JPH0626570B2 - Double layer syringe barrel - Google Patents
Double layer syringe barrelInfo
- Publication number
- JPH0626570B2 JPH0626570B2 JP3010399A JP1039991A JPH0626570B2 JP H0626570 B2 JPH0626570 B2 JP H0626570B2 JP 3010399 A JP3010399 A JP 3010399A JP 1039991 A JP1039991 A JP 1039991A JP H0626570 B2 JPH0626570 B2 JP H0626570B2
- Authority
- JP
- Japan
- Prior art keywords
- syringe
- solution
- freeze
- gasket
- syringe barrel
- 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.)
- Expired - Lifetime
Links
- 239000000243 solution Substances 0.000 claims description 79
- 238000002347 injection Methods 0.000 claims description 52
- 239000007924 injection Substances 0.000 claims description 52
- 239000003814 drug Substances 0.000 claims description 40
- 229940079593 drug Drugs 0.000 claims description 39
- 239000000843 powder Substances 0.000 claims description 26
- 229920002545 silicone oil Polymers 0.000 claims description 25
- 238000004108 freeze drying Methods 0.000 claims description 10
- 239000010410 layer Substances 0.000 claims description 9
- 239000011247 coating layer Substances 0.000 claims description 5
- 238000003860 storage Methods 0.000 claims description 5
- 238000000576 coating method Methods 0.000 description 21
- 239000011248 coating agent Substances 0.000 description 19
- 238000000034 method Methods 0.000 description 15
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 14
- 229910052710 silicon Inorganic materials 0.000 description 14
- 239000010703 silicon Substances 0.000 description 14
- 238000002474 experimental method Methods 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 4
- 239000007864 aqueous solution Substances 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 210000003811 finger Anatomy 0.000 description 4
- 229920005555 halobutyl Polymers 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 239000003921 oil Substances 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 238000003672 processing method Methods 0.000 description 3
- 239000004447 silicone coating Substances 0.000 description 3
- AJDIZQLSFPQPEY-UHFFFAOYSA-N 1,1,2-Trichlorotrifluoroethane Chemical compound FC(F)(Cl)C(F)(Cl)Cl AJDIZQLSFPQPEY-UHFFFAOYSA-N 0.000 description 2
- 239000004205 dimethyl polysiloxane Substances 0.000 description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- NBVXSUQYWXRMNV-UHFFFAOYSA-N fluoromethane Chemical compound FC NBVXSUQYWXRMNV-UHFFFAOYSA-N 0.000 description 2
- 239000008176 lyophilized powder Substances 0.000 description 2
- 238000005192 partition Methods 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 229920003002 synthetic resin Polymers 0.000 description 2
- 239000000057 synthetic resin Substances 0.000 description 2
- 239000013078 crystal Substances 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000006166 lysate Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000003813 thumb Anatomy 0.000 description 1
Landscapes
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
【０００１】[0001]
【産業上の利用分野】本発明は、注射筒内で凍結乾燥さ
れた薬液の凍結乾燥粉体と溶解液とを分離した状態で注
射筒内に収納しておき、使用時に凍結乾燥粉体と溶解液
とを混合調製して注射する二層式注射器の注射筒であっ
て、混合調製時に濁りが生じない様注射筒内壁のシリコ
ンコーテイング濃度に段差を設けた注射筒に関する。詳
しくは、注射針接続部側が下方に位置する倒立姿勢の注
射筒内での薬液の凍結乾燥によって得られた凍結乾燥粉
体を、当該注射筒内の底部に納め、この凍結乾燥粉体の
収納空間を、注射筒内に挿入された弾力性のある第一ガ
スケットによって仕切るとともに、前記凍結乾燥粉体の
溶解液を、前記第一ガスケットと注射筒内に挿入された
弾力性のある第二ガスケットとの間に収納し、さらに、
前記第二ガスケットにプランジャロッドを取り付けてあ
る二層式注射器の注射筒であって、凍結乾燥する薬液が
接する注射筒内壁のシリコンコーテイング濃度を低く
し、薬液が実質上接しない注射筒内壁のシリコンコーテ
イング濃度を通常の注射器のコーテイングに用いられる
濃度にした注射筒に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a freeze-dried powder of a drug solution freeze-dried in a syringe and a solution, which are stored in the syringe in a separated state. The present invention relates to an injection cylinder of a two-layer type syringe for mixing and preparing a solution and injecting the mixture, wherein the injection cylinder has a stepped silicon coating concentration on the inner wall of the injection cylinder so that turbidity does not occur during mixing and preparation. Specifically, the freeze-dried powder obtained by freeze-drying the drug solution in an inverted orientation of the syringe barrel with the needle connection part facing downward is stored in the bottom of the syringe barrel and the freeze-dried powder is stored. The space is partitioned by the elastic first gasket inserted in the syringe barrel, and the solution of the freeze-dried powder is separated by the first gasket and the elastic second gasket inserted in the syringe barrel. And store it between
A syringe of a two-layer syringe in which a plunger rod is attached to the second gasket, wherein the silicone coating on the inner wall of the syringe barrel in contact with the drug solution to be lyophilized is made low, and the silicone on the inner wall of the syringe barrel in which the drug solution does not substantially contact. The present invention relates to a syringe barrel having a coating concentration set to a concentration used for coating an ordinary syringe.
