Antimicrobial composition and container

Abstract

One embodiment of the present invention pertains to: an antimicrobial composition containing a resin and an aluminum sulfate compound; or a container for a pharmaceutical product, a quasi-pharmaceutical product, or a cosmetic, formed from the antimicrobial composition.

Description

Antimicrobial composition and container

[0001] One embodiment of the present invention relates to an antimicrobial composition or container.

[0002] In recent years, the number of processed products made from functional resins has been increasing, and in particular, antibacterial processed products made from resins with antibacterial functions are widely used in ordinary households. Known methods for imparting antibacterial functions to resins include forming a coating film containing an antibacterial agent on the surface of the resin and mixing an antibacterial agent into the resin.

[0003] As the antibacterial agent, organic antibacterial agents and inorganic antibacterial agents are known, but inorganic antibacterial agents such as silver-based antibacterial agents and zinc-based antibacterial agents are used because of their high antibacterial effect and high safety, etc. For example, Patent Document 1 discloses an eye dropper container formed of a resin containing silver-supported zirconium phosphate.

[0004] International Publication No. 2019 / 107569

[0005] However, when an inorganic antibacterial agent is mixed into a resin, since the antibacterial agent is an inorganic solid, it has poor dispersibility in the organic resin, and the antibacterial effect is not fully exerted, and there are problems such as discoloration (including cloudiness) and powdering of the resulting composition.

[0006] One embodiment of the present invention provides an antibacterial composition that contains a resin and an inorganic antibacterial agent, yet has excellent antibacterial effect and is suppressed from causing poor appearance.

[0007] A configuration example of the present invention is as follows.

[0008] [1] An antibacterial composition comprising a resin and an aluminum sulfate compound.

[0009] [2] The antibacterial composition according to [1], wherein the content of the aluminum sulfate compound is 0.09 to 5 parts by mass per 100 parts by mass of the resin.

[0010] [3] The antibacterial composition according to [1] or [2], wherein the resin comprises an ethylene-based resin or a propylene-based resin.

[0011] [4] A container for a pharmaceutical product, a quasi-drug product, or a cosmetic product formed from the antibacterial composition according to any one of [1] to [3].

[0012] According to one embodiment of the present invention, it is possible to provide an antibacterial composition that contains a resin and an inorganic antibacterial agent, yet has excellent antibacterial effect and is suppressed from causing poor appearance. According to one embodiment of the present invention, it is possible to provide an antibacterial composition that can be formed into a container that satisfies the requirements of the eluate test (pH) and ignition residue specified in Yakuhatsu No. 336.

[0013] Fig. 1 is a front view showing an example of an eye drop container with an inner stopper fitted into a container body, Fig. 2 is a cross-sectional explanatory view showing an example of an eye drop container with an inner stopper fitted into a container body, and Fig. 3 is a cross-sectional explanatory view showing an example of an eye drop container having a container body, an eye drop nozzle, and a cap.

[0014] <<Antibacterial Composition>> An antibacterial composition according to one embodiment of the present invention (hereinafter also referred to as "the composition") contains a resin and an aluminum sulfate compound.

[0015] The antibacterial activity value of the present composition is preferably 2.0 or more. The present composition having an antibacterial activity value in the above range can be said to have excellent antibacterial effect. The antibacterial activity value is specifically measured by the method described in the examples below.

[0016] <Resin> The resin is not particularly limited, and various thermoplastic resins or thermosetting resins can be used depending on the intended use of the composition. The resin used in the composition may be one type or two or more types.

[0017] Examples of the thermoplastic resin include α-olefin resins (e.g., ethylene resins, propylene resins), cyclic olefin resins (e.g., COP, COC), vinylcyclohexane (block) copolymers, diene resins (e.g., polyisoprene, polybutadiene), chlorine-containing resins (e.g., chlorinated polyethylene, polyvinyl chloride), styrene resins (acrylonitrile-styrene resin [AS resin], acrylonitrile-butadiene-styrene resin [ABS resin], methyl methacrylate-butadiene-styrene resin [MBS resin], methyl methacrylate-acrylonitrile-butadiene-styrene resin [MABS resin], acrylonitrile-acrylic rubber-styrene resin [AS resin], acrylonitrile-butadiene-styrene resin [MABS resin], acrylonitrile-acrylic rubber-styrene resin [AS resin], acrylonitrile-butadiene-styrene resin [ABS resin], methyl methacrylate-acrylonitrile-butadiene-styrene resin [MABS resin], acrylonitrile-acrylic rubber-styrene resin [AS resin], acrylonitrile-acrylic rubber-styrene resin [MABS ... Examples of suitable resins include polyethylene terephthalate (AAS resin), (meth)acrylic resins, ester resins (e.g., polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate), polycarbonate, polyphenylene ether, modified polyphenylene ether, amide resins (e.g., aliphatic polyamide, aromatic polyamide), polyphenylene sulfide, polyimide, polyether ether ketone, polysulfone, polyarylate, polyether ketone, polyether nitrile, polythioether sulfone, polyether sulfone, polybenzimidazole, polyamide imide, polyether imide, polyacetal, liquid crystal polymer, and thermoplastic polyurethane.

