注射填充用透明质酸钠监管发现的问题及应对策略  

Problems Found in the Supervision of Sodium Hyaluronate for Injection Filling and Corresponding Strategies

作　　者：郭艳 万佳 陶明 魏峥琦 梁冬林 储旭 孟鑫 李晔 GUO Yan;WAN Jia;TAO Ming;WEI Zhengqi;LIANG Donglin;CHU Xu;MENG Xin;LI Ye(Henan Institute for Medical Device Inspection,Zhengzhou,Henan,China 450018;Henan Drug Administration,Zhengzhou,Henan,China 450008)

机构地区：[1]河南省药品医疗器械检验院,河南郑州450018 [2]河南省药品监督管理局,河南郑州450008

出　　处：《中国药业》2024年第21期7-9,共3页China Pharmaceuticals

摘　　要：目的为注射填充用透明质酸钠监管中发现的问题提出相应监管策略。方法总结注射填充用透明质酸钠在注册、生产、经营、使用等监管环节中发现的问题,对发现的问题进行分析,并有针对性地提出应对策略。结果与结论在各环节的监管中发现的问题较多,主要为注射填充用透明质酸钠的非法制售,在医疗美容场所注射作为药品管理的透明质酸钠,在使用过程中出现较严重的不良反应,可能有交联剂残留物风险及免疫原性风险等副作用。针对这些问题,监管部门应严格把控注册关口和实施分类管理;加强监督检查,严查混乱使用情况;运用监督抽检手段,列入省级重点关注;主动监测不良反应,提高报告质量水平;敏锐捕捉热点舆情,深度关注“315”投诉举报。通过这些监管策略,积极思考监管方向,提高监管靶向性,做到科学监管,保障注射填充用透明质酸钠的使用安全。Objective To put forward corresponding regulatory strategies for the problems found in the supervision of Sodium Hyaluronate for Injection Filling.Methods The problems found in the supervision process of registration,production,operation,and use of Sodium Hyaluronate for Injection Filling were summarized and analyzed,and the targeted response strategies were put forward.Results and Conclusion There are many problems found in the supervision of various links,mainly as follows:illegal production and sale of Sodium Hyaluronate for Injection Filling,Injection of Sodium Hyaluronate used as drug management in medical beauty venues,serious adverse reactions during the application,and possible side effects such as crosslinking agent residue risk and immunogenicity risk.In response to these problems,regulatory authorities should strictly control the registration process and implement categorized management,strengthen supervision and inspection,strictly investigate the chaotic use,utilize supervision and sampling methods to be listed as a key focus at the provincial level,proactively monitor adverse drug reactions and improve the quality of reporting,sharp capture of hot public opinion and deep attention to ″ 315″ complaints and reports.Through these regulatory strategies,we should actively consider regulatory directions,improve regulatory targeting,achieve scientific supervision,and ensure the safety of the application of Sodium Hyaluronate for Injection Filling.

关 键 词：透明质酸钠 注射填充 医疗美容 药品监管 

分 类 号：R95[医药卫生—药学]