Sealing body for syringe

Abstract

To solve the following problem: foreign matter is produced in a syringe prefilled with a hydrogen peroxide solution for a long period of time.SOLUTION: A sealing body for a syringe according to the present invention is used to inhibit production of foreign matter produced by hydrogen peroxide. The sealing body for the syringe comprises a surface part that is brought into contact with a hydrogen peroxide solution infilled into the syringe. A material for the surface part is selected from the group consisting of a fluororubber, a fluororesin, a silicone rubber and an elastomer.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a syringe closure, and more particularly to a syringe closure suitable for storing a hydrogen peroxide solution in a syringe for an extended period of time. [Background technology]

[0002] Hydrogen peroxide solutions are used industrially as bleaching agents and in the food industry as disinfectants. Hydrogen peroxide solutions containing 2.5 to 3.5% (w / v) hydrogen peroxide are used medically as disinfectants.

[0003] A hydrogen peroxide solution can be used as a radiation sensitizer (Patent Document 1). Although hydrogen peroxide in a hydrogen peroxide solution is prone to decomposition to generate gas, it has been revealed that hydrogen peroxide has low reactivity with cycloolefin polymers (COP) or cycloolefin copolymers (COC) (Patent Document 2). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] WO2008 / 041514 [Patent Document 2] Patent Publication No. 2020-81835 Summary of the Invention [Problem to be solved by the invention]

[0005] However, a problem of foreign matter being generated in syringes that have been prefilled with hydrogen peroxide solution for a long period of time has become apparent. This problem is not disclosed in either Patent Document 1 or Patent Document 2.

[0006] The inventors investigated materials that may cause the generation of the above-mentioned foreign matter and found that the above-mentioned foreign matter is generated by gaskets and caps made of butyl rubber. In searching for materials that do not generate the above-mentioned foreign matter, they discovered that by using gaskets and caps made of certain materials in syringes filled with hydrogen peroxide solution, foreign matter does not generate in the hydrogen peroxide solution, and thus the present invention was completed. [Means for solving the problem]

[0007] The object of the present invention is to A syringe seal for suppressing the generation of foreign matter caused by hydrogen peroxide, the syringe sealing body has a surface portion that comes into contact with the hydrogen peroxide solution filled in the syringe, the material of the surface portion is selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer; Syringe seal The purpose is to provide

[0008] By using the syringe sealing body according to the present invention, it is possible to prevent the generation of foreign matter in a syringe that has been pre-filled with a hydrogen peroxide solution for a long period of time.

[0009] The syringe closure may include a gasket and a cap.

[0010] Another object of the present invention is to provide A syringe for suppressing the generation of foreign matter caused by hydrogen peroxide, comprising the syringe seal. The purpose is to provide

[0011] By using the syringe according to the present invention, it is possible to prevent the generation of foreign matter in a syringe that has been prefilled with a hydrogen peroxide solution for a long period of time.

[0012] The syringe may be pre-filled with a hydrogen peroxide solution. [Brief explanation of the drawings]

[0013] [Figure 1A] FIG. 1A shows a schematic diagram of a pre-filled syringe filled with a hydrogen peroxide solution according to this embodiment. [Figure 1B] FIG. 1B shows an end view of the cap and the cap seal member at the bottom of the cap. [Figure 1C] FIG. 1C shows a cap according to another embodiment, illustrating an end view of the cap body and the cap seal member 110 provided at the bottom of the cap body. [Figure 2] Figures 2A and B are photographs of a gasket made from butyl rubber. [Figure 3] 3A and 3B are photographs of a gasket (top-laminated gasket) in which the top surface (top surface that comes into contact with the hydrogen peroxide solution) of the gasket is laminated with polytetrafluoroethylene. [Figure 4] Figures 4A and B are photographs of a gasket made from fluororubber. [Figure 5] 5A and 5B are photographs of a gasket whose surface in contact with the hydrogen peroxide solution is made of polytetrafluoroethylene. [Figure 6] Figures 6A and B are photographs of the inside bottom of a cap made from butyl rubber. [Figure 7] 7A and B are photographs of a gasket made from silicone rubber. [Figure 8] 8A and B are photographs of a gasket made from a styrene-based thermoplastic elastomer. [Figure 9] 9A and B are photographs of a gasket made from a styrene-based thermoplastic elastomer. DETAILED DESCRIPTION OF THE INVENTION

