JP2021113221A - Pharmaceutical preparation containing loxoprofen - Google Patents
Pharmaceutical preparation containing loxoprofen Download PDFInfo
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- JP2021113221A JP2021113221A JP2021074047A JP2021074047A JP2021113221A JP 2021113221 A JP2021113221 A JP 2021113221A JP 2021074047 A JP2021074047 A JP 2021074047A JP 2021074047 A JP2021074047 A JP 2021074047A JP 2021113221 A JP2021113221 A JP 2021113221A
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- 229960002373 loxoprofen Drugs 0.000 title claims abstract description 45
- 239000000825 pharmaceutical preparation Substances 0.000 title description 50
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 title description 2
- 239000000203 mixture Substances 0.000 claims abstract description 82
- 239000007788 liquid Substances 0.000 claims abstract description 61
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 claims abstract description 44
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Abstract
Description
本発明は、ロキソニン(登録商標)の有効成分としても知られるロキソプロフェンを含有する医薬製剤等に関する。 The present invention relates to a pharmaceutical preparation containing loxoprofen, which is also known as an active ingredient of loxonin (registered trademark).
ロキソプロフェンは、フェニルプロピオン酸系の非ステロイド性消炎鎮痛剤(NSAID)の一種であり(非特許文献1)、優れた消炎鎮痛効果を発揮する。
そのため、外用消炎鎮痛剤の有効成分として広く利用されており、これまでに変形性関節症、筋肉痛、外傷後の腫脹・疼痛等の疾患並びに症状の消炎・鎮痛等を効能効果とする外用貼付剤(パップ剤、テープ剤等)や外用塗布剤(ゲル剤等)が開発・上市されている(非特許文献2)。
Loxoprofen is a type of phenylpropionic acid-based non-steroidal anti-inflammatory drug (NSAID) (Non-Patent Document 1), and exhibits an excellent anti-inflammatory analgesic effect.
Therefore, it is widely used as an active ingredient of topical anti-inflammatory analgesics, and has been applied externally for the purpose of anti-inflammatory / analgesic of diseases such as osteoarthritis, muscle pain, post-traumatic swelling / pain, and symptoms. Agents (popping agents, tape agents, etc.) and external coating agents (gel agents, etc.) have been developed and put on the market (Non-Patent Document 2).
ところで、トウガラシ、ノナン酸バニリルアミド(ノニル酸ワニリルアミド)等のトウガラシ又はその抽出物は外用消炎鎮痛剤等に配合されており、ロキソプロフェンと共に配合された外用剤も既に知られている(例えば、特許文献1、2)。 By the way, peppers such as capsicum and vanillylamide nonanoic acid (vanillylamide nonylate) or their extracts are blended in external anti-inflammatory analgesics and the like, and external preparations blended with loxoprofen are already known (for example, Patent Document 1). 2, 2).
ロキソプロフェンを外用剤の有効成分として利用する場合、ローション剤、ゲル剤やクリーム剤等の外用塗布剤のように、液状あるいは半固形状の組成物として患部に塗布等することにより使用するのが、患部の位置、形状や範囲に応じて柔軟に必要な量だけ投与する観点から好ましい。また、ロキソプロフェンを液状又は半固形状の組成物に安定的に配合する技術が確立できれば、外用剤のみならず内服薬(経口液剤等)への応用も可能となる。
そこで本発明者が、ロキソプロフェンを液状又は半固形状の組成物に安定的に配合する技術を確立するため、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物を調製し保存安定性を評価したところ、意外にも、高温条件下での保存により経時的に変色が生じ得ることが判明した。
When loxoprofen is used as an active ingredient of an external preparation, it is used by applying it to the affected area as a liquid or semi-solid composition like an external coating such as a lotion, a gel or a cream. It is preferable from the viewpoint of flexibly administering the required amount according to the position, shape and range of the affected area. Further, if a technique for stably blending loxoprofen into a liquid or semi-solid composition can be established, it can be applied not only to external preparations but also to internal medicines (oral liquid preparations, etc.).
Therefore, in order to establish a technique for stably blending loxoprofen into a liquid or semi-solid composition, the present inventor prepares a liquid or semi-solid composition containing loxoprofen or a salt thereof to improve storage stability. As a result of evaluation, it was surprisingly found that discoloration may occur over time when stored under high temperature conditions.
従って、本発明の課題は、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物の、高温保存時における変色を抑制する手段を提供することである。 Therefore, an object of the present invention is to provide a means for suppressing discoloration of a liquid or semi-solid composition containing loxoprofen or a salt thereof at high temperature storage.