[0018] Examples of the thermosetting resin include polyurethane, phenol resin, melamine resin, urea resin, unsaturated polyester resin, diallyl phthalate resin, silicone resin, fluorine resin, and epoxy resin.

[0019] The resin may be a resin using only biomass-derived raw materials as its raw materials (e.g., olefin), a resin using only fossil fuel-derived raw materials, or a resin using both biomass-derived raw materials and fossil fuel-derived raw materials. The resin using biomass-derived raw materials is preferred from the viewpoint of reducing environmental load (mainly greenhouse gas reduction).

[0020] Among these, the resin is preferably a thermoplastic resin, more preferably an α-olefin resin, a cyclic olefin resin, or a vinylcyclohexane (block) copolymer, and even more preferably an α-olefin resin, from the viewpoint that a molded article (particularly a container) having a desired shape can be easily formed by a molding method such as injection molding.

[0021] α-Olefin Resin Suitable examples of the α-olefin resin include ethylene resins and propylene resins.

[0022] Ethylene-based resins are resins whose main component is a structural unit derived from ethylene, and specific examples thereof include ethylene homopolymers and copolymers of ethylene with one or more monomers other than ethylene (ethylene copolymers).Specific examples of ethylene-based resins include high-density polyethylene (HDPE), medium-density polyethylene (MDPE), low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE).

[0023] Examples of the other monomers include propylene and α-olefins having 4 to 20 carbon atoms. Examples of the α-olefins having 4 to 20 carbon atoms include 1-butene, 1-pentene, 3-methyl-1-butene, 1-hexene, 4-methyl-1-pentene, 3-methyl-1-pentene, 1-octene, 1-decene, 1-dodecene, 1-tetradecene, 1-hexadecene, 1-octadecene, and 1-eicosene. Preferred examples of the other monomers include propylene, 1-butene, 1-hexene, and 4-methyl-1-pentene, and more preferably propylene. One or more types of the other monomers can be used.

[0024] Polypropylene-based resins are resins whose main component is a structural unit derived from propylene, and specific examples include propylene homopolymers and copolymers of propylene and one or more comonomers other than propylene (propylene copolymers).

[0025] The stereoregularity of the polypropylene resin is not particularly limited, and the propylene copolymer may be a random copolymer or a block copolymer, but is preferably a random copolymer.

[0026] Examples of the comonomer include ethylene and α-olefins having 4 to 20 carbon atoms. Examples of the α-olefins having 4 to 20 carbon atoms include the same α-olefins as the α-olefins having 4 to 20 carbon atoms listed in the section on ethylene-based resins. Preferred examples of the comonomer include ethylene, 1-butene, 1-hexene, and 4-methyl-1-pentene, and ethylene is more preferred. One or more types of the comonomers can be used.

[0027] The content of the comonomer-derived structural units in the propylene copolymer is preferably 4.0% by mass or less, more preferably 3.8% by mass or less, and even more preferably 3.5% by mass or less, relative to 100% by mass of all structural units constituting the propylene copolymer, from the viewpoint of being able to reduce the amount of impurities eluted from the composition and molded articles obtained from the composition, and the lower limit thereof is not particularly limited, but is, for example, 1.0% by mass.

[0028] Cyclic olefin resins Examples of the cyclic olefin resins include COP and COC. COPs include resins obtained by (co)polymerizing one or more cyclic olefins, or hydrogenated versions of such resins. COCs include resins obtained by copolymerizing one or more cyclic olefins with one or more monomers copolymerizable with the cyclic olefin, or hydrogenated versions of such resins. Furthermore, the cyclic olefin resin may be a graft-modified product obtained by modifying the resin or its hydrogenated version with an unsaturated carboxylic acid or a derivative thereof.

