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Medicinal composition containing oxytocin analogue, as well as preparation method and application thereof

A technology of oxytocin and composition, which is applied in the field of pharmaceutical compositions containing oxytocin analogues, can solve the problems of deamidation impurities, unknown impurities, etc., achieve high stability, and eliminate the effect of uterine sensitivity differences

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

[0008] One of the technical problems to be solved by the present invention is to provide a method for providing the above-mentioned oxytocin-containing analogues in view of the technical problems of deamidation impurities, hydrolyzed impurities, and unknown impurities produced by oxytocin analog pharmaceutical compositions during long-term storage at 30°C. Pharmaceutical composition and preparation method of

Method used

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  • Medicinal composition containing oxytocin analogue, as well as preparation method and application thereof
  • Medicinal composition containing oxytocin analogue, as well as preparation method and application thereof
  • Medicinal composition containing oxytocin analogue, as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Example 1 The prior art was used to prepare oxytocin powder for injection.

[0062] Oxytocin 10000IU

[0063] Mannitol 50.0g

[0064] Add water for injection to a total volume of 1000ml

[0065] Weigh the raw and auxiliary materials according to the prescription amount, dissolve mannitol and oxytocin with water for injection and mix them evenly, and continue to add an appropriate amount of water for injection to reach the total volume; filter the prepared solution through a 0.22 μm filter for sterilization, and use 1.0ml / tube Subpackage. lyophilized.

[0066] Reduce the temperature of the plate layer to below -40°C within 1 hour and keep it warm for 3 hours. Turn on the vacuum, start to heat up, keep at -25°C for 2 hours, at -20-10°C for 2 hours, at -5°C for 2 hours, at 10°C for 5 hours, and at 35°C for 5 hours.

Embodiment 2

[0067] Example 2 The prior art was used to prepare oxytocin powder for injection.

[0068]

[0069] Weigh the raw and auxiliary materials according to the prescription amount, dissolve oxytocin and mannitol respectively with water for injection, and mix them evenly. Adjust the pH to 3.5 with citric acid, continue to add injections to the total volume, filter through 0.2um, and dispense at 1.0ml / cartridge. lyophilized.

[0070] Reduce the temperature of the plate layer to below -40°C within 1 hour and keep it warm for 1.5-3 hours. Turn on the vacuum, start to heat up, keep warm at -35~-25°C for 2 hours, keep warm at -20~-10°C for 2 hours, keep warm at -5~5°C for 2 hours, and keep warm at 10~35°C for 5 hours.

Embodiment 3

[0071] Example 3 uses the oxytocin powder injection prepared by the prior art.

[0072]

[0073]

[0074] Weigh the raw and auxiliary materials according to the prescription amount, dissolve oxytocin, mannitol, and cysteine ​​hydrochloride with water for injection, and mix well. Continue to add injections to the total volume, filter through 0.2um, and dispense at 1.0ml / cartridge. lyophilized.

[0075] Reduce the temperature of the plate layer to below -40°C within 1 hour and keep it warm for 1.5-3 hours. Turn on the vacuum, start to heat up, keep at -35 to -25°C for 2 hours, at -20 to -10°C for 2 hours, at -5 to 5°C for 2 hours, and at 10 to 35°C for 5 hours.

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PUM

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Abstract

The invention relates to a medicinal composition containing an oxytocin analogue, as well as a preparation method and application thereof. The medicinal composition is prepared from the oxytocin analogue, excipient and divalent metal ion salt, wherein the divalent metal ion salt is a solution of one or combination of two or more than two of calcium chloride, calcium acetate, calcium citrate, calcium tartrate, zinc chloride, zinc gluconate, calcium gluconate, calcium sulfate, zinc sulfate, zinc acetate and zinc citrate. The medicinal composition can be used for eliminating the uterine sensitivity difference and is stable in long-time storage at 30 DEG C.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a pharmaceutical composition containing oxytocin analogues. Background technique [0002] Oxytocin, also known as oxytocin, is a uterine contraction drug, which can be extracted or chemically synthesized from the posterior lobe of the pituitary gland in animals. The chemically synthesized product does not contain vasopressin, has no pressor effect, and has selective stimulation of uterine smooth muscle It can strengthen its contraction, the labor uterus is most sensitive to oxytocin (increased estrogen secretion), the immature uterus has no response to this product, the uterine response to oxytocin in the early or middle pregnancy is low, and it gradually increases in the late pregnancy , reaching the highest level before labor. A small dose can strengthen the rhythmic contraction of the smooth muscle at the bottom of the uterus, strengthen its contraction force, and accelerate its cont...

Claims

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Application Information

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IPC IPC(8): A61K38/11A61K47/02A61K9/19A61P15/04A61K38/095
CPCA61K38/095A61K9/19A61K47/02A61P15/04A61K9/0019
Inventor 郑春莲陶安进卢国勇袁建成戴荣欢
Owner HYBIO PHARMA
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