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不同分子量比例交联透明质酸钠凝胶皮下注射:动物实验研究与皮下注射临床试验

[Crosslinking sodium hyaluronate gel with different ratio of molecular weight for subcutaneous injection: animal experimental study and clinical trials subcutaneous injection].

作者信息

Ran Weizhi, Wang Xiaoli, Hu Yuefei, Gao Songying, Yang Yahong, Sun Jian, Sun Shuming, Liu Zhongmei, Wang Jiangling

出版信息

Zhonghua Zheng Xing Wai Ke Za Zhi. 2015 May;31(3):198-201.

PMID:26536688
Abstract

OBJECTIVE

To investigate the biocompatibility and degradation rate of crosslinking sodium hyaluronate gel with different ratio of molecular weight, so as to choose the effective, safe and totally degraded hyaluronate gel for aesthetic injection.

METHODS

(1) Compound colloid was formed by cross-linking the divinyl sulphone and sodium hyaluronate with different molecular weight (4 x 10(5), 8 x 10(5), 10 x 10(5), 12 x 10(5)). (2) Healthy level KM mice was randomly divided into two groups to receive hyaluronic acid gel or liquid injection. Each group was subdivided into three subgroup to receive hyaluronic acid with different molecular weight. The biocompatibility and degradation rate, of hyaluronate were observed at 7, 90, 180 days after injection. At the same time, different molecular weight of sodium hyaluronate gel is sealed or exposed respectively under the low temperature preservation to observe its natural degradation rate. (3) The most stable colloid was selected as aesthetic injector for volunteers to observe the aesthetic effect.

RESULTS

The sodium hyaluronate gel with molecular of 4 x 10(5) was completely degraded 90 days later. The sodium hyaluronate gel with molecular of 8 x 10(5) was completely degraded 180 days later. The sodium hyaluronate gel with molecular of 10 x 10(5) was degraded to 90.0% after 180 days. The sodium hyaluronate liquid can be degraded completely within 7 days. The colloid could be kept for at least 12 months when sealed under low temperature, but was totally degraded when exposed for I d. Sodium hyaluronate gel with molecular 10 x 10(5) was confirmed to be kept for at least 6 months in animal experiment and clinical trials.

CONCLUSIONS

Under the same condition of material ratio, the higher the molecular weight is, the lower the degradation rate is. But the liquidity of gel is not good for injection when molecular weight is too large. It suggests that Sodium hyaluronate gel with molecular 10 x 10(5) maybe the best choice in cosmetic injections.

摘要

目的

研究不同分子量比例的交联透明质酸钠凝胶的生物相容性和降解率,以便选择有效、安全且能完全降解的透明质酸钠凝胶用于美容注射。

方法

(1)用二乙烯砜与不同分子量(4×10⁵、8×10⁵、10×10⁵、12×10⁵)的透明质酸钠交联形成复合胶体。(2)将健康级KM小鼠随机分为两组,分别接受透明质酸凝胶或液体注射。每组再细分为三个亚组,接受不同分子量的透明质酸。在注射后7天、90天、180天观察透明质酸盐的生物相容性和降解率。同时,将不同分子量的透明质酸钠凝胶分别在低温保存下密封或暴露,观察其自然降解率。(3)选择最稳定的胶体作为美容注射剂给志愿者使用,观察美容效果。

结果

分子量为4×10⁵的透明质酸钠凝胶90天后完全降解。分子量为8×10⁵的透明质酸钠凝胶180天后完全降解。分子量为10×10⁵的透明质酸钠凝胶180天后降解至90.0%。透明质酸钠液体7天内可完全降解。该胶体低温密封保存时可至少保存12个月,但暴露1天则完全降解。在动物实验和临床试验中,分子量为10×10⁵的透明质酸钠凝胶被证实至少可保存6个月。

结论

在相同材料比例条件下,分子量越高,降解率越低。但当分子量过大时,凝胶的流动性不利于注射。这表明分子量为10×10⁵的透明质酸钠凝胶可能是美容注射的最佳选择。

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