[0014] definition For convenience, certain terms used in this application are collected here. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0015] Although the numerical ranges and parameters set forth in the present invention are approximate, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in each test measurement. Also, as used herein, the term "about" generally means within 10%, 5%, 1%, or 0.5% of a given value or range. Alternatively, the term "about" means within an acceptable standard error as considered by one of ordinary skill in the art.

[0016] Hereinafter, embodiments of the present invention will be described. The following embodiments are merely examples, and the scope of the present invention is not limited to those shown in the following embodiments. Note that, to avoid repetition, explanations of similar content will be omitted as appropriate.

[0017] 1 prefilled syringe FIG. 1A shows a schematic diagram of a syringe 10 (hereinafter, "prefilled syringe 1") filled with a hydrogen peroxide solution 50. The syringe 10 includes a barrel 20, a syringe seal 100 (cap 40 and gasket 60), and a plunger rod 70. One end of the syringe 10 includes a needle attachment portion 30 through which the hydrogen peroxide solution 50 is discharged, and the other end of the syringe 10 includes an opening 80 for inserting the plunger rod 70, with a flange 90 around the opening 80. The flange 90 does not necessarily have to be provided. In the prefilled syringe 1 shown in FIG. 1A, the needle attachment portion 30 is provided with a cap 40 to seal the filled hydrogen peroxide solution 50, and the plunger rod 70 with a gasket 60 is inserted through the opening 80.

[0018] FIG. 1B shows an end view of the cap 40. FIG. 1B schematically shows a cross section of the cap 40 along the longitudinal central axis of the syringe 10 equipped with the cap 40. The cap 40 is composed of a cylindrical wall 44, an insertion port 42 at one end of the cylindrical wall 44, and a sealing portion 45 at the other end of the cylindrical wall 44. A spiral groove 43 is present on the inner wall of the cap 40, and can be threadedly engaged with the threads 32 on the outer wall 31 of the needle attachment portion 30. The spiral groove 43 does not have to be present on the inner wall of the cap 40. If the spiral groove 43 is not present on the inner wall of the cap 40, the threads 31 will not be present on the outer wall 31 of the needle attachment portion 30, and the needle attachment portion 30 can be frictionally fitted into the cap 40. When the needle mounting part 30 is inserted into the cap 40 , the tip of the needle mounting part 30 abuts against the bottom part 41 of the sealing part 45 , preventing the hydrogen peroxide solution 50 from being discharged from the needle mounting part 30 .

[0019] FIG. 1C shows a cap 40A according to another embodiment. FIG. 1C shows an end view of a cap body 46 and a cap seal member 110 provided on the bottom portion 41A of the cap body 46. The cap 40A shown in FIG. 1C is identical to the cap 40 shown in FIG. 1B except for the cap seal member 110. The cap body 46 is composed of a cylindrical wall 44A, an insertion opening 42A provided at one end of the cylindrical wall 44A, and a sealing portion 45A provided at the other end of the cylindrical wall 44A. A spiral groove 43A is present on the inner wall of the cap body 46, which can be threadedly engaged with the thread 32 on the outer wall 31 of the needle mounting portion 30. The spiral groove 43A does not necessarily have to be present on the inner wall of the cap body 46. If the spiral groove 43A is not present on the inner wall of the cap body 46, the thread 31 will not be present on the outer wall 31 of the needle mounting portion 30, and the needle mounting portion 30 can be frictionally fitted into the cap body 46. When the needle mounting part 30 is inserted into the cap body 46, the tip of the needle mounting part 30 comes into contact with the cap seal member 110, and the discharge of the hydrogen peroxide solution 50 from the needle mounting part 30 is suppressed.

