Examination and screening of the bacteriostatic efficacy of bacteriostatic agents in Baimai ointment prescriptions

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Author: MU Jianping XIE Nan  TENG Baoxia HE Xiaowen GAO Yuan HE Xiaoying

Affiliation: Gansu Institute for Drug Control, Lanzhou 730060, China

Keywords: Baimai ointment Bacteriostatic efficacy Prescription screening Bacteriostatic agent

DOI: 10.12173/j.issn.2097-4922.20250430

Reference: MU Jianping, XIE Nan, TENG Baoxia, HE Xiaowen, GAO Yuan, HE Xiaoying. Examination and screening of the bacteriostatic efficacy of bacteriostatic agents in Baimai ointment prescriptions[J]. Yaoxue QianYan Zazhi, 2025, 29(8): 1314-1320. DOI: 10.12173/j.issn.2097-4922.20250430.[Article in Chinese]  Copied

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Abstract

Objective To investigate the bacteriostatic efficacy of different bacteriostatic agents in Baimai ointment and screen for the best prescription.

Methods According to General Rule 1121 of the Chinese Pharmacopoeia (2020 edition), five positive bacteria were selected as indicator bacteria to test the bacteriostatic efficacy of Baimai ointment samples with four different prescriptions.

Results The bacteriostatic efficacy of sample 2 on Staphylococcus aureus did not meet the standard at 7 days (the lg value only decreased by 2.9), and both Staphylococcus aureus and Aspergillus niger showed proliferation at 28 days (the lg value increased by more than 0.5). Sample 4 showed continuous proliferation of Pseudomonas aeruginosa at 7, 14, and 28 days, and proliferation of Candida albicans also occurred at 28 days (with an increase in lg value>0.5). Samples 1 and 3 meet the requirements of the pharmacopoeia, with sample 1 showing the best bacteriostatic efficacy.

Conclusion In the development process of Baimai ointment prescriptions, it is necessary to systematically evaluate the bacteriostatic efficacy of the prescription and select appropriate types and doses of bacteriostatic agents to ensure the safety of the formulation.

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1.范佳佳, 李鑫, 孙洪昊, 等. 基于藏族医学理论的白脉病内涵挖掘及白脉软膏组方用法分析[J]. 中国中药杂志, 2022, 47(5): 1409-1414. [Fan JJ, Li X, Sun HH, et al. Connotation of Baimai disease and analysis of compatibility and usage of Baimai Ointment: based on Tibetan medicine theory[J]. China Journal of Chinese Materia Medica, 2022, 47(5): 1409-1414.] DOI: 10.19540/j.cnki.cjcmm.20211224.501.

2.刘琳琳, 董历子, 崔越, 等. 人干扰素α1b喷雾剂抑菌剂筛选及抑菌效力研究[J]. 药物分析杂志, 2024, 44(2): 359-367. [Liu LL, Dong LZ, Cui Y, et al. Study on the screening and bacteriostatic efficacy of bacteriostatic agent in human interferon α1b spray[J]. Chinese Journal of Pharmaceutical Analysis, 2024, 44(2): 359-367.] DOI: 10.16155/j.0254-1793.2024.02.20.

3.李辉, 周发友, 杨晓莉, 等. 《中华人民共和国药典》2020年版抑菌效力检查法解析[J]. 中国新药杂志, 2021, 30(12): 1063-1067. [Li H, Zhou FY, Yang XL, et al. Interpretation of the antimicrobial effectiveness test of Chinese Pharmacopoeia 2020 edition[J]. Chinese Journal of New Drugs, 2021, 30(12): 1063-1067.] DOI: 10.3969/j.issn.1003-3734.2021.12.002.

4.牟建平, 滕宝霞, 贺晓文, 等. 色甘酸钠滴眼液中抑菌剂抑菌效力的评价[J]. 中国医药工业杂志, 2021, 52(10): 1361-1365. [Mu JP, Teng BX, He XW, et al. Evaluation of bacteriostatic efficacy of the bacteriostatic agent in sodium cromoglycate eye drops[J]. Chinese Journal of Pharmaceuticals, 2021, 52(10): 1361-1365.] DOI: 10.16522/j.cnki.cjph.2021.10.013.

