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Dust mite allergen quick-disintegrating sublingual tablet vaccine and preparation method thereof

A sublingual tablet and allergen technology, which is applied in the field of pharmaceuticals containing allergen active protein, can solve the problems of not achieving rapid release of active ingredients, high requirements for storage conditions, and unstable biological activity.

Inactive Publication Date: 2018-10-02
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

However, as a liquid preparation of biological products, sublingual drops still have the disadvantages of unstable biological activity, short validity period, and high requirements for storage conditions.
Gradually, there are studies on the preparation of solid dosage forms such as sublingual buccal tablets by means of tablet compression, but the disintegration speed of the tablets prepared by tablet compression is slow under the tongue, and the effect of rapid release of active ingredients cannot be achieved.

Method used

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  • Dust mite allergen quick-disintegrating sublingual tablet vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of house dust mite allergen stock solution

[0024] 1) Collect the pure dust mite body by mechanical shaking method, and then use a 40-100 mesh sieve to remove impurities, and perform purity detection, morphological and molecular biology identification on the collected dust mite body.

[0025] 2) Add absolute ethanol to the dust mite body obtained in 1) at a volume ratio of 1:5, degrease at room temperature with intermittent stirring for 3 hours each time until the supernatant is colorless, and dry the degreased solids naturally to No ethanol smell.

[0026] 3) Add 1,000 g of degreased dust mite mite body to 25,000 ml of 200 mM pH 8.0 disodium hydrogen phosphate-sodium dihydrogen phosphate buffer at a feed ratio of 1:25 (W:V), and stir at 4°C for 24 hours.

[0027] 4) Centrifuge the extracted extract at 6000rpm at 4°C for 15min. Take the supernatant after centrifugation at 8000rpm at 4°C for 30min.

[0028] 5) Clarify and filter the extract afte...

Embodiment 2

[0030] The preparation of embodiment 2 dust mite allergen stoste

[0031] 1) Collect pure mite body of D. farinae by mechanical shaking method, then use 40-100 mesh sieve to remove impurities, and conduct purity detection, morphological and molecular biological identification on collected mite body of D. farinae.

[0032] 2) Add dehydrated ethanol to the dust mite body obtained in 1) at a volume ratio of 1:5, degrease at room temperature with intermittent stirring, for 3 hours each time, until the supernatant is colorless, and dry the degreased solid naturally until it is colorless. Ethanol smell.

[0033] 3) Add 1,000 g of degreased dust mite mite body to 25,000 ml of 200 mM pH 8.0 disodium hydrogen phosphate-sodium dihydrogen phosphate buffer at a feed ratio of 1:25 (W:V), and stir at 4°C for 24 hours.

[0034] 4) Centrifuge the extracted extract at 6000rpm at 4°C for 15min. Take the supernatant after centrifugation at 8000rpm at 4°C for 30min.

[0035] 5) Clarify and fil...

Embodiment 3

[0037] Example 3 Preparation of mixed dust mite allergen stock solution

[0038] 1) The dust mite allergen stock solution obtained in Example 1 and Example 2 and the dust mite allergen stock solution were mixed at a ratio of 1:5 to 5:1.

[0039] 2) The activity of the mixed stock solution obtained in 1) is measured by immunofluorescence method, and the activity is not lower than 50000 AU / ml.

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Abstract

The invention provides a dust mite allergen quick-disintegrating sublingual tablet vaccine and a preparation method thereof. The vaccine is a quick-disintegrating sublingual tablet of dust mite allergens prepared by direct freeze-drying method, and contains dust mite allergens and corresponding excipients, flavoring agent, pigments, etc. in which the dust mite allergens are Dermatophagoides pteronyssinus allergens or Dermatophagoides farinae allergens or mixed dust mite allergens of both. The sublingual tablet vaccine has the advantages of stable biological activity, long effect period, easy storage, convenient use, disintegration, quick release of active ingredients and the like compared with the traditional allergen sublingual drop vaccine and can provide more convenient and reliable specific desensitization treatment means for patients allergic to dust mites.

Description

technical field [0001] The invention relates to a drug containing an allergen (allergen) active protein, in particular to a dust mite allergen rapid-disintegrating sublingual tablet vaccine prepared by a direct freeze-drying method, and a preparation method of the product. Background technique [0002] Allergic diseases (also known as allergic diseases) include atopic dermatitis, food allergy, allergic rhinitis and allergic asthma, etc., the incidence of which is increasing day by day, and the condition is becoming more and more complicated. WHO has listed allergic diseases as key research and prevention diseases in the 21st century. Although allergic disease is generally considered a chronic disease, death due to severe allergic asthma or airway edema is not uncommon. And it has been widely recognized all over the world that allergic diseases will seriously reduce the quality of life and health of patients. [0003] Allergic diseases are mostly type I allergic diseases, w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/35A61K9/20A61K47/26A61K47/18A61P37/08A61P11/02A61P11/06
CPCA61K39/35A61K9/006A61K9/2013A61K9/2018
Inventor 裴潇竹白彩明马晓晖
Owner 北京新华联协和药业有限责任公司
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