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Calf spleen extract injection prepared by inphase opposition column chromatography and preparation thereof

A technology for extracts and injections, which is applied to the preparation of calf spleen extract injections by reversed-phase column chromatography and the field of preparation, can solve the problems of affecting the efficacy of medicines, unstable pharmacological activity, occurrence of allergic reactions, etc., and reduce production. Process flow, reduced impurity content, less toxic and side effects

Active Publication Date: 2011-02-16
吉林敖东洮南药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the calf spleen extract injection products currently on the market have many impurities, sometimes allergic reactions occur, and the pharmacological activity is unstable, which affects the efficacy of the drug.

Method used

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  • Calf spleen extract injection prepared by inphase opposition column chromatography and preparation thereof
  • Calf spleen extract injection prepared by inphase opposition column chromatography and preparation thereof
  • Calf spleen extract injection prepared by inphase opposition column chromatography and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 1. Take calf spleen extract injection 200ml, load it on an anion exchange column for reverse phase chromatography (DEAE cellulose);

[0038] 2. The balance solution is 5-20mmol / ml, pH5-7 phosphate buffer;

[0039] 3. Collect activity peaks that have the effect of increasing white blood cells.

Embodiment 2

[0041] 1. Take calf spleen extract injection 200ml, load it on a 400ml macroporous weakly basic acrylic anion exchange resin chromatography column (D311) for reverse phase chromatography;

[0042] 2. The balance solution is 10mmol / ml phosphate buffer solution with pH 5-7;

[0043] 3. Collect activity peaks that have the effect of increasing white blood cells. See figure 2 .

Embodiment 3

[0045] 1. Take calf spleen extract injection 100ml, and load the sample on 250ml 330 weakly basic epoxy anion exchange resin chromatography column;

[0046] 2. The balance solution is 5-20mmol / ml, pH5-7 phosphate buffer;

[0047] 3. Collect activity peaks that have the effect of increasing white blood cells. See figure 2 .

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PUM

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Abstract

The invention discloses a calf spleen extract injection prepared by reversed-phase column chromatography and a preparation method thereof. The original calf spleen extract solution is purified by reversed-phase column chromatography with simple process, so as to remarkably improve the stability of product and the quality standard of pharmacologically active substance. The inventive method utilizes the reversed-phase column chromatography instead of conventional adsorption, elution and ion-exchange column chromatography, so as to reduce production process and meet the requirement of improving product quality standard. Compared with the prior calf spleen extract solution, the inventive product has the advantages of low toxic and side effects and low content of pigment impurities. The No.7 peak area in HPLC chromatogram is improved from 17.66% before reversed-phase chromatography to 51.82% after reversed-phase chromatography, thus indicating high unit content of effective component.

Description

technical field [0001] The invention relates to a production process of a calf spleen extract injection, in particular provides a calf spleen extract injection prepared by reverse-phase column chromatography and a preparation method thereof, belonging to the technical field of biopharmaceuticals. Background technique [0002] Many studies have confirmed that low-molecular-weight tumor suppressors widely exist in various tissue cells and body fluids in organisms, which may be specific synthesis of tissue cells or intermediate products of substance metabolism. Its structure and physical and chemical properties are different, but it plays an important role in the process of eliminating malignant transformed cells in vivo and preventing tumor occurrence and development. [0003] It has been reported in the literature that the polypeptide substances extracted from pig spleen have natural biological activity, which can not only inhibit the growth of tumors, but also stimulate the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K35/28A61P7/00A61P35/00A61K35/26
Inventor 滕利荣田晓乐张志文孟庆繁逯家辉袁利佳
Owner 吉林敖东洮南药业股份有限公司
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