JP6604521B2 - 医薬容器用ホウケイ酸ガラス及び医薬容器用ガラス管 - Google Patents
医薬容器用ホウケイ酸ガラス及び医薬容器用ガラス管 Download PDFInfo
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- JP6604521B2 JP6604521B2 JP2016546572A JP2016546572A JP6604521B2 JP 6604521 B2 JP6604521 B2 JP 6604521B2 JP 2016546572 A JP2016546572 A JP 2016546572A JP 2016546572 A JP2016546572 A JP 2016546572A JP 6604521 B2 JP6604521 B2 JP 6604521B2
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- Prior art keywords
- glass
- borosilicate glass
- pharmaceutical
- content
- pharmaceutical containers
- Prior art date
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Classifications
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- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/089—Glass compositions containing silica with 40% to 90% silica, by weight containing boron
- C03C3/091—Glass compositions containing silica with 40% to 90% silica, by weight containing boron containing aluminium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
- C03B23/00—Re-forming shaped glass
- C03B23/04—Re-forming tubes or rods
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C1/00—Ingredients generally applicable to manufacture of glasses, glazes, or vitreous enamels
- C03C1/004—Refining agents
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/083—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound
- C03C3/085—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound containing an oxide of a divalent metal
- C03C3/087—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound containing an oxide of a divalent metal containing calcium oxide, e.g. common sheet or container glass
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/11—Glass compositions containing silica with 40% to 90% silica, by weight containing halogen or nitrogen
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C4/00—Compositions for glass with special properties
- C03C4/20—Compositions for glass with special properties for chemical resistant glass
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C2217/00—Coatings on glass
- C03C2217/20—Materials for coating a single layer on glass
- C03C2217/28—Other inorganic materials
Description
(a)充填される薬液中の成分とガラス中の成分が反応しないこと
(b)充填される薬液を汚染しないように化学的耐久性や加水分解抵抗性が高いこと
(c)ガラス管の製造工程や、バイアル、アンプル等への加工時に、サーマルショックによる破損が生じ難いように低熱膨張係数であること
(d)バイアル、アンプル等への加工が低温で行えるように、作業温度が低いこと
これらの要求特性を満足する標準的な医薬容器用ホウケイ酸ガラスは、構成成分として、SiO2、B2O3、Al2O3、Na2O、K2O、CaO、BaOと少量の清澄剤を含有している。(例えば特許文献1)
本発明においては、さらにFe2O3を0.0001〜0.04質量%含有することが好ましい。
次に、各試料について透過率を評価した。結果を表3、4に示す。
Snイオンの溶出量は、加水分解抵抗性試験後の試験液について、ICP発光分析装置(バリアン製)にて分析を行った。詳細な試験手順は以下の通りである。加水分解抵抗性試験後の試験溶液をメンブランフィルターでろ過して遠沈管に採取した。Sn含有量が0mg/L、0.05mg/L、0.5mg/L、1.0mg/Lとなるように、Sn標準液(和光純薬工業製)を希釈して、標準溶液を作製した。それらの標準溶液から検量線を作成し、試験液中のSn溶出量を算出した。Snの測定波長は189.925nmとした。
ガラスの透過率は、作製したインゴットの中央部から縦3cm、横2cm、板厚1mmの試料を切り出し、両面を研磨したあと、分光光度計を用いて300〜800nmでの透過率を測定した。400nmでの透過率が90%以上であれば○、90%よりも低ければ×と判定した。
Claims (9)
- 質量%でSiO2 70.0〜78.0%、Al2O3 5.0〜8.0%、B2O3 5.0〜12.0%、CaO 0〜4.0%、BaO 0〜4.0%、Na2O 4.0〜8.0%、K2O 0〜5.0%、SnO2 0.001〜0.1%、Cl 0.01〜0.5%含有することを特徴とする医薬容器用ホウケイ酸ガラス。
- さらにFe2O3を0.0001〜0.04質量%含有することを特徴とする請求項1に記載の医薬容器用ホウケイ酸ガラス。
- As2O3及びSb2O3を含有しないことを特徴とする請求項1又は2に記載の医薬容器用ホウケイ酸ガラス。
- ヨーロッパ薬局方7.0に準じた加水分解抵抗性試験の粉末試験法において、試験溶液中のSnイオン溶出量が1.0ppm以下であることを特徴とする請求項1〜3の何れかに記載の医薬容器用ホウケイ酸ガラス。
- ヨーロッパ薬局方7.0に準じた加水分解抵抗性試験の粉末試験法において、単位ガラス質量当たりの0.02mol/Lの塩酸の消費量が0.030mL以下であることを特徴とする請求項1〜4の何れかに記載の医薬容器用ホウケイ酸ガラス。
- DIN12116に準じた耐酸性試験において、面積あたりの質量減少量が1.0mg/dm2以下となることを特徴とする請求項1〜5の何れかに記載の医薬容器用ホウケイ酸ガラス。
- 1200℃以下の作業温度を有することを特徴とする請求項1〜6の何れかに記載の医薬容器用ホウケイ酸ガラス。
- 104.5dPa・s以上の液相粘度を有することを特徴とする請求項1〜7の何れかに記載の医薬容器用ホウケイ酸ガラス。
- 請求項1〜8の何れかに記載の医薬容器用ホウケイ酸ガラスからなることを特徴とする医薬容器用ガラス管。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2014180919 | 2014-09-05 | ||
JP2014180919 | 2014-09-05 | ||
JP2014235214 | 2014-11-20 | ||
JP2014235214 | 2014-11-20 | ||
