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Preparation method of protamine sulfate

A technology of protamine sulfate and sulfuric acid solution is applied in the field of biomedicine, and can solve the problems such as the inability to meet the quality requirements of protamine sulfate, and achieve the effects of low cost, simple process and mild process.

Active Publication Date: 2012-11-28
QINGDAO KANGYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 2. Traditional production process of protamine sulfate
Using the traditional production process, its specific rotation can only reach -30°, which can no longer meet the quality requirements of the new Pharmacopoeia for protamine sulfate

Method used

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  • Preparation method of protamine sulfate
  • Preparation method of protamine sulfate
  • Preparation method of protamine sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The protamine essence of salmon is crushed, extracted with water, filtered, and the filtrate is precipitated with ethanol to obtain the crude product of protamine sulfate, which is then subjected to the following operations:

[0030] (1) Sulfuric acid extraction process

[0031] Add 601 ml of 3 volume % sulfuric acid solution to 300.5 g of protamine sulfate crude product, stir for 2 hours, filter, and take the filtrate;

[0032] The filtrate was precipitated with 1800ml of 95% ethanol. After 12 hours, discard the ethanol in the upper layer, filter the sediment in the lower layer, discard the filtrate, and weigh 60g of the solid;

[0033] (2) Heating extraction process

[0034] Add 240ml of water to the solid and stir to dissolve, continue to heat the solution to 65°C, keep it warm for 30 minutes, filter to get the filtrate, discard the filter residue, and measure the volume of the filtrate to 240ml;

[0035] Add 720ml of 95% ethanol to precipitate, discard the upper l...

Embodiment 2

[0042] The 3 volume % sulfuric acid solution in the step (1) in the embodiment 1 is changed into the 6 volume % sulfuric acid solution; The solution heating temperature of the step (2) is changed into heating to 70 ℃; The low temperature treatment in the step (3) The temperature was changed to 3° C., and the other process conditions were the same as in Example 1, and finally 26.78 g of the refined product was obtained.

Embodiment 3

[0044] The 3 volume % sulfuric acid solution in the step (1) among the embodiment 1 is changed into 9 volume % sulfuric acid solution; The solution heating temperature of step (2) is changed into heating to 75 ℃; The low temperature treatment in the step (3) The temperature was changed to 14° C., and the other process conditions were the same as in Example 1, and finally 27.06 g of the refined product was obtained.

[0045] Traditional production process:

[0046] Qingdao Kangyuan Pharmaceutical Co., Ltd.

[0047] Protamine Sulfate Finished Product Inspection Report

[0048]

[0049]

[0050] Adopt the production technique of the embodiment of the present invention 1:

[0051] Qingdao Kangyuan Pharmaceutical Co., Ltd.

[0052] Protamine Sulfate Finished Product Inspection Report

[0053] Batch number: KP110901

[0054]

[0055]

[0056] Adopt the production technique of the embodiment of the present invention 2:

[0057] Qingdao Kangyuan Pharmaceutical Co., L...

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PUM

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Abstract

The invention discloses a preparation method of protamine sulfate. According to Chinese Pharmacopoeia 2010 Edition, the quality standard of protamine sulfate is raised, and the requirement of specific rotation (-65 degrees to -85 degrees) index is increased. In sperm from fish, protamine usually exists in the form of nucleic acid-protein. By using a traditional production technology, a finished product of protamine sulfate contains nucleic acid impurity, thus the specific rotation only reaches -30 degrees that can not satisfy the quality requirement of protamine sulfate in the new pharmacopoeia. According to the invention, by extracting with 3% sulfuric acid, extracting with warm water of 50-79 DEG C, conducting alcohol deposition, conducting low temperature treatment, and using salmon milt as a raw material, the protamine sulfate is prepared, and the specific rotation reaches -72 degrees.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a process for extracting protamine sulfate by using fresh mature sperm of suitable fish as raw materials. Background technique [0002] 1. The role of protamine sulfate [0003] 1) Protamine sulfate is an indispensable and irreplaceable anti-heparin drug in cardiopulmonary bypass cardiac surgery. At the end of cardiac surgery, patients need to use protamine sulfate to relieve anticoagulation and prevent massive bleeding. "Life-saving medicine", "heart-saving medicine". [0004] 2) Protamine sulfate combines with insulin to delay the release of insulin, thereby prolonging the hypoglycemic effect of insulin, and is used to manufacture long-acting insulin. [0005] 3) Strengthen and assist in the treatment of male infertility. Research results at home and abroad show that DNA in protamine sulfate can promote cell activation and enhance reproductive ability; arginine stimulates the rele...

Claims

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Application Information

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IPC IPC(8): C07K14/46C07K1/36C07K1/34C07K1/30
Inventor 刘乃山葛翠凤刘振海刘翠珍
Owner QINGDAO KANGYUAN PHARMA