JP2006006791A - Rubber stopper for sealing injection nozzle of pre-filed syringe - Google Patents

Rubber stopper for sealing injection nozzle of pre-filed syringe Download PDF

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JP2006006791A
JP2006006791A JP2004191093A JP2004191093A JP2006006791A JP 2006006791 A JP2006006791 A JP 2006006791A JP 2004191093 A JP2004191093 A JP 2004191093A JP 2004191093 A JP2004191093 A JP 2004191093A JP 2006006791 A JP2006006791 A JP 2006006791A
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injection nozzle
nozzle
insertion hole
syringe
injection
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Japanese (ja)
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Morihiro Sudo
盛皓 須藤
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Daikyo Seiko Ltd
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Daikyo Seiko Ltd
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Priority to JP2004191093A priority Critical patent/JP2006006791A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sealing rubber stopper to be applied to an injection nozzle of a pre-filled syringe, which keeps the injection nozzle tightly sealed, allows easy detachment when an injection needle is applied, and prevents it from sticking to the injection nozzle while sterilized by heating or the like, transmitted, and stored. <P>SOLUTION: The sealing rubber stopper to be applied to an injection nozzle of a pre-filled syringe comprises a surface having no contact with the injection nozzle, which is provided on a part of an inner surface of its opening for inserting the injection nozzle. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

本発明は、容器兼用注射器〔プレフィルドシリンジ（ｐｒｅ−ｆｉｌｌｅｄ ｓｙｒｉｎｇｅ）〕の注射ノズルに装着するゴム製の密封栓に関し、加熱等の滅菌による注射ノズルへの固着が防止され、使用時の注射ノズルからの密封栓の取り外しが容易な容器兼用注射器の注射ノズル用密封ゴム栓に関する。   The present invention relates to a rubber sealing plug attached to an injection nozzle of a container-combined syringe [pre-filled syringe], which prevents sticking to the injection nozzle due to sterilization such as heating and the like. The present invention relates to a sealing rubber stopper for an injection nozzle of a syringe that is also used as a container in which the sealing stopper can be easily removed.

近年、薬液や栄養剤等を予め注射器の注射筒内に充填、密封したプレフィルドシリンジと称される容器兼用注射器が使用されるようになってきた。容器兼用注射器の使用によって、アンプルやバイアル等の容器から薬液等を注射器に吸引する際の誤操作、異物混入汚染や注射針の損傷等が防止でき、更に、緊急時の揺変性（チクソトロピック性）薬液等を注射器へ吸引する手間や時間を省くことが可能となった。   2. Description of the Related Art In recent years, a container / syringe called a prefilled syringe in which a liquid medicine or a nutrient is filled in a syringe barrel in advance and sealed has been used. By using a syringe that can also be used as a container, it is possible to prevent accidental operation when a drug solution or the like is sucked into a syringe from a container such as an ampoule or a vial, contamination of a foreign substance, damage to a needle, etc., and thixotropy in an emergency. It has become possible to save the labor and time for sucking the drug solution into the syringe.

本発明におけるプレフィルドシリンジは、図９に１例を示すように従来の注射器とは形状は同じである。通常、注射筒に薬液等充填する際には、先ず注射ノズルに密封ゴム栓（ノズルキャップと称される）を被せ、減圧下の注射筒内に薬液等を充填し、フランジ側にはピストンが挿入されて注射筒は密封される。この状態でプレフィルドシリンジは、加熱等による滅菌処理を経、医薬品として医薬品販売会社や病院等に供給される。薬液等を投与する際に、密封ゴム栓は注射ノズルから取り除かれ、注射ノズルに注射針が装着される。
ところが、上記の滅菌処理によって、あるいは滅菌処理されて医薬品として輸送中あるいは保管中に、従来のノズルキャップ（１例を図１０に示す）は、注射ノズルの挿入部分が全て注射ノズル挿入孔の内面と密着するように形成されていることから、ノズルキャップは注射ノズルに固着し、輸送や保管中に抜け落ちることもなく、密封状態の保持には好ましいが、使用に際しての注射ノズルからのノズルキャップの取り外しが著しく阻害されることがあり、改善が要望されている。 The prefilled syringe in the present invention has the same shape as a conventional syringe as shown in FIG. Normally, when filling a syringe with a liquid medicine, the injection nozzle is first covered with a sealing rubber stopper (called a nozzle cap), and the liquid medicine is filled in the syringe under reduced pressure. Once inserted, the syringe barrel is sealed. In this state, the prefilled syringe is sterilized by heating or the like, and supplied as a medicine to a pharmaceutical sales company, a hospital, or the like. When a drug solution or the like is administered, the sealed rubber stopper is removed from the injection nozzle, and an injection needle is attached to the injection nozzle.
However, the conventional nozzle cap (one example is shown in FIG. 10) is completely inserted into the inner surface of the injection nozzle insertion hole by the above-described sterilization treatment or during sterilization and transportation or storage as a pharmaceutical product. The nozzle cap adheres to the injection nozzle and is not dropped during transportation or storage, and is preferable for maintaining a sealed state. Removal can be severely hindered and improvements are desired.

