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...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。展开更多
We in this paper give a decomposition concerning the general matrix triplet over an arbitrary divisionring F with the same row or column numbers. We also design a practical algorithm for the decomposition of thematrix...We in this paper give a decomposition concerning the general matrix triplet over an arbitrary divisionring F with the same row or column numbers. We also design a practical algorithm for the decomposition of thematrix triplet. As applications, we present necessary and suficient conditions for the existence of the generalsolutions to the system of matrix equations DXA = C1, EXB = C2, F XC = C3 and the matrix equation AXD + BY E + CZF = Gover F. We give the expressions of the general solutions to the system and the matrix equation when thesolvability conditions are satisfied. Moreover, we present numerical examples to illustrate the results of thispaper. We also mention the other applications of the equivalence canonical form, for instance, for the compressionof color images.展开更多
文摘目的: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。
基金supported by National Natural Science Foundation of China (GrantNo. 60672160)the Ph.D. Programs Foundation of Ministry of Education of China (Grant No. 20093108110001)+3 种基金the Scientific Research Innovation Foundation of Shanghai Municipal Education Commission (Grant No. 09YZ13)the Netherlands Organization for Scientific Research (NWO)Singapore MoE Tier 1 Research Grant RG60/07Shanghai Leading Academic Discipline Project (Grant No. J50101)
文摘We in this paper give a decomposition concerning the general matrix triplet over an arbitrary divisionring F with the same row or column numbers. We also design a practical algorithm for the decomposition of thematrix triplet. As applications, we present necessary and suficient conditions for the existence of the generalsolutions to the system of matrix equations DXA = C1, EXB = C2, F XC = C3 and the matrix equation AXD + BY E + CZF = Gover F. We give the expressions of the general solutions to the system and the matrix equation when thesolvability conditions are satisfied. Moreover, we present numerical examples to illustrate the results of thispaper. We also mention the other applications of the equivalence canonical form, for instance, for the compressionof color images.