人干扰素α1b喷雾剂抑菌剂筛选及抑菌效力研究
Study on the screening and bacteriostatic efficacy of bacteriostatic agent in human interferon α1b spray
刘琳琳 1董历子 1崔越 1朱秋媚 1苏畅 1张宇 1刘景会1
作者信息
- 1. 长春生物制品研究所有限责任公司,长春 130012
- 折叠
摘要
目的:探索人干扰素α1b喷雾剂制剂处方中抑菌剂及其最低有效抑菌浓度,确定抑菌剂的合理添加剂量.方法:应用生物学活性检测方法进行人干扰素α1 b喷雾剂制剂处方中抑菌剂的筛选,确定抑菌剂,然后按照2020年版《中华人民共和国药典》通则1121抑菌效力检查法测定抑菌效力确定抑菌剂的最低有效抑菌浓度.以金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和黑曲霉为试验菌株,进行菌落计数方法适用性试验.设计抑菌剂剂量筛选试验,对不同浓度的抑菌剂分别对4种试验菌的抑菌效果进行考察,筛选出抑菌剂的合理添加量.结果:筛选出人干扰素α1b喷雾剂制剂处方中的抑菌剂为苯扎溴铵;苯扎溴铵浓度为0.05～0.1 mg·mL-1时对金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和黑曲霉的抑菌效力均符合A级.结论:确定了人干扰素α1b喷雾剂制剂处方中抑菌剂苯扎溴铵的最低有效抑菌浓度为 0.05 mg·mL-1.
Abstract
Objective:To explore the minimum effective inhibitory concentration of bacteriostatic agent in the prescription of human interferon α1b spray,and to determine the reasonable dosage of bacteriostatic agent.Methods:Biological activity detection method was used to screen bacteriostatic agents in the prescription of hu-man interferon α1b spray preparation,determine bacteriostatic agents.The bacteriostatic efficacy was determined according to the bacteriostatic efficacy test method of general principles 1121 of the Chinese Pharmacopoeia 2020 edition to determine the minimum effective bacteriostatic concentration of bacteriostatic agents.Staphylococcus aureus,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as test strains to test the applicability of colony counting method.The dose screening test of bacteriostatic agent was designed to investigate the bacteriostatic effect of bacteriostatic agent with different concentrations on four kinds of experimental bacteria,and the reasonable dosage of bacteriostatic agent was selected.Results:Benzalkonium bromide was screened out as the bacteriostatic agent in the prescription of human interferon α1b spray.When the concentration of Benzalko-nium bromide was 0.05-0.1 mg·mL-1,its bacteriostatic efficacy against Staphylococcus aureus,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger met the grade A criteria.Conclusion:The minimum effective bacteriostatic concentration of benzalkonium bromide in the prescription of human interferon α1b spray is deter-mined to be 0.05 mg·mL-1.
关键词
人干扰素α1b/喷雾剂/抑菌剂/苯扎溴铵/抑菌效力/最低有效抑菌浓度Key words
human interferon α1b/spray/bacteriostatic agent/benzalkonium bromide/bacteriostatic efficacy/minimum effective bacteriostatic concentration引用本文复制引用
基金项目
吉林省科技发展计划基金项目(20160307028YY)
出版年
2024
NETL
NSTL
万方数据