颗粒剂生产直混工艺中主要辅料的粒度标准研究  

Study on Particle Size Standard of Main Excipients in Direct Mixing Process of Granule Production

作　　者：冼海燕 韩亚美 陈慧 XIAN Haiyan;HAN Yamei;CHEN Hui

机构地区：[1]海南赞邦制药有限公司,海南海口570100

出　　处：《化工设计通讯》2025年第1期93-96,共4页Chemical Engineering Design Communications

摘　　要：药品生产过程中,颗粒剂的直接混合生产工艺,对原辅料的粒度有较高的要求,合适的、匹配的粒度有助于粉体的混合均匀。对本厂的一个颗粒剂产品的主要辅料——蔗糖的粒度研究,通过三批生产工艺验证的数据支持,旨在除了增加备选供应商,降低单一供应商引起物料供应断供而引起生产中断的风险外,更重要的是研究并制订适当的粒度标准,确保采购的物料满足生产工艺的需求,保证该颗粒剂产品的质量均匀性。In the process of drug production,the direct mixing process of granules has high requirements on the particle size of raw materials,and the appropriate and matched particle size is conducive to the uniform mixing of powders.This paper studies the particle size of sucrose,the main auxiliary material of one of our plant's granules product,supported by three batches of production process validation data,aiming to increase alternative suppliers and reduce the risk of production interruption caused by a single supplier's material supply interruption.More importantly,it studies and develops appropriate particle size standards to ensure that the purchased materials meet the needs of the production process.The quality uniformity of the granule was ensured.

关 键 词：粒度标准 颗粒剂 直混工艺 主要辅料 蔗糖 

分 类 号：TQ222.23[化学工程—有机化工]