【０００２】[0002]
【従来の技術】医薬品の剤型には種々のものがあるが、
注射剤等の水性製剤の場合、製剤化する時点で最終形態
である溶液の形にしておくのが好ましいが、薬物によっ
ては溶解状態では不安定となるものが少なくない。そこ
で、このような薬物の場合、一般には使用時に溶解して
用いる方法、すなわち、用時溶解の方法が用いられてい
る。さらに、薬物によっては結晶として得られなかった
り、吸湿性が高かったりすることもあり、そのような場
合には、薬物を凍結乾燥粉体の形にして使用に供される
ことが多い。そして、注射剤の場合、バイアル瓶等に凍
結乾燥粉体を入れ、溶解液を注入することにより溶解
し、注射針で吸い上げる方法が一般的に用いられてい
る。しかし、溶解液と凍結乾燥粉体を最初から注射筒内
に納めておくのがより好便であり、又、手術時に用いる
場合は特に無菌状態に保つことを考慮する必要がある。
そこで、薬物と溶解液を最初から注射筒内に納め、使用
直前に注射筒内で溶解する方法、すなわち、凍結乾燥粉
体等の形態の薬物を注射筒内の注射針接続部側の底部に
入れ、注射筒内のプランジャロッド取り付け側に薬物の
溶解液を入れ、薬物収納部と溶解液収納部とを適当な方
法で仕切り、使用時に適当な方法で溶解液と薬物とを混
合して溶解する方法が提案されている（特公昭５０−４
９９２号公報、特開昭６０−７２５６１号公報、実公昭
４９−１４４６５号公報等）。2. Description of the Related Art There are various types of pharmaceuticals,
In the case of an aqueous preparation such as an injection, it is preferable that it is in the form of a solution which is the final form at the time of formulation, but some drugs are unstable in a dissolved state. Therefore, in the case of such a drug, a method of dissolving the drug at the time of use, that is, a method of dissolving at the time of use is generally used. Further, depending on the drug, it may not be obtained as crystals or may have high hygroscopicity. In such a case, the drug is often used in the form of lyophilized powder. In the case of an injection, a method is generally used in which a freeze-dried powder is put in a vial bottle or the like, the solution is injected to dissolve it, and the solution is sucked up with an injection needle. However, it is more convenient to store the lysate and the lyophilized powder in the syringe from the beginning, and it is necessary to consider keeping the state of sterility particularly when used during surgery.
Therefore, a method in which the drug and the solution are stored in the syringe from the beginning and the drug is dissolved in the syringe immediately before use, that is, the drug in the form of freeze-dried powder or the like is placed in the bottom of the syringe on the side where the needle is connected Insert the solution of the drug into the syringe rod mounting side in the syringe barrel, partition the drug storage part and the solution storage part by an appropriate method, and mix and dissolve the solution and drug by an appropriate method at the time of use A method for doing so has been proposed (Japanese Patent Publication No. 50-4).
992, JP-A-60-72561, JP-B-49-14465, etc.).
【０００３】[0003]
【発明が解決しようとする課題】しかし、凍結乾燥粉体
は静電気を帯び易く、また、量も微量な場合が多く、正
確に注射筒内に入れるのは容易でない。そこで、このよ
うな短所を改良するには、凍結乾燥を注射筒内で行う方
法が考えられる。一方、注射筒の内壁は、ガスケット及
びプランジャロッドの動きをスムーズにするために、通
常１〜５％（Ｗ／Ｖ）の濃度のシリコンオイル溶液でコ
ーテイング処理して使用されている。ところが、上記の
ような濃度でシリコンコーテイングした注射筒内に凍結
乾燥すべき薬液を入れ、凍結乾燥して得られる凍結乾燥
粉体を溶解液で溶解すると濁りを生じてしまい、医薬品
としては適切でなくなる問題があった。本発明の目的
は、注射筒の内壁にシリコンコーテイングを施してガス
ケット及びプランジャロッドの動きをスムーズな状態に
維持しながらも、凍結乾燥粉体を溶解液で溶解する際の
濁りを使用に支障の無い程度にまで抑制する点にある。However, the freeze-dried powder is liable to be charged with static electricity, and the amount thereof is very small in many cases, so that it is not easy to put it in a syringe accurately. Therefore, in order to improve such disadvantages, a method of performing freeze-drying in a syringe can be considered. On the other hand, the inner wall of the syringe barrel is usually coated with a silicone oil solution having a concentration of 1 to 5% (W / V) for smooth movement of the gasket and the plunger rod. However, when the drug solution to be freeze-dried is placed in a silicone-coated syringe at the above concentration and the freeze-dried powder obtained by freeze-drying is dissolved in a dissolution solution, it becomes cloudy and is not suitable as a drug. There was a problem that disappeared. The object of the present invention is to provide a silicone coating on the inner wall of the syringe barrel to keep the movement of the gasket and the plunger rod in a smooth state, while hindering the use of turbidity when the freeze-dried powder is dissolved in the solution. The point is to suppress it to the extent that it does not exist.
【０００４】[0004]
【課題を解決するための手段】上記の目的を達成するた
めに、本発明では、注射針接続部側が下方に位置する倒
立姿勢の注射筒内での薬液の凍結乾燥によって得られた
凍結乾燥粉体を、当該注射筒内の底部に納め、この凍結
乾燥粉体の収納空間を、注射筒内に挿入された弾力性の
ある第一ガスケットによって仕切るとともに、前記凍結
乾燥粉体の溶解液を、前記第一ガスケットと注射筒内に
挿入された弾力性のある第二ガスケットとの間に収納
し、さらに、前記第二ガスケットにプランジャロッドを
取り付けてある二層式注射器の注射筒において、凍結乾
燥する薬液が接する注射筒の内壁に、０．３％（Ｗ／
Ｖ）以下の濃度のシリコンオイル溶液でコーテイング処
理し、薬液が実質上接しない注射筒の内壁には、１％
（Ｗ／Ｖ）以上の濃度のシリコンオイル溶液でコーテイ
ング処理された被覆層を形成したのである。In order to achieve the above object, in the present invention, a freeze-dried powder obtained by freeze-drying a drug solution in an inverted syringe barrel in which an injection needle connection side is located downward. The body is stored in the bottom of the syringe barrel, the storage space of the freeze-dried powder is partitioned by the elastic first gasket inserted in the syringe barrel, and the solution of the freeze-dried powder is In a syringe of a two-layer type syringe, which is housed between the first gasket and a resilient second gasket inserted in the syringe barrel, and further a plunger rod is attached to the second gasket, freeze-drying 0.3% (W /
V) Coating treatment with a silicone oil solution having the following concentration, and 1% on the inner wall of the syringe, which is not substantially in contact with the drug solution
The coating layer was formed by coating with a silicone oil solution having a concentration of (W / V) or higher.
