Idiotoxin solvent and preparation method thereof

A technology of allergens and solvents, which is applied in the direction of allergen antigen components, inorganic non-effective components, polymer compound non-effective components, etc., can solve the problems of loss, poor protein stability, and low effective active protein concentration, and achieve improved Effectiveness, improved stability, and improved clarity

Inactive Publication Date: 2011-09-14
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

The effective active protein concentration of the allergen vaccine is very low at high dilution. Under this condition, the protein stability is poor and it is easy to lose due to the adsorption of the container or the denaturation caused by phenol.

Method used

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  • Idiotoxin solvent and preparation method thereof
  • Idiotoxin solvent and preparation method thereof
  • Idiotoxin solvent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1: Allergen Vehicle

[0047] 1. Composition: 50mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution, 0.5g / 100ml sodium chloride, 0.4g / 100ml phenol, 0.03g / 100ml human serum albumin, pH8.0, the specification of the injection is 1.8ml / bottle.

[0048] 2. Preparation method (such as figure 1 shown in the flowchart)

[0049] 1) Weigh 99.23g disodium hydrogen phosphate (0.699mol), 6.12g sodium dihydrogen phosphate (0.051mol), 75g sodium chloride and 60g phenol, dissolve in 2L 60°C water for injection, and dilute to 60°C water for injection 8L, spare;

[0050] 2) When the temperature drops to 30°C, add 0.2% activated carbon for needles, and stir at 30°C for 30 minutes;

[0051] 3) Filter the solution using a 1 μm titanium rod to remove carbon particles. The decarburized salt solution is adjusted to 14.5 L with 60°C injection water, and 0.05% activated carbon for needles is added, stirred and adsorbed at 60°C for 30 minutes, and filtered with a...

Embodiment 2

[0062] Example 2: Allergen Vehicle

[0063] 1. Composition: 50mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution, 0.5g / 100ml sodium chloride, 0.4g / 100ml phenol, 0.03g / 100ml human albumin, pH7.0, the specification of the injection is 1.8 ml / bottle.

[0064] 2. Preparation method:

[0065] 1) Weigh 72.85g disodium hydrogen phosphate (0.512mol), 28.44g sodium dihydrogen phosphate (0.237mol), 75g sodium chloride, 60g phenol, dissolve in 2L 60°C water for injection, and dilute to 60°C water for injection 8L;

[0066] 2) When the temperature drops to 30°C, add 0.2% activated carbon for needles, and stir at 30°C for 30 minutes;

[0067] 3) Filter the solution with a 1 μm titanium rod to remove carbon particles, and dilute the decarbonized salt solution to 14.5 L with 60°C water for injection; add 0.05% activated carbon for needles, stir and adsorb at 60°C for 30 minutes, and filter with a 0.8 μm membrane , to remove activated carbon;

[0068] 4) Add 22.5m...

Embodiment 3

[0072] Example 3: Allergen Vehicle

[0073] 1. Composition: 50mM disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution, 0.5% sodium chloride, 0.4% phenol, 0.03% human serum albumin, pH6.0, the specification is 1.8ml / bottle.

[0074] 2. Preparation method:

[0075] 1) Weigh 18.96g disodium hydrogen phosphate (0.134mol), 73.98g sodium dihydrogen phosphate (0.616mol), 75g sodium chloride, and 60g phenol, dissolve them in 2L 60°C water for injection, and make up to volume with 60°C water for injection up to 8L;

[0076] 2) When the temperature drops to 30°C, add 0.2% activated carbon for needles, and stir at 30°C for 30 minutes;

[0077] 3) Then use a 1 μm titanium rod to filter the solution to remove carbon particles, and the decarburized salt solution is adjusted to 14.5 L with 60°C injection water; add 0.05% activated carbon for needles, stir and adsorb at 60°C for 30 minutes, and filter with a 0.8 μm membrane , to remove activated carbon;

[0078] 4) Add ...

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Abstract

The invention relates to an idiotoxin solvent and a preparation method thereof. The idiotoxin solvent comprises the following components of human albumin, sodium chloride, phenol and a sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution. An idiotoxin prepared by diluting the idiotoxin solvent is more stable, active protein is not easy to denaturize or be adsorbed, and thus effectiveness of idiotoxin vaccine use is improved.

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. [0003] Allergen-specific desensitization therapy has a history of more than 100 years since Noon and Freeman first used pollen extracts to treat hay fever in 1911. During this century, therapeutic allergen products have undergone a series of technological changes. From the original allergen rough infusion to standardized allergen vaccines (including modified allergens, gene recombinant allergens, etc., and different administration methods such as sublingual drops, tablets, etc.). [0004] The allergen rough infusion was initially used for the treatment of allergic diseases, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K39/35A61P37/08A61K47/02A61K47/10
Inventor 白彩明裴潇竹姜敏汤承祁任雅丽何立峰牛占坡乔秉善
Owner 北京新华联协和药业有限责任公司
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