【作者】 李峰；

【导师】 黄青山； 张继恩；

【作者基本信息】 复旦大学 ， 生物工程（专业学位）， 2014， 硕士

【摘要】 本文主要研制以重组溶葡萄球菌酶为主药抑菌成分,具有高吸收渗出液的水胶体创口敷料。通过正交试验研究了羧甲基纤维素钠(CMC-Na)、聚乙烯醇(PVA)和明胶的基质配比,根据外观及吸水率评价处方,并且对重组溶葡萄球菌酶水胶体液体吸收性、水蒸气透过性、阻菌性的研究发现,处方9的重组溶葡萄球菌酶水胶体性能优良。通过对重组溶葡萄球菌酶水胶体进行体外缓释度、细菌杀灭率、重量差异、微生物限度的质量研究发现：在体外缓释试验2h已达到标示量的80%以上；且体外缓释试验液在2h时的细菌杀灭率已达到90%以上；重量差异限度在士7.5%以内；微生物限度检验结果符合要求,由此建立重组溶葡萄球菌酶水胶体创口敷料的质量标准草案。更多还原

【Abstract】 Lysostaphin is an enzyme with a wide-spectrum antibacterial activity, which has been widely used in treatment of multi-bacterial infection. This research focus on the development of a hydrocolloid wound dressing with recombinant lysostaphin as main component. We chose polyvinyl alcohol(PVA), Carboxymethylcellulose sodium(CMC-Na) and gelatin as matrix to prepare several hydrocolloids and evaluated with liquid absorptivity, water vapor permeability, bacteria blocking ability and other methods. We found the optimal proportion of 5% PVA,3% CMC-Na and 10% gelatin, which has the highest stability and good repeatability. The release of the recombinant lysostaphin from the hydrocolloid in in vitro sustained release test of 2 hours has reached more than 80% of the labeled amount; in vitro sustained release test solution of 2 hours has bacteria killing rate of over 90%; the weight variation limit is within ±7.5%; microbial limit test results meet the requirements. The quality research methods have good reproducibility and can be used for quality control on sustained release and bacteria killing rate of the preparation; in addition the quality research confirms that the production process of recombinant lysostaphin hydrocolloid is stable and the product is a wound dressing with good antibacterial property. By studying the quality of the in vitro release degree, bacteria killing rate, weight variation, microbial limit of recombinant lysostaphin hydrocolloid, we established a quality standard of recombinant lysostaphin hydrocolloid wound dressing.更多还原