Biocompatibility analysis of hyaluronic acid sodium gels for medical application.
- Author:
Yaning WANG
1
;
Tun YUAN
;
Lifang JIA
;
Wen ZOU
;
Jie LIANG
Author Information
1. National Engineering Research Center for Biomaterials, Sichuan University, 610064, China.
- Publication Type:Journal Article
- MeSH:
Animals;
Biocompatible Materials;
standards;
Cross-Linking Reagents;
chemistry;
Gels;
Hyaluronic Acid;
standards;
Mice;
Pilot Projects;
Quality Control;
Rabbits;
Rats;
Rats, Sprague-Dawley;
Toxicity Tests;
methods
- From:
Journal of Biomedical Engineering
2012;29(4):716-721
- CountryChina
- Language:Chinese
-
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.