本発明は上記の事情に鑑みてなされたものであり、本発明の課題は、加熱等の滅菌処理や滅菌処理後の輸送、保管中のノズルキャップの注射ノズルへの固着が防止されるとともに、密封状態の保持も充分で、注射針取り付け時の取り外しが容易な容器兼用注射器の注射ノズルに装着するゴム製密封栓を提供することにある。   The present invention has been made in view of the above circumstances, the problem of the present invention is that sterilization treatment such as heating, transportation after sterilization treatment, sticking to the injection nozzle of the nozzle cap during storage is prevented, It is an object of the present invention to provide a rubber sealing plug that can be attached to an injection nozzle of a container-use syringe that is sufficiently sealed and can be easily removed when an injection needle is attached.

上記課題は以下の本発明によって達せられる。即ち、本発明は、容器兼用注射器の注射ノズルに装着するゴム製密封栓において、上記密封栓の注射ノズル挿入孔の内面の一部に注射ノズルとの非接触面が形成されていることを特徴とする容器兼用注射器の注射ノズル用密封ゴム栓である。   The above-mentioned subject is attained by the following present invention. That is, the present invention is a rubber sealing plug to be attached to an injection nozzle of a container / use syringe, wherein a non-contact surface with the injection nozzle is formed on a part of the inner surface of the injection nozzle insertion hole of the sealing plug. It is a sealing rubber stopper for the injection nozzle of the syringe that also serves as a container.

本発明によれば、薬液が充填され、密封された状態での容器兼用注射器を加熱等により滅菌処理を行っても、又、滅菌処理された医薬品として保管中あるいは輸送中の注射ノズルへの固着が防止されるとともに密封性も充分に保持される容器兼用注射器の注射ノズルに装着するゴム製密封栓が提供される。   According to the present invention, even when a container-filled syringe filled with a drug solution and sealed is sterilized by heating or the like, it is also fixed to an injection nozzle being stored or transported as a sterilized pharmaceutical product. A rubber sealing plug is provided that is attached to the injection nozzle of a container-use syringe that is prevented from being blocked and has sufficient sealing performance.

次に発明を実施するための最良の形態を挙げて本発明を更に詳細に説明する。
本発明の容器兼用注射器の注射ノズルに被せるゴム製の密封栓（以下ノズルキャップという）は、外形は特に限定されないが、通常、円柱状ないし円錐台状の形状を有し、従来のゴム製ノズルキャップと形状は同じである。通常、ノズルキャップの大きさは、外形を円柱状としたとき、例えば、外径は約６〜２０ｍｍ、高さは約１０〜１５ｍｍ程度であり、これに平均直径が約３．５〜５．０ｍｍ程度、深さが約５〜１２ｍｍ程度の注射ノズル（ＩＳＯで規定されたテーパー角度を有する）挿入孔が形成されている。
従来のノズルキャップは、図１０の（ａ）〜（ｃ）に例示するように、その注射ノズル挿入孔は、注射ノズルのほぼ全長ないし全長の約８０％以上が密接して挿入されるように注射ノズルと相似形に形成されている。そのため、加熱等の滅菌等によりノズルキャップは注射ノズルに固着する。 Next, the present invention will be described in more detail with reference to the best mode for carrying out the invention.
The rubber sealing stopper (hereinafter referred to as nozzle cap) to be put on the injection nozzle of the container-use syringe of the present invention is not particularly limited in outer shape, but usually has a cylindrical or truncated cone shape, and is a conventional rubber nozzle. The cap and shape are the same. Normally, when the outer shape of the nozzle cap is cylindrical, the outer diameter is about 6 to 20 mm, the height is about 10 to 15 mm, and the average diameter is about 3.5 to 5 mm. An injection hole (having a taper angle defined by ISO) of about 0 mm and a depth of about 5 to 12 mm is formed.
As illustrated in FIGS. 10A to 10C, the conventional nozzle cap has an injection nozzle insertion hole in which almost the entire length of the injection nozzle or about 80% or more of the total length is inserted closely. It is formed similar to the injection nozzle. Therefore, the nozzle cap is fixed to the injection nozzle by sterilization such as heating.

