摘要
背景：国外商品化的硫酸钙产品尽管临床应用效果较好，但存在依赖进口和价格较高的缺陷。目的：自行构建骨植入型硫酸钙，庆大霉素药物释放系统，并评价其生物相容性。设计、时间及地点：观察对比实验，于2005—10／2006—09在解放军总医院骨科研究所完成。材料：以自制柠檬酸化半水硫酸钙为庆大霉素的载药基质，制备硫酸钙/庆大霉素植入剂抗生素含量5％。方法：根据医疗器械生物学评价实验选择指南（ISO标准10993—1，1997）和国家标准GB／T16886—1选择红细胞溶血实验、细胞毒性实验、热原实验、肌肉内植入实验及骨内植入实验评价硫酸钙，庆大霉素抗生素释放系统的生物相容性。主要观察指标：红细胞溶血率、细胞相对增殖率、体温升高情况及组织相容性。结果：①抗生素释放系统红细胞溶血率为2．02％，小于阳性标准。②细胞毒性实验：实验组细胞相对增殖率和对照组无显著性差别，毒性评分为0～1级。③热原反应：家兔平均体温升高为0．3℃，符合医用材料的热源反应要求。④肌肉内植入实验：抗生素释放系统在肌肉组织内可逐渐降解，材料周围未见大量炎性细胞浸润，组织无排斥。⑤骨内植入实验：骨组织内抗生素释放系统可逐步降解，并逐渐被骨性组织替代，无排斥现象及肝肾毒性。结论：构建的硫酸钙，庆大霉素释放系统不会引起机体本身的溶血反应，不具有细胞毒性和致热源作用，可逐步降解，无排斥现象，具有良好的生物相容性和安全性。
BACKGROUND： Commercial calcium sulfate is mainly imported and costs high, although it achieves wide application. OBJECTIVE： To develop bone-implanted calcium sulfate/gentamycin delivery system and to evaluate its biocompatibility. DESIGN, TIME AND SETTING： The experiment, a controlled trial, was finished in Institute of Orthopaedics, General Hospital of Chinese PLA from October 2005 to September 2006. MATERIALS： The bone-implanted calcium sulfate/gentamycin delivery system （5%） was prepared using citrated calcium sulfate as antibiotic delivery matrix. METHODS： According to ISO 10993-1 and GB/T 16886-1 standards, the following biological experiments had been performed to evaluate the biocompatibility of the calcium sulfate/gentamycin drug delivery system： haemolysis test, cytotoxicity test, pyrogenic test, intramusculary implanting test and bone implanting test. MAIN OUTCOME MEASURES： The rate of haemolysis, the relative proliferation rate of cells, the sum of rising temperature and histocompatibility. RESULTS： In the antibiotic delivery system, the rate of haemolysis was 2.02%, which was smaller than the positive standard for haemolysis test. There was no significant difference in the relative proliferation rate between the experiment group and the control group, in which the toxicity was scored as 0 1 grade. The body temperature of the rabbits was raised by 0.3 ℃ in pyrogenic test, which accorded with the requirement of medical materials. The antibiotic delivery system could be absorbed when being implanted in the muscle, and no apparent inflammatory response or rejection was observed in the surrounding tissue. After being implanted in the bone, antibiotic delivery system was replaced by osseous tissue, without rejection or the toxicity of kidney and liver. CONCLUSION： The calcium sulfate/gentamycin delivery systems are biocompatible and safe, without hemolytic reaction, hemolytic reaction or pyrogenic effect. It also can gradually degrade.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2008年第36期7031-7035,共5页
Journal of Clinical Rehabilitative Tissue Engineering Research
