Bovine type tuberculin standard substance and preparation method thereof

A technology of tuberculin and reference material, which is applied in the field of bovine tuberculin reference material and its preparation, and can solve the problem of high quality requirements

Inactive Publication Date: 2010-06-16
CHINA INST OF VETERINARY DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the quality requirements of standard products are high, and the preparation methods and inspection or calibration methods are strict. There are no relevant reports on the preparation procedures and calibration methods.

Method used

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  • Bovine type tuberculin standard substance and preparation method thereof
  • Bovine type tuberculin standard substance and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] The preparation of embodiment 1 bovine type purification tuberculin national standard substance

[0104] 1. Medium

[0105] Sutong Synthetic Medium (Committee for Regulations of Veterinary Biological Products of Ministry of Agriculture. Regulations of Veterinary Biological Products of the People's Republic of China, 2000 edition, Chemical Industry Press, 2000) includes as follows, asparagine 4g, citric acid 2g, magnesium sulfate 0.5 g, dipotassium hydrogen phosphate 0.5g, ferric ammonium citrate 0.05g, glycerin 60ml, each component is analytically pure. Add 940ml of distilled water to prepare a total of 50000ml.

[0106] 2. Strains

[0107] Mycobacterium bovis C68001 and C68002 strains (provided by China Veterinary Drug Administration).

[0108] (1) Preparation of seeds for production

[0109] 1) Primary seed preparation

[0110] Inoculation After unsealing the freeze-dried strains, inoculate Ogawa culture medium and culture them in a 37°C greenhouse for about two ...

Embodiment 2

[0137] The finished product inspection of embodiment 2 bovine type purification tuberculin national reference material

[0138] 1. Homogeneity test Take 15 samples, and use the Kjeldahl method to measure the tuberculin protein content in each ampoule. The results are shown in Table 3.

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Abstract

The invention relates to bovine type tuberculin standard substance and a preparation method thereof. The bovine type tuberculin standard substance is prepared by the following steps of: preparing bovine type tuberculin through processes of culturing, inactivating, filtering, purifying, and the like by utilizing mycobacteriumbovis separated in China; measuring the contents of protein, nucleic acid and polysaccharide in the bovine type tuberculin; and preparing the bovine type tuberculin standard substance by combining biological test measurement.

Description

technical field [0001] The invention relates to a bovine tuberculin standard substance and a preparation method thereof, and belongs to the technical fields of standard substance technology and veterinary biological products. Background technique [0002] Bovine tuberculosis is a chronic bacterial disease on animals and humans caused by Mycobacterium bovis. The disease is distributed worldwide and is also the main infectious disease of cattle in my country. Health threat is greater. Since my country implements an elimination system for bovine tuberculosis-positive cattle, bovine tuberculosis diagnostic technology is particularly important, and bovine tuberculin diagnostic technology is the only diagnostic method recommended by the World Organization for Animal Health (OIE). The potency calibration of the purified bovine tuberculin product is to use the skin allergy method of guinea pigs, use the standard product as a control, and determine the international unit (IU) of the ...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K49/00
Inventor关孚时王在时林朝洪申咏红肖朝云李翠戴志红张秀英陆连寿蒋卉
OwnerCHINA INST OF VETERINARY DRUG CONTROL