摘要
目的制备重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)喷雾剂,并分析其药效性能。方法以复合稳定剂维持主药生物稳定性,加入吸收促进剂,以5种配方制备rhGM-CSF液体喷雾剂,并对其进行主要质量指标、稳定性检测及动物药效学试验。结果以优选的制剂配方配制的rhGM-CSF喷雾剂各项主要质量指标均合格,且稳定性良好。动物药效学试验结果显示,此喷雾剂与抗病毒药物联合使用,抵抗流感病毒感染的效果更好,且具有抗单纯疱疹病毒感染和抗白色念珠菌感染的作用。结论所制备的rhGM-CSF喷雾剂药效良好,具有临床应用价值。
Objective To prepare recombinant human granulocyte-macrophage colony-stimulating factor （rhGM-CSF） spray and study its pharmacodynamics. Methods rhGM-CSF spray was prepared by maintaining the biological stability of essential components with compound stabilizer and adding absorption enhancer and subjected to control and stability tests, the studied for phannacodynamics in animals. Results The prepared rhGM-CSF spray was qualified in control tests and showed good stability. Animal experiment proved that the rhGM-CSF spray combined with antiviral drug was more effective in prevention of influenza virus infection than antiviral drug alone. The spray also showed protections against herpes simplex virus and Candida albicans infections. Conclusion The prepared rhGM-CSF spray showed good curative effect, which was of a certain significance in clinical application.
出处
《中国生物制品学杂志》
CAS
CSCD
2009年第8期795-798,共4页
Chinese Journal of Biologicals
基金
深圳科技信息发展局科技发展项目(2008-342)
关键词
粒细胞巨噬细胞集落刺激因子
喷雾剂
制备
药效学
Granulocyte-macrophage colony-stimulating factor （GM-CSF）
Spray
Preparation
Pharmacodynamics
