Injection containing carbetocin and stabilizer and storable at normal temperature

A technology for storing carbetocin at room temperature, which is applied in the field of injections containing carbetocin and stabilizers, which can solve problems such as poor stability, reduce the risk of clinical use, and increase impurities, and achieve the effect of improving stability

Pending Publication Date: 2020-04-17
CHANGCHUN SHENGJINNUO BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with general drugs, peptides are easily affected by external environments such as light and heat, and have extremely poor stability, especially thermal instability. They will degrade rapidly in liquid solutions at room temperature, so peptide preparations usually need to be stored at low temperature
At present, the brand name of the original carbetocin product on the market in China is It needs to be kept away from light at 2-8°C, which will increase the cost of production, storage and transportation for enterprises, thus increasing the burden of medication for patients
And in the stability test, its impurities increased significantly, which brought certain risks to clinical use. Therefore, it has important clinical significance to provide a pharmaceutical preparation that increases the stability of carbetocin, controls the generation of impurities, and reduces the risk of clinical use.

Method used

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  • Injection containing carbetocin and stabilizer and storable at normal temperature
  • Injection containing carbetocin and stabilizer and storable at normal temperature
  • Injection containing carbetocin and stabilizer and storable at normal temperature

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025]

[0026] Preparation Process:

[0027] Weigh glycine, cysteine, and sodium chloride according to the recipe quantity, stir and dissolve at 50°C, add hydrochloric acid to adjust the pH to 4.0±0.2, remove the heat source by ultrafiltration, let cool to below 30°C, add calcium carbonate Betocin, dissolve and mix well. Sterile filtered, filled, and protected with nitrogen.

Embodiment 2

[0029] name Dosage carbetocin 0.10g Glycine 1.50g Methionine 0.15g hydrochloric acid Adjust pH4.0±0.2 Sodium chloride 9.00g Add water for injection to 1000ml

[0030] Preparation Process:

[0031] Weigh glycine, methionine, and sodium chloride according to the recipe quantity, stir and dissolve at 50°C, add hydrochloric acid to adjust the pH to 4.0±0.2, remove the heat source by ultrafiltration, let cool to below 30°C, add carbetocin element, dissolve and mix. Sterile filtered, filled, and protected with nitrogen.

Embodiment 3

[0033]

[0034]

[0035] Preparation Process:

[0036] Weigh glycine, cysteine ​​and mannitol according to the recipe quantity, stir and dissolve at 50°C, add fumaric acid to adjust the pH to 4.0±0.2, remove the heat source by ultrafiltration of the solution, let it cool to below 30°C, add Carbetocin, dissolve and mix well. Sterile filtered, filled, and protected with nitrogen.

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PUM

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Abstract

The invention relates to an injection containing carbetocin and a stabilizer and storable at a normal temperature. The injection can be stored at normal temperature and comprises carbetocin, the stabilizer, a pH regulator and water for injection, wherein the stabilizer is composed of compound amino acid, so the stability of the injection can be improved. The injection is used for preventing uterine tension insufficiency and postpartum hemorrhage.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an injection containing carbetocin and a stabilizer that can be stored at room temperature. Background technique [0002] Carbetocin is a synthetic long-acting oxytocin analog with agonist properties that binds to oxytocin receptors in uterine smooth muscle to synchronize, regularize, enhance and prolong uterine contractions It is used for selective epidural or spinal anesthesia for uterine rupture surgery to prevent uterine atony and postpartum hemorrhage. It has fast onset, long duration of action, and safe and effective clinical application. urgently needed medicines. [0003] Postpartum hemorrhage is one of the most common and most dangerous clinical complications in obstetrics and gynecology. With the delay of primiparous age, the increase of caesarean section rate and the increase of macrosomia among women of childbearing age in my country, the incidence of postpartum he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/095A61K47/18A61K47/12A61K47/26A61K47/02A61K47/04A61P15/04A61P7/04
CPCA61K9/08A61K9/0019A61K38/095A61K47/183A61K47/12A61K47/26A61K47/02A61P15/04A61P7/04
Inventor 孟钢张军才永久白冰张华崔明慧徐婷王宏燕
Owner CHANGCHUN SHENGJINNUO BIOLOGICAL PHARMA
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