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Preparation method of carbetocin injection

A technology of carbetocin and injection, which is applied in the field of preparation of carbetocin injection, can solve the problems of large increase of impurities and unresolved problems, and achieve the effect of good and stable product quality

Pending Publication Date: 2020-03-24
HANGZHOU HEZE PHARMA TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned invention mainly improves the pH change and the large increase of impurities in the preparation product in the stability test by adjusting the types of excipients in the prescription, but it does not solve the above-mentioned technical defects in the product preparation process

Method used

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  • Preparation method of carbetocin injection
  • Preparation method of carbetocin injection

Examples

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Effect test

Embodiment 1

[0031] Preparation of Carbetocin Injection

[0032] 1) Metal utensils are first soaked in an aqueous solution containing 0.1% edetate disodium, heated to 40°C and kept warm for 1 hour, then rinsed with water for injection, and sterilized for later use;

[0033] 2) Dissolve carbetocin and excipients, add water to volume, and stir to mix completely;

[0034] 3) 0.22μm sterile filtration;

[0035] 4) Filling and capping, ready to serve.

Embodiment 2

[0037] Preparation of Carbetocin Injection

[0038] 1) Metal utensils are soaked in an aqueous solution containing 0.05% calcium sodium edetate, heated to 60°C and kept warm for 2 hours, then rinsed with water for injection, and sterilized for later use;

[0039] 2) Dissolve carbetocin and excipients, add water to volume, and stir to mix completely;

[0040] 3) 0.22μm sterile filtration;

[0041] 4) Filling and capping, ready to serve.

Embodiment 3

[0043] Preparation of Carbetocin Injection

[0044] 1) Metal utensils are soaked in an aqueous solution containing 0.5% calcium sodium edetate, heated to 50°C and kept warm for 1 hour, then rinsed with water for injection, and sterilized for later use;

[0045] 2) Dissolve carbetocin and excipients, add water to volume, and stir to mix completely;

[0046] 3) 0.22μm sterile filtration;

[0047] 4) Filling and capping, ready to serve.

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Abstract

The invention discloses a preparation method of a carbetocin injection, which at least comprises the following steps: cleaning a container, dissolving carbetocin and auxiliary materials, adding waterto a constant volume, stirring and mixing, filtering and filling. Metal devices used in the liquid preparation process are all cleaned with an aqueous solution containing a metal chelating agent. By means of the preparation method, conventional metal containers can be adopted for production, and the prepared product is good in quality and stability.

Description

technical field [0001] The invention relates to a preparation method of carbetocin injection, which belongs to the technical field of medicine preparation. Background technique [0002] Carbetocin is a synthetic long-acting nonapeptide analog of oxytocin with agonist properties. A single dose intravenously may be administered immediately after cesarean section under epidural or spinal anesthesia. It is clinically used after cesarean section under selective epidural or spinal anesthesia to prevent uterine atony and postpartum hemorrhage. [0003] In the preparation process of carbetocin injection, it was found that when the liquid medicine was in contact with metal utensils, such as liquid preparation tanks, liquid storage tanks, pipelines, filling needles, etc., the impurities in the product increased sharply, and with the contact time The prolongation, impurity growth is more significant, which will not be conducive to the quality control of the product, but also bring gr...

Claims

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Application Information

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IPC IPC(8): A61K38/095A61K9/08A61K47/18A61P7/04A61P15/04
CPCA61K38/095A61K9/08A61K9/0019A61K47/183A61P7/04A61P15/04
Inventor 倪晟廖志雄张迎春赵航
Owner HANGZHOU HEZE PHARMA TECH
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