从注射剂的基本要求浅谈化药注射剂装量按规格管理的必要性  

Analysis the Necessarity of Managing the Volume of Chemical Drug Injection According to Specifications from the Basic Requirements of Injection

作　　者：李丹[1] 徐倩[1] 梁先明[1] 刘艳华[1] 苏富琴[1] 储小平 汪霞[1] LI Dan;XU Qian;LIANG Xian-ming;LIU Yan-hua;SU Fu-qin;CHU Xiao-ping;WANG Xia(China Institute of Veterinary Drug Control, Beijing 100081,China)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2022年第3期11-15,共5页Chinese Journal of Veterinary Drug

摘　　要：近年来我国兽用化学药品发展迅速,兽用注射剂药物品种规格不断增加。兽药规格是兽药标准规定的内容之一,它与兽药的研究、生产、使用、质量检验等密切相关。兽用注射剂规格对兽药有效性、安全性和经济性等有直接关系。因此,兽用注射剂规格的确定、增加或改变必须严格管理,综合慎重考虑兽药典要求、注册要求、生产要求等,确保兽用注射剂药物的安全、有效、质量可控。In recent years,veterinary chemical drugs developed rapidly in China,and the varieties and specifications of veterinary injections have been increasing.Veterinary drug specification is one of the contents of veterinary drug standards,which is closely related to veterinary drug research,production,use and quality inspection.Veterinary injection specification is directly related to drug effectiveness,safety and economy.Therefore,the determination,increase or change of veterinary injection specifications must be strictly managed,and the veterinary pharmacopoeia requirements,registration requirements and production requirements must be carefully considered comprehensively to ensure the safety,effectiveness and quality control of veterinary injection drugs.

关 键 词：注射剂 装量 规格 兽药 

分 类 号：S851.66[农业科学—预防兽医学]