Tian Wenxiu, Li Xue, Li Wenjie, Xue Aile, Zheng Minyue, Lin Xiao, Hong Yanlong
Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Pudong District, Shanghai 201203, China.
College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Pudong District, Shanghai 201203, China.
Pharmaceuticals (Basel). 2023 Oct 23;16(10):1505. doi: 10.3390/ph16101505.
As the precursor of pellets, the extrudate has a direct impact on the molding quality of the pellets. Therefore, the correlation between the surface roughness of the extrudates and the molding quality of pellets with pure microcrystalline cellulose (MCC) formulations and those containing traditional Chinese medicine (TCM) formulations was explored. MCC was used as a pelleting agent, mixer torque rheometry (MTR) was used to guide the optimal dosage of the wetting agent, and TCM extracts (drug loadings of 20% to 40%) were selected as model drugs to prepare the extrudates and pellets under the same extrusion spheronization process conditions. The surface roughness and texture parameters of extrudates were analyzed via a microscope and texture analyzer, respectively, and the quality of pellets was evaluated. The extrudate roughness of the pure MCC prescription decreased and then increased with increasing water addition, while the extrudate roughness of the prescription containing TCM extracts tended to increase and then decrease. The addition of water affected the extrudate properties, with TCM extract molecules filling gaps in the MCC structure, leading to rough surfaces. The extrudate roughness of the TCM prescriptions was significantly greater than that of the pure MCC prescriptions at optimal water addition levels, resulting in ideal pellets.
作为颗粒剂的前驱体,挤出物对颗粒剂的成型质量有直接影响。因此,研究了纯微晶纤维素(MCC)配方和含中药(TCM)配方的挤出物表面粗糙度与颗粒剂成型质量之间的相关性。以MCC为制粒剂,采用混炼转矩流变仪(MTR)指导润湿剂的最佳用量,并选择中药提取物(载药量20%至40%)作为模型药物,在相同的挤出滚圆工艺条件下制备挤出物和颗粒剂。分别通过显微镜和纹理分析仪分析挤出物的表面粗糙度和纹理参数,并对颗粒剂的质量进行评价。纯MCC处方的挤出物粗糙度随加水量的增加先降低后升高,而含中药提取物处方的挤出物粗糙度则呈先升高后降低的趋势。加水影响了挤出物的性能,中药提取物分子填充了MCC结构中的间隙,导致表面粗糙。在最佳加水量下,中药处方的挤出物粗糙度显著大于纯MCC处方,从而得到理想的颗粒剂。