CA2199303C - Sanitary container and production process thereof - Google Patents

Sanitary container and production process thereof Download PDF

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Publication number
CA2199303C
CA2199303C CA002199303A CA2199303A CA2199303C CA 2199303 C CA2199303 C CA 2199303C CA 002199303 A CA002199303 A CA 002199303A CA 2199303 A CA2199303 A CA 2199303A CA 2199303 C CA2199303 C CA 2199303C
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Prior art keywords
pigment
plastic
container
sanitary container
pigment yellow
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Expired - Lifetime
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CA002199303A
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French (fr)
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CA2199303A1 (en
Inventor
Morihiro Sudo
Yasushi Kawachi
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Daikyo Seiko Ltd
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Daikyo Seiko Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/02Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/30Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants by excluding light or other outside radiation
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08KUse of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00Use of organic ingredients
    • C08K5/0008Organic ingredients according to more than one of the "one dot" groups of C08K5/01 - C08K5/59
    • C08K5/0041Optical brightening agents, organic pigments
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1372Randomly noninterengaged or randomly contacting fibers, filaments, particles, or flakes

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Polymers & Plastics (AREA)
  • Ceramic Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Packages (AREA)
  • Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
  • General Preparation And Processing Of Foods (AREA)

Abstract

A sanitary container is molded from a plastic, for example, a cyclic olefin polymer or a hydrogenation product thereof. The plastic has been added with at least one pigment selected from the group consisting of C.I. Pigment Yellow 147, C.I. Pigment Yellow 180 and C.I. Pigment Yellow 181. The content of the at least one pigment may preferably range from 0.01 to 0.3 wt.%
based the plastic. The sanitary container can cut off ultraviolet rays with coloration of such an extent as still permitting easy visual recognition of its content.
Use of the sanitary container therefore makes it possible to stably store a material requiring sanitation such as a medicine such as a vaccine, antibiotic, vitamin, saccharide, amino acid or electrolyte, a nutrient solution, a transfusion solution, a cosmetic, a food such as a seasoning agent, or the like or a material similar to the above-mentioned material over a long period of time while maintaining cleanliness.

Description

~~~~~~03 SANITARY CONTAINER
BACKGROUND OF THE INVENTION
a) Field of the Invention This invention relates to a plastic-made sanitary container capable of stably storing a medicine such as a vaccine, antibiotic, vitamin or amino acid, a nutrient solution, a transfusion solution, a cosmetic, a food such as a seasoning agent, or the like over a long period of time while maintaining cleanliness.
b) Description of the Related Art Medicines, foods, cosmetics and other sanitary products have conventionally been stored in sanitary containers in many instances. Such sanitary containers must be able to protect their contents from intrusion of microorganisms and also to prevent their contents from a quality change, deterioration or the like by ultraviolet rays or the like.
The intrusion of microorganisms into a container is prevented by sealing the container or hermetically closing the container with a rubber plug or the like, whereas the quality change, deterioration or the like of a content by ultraviolet rays or the like is avoided by adding a deterioration preventive to the content or adding an ultraviolet absorber to a sanitary container ~~ 993x3 itself.
Incidentally, glass-made containers have conven-tionally been used for many years as containers most suited from viewpoint of sanitation for medicines, nutrient solutions, transfusion solutions, foods and the like.
Glass-made containers are often made of soda-lime glass (soft glass), because soda-lime glass as a raw material for the glass-made containers permits easy melting and molding, has chemical durability and is of low price. A container made of soft glass may however undergo a quality or property change at a glass surface thereof by moisture in the surrounding atmosphere or by a solution contained therein. Described specifically, the glass may be hydrolyzed with water so that an alkali (Na+) may be dissolved out into the solution contained in the container or tiny chips called "flakes" may be formed.
Upon use of a glass-made container as a container for a sanitary product such as a medicine, the glass-made container may be subjected at an inner wall there-of to bloom treatment that the inner wall is treated with sulfur, sulfurous acid gas, ammonium sulfate or the like to eliminate alkalis, or a pH-regulating buff-er, a quality or property change preventive or the like may be added to the content.
