CN101677904A - Method for storing the inhalation anesthesia and container thereof - Google Patents

Method for storing the inhalation anesthesia and container thereof Download PDF

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Publication number
CN101677904A
CN101677904A CN200880015836A CN200880015836A CN101677904A CN 101677904 A CN101677904 A CN 101677904A CN 200880015836 A CN200880015836 A CN 200880015836A CN 200880015836 A CN200880015836 A CN 200880015836A CN 101677904 A CN101677904 A CN 101677904A
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CN
China
Prior art keywords
container
lid
inner space
anesthetic
opening
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN200880015836A
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Chinese (zh)
Inventor
蒋素梅
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jiangsu Hengrui Medicine Co Ltd
Original Assignee
Jiangsu Hengrui Medicine Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/CN2007/070900 external-priority patent/WO2009049460A1/en
Application filed by Jiangsu Hengrui Medicine Co Ltd filed Critical Jiangsu Hengrui Medicine Co Ltd
Priority to CN200880015836A priority Critical patent/CN101677904A/en
Publication of CN101677904A publication Critical patent/CN101677904A/en
Pending legal-status Critical Current

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Abstract

The use of a cyclo-olefin copolymer (COC) material for manufacturing a container used to store an anesthetic. Also a container, said container comprising a container body and a cap, wherein the material of the interior surface of said container body is a COC.

