Human immunoglobulin resisting hand-foot-and-mouth disease and preparation method of human immunoglobulin

An immunoglobulin, hand, foot and mouth technology, applied in the preparation method of antiviral immunoglobulin, immunoglobulin, peptide, etc., can solve the problem of low specificity, achieve good specificity, strong operability, improve filtration effect of effect

Active Publication Date: 2016-06-15
哈尔滨派斯菲科生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there is no clinical vaccine or specific and efficient antiviral drug to prevent EV71 virus infection. Intravenous injection of human immunoglobulin (IVIG) can effectively resist the occurrence and development of inflammation, and it is effective for patients infected with hand, foot and mouth disease. Certain therapeutic effect, but not strong specificity

Method used

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  • Human immunoglobulin resisting hand-foot-and-mouth disease and preparation method of human immunoglobulin
  • Human immunoglobulin resisting hand-foot-and-mouth disease and preparation method of human immunoglobulin
  • Human immunoglobulin resisting hand-foot-and-mouth disease and preparation method of human immunoglobulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] 1. Plasma screening and collection of plasma donors:

[0058] Select plasma, and use the neutralization test method to detect the neutralization titer of anti-hand-foot-mouth disease antibodies in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:80; the protein content (detected by the biuret method) is greater than or equal to 55g / L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method is negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibodies, and HCV antibodies. Frozen storage at low temperature below -20℃, and the shelf life is not more than 2 years.

[0059] 2. Neutralization experiment method to determine antibody titer in raw plasma:

[0060] (A) Pre-dilute the plasma sample with the cell maintenance solution (DMEM cell culture medium containing 3% fetal bovine serum), inactivate it at 56°C for 30 minutes, and then continue to dilute it by 10 times, namely The ...

Embodiment 2

[0089] 1. Plasma screening and collection of plasma donors:

[0090] Select plasma, and use the neutralization test method to detect the neutralization titer of anti-hand-foot-mouth disease antibodies in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:80; the protein content (detected by the biuret method) is greater than or equal to 55g / L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method is negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibodies, and HCV antibodies. Frozen storage at low temperature below -20℃, and the shelf life is not more than 2 years.

[0091] 2. Neutralization experiment method to determine antibody titer in raw plasma:

[0092] (A) Pre-dilute the plasma sample with the cell maintenance solution (DMEM cell culture medium containing 3% fetal bovine serum), inactivate it at 56°C for 30 minutes, and then continue to dilute it by 10 times, namely The ...

Embodiment 3

[0113] 1. Plasma screening and collection of plasma donors:

[0114] Select plasma, and use the neutralization test method to detect the neutralization titer of anti-hand-foot-mouth disease antibodies in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:80; the protein content (detected by the biuret method) is greater than or equal to 55g / L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method is negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibodies, and HCV antibodies. Frozen storage at low temperature below -20℃, and the shelf life is not more than 2 years.

[0115] 2. Neutralization experiment method to determine antibody titer in raw plasma:

[0116] (A) Pre-dilute the plasma sample with the cell maintenance solution (DMEM cell culture medium containing 3% fetal bovine serum), inactivate it at 56°C for 30 minutes, and then continue to dilute it by 10 times, namely The ...

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Abstract

The invention relates to human immunoglobulin resisting the hand-foot-and-mouth disease and a preparation method of the human immunoglobulin. The hand-foot-and-mouth virus-neutralizing antibody titer is larger than or equal to 1:800. The preparation method comprises steps as follows: (1) efficient positive plasma with the hand-foot-and-mouth virus-neutralizing antibody titer larger than or equal to 1:80 is screened; (2) the screened efficient positive plasma is mixed; (3) the mixed plasma is separated with a low-temperature ethanol filter pressing method, immunoglobulin components II are purified and separated with an ion-exchange column chromatography method, and the immunoglobulin with the purity ranging from 98.5% to 100% is obtained through filtration, chromatography, ultrafiltration, preparation, incubation of inactivated viruses at low pH, virus removal through nanofilm filtration and subpackaging. By means of the preparation and production method, the hand-foot-and-mouth virus-neutralizing antibody titer, the purity and the recovery rate are high, enteroviruses can be treated in a targeted manner, and the human immunoglobulin is an effective medicine for treating an enterovirus infectious disease, is safe and reliable and has higher social benefits and economic benefits.

Description

Technical field [0001] The invention relates to therapeutic blood products in the field of biopharmaceuticals, in particular to an immunoglobulin resistant to hand-foot-mouth patients and a preparation method thereof. Background technique [0002] EV71 virus belongs to the enterovirus genus of Parvoviridae. It is a single-stranded positive-stranded RNA virus. It is mainly composed of Coxsackie virus (Cox), Echo virus (Echo), enterovirus 71 (EV71) or Several causes. The early pathogen of the disease is mainly CoxA16 type. In 1969, researchers isolated enterovirus 71 (EV71) from stool samples of infants suffering from central nervous system diseases. Since 1974, the EV71 virus has had multiple outbreaks worldwide, mainly causing hand-foot-mouth disease (HFMD) and aseptic meningitis, brainstem encephalitis and poliomyelitis-like paralysis in infants (0-6 years old). A variety of diseases related to the nervous system, and pulmonary edema, pulmonary hemorrhage, and myocarditis cau...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/10C07K1/36C07K1/34C07K1/18
CPCC07K16/1009C07K2317/10C07K2317/90
Inventor 闫磊李常禄杨金平于引航陈东明杨莉孙晓东孙婷
Owner 哈尔滨派斯菲科生物制药有限公司
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