そこで本発明者は、この課題を解決すべくさらに検討したところ、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物に、さらにトウガラシ軟エキス、ノナン酸バニリルアミドに代表されるトウガラシ又はその抽出物を含有せしめ、かつ、ポリエチレンに代表されるポリオレフィン系樹脂製の容器に収容することにより、高温保存時の変色を抑制できることを見出し、本発明を完成した。 Therefore, the present inventor further investigated to solve this problem, and found that a liquid or semi-solid composition containing loxoprofene or a salt thereof was further combined with a soft and chili pepper extract, a capsicum represented by nonanoic acid vanillylamide, or an extraction thereof. The present invention has been completed by finding that discoloration during high-temperature storage can be suppressed by containing a substance and storing it in a container made of a polyolefin resin typified by polyethylene.
すなわち、本発明は、次の成分(A)及び(B):
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物が、ポリオレフィン系樹脂製容器に収容されてなる、医薬製剤を提供するものである。
また、本発明は、次の成分(A)及び(B):
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物を、ポリオレフィン系樹脂製容器に収容する工程を含む、組成物の変色の抑制方法を提供するものである。
That is, the present invention describes the following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
The liquid or semi-solid composition containing the above is contained in a polyolefin-based resin container to provide a pharmaceutical preparation.
Further, in the present invention, the following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
The present invention provides a method for suppressing discoloration of a composition, which comprises a step of accommodating a liquid or semi-solid composition containing the above in a polyolefin-based resin container.
本発明によれば、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物の、高温保存時における変色を抑制できる。従って、保存安定性に優れた、ロキソプロフェン又はその塩を含有する医薬を提供することができる。 According to the present invention, discoloration of a liquid or semi-solid composition containing loxoprofen or a salt thereof at high temperature storage can be suppressed. Therefore, it is possible to provide a drug containing loxoprofen or a salt thereof, which has excellent storage stability.
まず、「医薬製剤」の態様の発明について以下に説明する。
<成分(A)>
本発明において、「ロキソプロフェン又はその塩」には、ロキソプロフェンそのもののほか、ロキソプロフェンの薬学上許容される塩、さらにはロキソプロフェンやその薬学上許容される塩と水やアルコール等との溶媒和物も含まれる。これらは公知の化合物であり、公知の方法により製造できるほか、市販のものを用いることができる。本発明において、ロキソプロフェン又はその塩としては、ロキソプロフェンナトリウム水和物(化学名: Monosodium 2-[4-[(2-oxocyclopentyl)methyl]phenyl]propanoate dihydrate)が好ましい。
First, the invention of the aspect of the "pharmaceutical preparation" will be described below.
<Ingredient (A)>
In the present invention, "loxoprofen or a salt thereof" includes not only loxoprofen itself, but also a pharmaceutically acceptable salt of loxoprofen, and a solvate of loxoprofen or a pharmaceutically acceptable salt thereof and water, alcohol, or the like. Is done. These are known compounds and can be produced by known methods, or commercially available compounds can be used. In the present invention, as loxoprofen or a salt thereof, loxoprofen sodium hydrate (chemical name: Monosodium 2- [4-[(2-oxocyclopentyl) methyl] phenyl] propanoate dihydrate) is preferable.
本発明において、液状又は半固形状の組成物中のロキソプロフェン又はその塩の含有量は特に限定されず、所望の消炎鎮痛効果に応じて適宜検討して決定すればよい。本発明においては、ロキソプロフェン又はその塩を組成物全質量に対して、ロキソプロフェンナトリウム無水物換算で0.01〜10質量%含有するのが好ましく、0.1〜5質量%含有するのがより好ましく、0.5〜3質量%含有するのが特に好ましい。 In the present invention, the content of loxoprofen or a salt thereof in the liquid or semi-solid composition is not particularly limited, and may be appropriately examined and determined according to the desired anti-inflammatory and analgesic effect. In the present invention, loxoprofen or a salt thereof is preferably contained in an amount of 0.01 to 10% by mass, more preferably 0.1 to 5% by mass, in terms of loxoprofen sodium anhydride, based on the total mass of the composition. , 0.5 to 3% by mass is particularly preferable.