【０００５】[0005]
【作用】凍結乾燥粉体を溶解液で溶解する際の濁りの原
因を種々検討した結果、濁りの原因がシリコンコーテイ
ングにあることが判明した。そこで、濁りの生じないシ
リコンコーテイング濃度を鋭意研究した。その研究過程
での実験によって得られたシリコンオイル溶液濃度と濁
り及び摺動力の関係を後記の表１に示す。この実験結果
から明らかなように、０．３％（Ｗ／Ｖ）以下の濃度に
すると実質的に濁りが生じないことを見出した。さら
に、凍結乾燥すべき薬液を入れる部分、即ち、薬液が接
触する注射筒の内壁部分におけるシリコンコーテイング
濃度を薄くしても、ガスケット及びプランジャロッドの
動きには実質上殆ど影響を与えないことも同時に見出し
たのである。[Function] As a result of various studies on the cause of turbidity when the freeze-dried powder was dissolved in the solution, it was found that the cause of the turbidity was the silicon coating. Therefore, the silicon coating concentration without turbidity was earnestly studied. Table 1 below shows the relationship between the concentration of the silicone oil solution and the turbidity and sliding force obtained by the experiment in the research process. As is clear from the results of this experiment, it was found that turbidity does not substantially occur at a concentration of 0.3% (W / V) or less. Furthermore, even if the silicone coating concentration in the portion containing the drug solution to be freeze-dried, that is, the inner wall part of the syringe in contact with the drug solution is reduced, it does not substantially affect the movement of the gasket and the plunger rod. I found it.
【０００６】[0006]
【発明の効果】従って、注射筒の内壁に施される被覆層
のシリコンコーテイング濃度に上記のような差を設ける
ことにより、ガスケット及びプランジャロッドの動きを
スムーズな状態に維持しながらも、注射筒内での薬液の
凍結乾燥によって得られた凍結乾燥粉体と溶解液とを注
射筒内で用時溶解する際の濁りを使用に支障の無い程度
にまで抑制することができるようになった。Therefore, by providing the above-mentioned difference in the silicon coating concentration of the coating layer applied to the inner wall of the injection cylinder, the injection cylinder can be maintained while the gasket and the plunger rod move smoothly. It became possible to suppress the turbidity at the time of dissolving the freeze-dried powder obtained by freeze-drying the drug solution inside and the solution in the syringe at the time of use to such an extent that the use is not hindered.
【０００７】[0007]
【実施例】以下、本発明の実施例を図面に基づいて説明
する。図１乃至図４は二層式注射器を示し、これは、注
射針１に対する針接続部２を備えた円筒状の注射筒３内
に、当該注射筒３の他端に形成した開口３ａを通して弾
性力のある二個の第一ガスケット４及び第二ガスケット
５が摺動自在に挿入されている。この第一ガスケット４
及び第二ガスケット５は、注射筒３の内径よりも少し大
なる直径を有する円筒状のハロゲン化ブチルゴムから製
作されていて、注射筒３への挿入時に、当該注射筒３の
内壁との間を流体気密状態にシールするように構成され
ている。そして、第一ガスケット４及び第二ガスケット
５によって流体気密状態で仕切られる二つの室３Ａ，３
Ｂのうち、針接続部２側に位置する第一室３Ａには、針
接続部２側が下方に位置する倒立姿勢の注射筒３内での
薬液の凍結乾燥によって得られた凍結乾燥粉体ａが収納
され、他方、開口３ａ側に位置する第二室３Ｂには、凍
結乾燥粉体ａを溶解する溶解液ｂが収納されている。注
射筒３の開口３ａ側に位置する第二ガスケット５には、
当該第二ガスケット５を注射筒３の筒軸芯方向に摺動操
作するためのプランジャロッド６が着脱自在に螺合固定
されているとともに、このプランジャロッド６の先端部
には、注射筒３の内径よりも偏平状の親指用当て部７が
形成されている。また、注射筒３の外周面の開口３ａ側
端部には、直径方向外方に突出する鍔部８が一体形成さ
れており、さらに、注射筒３の筒軸芯方向の中間部分に
は、半径方向外方に膨出する隆起部３Ｃが形成されてい
て、当該隆起部３Ｃの内面側に、注射筒３の第一室３Ａ
と第二室３Ｂとを連通接続するためのバイパス路９が現
出されている。このバイパス路９の筒軸芯方向長さは、
針接続部２側に位置する第一ガスケット４の筒軸芯方向
長さよりも少し長く構成されていて、図２に示すよう
に、プランジャロッド６の押し込み操作によって第一ガ
スケット４がバイパス路９の領域内に位置したとき、第
二室３Ｂ内の溶解液ｂをバイパス路９を通して第一室３
Ａ内に導くように構成されている。また、前記注射筒３
の外周面のうち、鍔部８と隆起部３Ｃとの間に位置する
筒部分には、当該筒部分に対して着脱自在な合成樹脂製
のホルダ１０が設けられている。このホルダ１０は、注
射筒３の筒軸芯を通る仮想平面で二分割されていて、そ
の両分割ホルダ部１０Ａ，１０Ｂの接合面のうち、注射
筒３の開口３ａ側に位置する端部と針接続部２側に位置
する端部の各二箇所には夫々、注射筒３の直径方向から
互いに弾性的に嵌合する雌雄の接続部１０ａ，１０ｂが
一体形成されている。また、このホルダ１０の分割ホル
ダ部１０Ａ，１０Ｂのうち、注射筒３の開口３ａ側に位
置する端部には、鍔部８よりも直径方向外方に突出する
一対の支持片１１ａ，１１ｂからなる第一指掛部１１が
一体形成されており、他方、針接続部２側に位置する端
部には、筒軸芯方向視における形状が第一指掛部１１の
支持片１１ａ，１１ｂと同一形状を呈する一対の支持片
１２ａ，１２ｂからなる第二指掛部１２が一体形成され
ている。第一指掛部１１の支持片１１ａ，１１ｂのう