[0029] The cyclic olefin is not particularly limited, and examples thereof include norbornene-based compounds such as norbornene, 6-methylnorbornene, 6-ethylnorbornene, 5-propylnorbornene, 6-n-butylnorbornene, 1-methylnorbornene, 7-methylnorbornene, 5,6-dimethylnorbornene, 5-phenylnorbornene, and 5-benzylnorbornene; 8-methyltetracyclo-3-dodecene, 8-ethyltetracyclo-3-dodecene, 5, tetracyclododecene compounds such as 10-dimethyltetracyclo-3-dodecene; and cycloalkene compounds such as cyclobutene, cyclopentene, cyclohexene, 3,4-dimethylcyclopentene, 3-methylcyclohexene, 2-(2-methylbutyl)-1-cyclohexene, cyclooctene, and 3a,5,6,7a-tetrahydro-4,7-methano-1H-indene; and the like, as described in JP-A-2005-263287.

[0030] Examples of the monomer copolymerizable with the cyclic olefin include α-olefins having 2 to 20 carbon atoms, such as ethylene, propylene, 1-butene, 1-pentene, 1-hexene, 3-methyl-1-butene, 3-methyl-1-pentene, 3-ethyl-1-pentene, 4-methyl-1-pentene, 4-methyl-1-hexene, 4,4-dimethyl-1-hexene, 4,4-dimethyl-1-pentene, 4-ethyl-1-hexene, 3-ethyl-1-hexene, 1-octene, 1-decene, 1-dodecene, 1-tetradecene, 1-hexadecene, 1-octadecene, and 1-eicosene; and non-conjugated dienes, such as 1,4-hexadiene, 4-methyl-1,4-hexadiene, 5-methyl-1,4-hexadiene, and 1,7-octadiene.

[0031] <Aluminum Sulfate Compound> Examples of the aluminum sulfate compound include aluminum sulfate, aluminum sulfate salts, aluminum sulfate hydrates, and aluminum sulfate salt hydrates. The aluminum sulfate compound used in the present composition may be one type or two or more types.

[0032] The aluminum sulfate refers to anhydrous aluminum sulfate. Examples of aluminum sulfate salts include sodium, potassium, and ammonium salts. Examples of hydrates include the octahydrate, dodecahydrate, 14-18 hydrate, and 27 hydrate.

[0033] The content of the aluminum sulfate compound in the composition is preferably 0.09 to 5 parts by mass, more preferably 0.09 to 3 parts by mass, and even more preferably 0.09 to 1 part by mass, per 100 parts by mass of the resin, from the viewpoints that a composition and a molded article having an excellent antibacterial effect and being inhibited from causing discoloration, including cloudiness, powdering, foaming, and the like, can be easily obtained.

[0034] The content of anhydrous aluminum sulfate and anhydrous aluminum sulfate salt in the composition is preferably 0.09 to 0.40 parts by mass, and more preferably 0.09 to 0.35 parts by mass, relative to 100 parts by mass of the resin, from the viewpoints that the antibacterial effect of the aluminum sulfate compound, which is an antibacterial agent, is unlikely to decrease, and a composition and molded article can be easily obtained that have an ignition residue value of 0.10% or less when tested in accordance with 1.1 Ignition Residue of 1 Ashing Test in the Japanese Pharmacopoeia General Test Method "Testing Methods for Plastic Pharmaceutical Containers" specified in Yakuhatsu No. 336. The content of anhydrous aluminum sulfate and anhydrous aluminum sulfate salt in the present composition is an amount obtained by taking into consideration the purity of the raw material (commercially available product) when commercially available anhydrous aluminum sulfate or anhydrous aluminum sulfate salt is used as the aluminum sulfate compound, which is a raw material for preparing the present composition; and when commercially available aluminum sulfate hydrate or aluminum sulfate salt hydrate is used as the aluminum sulfate compound, which is a raw material for preparing the present composition, the content of the raw material (commercially available product) is a value obtained by taking into consideration the purity of the raw material (commercially available product) and the amount of water in the hydrate.

