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Process for preparing calf blood protein-removed extraction injection

A preparation process and protein removal technology, which can be used in drug delivery, drug combination, cardiovascular system diseases, etc., can solve the problems of many steps, impurities, loss of active ingredients, etc., and achieve high biological activity, safe application, and resource saving. Effect

Active Publication Date: 2007-12-12
HEILONGJIANG ZBD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, calf blood deproteinized extract injection is mainly prepared by concentrating calf blood, ultrafiltration or dialysis. In the key deproteinization process, there are often many steps and a long time, so that the active ingredients are lost more
For example, CN1579420A discloses a preparation process of deproteinized calf blood extract infusion, which uses acid-base denaturation method to remove protein, and the amount of acid and alkali added is required to be accurate, which will more or less lead to acid or alkaline protein removal. Will cause other impurities and affect product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Take 200 liters of calf serum, stir for 5 minutes, filter through gauze to remove fibrin, centrifuge at 5000rpm for 2 minutes, filter with filter paper, fine filter with a 0.2μm filter membrane, perform ultrafiltration with a 10000 molecular weight ultrafilter, and then use an 8000 molecular weight ultrafilter Ultrafiltration was carried out with a filter, and the ultrafiltrate was concentrated under reduced pressure at 70°C to 22% of the original volume, which was 44 liters. Use 7% HCl to adjust the pH value to 6.5, sterilize at 100°C for 30 minutes, freeze at -10°C for 2 days, and place it slowly for 3 days to further remove impurities, use 7% HCl to adjust the pH value to 6.5, and use a 6000 molecular weight ultrafilter Perform ultrafiltration to remove macromolecular impurities, perform sterilizing filtration through a 0.2 μm filter membrane and a sterile sleeve, fill, and sterilize to obtain the product.

Embodiment 2

[0019] Take 500 liters of calf serum, stir for 10 minutes, filter through gauze to remove fibrin, centrifuge at 10,000 rpm for 1 minute, filter with filter paper, fine filter with a 0.45 μm filter membrane, ultrafilter with a 20,000 molecular weight ultrafilter, and then use a 5,000 molecular weight ultrafilter Ultrafiltration was carried out with a filter, and the ultrafiltrate was concentrated under reduced pressure at 50°C to 18% of the original volume, which was 90 liters. Adjust the pH value to 7.5, sterilize at 100°C for 30 minutes, freeze at -18°C for 1 day, and place it slowly for 15 days to further remove impurities, adjust the pH value to 5.5, and perform ultrafiltration with a 5000 molecular weight ultrafilter to remove macromolecular impurities. 0.45μm filter membrane fine filter and sterile sleeve for sterilizing filtration, filling and sterilizing, ready to use.

Embodiment 3

[0021] Take 400 liters of calf serum, stir for 8 minutes, filter through gauze to remove fibrin, centrifuge at 8000 rpm for 2 minutes, filter with filter paper, fine filter with a 0.65 μm filter membrane, perform ultrafiltration with a 15000 molecular weight ultrafilter, and then use a 6000 molecular weight ultrafilter Ultrafiltration was carried out with a filter, and the ultrafiltrate was concentrated under reduced pressure below 70°C to 20% of the original volume, which was 80 liters. Adjust the pH value to 7, sterilize at 100°C for 30 minutes, freeze at -15°C for 1 day, place it slowly for 8 days, further remove impurities, adjust the pH value to 6, and perform ultrafiltration with an ultrafilter with a molecular weight of 8000 to remove macromolecular impurities. 0.3μm filter membrane fine filter and sterile sleeve for sterilizing filtration, filling and sterilizing, ready to use.

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PUM

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Abstract

The invention relates to albumen removed extraction of calf blood for injection and its preparing process comprising the steps of, mixing, straining, removing water-insoluble proteins, centrifuging, filtering, fine filtering, hyperfiltrating, decompression concentrating, adjusting pH to 6.5-7.5, sterilizing, freezing, adjusting pH to 5.5-6.5, carrying out hyperfiltration filtering, degerming, loading and sterilizing.

Description

technical field [0001] The invention belongs to the field of medical biochemical drugs, and in particular relates to a preparation process of calf blood deproteinized extract injection. Background technique [0002] The "calf blood deproteinized extract" extracted from calf blood is a small molecule biologically active substance, containing small molecule polypeptides, amino acids, nucleotides and other substances. Calf blood deproteinized extract injection can enhance the uptake and utilization of oxygen and glucose by tissue cells, improve the hypoxic state of cells and the internal environment of the body, increase the blood flow of the heart, brain, liver and other organs, and improve microcirculation. In the case of low blood oxygen and increased energy demand, it can promote energy metabolism and increase blood supply. [0003] At present, calf blood deproteinized extract injection is mainly prepared by concentrating calf blood, ultrafiltration or dialysis. In the key...

Claims

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Application Information

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IPC IPC(8): A61K35/14A61K9/08A61P9/10A61P39/00
Inventor 方同华
Owner HEILONGJIANG ZBD PHARMA