一种盐酸吡硫醇新剂型的制备方法
Preparation Method for a New Dosage Form of Pyritinol Hydrochloride
何成生 1曹智铭 1关建丽 1陈承瑜 1柯施华1
作者信息
- 1. 嘉亨(珠海横琴)医药科技有限公司,广东 珠海 519000
- 折叠
摘要
开发一种盐酸吡硫醇干混悬剂的新剂型,并建立制备方法.制备方法:包括处方研究,原辅料相容性实验,处方筛选;然后是小试工艺开发,操作步骤,以及各步骤的设备控制参数、中控质量标准;最后通过中试确立生产设备,以及生产流程.结果:经送样检测,中试产品符合预期的质量目标和要求,表明该盐酸吡硫醇干混悬剂的制备方法适合工业化生产.
Abstract
To develop a new dosage form of pyritinol hydrochloride dry suspension and establish production process.Method:including prescription study,the compatibility test of raw materials and excipient,and prescription screening;then small-scale process development,operating steps,parameters of equipment for each step,and in-process control quality standards;finally,establishing production equipment through pilot trials,and production process.Results:sampling and test,the results of the pilot product met the expected quality objectives and requirements,indicating that the preparation method of pyritinol hydrochloride dry suspension is suitable for industrial production.
关键词
盐酸吡硫醇/干混悬剂/小试/中试/制备方法Key words
pyritinol hydrochloride/dry suspension/small scale test/pilot scale test/preparation method引用本文复制引用
出版年
2024
NETL
NSTL
万方数据