A novel environmental friendly wheat seed coating agent was prepared from the natural polymer,biological pesticide,microfertilizer,microelements and other additives.The laboratory and field test results showed that it...A novel environmental friendly wheat seed coating agent was prepared from the natural polymer,biological pesticide,microfertilizer,microelements and other additives.The laboratory and field test results showed that it could enhance the yield up to 16% and reduce its input cost to 1/6 as compared with the conventional wheat seed coating agent.It is safe without causing any pollution and would have significant economic and environmental benefits.展开更多
目的对磺胺嘧啶锌软膏的质量现状进行综合评价。方法基于质量源于设计(quality by design,QbD)理念,建立HPLC法测定磺胺嘧啶锌软膏的含量、有关物质与抑菌剂含量,并开展水活度、抑菌效力、酸碱度、体外释放等相关探索性研究项目。采用...目的对磺胺嘧啶锌软膏的质量现状进行综合评价。方法基于质量源于设计(quality by design,QbD)理念,建立HPLC法测定磺胺嘧啶锌软膏的含量、有关物质与抑菌剂含量,并开展水活度、抑菌效力、酸碱度、体外释放等相关探索性研究项目。采用法定标准检验与探索性研究相结合,对国家药品抽检的29批次样品与调研企业收集的样品进行检验,并对测定结果统计分析与汇总,进而科学公正地评价其质量。结果法定标准检验结果显示,29批次磺胺嘧啶锌软膏的合格率为100%。探索性研究提示磺胺嘧啶锌软膏的处方仍有进一步优化的空间,可通过优化处方设计提高释放率和降低黏稠度,并选择合适的抑菌剂种类,增强对真菌的抑菌效力等改善产品疗效。同时,提示原料质量与软膏生产过程控制对软膏质量起着不容忽视的作用。现行标准中鉴别项有待优化,含量测定方法为永停滴定法,受基质干扰,新建专属性更强的HPLC法。结论目前磺胺嘧啶锌软膏整体质量一般,软膏和原料质量标准有待提高,建议企业优化处方设计,同时关注原料质量与软膏生产过程控制,从而全面提高产品质量。展开更多
基金supported by the Scientific and Tech-nological Project of Zhejiang Province,China (ZK-20061103)
文摘A novel environmental friendly wheat seed coating agent was prepared from the natural polymer,biological pesticide,microfertilizer,microelements and other additives.The laboratory and field test results showed that it could enhance the yield up to 16% and reduce its input cost to 1/6 as compared with the conventional wheat seed coating agent.It is safe without causing any pollution and would have significant economic and environmental benefits.
文摘目的对磺胺嘧啶锌软膏的质量现状进行综合评价。方法基于质量源于设计(quality by design,QbD)理念,建立HPLC法测定磺胺嘧啶锌软膏的含量、有关物质与抑菌剂含量,并开展水活度、抑菌效力、酸碱度、体外释放等相关探索性研究项目。采用法定标准检验与探索性研究相结合,对国家药品抽检的29批次样品与调研企业收集的样品进行检验,并对测定结果统计分析与汇总,进而科学公正地评价其质量。结果法定标准检验结果显示,29批次磺胺嘧啶锌软膏的合格率为100%。探索性研究提示磺胺嘧啶锌软膏的处方仍有进一步优化的空间,可通过优化处方设计提高释放率和降低黏稠度,并选择合适的抑菌剂种类,增强对真菌的抑菌效力等改善产品疗效。同时,提示原料质量与软膏生产过程控制对软膏质量起着不容忽视的作用。现行标准中鉴别项有待优化,含量测定方法为永停滴定法,受基质干扰,新建专属性更强的HPLC法。结论目前磺胺嘧啶锌软膏整体质量一般,软膏和原料质量标准有待提高,建议企业优化处方设计,同时关注原料质量与软膏生产过程控制,从而全面提高产品质量。