Stable insulin analogue injection and preparation method thereof

A technology for insulin analogues and injections, which is applied in the field of medicine, can solve problems such as oxidative damage and shock, and achieve the effects of improved stability, simple preparation process, prevention of oxidative damage, and even changes in the color of the liquid medicine

Inactive Publication Date: 2019-04-19
江苏万邦医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, insulin analogs are also susceptible to oxygen oxidation damage, especially when exposed to light, the rate of the oxidation reaction is amazing, which is also a problem that needs to be solved to improve the stability of insulin analog injections

Method used

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  • Stable insulin analogue injection and preparation method thereof
  • Stable insulin analogue injection and preparation method thereof
  • Stable insulin analogue injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation of Recombinant Insulin Lispro Injection

[0027] Prepare the injection according to the following formula:

[0028]

[0029]

[0030] The specific preparation method is as follows:

[0031] Recombinant insulin lispro injection prescription 1 preparation process:

[0032] (1) Add phenol, m-cresol, glycerin, disodium hydrogen phosphate, and zinc chloride into water for injection, stir until completely dissolved, and obtain solution ①;

[0033] (2) Add the recombinant insulin lispro into the water for injection, add a pH regulator to adjust the pH value of the liquid to 2.8-3.2, stir until clear to obtain a solution, add solution ② to obtain solution ③.

[0034] (3) Add the solution ① into the solution ③ under the condition of stirring, mix evenly, add a pH regulator to adjust the pH value of the medicinal solution to 7.0-7.8, constant volume, filter and sterilize to obtain the product.

[0035] Preparation process of Recombinant Insulin Lispro Injecti...

Embodiment 2

[0053] Preparation of recombinant insulin glargine injection

[0054] Prepare the injection according to the following formula:

[0055]

[0056]

[0057] The specific preparation method is as follows:

[0058] Recombinant insulin glargine injection prescription 1 preparation process:

[0059] (1) Add m-cresol, glycerin, and zinc chloride to water for injection, stir until completely dissolved, and obtain solution ①;

[0060] (2) Add the recombinant insulin glargine into the water for injection, add a pH regulator to adjust the pH value of the liquid to 3.0-4.0, stir until clear to obtain a solution, and obtain solution ②.

[0061] (3) Add the solution ① into the solution ② under the condition of stirring, mix well, adjust the pH value to 3.5-4.5, constant volume, filter and sterilize to obtain the product.

[0062] Recombinant insulin glargine injection prescription 2 preparation process

[0063] (1) Add m-cresol, glycerin, and zinc chloride to water for injection, ...

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a stable insulin analogue injection and a preparation method thereof. The insulin analogue injection comprises L-histidine and a derivative, capable of being accepted in medicine, of L-histidine; L-histidine and the derivative, capable of being accepted in medicine, of L-histidine are used as a stabilizer and an antioxidant in the injection, deamidization, peptide chain splitting decomposition and a polymerization reaction of an insulin analogue are reduced, the oxidation resistance of the insulin analogue injection is improved, and the situation is avoided that the insulin analogue injection is oxidized and damaged in the storage process, and even the color of a medicine solution is changed. The preparation technology is simple, convenient to use and suitable for industry and large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a stable insulin analog injection and a preparation method thereof. Background technique [0002] Diabetes is the third chronic disease that seriously threatens human health after tumors and cardiovascular diseases. For islet cell lesions, insulin cannot be secreted, and foreign aid insulin needs to be supplemented. A large part of insulin used by humans comes from animals. Porcine and bovine insulin extracted from animal organs are limited by the source of the organ, and due to the difference in the primary structure, it may cause immunogenicity problems, which may lead to a series of side effects. [0003] In the late 1990s, in the in-depth study of the structure and composition of insulin, it was discovered that modification of the peptide chain may change the physical and chemical properties and biological characteristics of insulin, so that it can develop insulin that is mo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/28A61K47/18A61P3/10
CPCA61K9/0019A61K9/08A61K38/28A61K47/183A61P3/10
Inventor 梅丽栗凤娟文良柱牛瑞娟王军军
Owner 江苏万邦医药科技有限公司
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