一方、本発明のノズルキャップは、注射ノズル挿入孔の一部に、注射ノズルと接触しない面（非接触面）が形成されていることが特徴である。この非接触面は、注射ノズル挿入孔の注射ノズルとの密接面に部分的に形成されたもの（例えば、図１参照）でも、注射ノズルとの密接面と非接触面が独立に形成されたもの（例えば、図２参照）であっても、又、これらの組み合わせであってもよい（例えば、図３参照）。   On the other hand, the nozzle cap of the present invention is characterized in that a surface that does not contact the injection nozzle (non-contact surface) is formed in a part of the injection nozzle insertion hole. This non-contact surface was formed partially on the contact surface of the injection nozzle insertion hole with the injection nozzle (for example, see FIG. 1), but the contact surface with the injection nozzle and the non-contact surface were formed independently. (For example, see FIG. 2) or a combination thereof (for example, see FIG. 3).

注射ノズル挿入孔（その内面）の一部に形成される注射ノズルとの非接触面は、ノズルキャップの注射ノズルへの固着が防止されて、ノズルキャップの取り外しが容易で、且つ密封性が保持される（液漏れしない）限り、どのように形成されていてもよく、非接触面の設置箇所、形状、大きさ、個数等は特に制限されない。非接触面の面積（大きさ）は、ノズルキャップ内面が、全てあるいは一部だけフッ素系樹脂やオレフィン系樹脂等の樹脂フィルムでラミネートされているか、全くラミネートされていないかによっても異なってくる。ノズルキャップ内面が全て樹脂フィルムでラミネートされている場合は、非接触面の面積は、注射ノズル（注射筒の天面部との付け根から先端部までをいう）の外側面の表面積の約５〜５０％程度、注射ノズル内面の一部がラミネートされている場合には、ラミネート部分の大きさにもよるが、約１０〜７０％程度、注射ノズル内面が全くラミネートされていない場合には、約５０〜８５％程度となるように形成されていることが好ましい。   The non-contact surface with the injection nozzle formed in a part of the injection nozzle insertion hole (the inner surface thereof) prevents the nozzle cap from adhering to the injection nozzle, so that the nozzle cap can be easily removed and the sealing performance is maintained. As long as it is formed (no liquid leakage), it may be formed in any way, and the installation location, shape, size, number, etc. of the non-contact surface are not particularly limited. The area (size) of the non-contact surface varies depending on whether the inner surface of the nozzle cap is all or partly laminated with a resin film such as a fluorine resin or an olefin resin, or not at all. When the inner surface of the nozzle cap is entirely laminated with a resin film, the area of the non-contact surface is about 5 to 50 of the surface area of the outer surface of the injection nozzle (from the root to the top of the injection cylinder). About 50%, when a part of the inner surface of the injection nozzle is laminated, depending on the size of the laminated part, about 10 to 70%, about 50% when the inner surface of the injection nozzle is not laminated at all. It is preferable that it is formed to be about ˜85%.

