Study on the Applicability of Microbial Limit Test Methods for Licorice Decoction Pieces with Homology of Medicine and Food

Expand
  • 1.Center for Food and Drug Inspection of Yunnan Province, Yunnan Kunming 650200, China;
    2.The First Affiliated Hospital of Kunming Medical University, Yunnan Kunming 650032, China;
    3.Yunnan College of Business Management, Yunnan Kunming 650106, China;
    4.Yunnan New Century Pharmaceutical Co., Ltd., Yunnan Kunming 650106, China

Received date: 2025-09-08

  Revised date: 2026-02-13

  Accepted date: 2026-05-19

  Online published: 2026-05-19

Abstract

Objective: To explore the microbial limit test methods applicable to licorice decoction pieces. Methods: According to the requirements of Chinese Pharmacopoeia (2025 edition,Part Ⅳ)general rules 1108, the conventional method,Incremental Dilution method and direct inoculation method were adopted for applicability test of the microbial limit test method for Licorice decoction pieces from three manufacturers. Results: When the conventional method was used for total aerobic microbial count and total thermophilic microbial count, the recovery rate of Pseudomonas aeruginosa and Staphylococcus aureus failed to meet the requirements(0.5~2.0). After a 50-fold dilution of the test solution, the recovery of Pseudomonas aeruginosa met the requirements. Following a 100-fold dilution, the inhibitory effect on Staphylococcus aureus was effectively eliminated, and the recovery rates of all test strains met the requirements. The conventional method was employed for the determination of total combined yeasts and molds counts, and the recovery rates of all strains were within the required range. In the tests for controlled microorganisms, both the method suitability test and positive control test successfully detected the target strains, with no growth was observed in the negative control, conforming to the pharmacopoeial requirements. Conclusion: The microbial limit test methods of Licorice decoction pieces established in this research is simple and reliable, and can be used for the routine quality control of Licorice decoction pieces.It also provides a methodological reference for the microbial limit inspection of Chinese patent medicines such as Compound Glycyrrhiza Tablets.

Cite this article

NIU Jiezhen, ZHANG Yuanqing, HAN Hongsheng, HE Ju, LV Juan, XIA Guozhi . Study on the Applicability of Microbial Limit Test Methods for Licorice Decoction Pieces with Homology of Medicine and Food[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(2) : 124 -124-127 . DOI: 10.2095-3593.2026.040007

References

 [1] 张平,石春红,胡亚英,等. 50种中药煎煮类饮片微生物检查方法研究及污染情况分析[J]. 中国药业,2021,30(3):40-44.
     [2] 汪杨,王嫣,杨雅婷,等. 甘草饮片中微生物及真菌毒素污染状况考察[J]. 中国药师,2021,24(11):2114-2117.
     [3] 苏雨楠. 甘肃中药饮片产业现状分析及高质量发展策略研究[D]. 兰州:兰州大学,2023.
     [4] 胡昌勤. 药品微生物控制体系建设现状与展望[J]. 中国现代应用药学,2021,38(5):513-519.
     [5] 李葆莉,胡炳义. 国家药典中药彩色图鉴[M]. 北京:军事医学出版社,2015:56-57.
     [6] 梁爱华. “药食同源”有讲究[J]. 中国食品药品监管,2018,(4):81-84.
     [7] 国家药典委员会. 中华人民共和国药典(一部)[M]. 2025年版. 北京:中国医药科技出版社,2025:91-92.
     [8] 陈子珺,路舒黎. “国老”甘草:味道甘甜,运用广泛[J]. 中医健康养生,2022,8(4):29-30.
     [9] 牛丕莲. 甘草多糖提取纯化、结构表征及其抗心肌纤维化机制研究[D]. 银川:宁夏大学,2025.
     [10] 杨波. 甘肃道地中药材甘草的化学成分及生物活性研究[D]. 西安:西安理工大学,2024.
     [11] 周晶晶,周洁,窦霞,等. 不同炮制方法对甘草化学成分及药理作的影响研究[J]. 中华中医药学刊,2024,42(5):244-249.
     [12] 申应德,张文萌,王伟,等. 中药饮片金银花的微生物污染分析[J]. 中国药物评价,2022,39(1):36-40.
     [13] 高霞,严筱楠,高娟,等. 金银花微生物限度检查方法适用性研究及污染状况分析[J]. 药物生物技术,2024,31(6):647-651.
     [14] 刘鹏,战宏利,杨美琴,等. 红花的微生物污染状况分析[J]. 药物分析杂志,2015,35(7):1257-1262.
     [15] 国家药典委员会. 中华人民共和国药典(四部) [M]. 2025年版. 北京:中国医药科技出版社,2025:709-712.
     [16] 王兴娜,黄瑞琪,鹿小诗,等. 5种中草药及复配液的抑菌性研究[J]. 安徽农业科学,2020,48(6):156-158.
     [17] 张舒涵,梁海运,孙佳慧,等. 甘草提取物对Staphylococcus aureus的抑菌活性及作用机理[J]. 食品与发酵工业,2024,50(10):259-265.
     [18] Wei T, Lin G, Liu L, et al. Study of antimicrobial effects of different types of glycyrrhiza extracts by microcalorimetry[J]. Bulletin-Korean Chemical Society,2014,35(8):2460-2464.
     [19] 戴莹莹,魏永忠,吴酉芝,等. 甘草活性成分及抑菌机制研究进展[J]. 现代食品,2025,(7):33-35.
Outlines

/

[an error occurred while processing this directive]