Method for preparing human immunoglobulin for intravenous injection

A technology of human immunoglobulin and intravenous injection, which is applied in the field of preparation of intravenous human immunoglobulin, can solve problems such as easy occurrence of adverse reactions, and achieve the effects of good market application prospects, high biological activity and low content of impurity factors.

Active Publication Date: 2015-03-11
GUIZHOU TAIBANG BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the content of IgA in the immunoglobulin preparation prepared by the current low-temperature ethanol process is relatively high, and patients with congenital selective IgA deficiency are prone to adverse reactions after

Method used

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  • Method for preparing human immunoglobulin for intravenous injection
  • Method for preparing human immunoglobulin for intravenous injection
  • Method for preparing human immunoglobulin for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 uses the present invention to prepare the production method of intravenous injection human immunoglobulin

[0039] 1. Experimental materials

[0040] The Cohn method component I+II+II precipitation (FI+II+II) was prepared according to the low-temperature ethanol precipitation method recorded in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0041] 2. Experimental method

[0042] In the following methods, in the steps involving stirring, the stirring frequency is 70-90 rpm / min, and the purpose of stirring is to fully mix the solution.

[0043] 2.1 Confirmation of Cohn method component Ⅰ+Ⅱ+Ⅱ precipitation (F Ⅰ+Ⅱ+Ⅱ precipitation)

[0044] 2.1.1 The original production plasma used for FⅠ+Ⅱ+Ⅱ precipitation should comply with the provisions of the "Chinese Pharmacopoeia" on the regulation of human plasma used in the production of blood products.

[0045] 2.1.2 Before starting the operation, confirm the batch numb...

experiment example 1

[0139] Experimental Example 1 Detection of the Fc segment of the intravenous injection of human immunoglobulin products of the present invention

[0140] 1. Experimental materials

[0141] 1.1 Medicine The present invention injects human immunoglobulin (5% 2.5g / bottle, batch number: 20130511, 20130512, 20130513, 20130514, 20130515, 20130516, 20130617, 20130618, 20130619), Octapharma Biological Products Co., Ltd. produces intravenous human immunoglobulin Protein 5%, batch number: C141E8532), intravenous injection of human immunoglobulin reference standard (for Fc segment function and molecular weight detection): European Medicines and Medical Quality Administration, batch number Y0001512.

[0142] 2. Detection method

[0143] Prepare the reference standard solution:

[0144] a. European reference standard solution

[0145] Adjust the pH of the reference product to 6.8-7.0 with sodium hydroxide solution, and then dilute the IgG concentration of the reference product to 40 mg / ...

experiment example 2

[0156] Experimental example 2 Detection of blood coagulation activator level of intravenous injection of human immunoglobulin products of the present invention

[0157] 1. Experimental materials

[0158] 1.1药品本发明静注人免疫球蛋白(批号:2090101、20090102、20090203、20100202、20100916、20101004、20100921、20101221、20101209、20101221、20110615、20110716、20110819、20110614、20110820),Octapharma生物制品有限公司生产 Intravenous injection of human immunoglobulin (5%, lot number: A125A853C, A140B8541, C141E8532; 10%, lot number: A105C843J, A127A8439C148A843B, B148A8444)

[0159] 1.2 Main reagents and consumables

[0160] Blood coagulation factor Ⅱ, Ⅴ, Ⅶ, Ⅸ, Ⅹ, Ⅺ, Ⅻ deficient plasma: American Pacific Company; APTT reagent: Chengdu Concord Biotechnology Center; PT reagent: Chengdu Concord Biotechnology Center; corn trypsin inhibitor (CTI): Germany Merck Calbiochem; FⅪa standard: Merck Calbiochem, Germany; thrombin fluorescent peptide substrate: Bachem, Switzerland; cephalin: American Roche diagnostics;

[0161] 1.3 Ma...

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Abstract

The invention provides a method for preparing human immunoglobulin for intravenous injection. The method comprises the following steps of a, dissolving: taking a Cohn method F II precipitation; dissolving the precipitation in water for injection; performing clarifying filtration; adjusting the pH value to 6.60+/-0.1; uniformly stirring; adjusting the electrical conductivity to 1.40+/-0.05ms/cm; adjusting the temperature to 0-5DEG C, and uniformly stirring; b, performing chromatography: purifying by using a chromatographic column of DEAE Sepharose Fast Flow, and collecting human immunoglobulin component liquid; c, performing ultrafiltration: performing ultrafiltration and dialysis on flow penetrating liquid in the step b; when the osmotic pressure is lower than 30mOs mol/kg, concentrating the treated liquid until the protein concentration is 4.0 percent+/-1 percent (w/v) to obtain concentrated solution; d, inactivating virus: adding sorbitol in the concentrated solution until the concentration is (33+/-1) percent (w/v), adjusting the pH value to 5.00+/-0.1; keeping the temperature 60+/-0.5DEG C constant for 10 hours, cooling and performing clarifying filtration; e, performing ultrafiltration and dialysis and preparing to obtain the human immunoglobulin. The human immunoglobulin prepared by the method disclosed by the invention is high in purity; an Fc segment is high in biological activity and good in quality; IgA and other impurity factors are in low in content; the method has the advantages of few side effects, high yield and good market application prospect.

Description

technical field [0001] The invention belongs to the field of blood products, in particular to a method for preparing intravenous human immunoglobulin. Background technique [0002] Intravenous injection of human immunoglobulin (pH4, hereinafter referred to as IVIG) is the immunoglobulin component extracted from the plasma of healthy people by low-temperature ethanol protein separation, and refined through further processing and virus inactivation. IVIG has dual therapeutic effects of immune replacement and immune regulation, and is widely used clinically, and has remarkable effects in the treatment of primary or acquired immunoglobulin deficiency, bacterial infection, viral infection, blood system disease, Kawasaki disease, etc. [0003] In order to ensure the curative effect of IVIG clinical treatment, it is very important to carry out strict quality control. Pharmacopoeias in Europe, the United States and my country all have corresponding regulations on the quality control...

Claims

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Application Information

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IPC IPC(8): C07K16/06C07K1/36C07K1/34C07K1/30C07K1/16
Inventor 陈云华卢斌袁诚陈艾军赵学梅袁靖刘欣晏杨刚
Owner GUIZHOU TAIBANG BIOLOGICAL PROD
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