JPS62137065A - Syringe - Google Patents

Syringe

Info

Publication number
JPS62137065A
JPS62137065A JP60278199A JP27819985A JPS62137065A JP S62137065 A JPS62137065 A JP S62137065A JP 60278199 A JP60278199 A JP 60278199A JP 27819985 A JP27819985 A JP 27819985A JP S62137065 A JPS62137065 A JP S62137065A
Authority
JP
Japan
Prior art keywords
syringe
olefin copolymer
outer cylinder
ethylene
linear ethylene
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP60278199A
Other languages
Japanese (ja)
Inventor
鈴木 龍夫
啓之介 磯野
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to JP60278199A priority Critical patent/JPS62137065A/en
Publication of JPS62137065A publication Critical patent/JPS62137065A/en
Pending legal-status Critical Current

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Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。
(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

【発明の詳細な説明】 [産業上の利用分野] 本発明は、シリンジに関する。特に、γ線滅菌に耐えう
るシリンジに関する。
DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a syringe. In particular, it relates to a syringe that can withstand gamma ray sterilization.

[従来の技術] 従来、シリンジは1種々の医薬品を体内に注入するのに
用いられるので、耐薬品性に優れていることが要求され
ており、その外筒は、ポリプロピレン、ポリメチルペン
テン等が使用されていた。
[Prior Art] Conventionally, syringes are used to inject various types of pharmaceuticals into the body, so they are required to have excellent chemical resistance, and their outer cylinders are made of polypropylene, polymethylpentene, etc. It was used.

ポリプロピレンは、結晶化度が大きいために透明性が悪
いので透明性を向上させるために、ジベンジリデンソル
ビトール及びそのアルキル誘導体等の造核剤を添加して
いる。すなわち、造核剤を添加することにより、小さな
結晶を生成し透明性を良くしていた。また滅菌は、シリ
ンジの材質上。
Polypropylene has poor transparency due to its high degree of crystallinity, so nucleating agents such as dibenzylidene sorbitol and its alkyl derivatives are added to improve transparency. That is, by adding a nucleating agent, small crystals were generated and transparency was improved. Sterilization also depends on the material of the syringe.

エチレンオキサイドガス滅菌法によりおこなわれていた
It was sterilized using ethylene oxide gas.

[発明が解決しようとする問題点] 近年、滅菌の安全性、操作の簡便さ、エチレンオキサイ
ドガスの吸着残留による悪影響を考慮すると、γ線によ
る滅菌のほうが優れておりγ線による滅菌が望まれてい
る。しかしながら、ポリプロピレンは、γ線を照射する
とポリプロピレン分子が分解し、極度に強度が低下する
ので、ポリプロピレン製のシリンジはγ線による滅菌を
行うことができなかった。また、ポリプロピレン製のシ
リンジは、透明性に劣り薬液等の採取量がわがりにくい
ので薬液等の内容液を見易くするため及び商品イメージ
を向上させるために、ジベンジリデンソルビトール及び
そのアルキル誘導体等の造核剤を添加して、その透明性
を向上させていた。ジベンジリデンソルビトール及びそ
のアルキル誘導体等の造核剤を添加したポリプロピレン
製のシリンジは、添加された造核剤が溶出しやすく生体
に好ましくなかった。さらに成形性の上でも、造核剤が
異物として金型を汚し、たびたび金型をトルエン等の溶
剤で洗浄する必要があり、その上、造核剤を添加した成
形物は静電気を帯やすく、ゴミ等の付着、離型に関する
問題等、成形上の不都合が生じていた。
[Problems to be Solved by the Invention] In recent years, sterilization using gamma rays has become desirable because it is superior to sterilization, considering the safety of sterilization, the ease of operation, and the negative effects of adsorbed residual ethylene oxide gas. ing. However, when polypropylene is irradiated with gamma rays, the polypropylene molecules decompose and its strength is extremely reduced, so syringes made of polypropylene cannot be sterilized with gamma rays. In addition, polypropylene syringes have poor transparency and are difficult to collect, so in order to make the contents of the drug solution easier to see and to improve the product image, dibenzylidene sorbitol and its alkyl derivatives are used. A nucleating agent was added to improve its transparency. Syringes made of polypropylene to which nucleating agents such as dibenzylidene sorbitol and its alkyl derivatives have been added are unfavorable to living organisms because the added nucleating agents tend to elute. Furthermore, in terms of moldability, the nucleating agent contaminates the mold as foreign matter, requiring frequent cleaning of the mold with a solvent such as toluene, and in addition, molded products containing a nucleating agent are susceptible to static electricity. Molding problems such as adhesion of dust and mold release problems have occurred.