On the other hand, a container made of borosili-Gate glass (hard glass) undergoes alkali dissolution or flake formation, such as that mentioned above, less compared with a container made of soft glass. Hard glass is therefore most suited for the production of containers (ampoules) for injectable preparations, which containers (ampoules) require higher chemical durability. If the temperature or time is inadequate upon processing such as production of a container, hard glass may also become non-uniform in its glass struc-ture so that an alkali may be dissolved out from an in-ner wall of the container or flakes may be formed from the inner wall of the container. To cope with this potential problem, surface treatment such as bloom treatment or fluoride treatment may be applied to the inner wall of the container, or silica coating or the like may be performed by coating Si02 on the inner wall of the container by a CVD process or the like to form a coating of Si02 there.
If a medicine, food or the like in a glass-made container is inferior in light resistance (ultraviolet light resistance), the transparency as a merit of the glass-made container conversely acts as a demerit.
Iron-manganese compound or the like is therefore added d ~~' X9303 to glass so that the glass-made container is used as a colored, light-shielding glass-made container. In this case, however, there is a potential problem that these metals may mix in the content such as the medicine or food.
In addition to the above-described problem of dissolution-out of alkalis on glass-made containers, there is another potential problem that may arise upon opening glass-made ampoules. Recent ampoules include lp an increasing number of ampoules which like ampoules of the easy-cut type, can be easily opened without using any special tool. It has however been pointed out that like conventional ampoules, such recent ampoules also become dangerous due to formation of sharp edges at cut faces and upon being cut, they form glass chips having a potential danger when mixed in medicine solutions. A
glass-made container may have a still further problem that depending on the kind of a medicine, the glass-made container may adsorb thereon the medicine in a greater amount than a plastic-made container.
Concerning the quality of glass upon its use as a material for medicine containers, various standard values are specified from the standpoints of safety and sanitation under the "Testing Method for Glass Con-tainers for Injectable Preparations" in The Pharma-~~~~a~
copoeia of Japan (thirteenth edition) (hereinafter ab-breviated as "JP13") and also in the United States Pharmacopeia XXIII (hereinafter abbreviated as "USP"), the British Pharmacopoeia (hereinafter abbreviated as "BP"), and the like.
To avoid such problems, there is now an increas-ing tendency to adopt plastic-made containers in place of glass-made containers. As official standards for plastic-made containers, there are standards for polyethylene (PE), polypropylene (PP) and polyvinyl chloride (PVC) as specified in the eighth edition of the Pharmacopoeia of Japan (1971). Further, testing methods for plastic containers for transfusion solu-tions are also specified in the USP 17, the BS, the Pharmacopoeia of France, the Pharmacopoeia of Switzer-land, Deutsche Industrie Norm (DIN - German Industrial Standards) (DIN58365), etc. They are also specified in Notification No. 370 of the Ministry of Health and Wel-fare issued under the Food Sanitation Law, Notification No. 20 of the same Ministry issued under the same Law (February, 1982), and the Food Additive Support F of U.S. Food and Drug Administration (FDA).
Plastics have an advantage over glass in that the former are lighter in weight than the latter. On the other hand, plastics are accompanied by disadvantages ~~_9~303 such that depending on the kinds of the plastics, they have poor moldability or formability and/or can provide only molded or otherwise formed products having in-sufficient strength and/or inferior gas transmission 5~ resistance and/or water vapor transmission resistance.
Moreover, plastics are also inferior in ultraviolet ray transmission resistance (ultraviolet ray shielding property) to glass. It was therefore the situation that no plastics equipped in a well-balanced manner with properties required for sanitary containers had been found yet [see Japanese Patent Application Laid-Open (Kokai) No. HEI 5-293159].
Incidentally, concerning the light-shielding property (ultraviolet ray transmission resistance) of a colored container, the "Testing Method for Glass Con-tainers for Injectable Preparations" in The Pharma-copoeia of Japan (thirteenth edition) specifies that the transmission rate should be 50% or lower at wavelengths of from 290 to 450 nm and 60% or higher (45% or higher in the case of a container having a wall thickness of 1.0 mm or greater) at wavelengths of form 590 to 610 nm. On the other hand, it is also specified in the USP that the transmission rate of a plastic-made container should be 15% or lower at wavelengths of from 290 to 450 nm.
