Objective The purpose of this study was to observe and evaluate the intracutaneous filling effect of Nanohydroxyapatite/Carboxymethyl Chitosan composite (N-HA/CMCTS) as a new kind of soft tissue filling agent. Methods N-HA and CMCTS were used to make three kinds of composite (A、B、C) for different proportion (1:1、4:6、3:7),and another material D is Physiological saline. Sixty-four wistar rats were divided into 4 groups.These different kinds of materials were injected randomly and subcutaneously on the back of each rat. At time points 1,4,8 and 12 weeks after injection,some of the rats were sacrificed to be evaluated with anatomy and histology. Results No apparent reject reaction was found. A mild inflammatory infiltrate was found on the back of the other rats of A,B and C. Fiber tissue surrounding the composite was not pronounced, and the collagen became more and abnormal fiber cells were not found at 1～12 weeks postoperatively. Conclusion Nano-hydroxyapatite /Carboxymethyl Chitosan composite has good histocompatibility and plasticity in vivo. It was not toxic and excitant. It was absorbed slowly and promoted collagen secretion. As such,this material may become a new kind of injectable soft tissue filling agent.%目的:通过纳米羟基磷灰石/羧甲基壳聚糖(N-HA/CMCTS)复合生物材料制备注射性软组织填充剂,初步了解其注入大鼠体内后组织反应、包膜形成、在体内吸收及其对胶原生成的影响情况.方法:按预先设计制成3种不同比例的复合材料(羧甲基壳聚糖与纳米羟基磷灰石的比例分别为1:1、4:6、3:7),分别标记为A、B、C,另有一份生理盐水标记为D.64只wistar大鼠随机分成4组,在四组大鼠背部左右两侧各设计一个圆形注射区,随机取三组注射复合材料,第四组注射生理盐水,每组所注射的复合材料也是随机的.分别于第1、4、8、12周处死动物切取标本,行肉眼及组织学观察.结果:复合材料植入区未见明显排异反应,A、B、C三组其他所有大鼠注射部位的皮肤稍有红肿,无渗出,D组未见明显的炎症反应,1～12周复合材料周围未见明显的纤维包膜形成,胶原生成逐渐增多,纤维细胞未见明显异常.结论:纳米羟基磷灰石/羧甲基壳聚糖(N-HA/CMCTS)复合生物材料有良好的组织相容性,无毒、无刺激性,吸收慢、可塑形并可促进胶原分泌,有望成为一种新型的注射性软组织填充剂应用于整形美容领域.
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