JPH04246364A - Injection cylinder for two-layer type injector - Google Patents
Injection cylinder for two-layer type injectorInfo
- Publication number
- JPH04246364A JPH04246364A JP3010399A JP1039991A JPH04246364A JP H04246364 A JPH04246364 A JP H04246364A JP 3010399 A JP3010399 A JP 3010399A JP 1039991 A JP1039991 A JP 1039991A JP H04246364 A JPH04246364 A JP H04246364A
- Authority
- JP
- Japan
- Prior art keywords
- syringe barrel
- solution
- silicone oil
- freeze
- syringe
- 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.)
- Granted
Links
- 238000002347 injection Methods 0.000 title abstract description 17
- 239000007924 injection Substances 0.000 title abstract description 17
- 229920002545 silicone oil Polymers 0.000 claims abstract description 35
- 239000011247 coating layer Substances 0.000 claims abstract description 7
- 239000008176 lyophilized powder Substances 0.000 claims abstract description 7
- 239000003814 drug Substances 0.000 claims description 35
- 229940079593 drug Drugs 0.000 claims description 34
- 239000000843 powder Substances 0.000 claims description 23
- 238000004108 freeze drying Methods 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 7
- 238000000034 method Methods 0.000 abstract description 19
- 238000000576 coating method Methods 0.000 abstract description 18
- 239000011248 coating agent Substances 0.000 abstract description 15
- 239000004447 silicone coating Substances 0.000 abstract description 9
- 239000007788 liquid Substances 0.000 abstract description 8
- 239000000126 substance Substances 0.000 abstract description 8
- 238000005507 spraying Methods 0.000 abstract description 3
- -1 hydrocarbon fluoride Chemical class 0.000 abstract description 2
- 239000004215 Carbon black (E152) Substances 0.000 abstract 1
- 229930195733 hydrocarbon Natural products 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 77
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 7
- 239000010410 layer Substances 0.000 description 7
- 229910052710 silicon Inorganic materials 0.000 description 7
- 239000010703 silicon Substances 0.000 description 7
- NBVXSUQYWXRMNV-UHFFFAOYSA-N fluoromethane Chemical compound FC NBVXSUQYWXRMNV-UHFFFAOYSA-N 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
- 238000002474 experimental method Methods 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
- 239000008213 purified water Substances 0.000 description 4
- 210000003811 finger Anatomy 0.000 description 3
- 238000002156 mixing Methods 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
- 238000010586 diagram Methods 0.000 description 2
- 239000004205 dimethyl polysiloxane Substances 0.000 description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000011160 research 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
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007429 general method Methods 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
- 238000005192 partition Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000005086 pumping 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)
Abstract
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。[Industrial Application Field] The present invention is characterized in that the lyophilized powder of a medicinal solution freeze-dried in the syringe and the solution are stored in the syringe in a separated state, and when used, the lyophilized powder and the solution are stored in the syringe. This invention relates to a syringe barrel of a two-layer syringe for mixing and preparing a solution with a solution and injecting the same, in which a step is provided in the silicon coating concentration on the inner wall of the syringe barrel so that turbidity does not occur during mixing and preparation. Specifically, a freeze-dried powder obtained by freeze-drying a drug solution in an inverted syringe barrel with the needle connection side facing downward is stored in the bottom of the syringe barrel, and the freeze-dried powder is stored at the bottom of the syringe barrel. The space is partitioned by a first elastic gasket inserted into the syringe barrel, and the solution of the freeze-dried powder is divided between the first gasket and a second elastic gasket inserted into the syringe barrel. It is stored between the
The syringe barrel of a two-layer syringe has a plunger rod attached to the second gasket, and the silicone coating concentration on the inner wall of the syringe barrel, which is in contact with the drug solution to be freeze-dried, is lowered, and the silicone coating on the inner wall of the syringe barrel, where the drug solution does not substantially come into contact with, is reduced. The present invention relates to a syringe having a coating concentration that is used for coating ordinary syringes.
【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)。[Prior Art] There are various dosage forms of pharmaceuticals.
