目的以湿法制粒工艺制备的肿节风-微晶纤维素(MCC)颗粒为研究对象,研究颗粒粉体学性质及其与片剂成型性的相关性。方法通过不同工艺和处方得到6种肿节风-MCC混合粉,采用摇摆挤出和高速搅拌2种湿法制粒方式得到12种颗粒,以粒径、比表面积(SSA)、孔容积(PV)、含水量(MC)、松密度(BD)、振实密度(TD)、压缩度(TI)、休止角(AOR)、Kawakita方程参数a、b为指标评价颗粒的粉体学性质,以颗粒在5、10、15、20、25、30kN压力下的抗张强度(TS)为指标评价片剂的成型性,运用多元数据分析研究片剂成型性与原料颗粒粉体学性质之间的相关性。结果基于多元数据分析,将颗粒粉体学性质提取出2个主成分:第1主成分代表形态参数,第2主成分为压缩特性参数。对片剂成型性影响较为显著的是颗粒压缩性、MC和表面形态。结论多元数据分析可以对肿节风颗粒按照原料粉制备工艺和制粒工艺进行简单快速地分类,并用于分析肿节风片剂的成型性与原料颗粒粉体学性质的关系;通过控制颗粒的压缩性、MC和表面形态,可以得到具有良好成型性的片剂,对片剂制备提供指导。
Objective To investigate the correlations between micromeritic primary properties and compactibility of granules produced by wet granulation ofSarcandrae Herba with soluble starch and microcrystalline cellulose (MCC). Methods Micromeritic primary properties and compactibility of granules produced by wet granulation which was obtained by different prescriptions and processes were determined. Particle size (D90), specific surface area (SSA), pore volume (PV), moisture content (MC), bulk density (BD), tap density (TD), tap index (TI), angle of repose (AOR), and Kawakita equation parameters a and b were used as evaluation indexs to study the micromeritic primary properties of granulation. The tensile strengths of granules at 5, 10, 15, 20, 25, and 30 kN pressure were used as the indexs to evaluate the compactibility of granules produced. Multivariate analysis was applied to evaluating the correlations between micromeritic primary properties and compactibility of granules produced. Results The micromeritic primary properties of granules could be extracted as two principal components, morphology parameter and compressibility parameter. The significant effects on the tablet eompactibility are the compressibility, moisture, and surface morphology of granules produced. Conclusion Multivariate data analysis could make the quick and easy classification of Sarcandrae Herba Granule. The correlation between granules micromeritic primary properties and tablet compactibility is given. By controlling compressibility, moisture, and surface morphology of granules produced, the tablets with good compactibility can be obtained.