More-stable carbetocin acetate injection

A technology of carbetocin acetate and glacial acetic acid, which is applied in the field of preparations and can solve problems such as poor stability and unfavorable patient acceptance

Inactive Publication Date: 2011-08-10
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has poor stability and can only be stored in the refrigerator at a temperature of 2°C to 8°C, and cannot be frozen; when it is injected intravenously or intramuscularly, it will cause pain at the injection site, which is not conducive to patient acceptance

Method used

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  • More-stable carbetocin acetate injection
  • More-stable carbetocin acetate injection
  • More-stable carbetocin acetate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Carbetocin acetate (100 μg / ml as carbetocin), 9.0 mg / ml sodium chloride, 0.1% w / v sodium bisulfite, 2% w / v benzyl alcohol, pH adjusted with glacial acetic acid is 3.8, and its preparation process is as follows:

[0025] Weigh carbetocin acetate (calculated as carbetocin 100mg), 9.0g sodium chloride, 1.0g sodium bisulfite, 20.0g benzyl alcohol, dissolve completely with 80% water for injection of the prescribed amount, and dissolve with glacial acetic acid Adjust pH to 3.8, add water for injection to 1000ml. Before filtering, add 5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize 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, filled into 1ml sterile ampoules, and sealed. Make each tube equivalent to 100 μg carbetocin.

[0026] 1000 sticks of carbetocin acetate injection (containing 100 μg of carbetocin) were prepared by ...

Embodiment 2

[0058] Carbetocin acetate (100 μg / ml as carbetocin), 9.0 mg / ml sodium chloride, 0.1% w / v sodium metabisulfite, 0.4% w / v chlorobutanol, adjusted with glacial acetic acid pH is 3.8, and its preparation process is as follows:

[0059] Weigh carbetocin acetate (calculated as carbetocin 100mg), 9.0g sodium chloride, 1.0g sodium metabisulfite, 4.0g chlorobutanol, dissolve completely with prescription amount 80% water for injection, and use ice Adjust pH to 3.8 with acetic acid, add water for injection to 1000ml. Before filtering, add 5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize 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, filled into 1ml sterile ampoules, and sealed. Make each tube equivalent to 100 μg carbetocin.

[0060] 1000 sticks of carbetocin acetate injection (containing 100 μg of carbetocin) were prepared by the pre...

Embodiment 3

[0092] Carbetocin acetate (100 μg / ml as carbetocin), 5% w / v glucose, 0.1% w / v ascorbic acid, 2% w / v benzyl alcohol, adjusted pH to 3.8 with glacial acetic acid, and The preparation process is as follows:

[0093] Weigh carbetocin acetate (calculated as carbetocin 100mg), 50.0g glucose, 1.0g ascorbic acid, 20.0g benzyl alcohol, dissolve completely with 80% water for injection of prescription quantity, adjust pH to 3.8 with glacial acetic acid, Add water for injection to 1000ml. Before filtering, add 5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize 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, filled into 1ml sterile ampoules, and sealed. Make each tube equivalent to 100 μg carbetocin.

[0094] 1000 sticks of carbetocin acetate injection (containing 100 μg of carbetocin) were prepared by the present embodiment, and its stabi...

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PUM

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Abstract

The invention relates to a more-stable carbetocin acetate injection. The preparation consists of carbetocin acetate, an isoosmotic adjusting agent, a pH value regulating agent, an antioxidant, a local analgetic and a solvent, wherein the addition of the antioxidant can improve the stability of the preparation, and the addition of the local analgetic can relieve pains of a patient but does not affect the basic remedy. The process for preparing the preparation mainly comprises the following steps: weighing, dissolving, adsorbing a heat source by activated carbon, filtering, filtering by a terminal, subpackaging and sealing. The preparation is used for preventing and treating insufficient uterus tension and postpartum hemorrhage. The preparation has stable quality and an exact curative effect, and can be accepted by patients.

Description

Technical field: [0001] The invention relates to the field of preparations, in particular to a more stable carbetocin acetate injection. Background technique: [0002] Carbetocin is a synthetic long-acting nonapeptide analogue of oxytocin with agonist properties. A single dose intravenously may be administered 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 parturition. Carbetocin therefore has no effect on the non-pregnant uterus, but has p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/08A61K47/26A61P15/04
Inventor 姚志勇支钦李新宇
Owner SHENZHEN JYMED TECH
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