摘要
目的:为大孔吸附树脂的使用及质量控制提供参考和借鉴。方法:通过查阅、整理相关文献,从大孔吸附树脂的组成、应用原理以及影响树脂吸附性因素等方面对相关研究进行梳理,汇总大孔吸附树脂在中药领域中的应用研究,分析目前大孔吸附树脂的监管法规情况。结果与结论:大孔吸附树脂作为一款绿色、环保材料,在中药材、中药制剂方面的应用地位逐年上升,合理、规范地使用大孔吸附树脂在中药研究中具有重要意义。国内外对大孔吸附树脂溶剂残留问题有部分规定,但内容不全,部分品种无树脂残留检测,缺少树脂相关通用性技术指导原则,行业标准更新缓慢。因此,应规范大孔吸附树脂的生产,提高、完善大孔吸附树脂相关技术指导原则及标准,为合理、安全、可靠地使用大孔吸附树脂提供更有利的支持。
Objective:To provide references for the use and quality control of macroporous adsorption resin.Methods:By referring to and sorting out relevant literature,related researches were summarized on composition,application principles and influencing factors of macroporous adsorption resin, etc.,and the application research of macroporous adsorption resin in the field of traditional Chinese medicines was summarized.The current supervision and regulations of macroporous adsorption resin were analyzed.Results and Conclusion:As a green and environmental protection material,the application of macroporous adsorption resin in traditional Chinese medicines and traditional Chinese medicine preparations has been increased year by year.Reasonable and standardized use of macroporous adsorption resin in traditional Chinese medicines is of great significance to the research work.There are some regulations on solvent residues of macroporous adsorption resin at home and abroad,but the contents are incomplete.Some varieties do not have resin residue detection,and there is a lack of general technical guiding principles related to resins.The update of industry standards is slow.Therefore,it is necessary to standardize the production of macroporous adsorption resin,improve and perfect the technical guidelines and standards of macroporous adsorption resin so as to provide more favorable support for rational,safe and reliable use of macroporous adsorption resin.
作者
王丹丹
刘芫汐
左甜甜
昝珂
金红宇
Wang Dandan;Liu Yuanxi;Zuo Tiantian;Zan Ke;Jin Hongyu(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2022年第7期826-835,共10页
Chinese Pharmaceutical Affairs
关键词
大孔吸附树脂
型号
应用
法规
macroporous adsorption resin
model
application
regulations