JP2007061192A - Vessel for ophthalmic medicine blended with chlorine dioxide - Google Patents
Vessel for ophthalmic medicine blended with chlorine dioxide Download PDFInfo
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- JP2007061192A JP2007061192A JP2005248017A JP2005248017A JP2007061192A JP 2007061192 A JP2007061192 A JP 2007061192A JP 2005248017 A JP2005248017 A JP 2005248017A JP 2005248017 A JP2005248017 A JP 2005248017A JP 2007061192 A JP2007061192 A JP 2007061192A
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- OSVXSBDYLRYLIG-UHFFFAOYSA-N dioxidochlorine(.) Chemical compound O=Cl=O OSVXSBDYLRYLIG-UHFFFAOYSA-N 0.000 title claims abstract description 79
- 235000019398 chlorine dioxide Nutrition 0.000 title claims abstract description 40
- 239000004155 Chlorine dioxide Substances 0.000 title claims abstract description 39
- 229940023490 ophthalmic product Drugs 0.000 title abstract 4
- 239000000463 material Substances 0.000 claims abstract description 18
- 238000004040 coloring Methods 0.000 claims abstract description 12
- 238000002834 transmittance Methods 0.000 claims description 37
- 238000002360 preparation method Methods 0.000 claims description 18
- 239000000049 pigment Substances 0.000 claims description 12
- -1 polyethylene terephthalate Polymers 0.000 claims description 8
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 7
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 7
- 239000002904 solvent Substances 0.000 claims description 7
- 229920005992 thermoplastic resin Polymers 0.000 claims description 5
- PYKYMHQGRFAEBM-UHFFFAOYSA-N anthraquinone Natural products CCC(=O)c1c(O)c2C(=O)C3C(C=CC=C3O)C(=O)c2cc1CC(=O)OC PYKYMHQGRFAEBM-UHFFFAOYSA-N 0.000 claims description 4
- 150000004056 anthraquinones Chemical class 0.000 claims description 4
- 239000012860 organic pigment Substances 0.000 claims description 3
- DGBWPZSGHAXYGK-UHFFFAOYSA-N perinone Chemical compound C12=NC3=CC=CC=C3N2C(=O)C2=CC=C3C4=C2C1=CC=C4C(=O)N1C2=CC=CC=C2N=C13 DGBWPZSGHAXYGK-UHFFFAOYSA-N 0.000 claims description 3
- 239000012815 thermoplastic material Substances 0.000 claims 1
- 239000012780 transparent material Substances 0.000 claims 1
- 229920006352 transparent thermoplastic Polymers 0.000 claims 1
- 229920005989 resin Polymers 0.000 abstract description 23
- 239000011347 resin Substances 0.000 abstract description 23
- 238000011179 visual inspection Methods 0.000 abstract description 11
- 230000002421 anti-septic effect Effects 0.000 abstract description 7
- 239000003732 agents acting on the eye Substances 0.000 description 29
- 229940125702 ophthalmic agent Drugs 0.000 description 29
- 230000000052 comparative effect Effects 0.000 description 14
- 239000003889 eye drop Substances 0.000 description 12
- 230000005540 biological transmission Effects 0.000 description 11
- 238000006303 photolysis reaction Methods 0.000 description 9
- 239000000975 dye Substances 0.000 description 8
- 229940012356 eye drops Drugs 0.000 description 8
- 150000001875 compounds Chemical class 0.000 description 7
- 238000002156 mixing Methods 0.000 description 6
- 239000003755 preservative agent Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- 125000002091 cationic group Chemical group 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 238000001782 photodegradation Methods 0.000 description 4
- 239000003086 colorant Substances 0.000 description 3
- 239000013065 commercial product Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000015843 photosynthesis, light reaction Effects 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- UKLNMMHNWFDKNT-UHFFFAOYSA-M sodium chlorite Chemical compound [Na+].[O-]Cl=O UKLNMMHNWFDKNT-UHFFFAOYSA-M 0.000 description 2
