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Stable film agent medicinal composition containing allergen and preparation method thereof

A composition and allergen technology, which is applied in the directions of drug combination, allergen antigen components, sheet-like delivery, etc., can solve the problems of inconvenient transportation, storage, carrying, inconvenience of accurate quantitative administration, large dosage and volume, etc. , to achieve the effect of light weight, easy transportation and convenient use

Active Publication Date: 2011-05-11
ZHEJIANG WOLWO BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the dosage form of sublingual administration of desensitization drugs is mainly sublingual drops, but sublingual drops are liquid preparations, and allergens are active proteins, and active proteins generally need to be stored at low temperature to survive. Maintain the activity to ensure the curative effect, which brings inconvenience to transportation, storage, carrying and use; and the dosage is gradually increased from small to large, especially when the optimal maintenance dose is reached, the volume of liquid administration is large, which makes the patient especially It is inconvenient for accurate quantitative administration of children and elderly patients, which is not conducive to the implementation of standardized administration

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The preparation of embodiment 1 allergen extract

[0068] (1) Preparation of dust mite (Dermatophagoides farinae) allergen extract

[0069] (1) Cleaning, grinding, degreasing and drying

[0070] Cultivate D. farinae in a flour medium at a temperature of 25° C. and a humidity of 70% to 80%, so that the density reaches 300 to 500 per gram. Suspend and separate with saturated NaCl solution, and collect the mite body of Dermatophagoides farinae. The obtained Dermatophagoides farinae mite bodies were suspended and washed with physiological saline, dried and stored at -20°C for later use. Weigh the worm body, grind the worm body with liquid nitrogen, soak and degrease it with acetone for 3 times continuously, 4 hours each time, until the acetone after degreasing is colorless, dry the degreased solid naturally until there is no smell of acetone, and then weigh it. Heavy.

[0071] (2) Leaching

[0072] Soak and extract both D. farinae body and physiological saline at 1:25 ...

Embodiment 2

[0095] The preparation of embodiment 2 film

[0096] (1) Preparation of film-forming solution

[0097] Dissolve each component in formula 1 to formula 6 in Table 1 in 120ml of purified water, warm bath at 40°C, fully swell, and let stand for 2 to 8 hours until the bubbles generated during the mixing process are eliminated.

[0098] Table 1

[0099]

Recipe 1

Recipe 2

Recipe 3

Recipe 4

Recipe 5

Recipe 6

sodium alginate

4.2g

3.3g

5.7g

2.9g

9.7g

2.2g

Pullulan

1.1g

0.6g

1.4g

sucrose

0.9g

2.2g

1.0g

glycerin

0.15g

0.25g

0.44g

Tween 80

0.18g

0.25g

silica

2.2g

6.6g

Simethicone

0.1g

0.1g

0.1g

0.1g

0.1g

0.1g

Potassium sorbate

0.01g

0.01g

0.01g

0.01g

0.01g

0.01g

[0100] Not...

Embodiment 3

[0108] The assay method of embodiment 3 allergen activity

[0109] (1) Determination of total allergen activity

[0110] Method: Mix the allergen to be tested with its corresponding standard serum mixture in equal volumes, and use the corresponding standard serum mixture and purified water as a control, incubate in a 37°C incubator for 1 hour, then take it out and let it stand In the refrigerator at 4°C overnight (9-12 hours). Transfer the sample after staying overnight at 4°C to a sterilized glass test tube, and use a Unicap100 instrument (Sweden Pharmacia Company) to measure the sIgE content (according to the Immun CAP diagnostic system of Sweden Pharmacia Company, UniCAP automatically detects allergies in vitro The original system instructions operate.) The relative content of sIgE measured by the dust mite standard serum mixture (mixed with equal volume of purified water) is 85.36KUA / L, and the relative content of sIgE measured by the standard serum mixture of North Artem...

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Abstract

The invention discloses a stable film agent medicinal composition containing an allergen, which comprises a theoretically effective amount of allergen, a film-forming material and a pharmaceutically acceptable carrier. In a preferable embodiment, the film-forming material accounts for 30 to 99 percent of the mass of the entire film agent medicinal composition. In addition, the invention also relates to a preparation method of the film agent medicinal composition. The application of the allergen film agent makes the standard medicament administration in allergen specific immunotherapy convenient.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a stable allergen-containing film pharmaceutical composition and a preparation method thereof. Background technique [0002] Allergic diseases (also known as allergic diseases) are a class of diseases with high incidence, serious harm and great social impact. In 2005, the World Allergy Organization (WAO) published an epidemiological survey of allergic diseases in 30 countries, and the results showed that 22% of the 1.2 billion people in these countries suffered from IgE-mediated allergic diseases. In developed countries, allergic diseases have become the sixth largest chronic disease due to their high incidence, and about 15-20% of the population suffer from various allergic diseases, mainly including allergic asthma, allergic rhinitis, idiopathic Allergic dermatitis, allergic conjunctivitis, etc. [0003] Allergy is an abnormal, harmful, pathological imm...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K39/35A61K39/36A61P37/08
Inventor 管祯玮
Owner ZHEJIANG WOLWO BIOTECH
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