In the case of aqueous preparations such as injections, it is preferable to take the form of a final solution at the time of formulation, but some drugs are often unstable in a dissolved state. Therefore, in the case of such drugs, a method is generally used in which they are dissolved before use, that is, a method of dissolving them before use is used. Furthermore, some drugs may not be obtained as crystals or may have high hygroscopicity, and in such cases, drugs are often used in the form of lyophilized powder. In the case of injections, the commonly used method is to put freeze-dried powder into a vial or the like, dissolve it by injecting a solution, and suck it up with a syringe needle. However, it is more convenient to store the solution and the lyophilized powder in the syringe barrel from the beginning, and when using it during surgery, it is necessary to take into account keeping it in a sterile state. Therefore, there is a method in which the drug and solution are placed in the syringe from the beginning and dissolved in the syringe immediately before use. In other words, the drug in the form of freeze-dried powder is placed in the bottom of the syringe on the needle connection side. Put the drug solution into the side of the syringe where the plunger rod is attached, separate the drug storage part and the solution storage part in an appropriate way, and mix the solution and drug in an appropriate way to dissolve the drug. A method has been proposed to
992, JP-A-60-72561, Japanese Utility Model Publication No. 14465-1980, 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。[Problems to be Solved by the Invention] However, freeze-dried powder tends to be charged with static electricity, and the amount is often very small, so it is difficult to accurately put it into a syringe barrel. Therefore, in order to improve these disadvantages, a method of performing freeze-drying within a syringe barrel may 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) in order to smooth the movement of the gasket and plunger rod. However, when a drug solution to be freeze-dried is placed in a silicone-coated syringe at the concentration mentioned above and the freeze-dried powder obtained by freeze-drying is dissolved in a solution, it becomes cloudy, making it unsuitable for use as a pharmaceutical product. There was a problem that disappeared. The purpose of the present invention is to apply a silicone coating to the inner wall of the syringe barrel to maintain smooth movement of the gasket and plunger rod, while also preventing turbidity from occurring when the freeze-dried powder is dissolved with a dissolving 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。[Means for Solving the Problems] In order to achieve the above object, the present invention provides a freeze-dried powder obtained by freeze-drying a drug solution in an inverted syringe barrel with the needle connection side facing downward. The body is placed in the bottom of the syringe barrel, the storage space for the freeze-dried powder is partitioned off by a first elastic gasket inserted into the syringe barrel, and the solution of the freeze-dried powder is A syringe barrel of a two-layer syringe, which is stored between the first gasket and an elastic second gasket inserted into the syringe barrel, and further has a plunger rod attached to the second gasket, is freeze-dried. 0.3% (W/V) on the inner wall of the syringe barrel that is in contact with the drug solution.
The inner wall of the syringe barrel is coated with a silicone oil solution with a concentration of 1% (W/
V) A coating layer was formed by coating with a silicone oil solution having a concentration above.
【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。[Operation] As a result of various studies on the causes of turbidity when lyophilized powder is dissolved in a dissolving solution, it was found that the cause of turbidity was silicone coating. Therefore, we conducted extensive research on the silicone coating concentration that would not cause turbidity. Table 1 below shows the relationship between silicone oil solution concentration, turbidity, and sliding force obtained through experiments during the research process. As is clear from the results of this experiment, it has been found that substantially no turbidity occurs when the concentration is 0.3% (W/V) or less. Furthermore, even if the concentration of silicone coating is reduced in the area containing the drug solution to be freeze-dried, that is, the inner wall portion of the syringe barrel that comes into contact with the drug solution, there is virtually no effect on the movement of the gasket and 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。[Effects of the Invention] Therefore, by providing the above-mentioned difference in the silicone coating concentration of the coating layer applied to the inner wall of the syringe barrel, the movement of the gasket and plunger rod can be maintained in a smooth state, while the syringe barrel can be maintained smoothly. It has become possible to suppress turbidity when the freeze-dried powder obtained by freeze-drying the drug solution and the solution are dissolved in the syringe barrel before use to a level that does not interfere with use.
