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中文摘要：
利用反应沉淀法进行了阿奇霉素微粉化的实验研究,考察了NaOH溶液浓度、搅拌速度、搅拌时间和反应温度等因素对产品粒度、形貌、分散性及收率的影响.分别采用扫描电镜（SEM）、比表面分析仪、X射线衍射仪（XRD）和红外光谱仪（FT-IR）对产品进行了分析与表征,并对微粉化产品和原料药进行了溶出性能研究.实验结果表明,利用此方法可以制备得到平均粒径约为413 nm的无定型阿奇霉素超微粉体,与原料药相比,微粉化的阿奇霉素粉体比表面积增加了约27倍,相应地,药物的溶出性能较原料药明显改善.
英文摘要：
Amorphous ultra-fine azithromycin （AZM） powder was prepared by a reactive precipitation method. The effects of the operation parameters, such as concentration of NaOH solution, stirring speed and time, and reaction temperature on the particle size, morphology, dispersion and yield of the products were experimentally investigated. The as-prepared particles were characterized by SEM, BET, XRD and FT-IR techniques. The dissolution rates of the ultra-fine products and commercial crude drug were also tested. The results indicated that ultra-fine AZM with a mean particle size of 413 nm could be obtained. The BET specific surface area of the micronized AZM product was about 27 times as much as that of the commercial crude drug. Furthermore, the as-prepared AZM ultra-fine particles exhibited a significantly enhanced dissolution property, compared with the raw materials.
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