics of Shanghai,Shanghai 200020,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《药学研究》2022年第3期149-152,共4页Journal of Pharmaceutical Research

摘　　要：目的对蔗糖中颗粒杂质进行提取制备并进行体外补体激活研究。方法超滤法提取制备蔗糖中的颗粒杂质并对其进行粒子表征;以巨噬细胞为模型使用ELISA法测定颗粒杂质激活细胞的C3a、C5a、C4a和Bb的表达水平。结果蔗糖中颗粒杂质可促进C3a的产生,激活C5转化酶,产生C5a,提高C4a和Bb的表达。结论蔗糖中的颗粒杂质能够激活巨噬细胞的补体,进行质量控制时应关注其中的颗粒杂质。Objective To extract and prepare particle impurity in sucrose and study the in vitro complement activation.Methods The particle impurity in sucrose was extracted and prepared by ultrafiltration and their particle sizes were characterized.The macrophage in vitro complement activation model was established to compare and analyze the complement activation of the particle impurity in sucrose by ELISA,and the levels of two key signaling molecules C3a and C5a of complement pro-inflammatory characteristics were quantified,and levels of C4a and Bb were measured.Results The insoluble particles in sucrose were nano-sized,and promoted the production of C3a,activated C5 invertase,produced C5a,and increased the expression of C4a and Bb.Conclusion Granular impurities in sucrose could activate the complement of macrophages in vitro,thus they should be paid attention to in the quality control of sucrose for use of biologic products.

关 键 词：蔗糖 生物制品 辅料 颗粒 补体激活 

分 类 号：R945[医药卫生—微生物与生化药学]