【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***部3Cが形成されてい
て、当該***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3A
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***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1
2a,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−200
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 Hereinafter, embodiments of the present invention will be explained based on the drawings. 1 to 4 show a two-layer syringe, in which an elastic tube is inserted into a cylindrical syringe barrel 3 with a needle connection 2 for the syringe needle 1 through an opening 3a formed at the other end of the syringe barrel 3. Two strong gaskets, a first gasket 4 and a 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 syringe 3, and when inserted into the syringe 3, there is a gap between the inner wall of the syringe 3 and the inner wall of the syringe 3. Configured to provide a fluid-tight seal. Two chambers 3A, 3 are partitioned in a fluid-tight manner by a first gasket 4 and a second gasket 5.
In B, the first chamber 3A located on the needle connection part 2 side contains freeze-dried powder a obtained by freeze-drying the drug solution in the syringe barrel 3 in an inverted position with the needle connection part 2 side facing downward. On the other hand, the second chamber 3B located on the opening 3a side stores a dissolving liquid b for dissolving the freeze-dried powder a. The second gasket 5 located on the opening 3a side of the syringe barrel 3 includes:
A plunger rod 6 for slidingly operating the second gasket 5 in the direction of the cylinder axis of the syringe barrel 3 is removably screwed and fixed to the tip of the plunger rod 6. A thumb rest 7 is formed that is flatter than the inner diameter. Further, a flange portion 8 projecting outward in the diametrical direction is integrally formed at the end of the outer circumferential surface of the syringe barrel 3 on the side of the opening 3a, and furthermore, at an intermediate portion of the syringe barrel 3 in the direction of the cylinder axis, A raised portion 3C that bulges outward in the radial direction is formed, and the first chamber 3A of the syringe barrel 3 is formed on the inner surface of the raised portion 3C.
A bypass passage 9 for communicating and connecting the second chamber 3B and the second chamber 3B is exposed. The length of this bypass passage 9 in the cylinder axis direction is:
The length of the first gasket 4 located on the side of the needle connection part 2 in the cylinder axis direction is slightly longer than that of the first gasket 4, and as shown in FIG. When located within the area, the solution b in the second chamber 3B is passed through the bypass passage 9 to the first chamber 3A.
It is designed to lead inward. Further, on the outer circumferential surface of the syringe barrel 3, a holder 10 made of synthetic resin is provided on a cylindrical portion located between the collar portion 8 and the raised portion 3C, which is detachably attached to the cylindrical portion. . This holder 10 is divided into two parts along an imaginary plane passing through the cylinder axis of the syringe barrel 3, and the end portion located on the opening 3a side of the syringe barrel 3 and the joint surface of the two divided holder parts 10A, 10B. Male and female connecting portions 10a and 10b, which elastically fit into each other from the diametrical direction of the syringe barrel 3, are integrally formed at each of two locations on the end portion located on the needle connecting portion 2 side. Also, at the end of the divided holder parts 10A and 10B of this holder 10 located on the opening 3a side of the syringe barrel 3, a pair of support pieces 11a and 11b that protrude outward in the diametrical direction than the collar part 8 is provided. On the other hand, the end portion located on the needle connecting portion 2 side has a shape that is similar to the support pieces 11a, 11b of the first finger hook portion 11 when viewed in the direction of the cylinder axis. A pair of support pieces 1 having the same shape
A second finger hook 12 consisting of 2a and 12b is integrally formed. Among the support pieces 11a and 11b of the first finger hook part 11,