5.蔡金莲, 郭智聪, 黄婉锋. 4批抗病毒口服液抑菌效力测定与评价[J]. 海峡药学, 2022, 34(10): 48-51. [Cai JL, Guo ZC, Huang WF. Determination and evaluation of antimicrobial effectiveness of four bat-ches of antiviral oral liquid[J]. Strait Pharmaceutical Journal, 2022, 34(10): 48-51.] DOI: 10.3969/j.issn.1006-3765.2022.10.013.

6.章瑛, 刘彭浩邦, 刘绪平, 等. 和肤洗剂中抑菌剂的抑菌效力评价[J]. 药品评价, 2021, 18(2): 74-77. [Zhang Y, Liu PHB, Liu XP, et al. Evaluation of antibacterial effect of antibacterial agents in Hefu lotion[J]. Drug Evaluation, 2021, 18(2): 74-77.] DOI: 10.19939/j.cnki.1672-2809.2021.02.04.

7.尉文霞, 裴社强, 杨宝. 盐酸特比萘芬乳膏抑菌效力考察及抑菌剂使用评价[J]. 科技创新与应用, 2025, 15(6): 56-60. [Wei WX, Pei SQ, Yang B. Evaluation of antimicrobial effectiveness and preservative usage in terbinafine hydrochloride cream[J]. Technology Innovation and Application, 2025, 15(6): 56-60.] DOI: 10.19981/j.CN23-1581/G3.2025.06.014.

8.肖璜, 林吉恒, 陈万胜, 等. 四国药典中抑菌剂效力检查法的比较[J]. 中国药品标准, 2014, 15(1): 10-12. [Xiao H, Lin JH, Chen WS, et al. Comparison of bacteriostat effect test method in four countries'pharmacopoeia[J]. Drug Standards of China, 2014, 15(1): 10-12.] DOI: CNKI:SUN:YPBZ.0.2014-01-004.

9.李辉, 周发友, 杨晓莉, 等. 中国药典2020年版抑菌效力检查法修订介绍[J]. 中国现代应用药学, 2021, 38(6): 655-660. [Li H, Zhou FY, Yang XL, et al. Introduction to the revision of the antimicrobial effectiveness testing of Chinese Pharmacopoeia 2020 edition[J]. Chinese Journal of Modern Applied Pharmacy, 2021, 38(6): 655-660.] DOI: 10.13748/j.cnki.issn1007-7693.2021.06.004.

10.中国药典2020年版. 四部[S]. 2020: 176.

11.潘雯, 陈伟盛. 硫酸软骨素滴眼液抑菌效力的研究[J]. 药物分析杂志, 2020, 40(9): 1709-1714. [Pan W, Chen WS. Studies on the antibacterial efficacy of chondroitin sulfate eye drops[J].Chinese Journal of Pharmaceutical Analysis, 2020, 40(9): 1709-1714.] DOI: 10.16155/j.0254-1793.2020.09.25.

12.韩林学, 张续, 邱天, 等. 对羟基苯甲酸酯类防腐剂的环境和人体暴露研究进展[J]. 环境化学, 2023, 42(8): 2563-2575. [Han LX, Zhang X, Qiu T, et al. Research progress in the study of environmental and human exposure to paraben preservatives[J]. Environmental Chemistry, 2023, 42(8): 2563-2575.] DOI: 10.7524/j.issn.0254-6108.2022032303.

13.毛腾霄, 程龙, 张聪聪, 等. 萘敏维滴眼液抑菌效力评价及抑菌剂最适浓度考察[J]. 药物分析杂志, 2018, 38(2): 319-325. [Mao TX., Cheng L, Zhang CC, et al. Study on the antimicrobial preservatives of NCVE and the optimal bacteriostatic concentration of bacteriostats[J]. Chinese Journal of Pharmaceutical Analysis, 2018, 38(2): 319-325.] DOI: 10.16155/j.0254-1793.2018.02.19.