ち、注射筒３の開口３ａ側に位置する端面には、鍔部８
に外装される一対の半円筒部１３Ａ，１３Ｂが一体に連
設され、さらに、これら両半円筒部１３Ａ，１３Ｂに
は、プランジャロッド６に外装した合成樹脂製の抜け止
め用ストッパー１４が筒軸芯方向から着脱自在に嵌合保
持されている。また、注射筒３の針接続部２に形成され
た注射孔には、当該針接続部２に装着される注射針１に
よって穿孔されるハロゲン化ブチルゴム製の栓１５が挿
入されている。そして、このように構成された二層式注
射器において、凍結乾燥する薬液が接する注射筒３の内
壁部分には、０．３％（Ｗ／Ｖ）以下の濃度のシリコン
オイル溶液でコーテイング処理された被覆層が形成され
ており、他方、薬液が実質上接しない注射筒３の内壁部
分には、１％（Ｗ／Ｖ）以上の濃度のシリコンオイル溶
液でコーテイング処理された被覆層が形成されている。
シリコンオイル溶液は、シリコンオイルを揮発製の高い
フッ化炭化水素（フロン）等の液化ガスに所望の濃度に
溶解したものを用いる。コーテイング処理方法の具体例
は後で詳述するが、本発明の注射筒３の一般的な製法と
しては、まず、０．３％（Ｗ／Ｖ）以下の濃度のシリコ
ンオイル溶液で注射筒３の内壁全体にコーテイングし、
次いで薬液収納部以外の注射筒３の内壁部分を１％（Ｗ
／Ｖ）以上の濃度のシリコンオイル溶液でコーテイング
する方法が挙げられる。勿論、薬液収納部の注射筒３の
内壁部分のみを０．３％（Ｗ／Ｖ）以下の濃度のシリコ
ンオイル溶液でコーテイングし、次いで薬液収納部以外
の注射筒３の内壁部分を１％（Ｗ／Ｖ）以上の濃度のシ
リコンオイル溶液でコーテイングしてもよいが、前者の
方が簡便である。また、コーテイングの方法としては、
シリコンオイル溶液を噴霧する方法、注射筒３の針接続
部２に形成された注射孔から吸引する方法、注射筒３を
シリコンオイル溶液槽に沈める方法等が挙げられる。さ
らに、０．３％（Ｗ／Ｖ）以下の濃度のシリコンオイル
溶液をコーテイングする範囲としては、凍結乾燥する薬
液が接する注射筒３の内壁部分となるのであるが、注射
筒３内での薬液の凍結乾燥によって得られた凍結乾燥粉
体ａと溶解液ｂとを注射筒３内で用時溶解する際の濁り
が使用に支障の無い程度あれば、コーテイング面積が凍
結乾燥する薬液が接する注射筒３内壁の表面積よりも少
し小さくなってもよい。実用面では、薬液が飛散する可
能性のある内壁部分をも含めて０．３％（Ｗ／Ｖ）以下
の濃度のシリコンオイル溶液でコーテイングすることが
好ましい。このようにして得られた注射筒３の針接続部
２を下にし、当該針接続部２の注射孔をゴム製の栓１５
により封じて倒立させ、注射筒３内に薬液を入れて凍結
乾燥する。次いで、注射筒３内に第一ガスケット４を挿
入したのち、溶解液ｂを入れ、上端側を第二ガスケット
５にて密閉する。使用時には、第二ガスケット５にプラ
ンジャロッド６を取付けるとともに、注射筒３の針接続
部２に注射針１を装着する。勿論、プランジャロッド６
は最初から第二ガスケット５に取付けておいてもよい。
次に、コーテイング処理方法の具体例について説明す
る。 〔第１実施例〕図５の（イ）、（ロ）に示すように、注
射筒３をそれの針接続部２が上に位置する状体に倒立さ
せ、この状態で開口３ａより挿入したノズル１６によ
り、濃度が０．１％（Ｗ／Ｖ）のシリコンオイル溶液
〔シリコンオイル（東レ・ダウコーニング社製ＳＨ−２
００を使用）をフロン１１３（三井・デュポンフロロケ
ミカル社製フレオンＴＦを使用）に溶解して調製した溶
液〕を噴霧塗布する。次いで、凍結乾燥する薬液が接触
する部分に溶液がかからないよう仕切り１７を先端部分
に設けたノズル１８を注射筒３の開口３ａより挿入し、
濃度が３％（Ｗ／Ｖ）のシリコンオイル溶液（０．１％
溶液と同様にして調製）を薬液が実質上接しない注射筒
３の内壁部分に塗布したのち乾燥処理する。 〔第２実施例〕図６の（イ）、（ロ）に示すように、
０．１％（Ｗ／Ｖ）の濃度のシリコンオイル溶液（前記
の第１実施例と同様にして調製）を収納した槽１９内
に、注射筒３をそれの針接続部２が上に位置する倒立姿
勢で少し沈め、注射筒３の針接続部２に形成された注射
孔から吸引して、注射筒３内の針接続部２にまで槽１９
内のシリコンオイル溶液を汲み上げる。次いで、槽１９
を３％（Ｗ／Ｖ）の濃度のシリコンオイル溶液（前記の
第１実施例と同様にして調製）を収納した槽２０に替
え、注射筒３をそれの針接続部２が上に位置する倒立姿
勢で再び少し沈めたのち、注射筒３の針接続部２に形成
された注射孔から吸引する。このとき、凍結乾燥する薬
液が接触する部分の直前まで、光センサ２１で汲み上げ
位置を検知しながら槽２０内のシリコンオイル溶液を汲
み上げたのち、注射筒３を槽２０から取出して乾燥処理
する。次に、本発明者は、シリコンオイル溶液の濃度と
濁り及び摺動力の関係を示す実験を行った。この実験で
は、凍結乾燥する薬液の例としてマンニトールの１０％
水溶液を用い、溶解液の例として精製水を用いた。ま
た、前記の第１実施例又は第２実施例の方法により作成
した注射筒３の針接続部２をゴムカバーで密封し、当該
針接続部２を下にした状態で注射筒３を倒立させ、マン
ニトールの１０％水溶液を入れて凍結乾燥する。次い
で、注射筒３内にハロゲン化ブチルゴム製の第一ガスケ
ット４を装着し、さらに、精製水を入れたのちハロゲン
化ブチルゴム製の第二ガスケット５を装着し、マンニト
ールの１０％水溶液及び精製水の入った注射器を作成し
た。そして、マンニトールの１０％水溶液の凍結乾燥粉
体を精製水で溶解したときにおける濁りの発生度合、及
び、プランジャロッド６を押し下げる際の抵抗力（摺動
力）を調べた。その実験結果を表１に示す。Embodiments of the present invention will be described below with reference to the drawings. 1 to 4 show a two-layer syringe, which is elastically inserted into a cylindrical barrel 3 having a needle connection 2 for a needle 1, through an opening 3a formed at the other end of the barrel 3. Two forceful first gasket 4 and second gasket 5 are slidably inserted. This first gasket 4
The second gasket 5 is made of a cylindrical halogenated butyl rubber having a diameter slightly larger than the inner diameter of the injection cylinder 3, and when inserted into the injection cylinder 3, a space between the inner wall of the injection cylinder 3 and the second gasket 5 is formed. It is configured to seal in a fluid tight manner. The two chambers 3A, 3 partitioned by the first gasket 4 and the second gasket 5 in a fluid-tight state