<成分(B)>
本発明において、「トウガラシ」は特に限定されず、例えば、第十六改正日本薬局方に収載のトウガラシ(Capsicum annuum Linne(Solanaceae)の果実)などを好適に用いることができる。トウガラシは必要に応じてその形態を調節することができ、小片、小塊に切断若しくは破砕、又は粉末に粉砕することができ、例えば、トウガラシを粉末とした「トウガラシ末」も本発明の「トウガラシ」として用いることができる。また、組成物・医薬製剤の製造時の取扱いの便宜等を考慮して、トウガラシに何らかの抽出処理を施したもの(本明細書において「トウガラシの抽出物」と称する。)を用いてもよい。
なお、「トウガラシの抽出物」には、抽出処理に加えて、加熱、乾燥、粉砕等の加工処理を施したものも包含される。具体的には、トウガラシを必要に応じて適当な大きさとした後に、適当な浸出液(抽出溶媒)を加えて浸出した液や、当該浸出液を濃縮した液(軟エキス、チンキ等)、さらにこれらを乾燥させたもの(乾燥エキス等)なども本発明の「トウガラシの抽出物」に包含される。
さらに、本発明において、「トウガラシの抽出物」としては、トウガラシの主成分である公知のカプサイシノイドを用いてもよい。当該カプサイシノイドとしては、カプサイシン、ノナン酸バニリルアミド(別名:ノニル酸ワニリルアミド)が好ましい。
<Ingredient (B)>
In the present invention, "capsicum" is not particularly limited, and for example, capsicum (fruit of Capsicum annuum Linne (Solanaceae)) listed in the 16th revised Japanese Pharmacopoeia can be preferably used. The morphology of capsicum can be adjusted as needed, and it can be cut or crushed into small pieces or lumps, or crushed into powder. Can be used as. In addition, in consideration of convenience of handling at the time of manufacturing the composition / pharmaceutical preparation, a red pepper that has undergone some extraction treatment (referred to as “red pepper extract” in the present specification) may be used.
The "capsicum extract" also includes those subjected to processing treatments such as heating, drying, and crushing in addition to the extraction treatment. Specifically, after making the capsicum into an appropriate size as needed, a solution leached by adding an appropriate leachate (extraction solvent), a solution obtained by concentrating the leachate (soft extract, tincture, etc.), and further, these are added. Dried products (dried extracts, etc.) are also included in the "capsicum extract" of the present invention.
Further, in the present invention, as the "extract of capsicum", a known capsaicinoid which is the main component of capsicum may be used. As the capsaicinoid, capsaicin and nonanoic acid vanillylamide (also known as nonylic acid vanillylamide) are preferable.
本発明において、「トウガラシ又はその抽出物」としては、トウガラシ、トウガラシ末、トウガラシエキス(軟エキス、乾燥エキス)、カプサイシン、ノナン酸バニリルアミドが好ましく、トウガラシ軟エキス、ノナン酸バニリルアミドが特に好ましい。 In the present invention, as the "capsicum or its extract", capsicum, capsicum powder, capsicum extract (soft extract, dried extract), capsaicin, nonanoic acid vanillylamide are preferable, and capsicum soft extract and nonanoic acid vanillylamide are particularly preferable.
トウガラシの抽出物の製造方法は特に限定されず、例えば第十六改正日本薬局方 製剤総則の「エキス剤」、「浸剤・煎剤」、「チンキ剤」、「流エキス剤」の項の記載など、公知の植物抽出物の製造方法を参考にして製造できる。具体的には例えば、トウガラシを必要に応じて切断、加熱、乾燥、粉砕等したうえ、適当な抽出溶媒を加えて抽出を行うことで、製造することができる。得られた抽出物は、必要に応じてさらに濃縮、乾燥等させてもよい。 The method for producing the extract of Togarashi is not particularly limited, and for example, the description in the sections of "extract", "immersion / decoction", "tincture", "flow extract", etc. , Can be produced with reference to a known method for producing a plant extract. Specifically, for example, it can be produced by cutting, heating, drying, crushing or the like, if necessary, and then adding an appropriate extraction solvent for extraction. The obtained extract may be further concentrated, dried or the like, if necessary.
