OBJECTIVETo improve our comprehensions to complement activation by biomaterial and lay the foundation for biosafety evaluation of solid biomaterials together with the corresponding blood contacting medical devices.

METHODSAnalyzed new requirements of current standards on complement activation by solid biomaterial as well as the mechanism of complement activation by solid biomaterial and how to select the related standards for inspection.

RESULTS AND CONCLUSIONThe new edition of international standards has enhanced types of blood contacting medical devices which are appropriate to complement activation test. It is badly in need of establishing the corresponding industry standards to regulate these requirements, since there have no uniform and admissive methods for inspection of complement activation by solid biomaterial.

The history of biomaterials research is seriously surveyed. It is found that an immutable way of thinking for developing biomaterials is rooted deeply in Western medicine and biology. It is necessary to modify or change the current status of thinking. In this paper, the author presents an idea to research and develop biomaterials via a combined way of thinking, i.e., combining together the wisdom and knowledge of Western medicine, Chinese medicine, and other disciplines.
Biocompatible Materials ; pharmacology ; Biomimetics ; methods ; Humans ; Thinking

The progress of research of the physical and chemical modification methods to improve the antithrombogenic property of biomedical polyurethane (PU) in the past five years is reviewed in this paper. The physical modification method includes physical blending, physical vapor deposition (PVD) and replication molding technique. Meanwhile, chemical modification method is focused on the covalent bonding to immobilized special molecular. Moreover, the covalent bonding method covered functionalizing the PU surface with tailor-made groups in the bulk and the activation of the surface to form unstable active sites for further reactions.
Animals ; Biocompatible Materials ; chemistry ; pharmacology ; Chemical Phenomena ; Fibrinolytic Agents ; chemistry ; pharmacology ; Humans ; Polyurethanes ; chemistry ; pharmacology

The perfluorocarbon (PFC) nanoparticle is a sort of new drug carrier in recent years, and it has lots of unique properties such as chemical stability, favourable biocompatibility, high aerobic capacity, targeting action to tissues or cells and so on. In this paper, we summarize the physico-chemical properties of the PFC nanoparticles. We also show the research progress of the PFC nanoparticles as a kind of drug carrier for targeted therapy of cardiovascular system, nervous system diseases and tumor. Further more, its characteristics of being selectively in target cells, tissues, and rapid release of drugs are expounded. PFC nanoparticles, as drug carriers for targeted diagnosis and treatment, have good prospect and clinical application value.
Animals ; Biocompatible Materials ; pharmacology ; Chemical Phenomena ; Drug Carriers ; pharmacology ; Drug Delivery Systems ; Fluorocarbons ; pharmacology ; Humans ; Nanoparticles

New bone formation in long-term intramuscle implant of Ca-P biomaterial was investigated in this experiment. After implanting into dog dorsal muscle for 15 months, a thin fibrous membrane that wrapped HA/TCP implant was still observed obviously. Three types of tissues, i.e. mesenchymal tissue, bone and bone marrow, regularly distributed in different pores of implant. Nearly all the pores of implants were occupied by bone. Bone in the pores located in the central region of implant was matured lamellar bone characterized by obvious lacuna and rich bone marrow. However, bone in the peripheral pores was immature woven bone without bone marrow formation. Furthermore, mesenchymal tissues only exist in the peripheral pores and usually were connected with immature woven bone. It was demonstrated that porous HA/TCP has bone inductivity and it could induce new bone formation at non-osseous site. Well-regulated distribution of mesenchymal tissue, bone and bone marrow in the pores suggest bone morphogenesis in the implant must obey a specific space-time program.
Animals ; Biocompatible Materials ; Bone Substitutes ; pharmacology ; Ceramics ; pharmacology ; Dogs ; Hydroxyapatites ; pharmacology ; Implants, Experimental ; Materials Testing ; Osteogenesis ; drug effects

Poly(epsilon-caprolactone) microspheres were fabricated with an average particle size of 5.08 +/- 0.23 microns. The effect of poly(epsilon-caprolactone) microspheres on apoptosis and cell cycle of fibroblast was studied with flow cytometry. The data obtained clearly indicated that poly(epsilon-caprolactone) microspheres purified in different ways showed different cytocompatibility. The well purified microspheres have good cytocompatibility.
Animals ; Biocompatible Materials ; chemical synthesis ; pharmacology ; Biodegradation, Environmental ; In Vitro Techniques ; Materials Testing ; Mice ; Microspheres ; Polyesters ; chemical synthesis ; pharmacology

Chitosan-carboxymethyl-chitosan complex film was prepared by freeze drying. Some tests in vivo and in animal were employed, in order to evaluate it on biology. All results indicated that the film has not only good surface compatibility but also good structural compatibility. It can be more suitable for GTR technology.
Animals ; Biocompatible Materials ; chemical synthesis ; pharmacology ; Chitin ; analogs & derivatives ; Chitosan ; Materials Testing ; Membranes, Artificial ; Rabbits ; Rats ; Skin Irritancy Tests

