目的 分析探索挤出滚圆法制备微丸的工艺参数如挤出转速、挤出筛网孔径及挤出次数对挤出物的质构特性及微丸成型质量的影响规律。方法 以微晶纤维素（MCC）为成球剂，以乳糖、Methocel E5级羟丙基甲基纤维素（E5）、Methocel E15级羟丙基甲基纤维素（E15）、Methocel K100级羟丙基甲基纤维素（K100）4种辅料及8种中药提取物（槟榔提取物、败酱草提取物、石菖蒲提取物、红藤提取物、补骨脂提取物、大川芎方提取物、川芎提取物、天麻提取物）为模型药物组成12个制剂处方，分别于3个水平的挤出转速、挤出筛网孔径及挤出次数条件下制备挤出物，一部分用来测定质构参数，另一部分滚圆后对微丸质量进行评价。结果 随着筛网孔径变大，挤出物表现出硬度减小的趋势、弹性及黏附性显著增大，即挤出物易产生形变及相互黏附，微丸的圆整度有降低的趋势，而粒径则显著增大；随着挤出次数的增加，挤出物的硬度、内聚性、咀嚼性及回复性均显著变大，而挤出转速对不同挤出物的质构特性呈现不同的影响。结论 在制备微丸时，可根据挤出物的质构特性，有目的地选择挤出工艺，以制备良好的球形微丸。

Objective To analyze the effect of extrusion factors such as extrusion speed, screen hole diameter, and extrusion times on the texture properties of extrudate and the quality of pellets. Methods In this study, microcrystalline cellulose (MCC) as pelletization aid, lactose, Methocel E5 HPMC, Methocel E15 HPMC, Methocel K100 HPMC, and eight kinds of herbal extracts (extracts of Areca catechu, Patrinia scabiosae folia, Acorus tatarinowii, Sargentodoxa cuneata, Psoralea corylifolia, Dachuanxiong Decoction, Ligusticum chuanxiong, and Gastrodia elata) were used as model drugs. Extrudates were prepared under different levels of process parameters, and one part was used to measure the texture parameters, the other part used for quality evaluation after spheronization. Results With a large screen hole diameter, it showed that hardness of extrudate became lower and the adhesiveness as well as the springiness was significantly higher, leading to a large particle size and poor roundness of pellets. Repeated extrusion could increase hardness, cohesiveness, chewiness, and resilience of extrudate. Not any strong correlation was found between the extrusion speed and texture properties in the study. Conclusion The extrusion process could be purposefully selected to prepare ideal pellets accroding to texture properties of extrudate.

国家青年自然科学基金项目（81202923）；上海市卫计委新3年行动计划（ZY3-CCCX-3-5001，ZY3-CCCX-3-2002）；上海市科委项目资助（15DZ2292000）；上海市中医药科技创新项目（ZYKC201603003）