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

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  • 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

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.

Cite this article

GU Ying-lin, ZHANG Sheng-bo, JIA Yi-bing, REN Liang-chen . Study on microbial limit determination method and antibacterial components of Cangerzi Biyan capsules*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(5) : 885 -892 . DOI: 10.16155/j.0254-1793.2021.05.17

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