- 229960002218 sodium chlorite Drugs 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000006097 ultraviolet radiation absorber Substances 0.000 description 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 206010015946 Eye irritation Diseases 0.000 description 1
- 239000006096 absorbing agent Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 229960004050 aminobenzoic acid Drugs 0.000 description 1
- ALYNCZNDIQEVRV-UHFFFAOYSA-N aniline-p-carboxylic acid Natural products NC1=CC=C(C(O)=O)C=C1 ALYNCZNDIQEVRV-UHFFFAOYSA-N 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 239000000739 antihistaminic agent Substances 0.000 description 1
- 229940125715 antihistaminic agent Drugs 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 1
- 229960001950 benzethonium chloride Drugs 0.000 description 1
- QRUDEWIWKLJBPS-UHFFFAOYSA-N benzotriazole Chemical compound C1=CC=C2N[N][N]C2=C1 QRUDEWIWKLJBPS-UHFFFAOYSA-N 0.000 description 1
- 239000012964 benzotriazole Substances 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 150000001768 cations Chemical group 0.000 description 1
- 229960003333 chlorhexidine gluconate Drugs 0.000 description 1
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 125000000664 diazo group Chemical group [N-]=[N+]=[*] 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 1
- 231100000040 eye damage Toxicity 0.000 description 1
- 231100000013 eye irritation Toxicity 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 125000000623 heterocyclic group Chemical group 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- PXZQEOJJUGGUIB-UHFFFAOYSA-N isoindolin-1-one Chemical compound C1=CC=C2C(=O)NCC2=C1 PXZQEOJJUGGUIB-UHFFFAOYSA-N 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- NYGZLYXAPMMJTE-UHFFFAOYSA-M metanil yellow Chemical group [Na+].[O-]S(=O)(=O)C1=CC=CC(N=NC=2C=CC(NC=3C=CC=CC=3)=CC=2)=C1 NYGZLYXAPMMJTE-UHFFFAOYSA-M 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
本発明は二酸化塩素配合眼科用剤用容器に関する。 The present invention relates to a container for ophthalmic preparations containing chlorine dioxide.
点眼剤をはじめとする眼科用剤には、防腐剤として塩化ベンザルコニウム、塩化ベンゼトニウム、グルコン酸クロルヘキシジン等のカチオン基含有化合物、クロロブタノール、ｐ−アミノ安息香酸エステル及びソルビン酸等が単独で又は組み合わされて配合されている。
これらの防腐剤の中でも、カチオン基含有化合物は防腐効果に優れるため点眼剤用防腐剤として汎用されてきた。しかしながら、カチオン基含有化合物は、コンタクトレンズ（特にソフトコンタクトレンズ）との親和性が高いので、当該化合物を配合した点眼剤をコンタクトレンズ装着状態で点眼適用すると、カチオン基含有化合物がコンタクトレンズへ吸着し蓄積されて、コンタクトレンズの変質や物理的変化が生じることがある。更に、カチオン基含有化合物が蓄積したコンタクトレンズの装用は、眼障害発生の危険性がある。
このような背景から、点眼適用時に光へ曝露されることによって光分解する二酸化塩素が、ソフトコンタクトレンズに影響を与えず且つ安全性が高い防腐剤として注目されている（例えば、特許文献１及び特許文献２参照）。
しかしながら、光曝露による二酸化塩素の分解は急速に進行するので、二酸化塩素を配合した眼科用剤を製造し及び流通させる際には、二酸化塩素の光分解を抑制する手段を講ずる必要がある。
かかる手段の一つとして、不透明な遮光性容器を使用することが考えられる。しかしながら、不透明遮光性容器を用いた場合、容器内における眼科用剤（特に一般用点眼剤）の残存量、汚染状態及び眼科用剤組成物の分解（用剤中の粒子、溶状、色調により検出される）等の視覚的判断（視覚的検査）をユーザーが行えないという問題がある。
かかる問題に対処すべく、光透過特性の異なる複数種類の樹脂を組み合わせることにより、波長４２０ｎｍ〜５００ｎｍの光のみを透過するように構成した眼科用剤用容器が開発されている（例えば、特許文献３参照）。
しかしながら、二酸化塩素の光分解抑制と眼科用剤の視覚的検査の容易性とを同時に高いレベルで提供するという点で満足のいくものではなかった。
For ophthalmic preparations including eye drops, cation group-containing compounds such as benzalkonium chloride, benzethonium chloride, chlorhexidine gluconate, chlorobutanol, p-aminobenzoic acid ester and sorbic acid, etc. alone or as preservatives Combined and formulated.
Among these preservatives, cationic group-containing compounds have been widely used as preservatives for eye drops because of their excellent antiseptic effects. However, cationic group-containing compounds have a high affinity with contact lenses (especially soft contact lenses), so when an eye drop containing the compound is applied to the contact lens in an eyedrop state, the cationic group-containing compound is adsorbed to the contact lens. Accumulated and accumulated, contact lens alteration and physical change may occur. Furthermore, wearing a contact lens in which a cationic group-containing compound has accumulated has a risk of causing eye damage.