ポリメチルペンテンは、透明性に優れ、溶出物に関して
も比較的優れたオレフィン系樹脂であるが、耐衝撃性が
悪く、また価格も高いのでシリンジの外筒への使用には
適さなかった。
Polymethylpentene is an olefin resin that has excellent transparency and is relatively good in terms of eluates, but it has poor impact resistance and is expensive, so it is not suitable for use in the outer cylinder of a syringe.

[問題点を解決するための手段] 本発明は、外筒と成子とガスゲットで構成されるシリン
ジにおいて、少なくとも外筒か直鎖状のエチレン−αオ
レフィン共重合体を主成分とする合成樹脂で作製したシ
リンジを提供することにより上記問題点を解決した。
[Means for Solving the Problems] The present invention provides a syringe composed of an outer cylinder, a separator, and a gas get, in which at least the outer cylinder is made of a synthetic resin mainly composed of a linear ethylene-α olefin copolymer. The above problems were solved by providing a syringe made with.

一般には、高分子にγ線を照射すると、イオン化、励起
を経て分解や架橋が起こる。γ線照射によって生成した
。イオン、ラジカル、励起種は。
Generally, when a polymer is irradiated with gamma rays, decomposition and crosslinking occur through ionization and excitation. Produced by gamma irradiation. ions, radicals, and excited species.

イオン分子反応、ラジカル反応によって共有結合の解離
、結合の生成などが複雑な形で起こる。主な過程は、高
分子鎖の切断、側鎖の解離、高分子鎖間の橋かけである
。多くの高分子では、主鎖の切断と架橋が併行して生成
するが、主鎖の切断のみ優先して起こる高分子、架橋が
優先して起こる高分子などがある。γ線の照射とともに
高分子の分子量やその分布が変化し1分離型高分子では
Dissociation of covalent bonds and formation of bonds occur in complex ways through ionic and molecular reactions and radical reactions. The main processes are cleavage of polymer chains, dissociation of side chains, and cross-linking between polymer chains. In many polymers, main chain scission and crosslinking occur simultaneously, but there are some polymers in which only main chain scission occurs preferentially, and polymers in which crosslinking occurs preferentially. With γ-ray irradiation, the molecular weight and distribution of the polymer changes, resulting in one-separation type polymers.

しだいに分子量が減少し、架橋型高分子では、しだいに
網目構造が生成し、三次元的に巨大分子に変わっていく
。種々の高分子のなかで、一般的にはビニル型高分子は
架橋型に属し、ビニリデン型高分子は崩壊型に属する。
The molecular weight gradually decreases, and cross-linked polymers gradually form a network structure, turning into three-dimensional macromolecules. Among various polymers, generally vinyl type polymers belong to the crosslinked type, and vinylidene type polymers belong to the collapsed type.

ポリプロピレンは、ビニル型高分子であるが1通常のγ
線滅菌の条件では、主鎖の分解が優先して強度が低下す
るので。
Polypropylene is a vinyl type polymer, but 1 normal γ
Under wire sterilization conditions, main chain decomposition takes priority and strength decreases.

γ線滅菌が出来なかった。γ-ray sterilization was not possible.

本発明者らが、鋭意研究を重ねた結果、直鎖状のエチレ
ン−αオレフィン共重合体は、透明性を有し、耐衝撃性
に優れ、シリンジとしての強度を有しており、γ線を照
射しても樹脂の分解がおこらず1強度の低下がみられな
いことがわがっな。
As a result of intensive research by the present inventors, the linear ethylene-α olefin copolymer has transparency, excellent impact resistance, strength as a syringe, and γ-rays. It was found that the resin did not decompose and no decrease in strength was observed even when irradiated with .

すなわち、直鎖状のエチレン−αオレフィン共重合体は
架橋型に属し、γ線を照射することにより部分架橋がお
こり1機械的強度が増大するからである。
That is, the linear ethylene-α olefin copolymer belongs to the crosslinked type, and irradiation with gamma rays causes partial crosslinking and increases the mechanical strength.

また、直鎖状のエチレン−αオレフイン共重合体は、ポ
リプロピレン、低圧法による高密度ポリエチレンに比べ
て透明性が」:い。さらに、直鎖状のエチレン−αオレ
フィン共重合体は基本的には溶出性の高い成分を含まな
いので安全性が高い。
Furthermore, the linear ethylene-α olefin copolymer has less transparency than polypropylene or high-density polyethylene produced by a low-pressure process. Furthermore, the linear ethylene-α olefin copolymer basically does not contain any components that are highly eluting, so it is highly safe.

すなわち1本発明によれば、透明性、耐衝撃性に優れ、
溶出性の高い成分を含まず、γ線滅菌に耐えうるシリン
ジを提供することができる。
That is, according to the present invention, it has excellent transparency and impact resistance,
It is possible to provide a syringe that does not contain highly eluted components and can withstand gamma ray sterilization.