[0035] <Other Components> In addition to the resin and aluminum sulfate compound, the present composition may contain other components that have been used in conventional resin compositions, such as pH adjusters, stabilizers (e.g., antioxidants, heat stabilizers, light stabilizers, weather stabilizers), colorants, dispersants, fillers (e.g., talc, calcium carbonate, silica, alumina, carbon black, zinc oxide, zeolite, hydrotalcite, glass fiber, paper powder, wood powder), antistatic agents, lubricants, and nucleating agents, as needed for the desired application, provided that the effects of the present invention are not impaired. The present composition may contain each of these other components alone or in combination.

[0036] pH Adjuster When the present composition is used in, for example, an eye drop container, the eye drop container may be required to satisfy the specifications stipulated in Yakuhatsu No. 336. In particular, the container may be required to have a pH difference of 1.5 or less as determined in accordance with the pH of the 2-elution test (II) pH in the "Test Method for Plastic Pharmaceutical Containers" of the Japanese Pharmacopoeia General Test Methods. From the viewpoint of easily obtaining a composition and a molded article having such a pH difference of 1.5 or less, it is preferable that the present composition contains a pH adjuster.

[0037] Examples of the pH adjuster include amine compounds (e.g., alkanolamines such as dimethylethanolamine, diethanolamine, triethanolamine, and N-methyldiethanolamine; primary amines; secondary amines; tertiary amines; and quaternary ammonium salts); ammonia water; alkali metal hydroxides such as lithium hydroxide, sodium hydroxide, and potassium hydroxide; and alkali metal carbonates or bicarbonates such as lithium carbonate, sodium carbonate, potassium carbonate, and sodium bicarbonate.

[0038] Among these, amine compounds are preferred, and amine compounds having a hindered amine structure are more preferred, because the antibacterial effect of the aluminum sulfate compound, which is the antibacterial agent, is less likely to decrease, the pH difference can be reduced to 1.5 or less, and a composition and molded article can be easily obtained that have an ignition residue value of 0.10% or less when tested in accordance with 1.1 Ignition Residue of 1 Ashing Test of the Japanese Pharmacopoeia General Test Method "Test Method for Plastic Pharmaceutical Containers" as specified in Yakuhatsu No. 336.

[0039] The amine compound having a hindered amine structure is preferably a compound having two hydrocarbon groups at each of the 2-position and the 6-position on the piperidine ring (four in total), more preferably a 2,2,6,6-tetraalkylpiperidine derivative, even more preferably a 2,2,6,6-tetramethylpiperidine derivative, and particularly preferably a 1-alkyl-2,2,6,6-tetramethylpiperidine derivative or a 1-hydro-2,2,6,6-tetramethylpiperidine derivative. Specific examples include dimethyl succinate-1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethylpiperidine polycondensate, poly[{6-(1,1,3,3-tetramethylbutyl)amino-1,3,5-triazine-2,4-diyl}{(2,2,6,6-tetramethyl-4-piperidyl)imino}hexamethylene{(2,2,6,6-tetramethyl-4-piperidyl)imino}], N,N'-bis(3-aminopropyl)ethylenediamine-2,4-bis[N-butyl-N-(1,2,2,6,6-pentamethyl-4-piperidyl)amino]-6-chloro-1,3,5-triazine condensate, and bis(2,2,6,6-tetramethyl-4-piperidyl)sebacate.

[0040] The number average molecular weight of the amine compound having a hindered amine structure is preferably 400 or more, more preferably 400 to 5,000.

[0041] The melting point of the amine compound having a hindered amine structure is preferably 50 to 200°C, more preferably 70 to 150°C.

[0042] When a pH adjuster is used in the present composition, the amount of the pH adjuster used is preferably 10 to 55 parts by mass, more preferably 12 to 53 parts by mass, and even more preferably 15 to 50 parts by mass, per part by mass of the aluminum sulfate compound, from the viewpoints that the antibacterial effect of the aluminum sulfate compound is unlikely to be reduced, the pH difference can be made 1.5 or less, and a composition and a molded article having an ignition residue value of 0.10% or less can be easily obtained.

[0043] <Method for preparing the present composition> The method for preparing the present composition is not particularly limited, but a method in which the components are melt-kneaded using a conventionally known apparatus, specifically a single-screw extruder, a twin-screw extruder, a kneader, a mixer, a two-roll mill, etc. In this case, the order in which the components are added to the apparatus is not particularly limited.