From such a background, chlorine dioxide, which is photodegraded by exposure to light during eye drops application, has attracted attention as an antiseptic that does not affect soft contact lenses and has high safety (for example, Patent Document 1 and Patent Document 2).
However, since the decomposition of chlorine dioxide due to light exposure proceeds rapidly, it is necessary to take measures to suppress the photodecomposition of chlorine dioxide when producing and distributing ophthalmic preparations containing chlorine dioxide.
As one of such means, it is conceivable to use an opaque light-shielding container. However, when an opaque light-shielding container is used, the amount of ophthalmic agent (especially general eye drops) remaining in the container, contamination state, and decomposition of the ophthalmic agent composition (detected by particles, solution, and color tone in the agent) There is a problem that the user cannot make a visual judgment (visual inspection).
In order to cope with such a problem, an ophthalmic preparation container configured to transmit only light having a wavelength of 420 nm to 500 nm by combining a plurality of types of resins having different light transmission characteristics has been developed (for example, Patent Documents). 3).
However, it was not satisfactory in terms of providing a high level of suppression of chlorine dioxide photolysis and ease of visual inspection of ophthalmic agents at the same time.
したがって、本発明は、眼科用剤に配合した二酸化塩素の光分解を抑制しつつ、かつ、眼科用剤の容易な視覚的検査を可能ならしめる眼科用剤用容器を提供することを目的とする。 Therefore, an object of the present invention is to provide a container for an ophthalmic preparation that can suppress the photodecomposition of chlorine dioxide added to the ophthalmic preparation and enables easy visual inspection of the ophthalmic preparation. .
本発明者は上記目的を達成するため鋭意検討を行った結果、波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下であり、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上である有色透明な色材含有熱可塑性樹脂を眼科用剤用容器として用いると、当該容器内において二酸化塩素の光分解が有意に抑制されること、及び、当該容器が充填された眼科用剤の視覚的検査をしやすい色を呈することを見出した。本発明は、この知見に基づいてなされたものである。
すなわち、本発明は、二酸化塩素配合眼科用剤用の容器であって、波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下であり、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上である、有色透明な色材含有熱可塑性樹脂からなることを特徴とする容器に関するものである。
As a result of intensive studies to achieve the above object, the present inventor has a light transmittance of 10% or less at a wavelength of 200 nm to 500 nm and a light transmittance of 80% or more at a wavelength of 540 nm to 800 nm. When a colored transparent colorant-containing thermoplastic resin is used as an ophthalmic agent container, the photodecomposition of chlorine dioxide is significantly suppressed in the container, and the ophthalmic agent filled in the container is visually It was found that the color is easy to inspect. The present invention has been made based on this finding.
That is, the present invention is a container for a chlorine dioxide-containing ophthalmic agent, wherein the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less, and the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more. The present invention relates to a container comprising a colored transparent color material-containing thermoplastic resin.
本発明の眼科用剤用容器は、後述する実施例で示されるように、眼科用剤に配合された二酸化塩素の光分解を抑制して、その防腐効果を長期間発揮させることができる。更に、当該容器は、充填された眼科用剤を外部から視認しやすい色を呈するので、容器外部からの視覚的検査を容易ならしめることができる。したがって、本発明は二酸化塩素配合眼科用剤用の容器として好適に使用することができる。 The container for ophthalmic preparations of the present invention can suppress the photodecomposition of chlorine dioxide blended in the ophthalmic preparation and exhibit its antiseptic effect for a long period of time, as shown in the examples described later. Furthermore, since the container exhibits a color that allows the filled ophthalmic agent to be easily seen from the outside, visual inspection from the outside of the container can be facilitated. Therefore, the present invention can be suitably used as a container for a chlorine dioxide-containing ophthalmic agent.
