JPH08182740A - Medicine preservation container - Google Patents
Medicine preservation containerInfo
- Publication number
- JPH08182740A JPH08182740A JP6326545A JP32654594A JPH08182740A JP H08182740 A JPH08182740 A JP H08182740A JP 6326545 A JP6326545 A JP 6326545A JP 32654594 A JP32654594 A JP 32654594A JP H08182740 A JPH08182740 A JP H08182740A
- Authority
- JP
- Japan
- Prior art keywords
- container
- silicon oxide
- coated
- main component
- thermoplastic
- 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
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は薬剤保存容器に関するも
のである。薬剤保存容器の例としてはバイアル・プレフ
ィルドシリンジ・輸液バッグなどがある。FIELD OF THE INVENTION The present invention relates to a drug storage container. Examples of drug storage containers include vials, prefilled syringes, infusion bags, and the like.
【０００２】[0002]
【従来の技術】薬剤保存容器の材質としては熱可塑性プ
ラスチックが汎用されている。これはガラスに比べ破損
しにくい、廃棄し易い、軽いなどの理由からである。そ
のような熱可塑性プラスチックの材質としては環状ポリ
オレフィンコポリマー・ポリプロピレン・ポリメチルペ
ンテン・ポリエチレンなどが採用されている。2. Description of the Related Art Thermoplastics are commonly used as the material for drug storage containers. This is because it is less likely to break than glass, is easy to dispose of, and is light in weight. Cyclic polyolefin copolymer, polypropylene, polymethylpentene, polyethylene, etc. are adopted as the material of such thermoplastics.
【０００３】[0003]
【発明が解決しようとする課題】プラスチック製のバイ
アルやプレフィルドシリンジは、光学特性、水・酸素バ
リア性に関しガラス素材よりは劣り、なおも改良すべき
問題となっている。薬剤保存容器内にグルコースやアミ
ノ酸などの薬液が保存され長期間放置した場合、水や酸
素が容器壁から容器内へ透過し、容器内の薬剤が変質す
るということが問題になる。本発明はこの問題を解決す
るためになされたものである。Plastic vials and prefilled syringes are inferior to glass materials in optical properties and water / oxygen barrier properties, and are still problems to be improved. When a drug solution such as glucose or amino acid is stored in the drug storage container and left for a long period of time, there is a problem that water and oxygen permeate from the container wall into the container and the drug in the container is deteriorated. The present invention has been made to solve this problem.
【０００４】[0004]
【課題を解決するための手段】本発明は、熱可塑性プラ
スチック容器の外面が、酸化珪素を主成分とするセラミ
ックスで被覆されたことを特徴とする薬剤保存容器を要
旨とする。DISCLOSURE OF THE INVENTION The gist of the present invention is a drug storage container characterized in that an outer surface of a thermoplastic plastic container is coated with a ceramic containing silicon oxide as a main component.
【０００５】本発明において熱可塑性プラスチックと
は、環状ポリオレフィンコポリマー・ポリプロピレン・
ポリメチルペンテン・ポリエチレン・プロピレン−エチ
レン共重合体・エチレン−α−オレフィン共重合体から
なるグループから選択された材料のことを言う。In the present invention, the term "thermoplastic" means a cyclic polyolefin copolymer, polypropylene,
It refers to a material selected from the group consisting of polymethylpentene / polyethylene / propylene-ethylene copolymer / ethylene-α-olefin copolymer.
【０００６】本発明においてセラミックス層の酸素ガス
透過率が、２ｃｃ／ｍ2 ・２４ｈｒ・ａｔｍ以下である
ことが好ましい。膜の厚みは０．１〜１０μｍが好まし
い。In the present invention, the oxygen gas permeability of the ceramic layer is preferably 2 cc / m 2 · 24 hr · atm or less. The thickness of the film is preferably 0.1 to 10 μm.
【０００７】本発明は特にバイアル・プレフィルドシリ
ンジにおいて好ましい効果が得られるものである。本発
明において輸液容器とは輸液バッグ又は輸液ボトルを言
う。The present invention is particularly effective for vial prefilled syringes. In the present invention, the infusion container means an infusion bag or an infusion bottle.
【０００８】本発明において酸化珪素とは、一般式Ｓｉ
x Ｏy （ x＝１，２、 y＝０，１，２，３）すなわちＳ
ｉ、ＳｉＯ、ＳｉＯ2 、Ｓｉ2 Ｏ3 の形の混合物であ
る。これらは蒸着後大部分珪素酸化物の形で蒸着される
ものであり、一酸化珪素が最も適している。一酸化珪素
はそれ自身昇華性であり、比較的低温で蒸着できるので
本発明のようにガラスや金属に比べて耐熱性の劣るプラ
スチック上への真空蒸着には特に適している。In the present invention, silicon oxide means the general formula Si
x O y ( x = 1,2, y = 0,1,2,3), that is, S
It is a mixture in the form of i, SiO, SiO 2 , Si 2 O 3 . These are mostly deposited in the form of silicon oxide after deposition, with silicon monoxide being most suitable. Since silicon monoxide itself is sublimable and can be vapor-deposited at a relatively low temperature, it is particularly suitable for vacuum vapor-deposition on a plastic having poor heat resistance as compared with glass or metal as in the present invention.