Description

Method for storing the inhalation anesthesia and container thereof
Store the method and container technical field of suction-type anesthetic
The present invention relates to by cyclic olefin copolymerized macromolecule, and the material that the graft copolymer of ethene and octene is constituted is manufacturing the purposes in being used to deposit the container of anesthetic, and it is related to a kind of container, it includes container body and container cover, and the wherein material of the inner surface of the container body is to be combined to collectively form by the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene.Background technology
Compound seven fluorine protective embankment [fluoromethyl-1,1,1,3,3,3-hexafluoroisopropylether or (CF3)2CHOCH2F] it is a kind of widely used suction-type anesthetic, it is packaged in glass, in rustless steel container.But have found in some cases, seven fluorine protective embankments can interact with glass container, so as to promote the decomposition of seven fluorine protective embankments.Therefore, this interaction is considered as that decomposition due to seven fluorine protective embankments in the case of it there is lewis acid can produce catabolite such as hydrofluoric acid.
Glass material general at present is type III glass, and this material contains silica, calcium hydroxide, sodium hydroxide and aluminum oxide.The aluminum oxide contained in type III glass can cause lewis acidic effect when being directly exposed in seven fluorine protective embankments, so as to promote the decomposition of seven fluorine protective embankments, the inner surface of the catabolite such as hydrofluoric acid etch glass produced by this decomposition reaction, so that more aluminum oxide are exposed in seven fluorine protective embankments, the decomposition of seven fluorine protective embankments is so further promoted, the use of product is have impact on.
People have done effort, by using it is stable, be not likely to produce lewis acidic container and carry out the fluorine protective embankment of packaging seven, or suppress the decomposition of seven fluorine protective embankments using the Lewis acid inhibitor of sufficient amount, these inventions have all obtained corresponding patent such as CN 1152674C and CN 1170516C, wherein CN 1170516C mainly select the materials such as polyethylene naphthalenedicarboxylate ester, polymethylpentene, polypropylene, polyethylene, ionomeric resins that container is made, and stablizing seven fluorine protective embankments, suppression degraded to guarantee has obvious action.
But packaging material is not limited only to the material described by above-mentioned patent, with the continuous improvement of high polymer material technology, increasing high polymer material is used for Key works Drug packing, and we have also discovered the packaging material of some suitable seven fluorine protective embankments outside the material described in above-mentioned patent.Preferable material is cyclic olefin copolymerized macromolecule（COC), this material is free of the lewis acid that seven fluorine protective embankments can be promoted to decompose, and the fluorine protective embankment of containers store seven is made of this material, is not required to addition lewis acid and suppresses Agent suppresses the decomposition of seven fluorine protective embankments.
Cyclic olefin copolymerized macromolecule (COC) is Ticona（Ticona) company develops, its trade name TOPAS, is the transparent copolymerized macromolecule of amorphism with cyclic olefin structure.Cyclic olefin copolymer belongs to a new range kind of unformed thermoplastic engineering plastics, with very high transparency, moisture barrier, heat distortion temperature（HDT), the features such as chemical proofing.COC has and PMMA (polymethyl methacrylate, acrylic resin）The optical property that is mutually equal to and with higher than PC (makrolon）Heat resistance, also with the dimensional stability more more excellent than PMMA and PC, also with improve vapor air-tightness, increase rigidity, heat resistance, easily assign cutting performance the advantages of.The material of the grades of TOPAS (COC) 8007, which is mainly used in, processes the various bottles for being used to contain anesthetic and medicine, these bottles can be subjected to all method for disinfection progress sterilizing that people are generally used, such as moise-heat sterilization, ethylene oxide sterilization, electronics and gamma-radiation sterilization, therefore, cyclic olefin copolymerized macromolecule (COC) has a wide range of applications in acceptable packaging material field.For glass, stainless steel material, the lewis acid such as its not salic, iron oxide, so as to ensure that the storage stability of seven fluorine protective embankments.
TOPAS has very high security, and specification standards have obtained U.S. FDA certification.
NamSA is tested the samples of TOPAS (COC) 8007, under the use condition of FDA C to H classes, TOPAS (COC) 8007 complies fully with FDA requirement according to American Pharmacopeia.
