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Fast-acting insulin preparation and preparation method thereof

A technology of insulin and insulin aspart, which is applied in the field of medicine, can solve the problems of surprising and oxidative damage of insulin aspart, and achieve the effects of preventing oxidative damage, improving antioxidant performance, and improving stability

Inactive Publication Date: 2018-06-01
ZHUHAI JINBAIKANG BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, insulin aspart is also susceptible to oxidation damage by oxygen, especially when exposed to light, the rate of its oxidation reaction is amazing, which is also a problem that needs to be solved to improve the stability of insulin aspart injection

Method used

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  • Fast-acting insulin preparation and preparation method thereof
  • Fast-acting insulin preparation and preparation method thereof
  • Fast-acting insulin preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
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Embodiment Construction

[0021] The following examples are used to further describe the preparation process and implementation effect of the preparation of the present invention, but the protection scope of the present invention is not limited to the following examples.

[0022] Preparation of Insulin Aspart Injection

[0023] Prepare the injection according to the following formula:

[0024]

[0025]

[0026] The specific preparation method is as follows:

[0027] Preparation process of insulin aspart injection-1:

[0028] (1) Add zinc chloride, phenol, m-cresol, sodium chloride, glycerin and disodium hydrogen phosphate dihydrate to water for injection with a total preparation amount of 40-45%, stir until completely dissolved to obtain solution A, and set aside ;

[0029] (2) Put insulin aspart into water for injection with a total preparation amount of 40-45%, then add a pH regulator to adjust the pH value of the liquid to 2.0-3.0, stir until clear to obtain solution B, and set aside;

[0...

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Abstract

The invention discloses application of L-histidine and pharmaceutically-acceptable derivatives thereof in improvement of stability of fast-acting insulin preparation. The fast-acting insulin preparation is Insulin Aspart. Shown by experiments, the L-histidine and the pharmaceutically-acceptable derivatives thereof serve as a stabilizer and an antioxidant in injections, deamidization, peptide chaincracking and polymerization reactions of the Insulin Aspart are reduced, the oxidation resistance of Insulin Aspart injections is improved, and the Insulin Aspart injections are prevented from oxidated destruction even liquid medicine color change during storage. The preparation process is simple and convenient and is applicable to industrial and big production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a fast-acting insulin preparation and a preparation method thereof. Background technique [0002] Insulin is the main treatment drug for type 1 diabetes and most type 2 diabetes. At present, short-acting human insulin is the most widely used, but it has many shortcomings, especially the slow absorption and peak speed after subcutaneous injection. The postprandial insulin secretion status of normal individuals is different, so the control of postprandial blood sugar is not ideal. Since the peak of drug concentration cannot coincide with the peak of postprandial blood glucose, it is easy to cause postprandial hyperglycemia and hypoglycemia after drug absorption. In order to reduce the occurrence of diabetic adverse events and make intensive insulin therapy safer, more effective and more convenient, new rapid-acting insulin analogues are constantly being developed. [0003] Insulin aspart ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K38/28A61P3/10
CPCA61K9/08A61K9/0019A61K38/28A61K47/183
Inventor 胡波波夏玉平赖红星姚元锋祝捷马文柱肖拥军罗湘冀
Owner ZHUHAI JINBAIKANG BIOLOGICAL TECH CO LTD
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