首页|乳酸菌素颗粒体外生物活性的比较研究

乳酸菌素颗粒体外生物活性的比较研究

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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.
Consistency study on in vitro bioactivity of lactobacillin granules
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.

lactobacillin granulein vitro bioactivitygrowth promoting test in vitroin vitro bacteriostatic testcon-sistency evaluation

丁勃、郭君贞、孟晓丽、胡文红、刘新泳

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山东省食品药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室,济南 250101

山东大学药学院,济南 250012

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

国家药典委员会药品标准制修订研究课题

2020S10

2024

药物分析杂志
中国药学会

药物分析杂志

CSTPCD北大核心
影响因子:1.039
ISSN:0254-1793
年,卷(期):2024.44(2)
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