PCT/JP2015/073903 WO2016035619A1 (ja) | 2014-09-05 | 2015-08-25 | 医薬容器用ホウケイ酸ガラス及び医薬容器用ガラス管 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPWO2016035619A1 JPWO2016035619A1 (ja) | 2017-06-15 |
JP6604521B2 true JP6604521B2 (ja) | 2019-11-13 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2016546572A Active JP6604521B2 (ja) | 2014-09-05 | 2015-08-25 | 医薬容器用ホウケイ酸ガラス及び医薬容器用ガラス管 |
Country Status (5)
Country | Link |
---|---|
US (1) | US10099956B2 (ja) |
EP (1) | EP3190096B1 (ja) |
JP (1) | JP6604521B2 (ja) |
CN (1) | CN106687422B (ja) |
WO (1) | WO2016035619A1 (ja) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017014066A1 (ja) | 2015-07-17 | 2017-01-26 | 日本電気硝子株式会社 | 医薬容器用ホウケイ酸ガラス |
DE102017102482B4 (de) * | 2017-02-08 | 2019-11-21 | Schott Ag | Gläser mit verbesserter Ionenaustauschbarkeit und thermischer Ausdehnung |
US20180346368A1 (en) * | 2017-05-31 | 2018-12-06 | Nipro Corporation | Method of manufacturing glass vessel, and apparatus for manufacturing glass vessel |
US11542191B2 (en) * | 2017-10-20 | 2023-01-03 | Nippon Electric Glass Co., Ltd. | Glass for medicine container and glass tube for medicine container |
DE102019126332A1 (de) * | 2019-09-30 | 2021-04-01 | Schott Ag | Glasartikel, Verfahren zu deren Herstellung und Verwendungen |
EP3819268B1 (en) * | 2019-11-08 | 2021-09-29 | Schott AG | Toughenable glass with high hydrolytic resistance and reduced color tinge |
US11951713B2 (en) | 2020-12-10 | 2024-04-09 | Corning Incorporated | Glass with unique fracture behavior for vehicle windshield |
WO2023107300A1 (en) * | 2021-12-06 | 2023-06-15 | Corning Incorporated | Chemically durable borosilicate glass compositions for storing pharmaceutical compositions and articles formed therefrom |
CN114349336B (zh) * | 2022-01-13 | 2022-09-27 | 浙江大学 | 一种低膨胀硼硅酸盐透明琉璃及其制备方法和应用 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
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DE3722130A1 (de) | 1987-07-02 | 1989-01-12 | Schott Glaswerke | Borosilikatglas |
DE4430710C1 (de) * | 1994-08-30 | 1996-05-02 | Jenaer Glaswerk Gmbh | Borsäurearmes Borosilikatglas und seine Verwendung |
JP2000128572A (ja) * | 1998-10-26 | 2000-05-09 | Nippon Electric Glass Co Ltd | 硼珪酸ガラス及びその製造方法 |
DE10025465C2 (de) * | 1999-05-25 | 2003-03-27 | Eckhart Watzke | Lithiumoxidarmes Borosilicatglas und seine Verwendung |
WO2005042437A2 (en) * | 2003-09-30 | 2005-05-12 | Schott Ag | Antimicrobial glass and glass ceramic surfaces and their production |
JP6075600B2 (ja) | 2012-07-11 | 2017-02-08 | 日本電気硝子株式会社 | 医薬品容器用ガラス及びこれを用いたガラス管 |
JP2014037343A (ja) * | 2012-07-18 | 2014-02-27 | Nippon Electric Glass Co Ltd | 医薬品容器用ガラス及びこれを用いたガラス管 |
JP5971615B2 (ja) | 2012-07-30 | 2016-08-17 | 日本電気硝子株式会社 | ホウケイ酸ガラス |
DE202013011766U1 (de) * | 2013-04-26 | 2014-09-30 | Schott Ag | Borosilikatglas mit verbesserter hydrolytischer Beständigkeit zur bevorzugten Verwendung im Pharmabereich |
JP6508507B2 (ja) * | 2013-09-02 | 2019-05-08 | 日本電気硝子株式会社 | 医薬容器用ホウケイ酸ガラス |
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2015
- 2015-08-25 EP EP15838664.9A patent/EP3190096B1/en active Active
- 2015-08-25 CN CN201580047793.5A patent/CN106687422B/zh active Active
- 2015-08-25 WO PCT/JP2015/073903 patent/WO2016035619A1/ja active Application Filing
- 2015-08-25 JP JP2016546572A patent/JP6604521B2/ja active Active
- 2015-08-25 US US15/508,133 patent/US10099956B2/en active Active
Also Published As
Publication number | Publication date |
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EP3190096A4 (en) | 2018-04-25 |
EP3190096B1 (en) | 2019-06-19 |
WO2016035619A1 (ja) | 2016-03-10 |
US10099956B2 (en) | 2018-10-16 |
CN106687422A (zh) | 2017-05-17 |
JPWO2016035619A1 (ja) | 2017-06-15 |
CN106687422B (zh) | 2020-11-13 |
US20170283302A1 (en) | 2017-10-05 |
EP3190096A1 (en) | 2017-07-12 |
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