用于胶囊的粉末微量灌装技术

针对制剂生产中的胶囊灌装工艺环节,提出一种新型的粉体材料直接灌装技术。该技术结合振动激励下粉体材料在细管流道中流化的基本原理和出口流量的精确控制,实现了逐个胶囊的批量灌装。选取4种吸入级乳糖粉末,在不同的振动时间、振动电压等操作参数下进行灌装实验,分析了影响不同粉体材料胶囊灌装剂量准确性与剂间均一性的因素。结果表明:该技术对不同物性的粉体材料具有良好的适用性;灌装量与振动时间表现出良好的线性关系,在其他参数不变的条件下,能达到一个稳定的灌装速率;单剂灌装量随振动电压的增大而增加;在不同操作参数组合下,可实现较大范围的剂量灌装,为完成生产中多样化的灌装任务提供了可行性。研究成果为胶囊剂微量灌装进一步发展提供了可参考的实验依据。

Powder Micro-filling Technology for Encapsulation

A new powder direct-filling technology was proposed for capsule filling in manufacturing. The technology was capable of capsule batch-filling with fluidization mechanism of powder in a vibrating fine tubular channel and the control of powder discharge fully studied. Four inhalation-grade lactose products were selected to analyse the impact on dosage accuracy and uniformity of capsule filling with different powder materials by filling experiments under different process parameters such as vibrating time and voltage. Experimental results show that the filling technology has good applicability for powder materials with different physical properties. The dosing amount and the vibrating time show a good linear relationship, thus a stable filling rate is achieved under the condition with other parameters unchanged. The single dosage increases with the increase of voltage. Therefore, filling under different setups can achieve a large dosage range, which has demonstrated the feasibility for completing diversified filling tasks in production. The research achievements provides experimental basis for the further development of this technology.