一种新型软腭植入系统材料的制备:物理性能及其动物安全性评价

Preparation of a new material for palatal implant:Physical performance and animal safety assessment

目的:目前常用的软腭植入材料对苯二甲酸乙二醇酯具有轻度排斥反应、降解速率不可控等缺陷,所以探索一种新的治疗轻中度鼾症的软腭植入材料,并评价其相关物理性能及动物安全性。方法:实验于2006-06/2007-01在解放军广州军区总医院医学实验科生物人工骨实验室完成。①将羟基磷灰石颗粒、聚乳酸-三亚甲基碳酸酯按质量比1∶1的比例复合,利用有机溶剂注模法重组羟基磷灰石/聚乳酸-三亚甲基碳酸酯复合材料。②测试羟基磷灰石/聚乳酸-三亚甲基碳酸酯复合材料的弹性模量、拉伸强度、压缩强度、邵氏硬度等性能参数,并对材料进行急性毒性实验、溶血实验、致敏实验及热源实验等动物安全性评价。实验中对动物处置符合动物伦理学标准。结果:①物理性能:新的软腭植入系统材料羟基磷灰石/聚乳酸-三亚甲基碳酸酯的弹性模量为100.35MPa,拉伸强度为2.24MPa,变形10%压缩强度为0.41MPa,邵氏硬度为89.4。②安全性评价:全身急性毒性实验结果显示动物注射浸提液后无毒性症状;溶血实验结果显示材料的溶血率为3.09%,符合溶血实验的评价标准;致敏实验表明该材料无致敏作用;热源实验结果显示在每种材料初试的新西兰兔中,体温升高均在0.4℃以下,并且体温升高总度数在0.9℃以下,符合热源实验的评价标准。结论:羟基磷灰石/聚乳酸-三亚甲基碳酸酯软腭植入材料的弹性模量、拉伸强度、压缩强度、硬度等性能基本符合软腭植入的要求,并且具备基本的动物安全性。

AIM： The present commonly used palatal implant has side effects on polyethylene terephthalate, including slight rejection and uncontrollable degradation rate. This article is intended to search for a new material curing snoring for palatal implant, evaluate its physical properties and animal safety. METHODS： The experiment was performed at the Laboratory of Biological Artificial Bone, Department of Medical Research, Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA from June 2006 to January 2007. ①Organic solvent molding of hydroxyapatite and poly（lactide-co-trimethylene carbonate） （HA-P） （1：1） that proportionally mixed was performed to obtain palatal implant material. ②The mechanical behavior of the material was studied such as the modulus of elasticity, tensile strength, compress intensity and shaoshi hardness. Animal safety was evaluated by acute toxicity test, Hemolysis test, Sensitization test and Pyrogen tes further. Animal experiment met the animal ethical standard. RESULTS： ①The new material was prepared with an average modulus of elasticity of 100.35 MPa, tensile strength of 2,24 MPa, compressive intensity of 0,41 MPa deformed by 10%, shaoshi hardness of 89.4. ②Systemic acute toxicity test indicated that the animals had no toxical symptom after injecting infusion. Hemolysis test indicated that the material was consistent its criteria with hemolysis ratio of 3.09%. Sensitization test demonstrated it did not cause any hypersensitive reaction. Pyrogen test demonstrated its result corresponded to its assessment criteria; fervescence was below 0.4 %, and total increased degree was below 0.9 %. CONCLUSION： The new HA-P material basically satisfies with the desire of palatal implant, which has certain elasticity, toughness and hardness and the animal safety.