中国组织工程研究

中国组织工程研究 ›› 2010, Vol. 14 ›› Issue (12): 2114-2118.doi: 10.3969/j.issn.1673-8225.2010.12.007

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

载微球骨水泥的体内生物相容性

邓永忠1，李  森2，靳安民3，薛忠林4，张  辉3   

  1. 1解放军第四医院骨科，青海省西宁市  810007；2泸州医学院附属医院脊柱骨科，四川省泸州市646000；3南方医科大学珠江医院骨科中心，广东省广州市  510282；4江门市中心医院骨科，广东省江门市  529000
  • 出版日期:2010-03-19 发布日期:2010-03-19
  • 通讯作者: 张 辉，博士，副主任医师，南方医科大学珠江医院骨科中心，广东省广州市 510282 zhanghuixf@163.com
  • 作者简介:邓永忠，男，1968年生，广西壮族自治区灌阳市人，汉族，1992年解放军第一军医大学毕业，副主任医师，主要从事脊柱、骨与关节损伤等方面的研究。 Doctordyzhong@sina.com
  • 基金资助:

    广东省科技计划项目课题(2007B031003009)，课题名称：可注射抗肿瘤骨修复材料的研制。

Biocompatibility of bone cement containing microspheres in vivo

Deng Yong-zhong1, Li Sen2, Jin An-min3, Xue Zhong-lin4, Zhang Hui3　   

  1. 1 Department of Orthopaedics, Fourth Hospital of Chinese PLA, Xining   810007, Qinghai Province, China; 2 Department of Spinal Orthopaedics, Hospital Affiliated to Luzhou Medical College, Luzhou   646000, Sichuan Province, China; 3 Orthopaedics Center, Zhujiang Hospital, Southern Medical University, Guangzhou   510282, Guangdong Province, China; 4 Department of Orthopaedics, Central Hospital, Jiangmen   529000, Guangdong Province, China
  • Online:2010-03-19 Published:2010-03-19
  • Contact: Zhang Hui, Doctor, Associate chief physician, Orthopaedics Center, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, Guangdong Province, China zhanghuixf@163.com
  • About author:Deng Yong-zhong, Associate chief physician, Department of Orthopaedics, Fourth Hospital of Chinese PLA, Xining 810007, Qinghai Province, China Doctordyzhong@sina.com
  • Supported by:

    the Science and Technology Plan Program of Guangdong Province, No. 2007B03 1003009*

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摘要：

背景：课题组在前期实验中已经证实了载聚乳酸-聚羟基乙酸共聚物微球骨水泥具有较高的强度，良好的注射性能和体外可降解性能，但其生物相容性如何还不清楚。
目的：选择急性毒性试验，溶血试验，微核试验等检测载微球骨水泥的生物相容性。
方法：首先合成柱状骨水泥和包裹微球骨水泥，取1 g材料加入到100 mL的磷酸缓冲液中无菌条件下浸泡3 d后提取的上清液即为骨水泥浸提液和微球骨水泥浸提液。以急性毒性实验、溶血试验、微核试验和热原试验来考察材料的体内毒性。
结果与结论: 急性毒性实验结果显示，骨水泥浸提液组和微球骨水泥浸提液组(除高浓度微球骨水泥组外)与阴性对照组均无明显差异，说明该材料浸提液没有对小鼠产生明显的毒性反应。溶血实验显示，各组材料对健康人血的溶血率均未超过5%。微核实验结果显示除0.4 mL骨水泥组和0.4 mL微球骨水泥组的微核率与阴性对照组差异有显著性意义，其余各组差异无显著性意义，说明该微球骨水泥的浸提液无明显细胞遗传毒性作用，但是高浓度和高剂量组的微球骨水泥仍有较低的毒性作用，主要表现为溶血率和微核率的提高，因此在应用时要适当控制微球骨水泥的剂量和浓度。热原试验显示，注射后家兔平均体温升高为0.06 ℃，小于1.4 ℃，说明材料无致热作用。

关键词: 聚乳酸-聚羟基乙酸共聚物, 骨水泥, 微球, 体内生物相容性, 生物材料　

Abstract:

BACKGROUND: Our previous studies have confirmed that bone cement with polylactic acid-polyglycolic acid copolymer microspheres has a high strength, good injection property and in vitro degradable function, but its biocompatibility is still unclear.
OBJECTIVE: To select acute toxicity test, hemolytic test and micronucleus test, and to determine biocompatibility of bone cement containing microspheres.
METHODS: Columnar bone cement and microsphere-coated bone cement were synthesized. 1 g material was added into    100 mL phosphate buffer and immersed for 3 days under sterile condition to extract supernatant, namely bone cement leaching liquor and microsphere-coated bone cement leaching liquor. The toxicity of the product was detected using acute toxicity testing, hemolysis test, micronucleus test and pyrogen test.
RESULTS AND CONCLUSION: Acute toxicity testing results showed that no significant difference was determined between the bone cement leaching liquor and microsphere-coated bone cement leaching liquor groups (except high concentration of microsphere-coated bone cement group) and negative control group. This indicated that the leaching liquor had no significant toxic reaction in rats. Hemolysis test demonstrated that the hemolysis ratio was less than 5% in each cement group. Micronucleus test results exhibited that significant differences in micronuclear rates were determined between 0.4 mL bone cement and 0.4 mL microsphere-coated bone cement groups and negative control group, but no significant difference was detected among other groups. This revealed that this microsphere-coated bone cement leaching liquor did not show significant cell heredity toxic effects. Nevertheless, microsphere-coated bone cement in the high concentration and high dosage groups exhibited low toxic effects, mainly showing increased hemolysis rate and micronuclear rate. Thus, it was necessary to control the dosage and concentration of microsphere-coated bone cement. Pyrogen test confirmed that the average increased temperature was 0.06 ℃, lower than  1.4 ℃ in rabbits following injection. This shows no induced thermal effects of the material.

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