Hand-foot-and-mouth disease resistant human immunoglobulin, and preparation and using methods and application thereof

An immunoglobulin, hand, foot and mouth technology, applied in the direction of antiviral immunoglobulin, antiviral agents, antibodies, etc., can solve the problem that the clinical application is still a long time, and achieve the effect of product safety and reliability, satisfying supply, and significant curative effect.

Inactive Publication Date: 2011-09-21
HUALAN BIOLOGICAL ENG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are still many unresolved problems in safe and effective vaccines, and clinical application is still a long time away

Method used

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  • Hand-foot-and-mouth disease resistant human immunoglobulin, and preparation and using methods and application thereof
  • Hand-foot-and-mouth disease resistant human immunoglobulin, and preparation and using methods and application thereof

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0034] (1) Separation of components I+II+III.

[0035] Screen out 60L of raw plasma with an anti-EV71 antibody titer ranging from 1:8 to 1:16, soak and sterilize it in 75% ethanol solution for 2 to 3 minutes, rinse the surface of the plasma bag with purified water for 2 to 3 minutes, and use manual scissors Break the bags in a jacketed stainless steel tank, stirring gently. Simultaneously thaw by circulating water at 35°C. The plasma temperature was controlled at 0-2°C during the whole thawing process. Use 0.9% sodium chloride solution to adjust the plasma protein content to 50g / L, adjust the pH of the product to 5.7-6.3 with acetic acid / sodium acetate buffer solution with pH 4.0, stir and add 95% ethanol below -15°C to make the protein solution The final concentration of ethanol is 20%, the final temperature is controlled at -4~-6°C, and the reaction is stirred for 2 hours, and the filter aid diatomite and perlite are respectively added to the protein solution at 2 g / L, and...

specific Embodiment 2

[0054] (1) Separation of components I+II+III.

[0055] Screen out 50L of raw plasma with an anti-EV71 antibody titer of not less than 1:64, soak and disinfect in 75% ethanol solution for 2 to 3 minutes, rinse the surface of the plasma bag with purified water for 2 to 3 minutes, break the bag with manual scissors In a jacketed stainless steel tank, stir gently. Simultaneously thaw by circulating water at 20°C. The plasma temperature was controlled at 0-2°C during the whole thawing process. Use 0.9% sodium chloride solution to adjust the plasma protein content to 40g / L, adjust the pH of the product to 5.7 with acetic acid / sodium acetate buffer solution with pH 4.0, stir and add 95% ethanol below -15°C to make the ethanol in the protein solution final The concentration is 19%, the final temperature is controlled at -4~-6°C, and the reaction is stirred for 2 hours. The filter aid perlite is added to the protein solution at 5g / L, and the reaction is continued for 1 hour, and then...

specific Embodiment 3

[0071] (1) Separation of components I+II+III.

[0072] Screen out 70L of raw plasma with an anti-EV71 antibody titer ranging from 1:16 to 1:32, soak and sterilize it in 75% ethanol solution for 2 to 3 minutes, rinse the surface of the plasma bag with purified water for 2 to 3 minutes, and use manual scissors Break the bags in a jacketed stainless steel tank, stirring gently. Simultaneously thaw by circulating water at 20°C. The plasma temperature was controlled at 0-2°C during the whole thawing process. Use 0.9% sodium chloride solution to adjust the plasma protein content to 55g / L, adjust the pH of the product to 6.3 with acetic acid / sodium acetate buffer solution with pH 4.0, stir and add 95% ethanol below -15°C to make the ethanol in the protein solution final The concentration is 22%, the final temperature is controlled at -4~-6°C, and the reaction is stirred for 2 hours, and the filter aid diatomaceous earth is added to the protein solution at 10g / L, and the reaction is...

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Abstract

The invention relates to a hand-foot-and-mouth disease resistant human immunoglobulin, and preparation and using methods and application thereof in pharmacy. The preparation method comprises the following steps of: separating component I+II+III, I+III and II precipitates in turn by using a low-temperature methanol protein separation method; performing pasteurization on a component II precipitate; refining and purifying; performing dealcholization; preparing; and sterilizing, packaging and performing low-pH incubated inactivation. The product has antibody titer of not less than 1:640 for enteroviruses (including one or more of coxsackie virus, Echo and EV71), the immunoglobulin content is not less than 95.0 percent of the total protein content, and the sum of IgG monomer and dimer is not less than 95 percent; and the using method is that a specific antibody with titer of 160,000-320,000 is intravenously infused. The invention is suitable for industrial production; and the product has high-titer enterovirus resistant specificity, is safe and reliable, and can become an effective medicine for treating the hand-foot-and-mouth disease.

Description

technical field [0001] The invention relates to a therapeutic blood product in the field of biomedicine and a preparation method thereof, in particular to an anti-hand, foot and mouth patient immunoglobulin and its preparation, use and application. Background technique [0002] Hand-foot-mouth disease (HFMD) is one of the most prevalent infectious diseases in infants and young children in recent years. It is mainly caused by one or more of Coxsackie virus (Cox), echo virus (Echo), enterovirus type 71 (EV71). The early pathogen of the disease was mainly CoxA16 type, and the EV71 virus was first isolated and confirmed for the first time in 1969 from fecal samples of infants with central nervous system diseases in California. Since then, HFMD has spread in many countries and regions, such as Australia, Sweden, Japan, Bulgaria, Hungary, Malaysia, Singapore, inland China, Hong Kong and Taiwan. Among them, there were 3 major epidemics: (1) 1975 Bulgaria pandemic, a total of 705 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/10C07K1/22C07K1/14A61K39/42A61P31/14
Inventor 马小伟梁雪爽安文琪张勇朝王鹏张霞赵东升杨再维冯云安
Owner HUALAN BIOLOGICAL ENG INC
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