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Allergen solvent and preparation method thereof

An allergen and solvent technology, applied in the biological field, can solve the problems of poor stability of allergen solvents, inability to prepare stable products, and no clear formula ratio, etc., to achieve the effect of clear formula, good stability, and light clinical pain

Active Publication Date: 2019-07-19
PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The allergen vehicle contains the following components: human serum albumin, sodium chloride, phenol and sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution, but the preparation process of the allergen vehicle has poor operability, and the obtained allergen The stability of the original solvent is relatively poor, and the buffer system in the formula of the allergen solvent of the present application is a fluctuating value, there is no clear formula ratio, and the variation range of the pH value is relatively large. The fluctuation range of the pH value is larger, so the stable product meeting the national preparation standard cannot be prepared according to the preparation method described in the patent application

Method used

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  • Allergen solvent and preparation method thereof
  • Allergen solvent and preparation method thereof
  • Allergen solvent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1 allergen vehicle preparation

[0048] 1. Formula (take the preparation of 1000ml allergen solvent as an example):

[0049] Table 2: Formula list of allergen vehicle

[0050]

[0051] 2. Allergen solvent preparation

[0052] 1) Weigh 70.64g disodium hydrogen phosphate, 1.44g potassium dihydrogen phosphate, 20.00g sodium chloride and 12.00g phenol according to the allergen solvent formula, dissolve them completely with 2L water for injection, and set aside;

[0053] 2) Measure 7.2ml of 20% human serum albumin, add it to saline solution and mix evenly, dilute to 4.0L with water for injection, mix well and set aside;

[0054] 3) Soak the 0.22μm polyethersulfone filter membrane with water for injection for more than 12 hours in advance, then place it flat on the metal mesh inside the filter, assemble the filter tightly, and positively press the prepared extract with a pressure of ≤0.2MPa filter. [2, 8] ℃ for later use, the storage period does not exceed 3...

Embodiment 2

[0069] Embodiment 2: Stability investigation

[0070] According to (Chinese Pharmacopoeia 2015 edition four general rules 9001) in the drug substance and preparation stability test guideline, carry out the stability research investigation of influence factor test, accelerated test and long-term test to three batches of solvents of example 1 respectively, with physical and chemical detection, The sterility test and the detection of human serum albumin content are the inspection indexes, and the method is the same as that in Example 1.

[0071] 1. Influencing factor test:

[0072] 1) High temperature test: Take one batch of Example 1, remove the outer packaging, place it in a 40°C incubator for 10 days, and take samples for inspection on the 5th and 10th days.

[0073] 2) High humidity test: Take one batch of Example 1, remove the outer packaging, place it in a constant humidity airtight container, and place it at 25°C for 10 days at a relative humidity of 90%±5%. At the same ...

Embodiment 3

[0089] Example 3: Effect of solution pH stability in gradient dilution applications of allergen preparations

[0090] This experiment mainly verifies the pH stability of the solvent in the application of the gradient dilution of the allergen preparation, and uses isoelectric focusing (IEF) electrophoresis to measure the isoelectric point PI of the effective active protein of the allergen preparation as an auxiliary proof experiment. Use commercially available allergen solvents at home and abroad and the allergen solvents of the present invention to respectively mix 10000 AU / bottle (AU: allergy unit, allergen biological potency unit, is a measure of allergens in the endothelial cells of patients with specific allergies). Humulus pollen allergen freeze-dried reference product, 10000 AU / bottle juniper pollen allergen freeze-dried reference product, 10000 AU / bottle Artemisia grandis pollen allergen freeze-dried reference product 10,000 AU / bottle of house dust mite allergen freeze-...

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Abstract

The invention provides an allergen solvent and a preparation method of the solvent. A corresponding buffered solution and bacteriostat ingredients are added based on a traditional allergen solvent, sothat an allergen product prepared through diluting the allergen solvent provided by the invention is stable and does not change color easily, active protein is not easy to denature or adsorb onto theinner surface of a glass container, the stability and the valence of an allergen vaccine needing to be diluted through a solvent and the stability and the valence of an allergen intracutaneous diagnosis preparation are improved, and the allergen solvent has higher promotion value.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to an allergen solvent and a preparation method thereof. Background technique [0002] With changes in the global climate and human living environment, allergic diseases are on the rise year by year. In 2010, WHO defined allergic diseases as the fourth most important chronic diseases in the world. At present, allergic diseases are one of the major global health problems. More than 25% of the population in industrialized countries is plagued by allergic asthma, allergic rhinoconjunctivitis and allergic dermatitis. [0003] At the beginning of the last century, the extracts of grass, weeds, trees and other plant pollen were widely used in the in vivo and in vitro diagnosis and immunotherapy of hay fever. The World Health Organization (WHO) clearly pointed out in its guidance document on immune desensitization: " Allergy therapy is the only treatment that can alter the natur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K47/02A61K47/10A61K39/35A61P37/08
CPCA61K47/42A61K47/02A61K47/10A61K39/35A61P37/08
Inventor 周俊雄尹佳马武强
Owner PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI
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