Under the foregoing situation, the present applicant found that a cyclic olefin polymer is suited as a plastic for sanitary containers.
However, the cyclic olefin polymer has poor resistance to ultraviolet ray transmission (ultraviolet shielding property) like conventional plastics, and hence sanitary containers made of the cyclic olefin polymer have a potential problem in that their contents may be changed or deteriorated in quality by such rays.
t0 SUMMARY OF THE INVENTION
The present inventors therefore proceeded with extensive research to impart ultraviolet ray transmission resistance (ultraviolet ray shielding property) to plastic-made sanitary containers. As a result, it has been found that a certain type of organic pigments are significantly effective in blocking ultraviolet rays without lowering the transparency of plastics.
In one aspect of the present invention, there is thus provided a sanitary container molded from a plastic and including at least one pigment selected from the group consisting of C.I. Pigment Yellow 147, C.I. Pigment Yellow 180 and C.I. Pigment Yellow 181. More specifically, the plastic is selected from the group consisting of cyclic olefin polymers and hydrogenation products of cyclic olefin polymers.

_$_ The sanitary container according to the present invention can cut off ultraviolet rays with coloration of such an extent as still permitting easy visual recognition of its content.
5w Use of the sanitary container according to the present invention therefore makes it possible to stably store a material legally regulated under the Pharma-copoeia of Japan, the Food Sanitation Law or the like, for example, a material requiring sanitation such as a medicine such as a vaccine, antibiotic, vitamin, sac-charide, amino acid or electrolyte, a nutrient solu-tion, a transfusion solution, a cosmetic, a food such as a seasoning agent, or the like or a material similar to the above-mentioned material over a long period of time while maintaining cleanliness.
DETAILED DESCRIPTION OF THE INVENTION
AND PREFERRED EMBODIMENTS
The present invention will next be described spe-cifically by referring to certain embodiments of the present invention.
Examples of the plastic useful for the production of the plastic-made sanitary container in the present invention include those conventionally employed for the production of sanitary containers, such as PE, PP, PVC

~~'~ ~93Q3 - g _ and PET (polyethylene terephthalate), and cyclic olefin polymers and hydrogenation products thereof. Particu-larly preferred for the object of the present invention are cyclic olefin polymers and hydrogenation products thereof.
The cyclic olefin polymers or the hydrogenation products thereof can be ring-opened homopolymers of cyclic olefin monomers, ring-opened copolymers of cyclic olefin monomers and other monomers, addition homopolymers of cyclic olefin monomers, addition copolymers of cyclic olefin monomers and other monomers, and hydrogenation products of such homopolymers or copolymers.
The above cyclic olefin monomers include monocyclic olefin monomers, and polycyclic olefin monomers including bicyclic and higher cyclic com-pounds, as will be exemplified below.
Illustrative of the monocyclic olefin monomers usable for the production of the homopolymers or copolymers of the cyclic olefin monomers are monocyclic olefin monomers such as cyclopentene, cyclopentadiene, cyclohexene, methylcyclohexene and cyclooctene: lower-alkyl derivatives thereof containing, as substituent groups, 1 to 3 lower alkyl groups such as methyl and/or ethyl groups; and acrylate derivatives thereof.

n~'~~93d3 Illustrative of the polycyclic olefin monomers are dicyclopentadiene, 2,3-dihydrocyclopentadiene, bicyclo[2,2,1]-hepto-2-ene and derivatives thereof, tricyclo[4,3,0,12 5]-3-decene and derivatives thereof, tricyclo[4,4,0,125]-3-undecene and derivatives there-of, tetracyclo[4,4,0,125,07.10]_3_dodecene and deriva-tives thereof, pentacyclo[6,5,1,136,02,7,09.13]_4_ pentadecene and derivatives thereof, pentacyclo[7,4, 0,125,0,0813,19~12]-3-pentadecene and derivatives '10 thereof, and hexacyclo[6,6,1,13~6,110,13~02,7~~9,14]-4_ heptadecene and derivatives thereof.
