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Deproteinized calf blood extract composition as well as injection and preparation method thereof

A calf blood and protein-removing technology, applied in the field of medicine, can solve problems such as poor process reproducibility, incomplete protein removal, and reduced medicinal value, so as to achieve good process repeatability and ensure safety and stability , which is conducive to the effect of large-scale production

Active Publication Date: 2014-11-19
哈尔滨圣泰生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These methods all have the problem of incomplete removal of protein. During clinical use, adverse reactions will occur due to the ineffective removal of miscellaneous proteins. Organic substances such as amino acids, small peptides, nucleotides, purines, etc. are polymerized into macromolecular substances. It is easy to cause allergic reactions; and when removing impurity proteins by enzymatic hydrolysis, high temperature, acid-base and other methods, there are disadvantages of destroying the original biological activity and reducing its medicinal value; in addition, the removal of impurity proteins by acid-base methods will also introduce foreign substances Source ions, which will reduce its medicinal value; in addition, due to poor process reproducibility, it is difficult to produce on a large scale

Method used

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  • Deproteinized calf blood extract composition as well as injection and preparation method thereof
  • Deproteinized calf blood extract composition as well as injection and preparation method thereof
  • Deproteinized calf blood extract composition as well as injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] The preparation method of embodiment 1 calf blood deproteinized extract

[0074] A preparation method of calf blood deproteinized extract, comprising the steps of:

[0075] a) Slowing calf blood at 35°C for 20 minutes to obtain slowed calf blood;

[0076] b) adding hydrochloric acid solution to the slowed calf blood obtained in step a) for acid precipitation, adjusting the pH to 4.0 to obtain acidified calf blood; the hydrochloric acid solution is purified water with a mass fraction of 37% Hydrochloric acid is prepared according to the volume ratio of 1:1;

[0077] c) Freeze the acidified calf blood obtained in step b) at -25°C for 24 hours, then raise the temperature to 60°C at a rate of 1°C / min, and keep the temperature at 60°C for 1 hour. After the blood is thawed, centrifuge for 12 minutes at a centrifuge speed of 15,000 rpm, collect the supernatant, and set aside;

[0078] d) adding NaOH solution with a mass fraction of 20% to the supernatant obtained in step c)...

Embodiment 2

[0083] Embodiment 2 powder injection

[0084] prescription:

[0085] Calf blood deproteinized extract 4000g

[0086] Lyoprotectant 200g

[0087] Water for injection 4000g

[0088] The lyoprotectant is composed of trehalose and PEG in a weight ratio of 3:1;

[0089] Preparation method:

[0090] a) Prepare the dosing container: rinse the dosing container with water for injection and set aside;

[0091] b) Concentrated preparation: weigh the deproteinized calf blood extract of the prescribed amount, add water for injection according to the relative density of 1.0560 for concentrated preparation, and use a hollow fiber column with a cut-off molecular weight of 5000 Daltons to deproteinize the calf blood extract. Perform pre-filtration, and then use a membrane with a cut-off molecular weight of 5,000 Daltons to perform ultrafiltration on the deproteinized calf blood extract into a dilute tank to obtain a concentrated solution for use;

[0092] c) Dilute preparation: add water...

Embodiment 3

[0110] Embodiment 3 powder injection

[0111] prescription:

[0112] Calf blood deproteinized extract 4000g

[0113] Lyoprotectant 200g

[0114] Water for injection 4000g

[0115] The lyoprotectant is composed of trehalose and PEG in a weight ratio of 3:1;

[0116] Preparation method:

[0117] a) Prepare the dosing container: rinse the dosing container with water for injection and set aside;

[0118] b) Concentrated preparation: Weigh the calf blood deproteinized extract of the prescribed amount, add water for injection according to the relative density of 1.0580 for concentrated preparation, and use a hollow fiber column with a cut-off molecular weight of 5000 Daltons to deproteinize the calf blood deproteinized extract. Perform pre-filtration, and then use a membrane with a cut-off molecular weight of 5,000 Daltons to perform ultrafiltration on the deproteinized calf blood extract into a dilute tank to obtain a concentrated solution for use;

[0119] c) Dilute preparat...

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Abstract

The invention discloses a method for preparing a deproteinized calf blood extract. The method comprises the following steps: (a) performing negative catalysis; (b) performing acid precipitation; (c) freezing at a low temperature, raising the temperature, dissolving, centrifuging, and taking the supernatant; (d) performing alkali precipitation; (e) repeating the step (c); (f) performing alcohol precipitation and centrifuging the supernatant in the step (e), and taking the supernatant; (g) performing ultrafiltration and vacuum concentration on the supernatant in the step (f), thereby obtaining concentrated ultrafiltrate; and (h) performing ultrafiltration on the concentrated ultrafiltrate in the step (g), collecting the ultrafiltrate, thereby obtaining the product. According to the preparation method, the biological activity is not damaged, exogenous ions are not introduced, and hybrid proteins in the extract can be effectively removed. The injection prepared from the deproteinized calf blood extract does not cause anaphylactic reaction, is high in safety, and can effectively treat brain cell metabolic disorder diseases such as cerebral apoplexy, cerebral trauma, cerebral insufficiency and cerebral dementia and improve the cell oxygen content and microcirculation. According to a preparation method of the injection, the quality stability and safety of a final product can be fully guaranteed, a medicinal effect of the preparation is guaranteed, and side effects of the conventional preparation are eliminated.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a deproteinized calf blood extract and its injection and preparation method. technical background [0002] Calf blood deproteinized extract water injection, formerly known as: blood activity element injection, is made from fresh calf blood or serum through deproteinization, concentration, ultrafiltration or dialysis, and contains inorganic substances and small molecular organic substances sterile aqueous solution. It 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. It is used for the treatment of brain cell metabolic disorders such as cerebral ischemia, brain dementia, traumatic brain injury and brain insufficiency. At present, some preparation processes of calf blood prote...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/14A61K47/10A61K47/36A61K47/34A61K9/19A61K9/08A61P9/10A61P25/28
Inventor 姬彦峰
Owner 哈尔滨圣泰生物制药有限公司
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