図面を参照して本発明のノズルキャップの構造を説明する。
図１に本発明のノズルキャップの一例の概略断面図を示す。（ｉ）は注射ノズルに装着する（被せる）前のノズルキャップ１を示し、ノズルキャップ１は、その天面部２の下方に注射ノズル挿入孔３を有し、この注射ノズル挿入孔３内に注射ノズルが密に挿入される。この例では、注射ノズル挿入孔３は、注射ノズルの全長が注射ノズル挿入孔３の内面と密接するように形成されており、注射ノズル１１との非接触面４は注射ノズル挿入孔３の内面の任意の箇所に形成されている。（ii）はノズルキャップ１を注射ノズル１１に装着した状態を示す。この例ではノズルキャップ１の注射ノズル挿入孔３の下端部７の面が注射筒の天面部１０に密接しているが、ノズルキャップの下端部７の面の一部が上記天面部１０に密接するように形成されたものでも、又、図１０の（ｂ）や（ｃ）のように注射筒天面部１０と接触しないように形成されたものでもよい。ノズルキャップの下端部７の構造は、プレフィルドシリンジの密封性が保持される限りは特に限定されるものではない。図１のノズルキャップ１における注射ノズルとの非接触面４は、注射ノズル挿入孔３の注射ノズル１１と密接する面の長さ方向に、対称の位置に形成された４個の線状（ほぼ長方形）の凹部溝である。注射ノズル挿入孔３の内面の線状凹部溝は、注射ノズル挿入孔３の非接触面の面積が、前記の範囲になるように形成されている。 The structure of the nozzle cap of the present invention will be described with reference to the drawings.
FIG. 1 shows a schematic sectional view of an example of the nozzle cap of the present invention. (I) shows the nozzle cap 1 before being attached (covered) to the injection nozzle. The nozzle cap 1 has an injection nozzle insertion hole 3 below the top surface portion 2, and the injection is inserted into the injection nozzle insertion hole 3. The nozzle is inserted densely. In this example, the injection nozzle insertion hole 3 is formed such that the entire length of the injection nozzle is in close contact with the inner surface of the injection nozzle insertion hole 3, and the non-contact surface 4 with the injection nozzle 11 is the inner surface of the injection nozzle insertion hole 3. It is formed in any place. (Ii) shows a state in which the nozzle cap 1 is mounted on the injection nozzle 11. In this example, the surface of the lower end portion 7 of the injection nozzle insertion hole 3 of the nozzle cap 1 is in close contact with the top surface portion 10 of the syringe barrel, but a part of the surface of the lower end portion 7 of the nozzle cap is in close contact with the top surface portion 10. Alternatively, it may be formed so as not to come into contact with the syringe barrel top surface portion 10 as shown in FIGS. 10B and 10C. The structure of the lower end portion 7 of the nozzle cap is not particularly limited as long as the sealing performance of the prefilled syringe is maintained. The non-contact surface 4 with the injection nozzle in the nozzle cap 1 of FIG. 1 has four linear shapes (substantially approximately) formed at symmetrical positions in the length direction of the surface in contact with the injection nozzle 11 of the injection nozzle insertion hole 3. (Rectangular) concave groove. The linear concave groove on the inner surface of the injection nozzle insertion hole 3 is formed so that the area of the non-contact surface of the injection nozzle insertion hole 3 is in the above range.

本発明のノズルキャップの他の例を図２に示す。この例では、ノズルキャップ１の注射ノズル挿入孔３が注射ノズル１１との密接部とその下方の注射ノズル１１との非接触部とに形成され、この非接触部は注射ノズル１１と非相似の円錐台の形状の非接触面５に形成されている。即ち、注射ノズル挿入孔３は、その天面部２より下方の注射ノズル挿入孔３の全長の約７０％の部分が注射ノズル１１と密接する部分（１）と、その下方部が注射ノズル１１と接触しない部分（２）（非接触面５が形成されている部分）とから形成されている。注射ノズル挿入孔３の上記部分（２）の面積は、前記の範囲となるように形成されている。   Another example of the nozzle cap of the present invention is shown in FIG. In this example, the injection nozzle insertion hole 3 of the nozzle cap 1 is formed in a close contact portion with the injection nozzle 11 and a non-contact portion with the injection nozzle 11 therebelow, and this non-contact portion is not similar to the injection nozzle 11. It is formed on the non-contact surface 5 in the shape of a truncated cone. That is, the injection nozzle insertion hole 3 has a portion (1) in which about 70% of the total length of the injection nozzle insertion hole 3 below the top surface portion 2 is in close contact with the injection nozzle 11, and a lower portion of the injection nozzle insertion hole 3 with the injection nozzle 11. It is formed from the part (2) which does not contact (part in which the non-contact surface 5 is formed). The area of the portion (2) of the injection nozzle insertion hole 3 is formed to be in the above range.

