摘要
目的:建立苍耳子鼻炎胶囊的微生物限度检查法,探索抑菌成分含量与微生物限度检查法的相关性。方法:通过处方中单味药材的抑菌试验及黄芩苷含量的测定,初步确认影响微生物检出的抑菌成分;根据《中华人民共和国药典》2020年版四部非无菌产品微生物计数法、控制菌检查法的要求,分别对5个企业的15批样品微生物限度检查法进行方法适用性试验。结果:处方中黄芩苷、冰片、薄荷脑均有不同程度的抑菌作用;需氧菌计数采用薄膜过滤法,霉菌和酵母菌计数采用平皿法,控制菌采用培养基稀释法检查。结论:抑菌成分黄芩苷含量的高低直接影响微生物限度检查方法的适用性,采用薄膜过滤法、培养基稀释法可消除样品的抑菌活性,为其他含黄芩苷产品的微生物限度检查提供参考。该方法合理可靠,可有效控制产品质量。
Objective:To establish a microbial limit determination method for Cangerzi Biyan capsules and to explore the correlation between the content of antibacterial components and the microbial limit determination method.Methods:Through the antibacterial test of single medicinal materials and the determination of baicalin content in the prescription,the antibacterial components affecting microbial detection were preliminarily confirmed.According to the requirements of microbiological count method and control bacteria test method for non-sterile products in volumeⅣof Chinese Pharmacopoeia(2020 edition),the applicability test of microbial limit test method for 15 batches of samples from 5 enterprises was conducted.Results:Baicalin,borneol and menthol in the prescription had different degrees of bacteriostasis;membrane filtration method was used for aerobic bacteria count,plate method was used for mold and yeast count,and control bacteria were checked by medium dilution method.Conclusion:The content of antibacterial components directly affects the applicability of the microbial limit determination method.The use of different dilution levels of test solutions and increasing the amount of enrichment medium can eliminate the antibacterial activity of the sample,and this provides a reference for the microbial limit determination of other products containing baicalin.The method is reasonable and reliable,and can effectively control the product quality.
作者
顾英琳
张胜波
贾亦兵
任梁辰
GU Ying-li;ZHANG Sheng-bo;JIA Yi-bing;REN Liang-chen(College of Pharmacy,Jining Medical University,Jining 272067,China;Jining Center for Food and Drug Control,Jining 272073,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2021年第5期885-892,共8页
Chinese Journal of Pharmaceutical Analysis
基金
日照市科技局科技研发项目(日科字[2019]17-248)
济宁医学院大学生创新训练计划项目(CX2019068)。
关键词
苍耳子鼻炎胶囊
黄芩苷
微生物限度检查
抑菌成分
微生物回收
方法适用性
Cangerzi Biyan capsules
baicalin
microbial limit determination
antibacterial components
microbial recovery
applicability of method
