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Stable vaginal administrating pharmaceutical composition containing carbetocin and preparation method thereof

A technology of carbetocin and its composition, which is applied in the field of carbetocin’s pharmaceutical composition, can solve problems such as differences in effectiveness, and achieve the effect of stable uterine contraction and high stability

Inactive Publication Date: 2018-07-03
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The composition can effectively avoid the problem of differences in effectiveness due to individual differences

Method used

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  • Stable vaginal administrating pharmaceutical composition containing carbetocin and preparation method thereof
  • Stable vaginal administrating pharmaceutical composition containing carbetocin and preparation method thereof
  • Stable vaginal administrating pharmaceutical composition containing carbetocin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Preparation of carbetocin vaginal gel using prior art

[0032]

[0033] The hydroxypropyl cellulose was dissolved in water and allowed to stand for 2 hours to prepare a gel matrix. Dissolve citric acid in water, adjust the pH value to 4.2, then add carbetocin to dissolve and mix to make carbetocin drug solution, add the drug solution to the gel matrix and mix, add propylene glycol to mix, .

Embodiment 2

[0034] Example 2 The present invention was used to prepare carbetocin vaginal gel.

[0035]

[0036] The hydroxyethyl methylcellulose was dissolved in water and allowed to stand for 2 hours to prepare a gel matrix. Dissolve tartaric acid in water, and use sodium hydroxide to adjust the pH value of the solution to 4.2, add sodium cocoyl glutamate to dissolve, then add carbetocin to dissolve and mix well, and prepare carbetocin medicinal solution. Add the liquid medicine into the gel base and mix well, add propylene glycol and mix well.

Embodiment 3

[0037] Example 3 The present invention was used to prepare carbetocin vaginal gel.

[0038]

[0039] The hydroxyethyl carboxymethyl cellulose was dissolved in water and allowed to stand for 2 hours to prepare a gel matrix. Dissolve citric acid in water, and use sodium hydroxide to adjust the pH value of the solution to 4.5, add sodium lauroyl glutamate to dissolve, then add carbetocin to dissolve and mix, and prepare carbetocin medicinal solution. Add the liquid medicine into the gel base and mix well, add polyethylene glycol and mix well.

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing carbetocin. The pharmaceutical composition is characterized by containing the following components in percentage by weight: 0.5-7% (1-5%) of carbetocin, 1-10% (4-6%) of a water soluble matrix material, 0.5-5% (1-2%) of an amino acid anionic surfactant, 0.1-5% (1-2%) of a wetting agent, and the balance of water. The pharmaceutical composition containing carbetocin can solve clinical differences caused by individual differences effectively by adopting the anionic surfactant, and the stability of the pharmaceutical composition is guaranteed while the pharmaceutical composition stimulates uterine contraction effectively and stably.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a pharmaceutical composition of carbetocin. Background technique [0002] Carbetocin is a synthetic long-acting nonapeptide analog of oxytocin with agonist properties. A single dose intravenously may be given immediately after cesarean section under epidural or spinal anesthesia to prevent uterine hypotonia and postpartum hemorrhage. [0003] The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to the oxytocin receptors of uterine smooth muscle, causing rhythmic contractions of the uterus, increasing its frequency and increasing uterine tension on the basis of the original contractions. Oxytocin receptor levels in the uterus are low in the non-pregnant state, increase during pregnancy, and peak at delivery. Carbetocin therefore has no effect on the non-pregnant uterus, but has potent uterotonic ...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/18A61K38/11A61P15/00A61P7/04A61K38/095
CPCA61K9/0034A61K9/06A61K38/095A61K47/183A61K47/18A61P7/04A61P15/00
Inventor 郑春莲陶安进凌汝广林浩文袁建成
Owner HYBIO PHARMA
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