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Coenzyme Q10 injection medicinal composition packaged with plastic container

A technology for plastic containers and compositions, applied in the field of medicine, can solve the problems of turbid precipitate content, rapid decline, etc.

Inactive Publication Date: 2010-12-01
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The purpose of the present invention is to provide a coenzyme Q10 injection pharmaceutical composition packaged in a plastic container to overcome the problems of the existing coenzyme Q10 injection, which tends to produce turbidity and precipitation during long-term storage and the content drops rapidly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prescription: Coenzyme Q10 5g, Solutol HS 15 60g, glucose 30g, glycerol 10g, adjust the pH value to 4.0, and dilute to 50L with water for injection.

[0038] Technological process: Coenzyme Q10 injection is prepared through preparation, activated carbon treatment, filtration, filling, nitrogen filling, high temperature sterilization and other processes.

[0039] Packaging materials and containers: polyethylene (PE) plastic ampoule (2ml), polypropylene (PP) plastic ampoule (2ml), polyester (PET or PBT) plastic ampoule (2ml), polyvinyl chloride (PVC) plastic infusion bottle ( 50ml) and non-PVC multi-layer co-extruded (composite) film infusion bag (50ml). The packaging material and container of the reference substance: medium borosilicate glass ampoule or soda-lime glass infusion bottle.

[0040] Test conditions: Avoid light, store in a cool place (not exceeding 20°C). Trial duration: 24 months.

[0041] Test indicators: appearance, insoluble particles, pH value, relate...

Embodiment 2

[0044] Prescription: coenzyme Q10 5g, polysorbate 80 60g, sodium chloride 0.9%, thiourea 40, adjust the pH value to 4.0, and dilute to 100L with water for injection.

[0045] Technological process: Coenzyme Q10 injection is prepared through preparation, activated carbon treatment, filtration, filling, nitrogen filling, high temperature sterilization and other processes.

[0046] Packaging materials and containers: polyethylene (PE) plastic ampoule (2ml), polypropylene (PP) plastic ampoule (2ml), polyester (PET or PBT) plastic ampoule (2ml), polyvinyl chloride (PVC) plastic infusion bottle ( 50ml) and non-PVC multi-layer co-extruded (composite) film infusion bag (50ml). The packaging material and container of the reference substance: medium borosilicate glass ampoule or soda-lime glass infusion bottle.

[0047] Test conditions: Avoid light, store in a cool place (not exceeding 20°C). Trial duration: 24 months.

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PUM

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Abstract

The invention discloses a coenzyme Q10 injection medicinal composition packaged with a plastic container. The coenzyme Q10 is taken as an active ingredient, one or more of polysorbate, polyethylene glycol 15-hydroxy stearic acid ester (SolutolHS15), polyethylene glycol (PEG), poloxamer and polyoxyethylene fatty acid ester are taken as solubilizing agents, injection water is taken as a solvent, and the plastic container is taken as a packaging material which is directly contacted with coenzyme Q10 injection. The coenzyme Q10 injection packaged with the plastic container can effectively overcome the defects of turbidity, precipitation and the like which are easy to occur in coenzyme Q10 injection packaged with a glass container, so that the quality stability and clinical administration safety of the coenzyme Q10 injection are improved remarkably.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a novel coenzyme Q10 injection pharmaceutical composition which uses a plastic container as a packaging material for direct contact with medicines. [0002] Background technique [0003] Coenzyme Q10 is a fat-soluble quinone biopharmaceutical, which widely exists in plants, microbial cells, and animal hearts, livers, spleens, and kidneys. The advantages of this disease are widely used clinically. Coenzyme Q10 has the functions of natural anti-oxidation and activation of cell metabolism, which can significantly improve human immunity. Clinically, it is mainly used for the treatment of scurvy, aplastic anemia, duodenal ulcer, acute and chronic viral hepatitis, subacute liver necrosis, congestive heart disease, emphysema and other diseases, as well as adjuvant treatment for cancer patients. [0004] Coenzyme Q10 is difficult to dissolve in water, and the coenzyme Q10 injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/122A61K9/08A61P39/06A61P37/02A61J1/05
Inventor 刘红潘红春
Owner SOUTHWEST UNIV