摘要
目的:对生长抑素在新生产工艺下产生的有关物质进行分析,并对原料及制剂进行稳定性研究。方法:通过HPLC、制备液相色谱以及超高效液相色谱-飞行时间质谱串联系统等设备对有关物质进行分离、收集、定性及结构解析。此外,对生长抑素及制剂通过高温、光照、氧化以及酸解破坏实验进行了稳定性研究。结论:通过稳定性研究,结合生长抑素及其制剂的生产工艺可知,生长抑素在新的生产工艺过程中会产生新的工艺杂质。本研究为药典标准修订提供了依据。
Objective:To analyze the related substances produced in new production process of somatostatin,and the stability of raw materials and preparation was studied.Methods:The related substances were separated,collected,characterized and analyzed by high performance liquid chromatography,preparative liquid chromatography and ultra performance liquid chromatography-time-of-flight mass spectrometry tandem system.In addition,the stability of somatostatin and its preparation was studied under high temperature,light,oxidation and acidolysis destruction conditions.Conclusion:Based on the stability study combined with the production process of somatostatin and its preparation,somatostatin will produce new impurities in the new production process.This study provides a basis for revising pharmacopoeia standards.
作者
张伟
张慧
梁成罡
ZHANG Wei;ZHANG Hui;LIANG Cheng-gang(Division of Hormone,National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Researchand Evaluation of Chemical Drugs,Beijing102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第1期80-85,共6页
Chinese Journal of New Drugs
基金
国家药典委员会药品标准制修订研究课题(2020H012)。
关键词
生长抑素
新生产工艺
有关物质
稳定性
somatostatin
new production process
related substances
stability
