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A stable liquid pharmaceutical composition containing animal dander allergen

A technology of animal dander and liquid medicine, which is applied in the direction of drug combination, allergen antigen components, allergic diseases, etc., can solve the problems of short shelf life and achieve high stability effect

Active Publication Date: 2018-04-13
ZHEJIANG WOLWO BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The present invention aims to overcome the short shelf life of liquid pharmaceutical compositions containing animal dander allergens, and provide a liquid pharmaceutical composition containing animal dander allergens that can be stored stably for a long time

Method used

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  • A stable liquid pharmaceutical composition containing animal dander allergen
  • A stable liquid pharmaceutical composition containing animal dander allergen
  • A stable liquid pharmaceutical composition containing animal dander allergen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Example 1: Preparation of liquid pharmaceutical composition containing cat dander allergen

[0078] Select the cat dander allergen extract as the allergen to prepare a stable liquid pharmaceutical composition, and the specific steps are as follows:

[0079] 1. Crushing: liquid nitrogen crushes the raw materials of Chinese pastoral cat dander;

[0080] 2. Degreasing: Add acetone to degrease according to the mass volume ratio of about 1:10, stir for about 2 hours, filter, discard the acetone solution, and degrease for a total of 3 times. The degreasing liquid is basically colorless by visual inspection. The degreasing powder is dried for no less than 36 hours until there is no smell of acetone.

[0081] 3. Extraction: Add 50 mM pH 8.2 phosphate buffer containing 1.0% NaCl at 2-8° C. for an extraction ratio of 1:20 (w / v), and extract for 48-60 hours. Centrifuge and filter step by step until the 0.22μm membrane filter is smooth.

[0082] 4. Concentration: Divide the cru...

Embodiment 2

[0089] Example 2: Long-term stability test of liquid pharmaceutical composition containing cat dander allergen at 2-8°C

[0090] Four groups of liquid pharmaceutical compositions containing cat dander allergens were respectively prepared according to the four proportions of a, b, c, and d in Example 1 of the present invention. 0 month, 3 months, 6 months, 9 months, 12 months, and 24 months were tested. The total protein concentration was detected by Brandford method, and the main allergen protein Fel d 1 concentration was detected by ELISA method. The results are shown in Table 1:

[0091] Table 1

[0092]

[0093]

[0094] The test results showed that under the condition of 2-8°C, by the end of 24 months, the total protein concentration of the liquid pharmaceutical composition of group a decreased by 13.8%, and the main allergen protein concentration decreased by 15.6%; The protein concentration decreased by 12.3%, and the major allergen protein concentration decreas...

Embodiment 3

[0096] Example 3: Stability test of liquid pharmaceutical composition containing cat dander allergen at 25°C±2°C

[0097] Four groups of liquid pharmaceutical compositions containing cat dander allergen were respectively prepared according to the four proportions of a, b, c, and d in Example 1 of the present invention, which were placed under the condition of 25°C±2°C, and respectively At the end of the 0th month, 1st month, 2nd month, 3rd month and 6th month. The total protein concentration was detected by Brandford method, and the main allergen protein Fel d 1 concentration was detected by ELISA method. The results are shown in Table 2:

[0098] Table 2

[0099]

[0100]

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Abstract

The present invention provides a stable liquid pharmaceutical composition containing animal dander allergen. The liquid pharmaceutical composition comprises a therapeutically effective amount or a diagnostically effective amount of animal dander allergens, an effective buffering amount of a pH 5.0-7.0 buffer, aminocaproic acid with a concentration range of 0.1%-2.0% w / v, Polyols and pharmaceutical preservatives in concentrations ranging from 30% to 70% v / v. The liquid pharmaceutical composition can be made into dosage forms such as oral, subcutaneous injection, sublingual, aerosol, nasal cavity, skin pricking, etc., and can be applied to the diagnosis or treatment of allergies induced by animal dander allergens disease.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, in particular to a stable liquid pharmaceutical composition containing animal dander allergens. Background technique [0002] Allergic diseases are one of the most common diseases in the world today. The incidence of allergic diseases accounts for about 20% of the population. Allergic diseases may occur in all age groups from newborns to the elderly, and have obvious genetic predispositions. Allergic diseases include allergic asthma, allergic rhinitis, atopic dermatitis, allergic conjunctivitis, etc., which can even threaten people's lives in severe cases (anaphylactic shock). [0003] When the allergen contacts the human body through ingestion, inhalation, skin contact, etc., it will induce B cells to produce specific antibody IgE (sIgE). sIgE will firmly bind to the surface of mast cells and basophils. When the allergen re-enters the body, it binds to these sIgEs. This binding i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/35A61P37/08
Inventor 李勤
Owner ZHEJIANG WOLWO BIOTECH
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