XOM（ExxonMobile) the Exact of manufactureTMPlastomers is the copolymer of ethene and α-alkene, and it contains the very abundant kind including butylene, hexene, octene co-monomer, and it has following properties：Outstanding low-temperature impact resistance；Low-gravity；It is clean；Outstanding heat sealability；With various base polymer excellent compatibilities；Excellent compliance and puncture resistance；High inorganics filled property；Superior elongation and high resiliency；Brittle and decolouring etc. caused by radiation hardness. ExactTMPlastomers, model:EXACT 5061, is the graft copolymer of ethene and octene（ethylene alpha octene copolymers ).Meet FDA, regulation：21 CFR 177.1520 " olefin polymer " (c) 3.2c, can apply to contact the raw material and article of food.When temperature reaches heat filling or higher than 150 °F (be less than 212 °F), and in the tables 2 of 21 CFR 176.170 by H purposes C under the conditions of, olefin polymer article can contact all food types in table 1 in CFR CFR 176.170 (c).
In our embodiment, selection TOPAS (COC) 8007 and ExactTMPlastomers
The packing container that (EXACT 5061) is made preserves seven fluorine protective embankments.In the packing container, TOPAS (COC) 8007 as main material constituent, and EXACT 5061 is used as auxiliary element, it is therefore an objective to improve the drop resistance of container.The content of the invention
Made up a prescription product the present invention relates to one kind, the product includes：One container, the container material is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene, and the container limits an inner space；And in the fluorine institute of a certain amount of fluoroether-containing inhalation anesthetic seven of the interior volume limited.
The container has the inwall adjacent with the inner space that it is limited, and the inwall of the container is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene；The inner space limited in the container is put into seven fluorine protective embankments of scheduled volume.
The container limits one and is open, and the opening makes the inner space and external environment condition in fluid communication, and for the lid for the opening for sealing container restriction, the material for constituting the lid is high density polyethylene (HDPE)（HDPE), there is gasket seal the inside of the lid, and the pad can be contacted at the top of lid with the fluid in the container.Gasket material is polyethylene terephthalate（PET) film or polyethylene（PE) expanded material.The opening that the container is limited is sealed with the lid with gasket seal.And it is put into seven fluorine protective embankments of scheduled volume in the inner space that the container is limited.
In the present invention, the purposes of container is to hold seven fluorine protective embankments, and container can be general bottle-type or other shapes and capacity.
Have found, use the packing container with the graft copolymer preparation of cyclic olefin copolymerized macromolecule material and ethene and octene has desired vapor barrier properties, chemical compatibility and strength characteristics to hold seven fluorine protective embankments, can prepare the packaging materials such as film, bottle using general method for processing forming.
Use the packing container with the graft copolymer preparation of cyclic olefin copolymerized macromolecule material and ethene and octene has desired vapor barrier properties to hold seven fluorine protective embankments, and lewis acid is not contained, therefore in the absence of the possibility that the seven fluorine protective embankments for making to hold in container are degraded.
The example that can be used in the present invention cyclic olefin copolymerized macromolecule is the Topas 8007 (COC) that Ticona companies of the U.S. are provided, 8007 representatives are a kind of grades, it will be appreciated by those skilled in the art that, under the premise of the scope of scope of the present invention patent restriction is not departed from, the cyclic olefin copolymerized macromolecule of other grades can be used.
The graft copolymer that can be used in the present invention ethene and octene is XOM's manufacture Exact Plastomers, model:EXACT 5061, is the graft copolymer (ethylene alpha octene copolymers) of ethene and octene.
Seven fluorine protective embankments, which are mainly, is used as inhalant, therefore solution is the component that can be volatilized relatively, if the solution is decomposed, its catabolite produced is harmful to human body as the constituents such as hydrofluoric acid are once sucked, therefore, in the packaging of seven fluorine protective embankments in addition to ensureing the high-purity of the fluorine protective embankment of inhalant seven, more to ensure the stability of seven fluorine protective embankment solution.In addition, the seven fluorine protective embankment purity of the present invention are higher than 99.95 wt%, more preferably it is that purity is higher than 99.98 wt%, above-mentioned purity is calculated on the basis of water-free.
