6种医院抑菌制剂的微生物限度检查方法适用性研究

李敏; 龚亚; 曹健; 樊莉

doi:10.14009/j.issn.1672-2124.2021.08.013

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6种医院抑菌制剂的微生物限度检查方法适用性研究

论著 | 更新时间：2022-10-08

- 6种医院抑菌制剂的微生物限度检查方法适用性研究
- Applicability Research of Six Kinds of Microbial Limit Test Methods for Hospital Antibacterial Preparations
- 中国医院用药评价与分析 2021年21卷第8期页码：951-954
- 作者机构：
  
  陆军军医大学第二附属医院药剂科
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.08.013
  中图分类号： R927.1
- 纸质出版日期：2021，
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李敏, 龚亚, 曹健, 等. 6种医院抑菌制剂的微生物限度检查方法适用性研究[J]. 中国医院用药评价与分析, 2021,21(8):951-954.

LI Min, GONG Ya, CAO Jian, et al. Applicability Research of Six Kinds of Microbial Limit Test Methods for Hospital Antibacterial Preparations[J]. 2021,21(8):951-954.
李敏, 龚亚, 曹健, 等. 6种医院抑菌制剂的微生物限度检查方法适用性研究[J]. 中国医院用药评价与分析, 2021,21(8):951-954. DOI： 10.14009/j.issn.1672-2124.2021.08.013.

LI Min, GONG Ya, CAO Jian, et al. Applicability Research of Six Kinds of Microbial Limit Test Methods for Hospital Antibacterial Preparations[J]. 2021,21(8):951-954. DOI： 10.14009/j.issn.1672-2124.2021.08.013.

摘要

目的:建立6种医院抑菌制剂的微生物限度检查方法。方法:按照《中华人民共和国药典:四部》(2015年版)的规定

采用平皿法、培养基稀释法、薄膜过滤法和中和法进行6种医院抑菌制剂的微生物计数及控制菌检查方法适用性试验。结果:所建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种验证菌株的回收率均在0.5～2.0

控制菌(金黄色葡萄球菌、铜绿假单胞菌和大肠埃希菌)可检出。结论:结合平皿法、培养基稀释法、薄膜过滤法和中和法建立了多种含抗菌药物、消毒防腐药等抑菌制剂的微生物限度检查方法

方法简便可行

结果准确可靠。

Abstract

OBJECTIVE: To establish 6 kinds of microbial limit test method for hospital antibacterial preparations.METHODS: According to the requirements in Chinese Pharmacopoeia（ vol． Ⅳ

2015 edition）

to perform applicability test of 6 kinds of microbial counts and control bacteria examination on hospital antibacterial preparations based on plating method

medium diluted method

membrane filtration method and neutralization method. RESULTS:Corresponding to the inspection methods established before

the recovery rates of 5 verifying bacterial strains were from0. 5 to 2. 0

including Staphylococcus aureus

Pseudomonas aeruginosa

Bacillus subtilis

Candida albicans and Aspergillus niger

and the control bacteria（ Staphylococcus aureus

Pseudomonas aeruginosa

and Escherichia coli）could be detected. CONCLUSIONS: The various microbial limit test methods containing antibiotics

disinfectants and antiseptics established in combination with plating method

medium diluted method

membrane filtration method and neutralization method are simple and convenient

with accurate and reliable results.

关键词

微生物限度检查抑菌制剂培养基稀释法薄膜过滤法中和法

Keywords

Microbial limit testAntibacterial preparationsMedium diluted methodMembrane filtration methodNeutralization method

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