【０００９】セラミックスコーティングの方法には、ゾ
ルゲルコーティング法や蒸着法などがあるが、ゾルゲル
コーティング法は４００℃以上の加熱が必要で、一回の
コーティングで０．３ミクロン程度の膜厚しか得られな
い。それ故、本発明のようにプラスチックに被覆する場
合プラスチックが４００℃以上の高温下に耐えないので
蒸着法が好ましい。Ceramic coating methods include a sol-gel coating method and a vapor deposition method. The sol-gel coating method requires heating at 400 ° C. or higher, and a single coating can obtain a film thickness of about 0.3 μm. Absent. Therefore, when the plastic is coated as in the present invention, the plastic cannot withstand a high temperature of 400 ° C. or higher, and thus the vapor deposition method is preferable.
【００１０】[0010]
【作用】本発明は上述のように薬剤保存容器の表面が酸
化珪素を主成分とするセラミックスで被覆されているの
で被膜そのものはガラスに近い構造をもち、水・ガスバ
リア性に優れた薬剤保存容器が得られるわけである。As described above, according to the present invention, since the surface of the drug storage container is coated with the ceramic containing silicon oxide as the main component, the film itself has a structure similar to glass, and the drug storage container has excellent water / gas barrier properties. Is obtained.
【００１１】また、表面が１０μｍ以下のセラミックス
で被覆されていると耐擦傷性・耐摩耗性に優れ、プラス
チック製薬剤保存容器の透明性に害をなさない。When the surface is coated with ceramics having a thickness of 10 μm or less, the abrasion resistance and abrasion resistance are excellent, and the transparency of the plastic drug storage container is not impaired.
【００１２】[0012]
【発明の効果】本発明は上述のような構成による薬剤保
存容器であるので、本発明により水・ガスバリア性に優
れたものが得られる。EFFECTS OF THE INVENTION Since the present invention is a drug storage container having the above-mentioned constitution, a container excellent in water / gas barrier property can be obtained by the present invention.
【００１３】[0013]
（水蒸気透過性の試験）テトラシクロドデセンとエチレ
ンからなる環状オレフィンコポリマーから容量が３０ｃ
ｃのプラスチック容器（以下、ＣＯＰバイアルと言
う。）を作った。次いでこの容器の表面に高周波誘導加
熱方式により膜厚を０．５ミクロンとして酸化珪素で被
覆した。この容器に蒸留水を満たし、密封し、温度：４
０℃、相対湿度：７０％のもとで４週間放置した。液量
減少率をみて水蒸気透過率とした。その結果、水蒸気透
過率は０．０１０％であった。(Water vapor permeability test) The capacity is 30c from the cycloolefin copolymer consisting of tetracyclododecene and ethylene.
A plastic container (c) (hereinafter referred to as COP vial) was prepared. Then, the surface of this container was coated with silicon oxide by a high frequency induction heating method to a film thickness of 0.5 micron. Fill this container with distilled water, seal and temperature: 4
It was left for 4 weeks at 0 ° C. and relative humidity of 70%. The rate of decrease in liquid volume was used as the water vapor transmission rate. As a result, the water vapor transmission rate was 0.010%.
【００１４】比較例として、上記ＣＯＰバイアルに酸化
珪素で被覆を行わないで蒸留水を見たし、温度：４０
℃、相対湿度７０％のもとで４週間放置した。液量減少
率をみて水蒸気透過率とした。その結果水蒸気透過率は
０．０６４％であった。As a comparative example, the COP vial was examined for distilled water without coating with silicon oxide, and the temperature was 40.
It was allowed to stand for 4 weeks under the conditions of ℃ and 70% relative humidity. The rate of decrease in liquid volume was used as the water vapor transmission rate. As a result, the water vapor transmission rate was 0.064%.
【００１５】ポリプロピレンから容量が３０ｃｃのプラ
スチック容器（以下、ＰＰバイアルと言う。）を作っ
た。次いでこの容器の表面に高周波誘導加熱方式により
膜厚を０．５ミクロンとして酸化珪素で被覆した。この
容器に蒸留水を満たし、密封し、温度：４０℃、相対湿
度：７０％のもとで４週間放置した。液量減少率をみて
水蒸気透過率とした。その結果、水蒸気透過率は０．０
１２％であった。A plastic container having a capacity of 30 cc (hereinafter referred to as a PP vial) was made from polypropylene. Then, the surface of this container was coated with silicon oxide by a high frequency induction heating method to a film thickness of 0.5 micron. The container was filled with distilled water, sealed, and allowed to stand for 4 weeks at a temperature of 40 ° C. and a relative humidity of 70%. The rate of decrease in liquid volume was used as the water vapor transmission rate. As a result, the water vapor transmission rate is 0.0
It was 12%.
【００１６】比較例として、上記ＰＰバイアルに酸化珪
素で被覆を行わないで蒸留水を見たし、温度：４０℃、
相対湿度７０％のもとで４週間放置した。液量減少率を
みて水蒸気透過率とした。その結果水蒸気透過率は０．
０８３％であった。As a comparative example, the above PP vial was examined for distilled water without being coated with silicon oxide, and the temperature was 40 ° C.
