摘要
本研究旨在考察辅料和工艺对胃苏泡腾片压缩成型性的影响。以胃苏提取物及泡腾片中常用的代表性辅料(泡腾崩解剂、硬脂酸镁和乳糖)为研究对象,以抗张强度、压缩过程参数及屈服压等为评价指标,结合物理特性,考察了粉末直压与干法制粒压片工艺对胃苏泡腾片压缩成型性的影响。结果表明,泡腾崩解剂和制备工艺会显著影响粉体的物理性质和压缩性能。经Heckel方程分析可知胃苏提取物在压缩过程中主要发生塑性形变。与粉末直压工艺相比,干法制粒工艺所得颗粒的物理特性有显著变化,表现为压缩性能有所下降、流动性显著改善。综合考虑,干法制粒后压片比粉末直压法更适合胃苏泡腾片的制备。
This paper aimed to study the effects of excipients and preparation process on the compressibility of Weisu effervescent tablets. The representative excipients(effervescent disintegrating agent, magnesium stearate and lactose) commonly used in effervescent tablets and Weisu extract were employed in this research, and the tensile strength, parameters in the compression molding process and yield pressure were taken as the evaluation indexes. The effects of preparation process, direct compression and dry granulation tableting techniques, on the compressibility of Weisu effervescent tablets were investigated combined with physical characteristics. The results showed that the physical properties and compaction behavior of the powders were significantly affected by the effervescent disintegrating agent and the preparation process. The Heckel equations showed that the Weisu extract powder mainly exhibited plastic deformation during the compression process. Compared with direct compression, the physical properties of the granules prepared by dry granulation showed significant differences, such as lower compatibility and significantly improved flowability. Compared with direct compaction, dry granulation tableting was more suitable for the preparation of Weisu effervescent tablets when the actual production factors are taken into account.
作者
李敏
谭琴
韩小颖
吴革林
王永香
LI Min;TAN Qin;HAN Xiaoying;WU Gelin;WANG Yongxiang(Yangtze River Pharmaceutical Group Co,Ltd.,Taizhou 225321)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第7期1000-1008,共9页
Chinese Journal of Pharmaceuticals
基金
国家重点研发计划“中医药现代化研究”重点专项(2018YFC1706901)。
关键词
胃苏泡腾片
制备工艺
压缩成型
压缩过程参数
Weisu effervescent tablet
preparation process
compression molding
compression process parameters