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A kind of insulin aspart crystallization process

A technology of insulin aspart and crystallization, applied in the field of biomedicine, can solve the problems of affecting the quality of insulin products, difficult to effectively control the content of crystalline insulin, etc., and achieve the effect of high production efficiency

Active Publication Date: 2021-09-28
BEIJING HUIZHIHENG BIOTECHNOLOGY CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Patent CN101035557B discloses a method for crystallizing insulin aspart and its preparations. However, in this method, an alkaline solution and an acidic solution are directly mixed to prepare crystals, and it is difficult to effectively control the content of crystalline insulin in the solution.
Patent CN103342746B also discloses a stable insulin aspart crystallization method, but organic solvents are used in this method, and the residue of organic solvents will seriously affect the quality of insulin products

Method used

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  • A kind of insulin aspart crystallization process
  • A kind of insulin aspart crystallization process
  • A kind of insulin aspart crystallization process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Insulin aspart crystals were prepared as follows:

[0037] (1) Weigh insulin aspart, glycerin, phenol, m-cresol, sodium chloride, disodium hydrogen phosphate dihydrate and zinc chloride;

[0038] (2) Fully dissolve about 2.45 g of the insulin aspart with an appropriate amount of 0.1 mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 9.6 g of glycerin, 900 mg of phenol, and m-cresol 1032mg, sodium chloride 526.2mg, disodium hydrogen phosphate dihydrate 750mg; the amount of zinc chloride added to zinc is 13.72mg to obtain adjuvant solution; the insulin aspart solution is mixed with adjuvant solution, and ultrapure water Dilute to 600ml, and adjust the pH value to 7.1-7.44 with 0.5M sodium hydroxide solution;

[0039] (3) Take about 320mg of protamine sulfate, after swelling, add 1.6g of glycerin, 150mg of phenol, 172mg of m-cresol, 87.7mg of sodium chloride, 125mg of disodium hydrogen phosphate dihydrate, and use ultrapure water to prepare pro...

Embodiment 2

[0043] Insulin aspart crystals were prepared as follows:

[0044] (1) Weigh insulin aspart, glycerin, phenol, m-cresol, sodium chloride, disodium hydrogen phosphate dihydrate and zinc chloride;

[0045] (2) Fully dissolve about 2.45 g of the insulin aspart with an appropriate amount of 0.1 mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 11.2 g of glycerin, 1050 mg of phenol, and m-cresol 1204mg, sodium chloride 613.9mg, disodium hydrogen phosphate dihydrate 875mg; the amount of zinc chloride added to zinc is 13.72mg to obtain adjuvant solution; the insulin aspart solution is mixed with adjuvant solution, and ultrapure water Dilute to 600ml, and adjust the pH value to 7.1-7.44 with 0.5M sodium hydroxide solution;

[0046] (3) Take about 320mg of protamine sulfate, after swelling, use ultrapure water to prepare 100ml of protamine sulfate solution;

[0047] (4) Mix the mixed solution obtained in step (2) with the protamine sulfate solution obtaine...

Embodiment 3

[0050] Insulin aspart crystals were prepared as follows:

[0051] (1) Weigh insulin aspart, glycerin, phenol, m-cresol, sodium chloride, disodium hydrogen phosphate dihydrate and zinc chloride;

[0052] (2) Fully dissolve about 2.45 g of the insulin aspart with an appropriate amount of 0.1 mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 11.2 g of glycerin, 1050 mg of phenol, and m-cresol 1204mg, sodium chloride 613.9mg, disodium hydrogen phosphate dihydrate 1250mg; the amount of zinc chloride added to zinc is 13.72mg to obtain adjuvant solution; the insulin aspart solution is mixed with adjuvant solution, and ultrapure water Dilute to 600ml, and adjust the pH value to 7.1-7.44 with 0.5M sodium hydroxide solution;

[0053] (3) Take about 320mg of protamine sulfate, after swelling, use ultrapure water to prepare 100ml of protamine sulfate solution;

[0054] (4) Mix the mixed solution obtained in step (2) with the protamine sulfate solution obtain...

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Abstract

The invention provides a preparation method and application of insulin aspart crystal. The crystallization method of the present invention does not use organic solvents, and prepares crystals by mixing two solutions, and by optimizing the crystallization system, it contains insulin aspart, glycerin, phenol, m-cresol, sodium chloride, disodium hydrogen phosphate dihydrate, In the crystallization solution of zinc chloride and protamine sulfate, stable insulin aspart crystals were obtained. The insulin aspart crystals prepared by the method of the invention have regular shapes and uniform sizes, and the preparation method has high production efficiency and is convenient for industrial application.

Description

technical field [0001] The invention belongs to the field of biomedicine, and specifically relates to a human insulin analog and its crystallization method and application, more specifically, to a crystallization process of insulin aspart. Background technique [0002] Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia. The main feature is excessive drinking and eating but polyuria and weight loss caused by chronic hyperglycemia. The main cause of diabetes is the absolute or relative insufficiency of human insulin secretion, and / or the impairment of human body function, which leads to the impairment of insulin utilization. Diabetes leads to carbohydrate, protein and fat metabolism disorders in the human body, especially high blood sugar as the main sign, and further leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. [0003] Insulin is a protein hormone secreted by the is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/62C07K1/30
CPCC07K14/62
Inventor 曹海燕林兆生顾志强安丰伟詹巾卓黄蓉
Owner BEIJING HUIZHIHENG BIOTECHNOLOGY CO LTD
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