大容量注射剂中活性炭应用调研分析  

Investigation and Analysis on Application of Activated Charcoal in Large-volume Injections

作　　者：周冲 赵敏 董爱梅 张平 侯瑾 刘军田 武海军 ZHOU Chong;ZHAO Min;DONG Ai-mei;ZHANG Ping;HOU Jin;LIU Jun-tian;WU Hai-jun(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《食品与药品》2025年第1期I0009-I0012,共4页Food and Drug

摘　　要：目的通过了解活性炭在国内大容量注射剂中的应用现状、控制策略和变更意向等,为相关单位开展工艺变更研究工作提供参考,为后续监管工作提供支持。方法以问卷形式向国内大容量注射剂生产企业进行调研,调研内容包括现有大容量注射剂批准文号数量、使用活性炭的批准文号数量、后续变更意愿,及现有工艺下对采用活性炭品种的工艺控制策略等。结果纳入调研有20家生产企业,共1081个大容量注射剂批准文号,大部分在2015年之前获批,工艺中使用活性炭的产品占该阶段总数的90.24%。虽然调研中大部分企业认为现有技术条件下所持有的大容量注射剂品种不具有使用活性炭的必要性,但完成变更的品种较少,仅占总数的12.36%。现阶段企业主要通过提高控制标准等方式控制产品质量。结论调研结果表明,因工艺中去除活性炭的变更涉及成本、政策等方面,在目前政策没有强制性要求去掉活性炭的条件下,大部分企业扔持观望态度。本次调研为后续相关政策的制定提供了参考。Objective To provide reference for process change research carried out by relevant enterprises and offer insights for regulatory authorities to formulate corresponding policies and measures by understanding the application status,control tactics and change intentions of activated charcoal in large-volume injection(LVI)in China.Methods A questionnaire survey was conducted to domestic LVI manufacturers,covering the number of existing LVI approvals,the number of approvals using activated carbon,the willingness to change later,and the process control strategy for the LVI varieties using activated carbon under the existing process.Results There are 20 production enterprises included in the survey,with a total of 1081 approvals for LVI,most of which were approved before 2015.Products using activated carbon in the process account for 90.24%of the total products in this stage.Although most enterprises in the survey believe that LVI varieties held under existing technological conditions do not have the necessity to use activated carbon,only few varieties have completed the change,accounting for only 12.36%of the total.At present,the enterprises mainly control product quality by improving control standards.Conclusion The research results indicate that due to costs,policies,and other aspects involved in the changes of removing usage of activated carbon from the process,most enterprises hold a wait-and-see attitude under the condition that the current policy does not require the removal of usage of activated carbon.This survey can provide reference for the formulation of relevant policies in the future.

关 键 词：大容量注射剂 活性炭 变更 控制策略 

分 类 号：R944.1[医药卫生—药剂学] R95[医药卫生—药学]