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Carbetocin injection and preparation method thereof

A carbetocin and injection technology, applied in the field of medicine, can solve the problems of high impurity control requirements, high content control requirements, strict quality requirements, and chemical sensitivity of carbetocin

Active Publication Date: 2014-09-24
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] Although there are many methods for preparing carbetocin pharmaceutical compositions, especially its injections, in the prior art, due to the chemical sensitivity of carbetocin, its quality requirements are strict, such as strict impurity control requirements and / or High content control requirements

Method used

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  • Carbetocin injection and preparation method thereof
  • Carbetocin injection and preparation method thereof
  • Carbetocin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0211] Embodiment 1: Preparation of carbetocin injection

[0212] formula:

[0213] Carbetocin

0.1 mg,

Dextran 40

10 mg,

pH regulator

Appropriate amount, adjust the pH value to 4.0,

Water for Injection

Appropriate amount, add to 1ml.

[0214] Preparation method:

[0215] (1) Dissolve each solid excipient and carbetocin in an appropriate amount of water for injection, so that the volume of the solution reaches 80% of the theoretical prescription volume (ie about 0.8ml, the same below);

[0216] (2) Regulate the pH value of the solution to a specified value with an acid-base regulator;

[0217] (3) Add water for injection to 1ml, add 0.05% activated carbon to the liquid medicine, absorb pyrogen for 30 minutes under stirring, decarburize and filter. The filtrate was filtered through a 0.22 μm titanium rod filter, and then sterilized and filtered through a 0.22 μm microporous membrane, and 1 ml of the liquid medicine was f...

Embodiment 2

[0235] Embodiment 2: Preparation of carbetocin injection

[0236] formula:

[0237] Carbetocin

0.1 mg,

Dextran 40

10 mg,

Soy Lecithin

2.5 mg,

pH regulator

Appropriate amount, adjust the pH value to 4.0,

Water for Injection

Appropriate amount, add to 1ml.

[0238] Preparation method:

[0239] (1) Dissolve each solid excipient and carbetocin in an appropriate amount of water for injection, so that the volume of the solution reaches 80% of the theoretical prescription volume (ie about 0.8ml, the same below);

[0240] (2) Regulate the pH value of the solution to a specified value with an acid-base regulator;

[0241] (3) Add water for injection to 1ml, add 0.05% activated carbon to the liquid medicine, absorb pyrogen for 30 minutes under stirring, decarburize and filter. The filtrate was filtered through a 0.22 μm titanium rod filter, and then sterilized and filtered through a 0.22 μm microporous membrane, and 1...

Embodiment 3

[0251] Embodiment 3: Preparation of carbetocin injection

[0252] formula:

[0253] Carbetocin 2

[0254] Chlorobutanol

[0255] Prepared with reference to the method of Example 1, the injection Ex3 was obtained.

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PUM

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Abstract

The invention belongs to the technical field of medicines, relates to a carbetocin analogue, particularly relates to carbetocin, and more particularly relates to a carbetocin injection with excellent pharmaceutical performance. The carbetocin can be used for preventing uterine atony and postpartum hemorrhage after selective epidural or lumbar anesthesia cesarean section. The invention also relates to a preparation method of the carbetocin injection, further relates to medical application of the carbetocin. Particularly relates to the carbetocin injection disclosed by the invention contains carbetocin, saccharides and injection water.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an oxytocin analogue, in particular to a carbetocin, and more particularly to a carbetocin injection with excellent pharmaceutical properties. The carbetocin of the present invention can be used for selective epidural or spinal anesthesia after caesarean section to prevent uterine atony and postpartum hemorrhage. The invention also relates to a preparation method of carbetocin injection. Further, the present invention also relates to the medical application of carbetocin injection. Background technique [0002] Carbetocin, molecular formula C45H69N11O12S, molecular weight 988.16, CAS registration number 37025-55-1, chemical name: deamin-2-oxo-methyltyrosine-1-κ oxytocin, its chemical structural formula : [0003] [0004] Carbetocin is a synthetic long-acting nonapeptide analog of oxytocin with agonist properties. A single dose intravenously may be administered immediately ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/08A61K47/26A61K47/10A61P15/04
Inventor 吴国庆方专江威王敬张莲莲余茹苟治君赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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