A pair of semi-cylindrical portions 13A and 13B are integrally provided on the end face of the syringe barrel 3 located on the opening 3a side, and are enclosed in the collar portion 8. Furthermore, a plunger is provided in both semi-cylindrical portions 13A and 13B. A stopper 14 made of synthetic resin and externally wrapped around the rod 6 is fitted and held in a detachable manner from the direction of the axis of the cylinder. Further, a stopper 15 made of halogenated butyl rubber is inserted into the injection hole formed in the needle connection part 2 of the syringe barrel 3, which is pierced by the injection needle 1 attached to the needle connection part 2. In the two-layer syringe constructed in this manner, the inner wall portion of the syringe barrel 3 that comes into contact with the drug solution to be freeze-dried is coated with a silicone oil solution having a concentration of 0.3% (W/V) or less. 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 syringe barrel 3, which is not substantially in contact with the drug solution. There is. The silicone oil solution is prepared by dissolving silicone oil to a desired concentration in a highly volatile liquefied gas such as fluorocarbon (fluorocarbon). A specific example of the coating treatment method will be described in detail later, but as a general method for manufacturing the syringe barrel 3 of the present invention, first, the syringe barrel 3 is coated with a silicone oil solution having a concentration of 0.3% (W/V) or less. coating the entire inner wall of
Next, the inner wall part of the syringe barrel 3 other than the drug solution storage part was coated with 1% (W
/V) or more. Of course, only the inner wall portion of the syringe barrel 3 in the drug storage portion is coated with a silicone oil solution with 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 storage portion is coated with a silicone oil solution of 1% (W/V) or less. Although coating may be performed with a silicone oil solution having a concentration of W/V) or higher, the former method is simpler. In addition, as a coating method,
Examples include a method of spraying the silicone oil solution, a method of suctioning it from an injection hole formed in the needle connection part 2 of the syringe barrel 3, and a method of submerging the syringe barrel 3 in a silicone oil solution tank. Furthermore, the area to be coated with a silicone oil solution with a concentration of 0.3% (W/V) or less is the inner wall portion of the syringe barrel 3 that comes in contact with the drug solution to be freeze-dried; When the freeze-dried powder a obtained by freeze-drying and the solution b are dissolved in the syringe barrel 3 before use, if the turbidity does not interfere with use, the coating area will be in contact with the freeze-dried drug solution. It may be slightly smaller than the surface area of the inner wall of the cylinder 3. From a practical standpoint, it is preferable to coat the inner wall portion, including the inner wall portion where the chemical liquid may be scattered, with a silicone oil solution having a concentration of 0.3% (W/V) or less. With the needle connection part 2 of the syringe barrel 3 thus obtained facing down, the injection hole of the needle connection part 2 is inserted into the rubber stopper 15.
The syringe is sealed and inverted, and the drug solution is put into the syringe barrel 3 and freeze-dried. Next, after inserting the first gasket 4 into the syringe barrel 3, the solution b is added, and the upper end side is sealed with the second gasket 5. In use, the plunger rod 6 is attached to the second gasket 5, and the injection needle 1 is attached to the needle connection part 2 of the syringe barrel 3. Of course, plunger rod 6
may be attached to the second gasket 5 from the beginning. Next, a specific example of the coating method will be described. [First Example] As shown in FIGS. 5A and 5B, the syringe barrel 3 was placed upside down with the needle connection part 2 on top, and in this state it was inserted through the opening 3a. Using the nozzle 16, a silicone oil solution with a concentration of 0.1% (W/V) [silicone oil (SH-200 manufactured by Toray Dow Corning Co., Ltd.)
A solution prepared by dissolving Freon 113 (using Freon TF manufactured by Mitsui-DuPont Fluorochemicals)]
Apply by spraying. Next, a nozzle 18 with a partition 17 at the tip so that the solution does not come into contact with the liquid to be freeze-dried is inserted through the opening 3a of the syringe barrel 3, and a silicone oil solution with a concentration of 3% (W/V) ( A 0.1% solution (prepared in the same manner as the 0.1% solution) is applied to the inner wall portion of the syringe barrel 3 that is not substantially in contact with the drug solution, and then dried. [Second embodiment] As shown in (a) and (b) of FIG.