本発明のノズルキャップの他の例は図３に示すように、図２に示すノズルキャップ１の注射ノズル挿入孔３の注射ノズル１１と密接する部分（１）の内面に、図１に示すノズルキャップ１におけるのと同じ４個の線状凹部溝４が、上記部分（２）の非接触面５とともに形成された例である。注射ノズル挿入孔３の全非接触面の面積は、前記の範囲となるように形成されている。   As shown in FIG. 3, another example of the nozzle cap of the present invention is formed on the inner surface of the portion (1) in close contact with the injection nozzle 11 of the injection nozzle insertion hole 3 of the nozzle cap 1 shown in FIG. This is an example in which the same four linear recessed grooves 4 as in the cap 1 are formed together with the non-contact surface 5 of the part (2). The area of the entire non-contact surface of the injection nozzle insertion hole 3 is formed to be in the above range.

本発明における、図１〜３に示す線状凹部溝以外の部分的非接触面としては、例えば、ノズルキャップの注射ノズル挿入孔内面の円周方向に形成する複数の環状凹部溝（図８）、形状が円や楕円等の複数の凹部溝等が挙げられる。   As a partial non-contact surface other than the linear recessed groove shown in FIGS. 1 to 3 in the present invention, for example, a plurality of annular recessed grooves formed in the circumferential direction of the inner surface of the injection nozzle insertion hole of the nozzle cap (FIG. 8). And a plurality of concave grooves having a circular shape or an elliptical shape.

本発明においては、注射ノズルとの非接触面が形成されたノズルキャップによる密封性が保持される上で、ノズルキャップの注射ノズル挿入孔の天面部下面の注射ノズルの先端と接触する部位に、注射ノズルのノズル孔を塞ぐことができる突起（ノズル孔閉塞突起）を設けることが好ましい（図４）。突起の形状は注射ノズルのノズル孔を塞ぐことができる形状であれば特に限定されず、例えば、図４に示す球面凸状突起６が挙げられる。又、必要に応じてノズルキャップの注射ノズル挿入孔内面をフッ素系樹脂、ポリエチレン等の注射筒に充填される薬液等に対して溶解も膨潤もしないプラスチックのフィルムをラミネートすることもできる。突起の形状は上記以外のものでもよい。   In the present invention, in addition to maintaining the sealing performance by the nozzle cap formed with a non-contact surface with the injection nozzle, the portion that contacts the tip of the injection nozzle on the lower surface of the injection nozzle insertion hole of the nozzle cap, It is preferable to provide a protrusion (nozzle hole closing protrusion) that can close the nozzle hole of the injection nozzle (FIG. 4). The shape of the protrusion is not particularly limited as long as it can close the nozzle hole of the injection nozzle, and examples thereof include a spherical convex protrusion 6 shown in FIG. Further, if necessary, the inner surface of the injection nozzle insertion hole of the nozzle cap can be laminated with a plastic film that does not dissolve or swell with respect to a chemical solution or the like filled in a syringe such as a fluororesin or polyethylene. The shape of the protrusion may be other than the above.

本発明のプレフィルドシリンジ用のノズルキャップは、以上のような注射ノズルとの非接触面をノズルキャップの注射ノズル挿入孔の内面の一部に形成すること以外は従来のノズルキャップと同様にして製造される。本発明のノズルキャップの製造に用いられるゴム原料及び配合剤等も従来の注射器用ノズルキャップや医薬品及び医療用ゴム栓の製造に用いられているものはいずれも使用でき、特に限定されるものではない。   The nozzle cap for the prefilled syringe of the present invention is manufactured in the same manner as the conventional nozzle cap except that the non-contact surface with the injection nozzle as described above is formed on a part of the inner surface of the injection nozzle insertion hole of the nozzle cap. Is done. The rubber raw materials and compounding agents used in the production of the nozzle cap of the present invention can be any of those used in the production of conventional syringe nozzle caps and pharmaceutical and medical rubber stoppers, and are not particularly limited. Absent.

次に実施例及び比較例を挙げて本発明を具体的に説明する。   Next, the present invention will be specifically described with reference to examples and comparative examples.

