中国药业2023，Vol.32Issue(23)：12-17,6.DOI:10.3969/j.issn.1006-4931.2023.23.003
不同供应商十八醇对盐酸吗啡缓释片关键质量属性的影响
Effect of Stearyl Alcohol from Different Suppliers on Critical Quality Attributes of Morphine Hydrochloride Sustained-Release Tablets
摘要
Abstract
Objective To investigate the effect of stearyl alcohol from different suppliers on the critical quality attributes of Morphine Hydrochloride Sustained-Release Tablets.Methods Mixed stearyl alchol from two suppliers with morphine hydrochloride for excipient compatibility study.Morphine Hydrochloride Sustained-Release Tablets were prepared by melting granulation method,the critical quality attributes of products prepared by stearyl alcohol from two suppliers were compared and the stability study was carried out.Results Stearyl alcohol from the two suppliers had good compatibility with morphine hydrochloride,the critical quality attributes such as crystal form,hardness,fragility,content,related substances,and dissolution profiles of all products showed no significant differences and all products exhibited good stability.Conclusion Stearyl alcohol from two suppliers can be replaced with each other,ensuring the quality of Morphine Hydrochloride Sustained-Release Tablets was stable and controllable.关键词
十八醇/盐酸吗啡缓释片/关键质量属性/稳定性/相容性试验/供应商变更Key words
stearyl alcohol/Morphine Hydrochloride Sustained-Release Tablets/critical quality attributes/stability/compatibility test/supplier changes分类
医药卫生引用本文复制引用
董泽民,余春梅,熊莉平,徐洁,罗立骏,曾令高..不同供应商十八醇对盐酸吗啡缓释片关键质量属性的影响[J].中国药业,2023,32(23):12-17,6.基金项目
国家"重大新药创制"科技重大专项资助项目[2015ZX093001002007,2017ZX09101001]. （）
