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Etelcalcetide hydrochloride stabilizer

A stabilizer, tecatenide technology, which is applied in the field of ectatide hydrochloride stabilizer, can solve the problems of increased production, storage and transportation costs, cannot be placed in an environment above 25°C, and increased patient medication burden, etc. Time storage, pain relief, and preservation benefits

Active Publication Date: 2022-02-15
浙江湃肽生物股份有限公司深圳分公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The currently commercially available etecatide hydrochloride freeze-dried powder injection needs to be stored at 2-8°C in the dark, and cannot be placed in an environment above 25°C
This brings an increase in production, storage and transportation costs to the enterprise, thereby increasing the burden of medication for patients

Method used

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  • Etelcalcetide hydrochloride stabilizer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of Modified Polyethylene Glycol Modified Sulfaamidine

[0034] Dissolve 10 g of polyethylene glycol-4000 in 50 g of anhydrous pyridine, add 2 g of isatoic anhydride, stir and react at 50°C for 4-6 h; evaporate the pyridine after the reaction, and extract with chloroform; collect and extract the organic phase , ethyl acetate recrystallization, the obtained solid obtains modified polyethylene glycol;

[0035] Take 0.5 g of sulfamidine and add dichloromethane to prepare a 10 mg / mL solution, then add 8 g of modified polyethylene glycol, 0.5 g of DCC and 0.3 g of NHS, stir and react at room temperature for 24 h, filter, and add 200 mL of the filtrate Precipitate in cold ether, collect the precipitated solid, add to 40 mL of 1 M NaOH aqueous solution, stir at room temperature for 3 h, then add concentrated hydrochloric acid to pH = 3, then extract with dichloromethane 3 times, combine the organic phases, dry, concentrate, The concentrated solution was added to 20...

Embodiment 2

[0037] Preparation of Etekatide Hydrochloride Stabilizer

[0038] Take 1 g of the modified polyethylene glycol-modified sulfamidine prepared in Example 1, 10 g of sodium chloride, and 3 g of trehalose and dissolve them in PBS buffer (pH7) and set the volume to 1000 mL to obtain Eteca hydrochloride Peptide stabilizer.

Embodiment 3

[0040] Preparation of Etekatide Hydrochloride Stabilizer

[0041] Get 1 g of the modified polyethylene glycol modified sulfamidine prepared in Example 1, 10 g of sodium chloride, 3 g of trehalose, 0.5 g of zingiberone, and 1 g of sophoridine, which are dissolved in PBS buffer (pH7) and Dilute to 1000 mL to obtain etecatide hydrochloride stabilizer.

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PUM

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Abstract

The invention provides an etelcalcetide hydrochloride stabilizer, belonging to to the technical field of pharmaceutical peptides. The etelcalcetide hydrochloride stabilizer comprises modified polyethylene glycol-modified sulphaguanidine, wherein polyethylene glycol and isatoic anhydride are subjected to a carboxylation reaction to obtain modified polyethylene glycol, and the modified polyethylene glycol and sulphaguanidine are subjected to a condensation reaction to obtain the modified polyethylene glycol-modified sulphaguanidine. The modified polyethylene glycol-modified sulphaguanidine can prevent caking or denaturation failure of the etelcalcetide hydrochloride in a drying process of preparing freeze-dried etelcalcetide hydrochloride powder, and enables the etelcalcetide hydrochloride to stably exist under strong light irradiation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical peptides, and in particular relates to an etekatide hydrochloride stabilizer. Background technique [0002] Etecartide is a calcium-sensing receptor agonist, also known as a calcium-mimetic drug, which can regulate the secretion of parathyroid hormone from calcium-sensing receptors on the surface of parathyroid chief cells, and is suitable for the treatment of chronic kidney disease in adults after dialysis treatment. Secondary hyperparathyroidism. Etecartide consists of 3 D-configuration sulfamidines, 2 D-configuration alanines, 1 D-configuration arginineamide, 1 L-configuration cysteine ​​and 1 D-configuration Cysteine ​​(the N segment is blocked by acetyl group), in which D-configuration cysteine ​​and L-configuration cysteine ​​are linked together by disulfide bonds. The active ingredient of etekatide hydrochloride is an 8-amino acid polypeptide containing S-S bonds, and the stable co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K47/20A61K47/26A61K47/02A61K47/18A61K47/10A61K47/22A61P5/16A61P13/12A61P29/00C08G65/333C08G65/334A61K31/4375A61K31/12
CPCA61K38/08A61K31/4375A61K31/12A61K47/20A61K47/26A61K47/02A61K47/183A61K47/10A61K47/22A61P5/16A61P13/12A61P29/00A61P39/06C08G65/3348C08G65/33396C08G2650/04A61K2300/00
Inventor 张飞华汪岳斌叶有志吴潇钿
Owner 浙江湃肽生物股份有限公司深圳分公司
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