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Insulin aspart injection and preparation method thereof

A technology for insulin aspart and injection, which is used in pharmaceutical formulations, medical preparations containing active ingredients, and metabolic diseases, etc., can solve problems such as insulin resistance, and achieve improved insulin resistance, easy industrial production, and simple preparation technology. Effect

Active Publication Date: 2016-12-07
HEFEI TIANMAI BIOTECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although insulin is the drug of choice for the treatment of diabetes, it also has many disadvantages, such as insulin resistance caused by long-term use

Method used

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  • Insulin aspart injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of Insulin Aspart Injection

[0020] Insulin aspart 1.2mmol

[0021] α-mannan peptide 0.03mmol

[0022] m-cresol 2500mg

[0023] Zinc chloride 28mg

[0024] Add water for injection to 1000mL

[0025] Preparation Process:

[0026] (1) Add α-mannan peptide into 750mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;

[0027] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;

[0028] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.

Embodiment 2

[0029] Example 2 Preparation of Insulin Aspart Injection

[0030] Insulin aspart 0.6mmol

[0031] α-mannan peptide 0.03mmol

[0032] m-cresol 2500mg

[0033] Zinc chloride 28mg

[0034] Add water for injection to 1000mL

[0035] Preparation Process:

[0036] (1) Add α-mannan peptide into 700mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;

[0037] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;

[0038] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.

Embodiment 3

[0039] Example 3 Preparation of Insulin Aspart Injection

[0040] Insulin aspart 0.3mmol

[0041] α-mannan peptide 0.03mmol

[0042] m-cresol 2500mg

[0043] Zinc chloride 28mg

[0044] Add water for injection to 1000mL

[0045] Preparation Process:

[0046] (1) Add α-mannan peptide into 700mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;

[0047] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;

[0048] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.

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Abstract

The invention provides an insulin aspart injection and a preparation method thereof. The injection comprises insulin aspart, alpha-mannatide, a zinc salt and a bacteriostatic agent, wherein the concentration of insulin aspart in the injection ranges from 300 nmol / mL to 1,200 nmol / mL, and the concentration of alpha-mannatide in the injection ranges from 10 nmol / mL to 100 nmol / mL. The insulin aspart injection can improve insulin resistance and improve sensibility of target tissue to insulin, the medicine dose can be reduced to reach expected therapeutic indexes, the toxic and side effects such as hypoglycemia, edema and allergies cannot be caused, the possibility of occurrence of toxicity and medicine resistance is significantly decreased, and the treatment cost is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an insulin preparation, in particular to an injection containing insulin aspart and a preparation method thereof. Background technique [0002] At present, there are more than 382 million diabetic patients in the world, among which there are about 114 million diabetic patients over the age of 18 in China. Insulin has always been the most effective drug for treating diabetes, but ordinary insulin has many problems such as short action time, large absorption variation, obvious peak action, and high incidence of hypoglycemia, and is increasingly being replaced by insulin analogs (Cao Fenglin, Deng Shaoxiong . Insulin analogues: a new option for diabetes treatment [J]. Medical Review, 2007, 1(13): 32-34.). Recombinant insulin aspart, as a fast-acting insulin analogue, was developed using genetic engineering DNA recombination technology (Warren ML, Con...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/08A61K47/02A61P5/50A61P3/10A61K38/16
CPCA61K9/0019A61K9/08A61K38/16A61K38/28A61K47/02
Inventor 周伟朱珠亓振国张磊吕荟孟飞
Owner HEFEI TIANMAI BIOTECH DEV
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