Sample for verifying total number counting capability of aerobic bacteria in drug and preparation method thereof

A technology of proficiency testing and aerobic bacteria, applied in the direction of biochemical equipment and methods, microbiological determination/inspection, etc., can solve problems such as fatal risk and patient infection

Inactive Publication Date: 2017-09-08
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 total count of aerobic bacteria exceeds a certain limit, it will lead to the risk of infection or even death of the patient

Method used

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  • Sample for verifying total number counting capability of aerobic bacteria in drug and preparation method thereof
  • Sample for verifying total number counting capability of aerobic bacteria in drug and preparation method thereof
  • Sample for verifying total number counting capability of aerobic bacteria in drug and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Samples for proficiency verification of the total number of aerobic bacteria in medicines, the target bacteria include: Staphylococcus aureus, Bacillus cereus, Escherichia coli (E.coil), Klebsiella pneumoniae ( Klebsiella pneumoniae) and Citrobacter freundii.

[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 concentration of the target flora in the sample is 10 2 ~10 3 CFU / mL.

Embodiment 2

[0033] Such as figure 1 As shown, a method for preparing a test sample for counting the total number of aerobic bacteria in medicines in Example 1, including the selection of sample addition bacterial strains, preparation of freeze-drying protective agent, sample freeze-drying, sample uniformity and stability test IV steps, the specific steps are as follows:

[0034] 1. Selection of sample addition strains

[0035] According to target flora: Staphylococcus aureus, Bacillus cereus, Escherichia coli (E.coil), Klebsiella pneumoniae (Klebsiella pneumoniae) and Citrobacter freundii ), all standard strains were purchased from institutions designated by the government, and a strain certificate was 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.

[...

Embodiment 3

[0070] Each step of the preparation method of the proficiency verification sample for counting the total number of aerobic bacteria in the medicine 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, each in the target bacterial suspension The concentration of the target bacteria was 5×10 3 CFU / mL preparation; freeze-drying process 45h.

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PUM

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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 total number counting capability of aerobic bacteria in a drug and a preparation method thereof. The sample for verifying the total number counting capability of aerobic bacteria in the drug includes target florae easily contaminated in drugs or production process, wherein the target florae include staphylococcus aureus, bacillus cereus, escherichia coli, klebsiella pneumoniae and citrobacter freundii. 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 counting amount of the aerobic 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 test sample for counting the total number of aerobic 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 precedents for accreditation organizations at home and abroad to organize drug microbiology proficiency testing, the sample preparation methods for counting the total number of aerobic bacteria, as well as the data on uniformity and stability research are not exhaustive, that is, the standard for counting the total number of aerobic bacteria The samples are still in the blank field. [0003] The total number of aerobic bacteria refers to the total number of colonies (including the number of fungal colonies) grown on the tryptone soy agar medium. If the target flora is prone to change (reproduction and death, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/06C12Q1/24
CPCC12Q1/06C12Q1/24
Inventor 卢行安赵红阳刘汉霞潘裕红王伟孙英呂铮毕玉春
Owner 中检科(北京)测试认证有限公司
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