前記抽出溶媒としては例えば、メタノール、エタノール、イソプロパノール、n−ブタノール等の低級1価アルコール;エチレングリコール、プロピレングリコール、1,3−ブチレングリコール、グリセリン等の低級多価アルコール;ジエチルエーテル等のエーテル類;アセトン、エチルメチルケトン等のケトン類;酢酸エチル等のエステル類;アセトニトリル等のニトリル類;ペンタン、ヘキサン、シクロペンタン、シクロヘキサン等のアルカン類;ジクロロメタン、クロロホルム等のハロゲノアルカン類;ベンゼン、トルエン等の芳香族炭化水素;ジメチルホルムアミド;ジメチルスルホキシド;水(熱水を含む)等が挙げられる。これらは各々単独で用いてもよいし、2種以上を組み合わせて用いてもよい。本発明においては、水、エタノール、又は水/エタノール混液が好ましい。
抽出操作は特に限定されず、植物からの抽出操作に利用される公知の方法を適宜採用することができ、具体的には例えば、抽出溶媒への浸漬(冷浸、温浸、パーコレーション等)、超臨界流体や亜臨界流体を用いた抽出などが挙げられる。なお、抽出効率を上げるため、攪拌や抽出溶媒中でホモジナイズしてもよい。
抽出温度は特に限定されず、使用する抽出溶媒、抽出操作等により異なるが、5℃程度から抽出溶媒の沸点以下の温度とするのが好ましい。
抽出時間は特に限定されず、使用する抽出溶媒、抽出操作等により異なるが、1時間〜14日程度とするのが好ましい。
Examples of the extraction solvent include lower monohydric alcohols such as methanol, ethanol, isopropanol and n-butanol; lower polyhydric alcohols such as ethylene glycol, propylene glycol, 1,3-butylene glycol and glycerin; ethers such as diethyl ether. Ketones such as acetone and ethyl methyl ketone; esters such as ethyl acetate; nitriles such as acetonitrile; alkanes such as pentane, hexane, cyclopentane and cyclohexane; halogenoalkanes such as dichloromethane and chloroform; benzene, toluene and the like Aromatic hydrocarbons; dimethylformamide; dimethylsulfoxide; water (including hot water) and the like. Each of these may be used alone, or two or more thereof may be used in combination. In the present invention, water, ethanol, or a water / ethanol mixed solution is preferable.
The extraction operation is not particularly limited, and a known method used for the extraction operation from a plant can be appropriately adopted. Specifically, for example, immersion in an extraction solvent (cold immersion, warm immersion, percolation, etc.), Extraction using supercritical fluid or subcritical fluid can be mentioned. In addition, in order to improve the extraction efficiency, it may be homogenized with stirring or in an extraction solvent.
The extraction temperature is not particularly limited and varies depending on the extraction solvent used, the extraction operation and the like, but it is preferably a temperature of about 5 ° C. to a temperature equal to or lower than the boiling point of the extraction solvent.
The extraction time is not particularly limited and varies depending on the extraction solvent used, the extraction operation and the like, but is preferably about 1 hour to 14 days.
本発明において、トウガラシ又はその抽出物としては、市販品を用いることができ、具体的な市販品としては例えば、トウガラシエキス−B、トウガラシエキス−D、トウガラシエキス−N、トウガラシエキス−S、(局)トウガラシチンキ、(局)トウガラシ末(以上、日本粉末薬品株式会社)、ノニル酸ワニリルアミド(長岡実業株式会社)等が挙げられる。 In the present invention, a commercially available product can be used as the capsicum or an extract thereof, and specific commercial products include, for example, capsicum extract-B, capsicum extract-D, capsicum extract-N, capsicum extract-S, ( (Bureau) capsicum tincture, (bureau) capsicum powder (above, Nippon Powder Chemicals Co., Ltd.), nonylate vanillylamide (Nagaoka Kogyo Co., Ltd.) and the like.
本発明において、液状又は半固形状の組成物におけるトウガラシ又はその抽出物の含有量は特に限定されないが、変色抑制作用の観点から、トウガラシ又はその抽出物を原生薬換算量で、組成物全質量に対して0.01〜15質量%含有するのが好ましく、0.05〜10質量%含有するのがより好ましく、0.1〜8質量%含有するのが特に好ましい。また、特にトウガラシ又はその抽出物としてカプサイシン、ノナン酸バニリルアミド等のカプサシノイドを用いる場合においては、変色抑制作用の観点から、カプサイシノイドを組成物全質量に対して0.0001〜2質量%含有するのが好ましく、0.0005〜1質量%含有するのがより好ましく、0.001〜0.5質量%含有するのがさらに好ましく、0.005〜0.1質量%含有するのが特に好ましい。 In the present invention, the content of capsicum or its extract in the liquid or semi-solid composition is not particularly limited, but from the viewpoint of the discoloration suppressing action, the capsicum or its extract is used as a crude drug equivalent amount in the total mass of the composition. It is preferably contained in an amount of 0.01 to 15% by mass, more preferably 0.05 to 10% by mass, and particularly preferably 0.1 to 8% by mass. Further, particularly when a capsaicinoid such as capsaicin or nonanoic acid vanillylamide is used as the capsaicin or an extract thereof, it is recommended that the capsaicinoid be contained in an amount of 0.0001 to 2% by mass based on the total mass of the composition from the viewpoint of suppressing discoloration. It is preferably contained in an amount of 0.0005 to 1% by mass, more preferably 0.001 to 0.5% by mass, and particularly preferably 0.005 to 0.1% by mass.
