JP4498480B2 - Nasal formulation - Google Patents

Nasal formulation Download PDF

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Publication number
JP4498480B2
JP4498480B2 JP36219197A JP36219197A JP4498480B2 JP 4498480 B2 JP4498480 B2 JP 4498480B2 JP 36219197 A JP36219197 A JP 36219197A JP 36219197 A JP36219197 A JP 36219197A JP 4498480 B2 JP4498480 B2 JP 4498480B2
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JP
Japan
Prior art keywords
resin
spray
fluororesin
wall surface
container
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
JP36219197A
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Japanese (ja)
Other versions
JPH11171762A (en
Inventor
光司 土井
久幸 中山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Senju Pharmaceutical Co Ltd
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Senju Pharmaceutical Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
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Priority to JP36219197A priority Critical patent/JP4498480B2/en
Publication of JPH11171762A publication Critical patent/JPH11171762A/en
Application granted granted Critical
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Anticipated expiration legal-status Critical
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Description

【0001】
【発明の属する技術分野】
本発明は特定の容器に充填された点鼻用製剤に関する。
【0002】
【従来の技術】
鼻みず、鼻づまり等の鼻炎症状の緩解のために、従来抗ヒスタミン剤、殺菌剤、血管収縮剤などに加えて、メントール等のテルペノイドを清涼剤として配合した点鼻液が用いられ、それはポリエチレン又はポリプロピレン製の手動加圧式スプレー容器に充填して市販されている。
【0003】
【発明が解決しようとする課題】
本発明者らの研究の結果、テルペノイドを配合した点鼻薬をポリエチレンやポリプロピレン製のスプレー容器に充填するとテルペノイドが保存中に容器材料に吸収浸透、揮散してその含有量を長期間保持できないことが判った。
本発明はスプレー容器に充填したテルペノイド含有点鼻用製剤からテルペノイドの吸収浸透及び揮散を抑制して長期間の保存を可能にしようとするものである。
【0004】
【課題を解決するための手段】
本発明は、テルペノイド含有点鼻剤を、薬剤充填時に薬剤に接する内壁面の材料がエポキシ樹脂、ポリアミドイミド樹脂又はフッ素樹脂であるスプレー容器に充填してなる点鼻用製剤である。
【0005】
【実施の態様】
テルペノイドにはモノテルペン、セスキテルペン、ジテルペンが包含され、その例としては、メントール、ボルネオール、カンフル、ゲラニオール、シネオール、アネトール、リモネン、オイゲノール、ユーカリ油、ファルネソール、ネロリドール、フィトール又はセンブレンなどが挙げられる。好ましいのはメントール、ボルネオール、カンフル、ユーカリ油などである。
【0006】
テルペノイドは点鼻剤中に、必要に応じて選択される他の成分、例えば血管収縮剤、抗ヒスタミン剤、殺菌剤、消炎剤、局所麻酔剤、抗アレルギー剤、収斂剤などと共に配合することができる。
【0007】
本発明において、スプレー容器の充填薬剤に接する内壁面を形成する材料であるエポキシ樹脂としては、例えばエポキシフェノール樹脂が挙げられ、フッ素樹脂としては、例えばフッ化ビニリデン樹脂が挙げられる。
スプレー容器における充填薬剤に接する内壁面をこれらの樹脂で形成するには薬剤充填部自体をこれらの樹脂で作製してもよく、またこれらの樹脂で内壁面を塗装して樹脂の被膜として形成させてもよい。これらの樹脂面は充填された点鼻剤中のテルペノイドの吸収、揮散を妨げ、その含有量低下を抑制することができる。
【0008】
スプレー容器は手動噴射式又は自動噴射式スプレー容器を包含する。自動噴射式の場合はフロンやLPGのような液化ガスの代りに圧縮空気などの圧縮ガスを用いることもできる。
【0009】
【実施例】
以下に実施例の形で本発明をさらに説明する。
【0010】
実施例
試験液(点鼻薬)
〔処方〕