[0020] In this embodiment, the hydrogen peroxide solution 50 refers to a solution in which hydrogen peroxide is dissolved in a solvent (e.g., water), and may contain additives (e.g., phosphoric acid and phenacetin) as necessary. In this embodiment, the barrel 20 may be made of a single material or may be composed of multiple materials (including a multilayer structure such as a coating). In the case of a barrel 20 made of a single material, the entire barrel 20 is made of the above-mentioned resin. In the case of a barrel 20 composed of multiple materials, the portion of the barrel 20 that comes into direct contact with the hydrogen peroxide solution 50 may be made of the above-mentioned resin, and the other portions may be made of a material with high hydrogen peroxide decomposition ability, such as glass. In this embodiment, examples of the resin include cycloolefin polymer (COP), cycloolefin copolymer (COC), and polypropylene.

[0021] In this embodiment, the concentration of hydrogen peroxide in the hydrogen peroxide solution in the prefilled syringe is, for example, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.5, 1, 5, 10, 15, 20, 25, 30, 35, or 40%, and may be within a range between any two of the values ​​exemplified herein, for example, 0.01 to 40% (v / v), preferably 0.05 to 30% (v / v).

[0022] Syringe seal 100 The syringe sealing body 100 according to this embodiment suppresses the generation of foreign matter caused by hydrogen peroxide. The syringe sealing body 100 has a surface portion that comes into contact with the hydrogen peroxide solution 50 filled in the syringe 10. The material of the surface portion is selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer. The material of the syringe sealing body 100 may also be selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer. In another embodiment, a syringe 10 for suppressing the generation of foreign matter caused by hydrogen peroxide is provided, which includes the syringe sealing body 100 described above. In another embodiment, a pre-filled syringe 1 is provided that is filled with a hydrogen peroxide solution 50.

[0023] The syringe sealing body 100 may be composed of a surface portion and a main body portion (i.e., may be composed of two or more elements). The material of the surface portion is selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer. The main body portion preferably does not come into contact with the hydrogen peroxide solution 50 filled in the syringe 10. The material of the main body portion may be the same as the material of the surface portion. If the material of the main body portion is the same as the material of the surface portion, the main body portion may be integrally molded with the surface portion (i.e., the syringe sealing body 100 may be composed of only one element). If the main body portion does not come into contact with the hydrogen peroxide solution 50 filled in the syringe 10, the material of the main body portion may be a material that generates foreign matter when it comes into contact with the hydrogen peroxide solution 50 (e.g., butyl rubber). The syringe sealing body 100 may include a gasket 60 and a cap 40. In one embodiment, the syringe sealing body 100 is a gasket 60. In another embodiment, syringe closure 100 is cap 40. When syringe closure 100 is cap 40, cap 40 may be composed of a surface portion and a body portion. When cap 40 is composed of a surface portion and a body portion, the surface portion is cap seal member 100 and the body portion is cap body 46.

[0024] Foreign object "Foreign matter generated by hydrogen peroxide" refers to solid matter generated by the hydrogen peroxide solution 50 filled in the syringe 10. When the hydrogen peroxide solution 50 is administered to a living body, the solid matter may be introduced into the living body along with the hydrogen peroxide solution 50 or may hinder the discharge of the hydrogen peroxide solution 50 from the syringe 10. The "foreign matter" is a substance derived from rubber (butyl rubber). In one embodiment, the syringe sealing body 100 suppresses the generation of foreign matter generated by contact with hydrogen peroxide for a long period of time (e.g., one month, three months, six months or more). In one embodiment, the syringe sealing body 100 suppresses the generation of foreign matter generated by contact with hydrogen peroxide for a certain period of time (e.g., at least six months, at least three months, at least one month). "Suppressing the generation of foreign matter" means "suppressing the generation of foreign matter to an extent that does not adversely affect the administration of the hydrogen peroxide solution to a living body" or "suppressing the generation of foreign matter to an undetectable extent." The "undetectable extent" is determined based on the capabilities of analytical equipment used in quality control in the art.