以下、本発明について詳細に説明する。
本発明の眼科用剤用容器（以下、単に「容器」ともいう）は、波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下であり、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上であるという光透過特性を有する樹脂から構成される。
「波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下」とは、２００ｎｍ〜５００ｎｍの波長域における光透過率の平均値が１０％以下であることをいう。また、「波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下」には、２００ｎｍ〜５００ｎｍの全波長域において透過率が１０％以下である場合も含まれる。
「波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上」とは、５４０ｎｍ〜８００ｎｍの波長域における光透過率の平均値が８０％以上であることをいう。また、「波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上」には、５４０ｎｍ〜８００ｎｍの全波長域において透過率が８０％以上である場合も含まれる。
本発明の容器を構成する樹脂では、波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下、好ましくは５％以下、特に好ましくは２％以下である。波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下であると、眼科用剤に配合された二酸化塩素の光分解を有意に抑制することができる。
Hereinafter, the present invention will be described in detail.
The container for ophthalmic preparations of the present invention (hereinafter also simply referred to as “container”) has a light transmittance of 10% or less at a wavelength of 200 nm to 500 nm and a light transmittance of 80% at a wavelength of 540 nm to 800 nm. It is comprised from resin which has the light transmission characteristic that it is above.
“The transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less” means that the average value of the light transmittance in the wavelength region of 200 nm to 500 nm is 10% or less. Further, “the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less” includes a case where the transmittance is 10% or less in the entire wavelength region of 200 nm to 500 nm.
“The transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more” means that the average value of the light transmittance in the wavelength region of 540 nm to 800 nm is 80% or more. Further, “the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more” includes a case where the transmittance is 80% or more in the entire wavelength region of 540 nm to 800 nm.
In the resin constituting the container of the present invention, the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less, preferably 5% or less, particularly preferably 2% or less. When the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less, photodecomposition of chlorine dioxide blended in the ophthalmic agent can be significantly suppressed.
本発明の容器を構成する樹脂では、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上、好ましくは８２％以上、特に好ましくは８５％以上である。波長５４０ｎｍ〜８００ｎｍの光の透過率は８０％以上であると、前述の波長２００ｎｍ〜５００ｎｍの光のカットとの組み合わせにより、容器を充填された眼科用剤の視覚的検査をしやすい色とすることができる。
樹脂の透過率の測定方法は公知であり、例えば、ＪＩＳ Ｋ７１０５にしたがい測定することができる。
In the resin constituting the container of the present invention, the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more, preferably 82% or more, particularly preferably 85% or more. When the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more, a combination with the aforementioned cut of light having a wavelength of 200 nm to 500 nm makes the color easy for visual inspection of the ophthalmic agent filled in the container. be able to.
A method for measuring the transmittance of the resin is known, and for example, it can be measured according to JIS K7105.
本発明の容器を構成する樹脂としては、公知であり市場において容易に入手可能な熱可塑性樹脂を使用することができる。具体的には、ポリエチレンテレフタレート（ＰＥＴ）、ポリプロピレン（ＰＰ）及びポリエチレン（ＰＥ）等が挙げられる。これらの樹脂の中では、透明性に優れ、容器内の眼科用剤の視覚的検査を容易ならしめるＰＥＴが特に好ましい。
これらの樹脂には、本発明の容器を構成する樹脂に要求される光透過特性（波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上）に影響を与えない添加量範囲で、公知の紫外線吸収剤、着色剤（１種類単独でもよく、２種類以上の組み合わせでもよい）等を配合してもよい。
As the resin constituting the container of the present invention, a thermoplastic resin that is publicly known and easily available on the market can be used. Specific examples include polyethylene terephthalate (PET), polypropylene (PP), and polyethylene (PE). Among these resins, PET is particularly preferable because it is excellent in transparency and facilitates visual inspection of ophthalmic agents in the container.
These resins include light transmission characteristics required for the resin constituting the container of the present invention (the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less, and the transmittance of light having a wavelength of 540 nm to 800 nm is 80%. In the addition amount range that does not affect the above), known ultraviolet absorbers, colorants (one kind alone or two or more kinds in combination) may be blended.
