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Bacterial vaccine strain quality control method

A technology for strains and vaccines, applied in measuring devices, material analysis by electromagnetic means, instruments, etc., can solve problems such as quality control of unseen bacterial vaccine strains

Active Publication Date: 2016-06-01
NAT INST FOR FOOD & DRUG CONTROL
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Problems solved by technology

In recent years, with the development of biotechnology, a variety of molecular genetic analysis methods have come out one after another, such as pulse-field gel electrophoresis (PFGE) technology for the analysis of the whole genome of bacteria, but this method has not been used for bacterial vaccine strains. Therefore, in order to ensure the safety of the product from the source of the vaccine, it is urgent to establish a method for molecular genetic quality control of Leptospira vaccine strains to strengthen the quality control of vaccine strains

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  • Bacterial vaccine strain quality control method
  • Bacterial vaccine strain quality control method

Examples

Experimental program
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Effect test

Embodiment 1 1

[0022] Embodiment 1 general method

[0023] 1. Preparation of Bacterial PFGE Blocks

[0024] Take 10ml of the Leptospira vaccine strain grown in rabbit serum phosphate medium at 28°C for 7-10 days in a centrifuge tube, balance, centrifuge at 10,000rpm at 4°C for 20min, discard the supernatant, add 1ml of buffer solution (containing 1MTris, 0.5 MEDTA and 5M NaCl solution), transferred to a 1.5mleppendorf tube, and centrifuged at 6000rpm for 5 minutes. Pour off the supernatant. Add 400 μl of buffer solution according to the concentration of Leptospira bacteria to dissolve the precipitate and mix well, take 200 μl of bacterial suspension and place it in a 1.5 mleppendorf tube, and incubate at 37°C for 5 minutes. Add an equal amount of 1% gold medal agarose solution (purchased from Lonza Company, USA), mix well, add to the mold, and solidify at room temperature for about 15 minutes to obtain bacterial PFGE gel blocks.

[0025] 2. Treatment of Bacterial PFGE Blocks

[0026] Put...

Embodiment 2

[0030] Carry out the PFGE analysis method as described in Example 1 to the following Leptospira vaccine strains (all from Wuhan Institute of Biological Products Co., Ltd.): MarkerH9812; Jaundice and hemorrhagic group (Lai strain); Autumn group (Lin 4 strains) ; Influenza typhoid group (6 strains); MarkerH9812, obtained figure 1 The results shown.

[0031] This result shows that the number, size and distribution of DNA fragments of Leptospira vaccine strains of different serogroups are different, showing different PFGE patterns.

Embodiment 3

[0033] Different passages of a Leptospira vaccine strain influenza typhoid group (Lin 6 strains) (Leptospira Lin 6 strains were obtained from Wuhan Institute of Biological Products Co., Ltd. before animal passage and through animal passage; then The Leptospira strain is carried out one generation every 7 days or so on the in vitro artificial culture medium-rabbit serum phosphate medium, totally 20 generations) Carry out the PFGE analysis method as described in Example 1, obtain figure 2 The results shown.

[0034] This result shows that the DNA bands of the influenza typhoid group (Lin 6 strain) are completely consistent before animal subculture and within 20 generations after animal subculture, and have the same PFGE pattern. The culture characteristics and growth morphology of these different generations of strains on the rabbit serum phosphate medium were the same, and the results of serotype analysis of the strains of different generations were also consistent, which furt...

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Abstract

The invention relates to a leptospiral vaccine strain quality control method. The method comprises a, inoculating an animal with a leptospiral vaccine strain, collecting animal heart blood and culturing the leptospiras for leptospiral strain passage so that animal passage is realized, b, carrying out pulse-field gel electrophoresis (PFGF) analysis on different generations of the leptospiral vaccine strains before and after animal passage, and c, comparing the obtained DNA maps, wherein if the DNA maps are the same, different generations of the leptospiral vaccine strains before and after animal passage are stable. The method realizes analysis of the whole chromosome of the leptospiral strains and has the advantages of good repeatability, good distinguishing capability, stable result and clear result explanation.

Description

technical field [0001] This application relates to the field of biological products, in particular, to a method for quality control of bacterial vaccine strains. Background technique [0002] Bacteria for vaccine production refer to microorganisms such as bacteria, viruses, spirochetes and rickettsia isolated and screened from nature or clinically used for vaccine production and quality control, after identification, classification and fixed numbering. Pure culture of microorganisms. Bacterial strains are the material basis for vaccine research, production, and verification. Various bacterial vaccines, such as inactivated vaccines, live vaccines, or component-purified vaccines, are prepared through the expansion of bacterial strains and other processes. The quality of the production strain directly or indirectly affects the quality, safety and efficacy of the vaccine. Therefore, the strain must be strictly screened before it can be used as a vaccine production strain. At th...

Claims

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Application Information

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IPC IPC(8): G01N27/447
Inventor 王军志徐颖华张金龙辛晓芳
Owner NAT INST FOR FOOD & DRUG CONTROL
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