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目的:建立参芪扶正注射液大分子物质的检测方法,为评价其安全性提供依据。方法:采用超滤离心法分离参芪扶正注射液样品,采用MALDI-TOF-MS检测大分子物质,同时进行豚鼠全身主动过敏试验,根据大分子物质检测结果及过敏反应情况,分析两者之间的相关性。结果:参芪扶正注射液中间体存在分子量3800～4000 Da的大分子物质(植物蛋白与多糖),这些大分子物质会引起豚鼠过敏反应。经过生产过程的逐步除杂,大分子物质在参芪扶正注射液成品中已完全去除。结论:本研究建立了对参芪扶正注射液样品中大分子物质进行检测的方法,具有简便、实用等优点。
OBJECTIVE: To establish a method for the determination of macromolecules in Shenqi Fuzheng Injection, and provide a basis for evaluating its safety. Methods: The samples of Shenqi Fuzheng injection were isolated by ultrafiltration centrifugation. The macromolecules were detected by MALDI-TOF-MS. At the same time, the whole body active allergy test of guinea pigs was conducted. According to the detection results of macromolecules and the allergic reaction, Relevance. Results: There were macromolecules (plant proteins and polysaccharides) with the molecular weight of 3800-4000 Da in Shenqi Fuzheng injection intermediates. These macromolecules could cause allergic reaction in guinea pigs. After the gradual removal of the production process, macromolecular substances in Shenqi Fuzheng injection finished product has been completely removed. Conclusion: This study established a method for the determination of macromolecules in Shenqi Fuzheng injection samples, which has the advantages of simplicity and practicality.