[0025] Fluorine rubber Examples of fluororubbers include copolymers of vinylidene fluoride (VDF) and hexafluoropropylene (HFP) (binary FKM), copolymers of vinylidene fluoride (VDF), hexafluoropropylene (HFP), and tetrafluoroethylene (TFE) (ternary FKM), copolymers of tetrafluoroethylene (TFE) and propylene (Pr) (FEP), copolymers of vinylidene fluoride (VDF), propylene (Pr), and tetrafluoroethylene (TFE), and copolymers of ethylene (E) and tetrafluoroethylene (TFE). Examples of suitable copolymers include copolymers of vinylidene fluoride (VDF), tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE), copolymers of vinylidene fluoride (VDF), tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE), copolymers of vinylidene fluoride (VDF) and perfluoromethyl vinyl ether (PMVE), copolymers of tetrafluoroethylene (TFE) and perfluoroalkyl ether (PFAE), etc. It is preferable to use one or more of these.

[0026] Fluorine resin Examples of fluororesins include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene copolymer (ETFE), perfluoroalkoxyalkane (PFA), perfluoroethylene propene copolymer (FEP), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), and ethylene chlorotrifluoroethylene copolymer (ECTFE).

[0027] Silicone rubber As the silicone rubber, for example, a silicone rubber (cured silicone rubber) obtained by curing a silicone rubber composition can be used, but silicone rubber having a hardness of 20 or more and 80 or less, preferably 50 or more and 70 or less, measured with a durometer A hardness tester specified in JIS K 6249 can be used.

[0028] Elastomer Examples of the elastomer include styrene-based elastomers. Examples of the styrene-based elastomers include SBS (styrene-butadiene-styrene), SIS (styrene-isoprene-styrene), SEBS (styrene-ethylene-butadiene-styrene), and SEPS (styrene-ethylene-propylene-styrene). The material of the surface portion may be an elastomer (e.g., a styrene-based elastomer). The elastomer may be a thermoplastic elastomer.

[0029] Other embodiments A gasket for suppressing the generation of foreign matter caused by hydrogen peroxide is provided, the gasket being made of a material selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer. The gasket according to this embodiment is attached to the tip of a syringe plunger rod.

[0030] A cap for suppressing the generation of foreign matter caused by hydrogen peroxide is provided, the cap having a surface portion that comes into contact with the hydrogen peroxide solution filled in a syringe, the surface portion being made of a material selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer. The cap according to this embodiment is attached to a syringe. [Example]

[0031] Test 1 We investigated materials that suppress the generation of foreign matter caused by hydrogen peroxide. First, we manufactured gaskets (n=10) using the materials shown in Table 1.

[0032] [Table 1]

[0033] Each gasket was fitted onto a plunger rod, and the gasketed plunger rod was attached to the barrel of a syringe. Hydrogen peroxide solution was filled into each syringe, and each syringe was sealed with a cap. The cap was made of chlorobutyl rubber (Experimental Example 5). Each syringe was stored in a thermostatic chamber set at 60°C and 75% RH (relative humidity) for three months. A syringe not filled with hydrogen peroxide solution was used as a control. After three months, each gasket was observed under a microscope.

[0034] Test 1 results About Experimental Example 1 Figures 2A and 2B are photographs of gaskets made with chlorobutyl rubber. Figure 2A is a photograph of the control. The gasket made with chlorobutyl rubber developed foreign matter on the surface that had been in contact with the hydrogen peroxide solution (Figure 2B). Similar results were observed for the remaining nine gaskets (not shown).

[0035] About Experimental Example 2 Figures 3A and 3B are photographs of a gasket (top-laminated gasket) made of chlorobutyl rubber whose top surface (the surface that comes into contact with the hydrogen peroxide solution) is laminated with polytetrafluoroethylene (PTFE). Figure 3A is a photograph of a control. The top-laminated gasket did not produce any foreign matter on the top surface, but foreign matter did appear on the non-laminated surface (Figure 3B). Similar results were obtained for the remaining nine gaskets (not shown).

[0036] Regarding Experimental Example 3 Figures 4A and 4B are photographs of gaskets made from fluororubber. Figure 4A is a photograph of the control. No foreign matter was observed in the gasket made from fluororubber (Figure 4B). Similar results were obtained for the remaining nine gaskets (not shown).

