A kind of intravenous giant cell human immunoglobulin and its preparation method

Abstract

The invention relates to intravenously injected cytomegalovirus human immune globulin and a preparation method thereof, and the titer of a cytomegalovirus neutralizing antibody of the human immune globulin is larger than or equal to 1:500. The preparation method comprises the steps that 1, positive plasma with the titer of the cytomegalovirus neutralizing antibody larger than or equal to 1:20 is screened out; 2, the screened-out efficient positive plasma is mixed; 3, the mixed plasma is separated through a low-temperature ethanol filter-pressing method, an immune globulin component II is separated and purified by combining an ion-exchange column chromatography method, viruses are removed through filtration, chromatography, ultrafiltration, preparation, low-pH incubation virus inactivation and nanofilm filtration, the immune globulin with the purity of 98.5%-100% is obtained through subpackaging, and the antibody titer is not lower than 1:500. The cytomegalovirus human immune globulin prepared through the preparation and production method is high in antibody titer, purity and recovery rate and capable of conducting targeted treatment on cytomegalovirus, is an effectively drug for treating recessive and dominant infection caused by the cytomegalovirus in people, is safe and reliable and has larger social benefits and economic benefits.

Description

technical field

[0001] The invention relates to therapeutic blood products in the field of biopharmaceuticals, in particular to a giant cell human immunoglobulin and a preparation method thereof. Background technique

[0002] Human cytomegalovirus (HCMV), also known as human herpesvirus type 5 (HHV5), belongs to the betaherpesvirus subfamily. HCMV is one of the most common pathogens of human congenital virus infection, and the infection rate of this virus in adults in my country is as high as 95%. Ordinary people are usually recessive infection, but for immunocompromised populations, such as bone marrow and solid organ transplant recipients, HIV-infected patients and tumor patients, HCMV infection can lead to serious consequences. Primary or recurrent HCMV infection in pregnant women can cause neonatal intrauterine infection or perinatal infection to invade the fetus, which can cause central nervous system involvement, multiple organ damage, mental retardation or deafness i...

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