超微粉碎粉体改性技术对肿节风浸膏粉物性及其分散片质量的影响

Effects of Ultrafine Grinding and Powder Modification Technology on the Physical Properties of Glabrous Sarcandra Herb Extract Powders and Qualities of the Dispersible Tablets

采用超微粉碎结合改性剂对肿节风浸膏粉进行物理改性,探讨改性剂种类(微粉硅胶、乳糖、甘露醇、硫酸钙及硬脂酸镁)对肿节风浸膏粉物性及其分散片质量的影响。考察了肿节风浸膏粉改性前后的粒度分布、流动性、内聚力、吸湿性等粉体物理性质,采用热重分析、红外光谱和扫描电镜技术对不同的改性粉末进行表征,对比不同改性粉在水中的溶出行为,以及制备的分散片外观及分散均匀性的变化。结果显示,肿节风浸膏粉经超微粉碎结合改性剂处理后,各粉末的粒度分布均小于50μm,粉体的表面积增加,可压缩度提高,粉末内聚力增大,流动性变差,吸湿性增强。扫描电镜结果表明,仅微粉硅胶能较均匀地分散于浸膏粉表面;红外光谱及热重分析结果表明,改性粉未发生化学及热力学变化。体外溶出试验表明,除硬脂酸镁改性粉外,其余改性粉的20 min溶出率均达到95%以上,快于未改性粉。另外,改性浸膏粉制备的分散片外观黑斑明显减少,但崩解时间延长。在上述5种改性剂中,微粉硅胶改性粉制备的分散片外观较好,黑斑率为3.33%,崩解时间为58.3 s。

The effects of ultrafine grinding with different modifiers(micro-powder silica gel, lactose, mannitol, calcium sulfate and magnesium stearate) on the physical properties of Glabrous Sarcandra Herb extract powder and qualities of the corresponding dispersible tablets were investigated. The physical properties of the extract powder before and after modification were investigated, such as the particle size distribution, fluidity, cohesion and hygroscopicity. Thermogravimetric analysis, infrared analysis and scanning electron microscopy(SEM) were adopted to characterize these modified extract powders with different modifiers. Then, the dissolution test in water was carried out. Finally, dispersion uniformity of the dispersible tablets prepared with these different extract powders were evaluated and compared. The results showed that the particle size distributions of the extract powders treated with ultrafine grinding were all less than 50 μm. Almost all results of surface area, compressibility, cohesion and hygroscopicity for the modified extract powders were increased compared with the untreated extract powder, but their fluidity became worse. The results of SEM showed that only the micro-powder silica gel could be dispersed uniformly on the surface of the extract powder. It was confirmed that there were no chemical and thermodynamic changes in all modified extract powders by the results of infrared spectroscopy and thermogravimetric analysis. In vitro dissolution test showed that all the tested modifiers could improve the dissolution rate up to 95% within 20 min of the extract powder but magnesium stearate, compared with the untreated extract powder. In addition, the appearances, namely the black spots on tablets, of the dispersible tablets prepared by modified extract powders were significantly improved, but the disintegration time was prolonged. In conclusion, micro-powder silica gel had a remarkable effect on improvement of the physical properties of Glabrous Sarcandra Herb extract powder and the qualities of the dispersible tablets among the tested modifiers.