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

申请人： Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo

发明人： Shibuya, Takashi ,  Izawa, Seisuke ,  Nishimoto, Tomoyuki ,  Fukuda, Shigeharu ,  Miyake, Toshio

IPC分类号： C07H17/04 ,  C12P19/60

CPC分类号： C12P19/60 ,  A23L33/10 ,  A23L33/15 ,  A61K8/0241 ,  A61K8/676 ,  A61K8/732 ,  A61K31/7048 ,  A61K2800/57 ,  A61K2800/654 ,  A61Q19/02 ,  C07H17/04 ,  Y10T428/2982

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。