复方薄荷脑滴鼻液质量回顾与分析  

Quality Review and Analysis of Compound Menthol Nasal Drops

作　　者：刘敏 冯欣 陈丽芳 田佳懿 刘继业 段松冷 LIU Min;FENG Xin;CHEN Lifang;TIAN Jiayi;LIU Jiye;DUAN Songleng(Department of Pharmacy,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药学部,北京100038

出　　处：《医药导报》2025年第5期753-757,共5页Herald of Medicine

基　　金：北京市第三批中药骨干人才培养项目(京中医科字〔202259〕号)。

摘　　要：目的对复方薄荷脑滴鼻液的质量进行回顾与分析,及时发现不良趋势,制订改进措施,提高制剂质量。方法以复方薄荷脑滴鼻液有效成分樟脑和薄荷脑为指标,运用能力六合图对首都医科大学附属北京世纪坛医院30批次样品的质量进行回顾分析;应用失效模式与效应分析(FMEA)进行前瞻性质量风险管理。结果30批次的复方薄荷脑滴鼻液均符合质量标准,工艺均处于受控状态,但薄荷脑的工艺过程有潜在风险,对其进行风险管理,并制订改进措施。结论该院复方薄荷脑滴鼻液质量可控,通过工艺改进,可以持续保证药品质量。Objective The quality of compound menthol nasal drops was reviewed and analyzed,and identified the bad trend in time.The improvement measures were formulated to improve the quality of the preparation.Methods Taking camphor and menthol in compound menthol nasal drops of Beijing Shijitan Hospital,Capital Medical University,as indicators,the quality of 30 batches of samples was retrospectively analyzed using the capacity sixpack report.The failure mode and effect analysis(FMEA)were applied to the prospective quality risk management.Results All 30 batches of compound menthol nasal drops met the quality standards,and the process was under control.However,there were potential risks in the process of menthol,so risk management was carried out and improvement measures are formulated.Conclusion The compound menthol nasal drops of the hospital have stable quality,and the quality of the medicine can be continuously ensured with improved processes.

关 键 词：复方薄荷脑滴鼻液 质量控制 风险管理 能力六合图 失效模式与效应分析 

分 类 号：R286[医药卫生—中药学] R927.11[医药卫生—中医学]