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Production process of human immune globulin for intravenous injection

An immunoglobulin and production process technology, applied in the field of production process from protein stock solution to finished product, can solve the problems of difficult control of finished product quality, product contamination, impact on safety, etc.

Inactive Publication Date: 2007-12-19
陆荣政
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the existing Pharmacopoeia records, the production process from protein stock solution to finished product has not been made public. In practice, the specific processes adopted by various manufacturers are quite different. It is difficult to control the quality of the finished product, which is likely to cause pollution of the product itself and directly affect its safety. sex

Method used

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  • Production process of human immune globulin for intravenous injection
  • Production process of human immune globulin for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A production process of human immunoglobulin for intravenous injection according to the present invention, as shown in Figure 1, includes collecting healthy human plasma as a raw material according to the requirements of Pharmacopoeia, adopting low-temperature ethanol protein separation method to prepare human immunoglobulin stock solution, and pressing the finished product Specification preparation, verification, the production process from protein stock solution to finished products with protein concentration of 5% and 10% includes the following steps:

[0025] A) Concentrate the protein stock solution by ultrafiltration to a concentration of 5.5%±0.5%, add maltose to a content of 10%±1%, and adjust the pH value of the protein solution to 3.8-4.4 with 1M / L HCl;

[0026] B) Filter the protein solution through a 0.2 μm sterile filter element, and put it into a sealed serum bottle;

[0027] C) placed in a low pH incubation room, and incubated at a low pH of 24°C ± 1°C fo...

Embodiment 2

[0032] A production process of human immunoglobulin for intravenous injection according to the present invention, as shown in Figure 2, includes collecting healthy human plasma as a raw material according to the requirements of the Pharmacopoeia, and preparing human immunoglobulin stock solution by using low-temperature ethanol protein separation method, according to the specifications of the finished product Preparation, verification, and the production process from protein stock solution to finished products with protein concentration of 5% and 10% include the following steps:

[0033] A) Concentrate the protein stock solution by ultrafiltration to a concentration of 10.5±0.5% or 5.5±0.5%, add maltose to a content of 10%±1%, and adjust the pH value of the protein solution to 3.8-4.4 with 1M / L HCl;

[0034] B) Filter the protein solution through a 0.2 μm sterile filter element, and put it into a sealed serum bottle;

[0035] C) Place it in a low pH incubation room, and incuba...

Embodiment 3

[0039] Example 3: Detection of 5% and 10% intravenous human immunoglobulin products

[0040] In Example 1 and Example 2, the quality standards of 5% and 10% intravenous human immunoglobulin are the same, see Table 1 and Table 2 below.

[0041] Table 1: List of Quality Standards for 5% Intravenous Human Immunoglobulin Finished Products

[0042] Test items

[0043] Bovine, anti-pig, anti-goat sera do not produce precipitation lines. Immunoelectrophoresis, Master

[0044] Table 2: List of Quality Standards for 10% Intravenous Human Immunoglobulin Finished Products

[0045] Test items

[0046] anti-HBs

[0047] The following three batches of 5% intravenous human immunoglobulin products were selected for quality inspection, and these products were prepared by the production process described in Example 1 or Example 2 respectively.

[0048] Table 3: Quality Inspection Report of 5% Intravenous Human Immunoglobulin

[0049] (batch number ...

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Abstract

The present invention relates to production process of human immune globulin for intravenous injection with raw protein liquor. The raw protein liquor is first diluted and added with certain amount of maltose as the stabilizer, and then virus deactivated and eliminated to obtain two types of human immune globulin product for intravenous injection in the human immune globulin concentration of 5 % and 10 % separately. The production process has easy operation and saving in maltose, and the products has high safety.

Description

technical field [0001] The invention relates to the production process of human immunoglobulin for intravenous injection, especially the production process from protein stock solution to finished product. Background technique [0002] Human immunoglobulin for intravenous injection (referred to as "human immunoglobulin for intravenous injection") is isolated and purified from healthy human plasma by low-temperature ethanol protein separation method or other approved separation methods to remove anti-complement activity and undergo virus inactivation treatment, produced biological products. The manufacture and verification of this product are recorded in the 2005 edition of the Chinese Pharmacopoeia. According to the existing Pharmacopoeia records, the production process from protein stock solution to finished product has not been made public. In practice, the specific processes adopted by various manufacturers are quite different. It is difficult to control the quality of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K1/36A61K35/16
Inventor 陆荣政
Owner 陆荣政
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