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Preparation method of insulin aspart injection

A technology for preparing insulin aspart and drugs, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, which can solve problems such as time-consuming, limited production efficiency, and labor, and achieve increased stability. , Simplify the process steps and increase the safety effect

Active Publication Date: 2018-06-05
NANJING HANXIN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a kind of method for preparing stable insulin aspart injection, the process step of this method is simple, solves the multiple adjustment of pH value in the prior art, time-consuming, laborious, not suitable for large-scale production, restricts production Efficiency, the use of strong acid and strong base increases safety hazards and strong acid and strong base affect the stability of insulin aspart and other issues

Method used

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  • Preparation method of insulin aspart injection
  • Preparation method of insulin aspart injection
  • Preparation method of insulin aspart injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] 1. Prescription

[0047] insulin aspart

35g

glycerin

160g

phenol

15g

m-cresol

17.2g

Zinc chloride

0.196g

Sodium chloride

5.8g

Disodium phosphate

10g

[0048] 2. Solution preparation:

[0049] a): Weigh the disodium hydrogen phosphate of the prescribed amount, dissolve it with 4L of water for injection and add it to the liquid mixing tank;

[0050] b): Weigh the glycerin, phenol, m-cresol, sodium chloride, and zinc chloride of the prescribed amount, dissolve them in 1L of water for injection, and then add them to the liquid mixing tank in sequence;

[0051] c): the solution is stirred and mixed evenly;

[0052] d): Add the prescribed amount of insulin aspart powder into the liquid preparation tank while stirring, and mix and dissolve;

[0053] e): Supplement water for injection to 10L;

[0054] f): The medicinal solution is sterilized by filtering through a 0.22 μm filter membrane.

Embodiment 2

[0056] 1. Prescription

[0057] insulin aspart

35g

glycerin

160g

phenol

15g

m-cresol

17.2g

Zinc chloride

0.196g

Sodium chloride

5.8g

Disodium phosphate

10g

[0058] 2. Solution preparation:

[0059] a): Weigh the disodium hydrogen phosphate of the prescribed amount, dissolve it with 4L of water for injection and add it to the liquid mixing tank;

[0060] b): Add the prescribed amount of insulin aspart powder into the liquid preparation tank while stirring, and mix and dissolve;

[0061] c): Weighing glycerin, phenol, m-cresol, sodium chloride, and zinc chloride of the prescribed amount are dissolved in 1L of water for injection respectively, and then added to the liquid mixing tank in sequence;

[0062] d): the solution is stirred and mixed evenly;

[0063] e): Supplement water for injection to 10L;

[0064] f): The medicinal solution is sterilized by filtering through a 0.22 μm filter membrane. ...

Embodiment 3

[0066] 1. Prescription

[0067] insulin aspart

35g

glycerin

160g

phenol

30g

Zinc chloride

0.196g

Sodium chloride

5.8g

Disodium phosphate

10g

[0068] 2. Solution preparation:

[0069] a): Weigh the disodium hydrogen phosphate of the prescribed amount, dissolve it with 4L of water for injection and add it to the liquid mixing tank;

[0070] b): add the insulin aspart powder of the prescribed amount while stirring in the liquid preparation tank, mix and dissolve;

[0071] c): Glycerin, phenol, sodium chloride, and zinc chloride of the prescription amount were weighed and dissolved in 1L of water for injection respectively, and then added to the liquid mixing tank in sequence;

[0072] d): the solution is stirred and mixed evenly;

[0073] e): Supplement water for injection to 10L;

[0074] f): The medicinal solution is sterilized by filtering through a 0.22 μm filter membrane.

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Abstract

The invention provides a preparation method of an insulin aspart injection, relating to the field of pharmaceutical preparations, and aims to provide the preparation method of the insulin aspart injection simple to operate, safe and reliable and stable in quality. The method comprises the following steps: a) providing an alkaline buffer solution; b) providing a mixed solution of a phenol mixture,an isoosmotic adjusting agent and a stabilizer; c) uniformly mixing the solution; d) adding insulin aspart and uniformly mixing the insulin aspart with the solution; or the method comprises the following steps: a') providing the alkaline buffer solution; b') adding insulin aspart to be mixed and dissolved; c') providing the mixed solution of the phenol mixture, the isoosmotic adjusting agent and the stabilizer; and d') uniformly mixing the solution.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of insulin aspart. Background technique [0002] Recombinant insulin aspart (recombinant Asp B28 -Human insulin), as a fast-acting insulin analogue, belongs to the third generation of insulin. Proline (Pro) at position 28 is replaced (mutated) by negatively charged aspartic acid (Asp), which uses charge repulsion to prevent insulin monomers or dimers (B28 of one insulin molecule interacts with another insulin Molecular B23) self-aggregation reduces intermolecular aggregation. It can well simulate the secretion mode of human insulin, its pharmacokinetic properties are about half of conventional human insulin, its onset time is 10-20 minutes, peak time is 40 minutes, and the duration of action is shortened to 3-20 minutes 5 hours, so that patients can obtain good blood sugar control, and at the same time, it is not easy to superimpose the action of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K9/08A61K47/02A61K47/10A61P3/10
Inventor 王玮夏婉霞卢玮吴飞飞陈松张昊宁
Owner NANJING HANXIN PHARMA TECH CO LTD
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