本発明の容器を構成する樹脂に要求される光透過特性（波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上）は、前述の樹脂へ色材を配合することにより達成することができる。
「色材」とは、前述の光透過特性を樹脂へ付与することができる物質をいう。具体例としては顔料及び染料が挙げられる。
顔料としては、イソインドリノン系、アンスラキノン系、縮合アゾ系、モノアゾ系、ジスアゾ系の有機顔料等が挙げられる。具体的には、アンスラキノン系の有機顔料であるPigment Yellow 147が挙げられる。
染料としては、複素環系、チオインジコ系、アンスラキノン系、ペリノン系の染料等が挙げられる。具体的には、ペリノン系の染料であるSolvent Red 180が挙げられる。
これらの色材は、単独で又は２種以上の組み合わせ（例：２種以上の顔料の組み合わせ、２種以上の染料の組み合わせ、顔料と染料との組み合わせ）で使用することができる。 本発明では、Solvent Red 180（染料）とPigment Yellow 147（顔料）との組み合わせを好適に使用することができる。
前記の色材はいずれも公知物質であり、市場において容易に入手することができる。
色材の樹脂への配合量は、容器に要求される光透過特性を達成できる量であれば特に制限されない。例えば、樹脂としてＰＥＴを用い、色材として顔料と染料との組み合わせを用いる場合、色材の配合量は０．０１％〜１．５％、好ましくは０．０１〜１．０％、特に好ましくは０．０１〜０．５％である。
本発明の容器を構成する樹脂は、前述の色材の配合により所定の光透過特性（波長２００ｎｍ〜５００ｎｍの光の透過率が１０％以下、かつ、波長５４０ｎｍ〜８００ｎｍの光の透過率が８０％以上）を有するので、有色かつ透明である。
The light transmission characteristics required for the resin constituting the container of the present invention (the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less and the transmittance of light having a wavelength of 540 nm to 800 nm is 80% or more) This can be achieved by blending a coloring material with the resin.
“Coloring material” refers to a substance capable of imparting the above light transmission characteristics to a resin. Specific examples include pigments and dyes.
Examples of the pigment include isoindolinone-based, anthraquinone-based, condensed azo-based, monoazo-based, and disazo-based organic pigments. Specific examples include Pigment Yellow 147, which is an anthraquinone organic pigment.
Examples of the dye include heterocyclic, thioindico, anthraquinone, and perinone dyes. Specific examples include Solvent Red 180, which is a perinone-based dye.
These coloring materials can be used alone or in combination of two or more (eg, a combination of two or more pigments, a combination of two or more dyes, a combination of pigments and dyes). In the present invention, a combination of Solvent Red 180 (dye) and Pigment Yellow 147 (pigment) can be suitably used.
Any of the above-mentioned coloring materials is a known substance and can be easily obtained in the market.
The blending amount of the color material into the resin is not particularly limited as long as it can achieve the light transmission characteristics required for the container. For example, when PET is used as the resin and a combination of a pigment and a dye is used as the color material, the amount of the color material is 0.01% to 1.5%, preferably 0.01 to 1.0%, particularly preferably Is 0.01 to 0.5%.
The resin constituting the container of the present invention has a predetermined light transmission characteristic (the transmittance of light having a wavelength of 200 nm to 500 nm is 10% or less and the transmittance of light having a wavelength of 540 nm to 800 nm is 80% by mixing the above-described coloring material. % Or more), it is colored and transparent.
本発明の容器は、公知の着色樹脂容器の製造法を用いて製造することができる。
例えば、以下の工程：
（１）色材を樹脂へ配合する工程；及び
（２）着色樹脂を眼科用剤用容器へと成形する工程
を含む方法により製造することができる。
本発明の容器の形状は、眼科用剤の保存及び投与に適する任意の形状、例えばボトル形状や平面状の側壁を有するボトル形状等にすることができる。
また、本発明の容器には、充填される眼科用剤を封止するための封止手段（例えば、キャップ）を適宜設けることができる。
The container of this invention can be manufactured using the manufacturing method of a well-known colored resin container.
For example, the following steps:
(1) It can be manufactured by a method including a step of blending a coloring material into a resin; and (2) a step of molding a colored resin into a container for an ophthalmic preparation.
The shape of the container of the present invention can be any shape suitable for storage and administration of an ophthalmic agent, for example, a bottle shape or a bottle shape having a planar side wall.
Moreover, the container of this invention can be appropriately provided with a sealing means (for example, a cap) for sealing the ophthalmic agent to be filled.
