RESUMO
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.
RESUMO
In this paper, angelica broken wall powder(ABWP) was taken as the research object, HPLC fingerprint combined with multi-component determination(ferulic acid, senkyunolide I, coniferyl ferulate, ligustilide and 3-butylidenephthalide), physical fingerprint(D_(90), particle size distribution range, particle size distribution width, bulk density, tap density, inter-particle porosity, Carr index, specific surface area, pore volume, angle of repose, Hausner ratio, loss on drying and hygroscopicity)were used to characterize the quality attribute of ABWP; similarity analysis, cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were conducted to construct the quality evaluation method of holographic analysis based on traditional Chinese medicine QbD "4 H mode", in order to evaluate the quality of ABWP from different sources and find out differentiated indicators. The quality evaluation method could be used for scientific, comprehensive evaluation of the quality attribute of ABWP, and the quality consistency evaluation of cell-wall-broken powder of different sources or different processes.It provides new ideas for quality control and research of ultrafine granular powders of traditional Chinese medicine.