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Stable medicinal composition containing artemisia pollen allergen and preparation method thereof

A composition and allergen technology, applied in the direction of drug combination, allergen antigen components, drug delivery, etc., can solve the problems of complex composition and structure, reduced potency, short shelf life, etc.

Active Publication Date: 2010-12-08
ZHEJIANG WOLWO BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Due to the complex composition and structure of Artemisia pollen allergens, they are easily affected by physical or chemical factors to lose their activity and reduce their potency. Sometimes even in a low temperature environment, the long-term stability of their allergen activity cannot be guaranteed. The "shelf life" of such drugs is relatively short, which is not conducive to long-term storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1 Preparation of sublingual oral preparation of Artemisia annua pollen allergen

[0065] (1) Degreasing: Accurately weigh the dried Artemisia annua pollen, add acetone at a mass-volume ratio of 1:4, continuously stir and degrease for 2 hours, then let stand for 30 minutes, remove the upper layer of acetone, repeat the above degreasing process 4 times; The solid was paved and dried in a fume hood until it was a dry powder without the smell of acetone.

[0066] (2) Extraction: The degreasing pollen obtained in step (1) and 50 mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 8.0 are mixed at a ratio of 1:30 (W / V) and continuously stirred at 4°C. Extract for 48 hours; centrifuge at 10,000 r.p.m. at 4°C for 30 minutes to collect the supernatant; filter successively with ordinary filter paper and 0.45 μm microporous membrane to remove small particles and obtain a crude extract.

[0067] (3) concentration: the crude extract that ...

Embodiment 2

[0071] Example 2 Preparation of Artemisia annua pollen allergen skin pricking fluid

[0072] Steps (1)-(4) are the same as in Example 1, but use 150 mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer at pH 7.0 to replace the leaching buffer during ultrafiltration and concentration.

[0073] (5) Dilution: Dilute the Artemisia annua pollen allergen extract obtained in step (4) with 150 mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution at pH 7.0 to a total protein concentration of 1200 μg / ml, add Glycerol with a volume ratio of 1:1 (to make the final concentration 50% (v / v)), and then add phenol (to make the final concentration 0.2% (w / v)).

[0074] (6) Sterilization: Use a 0.22 μm sterile microporous filter membrane to filter and sterilize, sub-package and potting to obtain the finished product of Artemisia annua pollen allergen skin pricking liquid, the total protein concentration of the pricking liquid finished product is 600 μg / ml.

Embodiment 3

[0075] Example 3 Preparation of Artemisia grandis pollen allergen subcutaneous injection

[0076] (1) Degreasing: Accurately weigh the dried Artemisia grandis pollen, add acetone at a mass-volume ratio of 1:4, stir and degrease continuously for 2 hours, then let stand for 30 minutes, remove the upper layer of acetone, repeat the above degreasing process 4 times; The final solid was paved and dried in a fume hood until it was a dry powder without the smell of acetone.

[0077] (2) Extraction: The degreasing pollen obtained in step (1) and 50 mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 8.0 are mixed at a ratio of 1:30 (W / V) and continuously stirred at 4°C. Extract for 48 hours; centrifuge at 10,000 r.p.m. at 4°C for 30 minutes to collect the supernatant; filter successively with ordinary filter paper and 0.45 μm microporous membrane to remove small particles and obtain a crude extract.

[0078] (3) concentration: the crude extract obt...

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PUM

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Abstract

The invention provides a stable liquid medicinal composition. The liquid medicinal composition contains therapeutically effective amount or diagnostically effective amount of artemisia pollen allergen, buffering effective amount of buffer solution with pH of 5.0 to 7.0, and pharmaceutically acceptable carrier. The form of the liquid medicinal composition is preferable oral liquid, injection, sublingual buccal tablets, aerosol, nasal agent or skin pricking agent. The invention also provides a method for preparing the liquid medicinal composition. The liquid medicinal composition provided by the invention can be used for treating or diagnosing various allergic diseases caused by artemisia pollen, and has broad application prospect and clinical value in the field of allergic disease diagnosis and treatment.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a stable liquid pharmaceutical composition containing Artemisia pollen allergen, a preparation method and application thereof. Background technique [0002] Allergic disease is one of the most common and stubborn diseases in the world today, and it is a disease that seriously threatens human health. The incidence of allergic diseases accounts for about 20% of the population, and may occur in all age groups from newborns to middle-aged and elderly people. There is no obvious gender tendency, but there is an obvious genetic tendency. [0003] The main allergens that cause allergies are dust mites, pollen, house dust, mold, feathers, etc. Among them, pollen is an important class of allergens. Pollen is the male reproductive cell of higher plants. It is spread in the air under the action of wind or insects. Some people will have allergic reactions after inhali...

Claims

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Application Information

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IPC IPC(8): A61K39/36A61K9/08A61P37/08A61P11/02A61P17/00
Inventor 李勤
Owner ZHEJIANG WOLWO BIOTECH
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