Method for removing gas-phase impurities in sugammadex sodium, and method for preparing amorphous substance thereof

The present invention discloses a method for removing gas-phase impurities in sugammadex sodium. The method comprises steps such as water dissolving, distillation, drying and the like in mild conditions, and is suitable for mass production. The number and content of the gas-phase impurities in sugam...

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Hauptverfasser:	YANG GUANG, HE XIAOXIA, WANG ZHENG, WANG QI, HUO XIANGHONG, LIU QUN, QI HAOFEI, WANG QIANQIAN, BAI JUNPENG, HOU YUNZE, WANG JINGYI, XIAO YU, HU BAIYAN, WANG LICHUN, GAO HONG, MENG QIUYUE, LI FAGUANG
Format:	Patent
Sprache:	chi ; eng
Schlagworte:	CHEMISTRY COMPOSITIONS BASED THEREON DERIVATIVES THEREOF HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC MACROMOLECULAR COMPOUNDS POLYSACCHARIDES PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS THEIR PREPARATION OR CHEMICAL WORKING-UP
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Beschreibung
Zusammenfassung:	The present invention discloses a method for removing gas-phase impurities in sugammadex sodium. The method comprises steps such as water dissolving, distillation, drying and the like in mild conditions, and is suitable for mass production. The number and content of the gas-phase impurities in sugammadex pure sodium product prepared herein are superior to those in a previously developed product. The present invention further discloses a method for preparing an amorphous sugammadex sodium having high product stability and suitable for production. 本发明公开了一种去除舒更葡糖钠中气相杂质的方法，包括水溶、蒸馏和干燥等步骤，条件温和，适用于工业放大，制备得到的舒更葡糖钠纯品的气相杂质个数及含量优于原研制剂产品。本发明还进一步公开了一种无定型舒更葡糖钠的制备方法，产物稳定性高，适合制剂生产。