三七配方颗粒新型制备工艺研究及表征

目的:通过对比分析配方颗粒的吸湿性以及IR、DSC、XRD和SEM等表征结果,考察新型制备工艺的合理性与可行性。方法:通过考察不同混合方式下的三七配方颗粒的吸湿性,同时运用IR、XRD、DSC和SEM等分析手段对配方颗粒进行表征。结果:通过对比5种常用辅料,新型混合工艺制备的配方颗粒的平衡吸湿量较传统工艺降低范围在18%~30%,平衡时间延长范围在13%~17%;经新型混合工艺制备的配方颗粒其药物有效成分与辅料未发生物理与化学变化,提取物在颗粒中更多以无定形或微晶形式存在,同时颗粒表面结构有较大改观。结论:新型工艺制备的配方颗粒吸湿性较好,提取物与辅料未发生物理化学变化,表面结构平整光滑,说明新型制备工艺适用于中药配方颗粒的生产。

New Preparation Process Study and Characterization of Panax notoginseng Formula Granule

Objective:To investigate the rationality and feasibility of the new prepatation process by comparing and analyzing the hygroscopicity of the formulated granules and the characterization results of IR,DSC,XRD and SEM.Methods:The hygroscopicity of Panax notoginseng formula granules with different mixing methods was measured,and IR,XRD,DSC and SEM were used to characterize the formula granules.Results:By comparing five kinds of commonly materials,the equilibrium moisture absorption of formula granule prepared by the new mixing process was 18%~30% lower than traditional process.The hygroscopic balance time of formula granule was 13%~17% longer than traditional process.There were no physical and chemical changes in the active components and auxiliary materials of the formula granule prepared by the new mixing process,the extract was mostly amorphous or microcrystalline in the granule,and the granule surface structure had greatly improved.Conclusion:The formulated granules prepared by the new process have better hygroscopicity,no physical and chemical changes in extracts and excipients are observed,and the surface structure is smooth,it indicates that new preparation process is suitable for the production of traditional Chinese medicine formula granule.