摘要
〔目的〕制备乳铁蛋白凝胶剂,考察其相应的质量指标及安全性,为其应用于抗HPV病毒研究奠定基础。〔方法〕以凝胶剂的外观、稳定性及蛋白络合情况为指标,筛选出最佳的凝胶基质并确定制备工艺;以《中国药典》2015版的相关检测方法为依据,测定该制剂的pH值、黏度、微生物限度及蛋白质含量;制作乳铁蛋白含量不同的凝胶剂,以家兔为试验动物,观察给药部位的表观变化及存活情况,评价该制剂的安全性。〔结果〕以壳聚糖、甘油-明胶为凝胶基质所制得的凝胶剂均匀细腻且不发生蛋白络合;测得的制剂pH为4.0~5.0,黏度为200~300 mPa·s-1,微生物限度符合要求,含量测得值与实际加入量基本一致;整个安全性试验过程中家兔无死亡情况,给药部位无明显过敏、出血等不良现象。〔结论〕该制剂的基质廉价易得,制备工艺简单,质量可控,安全性高,为乳铁蛋白应用于临床提供了可参考性依据。
〔Objective〕To prepare the lactoferrin gel,to inspect the quality and safety of it,to lay the foundation for its application in the research of anti HPV virus.〔Methods〕Taking the appearance,stability and protein complex situation as the index of the lactoferrin gel,to select the best gel matrix and determining the preparation technology;pH,viscosity,microbial limit and protein content of the preparation are determined based on the correlation detection method of the ChP(2015);preparing different lactoferrin gels in lactoferrin content,using rabbits as the experimental animal,observing the change of drug site and survival of rabbits,and then evaluating the safety of the preparation.〔Results〕Taking the chitosan and glycerol gelatin as gel matrix,the gel is smooth and without protein complexation;pH is 4.0~5.0,viscosity is 200~300 mPa/s,microbial limit is in line with the requirement,measured value is basically consistent with the actual amount added;there were no deaths in the whole safety testing process,no obvious allergies,bleeding and other undesirable phenomena.〔Conclusion〕The preparation's matrix is cheap and easy to obtain,the preparation process is simple,the quality is controllable,and the safety is high,which provides a reference basis for the clinical application of lactoferrin.
作者
和晓春
刘伟芬
李禄辉
陈东晓
王海彦
李建业
蒲晓辉
HE Xiaochun;LIU Weifen;LI Luhui;CHEN Dongxiao;WANG Haiyan;LI Jianye;PU Xiaohui(Central Hospital of Henan energy coking coal company,Jiaozuo 454000,China;School of Pharmaceutical Engineering,Henan Vocational College of Applied Technology,Zhengzhou 450042,China;Institute of Pharmacy,Henan University,Kaifeng 475004,China;Nanjing Lacksen biological medicine technology Co.Ltd,Nanjing 211100,China)
出处
《河南大学学报（医学版）》
CAS
2020年第4期235-239,共5页
Journal of Henan University:Medical Science
关键词
乳铁蛋白凝胶剂
制备
含量测定
微生物限度
安全性评价
lactoferrin gel
preparation
content determination
microbial limit
safety evaluation