In the first chamber 3A located on the needle connection part 2 side of B, a freeze-dried powder a obtained by freeze-drying the drug solution in the inverted injection syringe 3 with the needle connection part 2 side located downward. On the other hand, in the second chamber 3B located on the side of the opening 3a, a solution b for dissolving the freeze-dried powder a is stored. In the second gasket 5 located on the side of the opening 3a of the injection cylinder 3,
A plunger rod 6 for slidably operating the second gasket 5 in the axial direction of the cylinder of the injection cylinder 3 is detachably screwed and fixed. A thumb pad 7 having a flatter shape than the inner diameter is formed. In addition, a flange portion 8 that projects outward in the diametrical direction is integrally formed at the end of the outer peripheral surface of the injection barrel 3 on the side of the opening 3a. A ridge 3C that bulges outward in the radial direction is formed, and the first chamber 3A of the injection cylinder 3 is provided on the inner surface side of the ridge 3C.
A bypass path 9 for exposing and connecting the second chamber 3B with the second chamber 3B is exposed. The length of the bypass passage 9 in the cylinder axis direction is
It is configured to be slightly longer than the length of the first gasket 4 located on the needle connecting portion 2 side in the cylinder axis direction. As shown in FIG. When located in the area, the dissolution liquid b in the second chamber 3B is passed through the bypass passage 9 to the first chamber 3B.
It is configured so as to lead into A. In addition, the syringe 3
A holder 10 made of synthetic resin that is attachable to and detachable from the tubular portion is provided on the tubular portion located between the collar portion 8 and the raised portion 3C on the outer peripheral surface of the. The holder 10 is divided into two parts on an imaginary plane that passes through the cylinder axis of the injection cylinder 3, and an end portion located on the side of the opening 3a of the injection cylinder 3 among the joint surfaces of the divided holder portions 10A and 10B. Male and female connecting portions 10a and 10b that are elastically fitted to each other in the diametrical direction of the injection barrel 3 are integrally formed at each of two positions of the end portion located on the needle connecting portion 2 side. Further, among the divided holder portions 10A and 10B of the holder 10, the end portion located on the side of the opening 3a of the injection barrel 3 is provided with a pair of support pieces 11a and 11b projecting outward in the diametrical direction from the collar portion 8. The first finger hooking portion 11 is integrally formed on the other hand, and on the other hand, at the end portion located on the needle connecting portion 2 side, the shape in the direction of the cylinder axis is the support pieces 11a and 11b of the first finger hooking portion 11. A second finger hook 12 is integrally formed of a pair of support pieces 12a and 12b having the same shape. Of the support pieces 11a and 11b of the first finger hook portion 11, the collar portion 8 is provided on the end surface located on the side of the opening 3a of the injection cylinder 3.