Examples of bicyclo[2,2,1]-hepto-2-ene deriva-tives include 5-methyl-bicyclo[2,2,1]-hepto-2-ene, 5-methoxy-bicyclo[2,2,1]-hepto-2-ene, 5-ethylidene-bicyclo[2,2,1]-hepto-2-ene, 5-phenyl-bicyclo[2,2,1]-hepto-2-ene, and 6-methoxycarbonyl-bicyclo[2,2,1]-hepto-2-ene.
Examples of tricyclo[4,3,0,125]-3-decene deriva-tives include 2-methyl-tricyclo[4,3,0,125]-3-decene and 5-methyl-tricyclo[4,3,0,12 5]-3-decene.
Examples of tetracyclo[4,4,0,12 5]-3-undecene derivatives include 10-methyl-tetracyclo[4,4,0,125]-3-undecene, and examples of tricyclo[4,3,0,125]-3-decene derivatives include 5-methyl-tricyclo[4,3,0,125]-3-decene.

~ ~~~o ~

Examples of tetracyclo[4,4,0,125,07.10]_3_ dodecene derivatives include 8-ethylidene-tetracyclo-[4,4,0,12.5,07,10]-3-dodecene, 8-methyl-tetracyclo-[4,4,0,12~5,07.1OJ_3-dodecene, 9-methyl-8-methoxy-carbonyl-tetracyclo[4,4,0,12.5,07.10]_3-dodecene, 5,10-dimethyl-tetracyclo[4,4,0,12.5,07,10]_3_dodecene.
Examples of hexacyclo[6,6,1,13~6,110,13~02,7~
09~14]-4-heptadecene derivatives include 12-methyl-hexacyclo[6,6,1,136,110,13~02,7~09,14]-4-heptadecene and 1,6-dimethyl-hexacyclo[6,6,1,13~6,110,13~02,7~
09,14]-4-heptadecene.
One example of the cyclic olefin polymer is an addition homopolymer of at least one cyclic olefin monomer or an addition copolymer of at least one cyclic olefin monomer and at least one other olefin monomer (for example, ethylene, propylene, 4-methylpentene-1, cyclopentene, cyclooctene, butadiene, isoprene, styrene or the like). This homopolymer or copolymer can be ob-tained by polymerizing the above monomer or monomers, for example, while using as a catalyst a known catalyst which is soluble in a hydrocarbon solvent and is com-posed of a vanadium compound or the like and an organoaluminum compound or the like [Japanese Patent Application Laid-Open (Kokai) No. HEI 6-157672, Japa-nese Patent Application Laid-Open (Kokai) No. HEI 5-~~~o~

43663, etc.].
Another example of the cyclic olefin polymer is a ring-opened homopolymer of the above monomer or a ring-opened copolymer of the above monomers. It can be ob-tained by homopolymerizing the above monomer or copolymerizing the above monomers, for example, while using as a catalyst a known catalyst such as (1) a catalyst composed of a halide or the nitrate of a platinum group metal such as ruthenium, rhodium, pal-'10 ladium, osmium or platinum and a reducing agent or (2) a catalyst composed of a compound of a transition metal such as titanium, molybdenum or tungsten and an organometal compound of a metal in one of Groups I to IV of the periodic table such as an organoaluminum com-pound or organotin compound [Japanese Patent Applica-tion Laid-Open (Kokai) No. HEI 6-157672, Japanese Patent Application Laid-Open (Kokai) No. HEI 5-43663, etc.].
Where the homopolymer or copolymer obtained as .:20 described above contains unsaturated bonds, the homopolymer or copolymer is hydrogenated by using a known hydrogenation catalyst. Examples of the hydrogenation catalyst include (1) Ziegler-type homogeneous catalysts which are each composed of an organic acid salt of titanium, cobalt, nickel or the ~~~A~

like and an organometal compound of lithium, aluminum or the like, (2) supported catalysts which are each composed of a carrier such as carbon or alumina and a platinum metal such as palladium or ruthenium supported on the carrier, and (3) catalysts which are each com-posed of a complex of one of the above-described platinum group metal [Japanese Patent Application Laid-Open (Kokai) No. HEI 6-157672].
