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A kind of preparation method of insulin glargine and insulin glargine prepared thereof

An insulin glargine and crystallization technology, which is applied in the preparation methods of peptides, insulin, chemical instruments and methods, etc., can solve the problems of excessive residual solvent and increase the operation steps of crystal washing in the later stage, so as to achieve less impurities and solvent residues and improve production. The effect of simple rate and composition

Active Publication Date: 2019-02-01
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned prior art uses a large amount of organic solvents such as acetonitrile and ethanol, which may cause the residual solvent to exceed the standard, and increase the operation steps of crystal washing in the later stage

Method used

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  • A kind of preparation method of insulin glargine and insulin glargine prepared thereof
  • A kind of preparation method of insulin glargine and insulin glargine prepared thereof
  • A kind of preparation method of insulin glargine and insulin glargine prepared thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 A kind of preparation method of recombinant insulin glargine crystal

[0058] 1) Prepare 1L of recombinant insulin glargine crystallization solution. The components and concentrations in the crystallization solution are: recombinant insulin glargine: 2g / L; acetic acid: 0.5mol / L; zinc chloride: 70mg / L; phenol: 3g / L L; specific operation process:

[0059] Measure 250ml of recombinant insulin glargine solution with a concentration of 8g / L; measure 28.6ml of acetic acid and dilute to 250ml with water; weigh 3g of phenol and dissolve it with as little water as possible; weigh 70mg of zinc chloride and dissolve it with as little water as possible dissolve;

[0060] Add pre-prepared acetic acid solution, phenol solution and zinc chloride solution to the recombinant insulin glargine solution, add water to make the volume to 1 L, and obtain the recombinant insulin glargine crystal solution.

[0061] 2) Stir the recombinant insulin glargine crystal solution obtained ...

Embodiment 2

[0065] Example 2 A kind of preparation method of recombinant insulin glargine

[0066] 1) Prepare 1L of recombinant insulin glargine crystallization solution. The components and concentrations in the crystallization solution are: recombinant insulin glargine: 4g / L; acetic acid: 0.8mol / L; zinc chloride: 100mg / L; phenol: 5g / L L; specific operation process:

[0067] Measure 500ml of recombinant insulin glargine solution with a concentration of 8g / L; measure 45.7ml of acetic acid and dilute to 300ml with water; weigh 5g of phenol and dissolve it with as little water as possible; weigh 100mg of zinc chloride and dissolve it with as little water as possible. dissolve;

[0068] Add recombinant insulin glargine solution, acetic acid solution and zinc chloride solution to the pre-prepared phenol solution, add water to make the volume to 1 L, and obtain the recombinant insulin glargine crystal solution.

[0069] 2) Stir the recombinant insulin glargine crystal solution obtained in s...

Embodiment 3

[0073] Example 3 A kind of preparation method of recombinant insulin glargine crystal

[0074] 1) Prepare 1L of recombinant insulin glargine crystallization solution. The components and concentrations in the crystallization solution are: recombinant insulin glargine: 1g / L; acetic acid: 0.4mol / L; zinc oxide: 40mg / L; phenol: 2g / L ; Specific operation process:

[0075] Measure 125ml of recombinant insulin glargine solution with a concentration of 8g / L; measure 22.8ml of acetic acid and dilute to 150ml with water; weigh 2g of phenol and dissolve it in as little water as possible; weigh 40mg of zinc oxide and use as little as 0.1mol / L is dissolved in hydrochloric acid;

[0076] Add the recombinant insulin glargine solution, acetic acid solution and phenol solution to the pre-prepared zinc salt solution, add water to make the volume up to 1L, and obtain the recombinant insulin glargine crystal solution.

[0077] 2) Stir the recombinant insulin glargine crystal solution obtained...

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Abstract

The invention provides a preparation method of insulin glargine and insulin glargine prepared by the same. With an insulin glargine solution as a raw material, the method comprises the following steps: mixing the insulin glargine solution, an organic acid, a phenol derivative, a zinc salt and water to obtain crystalline liquid; adjusting pH to 3-4 and preserving heat for 1-8 hours at 25-35 DEG C; adjusting pH to 7.0-8.0 and cooling to 2-8 DEG C; standing for 3-5 hours; centrifuging; and separating the solid and supernate. Compared with prior art, the preparation method provided by the invention realizes higher production efficiency and product quality so as to better guarantee the long-term medication safety of the patients.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a preparation method of human insulin analogue insulin glargine and the prepared insulin glargine. Background technique [0002] Insulin glargine replaces asparagine (Asn), which is naturally arranged at position 21 on the A chain of human insulin, with glycine (Gly), and adds two arginines to threonine (Thr) at position 30 of the B chain. (Arg) synthetic human insulin analogues for adults and children with type 1 diabetes and adults with type 2 diabetes. After subcutaneous injection, the molecules will immediately polymerize and form a stable hexamer under the skin, which increases the binding force between molecules, delays the time of dissolution and absorption, and releases a small amount of insulin glargine continuously, so it has predictable and long-lasting effects. Effective, flat, peak-free plasma concentration / time profile. Because of its long-acting p...

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 张海艳孟祥成郭银汉冷春生
Owner TONGHUA DONGBAO PHARMA
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