医用透明质酸钠凝胶生物相容性的比较分析  

Biocompatibility Analysis of Hyaluronic Acid Sodium Gels for Medical Application

作　　者：王亚宁[1,2] 袁暾[1,2] 贾莉芳 邹文[1,2] 梁洁[1,2] 

机构地区：[1]国家生物医学材料工程技术研究中心,四川大学,成都610064 [2]四川医疗器械生物材料和制品检验中心,成都610064

出　　处：《生物医学工程学杂志》2012年第4期716-721,共6页Journal of Biomedical Engineering

摘　　要：医用透明质酸钠凝胶被广泛用于眼科手术、骨科疾患治疗及美容等领域。2009年国内生产企业12家共33个产品,进口产品23个。由于生产厂商采用的生产工艺不同,产品性能存在较大差异。本文分别对4种透明质酸钠凝胶产品进行了全面的生物学评价实验。结果显示:除非交联凝胶A出现染色体畸变阳性、交联凝胶C出现亚慢性毒性外,其余试样各实验结果均为阴性。本文为正处于制定过程中的交联透明质酸钠凝胶行业标准以及YY0308-2004的修订提供了参考依据。Hyaluronan acid sodium gels are used in ophthalmic surgery, orthopedic treatment and cosmetic surgery. In 2009,there were 12 domestic manufacturers in China producing 33 kinds of products. 23 kinds of imported prod- ucts were allowed by SFDA to sale in the meantime. Since manufacturers use different production processes, product performances are quite different. According to the GB/T 16886.1-2001, we designed a pilot program to evaluate the sodium hyaluronate gel products comprehensively in this paper. The results showed that, except chromosome aberra- tion test of gel A and subchronic systemic toxicity of gel C appeared positive, the remaining samples of the test re- sults were negative. This article provides a reference to write standard of cross-linked hyaluronic sodium gel and the revision of standard YY0308-2004.

关 键 词：透明质酸钠 凝胶 生物安全性评价 生物材料 

分 类 号：R318.08[医药卫生—生物医学工程]