In the present invention, examples of the above-described hydrogenated homopolymer or copolymer include ring-opened homopolymers or copolymers and addition homopolymers or copolymers of polycyclic saturated hydrocarbon compounds containing two or more rings, which polycyclic saturated hydrocarbon compounds may have one or more substituent groups containing a polymerizable double bond.
Examples of such polycyclic hydrocarbon compounds include tricyclo[4,3,0,12 5]-decane, bis(allyloxy-carboxy)-tricyclo[4,3,0,12 5]-decane, bis(methacryl-oxy)-tricyclo[4,3,0,125]-decane, and bis(acryloxy)-tricyclo[4,3,0,12~5]-decane.
The pigment, which is added to the above-described plastic to reduce the transmission of ultra-violet rays in the present invention, is C.I. Pigment Yellow 147 [chemical name: 1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)-diimino]bis-9,10-anthracenedione], C.I. Pigment Yellow 180 [chemical name: 2,2'-[1,2-ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutanamide], C.I. Pig-went Yellow 181 [chemical name: N-[4-(aminocarbonyl)-phenyl]-4-[[1-[[2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide], or a mixture thereof. These pigments are represented by the below-described structural formulas, respectively.
Needless to say, these pigments are all readily avail-able on the market for use in the present invention and have no problem in safety and sanitation.
C.I. Pigment Yellow 147 O
''~YN °"o°
Ph C.I. Pigment Yellow 180 H H
NwC ,O
N O NHCO i H-N N ~CHZ~ N~1-- i HCONH N
H \ H

CH3 O ~ CHy C.I. Pictment Yellow 181 H
NwC
HZN-C O -C O =~V--CH-CONH N
H ~~ I O H
O O C~

No particular limitation is imposed on the amount of the pigment to be used. However, an unduly small amount cannot provide sufficient light-shielding prop-erty (ultraviolet ray transmission resistance) but an unduly large amount makes the coloration excessively deep and hence makes difficult the visibility of the content of the container. A preferred amount ranges from 0.01 to 0.3 wt.% based on the plastic. To facili-tate dispersion of the pigment in the plastic upon molding the container, it is preferred to knead the pigment with a vehicle resin in advance so that the pigment can be used as a high-concentration master batch (pigment concentration: 10 to 60 wt.%).
The plastic-made sanitary container according to the present invention can be produced by suitably ad-ding the above-described pigment and a phenol-base, thioether-base, phosphorus-base or the like age resister, an ultraviolet absorber, a higher fatty acid or an ester thereof and a processing aid such as a silicone oil, as needed, to the plastic, mixing and kneading the resultant mixture into a compound (com-position) in a conventional mixer such as a kneader, roll mixer or extruder, and then forming the compound into the container of a desired shape by one of various molding processes such as injection molding, combined injection-blow molding and combined extrusion-blow molding. It is to be noted that no particular limita-tion is imposed on the shape or the like and the mold-ing process of the container in the present invention.
Plastic-made sanitary containers according to the present invention can be used as containers of various shapes, for example, as containers for medicines, nutrient solutions and transfusion solutions, such as ampoules and vials: as contains for syringes; as con-tainers for various cosmetics; and as containers for various foods such as oils and soy sauce, for example, bottles.
The present invention will next be described spe-cifically by the following examples and comparative ex-ample, in which the designations of "part" or "parts"
and "%" are by weight basis unless otherwise specifi-cally indicated.
Example 1 Compounds with C.I. Pigment Yellow 147 ("Filester ~~~~93~~

Yellow RN", trade name; product of Ciba-Geigy Japan Limited) added in amounts of 0.05%, 0.1% and 0.2%, respectively, per 100 parts of a cyclic olefin polymer containing 0.2 part of an age resister ("Zeonex", trademark; product of Nippon Zeon Co., Ltd.) were pro-duced using a Brabender Plastograph. Using those com-pounds, vials of 25 mL in capacity were produced by injection molding. Those vials became deeper in yel-lowish coloration with the content of the pigment, but retained transparency.
At the same time, 2-mm thick sheets were also formed from the respective compounds by press forming.
