Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder

GONG Ya; LI Min; CAO Jian; ZHANG Rong

doi:10.14009/j.issn.1672-2124.2020.10.012

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Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder

更新时间：2022-10-08

- Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder
- Vol. 20, Issue 10, Pages: 1197-1199(2020)
- 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.1672-2124.2020.10.012
  CLC： R284
- Published：2020，
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[1]龚亚,李敏,曹健,张蓉.4种含中药原粉的医院中药制剂微生物限度检查方法的建立[J].中国医院用药评价与分析,2020,20(10):1197-1199+1203.

GONG Ya, LI Min, CAO Jian, et al. Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder. [J]. 20(10):1197-1199(2020)
[1]龚亚,李敏,曹健,张蓉.4种含中药原粉的医院中药制剂微生物限度检查方法的建立[J].中国医院用药评价与分析,2020,20(10):1197-1199+1203. DOI： 10.14009/j.issn.1672-2124.2020.10.012.

GONG Ya, LI Min, CAO Jian, et al. Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder. [J]. 20(10):1197-1199(2020) DOI： 10.14009/j.issn.1672-2124.2020.10.012.

摘要

目的:建立4种含中药原粉的医院中药制剂（延芍胃康胶囊、乳灵片、痔可平胶囊和延肾胶囊）的微生物限度检查方法。方法:根据《中华人民共和国药典:四部》（2015年版）通则1105、1106和1107的具体规则作为检测依据。采用平皿法对供试品进行处理

对稀释级别进行摸索。结果:在需氧菌、霉菌和酵母菌总数计数适用性试验中

在允许的稀释级别内

采用平皿稀释法进行试验

均可消除抑菌作用

对各试验菌的回收率均在0. 5～2. 0范围内。4种制剂均采用直接接种法进行控制菌检查

均无抑菌作用。结论:延芍胃康胶囊、乳灵片、痔可平胶囊和延肾胶囊均可采用平皿法进行需氧菌、霉菌和酵母菌总数检查

控制菌检查均可采用直接接种法。

Abstract

OBJECTIVE: To establish microbial limit test method for 4 kinds of hospital Chinese medicine preparations（ Yanshao Weikang capsules

Ruling tablets

Zhikeping capsules and Yanshen capsules） containing TCM powder. METHODS: According to specific rules of the four general rules 1105

1106 and 1107 of Pharmacopoeia of the People’s Republic of China（ 2015 edition） for testing basis. Plating method was adopted to process the test sample and explore the dilution level. RESULTS: In the applicability test for the total count of aerobic bacteria

molds and yeasts

within the allowable dilution level

the plating dilution method can eliminate antibacterial effect

and the recovery rate of each test bacteria was 0. 5-2. 0. All the 4 preparations were tested for bacteria control by direct inoculation method

none of which had antibacterial effect. CONCLUSIONS: Yanshao Weikang capsules

Ruling tablets

Zhikeping capsules and Yanshen capsules can all be tested for the total count of aerobic bacteria

molds and yeasts by plating method

and the control bacteria inspections can be conducted by direct inoculation.

关键词

中药原粉医院中药制剂微生物限度检查方法适用性

Keywords

Traditional Chinese medicine powderHospital Chinese medicine preparationMicrobial limit testMethod applicability

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Dept.of Pharmacy,Second Affiliated Hospital of Army Medical University

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