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Calf blood deproteinized extract composition and its injection and preparation method

A technology for calf blood and protein removal, applied in the field of medicine, can solve the problems of poor process reproducibility, incomplete protein removal, destruction of biological activity, etc., to achieve good process repeatability, ensure safety and stability, simple craftsmanship

Active Publication Date: 2017-10-20
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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  • Calf blood deproteinized extract composition and its injection and preparation method
  • Calf blood deproteinized extract composition and its injection and preparation method
  • Calf blood deproteinized extract composition and its injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[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...

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 ratio of parts by weight 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 preparatio...

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 ratio of parts by weight 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) Dil...

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Abstract

The invention discloses a method for preparing a protein-free extract of calf blood, which comprises the following steps: a) slowing down; b) acid precipitation; c) low-temperature freezing, heating up for dissolution, centrifugation, and supernatant; d) alkali precipitation ; e) repeating c) step; f) ethanol precipitation and centrifugation of the supernatant of step e), and taking the supernatant; g) ultrafiltration and vacuum concentration of the supernatant of step f) to obtain concentrated ultrafiltrate; h) ultrafiltering the concentrated ultrafiltrate in step g), and collecting the ultrafiltrate to obtain. The preparation method provided by the present invention neither destroys biological activity nor introduces exogenous ions, and can effectively remove impurities therein; the injection prepared from the deproteinized calf blood extract will not cause allergic reactions and is safe. High, can effectively treat brain cell metabolic disorders such as stroke, traumatic brain injury, brain insufficiency and brain dementia, improve cellular oxygen content and microcirculation; the preparation method of the injection can fully guarantee the quality stability and safety of the final product , to ensure the medicinal effect of the preparation, and to eliminate the side effects of the existing preparation.

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