実施例１、比較例１
図５に示すノズルキャップを、原料ゴムとしてブチルゴムを用い、加熱下の圧縮成形により２０個作製した。注射ノズル挿入孔の長さ（深さ）は１１．０ｍｍで、下半分は注射ノズルと非接触に形成されている。このノズルキャップは、注射ノズル挿入孔の注射ノズルとの非接触面の面積が、注射ノズル外側表面の表面積の約５５％である。
又、比較例として上記と同様にして注射ノズル挿入孔の下半分も注射ノズルと密接するノズルキャップを２０個作製した。 Example 1 and Comparative Example 1
20 nozzle caps shown in FIG. 5 were produced by compression molding under heating using butyl rubber as a raw rubber. The length (depth) of the injection nozzle insertion hole is 11.0 mm, and the lower half is formed in non-contact with the injection nozzle. In this nozzle cap, the area of the non-contact surface of the injection nozzle insertion hole with the injection nozzle is about 55% of the surface area of the outer surface of the injection nozzle.
Further, as a comparative example, 20 nozzle caps were prepared in the same manner as described above so that the lower half of the injection nozzle insertion hole was in close contact with the injection nozzle.

上記のノズルキャップをそれぞれ、容量が１５ｍｌのプレフィルドシリンジに装着し、減圧下に注射筒内に蒸留水を充填してフランジ側をピストンで密封した。これらのプレフィルドシリンジを１２１℃に設定されたオートクレーブ中に３０分間静置した後、オートクレーブより取り出し、充填水が室温となるまで放置、冷却した。
上記２種のノズルキャップについて注射ノズルへの固着性及び密封性（液漏れの有無）を確認した。以下のノズルキャップについても同様にしてノズルキャップの注射ノズルへの固着性及び密封性を確認した。固着性はノズルキャップを手で外して確認した。密封性はプレフィルドシリンジのノズルキャップ側を下にしてフランジで支え、液漏れの有無を観察した。以下の実施例及び比較例のノズルキャップについても同様にして固着性及び密封性を確認した。確認結果を表１に示す。 Each of the above-mentioned nozzle caps was attached to a prefilled syringe having a capacity of 15 ml, distilled water was filled into the syringe barrel under reduced pressure, and the flange side was sealed with a piston. These prefilled syringes were allowed to stand in an autoclave set at 121 ° C. for 30 minutes, then removed from the autoclave and allowed to cool until the filling water reached room temperature.
The above two types of nozzle caps were confirmed to be fixed to the injection nozzle and sealed (presence or absence of liquid leakage). The following nozzle caps were confirmed in the same manner as to whether the nozzle cap was fixed to the injection nozzle and sealed. Adherence was confirmed by removing the nozzle cap by hand. The sealing performance was supported by a flange with the nozzle cap side of the prefilled syringe down, and the presence or absence of liquid leakage was observed. For the nozzle caps of the following examples and comparative examples, the adhesion and sealing properties were confirmed in the same manner. The confirmation results are shown in Table 1.

実施例２
ノズルキャップの注射ノズル挿入孔の上半分の内面の対称の位置に４個の線状凹部溝（ほぼ長方形の凹部溝）を非接触面として形成した図６に示すノズルキャップを実施例１と同様にして２０個作製し、注射ノズルへの固着性と密封性を確認した。確認結果を表１に示す。このノズルキャップは、注射ノズルとの非接触面の面積が、注射ノズルの外側表面の面積の約６０％である。 Example 2
The nozzle cap shown in FIG. 6 in which four linear concave grooves (substantially rectangular concave grooves) are formed as non-contact surfaces at symmetrical positions on the inner surface of the upper half of the injection nozzle insertion hole of the nozzle cap is the same as in the first embodiment. 20 pieces were prepared, and the fixing property to the injection nozzle and the sealing property were confirmed. The confirmation results are shown in Table 1. In this nozzle cap, the area of the non-contact surface with the injection nozzle is about 60% of the area of the outer surface of the injection nozzle.

実施例３
実施例２における非接触面をさらに増加させた図７に示すノズルキャップ２０個を実施例２と同様にして作製し、注射ノズルへの固着性と密封性を確認した。確認結果を表１に示す。このノズルキャップは、注射ノズル挿入孔の注射ノズルとの非接触面の面積が、注射ノズルの外側表面の面積の約７０％である。 Example 3
7 nozzle caps shown in FIG. 7 in which the non-contact surface in Example 2 was further increased were produced in the same manner as in Example 2, and adhesion to the injection nozzle and sealing performance were confirmed. The confirmation results are shown in Table 1. In this nozzle cap, the area of the non-contact surface of the injection nozzle insertion hole with the injection nozzle is about 70% of the area of the outer surface of the injection nozzle.

