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Proficiency testing samples of bile-salt-resistant gram-negative bacteria in pharmaceuticals and its preparation method

A gram-negative bacteria and proficiency testing technology, which is applied in the field of bile salt-resistant gram-negative bacteria proficiency testing samples and their preparation fields, and can solve problems such as changes in the number of colonies

Active Publication Date: 2020-09-22
CHINESE ACAD OF INSPECTION & QUARANTINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the problem that the number of total viable bacteria in the determination sample of bile-salt-resistant Gram-negative bacteria can change in the process of transportation, storage and testing, etc., and to provide a kind of bile-salt-resistant Gram-resistant drug Negative bacteria proficiency test sample, the uniformity and stability meet the proficiency test requirements, another purpose of the present invention is to provide a preparation method for the sample, the process is simple, and the success rate is high

Method used

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  • Proficiency testing samples of bile-salt-resistant gram-negative bacteria in pharmaceuticals and its preparation method
  • Proficiency testing samples of bile-salt-resistant gram-negative bacteria in pharmaceuticals and its preparation method
  • Proficiency testing samples of bile-salt-resistant gram-negative bacteria in pharmaceuticals and its preparation method

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Experimental program
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Effect test

Embodiment 1

[0029] Samples for proficiency testing of bile-salt-resistant Gram-negative bacteria in medicines, including target flora and background flora, the target flora consists of Escherichia coli (E.coil), Klebsiella pneumoniae (Klebsiella pneumoniae), cloacae Bacillus (Enterobacter cloacae), Proteus mirabilis (Proteus mirabilis), Enterobacter aerogenes (Enterobacter aerogenes) and Freundii (Citrobacter freundii), the background flora consists of Staphylococcus aureus (Staphylococcus aureus), wax Composition of Bacillus cereus.

[0030] The sample is based on trehalose, skimmed milk powder and sterile water, wherein the volume fraction of trehalose is 12%, and the volume fraction of skimmed milk powder is 0.5%.

[0031] The target concentration of the target flora in the sample is 10 2 CFU / mL, the target concentration of background flora is 10 3 CFU / mL.

Embodiment 2

[0033] Such as figure 1 Shown, a kind of preparation method of the bile-salt-resistant Gram-negative bacteria proficiency verification sample in the medicine in embodiment 1, comprises the selection of sample addition strain, the preparation of lyoprotectant, sample freeze-drying, the homogeneity and the stability of sample Test four steps, the specific steps are as follows:

[0034] 1. Selection of sample addition strains

[0035] According to the target flora: Escherichia coli (E.coil), Klebsiella pneumoniae (Klebsiellapnenmoniae), Enterobacter cloacae (Enterobacter cloacae), Proteus mirabilis (Proteus mirabilis), Enterobacter aerogenes (Enterobacter aerogenes) and Fu Citrobacter freundii (Citrobacterfreundii), background flora: Staphylococcus aureus (Staphylococcus aureus), Bacillus cereus (Bacillus cereus) selected standard strains, all standard strains were purchased from institutions designated by the government, with strain certificates attached, The traceability of t...

Embodiment 3

[0070] The steps of the preparation method of the proficiency verification sample of bile-salt-resistant gram-negative bacteria in the medicine described in this example are all the same as in Example 2, and the different technical parameters are: the nutrient agar slant medium is selected as the bacterial strain culture medium; In the preparation of the suspension, the concentration of each target bacteria in the suspension of the target flora is according to 5×10 2 CFU / mL preparation, the concentration of each background bacteria in the background flora suspension according to 10 3 CFU / mL preparation; freeze-drying process 45h.

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Abstract

The invention belongs to the field of quality control on the aspect of microbial detection and particularly relates to a sample for verifying the capability of bile salt resistant gram-negative bacteria in a drug and a preparation method thereof. The sample for verifying the capability of bile salt resistant gram-negative bacteria in the drug includes target florae and background florae, wherein the target florae include escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, enterobacter aerogenes and citrobacter freundii, and the background florae include staphylococcus aureus and bacillus cereus. The homogeneity and stability meet the capability verifying requirements, the stability of the sample can be ensured to the most degree, and even if the convent of the escherichia coli in transportation and storage changes, and the total amount of the bile salt resistant gram-negative bacteria is also not affected on the aspect of statistical significance. The preparation method of the sample is simple in process and high in success rate.

Description

technical field [0001] The invention belongs to the quality control field of microbiological detection, and in particular relates to a sample for proficiency verification of bile-salt-resistant Gram-negative bacteria in medicine and a preparation method thereof. Background technique [0002] The field of pharmaceutical microbiology testing is very specific. At present, although there are domestic and foreign precedents for accreditation institutions to organize drug microbiology proficiency testing and large-scale preparation of microbial proficiency testing samples, the samples are all strains containing only bile-salt-resistant Gram-negative bacteria, and there is no background bacteria. The samples are quite different, and bile-salt-resistant Gram-negative bacteria are sensitive to temperature, and the stability of the samples is difficult to meet the requirements, that is, the standard samples of bile-salt-resistant Gram-negative bacteria are still in the blank field. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/24C12Q1/14C12Q1/10C12Q1/06C12R1/19C12R1/22C12R1/01C12R1/37C12R1/085C12R1/445
CPCC12Q1/06C12Q1/10C12Q1/14C12Q1/24G01N2333/24G01N2333/245G01N2333/26G01N2333/265G01N2333/31G01N2333/32
Inventor 卢行安徐大军刘柳赵红阳刘汉霞王伟孙英健陈若晞
Owner CHINESE ACAD OF INSPECTION & QUARANTINE
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