[0037] Regarding Experimental Example 4 Figures 5A and 5B are photographs of a gasket (ClearX) that combines a main body made of polytetrafluoroethylene (PTFE) on the surface that comes into contact with the hydrogen peroxide solution with a sealing ring made of silicone rubber containing ultra-high molecular weight polyethylene. Figure 5A is a photograph of the control. No foreign matter was observed in the gaskets made of polytetrafluoroethylene or silicone rubber (Figure 5B). Similar results were obtained for the remaining nine gaskets (not shown).

[0038] Regarding Experimental Example 5 Figures 6A and 6B are photographs of the inside bottom of a cap made of chlorobutyl rubber. Figure 6A is a photograph of the control. Foreign matter appeared on the inside bottom of the cap made of chlorobutyl rubber (i.e., the surface that comes into contact with the hydrogen peroxide solution) (Figure 6B). Similar results were observed for the remaining nine caps (not shown).

[0039] Test 2 Next, gaskets were manufactured using the materials (n=10) shown in Table 2. Except for the storage period of one month, they were stored under the same conditions as in Test 1. After one month, the gaskets were observed under a microscope.

[0040] [Table 2]

[0041] Test 2 results Regarding Experimental Example 6 Figure 7A is a photograph of the silicone rubber before storage in the hydrogen peroxide solution, and Figure 7B is a photograph of the silicone rubber after storage in the hydrogen peroxide solution. It was clear that no foreign matter was generated when the silicone rubber was stored in the hydrogen peroxide solution at 60°C for one month. Similar results were obtained for the remaining nine silicone rubbers (not shown).

[0042] Test 3 Next, gaskets were manufactured using the materials shown in Table 3 (Example 7: n=10, Example 8: n=1). They were stored under the same conditions as in Test 1. After each storage period, each material was observed under a microscope.

[0043] [Table 3]

[0044] Test 3 results Regarding Experimental Example 7 Figure 8A is a photograph of the styrenic thermoplastic elastomer before storage in the hydrogen peroxide solution, and Figure 8B is a photograph of the styrenic thermoplastic elastomer after storage in the hydrogen peroxide solution. It was clear that no foreign matter was generated when the styrenic thermoplastic elastomer was stored in the hydrogen peroxide solution at 60°C for three months. Similar results were obtained for the remaining nine styrenic thermoplastic elastomers (not shown).

[0045] Regarding Experimental Example 8 Figure 9A is a photograph of the styrene-based thermoplastic elastomer before storage in the hydrogen peroxide solution, and Figure 9B is a photograph of the styrene-based thermoplastic elastomer after storage in the hydrogen peroxide solution. It was found that no foreign matter was generated even when the silicone rubber was stored in the hydrogen peroxide solution at 60°C for one month. [Explanation of symbols]

[0046] 1 prefilled syringe 10 syringes 20 barrels 30 Needle attachment part 31 Exterior Wall 32 threads 32 40, 40A Cap 41, 41A bottom 42, 42A insertion port 43, 43A spiral groove 44, 44A Cylindrical wall 44 45, 45A Sealing part 45 46 Cap body 50 Hydrogen peroxide solution 60 gaskets 70 plunger rod 80 Opening 90 flange 100 Syringe seal 110 Cap seal member

Claims

1. A syringe seal for suppressing the generation of foreign matter caused by hydrogen peroxide, the syringe seal has a surface portion that comes into contact with the hydrogen peroxide solution filled in the syringe; the material of the surface portion is selected from the group consisting of fluororubber, fluororesin, silicone rubber, and elastomer; The foreign matter is foreign matter precipitated on the surface of the surface portion of the syringe sealing body. Syringe closure.

2. The syringe closure includes a gasket and a cap. The syringe sealing body according to claim 1 .

3. A syringe for suppressing the generation of foreign matter caused by hydrogen peroxide, comprising the syringe sealing body according to claim 1 or 2.

4. 4. The syringe of claim 3, pre-filled with a hydrogen peroxide solution.

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