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Protein protective agent for Pasteur inactivating human intravenous immunoglobulin and inactivation method of protein protective agent

A technology of human immunoglobulin and protein, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, antibodies, etc., can solve the problem of multimer increase, achieve the effect of protecting protein and improving product quality

Active Publication Date: 2014-02-05
BANGHE PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The invention provides a protein protectant for pasteurized inactivated intravenous injection of human immunoglobulin and its inactivation method, which solves the problem of increased multimers after the product is heated in the existing inactivation process of human serum albumin question

Method used

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  • Protein protective agent for Pasteur inactivating human intravenous immunoglobulin and inactivation method of protein protective agent
  • Protein protective agent for Pasteur inactivating human intravenous immunoglobulin and inactivation method of protein protective agent
  • Protein protective agent for Pasteur inactivating human intravenous immunoglobulin and inactivation method of protein protective agent

Examples

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Comparison scheme
Effect test

Embodiment 1

[0045] A pasteurized inactivation method for intravenous injection of human immunoglobulin, comprising the following steps:

[0046] First, add protein protectant to the intravenous human immunoglobulin solution before inactivation, then adjust the protein content of the sample to 40g / L-60g / L, pH value 4.7-5.3, stir for 30 minutes, and put it in a water bath at 60°C±1°C When the temperature of the solution reaches 60°C, keep the solution temperature at 60°C±0.5°C for 10 hours to complete the inactivation of the intravenous injection of human immunoglobulin. The protein protectant includes 60g / L sucrose and 30g / L arginine L, glycine 40g / L and sorbitol 250g / L. After inactivation, take it out and measure the change of polymers before and after heating. The determination method is determined according to the "Chinese Pharmacopoeia" 2010 edition three appendix VI R "Human immunoglobulin products IgG monomer plus dimer determination method". The measured multimer change content was...

Embodiment 2

[0048] A pasteurized inactivation method for intravenous injection of human immunoglobulin, comprising the following steps:

[0049] First, add protein protectant to the intravenous human immunoglobulin solution before inactivation, then adjust the protein content of the sample to 40g / L-60g / L, pH value 4.7-5.3, stir for 30 minutes, and put it in a water bath at 60°C±1°C In the process, when the temperature of the solution reaches 60°C, keep the solution temperature at 60°C±0.5°C for 10 hours to complete the inactivation of the intravenous injection of human immunoglobulin. The protein protectant includes 70g / L sucrose, 20g / L arginine L, glycine 30g / L and sorbitol 260g / L. After inactivation, take it out and measure the change of polymers before and after heating. The determination method is determined according to the "Chinese Pharmacopoeia" 2010 Edition Three Appendix VI R "Human Immunoglobulin Products IgG Monomer Plus Dimer Determination Method"; The multimer change content...

Embodiment 3

[0051] A pasteurized inactivation method for intravenous injection of human immunoglobulin, comprising the following steps:

[0052]First, add protein protectant to the intravenous human immunoglobulin solution before inactivation, then adjust the protein content of the sample to 40g / L-60g / L, pH value 4.7-5.3, stir for 30 minutes, and put it in a water bath at 60°C±1°C In the process, when the temperature of the solution reaches 60°C, keep the solution temperature at 60°C±0.5°C for 10 hours to complete the inactivation of the intravenous injection of human immunoglobulin. L, glycine 20g / L 1 and sorbitol 240g / L. After inactivation, take it out and measure the change of polymers before and after heating. The determination method is determined according to the "Chinese Pharmacopoeia" 2010 Edition Three Appendix VI R "Human Immunoglobulin Products IgG Monomer Plus Dimer Determination Method"; The multimer change content was 1.98%, and the multimer change content before inactivati...

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Abstract

The invention provides a protein protective agent for Pasteur inactivating human intravenous immunoglobulin and an inactivation method of the protein protective agent. A Pasteur inactivation method of human intravenous immunoglobulin comprises the following steps of adding the protein protective agent to a human intravenous immunoglobulin solution before inactivating; adjusting the content of sampled protein to be 40 to 60g / L, and adjusting pH (Potential of Hydrogen) to be 4.7 to 5.3; agitating for 30 minutes; transferring into a water bath under 60+ / - 1 DEG C; maintaining the solution at temperature of 60+ / -0.5 DEG C for 10 hours after the solution temperature reaches 60 DEG C, thus accomplishing the inactivation of human intravenous immunoglobulin, wherein the protein protective agent is saccharose, arginine, glycine and sorbitol which are respective 50 to 70g / L, 20 to 40g / L, 30 to 60g / L and 240 to 260g / L in final content. According to the protein protective agent, simple sorbitol is used as the protective agent, the content of a polymer is decreased from 4.12% to 1.96%, thus the protein can be protected well, and the product quality can be improved.

Description

technical field [0001] The invention provides a protein protectant and its inactivation method, especially a protein protectant for pasteurized inactivation of intravenous human immunoglobulin and its inactivation method. Background technique [0002] Human immunoglobulin is a group of proteins with antibody activity. After infusion, it can rapidly increase the IgG level in the recipient's blood, and enhance the body's anti-infection ability and immune regulation function. Since the raw material for intravenous injection of human immunoglobulin is healthy human plasma, although various detection reagents are used to screen plasma for plasma donors and a 90-day quarantine period system was implemented in 2007, which greatly protects patients from the risk of virus attack, they are still affected by the virus. The sensitivity of plasma screening reagents and technical limitations, and the potential threat of unknown viruses. Therefore, in the production process of blood produ...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K39/395
Inventor 张南时凯周素静肖灿华
Owner BANGHE PHARMA CO LTD
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