実施例４、比較例２
実施例２における非接触面に代えて図８に示す環状凹部溝を有するノズルキャップ２０個を実施例２と同様にして作製し、注射ノズルへの固着性と密封性を確認した。確認結果を表１に示す。このノズルキャップは、注射ノズル挿入孔の注射ノズルとの非接触面の面積が、注射ノズルの外側表面の面積の約７０％である。又、比較例として、同様にして注射ノズル挿入孔の注射ノズルとの非接触面の面積が、注射ノズルの外側表面の面積の約９０％であるノズルキャップも製造した。 Example 4 and Comparative Example 2
In place of the non-contact surface in Example 2, 20 nozzle caps having an annular recess groove shown in FIG. 8 were produced in the same manner as in Example 2, and adhesion to the injection nozzle and sealing performance were confirmed. The confirmation results are shown in Table 1. In this nozzle cap, the area of the non-contact surface of the injection nozzle insertion hole with the injection nozzle is about 70% of the area of the outer surface of the injection nozzle. Further, as a comparative example, a nozzle cap in which the area of the non-contact surface of the injection nozzle insertion hole with the injection nozzle was about 90% of the area of the outer surface of the injection nozzle was also manufactured.

Figure 2006006791
Figure 2006006791

本発明によれば、薬液が充填され、密封された状態での容器兼用注射器を加熱等により滅菌処理を行っても、注射ノズルへの固着が防止されるとともに密封性も充分に保持される容器兼用注射器の注射ノズルに装着するゴム製密封栓が提供される。   According to the present invention, a container filled with a chemical solution and sealed and prevented from sticking to an injection nozzle and sufficiently sealed even when the container-use syringe is sterilized by heating or the like. A rubber seal plug is provided for mounting on an injection nozzle of a combined-use syringe.

本発明の容器兼用注射器のノズルキャップの一例を説明する概略断面図である。（ｉ）は注射ノズル装着前、（ii）は注射ノズル装着状態である（概略断面図（上段）及びＡ−Ａ切断面（下段））。It is a schematic sectional drawing explaining an example of the nozzle cap of the syringe with a container of this invention. (I) is before injection nozzle mounting, (ii) is the injection nozzle mounting state (schematic cross-sectional view (upper stage) and AA cut surface (lower stage)). 本発明の容器兼用注射器のノズルキャップの一例を説明する概略断面図である。It is a schematic sectional drawing explaining an example of the nozzle cap of the syringe with a container of this invention. 本発明の容器兼用注射器のノズルキャップの一例を説明する概略断面図である。It is a schematic sectional drawing explaining an example of the nozzle cap of the syringe with a container of this invention. 本発明の容器兼用注射器のノズルキャップの一例を説明する概略断面図である。It is a schematic sectional drawing explaining an example of the nozzle cap of the syringe with a container of this invention. 実施例１のノズルキャップの概略断面図である。2 is a schematic cross-sectional view of a nozzle cap of Example 1. FIG. 実施例２のノズルキャップの概略断面図である。6 is a schematic cross-sectional view of a nozzle cap of Example 2. FIG. 実施例３のノズルキャップの概略断面図である。6 is a schematic cross-sectional view of a nozzle cap of Example 3. FIG. 実施例４のノズルキャップの概略断面図である。6 is a schematic sectional view of a nozzle cap of Example 4. FIG. 従来の容器兼用注射器を説明する概略断面図である。It is a schematic sectional drawing explaining the conventional container combined use syringe. 従来の容器兼用注射器のノズルキャップを説明する概略断面図である。It is a schematic sectional drawing explaining the nozzle cap of the conventional container combined use syringe.

符号の説明Explanation of symbols

１：本発明の容器兼用注射器のノズルキャップ
２：ノズルキャップの天面部
３：注射ノズル挿入孔
４：非接触面
５：非接触面
６：注射ノズルのノズル孔閉塞突起
７：ノズルキャップの下端部
１０：容器兼用注射器の天面部
１１：注射ノズル
1: Nozzle cap 2 of the syringe as a container of the present invention 2: Top surface portion of the nozzle cap 3: Injection nozzle insertion hole 4: Non-contact surface 5: Non-contact surface 6: Nozzle hole closing projection 7 of the injection nozzle: Lower end portion of the nozzle cap 10: Top surface portion of syringe also serving as a container 11: Injection nozzle

Claims (7)