A pair of semi-cylindrical parts 13A and 13B that are externally mounted on the cylindrical rod are integrally connected to each other. Further, a stopper 14 made of a synthetic resin that is externally mounted on the plunger rod 6 is attached to the semi-cylindrical parts 13A and 13B. It is fitted and held detachably from the core direction. In addition, a plug 15 made of halogenated butyl rubber that is pierced by the injection needle 1 attached to the needle connection portion 2 is inserted into the injection hole formed in the needle connection portion 2 of the injection cylinder 3. Then, in the two-layer syringe configured as described above, the inner wall portion of the injection cylinder 3 in contact with the freeze-dried drug solution was coated with a silicone oil solution having a concentration of 0.3% (W / V) or less. On the other hand, a coating layer is formed, and on the other hand, a coating layer coated with a silicone oil solution having a concentration of 1% (W / V) or more is formed on the inner wall portion of the injection cylinder 3 which is not substantially in contact with the drug solution. There is.
As the silicone oil solution, a solution obtained by dissolving silicone oil in a liquefied gas such as highly volatile fluorohydrocarbon (CFC) at a desired concentration is used. Although a specific example of the coating treatment method will be described in detail later, as a general manufacturing method of the syringe barrel 3 of the present invention, first, the syringe barrel 3 is made with a silicone oil solution having a concentration of 0.3% (W / V) or less. Coated on the entire inner wall of
Next, 1% (W
/ V) and a coating method with a silicone oil solution having a concentration of at least V. Of course, only the inner wall portion of the syringe barrel 3 of the drug solution storage portion is coated with a silicone oil solution having a concentration of 0.3% (W / V) or less, and then the inner wall portion of the syringe barrel 3 other than the drug solution reservoir portion is 1% ( Coating may be performed with a silicone oil solution having a concentration of W / V) or higher, but the former is simpler. Also, as a coating method,
Examples thereof include a method of spraying the silicone oil solution, a method of sucking through the injection hole formed in the needle connection part 2 of the injection cylinder 3, and a method of submerging the injection cylinder 3 in the silicone oil solution tank. Further, as a range for coating the silicone oil solution having a concentration of 0.3% (W / V) or less, the inner wall portion of the syringe 3 in contact with the drug solution to be freeze-dried comes into contact with the drug solution in the syringe 3. If the turbidity at the time of dissolving the freeze-dried powder a and the solution b obtained by the freeze-drying of the above in the syringe barrel 3 does not hinder the use, the injection in contact with the drug solution having a freeze-drying coating area It may be slightly smaller than the surface area of the inner wall of the cylinder 3. In terms of practical use, it is preferable to coat with a silicone oil solution having a concentration of 0.3% (W / V) or less, including the inner wall portion where the chemical solution may scatter. The needle connecting portion 2 of the injection barrel 3 thus obtained is placed downward, and the injection hole of the needle connecting portion 2 is provided with a rubber stopper 15
Then, it is sealed and inverted, and the drug solution is put into the syringe 3 and freeze-dried. Next, after inserting the first gasket 4 into the injection cylinder 3, the dissolution liquid b is put and the upper end side is sealed with the second gasket 5. At the time of use, the plunger rod 6 is attached to the second gasket 5, and the injection needle 1 is attached to the needle connection portion 2 of the injection cylinder 3. Of course, the plunger rod 6
May be attached to the second gasket 5 from the beginning.
Next, a specific example of the coating processing method will be described. [First Embodiment] As shown in (a) and (b) of FIG. 5, the syringe barrel 3 is inverted to a state in which the needle connecting portion 2 thereof is located above, and inserted through the opening 3a in this state. With the nozzle 16, a silicon oil solution having a concentration of 0.1% (W / V) [silicon oil (SH-2 manufactured by Toray Dow Corning Co., Ltd.
00) is dissolved in Freon 113 (using Freon TF manufactured by Mitsui DuPont Fluorochemical Co., Ltd.) to spray-apply. Next, a nozzle 18 provided with a partition 17 at the tip end thereof is inserted through the opening 3a of the injection cylinder 3 so that the solution does not come into contact with the portion in contact with the drug solution to be freeze-dried.
Silicon oil solution with a concentration of 3% (W / V) (0.1%
(Prepared in the same manner as the solution) is applied to the inner wall portion of the syringe 3 which is not substantially in contact with the drug solution, and then dried. [Second Embodiment] As shown in (a) and (b) of FIG.
The syringe barrel 3 is positioned with the needle connection part 2 thereof above in a tank 19 containing a silicone oil solution having a concentration of 0.1% (W / V) (prepared in the same manner as in the first embodiment). It is slightly sunk in an inverted position, sucked from the injection hole formed in the needle connection part 2 of the injection cylinder 3, and reaches the needle connection part 2 in the injection cylinder 3 to the tank 19
Pump up the silicone oil solution inside. Then, tank 19
Is replaced with a tank 20 containing a silicone oil solution having a concentration of 3% (W / V) (prepared in the same manner as in the first embodiment described above), and the syringe barrel 3 is positioned with the needle connection portion 2 thereof located above. After being slightly submerged again in the inverted posture, it is sucked from the injection hole formed in the needle connecting portion 2 of the injection cylinder 3. At this time, the silicon oil solution in the tank 20 is pumped up until the portion where the chemical liquid to be freeze-dried comes into contact is detected by the optical sensor 21, and then the injection cylinder 3 is taken out from the tank 20 and dried. Next, the present inventor conducted an experiment showing the relationship between the concentration of the silicone oil solution and the turbidity and sliding force. In this experiment, 10% of mannitol was used as an example of a lyophilized drug solution.
An aqueous solution was used, and purified water was used as an example of the solution. Further, the needle connecting part 2 of the injection cylinder 3 made by the method of the first embodiment or the second embodiment is sealed with a rubber cover, and the injection cylinder 3 is inverted with the needle connection part 2 facing down. Then, add a 10% aqueous solution of mannitol and freeze-dry. Then, the first gasket 4 made of halogenated butyl rubber is mounted in the syringe barrel 3, and further, the second gasket 5 made of halogenated butyl rubber is put in after the purified water is put in, and a 10% aqueous solution of mannitol and purified water is attached. I made a syringe inside. Then, the degree of turbidity generated when a freeze-dried powder of a 10% aqueous solution of mannitol was dissolved in purified water, and the resistance force (sliding force) when pushing down the plunger rod 6 were examined. The experimental results are shown in Table 1.
