摘要
研究了聚乙烯吡咯烷酮(PVP)粉碎加工过程中残留单体N-乙烯基吡咯烷酮(NVP)升高的机理,并采用高温脱除法和动态负压脱除法对PVP粉末进行了处理,并采用高效液相色谱仪、乌氏黏度计、激光粒度仪和粉体性能测试仪等分析了不同残留单体脱除工艺对PVP粉末各项指标的影响。结果表明:动态负压脱除法可有效脱除PVP粉末中的残留NVP,处理3 h后NVP残留量由13.30 mg/kg降低至3.60 mg/kg,满足NVP残留量低于10 mg/kg的药典标准,且对PVP粉末外观、粒径和粉体性能等物理特性未产生明显影响。
The increase of the residual N-vinyl pyrrolidone(NVP)in the milling process of polyvinyl pyrrolidone(PVP)was studied.The PVP powder was treated by high temperature removal method and dynamic negative pressure removal method to remove the residual NVP.The treated PVP powder was analyzed by high performance liquid chromatography(HPLC),Ubbelohde viscometer,Laser diffraction particle size analyzers and powder performance tester.The results showed that the residual NVP in PVP powder was effectively removed by the dynamic negative pressure removal method,and the residual NVP was reduced from 13.30 mg/kg to 3.60 mg/kg after 3 h treated,which met the pharmacopoeia standard of residual NVP less than 10 mg/kg,while,the appearance,particle size and powder properties of PVP products had a negligible effect in this method.
作者
孙旭东
张森林
张军伟
吕久利
SUN Xudong;ZHANG Senlin;ZHANG Junwei;LV Jiuli(Boai NKY Medical Holdings Ltd.,Jiaozuo 454450,China)
出处
《化学反应工程与工艺》
CAS
2021年第4期345-350,共6页
Chemical Reaction Engineering and Technology
基金
2018年国家工业强基工程项目(TC180A3Y1-29)
焦作市第二届创新创业领军团队基金。
