创愈灵敷料——一种多功能载药生物材料的生物学评价

Biological evaluation of ChuangYuLing dressing-a multifunctional medicine carrying biomaterial.

作者信息

Peng Rui, Zheng Qixin, Hao Jie, Zou Yang, Cheng Jie

机构信息

Department of Orthopedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.

出版信息

J Huazhong Univ Sci Technolog Med Sci. 2005;25(1):72-4, 77. doi: 10.1007/BF02831391.

DOI:10.1007/BF02831391

PMID:15934313

Abstract

The safety of Chuangyuling (CYL) dressing-a multifunctional medicine carrying biomaterial was evaluated in order to provide foundation for the application of CYL as material used in the wound healing. The traditional Chinese medicine (TCM) extract solution was compounded with scaffolds (gelatin and Bletilla hyacinthine gum), and then frozen and dried to form spongy and porous material CYL. According to the standard of biological evaluation of medical devices that was instituted by the ministry of health of China, the biological evaluation of CYL dressing was conducted. The results showed that all the contents of biological evaluation test consisting of acute toxicity, skin irritation, sensitization and cytotoxicity met the requirement of standards. It was concluded that the biomaterial carrying TCM (CYL dressing) is safe for application of wound healing.

摘要

为了给创愈灵（CYL）敷料——一种多功能载药生物材料在伤口愈合中的应用提供依据，对其安全性进行了评估。将中药提取液与支架材料（明胶和白及胶）混合，然后冷冻干燥制成海绵状多孔材料CYL。按照中国卫生部制定的医疗器械生物学评价标准，对CYL敷料进行了生物学评价。结果表明，由急性毒性、皮肤刺激性、致敏性和细胞毒性组成的生物学评价试验各项内容均符合标准要求。得出结论：载中药的生物材料（CYL敷料）用于伤口愈合是安全的。