磷霉素钙的晶型稳定性研究

刘会会; 郑玉林; 陈玉双; 刘永杰; 丁澦

doi:10.13748/j.cnki.issn1007-7693.2022.03.015

磷霉素钙的晶型稳定性研究

Study on the Crystal Stability of Fosfomycin Calcium

摘要

摘要: 目的对磷霉素钙晶型稳定性进行研究。方法将磷霉素钙分别置于对应环境中，制备样品后进行粉末X射线衍射（powder X-ray diffraction，PXRD）、差示扫描量热法分析（differential scanning calorimetry，DSC）、电镜扫描（scanning electron microscopy，SEM）以及热解重量分析（thermogravimetric analysis，TGA），对磷霉素钙晶型进行表征。结果磷霉素钙存在结晶型和无定型2种晶型，结晶型磷霉素钙在相对湿度（relative humidity，RH）92.5%放置30 d、150℃以下加热2 h，晶型稳定。结论结晶型磷霉素钙原料晶型稳定，与参比制剂一致，可以满足湿法制粒、流化床制粒对湿度和温度的要求，在一致性评价中，应当选择结晶型磷霉素钙作为制剂原料。

Abstract: OBJECTIVE To study the crystal stability of fosfomycin calcium. METHODS Phosphoromycin calcium was prepared in the corresponding environment and the sample was prepared by powder X-ray diffraction(PXRD), differential scanning calorimetry(DSC), scanning electron microscopy(SEM) and thermogravimetric analyzer(TGA) to characterize the fosfomycin calcium crystal form. RESULTS There were two crystal forms of fosfomycin calcium, crystalline and amorphous. The crystal form of fosfomycin calcium was stable under the conditions of relative humidity(RH) 92.5% for 30 d and 150℃ heating for 2 hours. CONCLUSION The crystal form of the crystalline fosfomycin calcium is stable, which can meet the humidity and temperature requirements of wet granulation and fluidized bed granulation. In the consistency evaluation, crystalline fosfomycin calcium should be selected.

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