本発明の容器を適用する眼科用剤は、必須の防腐剤成分として光分解性の二酸化塩素が配合されている。
二酸化塩素としては、二酸化塩素（例えば、Ocupure（登録商標）として販売されているもの）、安定化した二酸化塩素（例えば、Purite（登録商標）、Purogene（登録商標）として販売されているもの）、亜塩素酸ナトリウム、水成二酸化塩素等が挙げられる。
これらの二酸化塩素は公知化合物であり、市場において容易に入手可能である。
尚、眼科用剤は、前記の二酸化塩素を単独で、又は２種以上を組み合わせて含んでいてもよい。
二酸化塩素の眼科用剤への配合量は、防腐効果を発揮しつつ、かつ、使用者への悪影響を及ぼさない量であれば特に制限されない。例えば、眼科用剤が点眼剤の場合、通常、点眼剤全体の０．０００１〜０．１％（ｗ／ｖ）（重量／容量％）であり、好ましくは０．００１〜０．０２％（ｗ／ｖ）である。０．０００１％（ｗ／ｖ）以上であると二酸化塩素が防腐作用を十分発揮することができ、０．１％（ｗ／ｖ）以下であると点眼適用時の眼刺激を起こすことなく、良好な使用感を維持することができる。
眼科用剤は、使用目的に応じて必要とされる種々の成分をその通常の使用量において配合することができる。例えば、抗炎症剤、ビタミン剤、抗ヒスタミン剤等の有効成分及びｐＨ調節剤、緩衝剤、等張化剤、可溶化剤、保存剤等の添加剤を配合することができる。
眼科用剤の剤型としては、目薬（点眼剤）、洗眼剤及びコンタクトレンズ用装着液等が挙げられる。本発明の容器によって光分解が抑制される二酸化塩素は、コンタクトレンズ（特に、ソフトコンタクトレンズ）用剤の防腐剤として好適に用いられる。したがって、眼科用剤の用途としては、コンタクトレンズ用目薬及びコンタクトレンズ用装着液が好ましく、特にソフトコンタクトレンズ用目薬及びソフトコンタクトレンズ用装着液が好ましい。
The ophthalmic agent to which the container of the present invention is applied contains photodegradable chlorine dioxide as an essential preservative component.
As chlorine dioxide, chlorine dioxide (for example, sold as Ocupure (registered trademark)), stabilized chlorine dioxide (for example, sold as Purite (registered trademark), Purogene (registered trademark)), Examples include sodium chlorite and aqueous chlorine dioxide.
These chlorine dioxides are known compounds and are readily available on the market.
The ophthalmic agent may contain the above-mentioned chlorine dioxide alone or in combination of two or more.
The amount of chlorine dioxide added to the ophthalmic agent is not particularly limited as long as it exhibits an antiseptic effect and does not adversely affect the user. For example, when the ophthalmic preparation is an eye drop, it is usually 0.0001 to 0.1% (w / v) (weight / volume%) of the whole eye drop, preferably 0.001 to 0.02% ( w / v). If it is 0.0001% (w / v) or more, chlorine dioxide can sufficiently exert an antiseptic action, and if it is 0.1% (w / v) or less, without causing eye irritation at the time of ophthalmic application, Good usability can be maintained.
In the ophthalmic preparation, various components required for the purpose of use can be blended in the usual use amount. For example, active ingredients such as anti-inflammatory agents, vitamin agents and antihistamines and additives such as pH adjusters, buffers, isotonic agents, solubilizers, preservatives and the like can be blended.
Examples of the dosage form of the ophthalmic agent include eye drops (eye drops), eye wash, contact lens mounting liquid, and the like. Chlorine dioxide whose photodegradation is suppressed by the container of the present invention is suitably used as a preservative for contact lens (particularly soft contact lens) agents. Therefore, for the use of the ophthalmic agent, eye drops for contact lenses and mounting solutions for contact lenses are preferable, and eye drops for soft contact lenses and mounting solutions for soft contact lenses are particularly preferable.
次に、実施例を挙げて本発明を更に詳細に説明するが、本発明はこれによって限定されるものではない。 EXAMPLES Next, although an Example is given and this invention is demonstrated further in detail, this invention is not limited by this.
実施例１
色材としてのSolvent Red 180（市販品）及びPigment Yellow 147（市販品）を、樹脂としてのポリエチレンテレフタレート（市販品）へ公知の配合手段を用いて配合した。各色材の樹脂への配合量は、Solvent Red 180が0.00025％（ｗ/ｗ）であり、Pigment Yellow 147が0.22％（ｗ/ｗ）であった。得られた樹脂を公知のブロー成形手段により成形して、平面状の側壁を有するボトル形状の容器（容量１５ｍｌ）を製造した。
Example 1
Solvent Red 180 (commercial product) as a coloring material and Pigment Yellow 147 (commercial product) were blended into polyethylene terephthalate (commercial product) as a resin using a known blending means. The blending amount of each color material into the resin was 0.00025% (w / w) for Solvent Red 180 and 0.22% (w / w) for Pigment Yellow 147. The obtained resin was molded by a known blow molding means to produce a bottle-shaped container (capacity 15 ml) having a planar side wall.