It is an advantage of the invention that being packaged in TOPAS (COC) and ExactTMSeven fluorine protective embankments in the container that Plastomers (EXACT 5061) material makes are stable, and this solution is stored in the novel package, are still stablized under 40 °C of high temperature.
The moisture of seven stable fluorine protective embankments of the present invention between 1400 ppm, and packaging or is stored in TOPAS (COC) 8007 and Exact in 150 ppmTMIn the container that Plastomers (EXACT 5061) material is made；In another embodiment, water content is less than 140 ppm.Above-mentioned water content is detected by Karl-Ficher methods.Normal temperature storage is to 6 months or under 40 °C in this embodiment, 20% time storage of relative humidity 6 months, the purity of seven fluorine protective embankments is higher than 99.95 wt%, or even reaches that it is generally desirable to the present invention packs or be stored in TOPAS (COC) 8007 and Exact up to 99.98 wt% oTMThe seven fluorine protective embankments in packing container that Plastomers (EXACT 5061) material is made are non-degradable.
The purpose that following embodiments are merely to illustrate, rather than limitation the scope of the present invention.Embodiment
Embodiment
Embodiment 1
The present embodiment introduction is that water content is stored in TOPAS (COC) 8007 and Exact in 150 ppm to seven fluorine protective embankments between 1400 ppmTMThe stability in container that Plastomers (EXACT 5061) material is made.In the experiment started in January, 2008, detect that seven fluorine protective embankment water content are 165 ppm by Karl-Ficher methods.A seven fluorine protective embankment sample is placed in a container that previously TOPAS (COC) 8007 of dried 2 hours and Exact Plastomers (EXACT 5061) material be made at a temperature of 105 °C, sealing, then sample is placed under 40 °C, under relative humidity 75%, ambient relative humidity is kept.At 6 months, The purity of seven fluorine protective embankments is analyzed with gas chromatography, is as a result 99.959 wt%, effect of not decomposing.Embodiment 2
The present embodiment introduction is that water content is stored in TOPAS (COC) 6013 and Exact in 150 ppm to seven fluorine protective embankments between 1400 ppmTMThe stability in container that Plastomers (EXACT 5061) material is made.In the experiment started in January, 2008, detect that seven fluorine protective embankment water content are 1300 ppm by Karl-Ficher methods.A seven fluorine protective embankment sample is placed on a previously TOPAS (COC) 8007 and Exact of dried 2 hours at a temperature of 105 °CTMIn the container that Plastomers (EXACT 5061) material is made, then sample is placed under 40 °C, relative humidity 75% by sealing.After six months, the purity of seven fluorine protective embankments is analyzed with gas chromatography, is as a result 99.964 wt%, effect of not decomposing.Embodiment 3
The present embodiment introduction is that water content is stored in TOPAS in 140 below ppm seven fluorine protective embankments
(COC) 8007 and ExactTMThe stability in container that Plastomers (EXACT 5061) material is made.In the experiment started at 01 month 2008, detect that seven fluorine protective embankment water content are 80 ppm by Karl-Ficher methods.A seven fluorine protective embankment sample is placed on a previously TOPAS (COC) 8007 and Exact of dried 2 hours at a temperature of 105 °CTMIn the container that Plastomers (EXACT 5061) material is made, seal and packed with thermoplastic film, then sample is placed under 40 °C, under relative humidity 75%, keep ambient relative humidity.After six months, the purity of seven fluorine protective embankments is analyzed with gas chromatography, is as a result 99.959 wt%, effect of not decomposing.Embodiment 4
Other data in following table also demonstrate that seven fluorine protective embankments are stored in TOPAS (COC) 8007 and Exact for a long timeTMThe stability in container that Plastomers (EXACT 5061) material is made.The water content of seven fluorine protective embankments is determined through Karl Fischer methods, and seven fluorine protective embankments are placed on to 250 ml TOPAS (COC) 8007 and ExactTMIn the container that Plastomers (EXACT 5061) material is made, then stability test is carried out under certain condition or under room temperature condition by the fluorine protective embankment of part seven.In all experiments, the purity of seven fluorine protective embankments（Determined by gas chromatography）All illustrate not The effect of decomposing.
Although the invention has been described in detail to embodiment, it is done so that purpose solely for the purpose of illustration, rather than in order to carry out any limitation to the present invention.It will be appreciated by those skilled in the art that all within the scope of the present invention to any change of the invention carried out, change on the basis of the present invention.

