摘要
目的:建立药用复合膜加工助剂的残留溶剂谱,用以快速分析溶剂来源,方便指导生产工艺的改进。方法:采用气相色谱-质谱联用测定法对某企业38批药用复合膜的原辅料(油墨、溶剂、粘合剂)中的32种残留溶剂进行筛查分析,同时测定7批终产品中的残留溶剂,通过来源分析,针对性改进生产工艺,以降低溶剂残留量。结果:建立了该企业原辅料的残留溶剂谱,在终产品中找到10种残留溶剂,其中占比超过1%的溶剂有5种。分析来源并改进相关生产工艺后,溶剂残留总量明显下降。结论:建立原辅料的残留溶剂谱,有利于药用复合膜的质量控制。
Objective:To establish the residual solvent spectrum of the processing aids of the medicinal composite films,to quickly analyze the source of solvents and guide the improvement of the production process.Methods:Thirty-two kinds of residual solvents in 38 batches of raw and auxiliary materials(ink,solvent,adhesive)of medicinal composite films in an enterprise were screened and analyzed by gas chromatography-mass spectrometry.At the same time,the residual solvents in 7 batches of final products were determined.Through source analysis,the production process was improved to reduce the residual solvents.Results:The residual solvents spectrum of raw and auxiliary materials was established,and 10 kinds of residual solvents were found in the final products,among which the content of 5 residual solvents were more than 1%.After analyzing the source and improving the relevant production process,the total amount of residual solvents decreased significantly.Conclusion:The establishment of residual solvents spectrum of raw and auxiliary materials is beneficial to the quality control of medicinal composite films.
作者
陈超
刘珊
梁健谋
程磊
CHEN Chao;LIU Shan;LIANG Jian-mou;CHENG Lei(Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial,Hangzhou 310051,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2021年第12期2159-2170,共12页
Chinese Journal of Pharmaceutical Analysis