Figure 0004498480
【0011】
〔試験方法〕
ポリエチレン製及びポリプロピレン製の各容器(容量 5.5ml)にそれぞれ試験液 5mlを入れて気密にし、また、内壁面に内面コート剤のエポキシフェノール、ポリアミドイミド又はフッ化ビニリデン樹脂を塗布した各アルミ缶容器(容量15ml)にそれぞれ試験液14mlと圧縮空気(6.5Kg/cm2 )を入れて気密にし、室温で静置、保存した。4週間経過後、各試験液中のl−メントール及びユーカリ油の残存量をガスクロマトグラフィーにより測定した。
結果は下表のとおりである。
【0012】
〔試験結果〕
残存率(単位:%)
Figure 0004498480
【0013】
表から明かなように、ポリエチレン製の容器では、l−メントール及びユーカリ油が残存せず、ポリプロピレン製容器では残存率がそれぞれ僅かに15.6%及び16.5%である。一方、エポキシフェノール、ポリアミドイミド又はフッ化ビニリデン樹脂を内壁面に塗布した容器では残存率がそれぞれ65.2〜67.1%及び76.3〜78.9%を示した。この結果からエポキシフェノール、ポリアミドイミド、及びフッ化ビニリデン樹脂で内壁面が形成された容器には充填された薬剤中のテルペノイドの減少を顕著に抑制することが判る。
【0014】
【発明の効果】
本発明によれば、スプレー容器に充填されたテルペノイド含有点鼻剤中のテルペノイドが保存中に減少するのを抑制することができる。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a nasal preparation filled in a specific container.
[0002]
[Prior art]
In order to relieve nasal inflammation such as nasal congestion and nasal congestion, nasal drops containing terpenoids such as menthol as a refreshing agent in addition to antihistamines, bactericides, vasoconstrictors, etc. are used. Commercially available manually pressurized spray containers filled.
[0003]
[Problems to be solved by the invention]
As a result of our research, when nasal drops containing terpenoids are filled in a spray container made of polyethylene or polypropylene, the terpenoids cannot absorb and permeate into the container material during storage and keep its content for a long time. understood.
The present invention is intended to enable long-term storage by suppressing absorption penetration and volatilization of terpenoids from a terpenoid-containing nasal preparation filled in a spray container.
[0004]
[Means for Solving the Problems]
The present invention is a nasal preparation prepared by filling a terpenoid-containing nasal drop into a spray container in which the material of the inner wall surface that comes into contact with the drug at the time of drug filling is an epoxy resin, a polyamideimide resin, or a fluororesin.
[0005]
Embodiment
Terpenoids include monoterpenes, sesquiterpenes, diterpenes, examples of which include menthol, borneol, camphor, geraniol, cineol, anethole, limonene, eugenol, eucalyptus oil, farnesol, nerolidol, phytol or semblene. . Preference is given to menthol, borneol, camphor, eucalyptus oil and the like.
[0006]
Terpenoids can be blended in nasal drops with other components selected as necessary, for example, vasoconstrictors, antihistamines, bactericides, anti-inflammatory agents, local anesthetics, antiallergic agents, astringents and the like.
[0007]
In the present invention, examples of the epoxy resin that is a material forming the inner wall surface in contact with the filling agent of the spray container include an epoxy phenol resin, and examples of the fluororesin include a vinylidene fluoride resin.
In order to form the inner wall surface in contact with the filling drug in the spray container with these resins, the drug filling part itself may be made of these resins, or the inner wall surface may be painted with these resins to form a resin film. May be. These resin surfaces prevent absorption and volatilization of terpenoids in the filled nasal drops, and can suppress a decrease in the content thereof.
[0008]
Spray containers include manual spray or automatic spray spray containers. In the case of the automatic injection type, a compressed gas such as compressed air can be used instead of a liquefied gas such as Freon or LPG.
[0009]
【Example】
The invention is further described below in the form of examples.
[0010]
Example test solution (nasal drops)
[Prescription]
Figure 0004498480
[0011]
〔Test method〕
Each aluminum can container in which 5 ml of the test solution is put in a polyethylene container and a polypropylene container (capacity 5.5 ml), respectively, and the inner wall surface is coated with epoxyphenol, polyamideimide, or vinylidene fluoride resin. The test solution (14 ml) and compressed air (6.5 Kg / cm 2 ) were put in each (volume 15 ml) to make it airtight, and allowed to stand and stored at room temperature. After 4 weeks, the residual amounts of l-menthol and eucalyptus oil in each test solution were measured by gas chromatography.
The results are shown in the table below.
[0012]
〔Test results〕
Residual rate (unit:%)
Figure 0004498480
[0013]
As is apparent from the table, in the polyethylene container, 1-menthol and eucalyptus oil do not remain, and in the polypropylene container, the residual ratios are only 15.6% and 16.5%, respectively. On the other hand, in the container in which epoxyphenol, polyamideimide or vinylidene fluoride resin was applied to the inner wall surface, the residual ratios were 65.2 to 67.1% and 76.3 to 78.9%, respectively. From this result, it can be seen that the reduction of terpenoids in the drug filled in the container having the inner wall surface formed of epoxyphenol, polyamideimide, and vinylidene fluoride resin is remarkably suppressed.
[0014]
【The invention's effect】
ADVANTAGE OF THE INVENTION According to this invention, it can suppress that the terpenoid in the terpenoid containing nasal drop filled with the spray container reduces during a preservation | save.