【０００８】[0008]
【表１】 [Table 1]
【０００９】表中、濁りの発生度合における「−」は濁
りの発生が見られないこと、「＋」は濁りが発生してい
ること、「±」は実際の使用上問題とならない程度の状
態を示す。摺動力における「−」はスムーズにプランジ
ャロッド６が押し下げられること、「＋」は抵抗が大き
いこと、「±」は実際の使用上問題とならない程度の抵
抗を示す。この実験結果から、薬液接触部を０．３％
（Ｗ／Ｖ）以下の濃度でシリコンコーテイングし、薬液
非接触部を１％（Ｗ／Ｖ）以上の濃度、好ましくは、１
〜５％（Ｗ／Ｖ）の濃度でシリコンコーテイングする
と、本発明の目的とする注射筒３が得られることが判っ
た。In the table, "-" in the degree of turbidity indicates that no turbidity is observed, "+" indicates that turbidity occurs, and "±" indicates a state that does not cause any problem in actual use. Indicates. "-" In the sliding force indicates that the plunger rod 6 is smoothly pushed down, "+" indicates a large resistance, and "±" indicates a resistance that does not pose a problem in actual use. From the results of this experiment, the chemical contact area was 0.3%
Silicon coating is performed at a concentration of (W / V) or less, and the chemical non-contact portion has a concentration of 1% (W / V) or more, preferably 1
It has been found that when the silicon coating is carried out at a concentration of ˜5% (W / V), the syringe barrel 3 intended by the present invention can be obtained.
【００１０】〔その他の実施例〕 上述の実施例では、薬液と接触する注射筒３の内壁
のシリコンコーテイング濃度を０．３％（Ｗ／Ｖ）以下
と規定したが、薬液の量が少ない場合には、シリコンコ
ーテイングしなくても、ガスケット４，５及びプランジ
ャロッド６の動きには実質上殆ど障害はない。換言すれ
ば、冒記の特許請求の範囲における０．３％（Ｗ／Ｖ）
以下の濃度には０％を含むことになる。 本発明の注射筒３の応用は、薬液の種類によって限
定されるものではなく、凍結乾燥して使用する薬液全て
に応用できるものである。 上述の実施例では、シリコンオイルをフッ化炭化水
素（フロン）等の液化ガスに加えて所定濃度のシリコン
オイル溶液を作成したが、フッ化炭化水素を使用する代
わりに、シリコンオイルを水に懸濁させたものを用いて
もよい。さらに、使用するシリコンオイルは注射筒の内
部に塗布できるものであれば特に制限はなく、例えば、
ジメチルポリシロキサンや環状ポリジメチルシロキサン
などを挙げることができる。 上述の実施例では、注射筒３に設けたバイパス流路
９を通して第二室３Ｂ内の溶解液を第一室３Ａ内の凍結
乾燥粉体に導くように構成したが、第一ガスケット４自
体に、プランジャロッド６の押し込み操作時に第二室３
Ｂ内の溶解液を第一室３Ａ内の凍結乾燥粉体に導く弁構
造を設けて実施してもよい。要するに、プランジャロッ
ド６の押し込み操作時に、第二室３Ｂ内の溶解液を第一
室３Ａ内の凍結乾燥粉体に導くことのできるものであれ
ば、如何なる構造のものを用いてもよい。 本発明は、上述の実施例で説明したホルダ１０及び
ストッパー１４を有しない二層式注射器の注射筒にも適
用することができることは勿論である。 また、注射筒３、両ガスケット４，５、プランジャロッ
ド６の各形状、材質、寸法等は使用条件に応じて種々変
更可能である。[Other Embodiments] In the above-mentioned embodiments, the silicon coating concentration of the inner wall of the injection barrel 3 which comes into contact with the drug solution is specified to be 0.3% (W / V) or less, but when the amount of the drug solution is small. There is substantially no hindrance to the movement of the gaskets 4, 5 and the plunger rod 6 even without silicon coating. In other words, 0.3% (W / V) in the claims at the beginning
The following concentrations will include 0%. The application of the syringe 3 of the present invention is not limited by the type of drug solution, but can be applied to all drug solutions to be freeze-dried and used. In the above-mentioned embodiment, silicone oil was added to a liquefied gas such as fluorocarbon (CFC) to prepare a silicone oil solution having a predetermined concentration. However, instead of using fluorocarbon, the silicone oil was suspended in water. A turbid product may be used. Further, the silicone oil used is not particularly limited as long as it can be applied to the inside of the syringe, for example,
Examples thereof include dimethyl polysiloxane and cyclic polydimethyl siloxane. In the above-described embodiment, the dissolution liquid in the second chamber 3B is guided to the freeze-dried powder in the first chamber 3A through the bypass passage 9 provided in the injection cylinder 3, but the first gasket 4 itself , The second chamber 3 when pushing the plunger rod 6
A valve structure for guiding the solution in B to the freeze-dried powder in the first chamber 3A may be provided. In short, any structure may be used as long as it can guide the dissolved liquid in the second chamber 3B to the freeze-dried powder in the first chamber 3A during the pushing operation of the plunger rod 6. Of course, the present invention can be applied to the syringe barrel of the two-layer syringe without the holder 10 and the stopper 14 described in the above embodiments. Further, the shape, material, dimensions, etc. of the injection cylinder 3, the gaskets 4, 5, and the plunger rod 6 can be variously changed according to the usage conditions.
