Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

A kind of insulin glargine injection and preparation method thereof

A technology of insulin glargine and injection, which is applied in the field of medicine, can solve the problems of high production cost, no reference to the stability of insulin preparations, difficulty in mass production, etc., and achieve the effect of stable quality

Active Publication Date: 2019-04-26
SHANDONG NEWTIME PHARMA
View PDF11 Cites 0 Cited by
  • 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 the PEGylation preparation steps are too complicated, the equipment conditions are high, the production cost is high, and it is 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of insulin glargine injection and preparation method thereof
  • A kind of insulin glargine injection and preparation method thereof
  • A kind of 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.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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-arginine insulin (recombinant glycine-arginine insulin) is a long-acting insulin biological product obtained through genetic recombination technology and used to treat type Ⅰ and Ⅱ diabetes. Immediately polymerize, so the solubility is reduced, and insulin glargine precipitates are formed, the body's absorption is delayed, and the time of its hypoglycemic effect is also prolonged. 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 e...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/08A61K47/18A61P3/10
CPCA61K9/0019A61K9/08A61K38/28A61K47/186
Inventor 张贵民董其松程战立
Owner SHANDONG NEWTIME PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com