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Lyophilized mite allergen vaccine and preparation method thereof

An allergen, freeze-drying technology, applied in the directions of allergen antigen components, anti-infective drugs, drug combinations, etc., to achieve the effects of improving safety and effectiveness, overcoming instability, overcoming harm and side effects

Active Publication Date: 2013-06-05
北京新华联协和药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there is still no clinical evidence linking aluminum-containing vaccines to the development of neurodegenerative disorders such as Alzheimer's disease in humans, a link has been postulated and widely debated

Method used

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  • Lyophilized mite allergen vaccine and preparation method thereof
  • Lyophilized mite allergen vaccine and preparation method thereof
  • Lyophilized mite allergen vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Preparation of house dust mite allergen freeze-dried vaccine

[0032] Take out a bottle of dust mite working seeds from the working seed bank, and place it under the conditions of 25°C and 75% relative humidity for 25 days to recover. Observe the mite growth status and activity under the dissecting microscope. The mite grows well, and the medium has no fungal contamination. The working seeds are inoculated into the medium in a ratio of 1:30 (mite culture and medium weight ratio) (2 parts of experimental animals Feed, 2 parts of yeast powder, 1 part of pork powder), cultivated at 25°C and 75% relative humidity. After about 3 months of house dust mite culture, when the growth and proliferation are observed under the dissecting microscope, the whole mite culture is accurately weighed, and the density of the insect body is calculated by counting method under the optical microscope. The culture can be harvested when the insect body density reaches the standard of ...

Embodiment 2

[0038] Example 2 Preparation of the dust mite allergen freeze-dried vaccine

[0039] Take out a bottle of Dermatophagoides farinae working seeds from the working seed bank, and place them under the conditions of 25°C and 65% relative humidity for 15-30 days to recover. Observe mite growth status and activity under dissecting microscope, mite growth is good, culture medium does not have fungal contamination, working seed is inoculated culture medium (wheat germ powder: Yeast powder=1:1), cultured at 25°C and 65% relative humidity. After cultivating D. farinae for about 3 months, when the growth and proliferation were observed under the dissecting microscope, the whole mite culture was accurately weighed, and the density of the mites was calculated by counting method under the optical microscope. The culture can be harvested when the insect body density reaches the standard of about 50 mites / mg culture. Pour the Dermatophagoides farinae culture into a triangular flask, add abo...

Embodiment 3

[0045] Example 3 Preparation of Freeze-Dried Vaccines of Dust Mite and Dust Mite Allergens

[0046] Dust mite allergen active protein stock solution and Dermatophagoides farinae allergen active protein stock solution were prepared according to Example 1 and Example 2. After the stock solution passed the inspection, it was diluted to 20000 AU with mannitol solution, and the final concentration of mannitol was 2%. The diluted house dust mite allergen active protein stock solution and the dust mite allergen active protein stock solution were mixed at a ratio of 1:1 (volume ratio), filtered and sterilized and dispensed into vials, 1 ml per bottle. Put the half-tamped plug into the front box of the freeze dryer, freeze-dry according to the freeze-drying process of Example 1 and Example 2, and obtain the dust mite allergen mixture freeze-dried vaccine. . Gained freeze-dried vaccine is tested, and the results are shown in table 3:

[0047] Table 3 Inspection of dust mite allergen m...

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PUM

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Abstract

The invention provides a novel lyophilized mite allergen vaccine and a preparation method thereof. The vaccine is prepared by mixing and lyophilizing mite allergen activated protein, a lyophilization protective agent and phosphate buffer solution with pH value of 7.0-8.5 based on the weight ratio of 1:(100-1000):(70-140). Compared with the traditional water preparation, glycerol preparation and preparation containing an aluminum hydroxide adjuvant of the mite allergen vaccine, the lyophilized mite allergen vaccine overcomes use inconvenience of the glycerol preparation, instability of the water preparation and side effects resulting from the preparation containing the aluminum hydroxide adjuvant, thus providing an efficient vaccine product with good stability and good safety for patients allergic to dust mites.

Description

technical field [0001] The invention relates to a vaccine and a preparation method thereof, in particular to a mite allergen freeze-dried vaccine and a preparation method thereof. Background technique [0002] Allergic diseases are considered by the World Health Organization (WHO) to be a major global health problem. In 2010, WHO listed allergic diseases as the fourth most important chronic disease in the world. The total incidence of allergic diseases in the world is about 10-20%, including allergic asthma, which is a common clinical disease and frequently-occurring disease. At present, allergic diseases are becoming more and more serious. The main allergens causing allergies are dust mites, pollen, house dust, mold, feathers, etc., and dust mites are one of the most strongly distributed allergens in the world. [0003] Asthma is one of the most common diseases in the world today, and asthma patients account for about 2-10% of the total population. There are about 50 mill...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/35A61P33/14
Inventor 白彩明裴潇竹姜敏汤承祁牛占坡乔秉善
Owner 北京新华联协和药业有限责任公司
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