Claims (18)

  1. Claims:
    1. the purposes for the material that a kind of graft copolymer by cyclic olefin copolymerized macromolecule and ethene and octene is constituted, for manufacture the container for depositing anesthetic.
    2. purposes as claimed in claim 1, wherein, the anesthetic is fluoro-ether inhalation anesthetic.
    3. purposes as claimed in claim 2, wherein, the fluoro-ether is seven fluorine protective embankments.
    4. a kind of container, including container body and container cover, it is characterised in that the material of the inner surface of the container body is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene.
    5. container as claimed in claim 4, wherein, the container cover carries gasket seal.
    6. the container as described in claim 4 or 5, wherein, the material of the container cover is high density polyethylene (HDPE).
    7. container as claimed in claim 5, wherein, the material of the gasket seal is pet film or polyethylene foam-material.
    The product 8. one kind is made up a prescription, including：
    One container, the container material is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene, and the container limits an inner space, and in a certain amount of fluoroether-containing inhalation anesthetic of the interior volume limited.
    9. the product as claimed in claim 8 that makes up a prescription, wherein, the fluoro-ether inhalation anesthetic burns for seven fluorine.
    10. the product as claimed in claim 8 that makes up a prescription, wherein, the container limits one and is open, and the opening makes the inner space and external environment condition in fluid communication；The product that makes up a prescription also includes the lid with gasket seal, and the lid is used for the opening for sealing the container, and the material of the lid is poly- for high density Ethene.
    11. the product as claimed in claim 8 that makes up a prescription, wherein, the container limits one and is open, and the opening makes the inner space and external environment condition in fluid communication；The product that makes up a prescription also includes a lid, and there is gasket seal the inside of the lid, and the pad can be contacted at the top of the lid with the fluid in the container, wherein, the material of the pad is pet film and polyethylene foam-material.
    12.-kind make up a prescription product, including：
    One defines the container of inner space, the container has inner surface, the inner surface is adjacent with the inner space, and the inner surface is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene, and be put into the container restriction the inner space in scheduled volume seven fluorine protective embankments.
    13. a kind of method for storing the fluorine protective embankment of suction-type anesthetic seven, comprises the following steps：The fluorine protective embankment of anesthetic seven of scheduled volume is provided；The container for defining an inner space is provided, the container is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene；And seven fluorine protective embankments of the scheduled volume are put into the inner space of container restriction.
    14. the method for the fluorine protective embankment of suction-type anesthetic seven is stored as claimed in claim 13, wherein, the container limits one and is open, and the opening makes the inner space and external environment condition in being in fluid communication, and this method is further comprising the steps of：
    A lid for being configured to seal the opening that the container is limited is provided, the material for constituting the lid is high density polyethylene (HDPE)；The opening of container restriction is sealed with the lid.
    15. the method for the fluorine protective embankment of suction-type anesthetic seven is stored as claimed in claim 13, wherein, the container limits one and is open, and the opening makes the inner space and external environment condition in being in fluid communication, and this method is further comprising the steps of：
    One lid for being configured to seal the opening that the container is limited is provided, there is gasket seal the inside of the lid, the pad can be contacted at the top of the lid with the fluid in the container, and the material of the pad is cyclic olefin copolymerized macromolecule and the graft copolymer of ethene and octene；And seal the opening that the container is limited with the lid with gasket seal.
    16. a kind of method for storing the fluorine protective embankment of suction-type anesthetic seven, comprises the following steps：The fluorine protective embankment of anesthetic seven of scheduled volume is provided；The container for defining an inner space is provided, the container has the inwall adjacent with the inner space that it is limited, and the inwall of the container is made up of the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene；And seven fluorine protective embankments of scheduled volume are put into the inner space of container restriction.
    17. the method for the fluorine protective embankment of suction-type anesthetic seven is stored as claimed in claim 16, wherein, the container limits one and is open, and the opening makes the inner space and external environment condition in being in fluid communication, and this method is further comprising the steps of：
    The lid of the opening for sealing container restriction is provided, the material for constituting the lid is high density polyethylene (HDPE).
    18. the method for the fluorine protective embankment of suction-type anesthetic seven is stored as claimed in claim 16, wherein, lid with gasket seal is provided, the lid is the lid for sealing the opening of container restriction, the pad can be contacted at the top of the lid with the fluid in the container, the material of the pad is the graft copolymer of cyclic olefin copolymerized macromolecule and ethene and octene, and seals the opening that the container is limited with the lid with gasket seal.
CN200880015836A 2007-10-15 2008-10-15 Method for storing the inhalation anesthesia and container thereof Pending CN101677904A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN200880015836A CN101677904A (en) 2007-10-15 2008-10-15 Method for storing the inhalation anesthesia and container thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/CN2007/070900 WO2009049460A1 (en) 2007-10-15 2007-10-15 New packaging material for sevoflurane
CNPCT/CN2007/070900 2007-10-15
PCT/CN2008/072687 WO2009052739A1 (en) 2007-10-15 2008-10-15 Method for storing the inhalation anesthesia and container thereof
CN200880015836A CN101677904A (en) 2007-10-15 2008-10-15 Method for storing the inhalation anesthesia and container thereof

Publications (1)

Publication Number Publication Date
CN101677904A true CN101677904A (en) 2010-03-24

Family

ID=42029868

Family Applications (1)

Application Number Title Priority Date Filing Date
CN200880015836A Pending CN101677904A (en) 2007-10-15 2008-10-15 Method for storing the inhalation anesthesia and container thereof

Country Status (1)

Country Link
CN (1) CN101677904A (en)

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