容器兼用注射器の注射ノズルに装着するゴム製密封栓において、上記密封栓の注射ノズル挿入孔の内面の一部に注射ノズルとの非接触面が形成されていることを特徴とする容器兼用注射器の注射ノズル用密封ゴム栓。   A rubber seal plug to be attached to an injection nozzle of a container-use syringe, wherein the non-contact surface with the injection nozzle is formed on a part of the inner surface of the injection nozzle insertion hole of the seal plug. Sealed rubber stopper for injection nozzle. 注射ノズル挿入孔が、注射ノズルが密に挿入されるように形成されている請求項１に記載の容器兼用注射器の注射ノズル用密封ゴム栓。   2. The sealing rubber plug for an injection nozzle of a container-use syringe according to claim 1, wherein the injection nozzle insertion hole is formed so that the injection nozzle is closely inserted. 注射ノズル挿入孔が、その天面部下から順に注射ノズルが密に挿入される部分（１）と、注射ノズルと接触しない部分（２）とから構成されている請求項１に記載の容器兼用注射器の注射ノズル用密封ゴム栓。   2. The container-use syringe according to claim 1, wherein the injection nozzle insertion hole includes a portion (1) into which the injection nozzle is densely inserted in order from below the top surface portion and a portion (2) that does not contact the injection nozzle. Sealing rubber stopper for injection nozzles. 上記部分（１）に更に上記非接触面が形成されている請求項３に記載の容器兼用注射器の注射ノズル用密封ゴム栓。   The sealing rubber stopper for an injection nozzle of a syringe serving as a container according to claim 3, wherein the non-contact surface is further formed on the portion (1). 上記の注射ノズルとの非接触面が、注射ノズル挿入孔の長さ方向に形成された複数の線状凹部溝である請求項１〜４のいずれか１項に記載の容器兼用注射器の注射ノズル用密封ゴム栓。   The non-contact surface with the injection nozzle is a plurality of linear concave grooves formed in the length direction of the injection nozzle insertion hole. The injection nozzle of the container-use syringe according to any one of claims 1 to 4. Sealed rubber stopper. 上記の注射ノズルとの非接触面が、注射ノズル挿入孔の円周方向に形成された複数の環状凹部溝である請求項１〜４のいずれか１項に記載の容器兼用注射器の注射ノズル用密封ゴム栓。   The non-contact surface with the injection nozzle is a plurality of annular recess grooves formed in the circumferential direction of the injection nozzle insertion hole. Sealed rubber stopper. 注射ノズル挿入孔の天面部下端の注射ノズルの先端と接触する部位に、注射ノズルの孔を塞ぐ突起が形成されている請求項１〜６のいずれか１項に記載の容器兼用注射器の注射ノズル用密封ゴム栓。
The injection nozzle of the combined syringe according to any one of claims 1 to 6, wherein a projection that closes the hole of the injection nozzle is formed at a portion that contacts the tip of the injection nozzle at the lower end of the top surface portion of the injection nozzle insertion hole. Sealed rubber stopper.
JP2004191093A 2004-06-29 2004-06-29 Rubber stopper for sealing injection nozzle of pre-filed syringe Pending JP2006006791A (en)

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JP2009112352A (en) * 2007-11-01 2009-05-28 Nipro Corp Cap
US8529519B2 (en) 2008-04-01 2013-09-10 Seikagaku Corporation Tight-sealing cap for liquid drug-expelling part
KR20200006041A (en) * 2017-03-17 2020-01-17 라브메드 에이/에스 Ampoule plug
CN112755328A (en) * 2021-02-02 2021-05-07 江苏华兰药用新材料股份有限公司 Prefilled syringe cap, preparation method and device thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009112352A (en) * 2007-11-01 2009-05-28 Nipro Corp Cap
US8529519B2 (en) 2008-04-01 2013-09-10 Seikagaku Corporation Tight-sealing cap for liquid drug-expelling part
KR20200006041A (en) * 2017-03-17 2020-01-17 라브메드 에이/에스 Ampoule plug
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CN112755328A (en) * 2021-02-02 2021-05-07 江苏华兰药用新材料股份有限公司 Prefilled syringe cap, preparation method and device thereof
CN112755328B (en) * 2021-02-02 2023-12-15 江苏华兰药用新材料股份有限公司 Prefilled syringe protective cap, preparation method and device thereof

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