比較例１
色材を配合しなかったことを除いて、実施例１と同様の工程により容器を製造した。
Comparative Example 1
A container was produced by the same process as in Example 1 except that no colorant was blended.
比較例２
色材の代わりにベンゾトリアゾール系紫外線吸収剤（商品名：バイオソーブ550）０．１％（ｗ/ｗ）を樹脂へ配合したことを除いて、実施例１と同様の工程により容器を製造した。
Comparative Example 2
A container was produced in the same manner as in Example 1 except that 0.1% (w / w) of a benzotriazole ultraviolet absorber (trade name: Biosorb 550) was blended in the resin instead of the color material.
実施例及び比較例の容器の光透過特性
実施例及び比較例の容器の光透過特性を、ＪＩＳ Ｋ７１０５に準じて測定した。結果を表１に示す。更に表１の結果を図示したものを図１に示す。
表１
Light Transmission Characteristics of Containers of Examples and Comparative Examples The light transmission characteristics of the containers of Examples and Comparative Examples were measured according to JIS K7105. The results are shown in Table 1. Further, the results of Table 1 are shown in FIG.
Table 1
眼科用剤へ配合した二酸化塩素の光分解抑制
本試験例では、眼科用剤へ配合した二酸化塩素の光分解に対する容器の影響を評価した。試験には、二酸化塩素（Purite（登録商標））を亜塩素酸ナトリウムとして０．００５％（ｗ／ｖ）、ポリビニルアルコール（ＰＶＡ）を１．４％（ｗ/ｖ）並びに添加物としてのエデト酸ナトリウム（EDTA）及び塩化ナトリウム含有燐酸緩衝液を含む二酸化塩素配合眼科用剤を調製して使用した。次いで、実施例１及び比較例１〜２の各容器へ、眼科用剤をそれぞれ12ｍｌ充填した。
得られた眼科用剤充填容器を、ICH（日米ＥＵ医薬品規制調和国際会議）の「新原薬及び新製剤の光安定性ガイドライン」に準じて12万ルクスでの10時間照射を１サイクルとする光照射を合計で６サイクル行い、照射開始時、照射３サイクル後及び照射６サイクル後に眼科用剤中の二酸化塩素濃度を測定した。二酸化塩素濃度の測定は滴定法を用いて行った。結果を表２に示す。
表２．各容器中における二酸化塩素濃度（ｐｐｍ）
色材を全く添加しなかった比較例１の容器では、二酸化塩素の光分解が激しく起こり、照射６サイクル後の残存率が６７％まで低下した。
紫外線吸収剤を添加した比較例２の容器でも、二酸化塩素の光分解が起こり、照射６サイクル後の残存率が８４％まで低下した。
一方、実施例１の容器では、二酸化塩素の光分解がほとんど起こらず、照射６サイクル後であっても、暗所保管（９９％）と同程度の残存率（９８％）であった。
以上より、本発明の容器は、眼科用剤に配合された二酸化塩素の光分解を抑制し、その防腐効果を長期間発揮させることができることが理解される。
In this test example, the influence of the container on the photodegradation of chlorine dioxide blended in an ophthalmic agent was evaluated. The tests included 0.005% (w / v) chlorine dioxide (Purite®) as sodium chlorite, 1.4% (w / v) polyvinyl alcohol (PVA) and edet as an additive. A chlorine dioxide-containing ophthalmic preparation containing sodium phosphate (EDTA) and sodium chloride-containing phosphate buffer was prepared and used. Subsequently, each container of Example 1 and Comparative Examples 1-2 was filled with 12 ml of ophthalmic agents.
The obtained ophthalmic preparation-filled container is set to 1 cycle of irradiation for 1 hour at 120,000 lux in accordance with ICH (Japan-US EU Pharmaceutical Regulation Harmonization International Conference) Light irradiation was performed for a total of 6 cycles, and the chlorine dioxide concentration in the ophthalmic preparation was measured at the start of irradiation, after 3 cycles of irradiation, and after 6 cycles of irradiation. The chlorine dioxide concentration was measured using a titration method. The results are shown in Table 2.
Table 2. Chlorine dioxide concentration (ppm) in each container
In the container of Comparative Example 1 in which no coloring material was added, chlorine dioxide photodegradation occurred vigorously, and the residual ratio after 6 cycles of irradiation decreased to 67%.
