title: [Biocompatibility analysis of hyaluronic acid sodium gels for medical application].
abstract: 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 products 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 aberration test of gel A and subchronic systemic toxicity of gel C appeared positive, the remaining samples of the test results were negative. This article provides a reference to write standard of cross-linked hyaluronic sodium gel and the revision of standard YY0308-2004.
authors.affiliation: National Engineering Research Center for Biomaterials, Sichuan University, 610064, China.
authors.forename: Yaning
authors.initials: Y
authors.lastname: Wang
authors.forename: Tun
authors.initials: T
authors.lastname: Yuan
authors.forename: Lifang
authors.initials: L
authors.lastname: Jia
authors.forename: Wen
authors.initials: W
authors.lastname: Zou
authors.forename: Jie
authors.initials: J
authors.lastname: Liang
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000592:standards*; D003432:Cross-Linking Reagents / Q000737:chemistry; D005782:Gels; D006820:Hyaluronic Acid / Q000592:standards*; D051379:Mice; D010865:Pilot Projects; D011786:Quality Control; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests / Q000379:methods
chemical_list: D001672:Biocompatible Materials; D003432:Cross-Linking Reagents; D005782:Gels; D006820:Hyaluronic Acid