摘要
目的对国内外玻璃酸钠(sodium hyaluronate,HA)原料及产品的质量标准进行整理和汇总,分析各标准间差异,针对各标准对工艺参数的监控进行重点阐述。方法通过翻译整理对比国内外质量标准和方法,并将部分研究的实验数据进行整理分析,同时结合生产实践进行论述。结果国内外无论是HA原料还是产品其标准均存在一定差异,但根本控制点基本一致。结论企业应针对产品质量的控制要求并结合自身工艺特点制定合理可控的质量标准,才能保证临床使用的安全性和有效性。
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate（HA）,and to expatiate on the critical process monitoring parameters.Methods Different quality standards of HA were compared by translating and sorting,and some experimental data were analyzed as well as the manufacturing practice was elaborated.Results Differences exist in raw materials standard or specifications of products between domestic and foreign,but the basic control points are concordant.Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application
出处
《中国修复重建外科杂志》
CAS
CSCD
北大核心
2011年第9期1130-1135,共6页
Chinese Journal of Reparative and Reconstructive Surgery
关键词
玻璃酸钠
原料标准
产品标准
质量控制
Sodium hyaluronate Raw material standard Specification of product Quality control
