摘要
目的综述胸腺肽制剂概况及其质量安全存在的问题,为胸腺肽的进一步研究提供参考。方法查阅相关文献,整理胸腺肽制剂质量标准及其质量安全存在的问题,对其进行归纳总结。结果胸腺肽临床上常用的剂型有片剂、胶囊剂和注射剂3种。胸腺肽制剂的生产工艺相差较大,导致其有效性差别大。现行胸腺肽制剂的质量标准不全面,缺乏必要的安全性指标,需要进一步完善。例如,生物胺、兽药残留、重金属、致病微生物和病毒等有害物质,均可增加胸腺肽制剂临床应用的安全风险。结论整理和总结胸腺肽制剂质量现状及存在的问题,为研究胸腺肽制剂质量及安全风险提供参考。
Objective To review the recent research advances in thymosin preparation and existing problems of its quality and safety,and to provide reference for the further research.Methods The relevant literatures and data of thymosin preparation and existing problems of its quality and safety and its preparations were collected and summarized.Results The commonly used dosage forms of thymosin are tablets,capsules and injections.The production process of thymosin preparation is quite different,which leads to the difference of its effectiveness.The current quality standard of thymosin preparation is not comprehensive,which needs to be further improved and safety indexes should be added.Biological amines,veterinary drugs,heavy metals,pathogenic microorganisms and viruses may increase the risks of thymosin preparation in clinical application.Conclusion The existing problems of thymosin preparation were summarized to provide reference for the study of thymosin preparation and its quality and safety.
作者
陈小英
杨亚婷
王嫦鹤
刘海静
CHEN Xiaoying;YANG Yating;WANG Changhe;LIU Haijing(Shaanxi University of Chinese Medicine,Xianyang 712046,China;Shaanxi Institute for Food and Drug Control,Xi an 710065,China)
出处
《西北药学杂志》
CAS
2022年第1期156-159,共4页
Northwest Pharmaceutical Journal
基金
国家科技重大专项重大新药创制项目(编号:2017Z09101001)
陕西省创新能力支撑计划项目(编号:2020PT-041)。
关键词
胸腺肽制剂
生产工艺
质量标准
安全风险
thymosin preparation
production process
quality standard
safety risk
