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Dulaglutide injection and preparation method thereof

A technology for dulaglutide and injection, which is applied in the field of duraglutide injection and its preparation, and achieves the effects of good stability, stable quality, and non-degradable stability.

Inactive Publication Date: 2014-12-03
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, for dulaglutide, there is no marketed product at home and abroad

Method used

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  • Dulaglutide injection and preparation method thereof
  • Dulaglutide injection and preparation method thereof
  • Dulaglutide injection and preparation method thereof

Examples

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preparation example Construction

[0032] Another aspect of the present invention provides a method for preparing dilaglutide injection, the method comprising:

[0033] (1) The weight ratio of dulaglutide: pH regulator: solubilizer: bacteriostat: osmotic pressure regulator is 1.5: (2.0-35): (2-5): (7-16): (180 -420) to weigh each component;

[0034] (2) Add water for injection to the pH adjuster, stir and dissolve, so that the pH of the solution is 6-7.5;

[0035] (3) Add osmotic pressure regulator, stir and dissolve until the solution is clear;

[0036] (4) Add solubilizer and antibacterial agent, then add duraglutide, stir and dissolve until the solution is clear, and filter to sterilize;

[0037] Wherein the ratio of the weight sum of the five components in the step (1) to the volume of the added water for injection is 0.6-1.6 in mg / ml.

[0038] Wherein, the definition and selection range of pH regulator, solubilizer, bacteriostat and osmotic pressure regulator are as above.

[0039] Preferably, the prep...

Embodiment 1

[0063] The preparation of embodiment 1 degree laglutide injection

[0064] It is carried out in the 10,000-class clean room and the 100-class ultra-clean workbench in the clean room, and each component is taken:

[0065]

[0066] Weigh 330mg disodium hydrogen phosphate and 162mg sodium dihydrogen phosphate, add 210mL water for injection and stir to dissolve, make the pH of the solution 6-7.5, then add 24g mannitol, stir and dissolve until the solution is clear, then add 300mg Tween -20, 810mg of m-cresol, stir to dissolve evenly, weigh 150mg of duraglutide, make up the remaining solution, stir and dissolve until the solution is clear, filter and sterilize; pour the prepared solution into a siliconized and stoppered 3mL cartridge In the middle, roll the cap, and put it into a disposable injection pen, each 3ml, a total of 100 fillings.

Embodiment 2

[0067] Embodiment 2 The preparation of laglutide injection

[0068] It is carried out in the 10,000-class clean room and the 100-class ultra-clean workbench in the clean room, and each component is taken:

[0069]

[0070] Weigh 165mg of disodium hydrogen phosphate and 81mg of sodium dihydrogen phosphate, add 210mL of water for injection and stir to dissolve, make the pH of the solution 6-7.5, then add 24g of mannitol, stir and dissolve until the solution is clear, then add 300mg of Tween -20, 810mg of m-cresol, stir to dissolve evenly, weigh 150mg of duraglutide, make up the remaining solution, stir and dissolve until the solution is clear, filter and sterilize; pour the prepared solution into a siliconized and stoppered 3mL cartridge In the middle, roll the cap, and put it into a disposable injection pen, each 3ml, a total of 100 fillings.

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PUM

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Abstract

Disclosed are a dulaglutide injection and the preparation method thereof, the injection containing: dulaglutide, a pH regulator, a solubilizer, an antimicrobial agent, an osmotic pressure regulator, and water for injection, wherein, in addition to water for injection, the content of each component by weight ratio is: dulaglutide:the pH regulator:the solubilizer:the antimicrobial agent: the osmotic pressure regulator 1.5:(2.0-35):(2-5): 7-16:(180-420), and the ratio of the total weight of these five components and the volume of the water for injection in mg / ml is 0.6-1.6.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a dulaglutide injection and a preparation method thereof. Background technique [0002] The endocrine cells of the small intestine can produce a hormone that can promote the secretion of insulin after meals or oral glucose, so people named it Incretin, which can regulate 60% of the total insulin secretion after meals . There are two main types of incretins: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). [0003] After further research on the human body, it was found that the secretion of insulin after oral glucose and glucose infusion in patients with type 2 diabetes is equivalent, which suggests that the secretion of incretin in patients with type 2 diabetes is reduced, and the level of GIP after meals in patients with type 2 diabetes is similar to that of ordinary people. Similar, but GLP-1 is significantly reduced, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/02A61P3/10
CPCA61K9/0019A61K38/26A61P3/08A61P3/10
Inventor 王博郑春连刘建马亚平袁建成
Owner HYBIO PHARMA
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