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
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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.
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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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