It has been well known that fluorinated polyurethanes exhibit unique low surface energy, biocompatibility, biostability and nonsticking behavior. Consequently, these polymers have attracted considerable interest. In this study, the effect of various concentrations of fluorinated polyurethanes in the polyurethanes on the surface structures of the blends and their hemocompatibility were investigated by XPS, AFM, contact angle and platelet adhesion. It was found that the high concentration fluorine on the outer surfaces of the blends obtained with the low concentration of fluorinated polyurethanes (F: 0.342 wt%) in the blends was the same as that of the fluorinated poly(ether urethane)s, and all of the blends and the fluorinated poly(ether urethane)s had good hemocompatibility, compared with poly(ether urethane)s. The polymer blends and fluorinated poly(ether urethane)s suppressed platelet adhesion due to their high hydrophobicity and low surface tension. The XPS, AMF and contact angle results indicated that the high hydrophobicity of outer surface of the polyurethane blends is independent of the fluorinated polyurethanes content in the polymer blends but related to the concentration of the CF3 groups because the lower critical surface tensions and higher contact angle of many fluorinated surfaces reflect the concentration of CF3 groups.
Coated Materials, Biocompatible ; chemistry ; Ethers ; Fluorine ; Humans ; Platelet Adhesiveness ; Polyurethanes ; chemistry ; pharmacology ; Prostheses and Implants ; Surface Properties

A simple plasma spraying method was employed in coating hydroxyapaptite (HA) on to carbon/carbon composites (C/C composites). The morphology of the coating was examined under scanning electron microscope (SEM). The phase constitutions of the HA coating were determined by X-ray diffractometer (XRD). The shear strength of the HA coating-C/C composite substrates was detected. A hydroxyapatite coating with rough surface was observed. A considerable amount of amorphous phase appeared as a result from the coating process, which could be transformed into the morphous phase crystalline HA after subsequent heat treatment. The shear strength between the HA coating and C/C composite substrates was 7.15 MPa.
Bone Substitutes ; chemistry ; Carbon ; chemistry ; Carbon Compounds, Inorganic ; chemistry ; Coated Materials, Biocompatible ; chemistry ; Durapatite ; pharmacology ; Humans

OBJECTIVE: To investigate the preparation of decellularized small intestinal submucosa (dSIS) sponge scaffolds with chelated strontium (Sr) ions at different pH values, and to select the appropriate pH values for synthesizing Sr/dSIS scaffolds using the physicochemical properties and biocompatibility of the scaffolds as evaluation indexes. METHODS: (1) Sr/dSIS scaffolds preparation and grouping: After mixing dSIS solution and strontium chloride solution in equal volumes, adjusting pH of the solution to 3, 5, 7, and 9 respectively, porous scaffolds were prepared by freeze-drying method after full reaction at 37℃, which were named Sr/dSIS-3, -5, -7, and -9 respectively, and the dSIS scaffolds were used as the control group. (2) Physicochemical property evaluation: The bulk morphology of the scaffolds was observed in each group, the microscopic morphology analyzed by scanning electron microscopy, and the porosity and pore size determined, the surface elements analyzed by energy spectroscopy, the structure of functional groups analyzed by infrared spectroscopy, the chelation rate determined by atomic spectrophotometry, the water absorption rate detected by using specific gravity method, and the compression strength evaluated by universal mechanical testing machine.(3) Biocompatibility evaluation: The cytotoxicity and proliferative effect to bone mesenchymal stem cells (BMSCs) of each group were evaluated by Calcein-AM/PI double staining method. RESULTS: Scanning electron microscopy showed that the scaffolds of each group had an interconnected three-dimensional porous structure with no statistical difference in pore size and porosity. Energy spectrum analysis showed that strontium could be detected in Sr/dSIS-5, -7 and -9 groups, and strontium was uniformly distributed in the scaffolds. Functional group analysis further supported the formation of chelates in the Sr/dSIS-5, -7 and -9 groups. Chelation rate analysis showed that the Sr/dSIS-7 group had the highest strontium chelation rate, which was statistically different from the other groups (P < 0.05). The scaffolds in all the groups had good water absorption. The scaffolds in Sr/dSIS-5, -7 and -9 groups showed significantly improved mechanical properties compared with the control group (P < 0.05). The scaffolds in all the groups had good biocompatibility, and the Sr/dSIS-7 group showed the best proliferation of BMSCs. CONCLUSION When pH was 7, the Sr/dSIS scaffolds showed the highest strontium chelation rate and the best proliferation effect of BMSCs, which was the ideal pH value for the preparation of the Sr/dSIS scaffolds.
Tissue Scaffolds/chemistry* ; Biocompatible Materials ; Strontium/pharmacology* ; Ions ; Hydrogen-Ion Concentration ; Tissue Engineering/methods* ; Porosity