JP2004024384A - Medical use rubber stopper improved in liquid leakage - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a rubber stopper for a vial with which a liquid is hardly leaked, and low in coring and piercing resistance. <P>SOLUTION: This rubber stopper includes: a lid part 1 having upper and lower surfaces 11 and 12; and a leg part 2 arranged on the lower surface 12 of the lid part 1. A needle piercing part 3 at the center of the lid part 1 is recessed so as to position the lower surface 12 of the lid part 1 at a part between the upper and lower surfaces 31, 32 of the needle piercing part 3. <P>COPYRIGHT: (C)2004,JPO

Description

（注）各ゴム栓には補強剤としてタルク４０ｐｈｒが添加されている。
＊１：ウオ−レス硬さ計で測定。
＊２：エチレンテトラフルオロエチレン（商品名：テフゼル、デュポン社製）
＊３：ｄは図１の針刺し部の上面と蓋部の下面の距離を示す。
【０００９】
【表２】

＊１：発生したコアの数／刺通回数　を示す。
【００１０】
【発明の効果】
以上述べたことから明らかなように、本発明を採用することにより、液漏れが生じ難く、コアリングが少なく刺通抵抗の小さな、全体的に見てバランスのとれたバイアル用ゴム栓を提供することができる。
【図面の簡単な説明】
【図１】本発明のゴム栓を示す説明図である。
【図２】従来のゴム栓を示す説明図である。
【符号の説明】
１　蓋部
１１　上面
１２　下面
２　脚部
３　針刺し部分
３１　上面
３２　下面[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a rubber stopper for a vial having an improved liquid leakage. INDUSTRIAL APPLICABILITY The rubber stopper of the present invention not only has little liquid leakage, but also has good coring and piercing resistance, and is suitable for a rubber stopper for a vial for lyophilization, vaccine, and infusion.
[0002]
[Prior art]
Conventionally, butyl rubber, which has excellent gas impermeability, is often used as a material for forming a rubber stopper for a vial, but butyl rubber has poor rubber elasticity. There has been a liquid leakage problem such as a liquid leaking from the vicinity or the liquid leaking and dropping when the puncture needle is pulled out of the rubber stopper.
[0003]
Therefore, in order to eliminate such inconvenience of liquid leakage, conventionally, (1) the degree of vulcanization of the rubber stopper is increased, (2) a rubber material having good self-sealing property is used, and (3) the rubber stopper is used. Measures have been taken such as increasing the thickness of the portion through which the needle pierces, and (4) increasing the outer diameter of the rubber stopper leg.
However, in the method as described above, for example, in the above (1) and (3), there is a problem that coring is likely to occur and the piercing resistance is increased. In the above (2), the gas impermeability is deteriorated. However, in the above (4), problems such as the tendency of coring to occur and the plugging property of the rubber stopper being deteriorated occur, and thus cannot be said to be a balanced improvement measure.
[0004]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and it is an object of the present invention to provide a rubber stopper for a vial that is unlikely to cause liquid leakage, has little coring, and has a small piercing resistance.
[0005]
[Means for Solving the Problems]
The present inventors have conducted intensive studies to solve the above-mentioned problem, and as a result, as shown in FIG. 2, a conventional rubber plug (having a lid portion 51 and a leg portion 52, and a position of a lower surface 532 of a needle stick portion 53). Is higher than the position of the lower surface 512 of the lid 51), the needle stab 53 is lowered in the liquid contact side direction to reduce the stress of the needle stab 53 of the rubber stopper pressed by the mouth of the vial. And arrived at the present invention. That is, the present invention relates to a rubber stopper having a lid having an upper surface and a lower surface, and a leg provided on the lower surface of the lid, wherein the needle piercing portion at the center of the lid has an upper surface and a lower surface of the needle piercing portion. The present invention relates to a medical rubber stopper with improved liquid leakage, which is depressed so that the lower surface of the lid portion is located between the rubber stoppers.
Here, the thickness of the needle stuck portion is usually 80 to 100% of the thickness of the lid portion. In addition, the lower surface of the needle piercing portion has a thickness corresponding to 20 to 80% of the thickness of the needle piercing portion so that the stress of the needle piercing portion falls within an appropriate range when the rubber stopper is plugged into the mouth of the vial. Preferably, it is located below the lower surface of the lid.
[0006]
BEST MODE FOR CARRYING OUT THE INVENTION
Next, the rubber stopper of the present invention will be described with reference to the drawings.
FIG. 1 is an explanatory view showing a rubber stopper of the present invention.
As shown in FIG. 1, the rubber stopper of the present invention is a rubber stopper having a lid 1 having an upper surface 11 and a lower surface 12 and a leg 2 provided on the lower surface 12 of the lid 1. The needle piercing portion 3 at the center of the lid 1 is depressed so that the lower surface 12 of the lid 1 is located between the upper surface 31 and the lower surface 32 of the needle piercing portion 3.
Here, the thickness of the needle stab 3 is usually 80 to 100% of the thickness of the lid 1. The lower surface 32 of the needle piercing portion 3 has a thickness of 20 mm so that the stress of the needle piercing portion 3 falls within an appropriate range when a rubber stopper is plugged into the mouth of a vial (not shown). Preferably, it is positioned below the lower surface of the lid by a thickness corresponding to ~ 80%.
As a material for forming the rubber stopper, butyl rubber and halogenated butyl rubber are preferable, but besides, butadiene rubber, isoprene rubber, ethylene propylene rubber and the like can also be used. The present invention is also applicable to a so-called laminated rubber stopper in which polytetrafluoroethylene is laminated on a rubber stopper made of, for example, butyl rubber.
[0007]
[Test Example] Butyl rubber as shown in Table 1 having a leg outer diameter of 13.1 mm consisting of a lid having a diameter of 19.0 mm and a thickness of 3.0 mm, and a needle stick portion having a diameter of 5.0 mm and a thickness of 2.5 mm. 10 rubber stoppers were placed in a 35 mL vial having an inner diameter of 12.4 mm and an inner capacity of 35 mL containing 6 mL of water inside, and tightly wound with an aluminum cap. Next, a 20 mL syringe with an 18 gauge metal needle was prepared, and the metal needle was inserted from the needle piercing portion of the rubber stopper, 12 mL of air was inserted into the vial, and then the syringe was inserted while the metal needle was pierced. While maintaining the inverted state, 5 mL of water was removed from the vial, and 6 mL of air was further removed from the air layer in the vial, and the amount of liquid leakage generated at that time was measured. The results shown in Table 2 were obtained.
A 18-gauge metal needle was pierced at a piercing speed of 200 mm / min. At the time of piercing with an 18 gauge metal needle and a piercing speed of 6,000 mm / min. Table 2 shows the number of cores generated when the piercing was performed 10 times. However, the metal needle is replaced every two penetrations.
As the butyl rubber, HT1066 manufactured by Nippon Butyl Co., Ltd. was used.
From Table 2, it can be seen that the rubber stopper of the present invention has a tendency that coring slightly occurs and the piercing resistance slightly increases, but the problem of liquid leakage is greatly improved and the balance is good as a whole. It can be called a plug.
[0008]
[Table 1]

