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Insulin glargine injection and preparation method thereof

A technology for insulin glargine and injection, applied in the field of medicine, can solve the problems of high production cost, white spots in insulin glargine injection, and no mention of the stability of insulin preparations, etc., and achieve the effect of stable quality

Active Publication Date: 2016-05-25
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it does not mention that PEG and insulin are not covalently bonded to the stability of insulin preparations, and its PEGylation preparation steps are too complicated, requiring high equipment conditions and high production costs, making it difficult to achieve large-scale production
[0009] Chinese patent CN102188367A discloses a kind of insulin glargine injection and its preparation method. Its purpose is to solve the phenomenon of white spots in insulin glargine injection, which has not been solved fundamentally. With the prolongation of storage time, it is still white spots appear

Method used

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  • Insulin glargine injection and preparation method thereof
  • Insulin glargine injection and preparation method thereof
  • Insulin glargine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Add 1500ml of water for injection pre-cooled to room temperature in the beaker, add 7.27g of insulin glargine of the prescribed amount, add 1M hydrochloric acid solution while stirring to make it dissolve, add m-cresol 5.4g of the prescribed amount, 0.375g of zinc chloride, Benzalkonium chloride 5.5g, stir and mix, adjust the pH value of the solution to 3.5, add 85% glycerin 40.0g, absolute ethanol 40.0g, set the volume to 2000ml, stir the solution to a colorless clear liquid; filter, fill, Light inspection is the finished product.

Embodiment 2

[0025] Add 1500ml of water for injection pre-cooled to room temperature in the beaker, add 7.27g of insulin glargine of the prescribed amount, add 1M hydrochloric acid solution while stirring to make it dissolve, add m-cresol 5.4g of the prescribed amount, 0.375g of zinc chloride, Benzalkonium chloride 6.5g, stir and mix, adjust the pH value of the solution to 4.5, add 85% glycerin 40.0g, absolute ethanol 50.0g, set the volume to 2000ml, stir the solution to a colorless clear liquid; filter, fill, Light inspection is the finished product.

Embodiment 3

[0027] Add 1500ml of water for injection pre-cooled to room temperature in the beaker, add 7.27g of insulin glargine of the prescribed amount, add 1M hydrochloric acid solution while stirring to make it dissolve, add m-cresol 5.4g of the prescribed amount, 0.375g of zinc chloride, Benzalkonium chloride 6.0g, stir and mix, adjust the pH value of the solution to 4.0, add 85% glycerin 40.0g, absolute ethanol 45.0g, set the volume to 2000ml, stir the solution to a colorless clear liquid; filter, fill, Light inspection is the finished product.

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Abstract

The invention relates to an insulin glargine injection. The insulin glargine injection is prepared from insulin glargine, glycerin, absolute ethyl alcohol, m-cresol, zinc chloride, benzalkonium chloride, PH regulator and water for injection. The insulin glargine injection is prepared through the following steps that the prescription dose of the insulin glargine is added into an appropriate amount of water for injection, 1 M of a hydrochloric acid solution is added while stirring is conducted, and the insulin glargine is dissolved, wherein the water for injection is precooled to room temperature; the prescription dose of m-cresol, zinc chloride and benzalkonium chloride are added, the mixture is stirred to be uniform, and the solution pH value is adjusted with the PH regulator; the prescription dose of glycerin and absolute ethyl alcohol are added to the scale volume, and the solution is stirred to obtain colorless clear liquid; filtration, filling and light inspection are conducted, and a finished product is obtained. Compared with the prior art, the phenomenon that white points occur in the insulin glargine injection is relieved; meanwhile, the product is stable in quality, and an obvious change does not exit after related substances are unpacked and put at room temperature and the related substances are stored for a long time at 2-8 DEG C.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an insulin glargine injection and a preparation method thereof. Background technique [0002] Recombinant glycine-arginineinsulin (recombinantglycine-arginineinsulin) is a long-acting insulin biological product obtained through genetic recombination technology and used to treat type Ⅰ and Ⅱ diabetes. , thus reducing the solubility, forming insulin glargine precipitates, delaying the body's absorption, and prolonging the time of its hypoglycemic effect. Recombinant insulin glargine is a very convenient and effective drug for the treatment of type I and type II diabetes. Recombinant insulin glargine (trade name Lantus) produced by Aventis abroad is different from regular insulin in that the last aspartic acid at the 21st position of the carboxyl end of the A chain is replaced by glycine, and the 30th threonine at the carboxyl end of the B chain is replaced by glycine....

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/08A61K47/18A61P3/10
CPCA61K38/28A61K47/186A61K9/0019A61K9/08
Inventor 张贵民董其松程战立
Owner SHANDONG NEWTIME PHARMA
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