[关键词]
[摘要]
通过查阅近几年相关的文献资料,结合工作实践经验,以小剂量片剂甲基斑蝥胺片为例,对制粒过程中原辅料细度、粘合剂选择、主辅料混合、温度控制、颗粒质量等关键环节进行分析总结。为保证小剂量片剂的含量均匀度符合《中国药典》要求,原辅料细度要适宜、主辅料混合必须均匀,要有足够的时间混合、粘合剂的选择要科学合理、干燥方法要切合实际,以及颗粒质量必须符合工艺要求。
[Key word]
[Abstract]
This study was aimed to introduce the key link in the process of granulating of small-dose methyl cantharis amine tablets. Combined with practical experiences in daily jobs, related literatures in recent years from the fineness of raw materials, choice of main materials mixing, selection of adhesive, drying methods and grain quality were analyzed. The results showed that in order to ensure the content uniformity of small-dose tablets and conform to requirements of the Chinese Pharmacopoeia, the fineness of raw materials should be appropriate; the main supplementary material must be evenly mixed with enough time; the choice of adhesive should be scientific and reasonable;the drying method should be practical; and the grain quality should meet the technological requirements.
[中图分类号]
[基金项目]
重庆市科委科技平台与基地建设(科研院所创新能力建设)项目(cstc2012pt-kyys10001):重庆市GLP 中心能力提升建设,负责人:杨大 坚;重庆市科委科技平台与基地建设(科研院所创新能力建设)项目(cstc2012pt-kyys10004):中药新产品开发研究能力提升建设,负责 人:唐安明。