With respect to each of the sheets, its light transmis-sion rate was measured at wavelengths of from 290 to 450 nm and also at wavelengths of from 590 to 610 nm by a double-beam spectrophotometer ("Model 150-20", trade name; manufactured by Hitachi Ltd.). The results are shown below in Table 1.
Table 1 Transmission rate i of light (%) gment Content of p 290-450 nm 590-610 nm (%) 0 90> >90 0.05 35 >85 0.1 15 >75 0.2 10 >45 ~~ ~~~o ~

Example 2 Vials were produced in the same manner as in Ex-ample 1 except for the use of C.I. Pigment Yellow 180 instead of C.I. Pigment Yellow 147. Those vials became deeper in yellowish coloration with the content of the pigment, but retained transparency.
At the same time, 2-mm thick sheets were also formed from the same compounds, respectively, by press forming. With respect to each of the sheets, its light transmission rate was measured at wavelengths of from 290 to 450 nm and also at wavelengths of from 590 to 610 nm by the double-beam spectrophotometer ("Model 150-20", trade name: manufactured by Hitachi Ltd.).
The results were substantially the same as those ob-tained in Example 1.
Example 3 Vials were produced in the same manner as in Ex-ample 1 except for the use of C.I. Pigment Yellow 181 instead of C.I. Pigment Yellow 147. Those vials became deeper in yellowish coloration with the content of the pigment, but retained transparency.
At the same time, 2-mm thick sheets were also formed from the same compounds, respectively, by press forming. With respect to each of the sheets, its light transmission rate was measured at wavelengths of from ~ ~~ ~~~a ~

290 to 450 nm and also at wavelengths of from 590 to 610 nm by the double-beam spectrophotometer ("Model 150-20", trade name; manufactured by Hitachi Ltd.).
The results were substantially the same as those ob-tained in Example 1.
Example 4 Vials were produced in the same manner as in Ex-ample 1 except for the use of another cyclic olefin polymer ("APEL COC", trade name; product of Mitsui Petrochemical Industries, Ltd:) instead of the cyclic olefin polymer. Those vials became deeper in yellowish coloration with the content of the pigment, but retained transparency.
At the same time, 2-mm thick sheets were also formed from the respective compounds by press forming.
With respect to each of the sheets, its light transmis-sion rate was measured at wavelengths of from 290 to 450 nm and also at wavelengths of from 590 to 610 nm by a double-beam spectrophotometer ("Model 150-20", trade name; manufactured by Hitachi Ltd.). The results were substantially the same as those obtained in Example 1.
Comparative Example 1 Vials were produced in the same manner as in Ex-ample 1 except for the omission of the pigment.
Comparative Example 2 Vials were produced in the same manner as in Ex-ample 4 except for the omission of the pigment.
Comparative Example 3 Vials were produced in the same manner as in Ex-ample 1 except that instead of the pigment, 2-hydroxy-4-methoxybenzophenone ("Biosorb-100", trade name; pro-duct of Kyodo Chemical Co., Ltd.), an ultraviolet ab-sorber, was used in an amount of 0.2%.
Tests The vials obtained above in Examples 1-4 and Com-parative Examples 1-3 were subjected to the below-described tests after they had been thoroughly washed.
With respect to Examples 1-4, the tests were conducted on the vials which had the pigment concentration of 0.2%.
(1) Dissolution test:
A dissolution test was conducted following the "Testing Method for Plastic Containers for Aqueous In-fusions" prescribed in the Pharmacopoeia of Japan, Twelfth Edition.
(2) Quantity of fine particles:
Each vial was filled with 20 ml of dust-free water. After the vial was shaken for 10 minutes on a shaking machine, the vial was left standstill for 1 hour, and fine particles in the water, said fine parti-cles.being of 2.5 ~m or greater in particle size, were counted by a light-shielded, automatic fine particle counter (manufactured by HIAC Corp.) (3) Adsorption test of medical solution:
An ampoule of "Contomin Injection" (trade name;
product of Yoshitomi Pharmaceutical Industrial Co., Ltd.), which contained chlorpromazine hydrochloride at a concentration of 25 mg/5 ml, was added to physiological saline. The resulting solution was ad-justed to pH 7.0 with a hydrogen ion concentration regulator (product of Wako Pure Chemical Industries, Ltd.) to provide 500 mt of a testing medical solution.
