CAJ | 학술논문

目的：研究阶梯缓释抗结核纳米人工骨复合体(β-TCP/INH-RFP-PCL/SM-SA)的生物安全性。方法对β-TCP/INH-RFP-PCL/SM-SA复合体进行体外噻唑蓝(MTT)细胞毒性实验，动物体内急性全身毒性实验、原发性皮肤刺激实验、皮内刺激实验和致敏实验，并设置对照组进行比较。结果β-TCP/INH-RFP-PCL/SM-SA复合体MTT细胞毒性实验显示人工骨材料组细胞存活率在95%以上，细胞毒性1级。人工骨复合材料浸取液不引起豚鼠过敏。原发性皮肤刺激实验和皮内刺激实验均提示复合材料对兔皮肤、皮内无刺激反应。小鼠尾静脉注射后未出现明显全身毒性反应。结论β-TCP/INH-RFP-PCL/SM-SA无明显细胞毒性，具有良好的细胞相容性，在应用过程中能够降低直接使用抗结核药物所带来的生物毒性。动物全身毒性反应、皮肤/内刺激反应和急性过敏反应提示该材料具有良好的生物安全性。
목적：연구계제완석항결핵납미인공골복합체(β-TCP/INH-RFP-PCL/SM-SA)적생물안전성。방법대β-TCP/INH-RFP-PCL/SM-SA복합체진행체외새서람(MTT)세포독성실험，동물체내급성전신독성실험、원발성피부자격실험、피내자격실험화치민실험，병설치대조조진행비교。결과β-TCP/INH-RFP-PCL/SM-SA복합체MTT세포독성실험현시인공골재료조세포존활솔재95%이상，세포독성1급。인공골복합재료침취액불인기돈서과민。원발성피부자격실험화피내자격실험균제시복합재료대토피부、피내무자격반응。소서미정맥주사후미출현명현전신독성반응。결론β-TCP/INH-RFP-PCL/SM-SA무명현세포독성，구유량호적세포상용성，재응용과정중능구강저직접사용항결핵약물소대래적생물독성。동물전신독성반응、피부/내자격반응화급성과민반응제시해재료구유량호적생물안전성。
Objective To investigate the biological security of ladder-sustained-release anti-TB drugs artificial com-posite bone (β-TCP/INH-RFP-PCL/SM-SA). Methods MTT toxicity test, acute systemic toxicity test, intracutaneous irritation test and skin sensitization in stimulation were performed in the ladder-sustained-release anti-TB drugs artifi-cial composite bone. The results were compared with control group. Results MTT toxicity test showed that the survival rate of bone cells in artificial materials was more than 95% and cytotoxicity was on grade 1. Artificial bone composite material liquid did not cause allergic reaction in guinea pig. Primary skin irritation experiments and intradermal stimu-lation experiment suggested that composite materials to rabbit skin and intracutaneous no stimulation reaction. No obvi-ous systemic toxic reaction was found in mice after intravenous injection. Conclusion There is no MTT cytotoxicity in the ladder-sustained-release anti-TB drugs artificial composite bone. It can reduce the biological toxicity of anti-TB drugs and will not cause systemic toxic reaction, skin/hypodermic stimulation reactions and acute allergic reaction. It has good cell compatibility and biological security.