[0044] <<Molded Article>> The present composition is usually molded into a shape according to the desired application and used. The shape of the molded article is not particularly limited, and examples thereof include films (including plate-like bodies such as sheets, which may be stretched or unstretched), fibers, tubes, and containers. According to one embodiment of the present invention, molded articles having excellent antibacterial effects and suppressed appearance defects such as discoloration including cloudiness and powdering can be easily obtained. Among these, containers are preferred, and containers for pharmaceuticals, quasi-drugs, or cosmetics (containers for pharmaceuticals, quasi-drugs, or cosmetics) are more preferred, and eye drop containers are even more preferred, in terms of further demonstrating this effect.

[0045] According to one embodiment of the present invention, a transparent molded article, particularly a transparent container, can be easily obtained. The container is preferable because it allows the contents to be easily seen. Depending on the intended use or from the viewpoint of design, a colored molded article may be required. In this case, a conventionally known colorant may be used.

[0046] <Configuration of Eye Drop Container> The eye drop container is not particularly limited, but examples thereof include a container having a container body, a cap, and an inner plug or an eye drop nozzle.

[0047] The container body is not particularly limited as long as it has a bottom, a hollow cylindrical body continuing from the periphery of the bottom, a shoulder continuing from the body, and a tubular opening continuing from the shoulder, and is capable of containing ophthalmic solutions, and may have a conventionally known configuration. Specific examples of such container bodies include the container bodies shown in Figures 1 to 3.

[0048] Fig. 1 is a front view of an example of an eye drop container fitted with an inner stopper, which is one embodiment of the container body, and Fig. 2 is a cross-sectional view of the container body. The container body 1 in Fig. 1 is composed of a bottom 12, a hollow cylindrical body 13 connected to the periphery of the bottom 12, a shoulder 14 connected to the body 13, and a cylindrical opening 11 having a threaded portion formed on the outer circumferential surface.

[0049] 1, an inner stopper 2 for injecting liquid is fitted into the tubular opening portion 11. The inner stopper 2 is roughly composed of a circular plate portion 21, an outer cylinder portion 22 that is integral with the circular plate portion 21 and hangs down from the periphery of the circular plate portion 21, an inner cylinder portion 23 that hangs down from the underside of the circular plate portion 21, and a cylindrical liquid injecting portion 24 that protrudes from the upper surface of the circular plate portion 21, and the tubular opening portion 11 of the container body 1 is fitted into the gap between the outer cylinder portion 22 and the inner cylinder portion 23. A liquid injecting port 25 is formed at the tip of the liquid injecting portion 24, and a liquid passage portion 26 is formed to pass through from the liquid injecting port 25 to the underside of the circular plate portion 21, through which the eye drops extruded from the container body 1 pass.

[0050] 1 is usually used as an eye drop container by screwing a cap (not shown) onto the tubular opening 11 of the container body 1. The cap may be formed with a protrusion that closes the injection port 25 when the cap is attached.

[0051] 3 is a cross-sectional view of an eye drop container having a container body 1, an eye drop nozzle 3, and a cap 221. The eye drop container in Fig. 3 comprises the container body 1 filled with a predetermined amount (e.g., 5 mL) of eye drop (medicinal solution) Y, the eye drop nozzle 3 attached to the tubular opening 11 of the container body 1, and the cap 221 screwed onto the tubular opening 11 to protect the eye drop nozzle (dropping nozzle) 3.

[0052] The container body 1 in Figure 3 is composed of a bottom 12, a hollow cylindrical (bottle-shaped) body 13 that is continuous with the periphery of the bottom 12, a shoulder 14 that is continuous with the body 13, and an opening cylindrical portion 11 that is continuous with the shoulder and has a threaded portion formed on its outer surface.

[0053] The cap 221 has a threaded portion on its inner surface that can be attached and detached by screwing it onto the threaded portion on the outer surface of the tubular opening 11, and a protrusion 222 is formed on the inner surface of the upper part that can fit into the tip opening of the liquid inlet 312 of the eye drop nozzle 3 to seal it. When the cap 221 is screwed onto the tubular opening 11 in a closed state (the state shown in FIG. 3 ), the protrusion 222 closes the liquid inlet 312 and is in close contact with one or more of the upper surface of the flange 33 and the threaded portion, thereby sealing the inside of the container body 1.

[0054] 1 and 2 show a configuration in which the inner stopper 2 and the container body 1 are separate bodies, and Fig. 3 shows a configuration in which the eye drop nozzle 3 and the container body 1 are separate bodies, but this is not limiting and the two may be molded integrally. In this case, filling the container body 1 with the eye drops Y to be contained therein and molding the container body 1 may be performed simultaneously.

