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Deporteinnized calf serum injection and its preparing method

A technology for calf serum and injection, which is applied in the directions of pharmaceutical formulations, drug delivery, freeze-drying delivery, etc., can solve the problems of loss of active ingredient blood polypeptides, effective removal of unfavorable impurities, and more loss of active ingredients, and achieve the content of active ingredients. High, beneficial to clinical use, the effect of reducing impurity content

Inactive Publication Date: 2007-01-24
赵红梅
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, calf blood deproteinized extract is mainly prepared by concentrating calf blood, ultrafiltration or dialysis. In the key deproteinization process, there are often many steps and long time, so that the active ingredients are lost more
For example CN1569030A and CN1579420 all disclose a kind of preparation technology of deproteinized extract of calf blood, wherein need prepare under stronger acidity (for example pH3) and stronger alkaline (for example pH10) condition, will make wherein Serious loss of active ingredient blood peptides, not only is not conducive to the effective removal of impurities, but also may introduce new impurities, so the products prepared in this way are difficult to use clinically

Method used

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  • Deporteinnized calf serum injection and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Collect a total of 10 liters of venous blood from a 6-month-old calf, centrifuge the calf venous blood at 4000 rpm for 20 minutes at 4°C, add 30 grams of sodium citrate to the supernatant, stir well, and store at 4°C Refrigerate overnight, skim off the surface oil film, put into a centrifuge tube and centrifuge at 3000rpm for 15min, separate the blood cells, filter out the upper layer of plasma with double-layer gauze to obtain about 9.5 liters; the plasma is passed through a beaded chitosan column (blood volume: The amount of chitosan is 10:1), and the flow rate is controlled at 3ml / min.cm 2 , wash the column with 500ml of distilled water until the effluent is colorless to obtain 10 liters of chromatographic solution; add 10 liters of 95% ethanol to the chromatographic plasma under stirring, stir for 15 minutes, put into a centrifuge tube, and centrifuge at a speed of 5000 rpm for 15 minutes. Remove the protein precipitate; the supernatant was decompressed with a vacuu...

Embodiment 2

[0035] Collect 15 liters of venous blood from a 6-month-old calf, centrifuge the calf blood or serum at 3000 rpm for 30 minutes at 5°C, add 45 grams of sodium citrate to the supernatant, stir well, and refrigerate overnight at 4°C. After skimming off the surface oil film, pack into a centrifuge tube and centrifuge at 3000rpm for 15min to separate the blood cells, filter out the upper layer of plasma with double-layer gauze to obtain about 14.2 liters; The volume is 10:1), the flow rate is controlled at 2ml / min.cm 2 , wash the column with 800ml of distilled water from the top until the effluent is colorless to obtain 15 liters of chromatographic solution; add 30 liters of 96% ethanol to the chromatographic plasma under stirring, stir for 15min, put it into a centrifuge tube, and centrifuge at a speed of 5000rpm After 15 minutes, remove the protein precipitate; the supernatant was decompressed with a vacuum rotary evaporator at 37°C to recover 30 liters of ethanol, transferred t...

Embodiment 3

[0037] Collect 20 liters of venous blood from a 6-month-old calf, centrifuge the calf venous blood at 5000 rpm for 30 minutes at 5°C, add 60 grams of sodium citrate to the supernatant, stir well, refrigerate overnight at 4°C, skim After removing the surface oil film, put into a centrifuge tube and centrifuge at 4000rpm for 10min to separate the blood cells, and filter out the upper layer of plasma with double-layer gauze to obtain about 19 liters; 10:1), the flow rate is controlled at 1.2ml / min.cm 2 , wash the column with 1000ml of distilled water from the top until the effluent is colorless, and obtain 20 liters of chromatographic solution; add 30 liters of 80% ethanol to the chromatographic plasma under stirring, stir for 15 minutes, put it into a centrifuge tube, and centrifuge at a speed of 5000rpm 15min, remove the protein precipitation; use a vacuum rotary evaporator to depressurize the supernatant and recover 30 liters of ethanol at 37°C, transfer the distillate to a hy...

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Abstract

The present invention discloses a kind of deproteinized calf serum injection and its preparation process. Of the deproteinized calf serum injection, each milliliter contains solid 0.035-0.055 g, free amino acid 0.6-1.5 mg, and polypeptide 0.4-3.0 mg. The injection of the present invention has bacterial endotoxin content lower than 1 EU, and has pH value of 6.0-8.0. The injection has high effective component content, high bioactivity, high purity and low impurity content. Tests show that the injection of the present invention has high clinical curative effect, no any toxic side effect and no allergic reaction.

Description

technical field [0001] The invention relates to an injection, in particular to a deproteinized calf serum injection and a preparation method thereof, belonging to the field of medicines. Background technique [0002] Calf blood deproteinized extract (serotonin) has been popularized and applied all over the world for 50 years since it was successfully developed by Sugao Pharmaceutical Factory in Switzerland in 1955. Its injection contains 40-50 mg calf blood deproteinized extract per milliliter, 30% of which are amino acids, sugars, ketoacids, purines, nucleotides and oligopeptides with a relative molecular weight of 2500-3000, 70% is an inorganic component. Calf blood deproteinized extract can significantly improve the activity of reticuloendothelial system, increase enzyme activity, accelerate cell oxidative phosphorylation reaction and ATP synthesis, activate cell respiration, promote metabolism, and accelerate tissue regeneration. Clinically, it is mainly used to treat ...

Claims

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Application Information

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IPC IPC(8): A61K35/16A61K9/08A61K9/19A61P25/28
Inventor 郭东宇
Owner 赵红梅
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