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Sample for verifying capacity of staphylococcus aureus in medicine and preparation method thereof

A staphylococcal, proficiency-proven technology, applied in biochemical equipment and methods, microorganism-based methods, bacteria, etc., to solve problems such as fatal, direct patient infection with Staphylococcus aureus

Inactive Publication Date: 2017-09-22
中检科(北京)测试认证有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the number of Staphylococcus aureus contained in the drug exceeds a certain limit, it will cause the patient to be directly infected with Staphylococcus aureus, and there is even a fatal risk

Method used

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  • Sample for verifying capacity of staphylococcus aureus in medicine and preparation method thereof
  • Sample for verifying capacity of staphylococcus aureus in medicine and preparation method thereof
  • Sample for verifying capacity of staphylococcus aureus in medicine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Samples for proficiency testing of Staphylococcus aureus in medicines, including target bacteria and background flora, the target bacteria is Staphylococcus aureus, and the background flora consists of Escherichia coli (E.coil), pneumonia Klebsiella (Klebsiellapnenmoniae), 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 As shown, a preparation method for proficiency testing samples of Staphylococcus aureus in medicines in Example 1, including the selection of sample addition strains, preparation of lyoprotectant, sample freeze-drying, sample homogeneity and stability test four Steps, the specific steps are as follows:

[0034] 1. Selection of sample addition strains

[0035] According to target bacteria: Staphylococcus aureus (Staphylococcus aureus), background flora: Escherichia coli (E. The standard strains are all purchased from institutions designated by the government, and a strain certificate is attached to ensure the traceability of the strains.

[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 powder 0.5%) to prepare a lyoprotectant.

[0038] 3. Sample freeze-drying

[0039] (1) Strain recovery and passage

[0040] A...

Embodiment 3

[0070] Each step of the preparation method of the Staphylococcus aureus 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 staphylococcus aureus 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 staphylococcus aureus; the background flora consists of escherichia coli, klebsiella pneumonia 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 the total amount of the escherichia coli is not affected 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 quality control field of microbiological detection, and in particular relates to a sample for proficiency verification of Staphylococcus aureus 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 prepare large-scale microbial proficiency testing samples, the samples are all pure strains containing only Staphylococcus aureus, and there is no background bacteria, which is different from actual samples. Larger, that is, the standard sample of Staphylococcus aureus is still a blank field. [0003] Staphylococcus aureus is a common Gram-positive bacterium that is widely distributed in nature and can cause infections in humans and animals. After humans are infected with Staphylococcus aureus, ...

Claims

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Application Information

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IPC IPC(8): C12Q1/14C12N1/20C12R1/445C12R1/19C12R1/22C12R1/085
CPCC12N1/20C12Q1/14G01N2333/31
Inventor 赵红阳卢行安王建华陈若晞刘汉霞王伟王秀君孙英健
Owner 中检科(北京)测试认证有限公司
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