外筒に用いることができる直鎖状のエチレン−αオレフ
ィン共重合体は、密度が0.930 g / c nf
〜0.980 g / c nfであることが好ましい
。密度が0.930 g / c−rr?未満である直
鎖状のエチレン−αオレフィン共重合体で作製した外筒
は、柔らかくて薬液等の注入時の圧力に対して変形しや
すく。
The linear ethylene-α olefin copolymer that can be used for the outer cylinder has a density of 0.930 g/c nf
~0.980 g/cnf is preferred. Density is 0.930 g/c-rr? An outer cylinder made of a linear ethylene-α olefin copolymer having a molecular weight of less than 100 ml is soft and easily deforms under the pressure of injecting a chemical solution or the like.

気密試験において、所定の圧力を加えたとき外筒とガス
ケットの接触面から水の漏れが生じ、ディスポーザブル
注射筒基準に適合しない。気密試験は次の方法で行う。
In the airtightness test, water leaked from the contact surface between the outer cylinder and the gasket when a certain pressure was applied, and the product did not meet disposable syringe standards. The airtightness test shall be conducted in the following manner.

充分に水をふきとったシリンジに、その最大目盛、最大
目盛の3/4及び最大目盛の1/2の位置まで吸い入れ
、これを水平に固定して水が筒口から出ないようにした
後、筒口に次の表に掲げる圧力を10秒間加えたとき、
はめ合わせから水滴が落ちてはならない。
After thoroughly wiping off water, inhale the syringe to its maximum scale, 3/4 of the maximum scale, and 1/2 of the maximum scale, and fix it horizontally to prevent water from coming out of the cylinder mouth. When the pressure listed in the following table is applied to the tube mouth for 10 seconds,
There should be no water dripping from the fit.

直鎖状のエチレン−αオレフィン共重合体の密度を高く
するには、共重合体中のαオレフィンのモル比を小さく
することにより可能となる。
The density of the linear ethylene-α-olefin copolymer can be increased by decreasing the molar ratio of the α-olefin in the copolymer.

直鎖状のエチレン−αオレフィン共重合体のαオレフィ
ンは炭素数が4のブテン−1,炭素数が6のヘキセン−
1及び4メヂルペンテン−1,炭素数が8のオクテン−
1等であることが好ましい。
The α-olefins of the linear ethylene-α-olefin copolymer are butene-1, which has 4 carbon atoms, and hexene-1, which has 6 carbon atoms.
1 and 4 methylpentene-1, octene with 8 carbon atoms-
It is preferable that it be the 1st grade.

さらに好ましくは、αオレフィンが4メチルペンテン−
1,オクテン−1であることが好ましい。
More preferably, the α-olefin is 4-methylpentene-
1, octene-1 is preferred.

すなわち、αオレフィンが4メチルペンテン−1゜オク
テン−1である直鎖状のエチレン−αオレフィン共重合
体は、引張強度および耐衝撃性に優れているからである
That is, a linear ethylene-α-olefin copolymer in which the α-olefin is 4-methylpentene-1°octene-1 has excellent tensile strength and impact resistance.

このような特性を有する直鎖状のエチレン−αオレフィ
ン共重合体を用いて作製した外筒で構成されたシリンジ
は、低コストで作製でき、透明性。
A syringe constructed with an outer cylinder made using a linear ethylene-α olefin copolymer having such characteristics can be produced at low cost and is transparent.

耐衝撃性に優れ、溶出性の高い成分をほとんど含まない
ので安全性が高く、γ線滅菌することができる。
It has excellent impact resistance, contains almost no highly leachable components, is highly safe, and can be sterilized by gamma rays.

[実施例] 以下に1本発明を実施例により更に詳細に説明する。[Example] The present invention will be explained in more detail below with reference to Examples.

実施例1 密度が0.935 g / c nfであるエチレンと
オクテン−1の共重合体を用いて射出成形により、 2
5m1用の外筒1と成子2を作製した。作製した外筒の
肉厚は1.5 mmであった。成子の先端に、天然ゴム
製のガスケット3を取り付はシリンジを組み立てた。
Example 1 By injection molding using a copolymer of ethylene and octene-1 with a density of 0.935 g/cnf.
Outer cylinder 1 and Seiko 2 for 5 m1 were produced. The wall thickness of the produced outer cylinder was 1.5 mm. A natural rubber gasket 3 was attached to the tip of the syringe to assemble the syringe.

このシリンジを滅菌線量が2.5Mradでγ線滅菌し
た後、シリンジの耐衝撃性はほとんど変化がなかった。
After this syringe was sterilized with gamma rays at a sterilization dose of 2.5 Mrad, there was almost no change in the impact resistance of the syringe.

また、前記の方法に従って気密試験を行った結果、 2
.5 k g/ cm”の圧力を加えても水の漏れはな
かった。
In addition, as a result of conducting an airtight test according to the above method, 2
.. There was no leakage of water even when a pressure of 5 kg/cm'' was applied.

