标准研讨

苍耳子鼻炎胶囊微生物限度检查法与抑菌成分研究*

展开
  • 1.济宁医学院药学院,济宁 272067;
    2.济宁市食品药品检验检测中心,济宁 272073
第一作者 Tel:13792005812;E-mail:26510799@qq.com
**Tel:(0537)3165933;E-mail:1932876271@qq.com

收稿日期: 2020-06-23

  网络出版日期: 2024-07-12

基金资助

*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)

Study on microbial limit determination method and antibacterial components of Cangerzi Biyan capsules*

Expand
  • 1. College of Pharmacy, Jining Medical University, Jining 272067, China;
    2. Jining Center for Food and Drug Control, Jining 272073, China

Received date: 2020-06-23

  Online published: 2024-07-12

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。

本文引用格式

顾英琳, 张胜波, 贾亦兵, 任梁辰 . 苍耳子鼻炎胶囊微生物限度检查法与抑菌成分研究*[J]. 药物分析杂志, 2021 , 41(5) : 885 -892 . DOI: 10.16155/j.0254-1793.2021.05.17

Abstract

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 volume Ⅳ of 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.

参考文献

[1] 于悦, 王亚静, 皮佳鑫, 等.黄芩苷-冰片联合应用对表皮葡萄球菌的抑菌作用[J].中国实验方剂学杂志, 2013, 19(10):191
YU Y, WANG YJ, PI JX, et al.Antibacterial effect of baicalin borneol on Staphylococcus epidermidis[J].Chin J Exp Tradit Med Form, 2013, 19(10):191
[2] 赵洁, 刘艳玲, 韩冰, 等.咽康片主要原料体外抑菌实验研究[J].中国医药科学, 2012, 8(2):12
ZHAO J, LIU YL, HAN B, et al.Study on Bacteriostasis of main raw materials of Yankang tablets in vitro[J].China Med Pharm, 2012, 8(2):12
[3] 赖智捷, 巩江, 路锋, 等.石膏药学研究新进展[J].辽宁中医药大学学报, 2011, 13(3):42
LAI ZJ, GONG J, LU F, et al.New progress in gypsum pharmaceutical research[J].J Liaoning Univ Tradit Chin Med, 2011, 13(3):42
[4] 任永申, 邓鑫, 雷蕾, 等.基于抑菌效应成分指纹谱的黄芩质量评价[J].药学学报, 2019, 54(12):2155
REN YS, DENG X, LEI L, et al.Quality evaluation of Scutellaria baicalensis Georgi based on fingerprints of antibacterial components[J].Acta Pharm Sin, 2019, 54(12):2155
[5] 刘鹏, 战宏利, 严倩倩, 等.中成药口服给药制剂及其原料药微生物污染相关性分析[J].药物分析杂志, 2014, 34(6):1068
LIU P, ZHAN HL, YAN QQ, et al.Correlation analysis of microbial contamination of oral administration of Chinese patent medicine and its API[J].Chin J Pharm Anal, 2014, 34(6):1068
[6] 中华人民共和国药典2020 年版.四部[S].2020:160
ChP 2020.Vol Ⅳ[S].2020:160
[7] 于风平, 杨美琴, 特玉香, 等.含大黄、黄芩、黄连和黄柏药材的中成药微生物限度检查法的建立[J].药物分析杂志, 2010, 30(3):558
YU FP, YANG MQ, TE YX, et al.The establishment of microbial limit test of Chinese medicines containing rhubarb, baical skullcap root, Golden thread and amur cork-tree[J].Chin J Pharm Anal, 2010, 30(3):558
[8] 刘鹏, 马仕洪, 戴翚, 等.不同企业来源活血止痛胶囊微生物限度检查结果分析[J].中国药事, 2012, 26(10):1112
LIU P, MA SH, DAI H, et al.Analysis of microbial limit test results of Huoxuezhitong capsules from the same enterprise[J].Chin Pharm Aff, 2012, 26(10):1112
[9] 马仕洪, 刘鹏, 杨利红, 等.药品微生物限度检查方法适用性试验中加菌方式的实验研究[J].药物分析杂志, 2018, 38(5):877
MA SH, LIU P, YANG LH, et al.Experimental study on microorganism introduction method in suitability test of microbial limit test[J].Chin J Pharm Anal, 2018, 38(5):877
[10] 牛振东, 郝运伟, 刘文杰, 等.地拉罗司分散片微生物限度检查方法研究[J].中国现代应用药学, 2019, 36(1):36
NIU ZD, HAO YW, LIU WJ, et al.Study on microbial limit inspection method of delarox dispersible tablets[J].Chin J Mod Appl Pharm, 2019, 36(1):36
[11] 杨晓莉, 李辉, 马英英, 等.中国药典2015 年版非无菌产品微生物限度检查:微生物计数法解读[J].药物分析杂志, 2016, 36(6):1101
YANG XL, LI H, MA YY, et al.Interpretation of the microbiological examination of nonsterile products:microbial enumeration test of Chinese Pharmacopoeia 2015 edition[J].Chin J Pharm Anal, 2016, 36(6):1101
[12] 苏德模, 马越.药品微生物学检验技术[M].北京:华龄出版社, 2007
SU DM, MA Y.Maunal for Microbe Control of Drugs[M].Beijing:Hualing Press, 2007
[13] 田冬梅, 史春辉, 娄志红, 等.药品微生物计数法及方法适用性探讨[J].中国药物评价, 2017, 34(2):97
TIAN DM, SHI CH, LOU ZH, et al.Discussion of the microbiological counting method and the suitability test in pharmaceutical products[J].Chin J Drug Eval, 2017, 34(2):97
[14] 张媛媛, 曹苋恺, 李晓波.紫苏方胶囊微生物限度检查方法的研究[J].上海医药, 2018, 39(13):80
ZHANG YY, CAO XK, LI XB.Verification of microbial limit test method for Zisufang capsules[J].Shanghai Med Pharm J, 2018, 39(13):80
[15] 马仕洪, 胡昌勤.非无菌产品微生物计数测定法[J].药品技术审评论坛, 2009, 2(24):10
MA SH, HU CQ.Nonsterile products microbial enumeration tests[J].Forum Drug Eval, 2009, 2(24):10
[16] 胡昌勤. 药品微生物控制与展望[J].中国药学杂志, 2015, 50(20):1747
HU CQ.Drug microbiological control and prospect[J].Chin Pharm J, 2015, 50(20):1747
[17] 刘康连, 庞云娟, 周晓婷. 5 种同名异型中药制剂微生物限度检查法的建立与结果分析[J].中成药, 2017, 39(7):1515
LIU KL, PANG YJ, ZHOU XT.Establishment and result analysis of microbial limit inspection methods for 5 kinds of same name and different types of traditional Chinese medicine preparations[J].Chin Tradit Pat Med, 2017, 39(7):1515
[18] 马德宁, 金桂花, 崔铉, 等.药品微生物计数方法及方法适用性探析[J].中国卫生标准管理, 2017, 8(20):106
MA DN, JIN GH, CUI X, et al.Analysis on the applicability of drug microbial counting methods and methods[J].Chin J Health Stand Manage, 2017, 8(20):106
文章导航

/