Particulate composition containing anhydrous crystalline 2-O-alpha -D-glucosyl-L-ascorbic acid, process for producing the same, and uses thereof
    5.
    发明公开
    Particulate composition containing anhydrous crystalline 2-O-alpha -D-glucosyl-L-ascorbic acid, process for producing the same, and uses thereof 有权
    一种颗粒组合物,包含无水结晶2-O-α-D-葡萄糖基-L-抗坏血酸,生产工艺及其用途

    公开(公告)号:EP2301944A1

    公开(公告)日:2011-03-30

    申请号:EP10175307.7

    申请日:2010-09-03

    IPC分类号: C07H17/04 C12P19/60

    摘要: The present invention aims to provide a particulate composition containing anhydrous crystalline 2-O- α -D-glucosyl-L-ascorbic acid having a significantly, hardly solidifiable property compared to conventional ones in a grade for use in quasi-drugs; a process for producing the same; and uses thereof. The present invention solves the above object by providing a particulate composition containing anhydrous crystalline 2-O- α -D-glucosyl-L-ascorbic in an amount of over 98.0% by weight but less than 99.9% by weight, on a dry solid basis; or a degree of crystallinity of 90% or higher for anhydrous crystalline 2-O- α -D-glucosyl-L-ascorbic acid, when calculated based on a profile of powder X-ray diffraction analysis of the particulate composition, and a dynamic vapor sorption level of 0.01% by weight or lower, when kept at 25°C under a relative humidity of 35% by weight for 12 hours after removal water in the particulate composition under nitrogen gas stream; and by providing a process for producing the same and uses thereof.

    摘要翻译: 本发明的目的是提供一种粒状组合物包含具有显着地,难以固结属性相比于用于准药物中使用的等级常规的无水结晶2-O-±D-葡萄糖基-L-抗坏血酸; 其制造方法; 及其用途。 本发明通过在按重量计,但小于99.9%的大于98.0%的量提供颗粒组合物包含无水结晶的2-O-±D-葡萄糖基-L-抗坏血酸的重量,以干固体基础上解决了上述目的 ; 或无水结晶2-O-±D-葡萄糖基-L-抗坏血酸,当基于颗粒组合物的粉末X射线衍射分析的轮廓计算和动态蒸气度为90%或更高的结晶度的 的0.01%吸附量重量或更低,当在25℃的35%的相对湿度下保持重量12小时中在氮气气流中的颗粒组合物去除水之后; 并通过其制造和提供的方法及其用途。