Objective To investigate the currently-used biomaterials in reparative and reconstructive surgery and to clarify the relationship between the development of biomaterials and the progress of reparative and reconstructive surgery. Methods Based on the author’s many years’ scientific researches and combined with the literature available at home and abroad, the biomaterials used in the clinical practice, and their kinds and application fields were summarized. Results Based on the sufficient knowledge of the component structure of biomaterials and the patient’s pathological status, the matching biomaterials could be designed and developed. According to the analysis on some common defects occurring in the skin, bone, cartilage, vocalcord, nerve, and drum membrane, the methods of repairing the defects with biomaterials that we had developed, such as collagen, chitosan, and hyaluronate, achieved good results. Conclusion The rapid development of biomaterials can greatly promote progress of reparative and reconstructive surgery andthere exists a dependence relationship between the two. The related histological responses and the importance of biological estimation after implantation of biomaterials should be emphasized.
Objective To review and evaluate the extensive and further research and the application of the collagenbased biomaterials in the field of clinical medicine. Methods The clinical research and application of collagen-based biomaterials were comprehensively reviewed and evaluated on the basis of the up-to-date publications and our practical experiences in their studies and manufacturing. Results The following five aspects concerned with the collagen-based biomaterials were evaluated: biological property, quality control, formulation of substrate and clinical application, immunogenicity and clinical side effect, and potential of the market development. Conclusion Collgen-based biomaterials have a great potential and market space in their clinical application.
Objective To carry out a comprehensive and objective evaluation of viscosupplementation, so as to provide the actual judgments of effectiveness, development trends, and direction. Methods The related l iterature was reviewed, and the keys were the assessments from the international relevant advisory bodies and insurance companies and the evidence-based medicine on cl inic. Results Viscosupplementation has been gradually accepted. Although there are many different cl inical views of the viscosupplementation in the molecular weight of hyaluronan, injection dose, and the indications, intra-articular injection of hyaluronan for the treatment of osteoarthritis is well accepted. ConclusionViscosupplementation is one of the methods of treating osteoarthritis. As it has been already verified that hyaluronan iseffective in treating osteoarthritis of the knee and the periarthritis of shoulder, the hip joint injection is gradually recognized,and other small joints are going gradually.
【Abstract】 Objective To broaden the cl inical uses of fibrin-based biomaterials and to develop further study incell biology and to comprehensively understand and master related knowledge with regard to the present development status of fibrin. Methods Many relevant domestic and international papers were reviewed to make a summary. Results Recognization was obtained from four aspects, which were structure and function of fibrinogen, cl inical use of fibrin, fibrin scaffold for tissue engineering, and compounding biomaterials of fibrin. It showed that every aspect had great research extension and practical appl ication. Conclusion Besides a surgical hemostat and sealant, fibrin has great potentials in playing roles of tissue engineering scaffold, drug del ivery vehicle, and compounding material.
Objective To study the prevention of postoperative adhesion using carboxymethylcellulose(CMC). Methods The literature was reviewed extensively, concerning the physical and chemical characters of CMC, the mechanism of preventing adhesion, the effect on healing of anastomoses, the experimental researches and the clinical application. Results CMC was a polysaccharide with favorable biocompatibility, biodegradation, stable physical and chemical characters, and it can prevent postoperative adhesion. Conclusion CMC is with a wide outlook in prevention of postoperative adhesion.
Objective To investigate the latest development of tissue engineeredregenerative medicine in industrialization, with the intention to direct work in practical area. Methods A complete insight of regenerative medicine in industrialization was obtained through referring to update publications, visiting related websites, as well as learning from practical experience. Results The aerial view of the future of regenerative medicine was got based on knowledge of four different tissue engineering projects. Conclusion All present efforts should be devoted to regenerative medicine area meeting the industrialized trends.
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters. Methods Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated. Results Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant. Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
Objective To prepare carboxymethylchitin and study its properties. Methods Chitin was prepared from fresh shrimp shells and then carboxymethylchitin was prepared by the methods of alkalization and etherification as well as by the purification technique. The deacetylation degree of carboxymethylchitin was determined by the doublejump potentiometric titration method; the substitution degree was determined by the element analysis method; the carboxymethyl substitution position was analyzed by the Fourier transform infrared spectroscopy apparatus and the nuclear magnetic resonance spectroscopy apparatus; the relative molecular weight and its polydispersity were determined by the gel permeation chromatography with the multiple angle laser light scattering detection; the biological properties were tested according to the GB/T 16886 biological evaluation on medical devices. Results Carboxymethylchitin could be prepared by alkalization and etherification from chitin which was prepared from fresh shrimp shells by decalcification and deproteinization. The deacetylation degree of carboxymethylchitin was 13.76% according to the doublejump potentiometric titration; the degrees of deacetylation and substitution were 14.53% and 1.239 0 respectively according to the element analysis. The IR spectrum showed that the substitutive position was N,O-substitution, and the 13C-NMR spectrum showed that substitutive position of carboxymethylchitin was mostly primary substitution of 6-OH, and according to the substitutive proportion, the substitutive turns were in the following decreasing order: 6-OH, NH2, and 3-OH. The weightaveraged and the numberaveraged molecular weights and polydispersity were 6.25×105, 5.60×105 and 1.22, respectively. The results from the biological property test showed that carboxymethylchitin was a biomaterial that was sterile, pyrogen-free, acute toxicity-free, cytotoxicity-free, intracutaneous irritationfree, skin sensitization-free and biomaterial genotoxicity-free, with no side or adverse effects on the related tissues after implantation into the human body. Conclusion Carboxymethylchitin prepared from chitin by alkalization and etherification is amacromolecule biomaterial that has a low degree of deacetylation, a high degreeof substitution, and a good biocompatibility.
Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.
To evaluate the effect of deacetylation degree (DDA) on the gelation behavior of thermosensitive chitosan-β glycerol phosphate disodium salt pentahydrate (CH-GP) system and to compare their rheological behaviors before and after gelation. Methods A series of thermosensitive CH-GP samples with different DDAs (70%, 85%, 90%, 97%)were prepared by dissolving CH with 0.1 mol/L HCl solution, 5 samples for every single DDA, and then all these CH-GP solution samples processed the frequency sweep test and temperature sweep test (10-70℃ , 1℃ /min) on AR 2000ex rheometer, with pH value of 7.02. Also, all the results of hydrogel samples were processed a frequency sweep test. Results With CH concentration of 2% (w/v) and pH value of 7.02 , the gelating temperature of CH-GP systems with different DDAs (85%, 90%, 97%) were (59.90 ± 0.08), (48.10 ± 0.08), (37.10 ± 0.11) ℃ , respectively. While the gelating temperature of CH-GP system with 70% DDA was over 70℃ . There were statistically significant differences in temperature and time of gelation among groups with different DDAs (P lt; 0.05). Furthermore, storage modulus of such system raised from dozens Pa to a magnitude of several kPa during gelation , while loss modulus kept almost steady. Conclusion Gelating temperature and mechanical property of the system could be measured objectively by rheological characterization. Thus during designing tissue engineered scaffolds for various purposes, it is helpful applying selected CH with optimal DDA to different target tissues.