Cell/gene-activated biomaterials are the main tendency and characteristics of the biomaterial researches for the future. The gene delivery based on the polymeric materials as vectors has potential applications in gene therapy, regenerative medicine and tissue engineering. In this paper, the application of layer-by-layer (LBL) technique in advanced biomaterial surface engineering is reviewed and its potential application in the construction of in situ gene delivery system onto biomaterial surface is in turn addressed. These are of great significance to biomaterial researches.
Biocompatible Materials ; chemistry ; DNA ; metabolism ; pharmacokinetics ; Regenerative Medicine ; methods ; Surface Properties ; Tissue Engineering ; methods ; trends ; Tissue Scaffolds ; Transfection

Objective:To study the acute toxicity in mice and cytotoxicity of the impuritiy(3-amino-2-piperidinone hydrochloride) in ornithine. Methods:The mice were given the impurity by intravenous injection.The acute toxicity was observed and LD50in mice was calculated by Bliss method. According to the result of LD50,the mice were given the impurity respectively at high,medium and low dose. The changes of general condition and body weight were recorded,and the blood biochemical indices and histomorphology of organs and tissues were observed after 14 days. The cytotoxicity was measured on fibroblasts(L929) cells. Results:The LD50and 95% con-fidence limit of the impurity (intragastric administration) was 758.49-848.08 mg·kg-1.All the detected indices of the three groups (660,330 and 170 mg·kg-1) including general condition,weight change,biochemical indices,organ morphological and histological change were all within the normal ranges. The impurity significantly decreased the viability of L929 cells. The NOAEL value was 660 mg·kg-1in mice. Conclusion:The impurity has certain toxicity to mice and cells. The data can provide experimental basis for the quality standard establishment for ornithine and the safety improvement in clinic use.

Three-dimensional poly (epsilon-caprolactone)/silk sericin (PCL/SS) porous nanofibrous scaffolds were prepared by electrospinning. The structure and properties of the scaffolds were characterized by Scanning Electron Microscope (SEM), Transmission Electron Microscope (TEM), Fourier Transform Infrared Spectroscopy (FTIR) and water contact angle instrument. Studies on cell adhension and proliferation were carried out by culturing human primary skin fibroblast cells (FEK4) on these scaffolds using SEM and MTS. The experimental results showed that the PCL/SS nanofibrous scaffolds with SS nanoparticles had porous non-woven mesh structure with nanofibrous cross-linked with each other. Fiber diameter was very uniform and precise, and the secondary structure of SS protein had not been changed. Furthermore, the capability of hydrophile increased with the SS addition, which improved FEK4 cells adhesion and proliferation on the scaffolds.
Biocompatible Materials ; chemistry ; Cell Adhesion ; drug effects ; Cells, Cultured ; Fibroblasts ; cytology ; Microscopy, Electron ; Nanofibers ; chemistry ; Polyesters ; chemistry ; Sericins ; chemistry ; Silk ; chemistry ; Spectroscopy, Fourier Transform Infrared ; Tissue Scaffolds ; chemistry

OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.