摘要
目的:对乳酸菌素颗粒仿制药与市售药品的体外生物活性进行比较研究,包括对致病菌的抑制作用和对益生菌的促生长作用,探索肠道菌群调控类药物的体外生物活性的一致性评价方法。方法:建立2种培养体系,分别考察乳酸菌素颗粒对致病菌的抑制作用和对益生菌的促生长作用,采用配伍设计的两因素方差分析,Dunnett-t检验,结合微生物的生长曲线,对4种产品的体外生物活性进行比较研究,评价其活性差异。结果:仿制药与3种市售产品对金黄色葡萄球菌的体外抑制作用和对鼠李糖乳杆菌的体外促生长作用没有显著性差异(P>0.05)。结论:初步建立了微生物代谢产物类肠道菌群调控药物的体外生物活性评价方法,为相关制剂的开发与质量评价提供依据。
Objective:To compare the in vitro bioactivity between a generic lactobacillin granules drug and three commercial lactobacillin granules drugs,this study investigated inhibition on pathogenic bacteria,the growth pro⁃moting effect on probiotics,and establish a method to evaluate the in vitro bioactivity consistency of drugs that reg⁃ulate gut microbiota.Methods:Two culture systems were set up to investigate the inhibitory effect on pathogenic bacteria and the growth promoting effect on probiotics by lactobacillin granules.The in vitro bioactivity consistency of four products was evaluated by microbial growth curve and analyzed by two-way analysis of variance with Dun⁃nett-t test.Results:No significant difference(P>0.05)was observed on inhibition of Staphylococcus aureus and growth promotion of Lactobacillus rhamnosus between the generic lactobacillin granules and the commercial lactobacillin granules.Conclusion:This method could be used to evaluate the in vitro bioactivity of drugs that regulate gut microbiota,and provided guidance on relevant drug development and quality evaluation.
作者
丁勃
郭君贞
孟晓丽
胡文红
刘新泳
DING Bo;GUO Jun-zhen;MENG Xiao-li;HU Wen-hong;LIU Xin-yong(Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Jinan 250101,China;School of Pharmaceutical Sciences Shandong University,Jinan 250012,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2024年第2期272-279,共8页
Chinese Journal of Pharmaceutical Analysis
基金
国家药典委员会药品标准制修订研究课题微生态活菌制品分类及标准建立(2020S10)。
关键词
乳酸菌素颗粒
体外生物活性
体外促生长试验
体外抑菌试验
一致性评价
lactobacillin granule
in vitro bioactivity
growth promoting test in vitro
in vitro bacteriostatic test
con⁃sistency evaluation
作者简介
通信作者:刘新泳,Tel:(0531)88380270,E-mail:xinyongl@sdu.edu.cn;第一作者:丁勃,Tel:(0531)81216758,E-mail:muscularding@126.com。
