玻璃酸钠产品标准与质量控制.pdfVIP

1130 Chinese Journal of Reparative and Reconstructive Surgery, September 2011, Vol. 25, No.9 · · • 综 述 • 玻璃酸钠产品标准与质量控制 1 2 1 1 顾其胜 ， 王琼 付爱玲 【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。 【关键词】 玻璃酸钠 原料标准 产品标准 质量控制 1,2 1 PRODUCT STANDARD AND QUALITY CONTROL OF SODIUM HYALURONATE/GU Qisheng , WANG Qiong , FU 1 1 2 Ailing . Shanghai Jingfeng Pharmaceutical Corporation Limited, Shanghai, 201908, P.R.China; Shanghai Qisheng Institution of Biomaterials and Technology. Corresponding author: GU Qisheng, E-mail: qishenggu@163.com 【Abstract 】 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. 【Key words 】 Sodium hyalurona