首页> 外国专利> Particulate composition containing anhydrous crystalline 2-O--D-glucosyl-L-ascorbic acid, process for producing the same, and uses thereof

Particulate composition containing anhydrous crystalline 2-O--D-glucosyl-L-ascorbic acid, process for producing the same, and uses thereof

机译:包含无水结晶2-O-D-葡糖基-L-抗坏血酸的颗粒组合物,其制备方法及其用途

摘要

Disclosed are a particulate composition containing an anhydrous crystalline ascorbic acid 2-glucosid, a preparation method and a use thereof, wherein the particulate composition of the invention is significantly difficult to consolidate in comparison with the commonly used powder containing an anhydrous crystalline ascorbic acid 2-glucosid of quasi-drugs. Specifically, the particulate composition of the invention contains about 98.0 to about 99.9 wt% of ascorbic acid 2-glucosids based on anhydrides. The anhydrous crystalline ascorbic acid 2-glucosids contained in the composition has the crystallinity of more than 90% calculated based on the profile of X-Ray powder diffractometry or has dynamic vapor sorption of less than or equal to 0.01 wt% after free moisture in the powder is removed under the atmosphere of nitrogen and the remaining is kept for 12 hours at the temperature of 25C and relative humidity of 35 wt%. Provided is a particulate composition containing about 98.0 to about 99.9 wt% of anhydrous crystalline 2-O--D-glucosyl-L-ascorbic acid, which has dynamic vapor sorption of less than or equal to 0.01% after free moisture in the powder is removed under the atmosphere of nitrogen and the remaining is kept for 12 hours at the temperature of 25C and relative humidity of 35 wt%, contains D-glucoses and/or L-ascorbic acid, and has a reducing power of less than 1% over the composition.
机译:公开了一种包含无水结晶抗坏血酸2-葡萄糖苷的颗粒组合物,其制备方法和用途,其中与通常使用的包含无水结晶抗坏血酸2-葡萄糖的粉末相比,本发明的颗粒组合物明显难以固化。准药物的葡糖苷。具体地,本发明的颗粒组合物包含基于酸酐的约98.0至约99.9重量%的抗坏血酸2-葡糖苷。组合物中所含的无水结晶抗坏血酸2-葡糖苷具有基于X-射线粉末衍射仪的轮廓计算的大于90%的结晶度,或者在自由湿气中具有小于或等于0.01wt%的动态蒸气吸附。在氮气气氛下除去粉末,将剩余的粉末在25℃的温度和35wt%的相对湿度下保持12小时。提供了一种颗粒组合物,其包含约98.0至约99.9重量%的无水结晶2-O-D-葡糖基-L-抗坏血酸,在粉末中的自由水分被除去后,其动态蒸气吸附小于或等于0.01%。在氮气气氛中除去,剩余的在25℃的温度和35%重量的相对湿度下保持12小时,含有D-葡萄糖和/或L-抗坏血酸,并且在还原过程中还原力小于1%。组成。

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