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Insulin lispro-protamine sulfate preparation and preparation method thereof

A technology of protamine sulfate and insulin lispro, which is applied in the fields of biomedicine and pharmaceutics, can solve the problems of insufficient stability of insulin lispro suspension preparations, prolonging the preparation cycle, and cumbersome preparation process, so as to shorten the preparation cycle and facilitate operation , to ensure the effect of drug safety

Active Publication Date: 2016-05-04
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of this method is cumbersome, the crystallization time is long, and the configuration cycle is correspondingly prolonged
In addition, the application also discloses that the stability of the insulin lispro suspension preparation using disodium hydrogen phosphate as a buffer is not as good as that of TRIP (2-amino-2-hydroxymethyl-1,3-propanediol and its pharmaceutically accepted salts) ) as a suspension formulation of a buffer

Method used

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  • Insulin lispro-protamine sulfate preparation and preparation method thereof
  • Insulin lispro-protamine sulfate preparation and preparation method thereof
  • Insulin lispro-protamine sulfate preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Example 1 A kind of preparation method of insulin lispro protamine sulfate preparation (25R)

[0061] The preparation is 1000ml in total, including: insulin lispro: 3.47mg / ml, protamine sulfate: 0.28mg / ml, zinc: 0.025mg / ml, phenol: 0.715mg / ml, m-cresol: 1.76mg / ml, Glycerin: 16mg / ml, disodium hydrogen phosphate: 2.0mg / ml, the rest is water; prepared as follows:

[0062] 1) Prepare the preparation solution: weigh 0.715g phenol, 2g disodium hydrogen phosphate and the calculated amount of zinc oxide; dissolve the zinc oxide with 0.1mol / L hydrochloric acid as little as possible to obtain the zinc preparation solution; use as much disodium hydrogen phosphate as possible dissolving in a little water to obtain a disodium hydrogen phosphate preparation solution; dissolving phenol in as little water as possible to obtain a phenol preparation solution;

[0063] 2) Preparation of insulin lispro acidic solution: Weigh 3.47g of insulin lispro, add water to make a suspension, add 0...

Embodiment 2

[0068] Example 2 A kind of preparation method of insulin lispro protamine sulfate preparation (50R)

[0069] The preparation is 1000ml in total, including: insulin lispro: 3.47mg / ml, protamine sulfate: 0.19mg / ml, zinc: 0.0305mg / ml, phenol: 0.89mg / ml, m-cresol: 2.20mg / ml, Glycerin: 16mg / ml, disodium hydrogen phosphate: 2.0mg / ml, the rest is water; prepared as follows:

[0070] 1) Prepare the preparation solution: weigh 0.89g phenol, 2g disodium hydrogen phosphate and the calculated amount of zinc oxide; dissolve the zinc oxide with 0.1mol / L hydrochloric acid as little as possible to obtain the zinc preparation solution; use as much disodium hydrogen phosphate as possible dissolving in a little water to obtain a disodium hydrogen phosphate preparation solution; dissolving phenol in as little water as possible to obtain a phenol preparation solution;

[0071] 2) Preparation of insulin lispro acidic solution: Weigh 3.47g of insulin lispro, add water to make a suspension, add 0....

Embodiment 3

[0076] Example 3 A kind of preparation method of insulin lispro protamine sulfate preparation (75R)

[0077] The preparation is 1000ml in total, including: insulin lispro: 3.47mg / ml, protamine sulfate: 0.10mg / ml, zinc: 0.025mg / ml, phenol: 0.5mg / ml, m-cresol: 2.5mg / ml, Glycerin: 16mg / ml, disodium hydrogen phosphate: 2.5mg / ml, the rest is water; prepared as follows:

[0078] 1) Prepare the preparation solution: weigh 0.5g phenol, 2.5g disodium hydrogen phosphate and the calculated amount of zinc oxide; dissolve the zinc oxide with 0.1mol / L hydrochloric acid as little as possible to obtain the zinc preparation solution; dissolving in as little water as possible to obtain a disodium hydrogen phosphate preparation solution; dissolving phenol with as little water as possible to obtain a phenol preparation solution;

[0079] 2) Preparation of insulin lispro acidic solution: Weigh 3.47g of insulin lispro, add water to make a suspension, add 0.1mol / L hydrochloric acid to clarify the...

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Abstract

The invention provides a preparation method of an insulin lispro-protamine sulfate preparation. The insulin lispro-protamine sulfate preparation contains the following ingredients in concentration: 3.47mg / ml of insulin lispro, 0.095mg / ml to 0.28mg / ml of protamine sulfate, 0.025mg / ml to 0.05mg / ml of zinc, 0.5mg / ml to 1.0mg / ml of phenol, 1.5mg / ml to 2.5mg / ml of m-cresol, 16mg / ml of glycerine and 2mg / ml to 4mg / ml of disodium hydrogen phosphate. The preparation method comprises the steps of carrying out solution mixing on an acidic solution of insulin lispro and an alkaline solution of protamine sulfate, then, carrying out crystallization, adding an m-cresol and glycerine solution into completely-crystallized crystalline liquid, and carrying out uniform mixing, thereby obtaining the insulin lispro-protamine sulfate preparation. According to the preparation method, the consumed time is short, and the obtained product is stable in quality.

Description

technical field [0001] The invention belongs to the fields of biomedicine and pharmacy, and in particular relates to a preparation method of an insulin lispro protamine sulfate preparation and the prepared insulin lispro protamine sulfate preparation. Background technique [0002] Diabetes mellitus (Diabetes Mellitus) is a chronic comprehensive disease mainly caused by the disorder of glucose metabolism caused by absolute or relative insulin deficiency or decreased sensitivity of target cells to insulin, which seriously affects the health and quality of life of patients. With the improvement of economic level and material conditions, the incidence of diabetes continues to rise. According to the statistics of the International Diabetes Federation (IDF), there were about 100 million people with diabetes worldwide in the 1990s, and the number had rapidly increased to 246 million in 2007. It is estimated that there were about 415 million diabetics in the world in 2015, and the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K9/10A61K47/02A61K47/10A61K47/42A61P3/10
CPCA61K9/10A61K38/28A61K47/02A61K47/10A61K47/42
Inventor 张海艳武晓丽詹巾卓高冶郭银汉冷春生
Owner TONGHUA DONGBAO PHARMA
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