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Staphylococcus aureus adaptability test strain and preparation method thereof

A staphylococcus, applicability technology, applied in the field of Staphylococcus aureus applicability test strains and its preparation, can solve the problems of threatening the life safety of patients and infection of patients

Pending Publication Date: 2019-05-10
CHINESE ACAD OF INSPECTION & QUARANTINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If there is Staphylococcus aureus in the medicine, it is very easy to cause infection to the patient, directly threatening the life safety of the patient

Method used

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  • Staphylococcus aureus adaptability test strain and preparation method thereof
  • Staphylococcus aureus adaptability test strain and preparation method thereof
  • Staphylococcus aureus adaptability test strain and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The applicability test strain of Staphylococcus aureus contains only one target bacteria: Staphylococcus aureus, and the target concentration of the target bacteria is 500-2000 CFU per tube, and each tube contains 0.2g of lyophilized powder. The applicability test strain is based on trehalose, gelatin and sterile water, wherein the volume fraction of trehalose is 10% and the volume fraction of gelatin is 1%.

[0030] The sample belongs to the strain used for the applicability test in drug inspection, and is applied to the applicability test in the process of drug microorganism inspection. The specific test process steps are as follows:

[0031] After the sample is opened, immediately add 2 mL of sterile water for rehydration, vortex and shake to mix well, take 100 μL to inoculate the liquid medium to be tested or spread it on the medium to be tested, and incubate at 30-35 °C for 18-24 h . Observe whether the growth is good, and whether the colony size and morphologica...

Embodiment 2

[0033] like figure 1 As shown, a preparation method of the Staphylococcus aureus applicability test strain in Example 1, including the preparation of sample addition strains, the preparation of freeze-drying protective agent, sample freeze-drying, sample uniformity and stability test, sample determination There are five steps, the specific steps are as follows:

[0034] 1. Selection of sample addition strains

[0035] Only one target bacteria is included: Staphylococcusaureus, all of which are purchased from government-designated institutions and attached with a strain certificate to ensure the traceability of the strains.

[0036] 2. Preparation of lyophilized protective agent

[0037] The sample was prepared with trehalose and sterile water as a matrix (volume fraction: trehalose 10%, gelatin 1%) to prepare a lyophilized protective agent.

[0038] 3. Sample freeze-drying

[0039] (1) Strain recovery and passage

[0040] Inoculate the standard strains into nutrient agar ...

Embodiment 3

[0081] The steps of the preparation method for the applicability test strain of Staphylococcus aureus described in this example are the same as those in Example 2, and the different technical parameters are: the freeze-drying process is 45h.

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Abstract

The invention belongs to the field of quality control on the aspect of medicine microbiological detection, and particularly relates to a staphylococcus aureus adaptability test strain and a preparation method thereof. The staphylococcus aureus adaptability test strain only comprises a certain amount of staphylococcus aureus. The uniformity and the stability of the staphylococcus aureus adaptability test strain meet the requirements of adaptability test strains, the microbial content of the strain is within the adaptability test standard request range, the requirements of an adaptability test,a growth promoting test and the like in the medicine microbiological detection process are met to the maximum degree, a preparation method of a sample is provided, the process is simple, and the survival rate is high.

Description

technical field [0001] The invention belongs to the quality control field of microbiological detection, and particularly relates to a strain of Staphylococcus aureus applicability test and a preparation method thereof. Background technique [0002] Due to the particularity of medicines, the microbiological testing field of medicines is very special, and it is required that the test materials such as culture medium should be checked for suitability before each test. Most of the existing pure strains have not been quantified and can only be used for qualitative use, and there are only a few quantitative strains. For this type of quantitative strain, uniformity and stability are particularly important. The existing quantitative strains have problems such as poor stability and high requirements for transportation conditions. [0003] Staphylococcus aureus is a common Gram-positive bacteria, widely distributed in nature, can cause human and animal infection. After human infecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N1/20C12N1/04C12Q1/14C12R1/445
Inventor 卢行安李宏米伟惠王秀君王鸣雨张顺合潘裕红赵红阳
Owner CHINESE ACAD OF INSPECTION & QUARANTINE
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