浅谈直压工艺中的分层问题  

Talking About the Segregation Problem in Directly Compression Process

作　　者：陈荣震 商明红 唐云 Chen Rongzhen;Shang Minghong;Tang Yun(Jiangsu Chia Tai Fenghai Pharmaceutical Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]江苏正大丰海制药有限公司,江苏南京210046

出　　处：《山东化工》2022年第5期161-165,共5页Shandong Chemical Industry

摘　　要：目的:探讨原辅料的粒径、堆密度、体貌形态等对粉末直接压片工艺中分层的影响。方法:以模型药与不同填充剂混合,进行混合和压片过程中分层研究。结果:模型药I与粒径、堆密度差异较小的填充剂甘露醇100SD和甘露醇M200在混合和压片过程中分层风险较小,模型药Ⅱ与纤维素-乳糖80作为填充剂的处方在制备过程中分层风险较小。结论:在直压工艺中,辅料选用时需结合原辅料的粒径、堆密度、黏聚强度、静电效应等综合考虑,以减少物料分层风险。Objective:Discussion the influence of the particle size,bulk density and physical appearance of materials on the segregation of the powder in directly compression process.Methods:The model drug is mixed with fillers to study the segregation during powder mixing and tableting.Results:Model drug I and the fillers mannitol 100SD and mannitol M200 with small differences in particle size and bulk density have a lower risk of segregation during mixing and tableting.The prescription of model drug II and cellulose-lactose 80 as fillers is less risk of segregation in the process.Conclusion:In the direct pressure process,the selection of auxiliary materials should be combined with the particle size,bulk density,cohesive strength,electrostatic effect and other considerations of the raw materials to reduce the risk of segregation.

关 键 词：粉末直接压片 表面形态 分层 

分 类 号：TQ460.6[化学工程—制药化工]