银杏叶提取物制剂的质量提升和应用安全  

Quality improvement and rational use of Ginkgo biloba extract preparations

作　　者：梅隆[1] 李毅 张威[1] MEI Long;LI Yi;ZHANG Wei(Beijing Jishuitan Hospital,Capital Medical University,Beijing 100035,China)

机构地区：[1]首都医科大学附属北京积水潭医院,北京100035

出　　处：《中国新药杂志》2024年第4期339-344,共6页Chinese Journal of New Drugs

摘　　要：银杏叶提取物制剂在国内医药市场销售的产品众多,管理类别既有中药也有西药,且被列入国家卫生健康委员会重点监控品种。厘清各种制剂的药学特性、质量标准和风险管控点,有助于合理遴选药品及安全用药,并达到一定的治疗目的。本文拟通过探究不同国家对银杏叶提取物制剂的质量管理及《中华人民共和国药典》相关标准的提升,帮助药师了解银杏叶提取物制剂的质量管理,明确上市后药品质量监控对临床获益大于风险的意义。Ginkgo biloba extract has many products in China.They are classified into traditional Chinese medicine and Western medicine for management,and included in the key monitoring varieties lauched by National Health Commission.It will be helpful to understand the pharmaceutical characteristics,quality standards and risk management of the Ginkgo biloba extract preparations to rationally select drugs,use them safely and achieve certain therapeutic purposes.By exploring the quality management modes of Ginkgo biloba extract preparations in different countries and the improvement of relevant standards in Chinese pharmacopoeia,this paper intends to help pharmacists understand the quality management of ginkgo biloba extract preparations and clarify the significance of post-marketing surveillance to ensure clinical benefits greater than risks.

关 键 词：银杏叶提取物 质量标准 药典 合理用药 

分 类 号：R917[医药卫生—药物分析学]