溶菌酶肠溶微球的制备及质量评价  

Preparation and Quality Evaluation of Lysozyme Enteric Microspheres

作　　者：魏培 朱瑞娟 钱淼 杨文文 王娟弟 孙新堂 WEI Pei;ZHU Ruijuan;QIAN Miao;YANG Wenwen;WANG Juandi;SUN Xintang(Shandong Vocational Animal Science and Veterinary College,Weifang Shandong 261061,China;Gansu Institute for Drug Control,Lanzhou Gansu 730070,China;NMPA Key Laboratory for Quality Control of TCM,Lanzhou Gansu 730070,China;Weifang Key Laboratory of Animal Fermentation Technology,Weifang Shandong 261061,China)

机构地区：[1]山东畜牧兽医职业学院,山东潍坊261061 [2]甘肃省药品检验研究院,甘肃兰州730070 [3]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070 [4]潍坊市兽用微生物发酵重点实验室,山东潍坊261061

出　　处：《现代畜牧科技》2025年第2期42-44,共3页Modern Animal Husbandry Science & Technology

基　　金：山东省农业重大技术协同推广项目(SDNYXTTG-2024-04);中药材及饮片质量控制重点实验室项目(2023GSMPA-KL06,2024GSMPA-KL16)。

摘　　要：为制备溶菌酶肠溶微球,并对其进行质量评价和体外释放度考察,采用滴制法制备溶菌酶肠溶微球,以载药量、微球包封率为主要指标,正交设计优化溶菌酶肠溶微球的制备工艺。制得微球形态圆整,平均粒径(314.0±11.48)μm,包封率(91.13±1.89)%,载药量(11.66±0.76)%,微球在酸性介质中基本不释放,在肠溶介质中1 h释放低于30%,60 h释放达90%以上。该制备工艺稳定、操作简便,所制备微球包封率和载药量高,缓释效果好,可用于溶菌酶肠溶微球的制备。To prepare lysozyme enteric microspheres,and evaluate its quality and release in vitro.The preparation of lysozyme enteric-coated microspheres by drop method was carried out,with the loading capacity and encapsulation efficiency as the main indicators.The preparation process was optimized by orthogonal design.The as-prepared microspheres had a good appearance with the particle size of(314.0±11.48)μm.The encapsulation efficiency and drug loading were(91.13±1.89)%and(11.66±0.76)%,respectively.The lysozyme enteric microspheres did not release in acidic medium,the accumulative release rate of lysozyme from microspheres was less than 30%in 1 h and more than 90%in 60 h in enteric medium.The optimized process is stable and feasible for preparing lysozyme enteric microspheres with high encapsulation efficiency and drug loading,and good sustained release effect.

关 键 词：溶菌酶 微球 正交设计 质量评价 释放度 

分 类 号：S854.4[农业科学—临床兽医学]