Even in the container of Comparative Example 2 to which the ultraviolet absorber was added, chlorine dioxide photolysis occurred, and the residual ratio after 6 cycles of irradiation decreased to 84%.
On the other hand, in the container of Example 1, photodegradation of chlorine dioxide hardly occurred, and even after 6 cycles of irradiation, the residual rate (98%) was similar to that in dark storage (99%).
From the above, it is understood that the container of the present invention can suppress photodecomposition of chlorine dioxide blended in an ophthalmic agent and exert its antiseptic effect for a long period of time.
視覚的検査の容易性
実施例１及び比較例１〜２の容器へ前述の眼科用剤を充填することによって得た眼科用剤充填容器について、用剤中の異物を検出する方法としてＳＤ方式を採用する全自動検査装置（エーザイマシナリー社製ＡＩＭ）を用いて、容器充填状態の眼科用剤の視覚的検査の容易性を評価した。
実施例１の容器はアンバー色（琥珀色）かつ透明であった。この場合、容器外から容器内の眼科用剤の液量、異物の確認が可能であった。
比較例１の容器は無色透明であった。この場合、容器外から容器内の眼科用剤の液量、異物の確認が可能であった。
比較例２の容器は無色透明であった。この場合、容器外から容器内の眼科用剤の液量、異物の確認が可能であった。
以上より、実施例１の容器は、無色透明の比較例１及び２の容器と同様に、充填された眼科用剤の視覚的検査を容易に行うことができることが理解される。
Ease of visual inspection For the ophthalmic agent-filled container obtained by filling the containers of Example 1 and Comparative Examples 1 and 2 with the aforementioned ophthalmic agent, the SD method is used as a method for detecting foreign matter in the agent. The ease of visual inspection of an ophthalmic agent in a container-filled state was evaluated using a fully automatic inspection apparatus (AIM manufactured by Eisai Machinery Co., Ltd.).
The container of Example 1 was amber (dark blue) and transparent. In this case, it was possible to check the amount of the ophthalmic agent in the container and the foreign matter from outside the container.
The container of Comparative Example 1 was colorless and transparent. In this case, it was possible to check the amount of the ophthalmic agent in the container and the foreign matter from outside the container.
The container of Comparative Example 2 was colorless and transparent. In this case, it was possible to check the amount of the ophthalmic agent in the container and the foreign matter from outside the container.
From the above, it can be understood that the container of Example 1 can easily perform a visual inspection of the filled ophthalmic agent similarly to the colorless and transparent containers of Comparative Examples 1 and 2.
本発明の容器は、二酸化塩素配合眼科用剤用の容器として利用可能である。 The container of the present invention can be used as a container for an ophthalmic preparation containing chlorine dioxide.
Claims (7)
熱可塑性樹脂がポリエチレンテレフタレートであり、かつ、
色材がSolvent Red 180及びPigment Yellow 147である、請求項１記載の容器。 The transmittance of light having a wavelength of 200 nm to 500 nm is 2% or less, and the transmittance of light having a wavelength of 540 nm to 800 nm is 85% or more,
The thermoplastic resin is polyethylene terephthalate, and
The container according to claim 1, wherein the coloring materials are Solvent Red 180 and Pigment Yellow 147.
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| JP2005248017A JP2007061192A (en) | 2005-08-29 | 2005-08-29 | Vessel for ophthalmic medicine blended with chlorine dioxide |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5768338A (en) * | 1980-10-09 | 1982-04-26 | Teijin Ltd | Colored polyester vessel |
| JPH03109486U (en) * | 1990-02-23 | 1991-11-11 | ||
| JPH10114374A (en) * | 1996-08-19 | 1998-05-06 | Daikyo Seiko:Kk | Hygiene container |
| JP2003327279A (en) * | 2002-05-07 | 2003-11-19 | Allergan Inc | Container for conserving and identifying product |
-
2005
- 2005-08-29 JP JP2005248017A patent/JP2007061192A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5768338A (en) * | 1980-10-09 | 1982-04-26 | Teijin Ltd | Colored polyester vessel |
| JPH03109486U (en) * | 1990-02-23 | 1991-11-11 | ||
| JPH10114374A (en) * | 1996-08-19 | 1998-05-06 | Daikyo Seiko:Kk | Hygiene container |
| JP2003327279A (en) * | 2002-05-07 | 2003-11-19 | Allergan Inc | Container for conserving and identifying product |
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