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Use of acellular short corynebacteria preparation in preparation of medicine for treating tuberculosis

A coryneform brevis, cell-free preparation technology, applied in the field of medicine, can solve the problems of increasing the patient's economic bearing capacity, increasing the proportion of drug-resistant bacteria, difficult chemotherapy, etc. Effect

Inactive Publication Date: 2004-01-07
上海昌润生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the curative effect on the dormant Mycobacterium tuberculosis living in macrophages is poor, and it needs to be treated for 5 months or even longer, so this therapy has several defects: (1) Chemotherapy, especially some irregular chemotherapy, leads to the proportion of drug-resistant bacteria According to the epidemiological survey of tuberculosis, the proportion of primary drug-resistant bacteria was 26.2% in 1979 and rose to 47.8% in 1985, which brought great difficulties to chemotherapy
(2) Residual Mycobacterium tuberculosis after chemotherapy can still lead to recurrence
(3) Long-term chemotherapy directly increases the patient's economic affordability and liver and kidney toxicity
Although there are many methods for cell disruption, it is difficult to disrupt cells into nanoscale with uniform particle size.

Method used

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  • Use of acellular short corynebacteria preparation in preparation of medicine for treating tuberculosis
  • Use of acellular short corynebacteria preparation in preparation of medicine for treating tuberculosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] According to the method described in the 2000 edition of "China Biological Products Regulations", the establishment, verification and other verification of bacterial seed batches were carried out.

[0060] The medium used in this example is the thioglycolate medium (without agar) produced by Beijing Sanyao Science and Technology Development Company, and its ingredients are: tryptone 15g / l, yeast extract powder 5g / l, glucose 5g / l , sodium chloride 2.5g / l, L-cystine 0.5g / l, sodium thioglycolate 0.5g / l. The medium was filtered through a 0.22 μm membrane before use.

[0061] Open the CP (scientific name propionibacterium acnes, propionibacterium acnes) 771 (see "China Biological Products Regulations") strain tube, each tube contains 6 billion bacteria, and draw about 0.2-0.3ml of thioglycolate medium (excluding Agar), add it to the bottom of the strain tube to dissolve it completely, suck it out, add it to the middle tube (capacity 38ml), mix it with 8-10ml of the above me...

Embodiment 2

[0066] Referring to the method of Example 1, CP (scientific name propionibacterium acnes, propionibacterium acnes) 65101 (76-27) was inoculated in a nutrient tank after 4 consecutive passages, and was cultured in a thioglycolate medium (without agar) (before use) Filter the culture medium with a 0.45 μm membrane) and culture at 36-37°C for 6 days; check the bottles one by one under the microscope, and discard those contaminated by bacteria; combine and collect the bacteria without bacteria contamination, heat and boil for 60 minutes, and use ultra-high pressure jet Collider at 1500kgf / cm 2 Broken bacterium under pressure 5 times; The broken suspension was centrifuged at 8000rpm for 1 hour, washed with sterile normal saline for 5 times, sterility test (2000 edition "China Biological Products Regulation") and pyrogen detection (2000 edition Pharmacopoeia of the People's Republic of China ") is qualified to make a suspension with a solid content of 2.0mg / ml, and heat at 65°C for ...

Embodiment 3

[0070] With reference to the method of Example 1, CP (Propionibacterium acnes) 65102 (H-84) was inoculated in a nutrient tank after 4 consecutive passages, and cultured in a peptone medium at 36-37°C for 7 days; bottle by bottle Microscopic examination, those with contamination by miscellaneous bacteria were discarded; combined and collected bacterial cells without contamination by miscellaneous bacteria were heated and boiled for 30 minutes. 2 Broken thalli under pressure 10 times; The suspension after broken is centrifuged at 12000rpm, washes precipitate 4 times with sterile normal saline, sterility test (2000 version "Chinese Biological Products Regulations") and pyrogen detection (2000 version "People's Republic of China Regulations") Pharmacopoeia ") qualified to make a suspension with a solid content of 1.0mg / ml, heated at 65°C for 100 minutes to obtain NCP.

[0071] Detect (solid content 1mg / ml) NCP pyrogen 60EU / ml by limulus reagent method (2000 edition "Pharmacopoeia ...

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Abstract

The present invention discloses a non-cell corynebacterium parvum preparation (NCP) and its application in preparation of medicine for curing tuberculosis, in which the described NCP is a non-cell preparation prepared by breaking corynebacterium parvum, its grain size is less than 100 nm, and its heat source is less than 160 Eu / ml, protein content is 10-40% (g / g), nucleic acid content is 3-25% (g / g), the rest is polysaccharide. The tests show that it can obtain good therapeutic effect.

Description

technical field [0001] The invention relates to an immunomodulator, in particular to the use of a cell-free short coryneform bacillus preparation (NCP) in the preparation of medicines for treating tuberculosis, and belongs to the field of medicines. Background technique [0002] Corynebacterium breve bacterin (CPV, 1995 edition of "China Biological Products Regulations") or short Corynebacterium preparations (CPP, 2000 edition of "China Biological Products Regulations") is a non-specific immunomodulator. It is a dead bacterin vaccine made from Corynebacterium brevis (CP) inactivated by formaldehyde, and its preparation process is disclosed in the 1995 and 2000 editions of "China Biological Products Regulations". Currently used CPP preparations also include inactivated vaccines produced by Merleux Research Institute in France; inactivated vaccines produced by Wellcome Pharmaceuticals in the UK, etc. [0003] CPP has the ability to activate the mononuclear phagocyte system. ...

Claims

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Application Information

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IPC IPC(8): A61K35/74A61P31/06
Inventor 高尚先李守悌
Owner 上海昌润生物科技有限公司
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