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AssigneeShenzhen Neptunus Pharmaceutical Holdings Co., Ltd
InventorsHui Kang, Jinhua Zhao, Guanghui Yao, Weizhen Zeng, Milai Yin, Yong Li, Cunfang Wang, Lijuan Zhang, Dan Zhu, Hong Chen, Chuangui Huang, Yu Man, Jing Li, Hanlin Feng, Lin Yu
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The present invention relates to a novel crystalline form of a Compound 3,4′,5-trihydroxy-stilbene-3-β-D-glucoside (polydatin) and a method of preparation and use thereof, and to a pharmaceutical composition containing crystalline form I of 3,4′,5-trihydroxy-stilbene-3-β-D-glucoside. Crystalline form I of 3,4′,5-trihydroxy-stilbene-3-β-D-glucoside of the present invention has a stable crystalline morphology, a definite melting point and a good chemical stability. Such a novel form of 3,4′,5-trihydroxy-stilbene-3-β-D-glucoside possesses the properties required for the preparation of solid formulations and is easily tabletable and readily formable when formulated, which allows for substantial decrease in raw materials costs, more facile operations in production and easier control over quality in industrial drug production, and moreover, better convenience in storage.
Isolated single crystalline form I of 3,4′,5-trihydroxy-stilbene-3-β-D-glucoside, characterized in that said crystalline form exhibits a maximum DSC endotherm falling within the range of 225° C. to 228° C., and when detected by X-ray powder diffraction (XRD) using a Cu radiation source exhibits a XRD spectrum which at least comprises characteristic diffraction peaks with a distance of crystal face (d-value) of 5.27±0.2, 5.05±0.2, 4.49±0.2, 4.16±0.2 and 3.84±0.2 Å respectively.
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