[0055] The size of the container body is not particularly limited and may be designed so as to have a volume capable of holding 1 to 20 mL of ophthalmic solution. The height of the container body is, for example, 30 to 50 mm, and the height of the body is, for example, 20 to 40 mm. The average thickness of the body is, for example, 0.4 to 1.0 mm. The shape of the bottom is not particularly limited and may be, for example, a circle (including an ellipse, an oval, etc.) or a polygon (including a rectangle, a diamond, a pentagon, a hexagon, etc.). The diameter of the inlet may be appropriately set depending on the properties of the ophthalmic solution and is not particularly limited, but is usually designed to be in the range of 1 to 4 mm.

[0056] The materials constituting the container body 1, inner stopper 2, eye drop nozzle 3, and cap are not particularly limited, and the present composition may be used in at least one of them, but it is preferable that the present composition be used in all of them. Of these, materials that do not use the present composition can be materials that have been used in conventionally known members, such as injection-moldable thermoplastic resins such as polyethylene, polypropylene, and polyethylene terephthalate.

[0057] The method for manufacturing the container body, inner stopper, eye drop nozzle, cap, etc. is not particularly limited, and they may be manufactured by a conventionally known manufacturing method. However, it is preferable to manufacture them by injection molding, direct blow molding, and particularly injection (blow) molding, from the viewpoint that a container body, etc. having a desired shape can be easily formed.

[0058] Hereinafter, one embodiment of the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.

[0059] Example 1 An antibacterial composition was prepared by adding 100 parts by mass of PP-1 (Prime Polypro J315FB, manufactured by Prime Polymer Co., Ltd., random polypropylene) and 1,000 parts by mass of aluminum sulfate compound-1 to an injection molding machine and melt-kneading them at 200° C. The prepared antibacterial composition was injection-molded using the injection molding machine at a cylinder temperature of 200° C. to produce a container (inner stopper 2) having the shape shown in FIG.

[0060] Examples 2 to 5 and Comparative Examples 1 to 3 Antibacterial compositions and containers (inner stoppers) were prepared in the same manner as in Example 1, except that the type and amount of antibacterial agent used were changed as shown in Table 1.

[0061] Examples 21 to 28 Antibacterial compositions and containers (inner stoppers) were prepared in the same manner as in Example 1, except that the types of resin and antibacterial agent were changed as shown in Table 2.

[0062] The details of the resins used in each test are as follows: "PP-1": Prime Polypro J315FB, manufactured by Prime Polymer Co., Ltd. "PP-2": Novatec PP MG2TA, manufactured by Japan Polypropylene Corporation "PP-3": Sumitomo Noblen W531D, manufactured by Sumitomo Chemical Co., Ltd. "LDPE": Sumikathene G801, manufactured by Sumitomo Chemical Co., Ltd. "HDPE-1": Hi-Zex HZ3000B, manufactured by Prime Polymer Co., Ltd. "HDPE-2": SHC7260, manufactured by Braskem "SB": Xelas MC932, manufactured by Mitsubishi Chemical Corporation "COC": 6013S-04, manufactured by Polyplastics Co., Ltd.

[0063] Details of the antibacterial agents used in each test are as follows: "Aluminum sulfate compound-1": aluminum sulfate (dehydrated) for chemical use, manufactured by Kishida Chemical Co., Ltd. "Aluminum sulfate compound-2": burnt alum, manufactured by Goto Sangyo Co., Ltd. "Aluminum sulfate compound-3": aluminum sulfate 14-18 hydrate, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd. "Bactekiller": BM-102TG (Ag-Zn antibacterial agent), manufactured by Fuji Chemical Co., Ltd. "Zeoal": Zeaol AgA50 (silver ion-supported zeolite antibacterial agent), manufactured by Nakamura Choukou Co., Ltd.

[0064] <Antibacterial test (antibacterial activity value)> A shake method antibacterial test was conducted in accordance with the shake method in (2) Test Method II (2012 edition) of 2. Test methods for evaluating the antibacterial activity of antibacterial processed products of the Antibacterial Product Technology Council. Specifically, the antibacterial test was conducted as follows.

