注射用交联透明质酸钠凝胶的降解试验研究

Study on degradation of cross-linked sodium hyaluronate gel for injection

考察了不同交联程度的注射用透明质酸钠凝胶样品在37℃磷酸盐缓冲液中和酶加速条件下的降解情况及在家兔背部皮下植入的生物学反应,以获取安全有效的临床注射用面部填充剂。结果表明,溶胀度大、耐酶解系数小的低交联度透明质酸凝胶CHA1的体外降解速度较快;溶胀度约为45,抗酶解性能与对照品相近的中等交联度凝胶CHA4,自然条件下缓冲液中180 d质量保持率95%以上,家兔体内植入26 w时凝胶填充性无显著下降,具有较好的临床应用价值。

The degradation of sodium hyaluronate gel for injection with different cross-linking degree under the condition of neutralization and enzyme acceleration in phosphate buffer at 37℃and the biological reaction of subcutaneous implantation in the back of rabbits were investigated to obtain safe and effective facial filler for clinical injection.The results show that the degradation rate of low cross-linked hyaluronic acid gel CHA1 with high swelling degree and low enzymatic hydrolysis resistance coefficient is faster in vitro.The medium cross-linked gel CHA4 with a swelling degree of 45 and an anti-enzymatic property similar to that of the reference substance has a mass retention rate of more than 95%in the buffer solution for 180 d under natural conditions.The filling property of the gel does not significantly decrease when implanted in rabbits for 26 w,so it has good clinical application value.