Claims (6)

充填される薬剤が容器に接する内壁面をエポキシ樹脂、ポリアミドイミド樹脂又はフッ素樹脂で形成したスプレー容器にテルぺノイドを含有する鼻炎用点鼻剤を充填することを特徴とするスプレー剤保存中のテルペノイドの含量低下抑制方法。Epoxy resin inner wall surface of the agent to be filled is in contact with the container, the polyamide-imide resin, or a fluorine rhinitis point containing terpenoid in a spray container formed of resin nasal sprays agents during storage, characterized in that filling the A method for suppressing a decrease in terpenoid content. 内壁面がエポキシ樹脂、ポリアミドイミド樹脂又はフッ素樹脂の塗膜である請求項1記載の抑制方法。2. The suppressing method according to claim 1, wherein the inner wall surface is a coating film of an epoxy resin, a polyamideimide resin or a fluororesin. エポキシ樹脂がエポキシフェノール樹脂であり、フッ素樹脂がフッ化ビニリデン樹脂である請求項1記載の抑制方法。2. The suppression method according to claim 1, wherein the epoxy resin is an epoxy phenol resin and the fluororesin is a vinylidene fluoride resin. 充填される薬剤が容器に接する内壁面をエポキシ樹脂、ポリアミドイミド樹脂又はフッ素樹脂で形成したスプレー容器にテルペノイドを含有する点鼻用剤を充填することを特徴とする保存中のテルぺノイド含量低下の抑制されたスプレー剤の製造法。Reduced terpenoid content during storage, characterized by filling nasal drops containing terpenoids into spray containers with epoxy resin, polyamide- imide resin, or fluororesin formed on the inner wall surface where the drug to be filled comes into contact with the container Of controlled spray preparation. 内壁面がエポキシ樹脂、ポリアミドイミド樹脂又はフッ素樹脂の塗膜である請求項4記載のスプレー剤の製造法。5. The method for producing a spray according to claim 4, wherein the inner wall surface is a coating film of epoxy resin, polyamideimide resin or fluororesin. エポキシ樹脂がエポキシフェノール樹脂であり、フッ素樹脂がフッ化ビニリデン樹脂である請求項4又は5記載のスプレー剤の製造法。6. The method for producing a spray according to claim 4, wherein the epoxy resin is an epoxy phenol resin and the fluororesin is a vinylidene fluoride resin.
JP36219197A 1997-12-10 1997-12-10 Nasal formulation Expired - Lifetime JP4498480B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP36219197A JP4498480B2 (en) 1997-12-10 1997-12-10 Nasal formulation

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Application Number Priority Date Filing Date Title
JP36219197A JP4498480B2 (en) 1997-12-10 1997-12-10 Nasal formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2007189146A Division JP2007262100A (en) 2007-07-20 2007-07-20 Method for preventing reduction in content of terpenoid

Publications (2)

Publication Number Publication Date
JPH11171762A JPH11171762A (en) 1999-06-29
JP4498480B2 true JP4498480B2 (en) 2010-07-07

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001354549A (en) * 2000-06-08 2001-12-25 Koike Kagaku Kk Aerosol product for washing nasal cavity
TW523409B (en) * 2000-09-15 2003-03-11 Baxter Int Container for inhalation anesthetic

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