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

作　　者：董泽民 余春梅 熊莉平 徐洁 罗立骏 曾令高 DONG Zemin;YU Chunmei;XIONG Liping;XU Jie;LUO Lijun;ZENG Linggao(Southwest Pharmaceutical Co.,Ltd.,Chongqing,China 400038;Chongqing Institute for Food and Drug Control·NMPA Key Laboratory for Quality Monitoring of Narcotic Drugs and Psychotropic Substances,Chongqing,China 401121)

机构地区：[1]西南药业股份有限公司,重庆400038 [2]重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国药业》2023年第23期12-17,共6页China Pharmaceuticals

基　　金：国家“重大新药创制”科技重大专项资助项目[2015ZX093001002007,2017ZX09101001]。

摘　　要：目的考察2个供应商的十八醇对盐酸吗啡缓释片关键质量属性的影响。方法将2个供应商的十八醇与盐酸吗啡混合,进行原辅料相容性试验;采用熔融制粒法制备盐酸吗啡缓释片,比较2个供应商的十八醇所制备产品的关键质量属性,并考察其稳定性。结果2个供应商的十八醇与盐酸吗啡均有良好相容性;所制备的产品在晶型、硬度、脆碎度、含量、有关物质、溶出曲线等关键质量属性方面比较均无显著差异,且稳定性均良好。结论2个供应商的十八醇可相互替换,均能保证盐酸吗啡缓释片质量稳定、可控。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 

分 类 号：R917[医药卫生—药物分析学] R971.1[医药卫生—药学]