Main innovative achievements include:
1) Create a 125I isotope tracing technology that can directly label polylactide-glycolide to solve problems including tissue engineering scaffolds or drug buffers. Key issues such as distribution, metabolism and evaluation of degradation products of polylactide-glycolide degradation biomaterials including release carriers in the body;
2) Created a molecular filtration system for biological evaluation of medical devices A series of testing methods, including cross-linkage testing, in vitro and in vivo degradability, immunological toxicity, degradation product toxicokinetics, and quantitative determination of osteogenic capacity in vivo, have filled the gap in the biological evaluation and testing capabilities of some medical devices in my country and provided a basis for various types of medical treatments. Provide scientific and effective means for preclinical safety evaluation of devices;
3) China took the lead in carrying out standardized research on biological evaluation and created the national standard GB/T 16175 "Test Methods for Biological Evaluation of Medical Silicone Materials" standards and the draft industry standard "Method for Evaluation of In Vivo Degradation and Osteogenesis Performance of Porous Bioceramics", which has made important contributions to the risk assessment before my country's medical device market access;
4) Proposed the current national standard for the first time The evaluation criteria in GB/T16886.6-1997 do not apply to the histological evaluation of degradable devices or materials, which has been adopted by the ISO 10993-6-2007 standard promulgated in 2007;
5) Be the first to preliminarily explain the mechanism of cell damage caused by HAp nanoparticles and thrombosis caused by materials from the whole, cellular and molecular levels, and create labeling and in vivo tracing technology for SiO2 and HAp nanoparticles. Provide theoretical and technical support for the safe application of nanomaterials and interventional medical devices.
The above achievements have been promoted and applied through various forms such as invention patent authorization, promulgation of national standards, publication of monographs or textbooks, publication of treatises, and provision of training and testing services to the society. In particular, the results have improved the overall quality of the discipline. The academic status and external testing capabilities have enabled the discipline to obtain qualifications recognized by CNAS and SFDA, becoming an authoritative testing institution with a high reputation at home and abroad, and achieving significant social benefits.