[0065] A "1 / 500 NB medium" was prepared by diluting normal bouillon (NB) medium (manufactured by Nissui Pharmaceutical Co., Ltd.) 500 times with purified water and adjusting the pH to 7.0±0.2. Two pellets of the E. coli strain ATCC 8739 (Microbiologics, EZ-PECT™) were transferred to a vial containing 2 mL of hydration solution and placed in a thermostatic bath at 34-38°C for 30 minutes to prepare a suspension. Furthermore, from the containers (inner stoppers) prepared in Examples 1 to 5, Examples 21 to 28, and Comparative Examples 1 to 3, a suspension with a total surface area of ​​32±5 cm was prepared. ２A test piece (antibacterial treated test piece) was cut out so that the total surface area was 32±5 cm. ２ A test piece (unprocessed test piece) was cut out so that the

[0066] The prepared 1 / 500 NB medium was incubated with 10 ４ ~10 ５ The prepared suspension was added to prepare an inoculation solution. 10 mL of the inoculation solution and the test specimen were placed in a sterilized cup and cultured in a constant temperature bath at 35±1°C and 150±10 rpm (horizontal direction) for 24 hours with shaking to prepare a culture solution. The culture solution was diluted 10 times and 10 times with 0.85% by mass physiological saline. ２ double, 10 ３ double, 10 ４ double, 10 ５ double, 10 ６ times, and 10 ７ 1 mL of each diluted solution was placed in a sterilized petri dish, and 15 mL of warmed standard agar medium (manufactured by Nissui Pharmaceutical Co., Ltd.) was added thereto, followed by culturing in a constant temperature bath at 35°C for 24 hours, and the viable cell count was calculated from the number of colonies on the medium.

[0067] The viable cell count was calculated from the number of colonies on the medium in the same manner as above, except that ATCC 6538™ (Microbiologics, EZ-PECT™), an S. aureus strain, was used instead of ATCC 8739.

[0068] The "antibacterial activity value" against Escherichia coli and Staphylococcus aureus was calculated using the following formula, and the values ​​rounded down to two decimal places are shown in Table 1 or Table 2. An antibacterial activity value of 2.0 or higher was determined to have an "antibacterial effect." Antibacterial activity value = (Ut - U0) - (At - U0) = Ut - At U0: Mean logarithm of the number of viable bacteria immediately after inoculation when an untreated test piece was used Ut: Mean logarithm of the number of viable bacteria after 24 hours when an untreated test piece was used At: Mean logarithm of the number of viable bacteria after 24 hours when an antibacterial-treated test piece was used

[0069] <Appearance Evaluation> The appearance of the containers (inner stoppers) produced in Examples 1 to 5, Examples 21 to 28, and Comparative Examples 1 to 3 was visually evaluated according to the following evaluation criteria. The results are shown in Table 1 or Table 2. ⊚: The resulting container was transparent (no discoloration such as cloudiness occurred), and no powdering occurred. ◯: The resulting container was transparent but light brown, and no powdering occurred. △: The resulting container was slightly cloudy, but no powdering occurred. ×: The resulting container was discolored such as cloudiness or powdering occurred.

[0070]

[0071]

[0072] Example 6 An antibacterial composition was prepared by adding 100 parts by mass of polypropylene (Prime Polypro J315FB, manufactured by Prime Polymer Co., Ltd., random polypropylene), 0.23 parts by mass of the aluminum sulfate compound-1, and 2 parts by mass of HALS (Tinuvin 770DF, manufactured by BASF Japan Ltd.) to an injection molding machine, and melt-kneading the mixture at 200° C. The prepared antibacterial composition was injection-molded using the injection molding machine at a cylinder temperature of 200° C. to produce a container (inner stopper 2) having the shape shown in FIG.

[0073] Examples 7 and 8 Containers (inner stoppers 2) were produced in the same manner as in Example 6, except that the amount of HALS used was changed as shown in Table 3.

[0074] Example 9 An antibacterial composition was prepared by adding 100 parts by mass of polypropylene (Prime Polypro J315FB, manufactured by Prime Polymer Co., Ltd., random polypropylene), 0.18 parts by mass of the aluminum sulfate compound-1, and 0.27 parts by mass of sodium bicarbonate (manufactured by Kenei Pharmaceutical Co., Ltd.) to an injection molding machine, and melt-kneading the mixture at 200° C. The prepared antibacterial composition was injection-molded using the injection molding machine at a cylinder temperature of 200° C. to produce a container (inner stopper 2) having the shape shown in FIG.

[0075] <Elution Test (pH)> The elution test (pH) was carried out in accordance with Part II Elution Test (pH) of the Japanese Pharmacopoeia General Test Method "Test Method for Plastic Pharmaceutical Containers." Specifically, the test was carried out as follows.

