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Immunoglobulin for dog intravenous injection, its preparing method and the formulation thereof

A technology of immunoglobulin and injection, applied in the direction of antibodies, medical raw materials derived from mammals, anti-infective drugs, etc., can solve the problems of lack of immunoglobulin research and application literature reports, and achieve good biological adaptability and stable performance , the effect of good purity

Active Publication Date: 2009-12-16
FIELD OPERATION BLOOD TRANSFUSION INST OF PLA SCI ACAD OF MILITARY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no literature report on the research and application of intravenous immunoglobulin for dogs

Method used

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  • Immunoglobulin for dog intravenous injection, its preparing method and the formulation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1: Using low-temperature ethanol method to extract dog intravenous immunoglobulin

[0047] Described low-temperature ethanol method comprises the following steps:

[0048] 1).Melting slurry and adding ethanol

[0049] Melt 200,000 ml of plasma that meets the raw material requirements quickly at 37°C, and put it into a reaction tank under a sterile environment; gradually cool down to 0°C while stirring, and adjust the pH to 7.2 with acetic acid buffer with a pH of 4.0 Add 53.3% ethanol that is pre-cooled to -15°C--20°C while stirring, until the final concentration of ethanol volume is 8% (adding ethanol slowly, based on 100,000 ml of plasma, add 400-500ml per minute, 2-3 After the addition was completed), the temperature was maintained at -2°C--3°C. After the addition was completed, the stirring was continued for 1 hour, and the mixture was allowed to stand for 2 hours.

[0050] 2). Remove impurities

[0051] Use a continuous centrifuge to centrifuge, the temp...

Embodiment 2

[0057] Example 2: Using rivanol combined with low-temperature ethanol method to extract dog intravenous immunoglobulin

[0058] 1) Melt slurry and adjust pH

[0059] Melt 200,000 ml of plasma that meets the raw material requirements quickly at 37°C, and put it into a reaction tank under a sterile environment; slowly add Na at a concentration of 1% while stirring 2 CO 3 , adjust the pH to 8.5±0.1.

[0060] 2).Removal of albumin

[0061] Take canine plasma and add it to the reaction tank. Under stirring, add 2% rivanol equal to the volume of plasma to the reaction tank, stop stirring after adding, let it stand for 2 hours, take the supernatant and add 2% activated carbon, and stir for 30 minutes , let stand for 1 hour, pass through a B-3 plate, and collect the filtrate overnight.

[0062] 3). Precipitate immunoglobulin

[0063] The filtrate in step 2) was cooled to 0°C, 25% NaCl solution was added to a final concentration of 1%, 0.5mol / L acetic acid buffer was adjusted to p...

Embodiment 3

[0066] Example 3: Preparation of dog intravenous immunoglobulin preparation-maltose injection

[0067] On the basis of Example 1 or Example 2, continue the following steps: In Step 4) of Example 3, concentrate the solution, add maltose to 10%, and then sterilize and subpackage to obtain a protein content of 5% with added maltose Protective agent for intravenous immunoglobulin injection in dogs.

[0068] Using the same method, change the amount of maltose added, so that the content of maltose is changed at any desired concentration between 5% and 10%, so that the content of immunoglobulin is between 1% and 15%, and the concentration of maltose is between 5% and 10%. % of dogs received intravenous immunoglobulin injection.

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Abstract

The present invention relates to immunoglobulin for intravenous injection of dog, and its preparation process and preparations. Through low temperature ethanol process or rivanol combined low temperature ethanol process, blood plasma or serum from health dog is separated to prepare immunoglobulin with pH 3.0-5.4 and purity over 95 % for intravenous injection of dog. The said immunoglobulin is further compounded into immunoglobulin injection with protein content of 1-15 % and containing one or two kinds of protecting agents of 5-15 % maltose, 5-10 % glucose and 3-10 % glucose salt solution.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a canine intravenous immunoglobulin, a preparation method thereof and a canine intravenous immunoglobulin preparation. Background of the invention [0002] Pets are becoming more and more important in people's daily life, and pet health care has become an important topic. Dog blood products are biological products separated and extracted from canine plasma, also known as plasma derivatives. Such products are used for the treatment of canine diseases or passive immunization. [0003] One of the above-mentioned biological products is immunoglobulin (Ig), which is an important part of the body's immune system and plays an extremely important role in defense against infection and immune regulation. [0004] In terms of the way of use, immunoglobulin and immunoglobulin preparations are generally divided into two categories: intramuscular injection immunoglobulin (IMIG) and intravenous i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K35/16A61P37/02A61P31/00
Inventor 章金刚孙文种赵宝全王建国吕茂民熊景峰杨姝王晓菲
Owner FIELD OPERATION BLOOD TRANSFUSION INST OF PLA SCI ACAD OF MILITARY
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