三磷酸胞苷二钠晶体及其冻干粉针剂

Cytidine disodium triphosphate crystal and freeze-dried powder injection thereof

Abstract

本发明提供一种三磷酸胞苷二钠晶体,所述三磷酸胞苷二钠晶体使用Cu-Kα射线测量得到的X-射线粉末衍射谱图如图1所示。本发明所制备的三磷酸胞苷二钠晶体产品的纯度高,无机盐杂质少;具有良好的储存稳定性,不易吸湿变质,流动性好,制备成冻干粉针剂后装量精确;在冷冻干燥的过程中干燥温度低,避免受热分解;用药安全性大大提高;产品水分差异小,具有更小的批间差异,确保了产品质量的均一性。
The invention provides a cytidine disodium triphosphate crystal, of which an X-ray powder diffraction spectrogram obtained through Cu-K[alpha] ray measurement is represented as the picture 1. The cytidine disodium triphosphate crystal product is high in purity, is less in inorganic salt impurities, is excellent in storage stability, is not liable to absorb moisture and go bad and is good in flowability. The cytidine disodium triphosphate crystal, when being prepared into a freeze-dried powder injection, is accurate in measurement, is low in drying temperature during freeze drying, thereby avoiding thermal-decomposition and greatly improving drug safety. The cytidine disodium triphosphate crystal is less in moisture difference, is lesser in batch difference and is ensured in quality homogeneity.

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Patent Citations (2)

    Publication numberPublication dateAssigneeTitle
    CN-102757471-AOctober 31, 2012江西省康华医药科技有限公司Novel active cytidine disodium triphosphate compound and pharmaceutical composition thereof
    CN-103044509-AApril 17, 2013宁辉Gamma-cytidine-5'-disodium triphosphate crystal compound, and preparation method and drug composition of crystal compound

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