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Sample for verifying capacity of escherichia coli in medicine and preparation method thereof

An Escherichia coli, proficiency verification technology, applied in biochemical equipment and methods, microorganism-based methods, bacteria, etc., can solve the problems of patients infected with Escherichia coli, fatal, etc.

Inactive Publication Date: 2017-09-22
CHINESE ACAD OF INSPECTION & QUARANTINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If Escherichia coli is contained in the medicine, it will lead to direct infection of Escherichia coli in patients, and there is even a fatal risk

Method used

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  • Sample for verifying capacity of escherichia coli in medicine and preparation method thereof
  • Sample for verifying capacity of escherichia coli in medicine and preparation method thereof
  • Sample for verifying capacity of escherichia coli in medicine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Escherichia coli proficiency testing samples in medicines include target bacteria and background flora, the target bacteria is Escherichia coli (E.coli), and the background flora consists of Klebsiella pneumoniae (Klebsiella pneumoniae), gold Staphylococcus aureus (Staphylococcus aureus), Bacillus cereus (Bacillus cereus) composition.

[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 target bacteria 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 Escherichia coli proficiency test sample in the medicine in embodiment 1, comprises the selection of sample addition bacterial strain, the preparation of lyoprotectant, sample lyophilization, sample homogeneity and stability test four Steps, the specific steps are as follows:

[0034] 1. Selection of sample addition strains

[0035] Select standard strains according to target bacteria: Escherichia coli (E.coli), background flora: Klebsiella pneumoniae (Klebsiellapnenmoniae), Staphylococcus aureus (Staphylococcus aureus), Bacillus cereus (Bacilluscereus), all standard strains All were purchased from institutions designated by the government, and a strain certificate was attached to ensure the traceability of the strain.

[0036] 2. Preparation of lyoprotectant

[0037] The sample was prepared with trehalose, skimmed milk powder and sterilized water as the matrix (volume fraction: trehalose 12%, skimmed milk powde...

Embodiment 3

[0070] Each step of the preparation method of the Escherichia coli proficiency verification sample in the drug described in this embodiment is all the same as in Example 2, and the different technical parameters are: in the preparation of the bacterial suspension, the concentration of the target bacteria in the target bacterial suspension Concentration 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 of microbiological detection, and particularly relates to a sample for verifying capacity of escherichia coli in a medicine and a preparation method thereof. The sample for verifying the capacity of the escherichia coli in the medicine comprises a target flora and a background flora, wherein the target flora is escherichia coli; the background flora consists of klebsiella pneumonia, staphylococcus aureus and bacillus cereus. The uniformity and the stability of the sample meet capacity verifying requirements, so that the stability of a test sample can be ensured to the maximum extent, and even during transportation and storage, change of the escherichia coli content does not affect the total amount of the escherichia coli in the statistical sense; the preparation method of the sample is simple in process and high in successful rate.

Description

technical field [0001] The invention belongs to the field of quality control in microbiological detection, and in particular relates to a sample for proficiency verification of Escherichia coli 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 agencies to organize drug microbiology proficiency testing and prepare large-scale microbial proficiency testing samples, the samples are all pure strains containing only Escherichia coli, no background bacteria exist, and are different from actual samples. Larger, and Escherichia coli is sensitive to temperature, the stability of the sample is difficult to meet the requirements, that is, the standard sample of Escherichia coli is still a blank field. [0003] Escherichia coli, commonly known as Escherichia coli, is defined as: Gram-negative non-bacillus bacteria ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/10C12N1/20C12R1/19C12R1/22C12R1/445C12R1/085
CPCC12N1/20C12Q1/10G01N2333/245
Inventor 刘汉霞卢行安赵红阳刘柳呂敬章潘裕红毕玉春苏秀茹
Owner CHINESE ACAD OF INSPECTION & QUARANTINE
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