実施例2 密度が0.950 g / CTTI’であるエチレン
とオクテン−1の共重合体を用いて射出成形により、 
10ml用の外筒1と成子2を作製した。作製した外筒
の肉厚は1+nn+であった6吸子の先端に天然ゴム製
のガスケット3を取り付はシリンジを組み立てた。
Example 2 By injection molding using a copolymer of ethylene and octene-1 with a density of 0.950 g/CTTI'
Outer cylinder 1 and Seiko 2 for 10 ml were produced. The outer cylinder had a wall thickness of 1+nn+, and a gasket 3 made of natural rubber was attached to the tip of the six suckers to assemble a syringe.

このシリンジを滅菌線量が2.5Mradでγ線滅菌し
た後、シリンジの耐衝撃性はほとんど変化がなかった。
After this syringe was sterilized with gamma rays at a sterilization dose of 2.5 Mrad, there was almost no change in the impact resistance of the syringe.

また、前記の方法に従って気密試験を行った結果、3k
g/cm2の圧力を加えても水の漏れはなかった。
In addition, as a result of conducting an airtight test according to the above method, 3k
Even when a pressure of g/cm2 was applied, no water leaked.

[発明の効果] 一つ− 以上述べたように1本発明のシリンジは以下に示す利点
を有する。
[Effects of the Invention] One - As described above, the syringe of the present invention has the following advantages.

■γ線を照射しても樹脂の劣化を起こさないのでγ線滅
菌を行うことができる。
■ Gamma ray sterilization is possible because the resin does not deteriorate even when irradiated with gamma rays.

■溶出しやすい物質をほとんど含まないので安全である
■It is safe as it contains almost no substances that are easily eluted.

■樹脂の価格が低いので経済的である。■It is economical because the price of resin is low.

【図面の簡単な説明】[Brief explanation of drawings]

添付図は本発明によるシリンジの一実施例を示す正面図
である。
The attached figure is a front view showing one embodiment of a syringe according to the present invention.

Claims (3)

【特許請求の範囲】[Claims] (1)外筒と吸子とガスケットで構成されるシリンジで
あって、少なくとも外筒が直鎖状のエチレン−αオレフ
ィン共重合体を主成分とする合成樹脂で形成されている
ことを特徴とするシリンジ。
(1) A syringe consisting of an outer cylinder, a sucker, and a gasket, characterized in that at least the outer cylinder is made of a synthetic resin whose main component is a linear ethylene-α olefin copolymer. syringe.
(2)エチレン−αオレフィン共重合体の密度が0.9
30g/cm^3〜0.980g/cm^3である特許
請求の範囲第1項記載のシリンジ。
(2) Density of ethylene-α olefin copolymer is 0.9
The syringe according to claim 1, which has a weight of 30 g/cm^3 to 0.980 g/cm^3.
(3)エチレン−αオレフィン共重合体のαオレフィン
の炭素数が4〜8の範囲にある特許請求の範囲第1項ま
たは第2項記載のシリンジ。
(3) The syringe according to claim 1 or 2, wherein the α-olefin of the ethylene-α-olefin copolymer has a carbon number in the range of 4 to 8.
JP60278199A 1985-12-11 1985-12-11 Syringe Pending JPS62137065A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP60278199A JPS62137065A (en) 1985-12-11 1985-12-11 Syringe

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP60278199A JPS62137065A (en) 1985-12-11 1985-12-11 Syringe

Publications (1)

Publication Number Publication Date
JPS62137065A true JPS62137065A (en) 1987-06-19

Family

ID=17593976

Family Applications (1)

Application Number Title Priority Date Filing Date
JP60278199A Pending JPS62137065A (en) 1985-12-11 1985-12-11 Syringe

Country Status (1)

Country Link
JP (1) JPS62137065A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0709105A1 (en) * 1994-10-27 1996-05-01 Schott Glaswerke Pre-filled sterile disposable syringe with low quantity of particles for injection of compositions and method for its manufacture
WO1999030984A1 (en) * 1997-12-12 1999-06-24 Takeo Inagaki Dispenser and optical fiber connector
EP0920876A3 (en) * 1997-12-05 2000-12-20 Becton, Dickinson and Company Sterilizable medical articles

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0709105A1 (en) * 1994-10-27 1996-05-01 Schott Glaswerke Pre-filled sterile disposable syringe with low quantity of particles for injection of compositions and method for its manufacture
EP0920876A3 (en) * 1997-12-05 2000-12-20 Becton, Dickinson and Company Sterilizable medical articles
WO1999030984A1 (en) * 1997-12-12 1999-06-24 Takeo Inagaki Dispenser and optical fiber connector
US6367986B1 (en) 1997-12-12 2002-04-09 Takeo Inagaki Dispenser and optical fiber connector

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