.. In a tank 19 containing a silicone oil solution with a concentration of 1% (W/V) (prepared in the same manner as in the first embodiment),
Slightly sink the syringe barrel 3 in an inverted position with the needle connection part 2 on top, and draw suction through the injection hole formed in the needle connection part 2 of the syringe barrel 3 to the needle connection part 2 inside the syringe barrel 3. The silicone oil solution in the tank 19 is pumped up to the maximum level. Next, the tank 19 is
% (W/V) of silicone oil solution (the first
After replacing the syringe barrel 3 with the tank 20 containing the syringe (prepared in the same manner as in the example) and slightly submerging the syringe barrel 3 in an inverted position with its needle connection portion 2 facing upward, the needle connection portion 2 of the syringe barrel 3 is formed. Aspirate from the injection hole. At this time, the silicone oil solution in the tank 20 is pumped up to just before the part that comes into contact with the chemical solution to be freeze-dried, while the pumping position is detected by the optical sensor 21, and then the syringe barrel 3 is taken out from the tank 20 and subjected to drying processing. Next, the inventor conducted an experiment to show the relationship between the concentration of silicone oil solution, turbidity, and sliding force. In this experiment, a 10% aqueous solution of mannitol was used as an example of the chemical liquid to be freeze-dried, and purified water was used as an example of the solution. Further, the needle connection part 2 of the syringe barrel 3 prepared by the method of the first embodiment or the second embodiment is sealed with a rubber cover, and the syringe barrel 3 is held upside down with the needle connection part 2 facing down. Add a 10% aqueous solution of mannitol and freeze-dry. Next, a first gasket 4 made of halogenated butyl rubber is attached to the inside of the syringe barrel 3, purified water is added, a second gasket 5 made of halogenated butyl rubber is attached, and 10% of mannitol is added.
% aqueous solution and purified water were prepared. Then, the degree of turbidity generated when the 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 investigated. 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。[0009] In the table, in the degree of turbidity, "-" indicates that no turbidity is observed, "+" indicates that turbidity has occurred, and "±" indicates a state that does not pose a problem in actual use. shows. In the sliding force, "-" indicates that the plunger rod 6 is pushed down smoothly, "+" indicates that the resistance is large, and "±" indicates a resistance that does not pose a problem in actual use. From this experimental result, the chemical contact area was reduced to 0.3% (
Silicon coating is applied at a concentration of 1% (W/V) or lower, and the non-contact area is coated with silicon at a concentration of 1% (W/V) or higher, preferably 1 to 1% (W/V).
When silicon coating is applied at a concentration of 5% (W/V),
It has been found that the syringe barrel 3 which is the object of 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
3B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 Examples] ■ In the above-mentioned example, the silicon coating concentration on the inner wall of the syringe barrel 3 that comes into contact with the drug solution was specified to be 0.3% (W/V) or less, but if the amount of the drug solution is small In some cases, even without silicone coating, there is virtually no impediment to the movement of the gaskets 4, 5 and the plunger rod 6. In other words, 0.3% (W/V
) shall include 0%. (2) Application of the syringe barrel 3 of the present invention is not limited by the type of medicinal solution, but can be applied to all medicinal solutions that are used after being freeze-dried. ■ In the above example, silicone oil was added to liquefied gas such as fluorocarbon (fluorocarbon) to create a silicone oil solution with a predetermined concentration. However, instead of using fluorocarbon, silicone oil was added to water. A suspended product may also be used. Furthermore, the silicone oil to be used is not particularly limited as long as it can be applied to the inside of the syringe, and examples include dimethylpolysiloxane and cyclic polydimethylsiloxane. ■ In the above embodiment, the solution in the second chamber 3B is guided to the freeze-dried powder in the first chamber 3A through the bypass channel 9 provided in the syringe barrel 3, but the first gasket 4
It may be implemented by providing a valve structure for guiding the solution in the second chamber 3B to the freeze-dried powder in the first chamber 3A during the pushing operation of the plunger rod 6. In short, any structure may be used as long as it can guide the solution in the second chamber 3B to the freeze-dried powder in the first chamber 3A during the pushing operation of the plunger rod 6. (2) Of course, the present invention can also be applied to a syringe barrel of a two-layer syringe that does not have the holder 10 and stopper 14 described in the above embodiments. Further, the shapes, materials, dimensions, etc. of the syringe barrel 3, both gaskets 4 and 5, and the plunger rod 6 can be changed in various ways depending on the conditions of use.