It was left for 4 weeks under a relative humidity of 70%. The rate of decrease in liquid volume was used as the water vapor transmission rate. As a result, the water vapor transmission rate is 0.
It was 083%.
【００１７】（光透過率の試験）上記ＣＯＰバイアルに
注射液を入れて滅菌した。この容器の胴部の一部を約
０．９×４ｃｍの大きさにしたもの５個を作り、水に浸
漬して、波長４５０ｎｍの透過率の透過率を水を対照と
して測定した。その結果、透過率は８９．１８％であっ
たが、上記ＣＯＰバイアルに酸化珪素で被覆を行ってか
ら同様の試験をすると、透過率は８６．１１％であり、
被覆による透過率の低下は些少であった。(Test of Light Transmittance) An injection solution was put in the COP vial and sterilized. Five pieces were prepared by making a part of the body of this container about 0.9 × 4 cm in size, immersed in water, and the transmittance at a wavelength of 450 nm was measured using water as a control. As a result, the transmittance was 89.18%, but when the same test was performed after coating the COP vial with silicon oxide, the transmittance was 86.11%,
The decrease in transmittance due to the coating was insignificant.
【００１８】上記ＰＰバイアルに注射液を入れて滅菌し
た。この容器の胴部の一部を約０．９×４ｃｍの大きさ
にしたもの５個を作り、水に浸漬して、波長４５０ｎｍ
の透過率の透過率を水を対照として測定した。その結
果、透過率は７１．５２％であったが、上記ＰＰバイア
ルに酸化珪素で被覆を行ってから同様の試験をすると、
透過率は６９．２４％であり、この場合も被覆による透
過率の低下は些少であった。以上のことから、本発明に
よれば透過率の低下を抑えつつ、水・ガスバリア性の優
れた薬剤保存容器の得られることが分かる。An injection solution was placed in the PP vial and sterilized. Make 5 parts of the body of this container with a size of about 0.9 x 4 cm, immerse them in water, and set a wavelength of 450 nm.
The transmittance of water was measured using water as a control. As a result, the transmittance was 71.52%, but when a similar test was performed after coating the PP vial with silicon oxide,
The transmittance was 69.24%, and in this case also, the decrease in the transmittance due to the coating was insignificant. From the above, it can be seen that according to the present invention, a drug storage container having excellent water / gas barrier properties can be obtained while suppressing a decrease in transmittance.
Claims (6)
化珪素を主成分とするセラミックスで被覆されたことを
特徴とする薬剤保存容器。1. A drug storage container, characterized in that the outer surface of the thermoplastic container is coated with ceramics containing silicon oxide as a main component.
フィンコポリマー・ポリプロピレン・ポリメチルペンテ
ン・ポリエチレン・プロピレン−エチレン共重合体・エ
チレン−α−オレフィン共重合体からなるグループから
選択された材料である請求項１記載の薬剤保存容器。2. The thermoplastic is a material selected from the group consisting of cyclic polyolefin copolymer / polypropylene / polymethylpentene / polyethylene / propylene-ethylene copolymer / ethylene-α-olefin copolymer. The drug storage container described.
ｃｃ／ｍ2 ・２４ｈｒ・ａｔｍ以下である請求項１記載
の薬剤保存容器。3. The ceramic layer has an oxygen gas permeability of 2
The medicine storage container according to claim 1, which has a cc / m 2 · 24 hr · atm or less.
化珪素を主成分とするセラミックスで被覆されたことを
特徴とするバイアル。4. A vial characterized in that the outer surface of a thermoplastic container is coated with a ceramic containing silicon oxide as a main component.
化珪素を主成分とするセラミックスで被覆されたことを
特徴とするプレフィルドシリンジ。5. A prefilled syringe characterized in that the outer surface of a thermoplastic container is coated with a ceramic containing silicon oxide as a main component.
化珪素を主成分とするセラミックスで被覆されたことを
特徴とする輸液用容器。6. An infusion container, wherein the outer surface of the thermoplastic container is coated with a ceramic containing silicon oxide as a main component.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP6326545A JPH08182740A (en) | 1994-12-28 | 1994-12-28 | Medicine preservation container |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP6326545A JPH08182740A (en) | 1994-12-28 | 1994-12-28 | Medicine preservation container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH08182740A true JPH08182740A (en) | 1996-07-16 |
Family
ID=18189031
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP6326545A Pending JPH08182740A (en) | 1994-12-28 | 1994-12-28 | Medicine preservation container |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH08182740A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009263393A (en) * | 2001-10-12 | 2009-11-12 | Nipro Corp | Prefilled syringe of injectable solution containing shark-derived chondroitin sulfate iron colloid |
-
1994
- 1994-12-28 JP JP6326545A patent/JPH08182740A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009263393A (en) * | 2001-10-12 | 2009-11-12 | Nipro Corp | Prefilled syringe of injectable solution containing shark-derived chondroitin sulfate iron colloid |
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