海洋溶菌酶膜的制备及质量控制  

Preparation and Quality Control of Oceanic Lysozyme Film

作　　者：孙伟[1] 綦秀芬[1] 李恩泽[1] 刘玉爱[1] 戴莉玲[1] 

机构地区：[1]青岛大学医学院附属医院,青岛市266003

出　　处：《中国药房》2006年第4期267-269,共3页China Pharmacy

摘　　要：目的:制备海洋溶菌酶膜,并建立其质量控制方法。方法:以海洋溶菌酶为主药、羟丙基甲基纤维素为成膜材料制成膜剂,采用Folin-酚测定法和平板扩散法分别测定海洋溶菌酶的蛋白浓度和酶活性,以紫外分光光度法测定海洋溶菌酶膜中海洋溶菌酶的含量。结果:海洋溶菌酶的蛋白浓度和酶活性符合抑菌要求;样品平均回收率为101·0%(RSD=0·67%);样品放置6mo内各项指标均无明显变化。结论:本制剂制备工艺简单、质量可控,可为临床治疗阴道炎提供一种新型制剂。OBJECTIVE： To prepare oceanic lysozyme film and establish a method for its quality control, METHODS： Film agent was prepared with oceanic lysozyme as the principle agent and hydroxy propyl methylcellulose as the film- former. Folin- phenol method and agar plate diffusion method were used respectively to determine the concentration of albumen and enzyme activity of oceanic lysozyme; and the content of lysozyrne in the oceanic lysozyme film wan determined by ultraviolet spectrophotometry. RESULTS： Both albumen concentration and enzyme activity of oceanic lysozyme were up to the bacteriostatic requirement. The average recovery rate of sample was 101.0% （RSD=0.67% ）. Storing within 6 months, each index of the sample experienced no marked change. CONCLUSION：The preparation is simple in production, controllable in quality and it nerved as a new preparation for the clinical treatment of vaginitis.

关 键 词：海洋溶菌酶膜 蛋白浓度 酶活性 含量 稳定性 

分 类 号：R984[医药卫生—药品]