(Note) To each rubber stopper, 40 phr of talc is added as a reinforcing agent.
* 1: Measured with a Walles hardness tester.
* 2: Ethylene tetrafluoroethylene (trade name: Tefzel, manufactured by DuPont)
* 3: d indicates the distance between the upper surface of the needle stab in FIG. 1 and the lower surface of the lid.
[0009]
[Table 2]

* 1: Indicates the number of generated cores / number of piercings.
[0010]
【The invention's effect】
As is apparent from the above description, by adopting the present invention, it is possible to provide a rubber stopper for a vial in which liquid leakage hardly occurs, the coring is small and the piercing resistance is small, and the vial is balanced as a whole. be able to.
[Brief description of the drawings]
FIG. 1 is an explanatory view showing a rubber stopper of the present invention.
FIG. 2 is an explanatory view showing a conventional rubber stopper.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Lid part 11 Upper surface 12 Lower surface 2 Leg 3 Needle stick part 31 Upper surface 32 Lower surface

Claims (3)

A rubber stopper having a lid having an upper surface and a lower surface, and a leg provided on the lower surface of the lid, wherein a needle stab at the center of the lid is provided between the upper and lower surfaces of the needle stab. A medical rubber stopper with improved liquid leakage, which is depressed so that the lower surface of the part is located. The rubber stopper according to claim 1, wherein the thickness of the needle stab is 80 to 100% of the thickness of the lid. The rubber stopper according to claim 1, wherein the lower surface of the needle stab is located below the lower surface of the lid by a thickness corresponding to 20 to 80% of the thickness of the needle stab.

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