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Carbetocin pharmaceutical composition and preparation method thereof

A carbetocin and composition technology are applied in the field of pharmaceutical preparation compositions and preparations containing carbetocin, and can solve the problems of large increase in impurities and the like

Inactive Publication Date: 2011-11-02
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the commercially available product of carbetocin is called Qiaotexin ? , the pH changes in the stability test, and the impurities have a large increase, which will cause certain risks in clinical use. Therefore, it is important to provide a preparation composition that can increase the stability of carbetocin. significance

Method used

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  • Carbetocin pharmaceutical composition and preparation method thereof
  • Carbetocin pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Carbetocin 0.1g Sodium chloride 9g glacial acetic acid 0.41g Sodium acetate 0.1g Add water for injection to 1000ml

[0048] Preparation Process:

[0049] Weigh glacial acetic acid and sodium acetate according to the prescription amount, prepare a pH buffer solution, and set aside. The buffer solution is added with the prescribed amount of sodium chloride, dissolved, and mixed evenly, so as to prepare the auxiliary material liquid. The excipient liquid is ultrafiltered with an ultrafilter to remove heat source. Carbetocin was dissolved and added to the ultrafiltrate of the excipient that had been ultrafiltered and made to volume. Sterile filtration, sub-packaging, and filled with inert gas protection.

Embodiment 2

[0051] Carbetocin 0.1g Sodium chloride 9g tartaric acid Adjust pH4.0 Add water for injection to 1000ml

[0052] Preparation Process:

[0053] Weigh the raw and auxiliary materials according to the prescription quantity, and set aside. Dissolve the sodium chloride of prescription quantity, carry out ultrafiltration with ultrafilter instrument and remove heat source. Dissolve carbetocin and add it to the ultrafiltrate of the excipient that has been ultrafiltered, add water for injection close to the total volume, adjust the pH to 4.0 with tartaric acid, and finally add water for injection to constant volume. Sterile filtration, sub-packaging, and filled with inert gas protection.

Embodiment 3

[0055] Carbetocin 0.1g Mannitol 45.5g glacial acetic acid 0.41g Sodium acetate 0.1g Methionine 0.05g Add water for injection to 1000ml

[0056] Preparation Process:

[0057] Weigh glacial acetic acid and sodium acetate according to the prescription amount, prepare a pH buffer solution, and set aside. The buffer solution is added with prescribed amount of mannitol, dissolved, mixed evenly, and prepared as auxiliary material liquid. The excipient liquid is ultrafiltered with an ultrafilter to remove heat source. Dissolve methionine and carbetocin and add them to the ultrafiltered excipient solution and make to volume. Sterile filtration, sub-packaging, and filled with inert gas protection.

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Abstract

The invention relates to a stable pharmaceutical composition containing carbetocin, and a preparation method thereof. The stable pharmaceutical composition containing carbetocin contains carbetocin, a pH regulator, an isoosmotic regulator and pharmaceutically acceptable auxiliary materials. The composition is used for preventing uterine atony and postpartum hemorrhage after selective epidural or spinal anesthesia cesarean section. The pharmaceutical composition mainly exists in a liquid form and is used through parenteral administration forms, mainly injection and nasal spray.

Description

Technical field [0001] The preparation method of the preparation composition of the polypeptide drugs in the present invention especially involves a pharmaceutical preparation composition and preparation method containing a Kabelinyin. Background technique [0002] Kabelinchin is a synthetic long -actitative oxytic ninth peptide like a synthesis.Extraction or lumbar anesthesia can be administered immediately after cesarean section to prevent insufficient tension and postpartum bleeding. [0003] The clinical and pharmaceutical characteristics of Kabechinoplasma are similar to natural oxytocin produced.Like oxytocin, the combination of oxytocin receptors of cadroin and uterine smooth muscles causes the rhythmic contraction of the uterus. On the basis of the original contraction, it increases its frequency and increases the uterine tension.In the state of non -pregnancy, the oxytocin receptor content of the uterus is very low, which increases during pregnancy and peaks during child...

Claims

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Application Information

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IPC IPC(8): A61K38/11A61P15/00A61K38/095
Inventor 郑春莲谢圣坤马亚平袁建成
Owner HYBIO PHARMA
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