兽用中化药注射剂可见异物现状分析及对策探讨  

Analysis and Countermeasure of Visible Particulates in Veterinary Usage Injection for Chinese Medicine and Chemical Medicine

作　　者：张秀英[1] 龚旭昊[1] 戴青[1] 王轩 彭文绣 顾进华[1] 谷红[1] ZHANG Xiu-ying;GONG Xu-hao;DAI Qing;WANG Xuan;PENG Wen-xiu;GU Jin-hua;GU Hong(China Institute of Veterinary Drug Control,Key Biology Laboratory of Chinese Veterinary Medicine,Ministry of Agriculture and Rural Affairs,P.R.China,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所,农业农村部中兽医生物学重点实验室,北京100081

出　　处：《中国兽药杂志》2024年第11期52-59,共8页Chinese Journal of Veterinary Drug

基　　金：国家重点研发计划项目(2023YFD1800903-3)。

摘　　要：本文旨在探讨兽用中化药注射剂中可见异物的原因及对策。通过总结近5年兽药质量监督抽检中可见异物的检测情况,从人员、设备、原辅料质量、生产工艺、环境等方面对导致注射剂可见异物的主要原因进行了分析。基于产品全过程质量控制理念,有针对性的提出了系列控制对策和措施,希望有助于帮助兽药生产企业降低可见异物的发生概率,保障兽药质量安全和动物养殖健康。This article aims to explore the reasons and countermeasures of visible particulates in Veterinary usage injection for Chinese medicine and chemical medicine.By summarizing the testing situation of visible particulates in veterinary drug quality supervision and sampling in the past 5 years,the main causes of visible particulates in injection were analyzed from the aspects of personnel,equipment,raw material quality,production process and environment,etc.Based on the concept of whole-process quality control of products,a series of control measures were put forward.We hope it can help veterinary drug manufacturers reduce the probability of visible particulates occurring and ensure the quality safety of veterinary drugs and the health of animal breeding.

关 键 词：注射剂 可见异物 来源分析 控制策略 

分 类 号：S851.66[农业科学—预防兽医学]