Immunogenicity for medical devices of animal origin is the key and difficult point during immune safety evaluation for these devices. This paper firstly investigated the effect of collagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the influence factors on the MTT method and CFSE method. The results showed that collagen sponge extract cannot significantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.
Animals ; Cells, Cultured ; Collagen ; pharmacology ; Lymphocyte Activation ; drug effects ; Mice ; Porifera ; chemistry ; Spleen ; cytology

Objective To construct eukaryotic expression vector of small hairpin RNA vector targeting hepatitis B virus core protein in HepG2.2.15 cells,and to verify the interfering effect.Methods To design and synthesize small interfering RNA sequence against HBc gene (ayw subtype) which locates between 2147 bp to 2165 bp in the HBV genome.The siRNA fragment were inserted into pSilencer3.1-H1 neo vector.The recombinants were transformed into E.coli DHSα successfully.The recombinant plasmids were identified by Eco RI enzyme digestion and sequenced.Finally,The HepG2.2.15 cells were transfected with the vector by using lipofectamine method to identify its interfering effect.Results The eukaryotic expression vector containing small hairpin RNA targeting HBV core protein was constructed successfully and named as pshRNA-HBc.The recombinant plasmids were identified by SalI or EcoRI enzyme digestion and sequenced.The silencing effect was detected by using revere transcription polymerase chain reaction (RTPCR) and the secretion of HBsAg and HBeAg in the supernatant of HepG2.2.15 cells.The result showed that the interfering effect was specific and efficient.Conclusion The small interfering RNA targeting HBV core protein in HepG2.2.15 cells was constructed successfully,which may be useful for studying the biological functions of HBc in the future.

Immunogenicity for medical devices of animal origin is the key and diffi cult point during immune safety evaluation for these devices. This paper firstly investigated the effect of colagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the infl uence factors on the MTT method and CFSE method. The results showed that colagen sponge extract cannot signifi cantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.

In recent years,China has made great progress in basic nanomedicine,nanotoxicology and nanobiology research.Nanotechnology has been continuously applied in biomaterial and medical device,more and more medical devices applying nanomaterials are developed and manufactured.In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices,this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad,and discussed the current challenges in biological evaluation of nanomaterial medical devices,with a view to providing ideas for the safety evaluation and research of related products.