[0076] From the containers (inner stoppers) produced in Examples 6 to 9, the total surface area of ​​the front and back was 300 cm ２ A test specimen was cut out so that the test specimen was 3 cm long and 0.3 cm wide, and all the shredded test specimens were placed in a 200 mL hard glass container. Then, 100 mL of purified water was added to the hard glass container and heated at 70°C for 24 hours to obtain a test solution. A blank test solution was also obtained in the same manner as above, except that no test specimens were placed in the hard glass container. 20 mL of the obtained test solution and blank test solution were taken, and 1.0 mL of a solution prepared by dissolving 1.0 g of potassium chloride in water to make 1000 mL was added to each of the 20 mL test solution and blank test solution. The pH of both solutions was measured, and the difference was calculated. The results are shown in Table 3. Yakuhatsu No. 336 stipulates that this pH difference must be 1.5 or less.

[0077] <Ignition Residue> The test was carried out in accordance with Section 1.1 Ignition Residue, Section 1, Ashing Test, of the Japanese Pharmacopoeia General Test Methods "Test Methods for Plastic Pharmaceutical Containers." Specifically, the test was carried out as follows.

[0078] The crucible was first ignited at 600±50°C for 30 minutes, and after cooling, the mass of the crucible was precisely measured. The containers (inner stoppers) produced in Examples 6 to 9 were finely crushed, and 5 g of the crushed material was placed in the crucible whose mass had been measured. The mass of the crushed material was then precisely measured. 1 mL of sulfuric acid was added to the crucible containing the crushed material whose mass had been measured, and the crucible was gradually heated to completely carbonize the sample. After cooling to room temperature, another 1 mL of sulfuric acid was added, and the mixture was gradually heated until no more white smoke was produced. The mixture was further ignited at 600±50°C to incinerate the residue in the crucible. After cooling to room temperature, the mass of the resulting incinerated material was precisely measured. The ignition residue was calculated using the following formula. The results are shown in Table 3. Ignition residue = mass of incinerated material / mass of crushed material × 100. Yakuhatsu No. 336 stipulates that this ignition residue must be 0.1% or less.

[0079] <Appearance Evaluation> The appearance of the containers (inner stoppers) produced in Examples 6 to 9 was visually evaluated according to the same evaluation criteria as in the appearance evaluation of Example 1, etc. The results are shown in Table 3.

[0080]

[0081] Example 10 An antibacterial composition was prepared by adding 100 parts by mass of polypropylene (Prime Polypro J315FB, manufactured by Prime Polymer Co., Ltd., random polypropylene) and 0.23 parts by mass of the aluminum sulfate compound-3 to an injection molding machine and melt-kneading them at 200°C. In the prepared antibacterial composition, the amount of anhydrous aluminum sulfate excluding impurities, taking into account the purity and the amount of water in the hydrate, was 0.1247 parts by mass. The prepared antibacterial composition was injection-molded using an injection molding machine at a cylinder temperature of 200°C to produce a container (inner stopper 2) having the shape shown in Figure 2.

[0082] Examples 11 and 12 Containers (inner stoppers 2) were produced in the same manner as in Example 10, except that the type and amount of aluminum sulfate compound used were changed as shown in Table 4.

[0083] <Ignition Residue> The ignition residue of the containers (inner stoppers) produced in Examples 10 to 12 was measured in the same manner as in Example 6. The results are shown in Table 4.

[0084]

[0085] 1: Container body 2: Inner plug 3: Eye drop nozzle 11: Opening tube portion 12: Bottom portion 13: Body portion 14: Shoulder portion 21: Circular plate portion 22: Outer tube portion 23: Inner tube portion 24: Injection portion 25: Injection port 26: Injection portion 33: Flange portion 221: Cap 222: Convex portion 312: Injection port Y: Eye drop (medicinal solution)

Claims

1. An antimicrobial composition comprising a resin and an aluminum sulfate compound.

2. The antibacterial composition according to claim 1, wherein the content of the aluminum sulfate compound is 0.09 to 5 parts by mass per 100 parts by mass of the resin.

3. The antimicrobial composition of claim 1, wherein the resin comprises an ethylene-based resin or a propylene-based resin.

4. A container for a medicine, quasi-drug or cosmetic product formed from the antibacterial composition according to any one of claims 1 to 3.

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