摘要
目的:建立丹参破壁饮片物理属性的质量评价方法。方法:建立丹参破壁饮片的粒径分布和比表面积测定方法并进行方法学考察。以15个物理指标[D90(颗粒累积分布达90%时所对应的粒径),粒径分布范围,粒径分布宽度,松密度,振实密度,颗粒间空隙率,卡尔指数,比表面积,孔体积,休止角,平板角,豪斯纳比,明暗度L*,红绿色度a*,黄蓝色度b*]来表征丹参破壁饮片的质量属性和构建其物理指纹图谱。以相似度分析,聚类分析(CA),主成分分析(PCA)及正交偏最小二乘法-判别分析(OPLS-DA)等多元统计分析方法对不同年份生产的11批丹参破壁饮片(S1~S11)进行质量评价,找出样品批间差异性指标。结果:丹参破壁饮片的粒径分布和比表面积测定方法稳定可行、重复性良好。10批大生产样品(S1~S3,S5~S11)的物理指纹图谱与对照图谱的相似度均>0.85,但样品S4与对照图谱的相似度仅0.488;不同批次样品的物理属性指标有一定差异,其特征性差异指标分别为颗粒间空隙率、比表面积、孔体积、卡尔指数、粒径分布宽度、明暗度L*和黄蓝色度b*。结论:该方法可较为全面地评价丹参破壁饮片的物理质量属性,可反映药材本身物质基础差异或生产工艺对丹参破壁饮片成品物理性质的影响,从物理状态层面评价产品批间的质量一致性,为新型中药破壁饮片的质量控制研究提供新思路。
Objective: Taking ultrafine granular powder of Salviae Miltiorrhizae Radix et Rhizoma(UGPSMR)as the research object,to establish a method for evaluating its physical properties. Method: A method was established for measuring the particle size distribution and specific surface area of UGPSMR,and the methodological investigation was carried out. A total of 15 physical indicators[D90(particle size value when the cumulative particle distribution reaches 90%),particle size distribution range,particle size distribution width,bulk density,tap density,intergranular porosity,Carr index,specific surface area,pore volume,angle of repose,tablet angle,Hausner ratio,black to white degree L~*,red to green degree a~*,yellow to blue degree b~*]were used to characterize the quality attributes of UGPSMR and to construct the physical fingerprint.Multivariate statistical analysis methods such as similarity analysis,cluster analysis(CA),principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA)were used to evaluate the quality of 11 batches of UGPSMR(S1-S11)produced in different years,and to find out the difference index between samples from different batches. Result: The method for measuring the particle size distribution and specific surface area of UGPSMR was feasible and repeatable. The similarities between the physical fingerprint of 10 batches of samples(S1-S3,S5-S11)from production and control fingerprint of UGPSMR were above 0.85,but the similarity between sample S4 and the control fingerprint was only 0.488. There were some differences in physical property indicators between different batches of UGPSMR, and the characteristic difference indicators were intergranular porosity,specific surface area,pore volume,b~*,L~*,Carr index,particle size distribution width, respectively. Conclusion: This method can comprehensively evaluate the physical quality attributes of UGPSMR, and can reflect the effect of differences in material basis of the medicinal materials or production process on the physical properties of finished products,and can evaluate quality consistency between batches from the physical state level,which provides new ideas for the quality control of ultrafine granular powder of herbal medicine.
作者
张前亮
罗铮
邓雯
成金乐
ZHANG Qian-liang;LUO Zheng;DENG Wen;CHENG Jin-le(Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine,National Administration of Traditional Chinese Medicine,National and Local Joint Engineering Research Center for Ultrafine Granular Powder of Herbal Medicine,Zhongshan Zhongzhi Pharmaceutical Group Co.Ltd.,Zhongshan 528437,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2020年第23期145-152,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
广东省省级科技计划项目(2018B020207008)
广东省中药破壁饮片工程实验室项目(粤发改创新函[2018]3149号)
中山市协同创新中心项目(2016C1014)。
关键词
丹参破壁饮片
物理属性
粒径
综合质量评价
物理指纹图谱
多元统计分析
ultrafine granular powder of Salviae Miltiorrhizae Radix et Rhizoma
physical property
particle size
comprehensive quality evaluation
physical fingerprint
multivariate statistical analysis
