Method for reducing content of substance related to injection torasemide

The invention discloses a method for reducing the content of substances related to injection torasemide. According to the technical scheme, a reasonable isoelectric point, a reducing agent and blending temperature are selected to reduce the content of related substances of the injection torasemide....

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: LIU NAISHAN, DONG HUIYI, HUANG XIAOYAN
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention discloses a method for reducing the content of substances related to injection torasemide. According to the technical scheme, a reasonable isoelectric point, a reducing agent and blending temperature are selected to reduce the content of related substances of the injection torasemide. According to the method, the content of related substances can be reduced to be less than 0.5% through steps of dissolving a torasemide raw material medicine, adjusting the pH value and filtering, the quality standard of the injection torasemide meets various indexes provided by national medicine standards, and the method disclosed by the invention has the advantages of being rapid in product dissolving speed, gentle in process condition, simple to operate and the like. 本发明公开了种降低注射用托拉塞米有关物质含量的方法,技术方案是选择合理的等电点和还原剂及配料温度来降低注射用托拉塞米有关物质含量。通过托拉塞米原料药溶解、调节pH、以及过滤的配滤步骤使有关物质的含量降低至0.5%以下,其质量标准符合国家药品标准所规定的各项指标,本发明方法具有产品溶解速度快、工艺条件温和、操作简单等优点。