【００１１】尚、特許請求の範囲の項に図面との対照を
便利にするために符号を記すが、該記入により本発明は
添付図面の構成に限定されるものではない。It should be noted that reference numerals are given in the claims for convenience of comparison with the drawings, but the present invention is not limited to the configuration of the accompanying drawings by the entry.
【図１】本発明の二層式注射器を示す断面側面図FIG. 1 is a sectional side view showing a two-layer syringe of the present invention.
【図２】凍結乾燥粉体と溶解液との混合途中を示す断面
側面図FIG. 2 is a cross-sectional side view showing the process of mixing the freeze-dried powder and the solution.
【図３】全体の斜視図FIG. 3 is an overall perspective view
【図４】全体の分解斜視図FIG. 4 is an overall exploded perspective view
【図５】（イ）、（ロ）はシリコンコーテイング処理方
法の第１実施例を示す説明図5A and 5B are explanatory views showing a first embodiment of a silicon coating processing method.
【図６】（イ）、（ロ）はシリコンコーテイング処理方
法の第２実施例を示す説明図6A and 6B are explanatory views showing a second embodiment of the silicon coating processing method.
２ 注射針接続部 ３ 注射筒 ４ 第一ガスケット ５ 第二ガスケット ６ プランジャロッド ａ 凍結乾燥粉体 ｂ 溶解液 2 injection needle connection part 3 injection cylinder 4 first gasket 5 second gasket 6 plunger rod a freeze-dried powder b solution
Claims (1)
倒立姿勢の注射筒（３）内での薬液の凍結乾燥によって
得られた凍結乾燥粉体（ａ）を、当該注射筒（３）内の
底部に納め、この凍結乾燥粉体（ａ）の収納空間を、注
射筒（３）内に挿入された弾力性のある第一ガスケット
（４）によって仕切るとともに、前記凍結乾燥粉体
（ａ）の溶解液（ｂ）を、前記第一ガスケット（４）と
注射筒（３）内に挿入された弾力性のある第二ガスケッ
ト（５）との間に収納し、さらに、前記第二ガスケット
（５）にプランジャロッド（６）を取り付けてある二層
式注射器の注射筒であって、凍結乾燥する薬液が接する
注射筒（３）の内壁に、０．３％（Ｗ／Ｖ）以下の濃度
のシリコンオイル溶液でコーテイング処理し、薬液が実
質上接しない注射筒（３）の内壁には、１％（Ｗ／Ｖ）
以上の濃度のシリコンオイル溶液でコーテイング処理さ
れた被覆層を形成してある二層式注射器の注射筒。1. A freeze-dried powder (a) obtained by freeze-drying a medicinal solution in an inverted-shaped injection cylinder (3) with the injection needle connection part (2) side facing downward. ), The storage space for the freeze-dried powder (a) is partitioned by the elastic first gasket (4) inserted in the syringe barrel (3), and the freeze-dried powder ( The solution (b) of a) is contained between the first gasket (4) and the elastic second gasket (5) inserted in the syringe barrel (3), and the second solution (b) is further stored. A syringe of a two-layer syringe in which a plunger rod (6) is attached to a gasket (5), wherein the inner wall of the syringe (3) in contact with a freeze-dried drug solution is 0.3% (W / V) or less. Syringe tube (3 ) 1% (W / V) on the inner wall
A syringe barrel for a two-layer type syringe having a coating layer coated with a silicone oil solution having the above concentration.
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3010399A JPH0626570B2 (en) | 1991-01-31 | 1991-01-31 | Double layer syringe barrel |
| PCT/JP1991/001575 WO1992008504A1 (en) | 1990-11-17 | 1991-11-18 | Double-chamber type syringe barrel |
| US07/910,281 US5290228A (en) | 1990-11-17 | 1991-11-18 | Two-compartment syringe |
| DE69127614T DE69127614T2 (en) | 1990-11-17 | 1991-11-18 | SYRINGE CYLINDER WITH TWO CHAMBERS |
| EP91919798A EP0511402B1 (en) | 1990-11-17 | 1991-11-18 | Double-chamber type syringe barrel |
| AT91919798T ATE157886T1 (en) | 1990-11-17 | 1991-11-18 | SYRINGE CYLINDER WITH TWO CHAMBERS |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3010399A JPH0626570B2 (en) | 1991-01-31 | 1991-01-31 | Double layer syringe barrel |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH04246364A JPH04246364A (en) | 1992-09-02 |
| JPH0626570B2 true JPH0626570B2 (en) | 1994-04-13 |
Family
ID=11749060
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3010399A Expired - Lifetime JPH0626570B2 (en) | 1990-11-17 | 1991-01-31 | Double layer syringe barrel |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0626570B2 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3816904B2 (en) * | 1993-04-02 | 2006-08-30 | 第一製薬株式会社 | Container and syringe preparation method, chemical solution filling container and syringe preparation |
| US6537242B1 (en) * | 2000-06-06 | 2003-03-25 | Becton, Dickinson And Company | Method and apparatus for enhancing penetration of a member for the intradermal sampling or administration of a substance |
| MX354319B (en) * | 2011-01-24 | 2018-02-26 | Otsuka Pharma Co Ltd | Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient. |
| DE102015207228A1 (en) * | 2015-04-21 | 2016-10-27 | Vetter Pharma-Fertigung GmbH & Co. KG | Primary packaging and method of making a primary packaging |
| DE102017208255A1 (en) * | 2017-05-16 | 2018-11-22 | Vetter Pharma-Fertigung GmbH & Co. KG | Medicament container having an end plug, use of a stopper securing member for securing an end plug in a medicament container and stopper securing member |
-
1991
- 1991-01-31 JP JP3010399A patent/JPH0626570B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH04246364A (en) | 1992-09-02 |
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