【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。[0011] Note that although reference numerals are written in the claims for convenience of comparison with the drawings, the present invention is not limited to the structure of the accompanying drawings by such 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 cross-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[Figure 2
】Cross-sectional side view showing the process of mixing freeze-dried powder and solution
【図3】全体の斜視図[Figure 3] Overall perspective view
【図4】全体の分解斜視図[Figure 4] 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[Fig. 5] (A) and (B) are explanatory diagrams showing the first embodiment of the silicon coating treatment 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[Fig. 6] (A) and (B) are explanatory diagrams showing a second embodiment of the silicon coating treatment 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. Syringe needle connection part 3. Syringe barrel 4 First gasket 5 Second gasket 6 Plunger rod a Freeze-dried powder b Dissolution solution
Claims (1)
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)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。Claim 1: Freeze-dried powder (a) obtained by freeze-drying a drug solution in a syringe barrel (3) in an inverted position with the syringe needle connection part (2) side facing downward. ), and the storage space for this freeze-dried powder (a) is
The lyophilized powder (
The solution (b) of a) is stored between the first gasket (4) and an elastic second gasket (5) inserted into the syringe barrel (3), and gasket(
5) is a double-layered syringe barrel with a plunger rod (6) attached to the inner wall of the syringe barrel (3), which is in contact with the drug solution to be freeze-dried, with a concentration of 0.3% (W/V) or less. A coating layer coated with a silicone oil solution having a concentration of 1% (W/V) or more is formed on the inner wall of the syringe barrel (3), which is not substantially in contact with the drug solution. A syringe barrel of a double-layered syringe.
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 true JPH04246364A (en) | 1992-09-02 |
JPH0626570B2 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) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
JP2004057819A (en) * | 1993-04-02 | 2004-02-26 | Dai Ichi Seiyaku Co Ltd | Manufacturing method for receptacle and syringe product, receptacle for filling medicine liquid, and syringe product |
JP2014504511A (en) * | 2011-01-24 | 2014-02-24 | 大塚製薬株式会社 | Medical device containing cake-like composition containing aripiprazole as active ingredient, and cake-like composition containing aripiprazole as active ingredient |
JP2018513741A (en) * | 2015-04-21 | 2018-05-31 | フェッター ファルマ−フェルティグング ゲーエムベーハー ウント コンパニー カーゲー | Primary packaging material and method for producing primary packaging material |
-
1991
- 1991-01-31 JP JP3010399A patent/JPH0626570B2/en not_active Expired - Lifetime
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004057819A (en) * | 1993-04-02 | 2004-02-26 | Dai Ichi Seiyaku Co Ltd | Manufacturing method for receptacle and syringe product, receptacle for filling medicine liquid, and syringe product |
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 |
JP2014504511A (en) * | 2011-01-24 | 2014-02-24 | 大塚製薬株式会社 | Medical device containing cake-like composition containing aripiprazole as active ingredient, and cake-like composition containing aripiprazole as active ingredient |
KR20140114270A (en) * | 2011-01-24 | 2014-09-26 | 오츠카 세이야쿠 가부시키가이샤 | Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient |
JP2018513741A (en) * | 2015-04-21 | 2018-05-31 | フェッター ファルマ−フェルティグング ゲーエムベーハー ウント コンパニー カーゲー | Primary packaging material and method for producing primary packaging material |
JP2020121177A (en) * | 2015-04-21 | 2020-08-13 | フェッター ファルマ−フェルティグング ゲーエムベーハー ウント コンパニー カーゲー | Primary packaging material and method for manufacture of primary packaging material |
US10940037B2 (en) | 2015-04-21 | 2021-03-09 | Vetter Pharma-Fertigung GmbH & Co. KG | Primary packaging and method for the manufacture of a primary packaging |
Also Published As
Publication number | Publication date |
---|---|
JPH0626570B2 (en) | 1994-04-13 |
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