药用辅料甘露醇的质量评价研究  

Quality analysis of pharmaceutical excipient mannitol

作　　者：郭雅娟 余少文[1] 王彩媚[1] 胡淑君 林嗣翔 陈英[1] GUO Yajuan;YU Shaowen;WANG Caimei;HU Shujun;LIN Sixiang;CHEN Ying(Guangdong Institute for Drug Control,CFDA Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州510663

出　　处：《中国药品标准》2023年第5期534-541,共8页Drug Standards of China

基　　金：广东省医学科学技术研究基金项目(B2023285)。

摘　　要：目的:评价不同来源甘露醇的理化质量属性和功能相关质量属性,分析国内外甘露醇产品的质量差距。方法:按照《中国药典》2020年版二部甘露醇标准方法对78批甘露醇样品进行质量分析;借助Flex SEM 1000扫描电子显微镜考察甘露醇的晶型与微观结构,探索性研究甘露醇的粒度、粉体流动性和可压性等功能相关质量指标,评价国内外甘露醇产品的质量差异。结果:78批样品中,87.2%的样品红外图谱为β晶型,其他样品显示为δ晶型或混晶。国产甘露醇有关物质控制情况略优于进口产品;功能相关属性研究显示甘露醇存在α、β、δ 3种晶型,晶型不同可导致微观结构的差异,可影响粉体的功能相关指标如流动性、压缩度等;同时了解到国外企业为了更好地进行处方筛选,结合甘露醇的用途和功能相关指标对产品进行了分型。结论:目前国产甘露醇产品在杂质控制方面优于进口产品;国外企业更关注甘露醇功能相关属性,这是国内外产品的主要差距,建议国内企业对甘露醇作为药用辅料的功能等相关属性与应用进行深入地开发研究,以提高产品附加值。Objective:To evaluate the physicochemical properties and functionalindicators of mannitol produced by different manufacturers,and analyze the differences of domestic and imported mannitol products.Methods:Seventy-eight batches of mannitol samples were determined according to the Chinese Pharmacopeia 2020 VolⅡmannitol statutory tests.The crystal form and microstructure of mannitol were investigated by flex SEM 1000scanning electron microscope,at the same time,the functional indicators such as particle size,powder fluidity and compressibility of mannitol were analyzed,and the differences of demestic and imported mannitol were evaluated.Results:In 78 batches of samples,the proportion ofβcrystal form was 87.2%,while the remaining wereδor mixture of different crystal forms.Domestic mannitol was slightly better than imported mannitol in related substances.Exploratory research showed that mannitol has three crystal forms:α,β,δ,different crystal forms have different morphology,which may affect the functional indicators of mannitol,such as powder fluidity,compressibility,and so on,in addition,imported mannitol manufacturers classify their products according to functional indicators and applications,which provides convenience to choose appropriate excipients.Conclusion:At present,the domestic mannitolis slightly are better than imported mannitol in related substances.Imported manufacturers pay more attention to the functional indicators of mannitol,which is the main gap between domestic and imported mannitol.It is suggested that domestic manufacturers should pay more attention to the functional indicators and applications of mannitol,put effort into product development,and improve product′s additional value.

关 键 词：甘露醇 评价性抽验 质量评价 晶型 功能属性 

分 类 号：R921.2[医药卫生—药学]