Each vial was filled with this testing medical solu-tion, sealed by a rubber plug which was covered with a fluorinated resin film, and was allowed to stand for 10 months at room temperature. The content of chlor-promazine hydrochloride in the vial was determined by measuring an absorption of the testing medical solution at a wavelength of 245 nm by a spectrophotometer ("Model W2100", trade name; manufactured by Shimadzu Corp.). Assuming that the concentration of chlor-promazine hydrochloride immediately after the filling was 100%, an adsorbed quantity was expressed in terms of a decrease (%) in the concentration of chlor-promazine hydrochloride after allowed to stand for 10 ~~~~o~o~

months.
(4) Photo-deterioration test:
In a similar manner as the preparation of the medical solution in the above-described adsorption test, a medical solution containing vitamin K1 and vitamin B2 was prepared. Each vial was filled with this medical solution, followed by the exposure to ultraviolet rays (principal wavelengths: 340 to 450 nm) for 36 hours under a sunshine weatherometer ("We-SUN-He", trade name; manufactured by Suga Shikenki K.K.).
After the exposure, an adsorbed quantity of the medical solution [as measured in the same manner as in the above-described adsorption test (3)] and photo-degradations of vitamin K1 and vitamin B2 were determined. During the test, each vial was kept plugged. Incidentally, the photo-degradations of vitamin K1 and vitamin B2 were determined by the fol-lowing methods:
(a) Vitamin K1 The concentration of vitamin K1 still remaining in the medical solution in each vial after the exposure was measured at a wavelength of 254 nm by a UV detec-tor. Assuming that the concentration of vitamin K1 be-fore the exposure was 100%, the concentration of vitamin K1 after the exposure was expressed in terms of percentage (%).
(b) Vitamin B2 The concentration of vitamin B2 still remaining in the medical solution in each vial after the exposure was measured at a wavelength of 445 nm by an automatic spectrophotometer ("Model EPS-3T", trade name; manufac-tured by Hitachi Ltd.). Assuming that the concentra-tion of vitamin B2 before the exposure was 100%, the concentration of vitamin B2 after the exposure was ex-pressed in terms of percentage (%).
The results of the above tests are shown below in Table 2. ' It is evident from the results of the tests that the container according to the present invention can pass the dissolution test prescribed in the Pharma-copoeia of Japan and has excellent ultraviolet ray shielding property.

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Claims (7)

1. A sanitary container molded from a plastic, and including an ultraviolet ray shielding-effective amount of at least one pigment selected from the group consisting of C.I. Pigment Yellow 147, C.I. Pigment Yellow 180 and C.I.
Pigment Yellow 181, wherein said plastic is selected from the group consisting of cyclic olefin polymers and hydrogenation products of cyclic olefin polymers.
2. The sanitary container according to claim 1, wherein the pigment is Pigment Yellow 147.
3. The sanitary container according to claim 1, wherein the pigment is C.I. Pigment Yellow 180.
4. The sanitary container according to claim 1, wherein the pigment is C.I. Pigment Yellow 181.
5. The sanitary container according to any one of claims 1 to 4, wherein the container is transparent.
6. The sanitary container according to any one of claims 1 to 5, wherein the content of said at least on pigment is from 0.01 to 0.3 wt. % based on the plastic.
7. A sanitary container according to any one of claims 1 to 6, further including a product enclosed in the sanitary container.
CA002199303A 1996-08-19 1997-03-06 Sanitary container and production process thereof Expired - Lifetime CA2199303C (en)

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JP234667/1996 1996-08-19
JP23466796 1996-08-19

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EP0825223B1 (en) 2009-08-26
CA2199303A1 (en) 1998-02-19
DE69739549D1 (en) 2009-10-08
JPH10114374A (en) 1998-05-06
DK0825223T3 (en) 2009-11-09
ATE440898T1 (en) 2009-09-15
US6171670B1 (en) 2001-01-09
EP0825223A1 (en) 1998-02-25

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