本発明において、液状又は半固形状の組成物中のロキソプロフェン又はその塩とトウガラシ又はその抽出物の含有比は特に限定されず、変色抑制作用の観点から適宜検討して決定すればよいが、変色抑制作用の観点から、ロキソプロフェン又はその塩をロキソプロフェン無水物換算で1質量部に対し、トウガラシ又はその抽出物を原生薬換算量で0.01〜15質量部含有するのが好ましく、0.05〜10質量部含有するのがより好ましく、0.1〜8質量部含有するのが特に好ましい。また、特にトウガラシ又はその抽出物としてカプサイシン、ノナン酸バニリルアミド等のカプサイシノイドを用いる場合においては、変色抑制作用の観点から、ロキソプロフェン又はその塩をロキソプロフェンナトリウム無水物換算で1質量部に対し、カプサイシノイドを0.0001〜2質量部含有するのが好ましく、0.0005〜1質量部含有するのがより好ましく、0.001〜0.2質量部含有するのがさらに好ましく、0.005〜0.1質量部含有するのが特に好ましい。 In the present invention, the content ratio of loxoprofen or a salt thereof and an extract of loxoprofen or an extract thereof in a liquid or semi-solid composition is not particularly limited and may be appropriately examined and determined from the viewpoint of discoloration suppressing action. From the viewpoint of inhibitory action, loxoprofen or a salt thereof is preferably contained in an amount of 0.01 to 15 parts by mass, preferably 0.05 to 15 parts by mass in terms of a protozoan, with respect to 1 part by mass in terms of loxoprofen anhydride. It is more preferably contained in an amount of 10 parts by mass, and particularly preferably 0.1 to 8 parts by mass. In particular, when capsaicinoids such as capsaicin and nonanoic acid vanillylamide are used as capsaicin or its extract, from the viewpoint of discoloration inhibitory action, loxoprofen or a salt thereof is converted to 1 part by mass in terms of loxoprofen sodium anhydride, and capsaicinoid is 0. It is preferably contained in an amount of .0001 to 2 parts by mass, more preferably 0.0005 to 1 part by mass, further preferably 0.001 to 0.2 part by mass, and 0.005 to 0.1 part by mass. It is particularly preferable to contain a portion.
<液状又は半固形状の組成物>
本発明において、「液状又は半固形状の組成物」とは、常温(15〜25℃の範囲内のうちいずれかの温度)において液状あるいは半固形状の組成物を意味する。
本発明において組成物の性状は特に限定されず、溶液、コロイド溶液(ゾル(懸濁液や乳濁液))、ゲル等のいずれであってもよい。また、溶媒あるいは基剤の種類・性質等は特に限定されず、親水性であっても油性等の疎水性であってもよく、さらには異なる複数種の溶媒・基剤を適宜混合・乳化等して用いてもよい。こうした溶媒・基剤としては、具体的には例えば、後記の添加物として例示された成分等が挙げられる。
<Liquid or semi-solid composition>
In the present invention, the "liquid or semi-solid composition" means a liquid or semi-solid composition at room temperature (any temperature within the range of 15 to 25 ° C.).
In the present invention, the properties of the composition are not particularly limited, and may be any of a solution, a colloidal solution (sol (suspension or emulsion)), a gel and the like. The type and properties of the solvent or base are not particularly limited, and may be hydrophilic or hydrophobic such as oily, and a plurality of different solvents and bases may be appropriately mixed and emulsified. May be used. Specific examples of such a solvent / base include components exemplified as additives described later.
本発明においては、医薬製剤の使用時の安全性の観点から、液状又は半固形状の組成物が、水を含有するのが好ましい。ここで、組成物中の水の含有量は、特に限定されないが、医薬製剤の使用時の安全性や変色抑制作用の観点から、組成物全質量に対し1質量%以上であるのが好ましく、5質量%以上であるのがより好ましく、10〜90質量%であるのがさらに好ましく、20〜70質量%であるのがさらにより好ましく、30〜50質量%であるのが特に好ましい。 In the present invention, from the viewpoint of safety when using a pharmaceutical preparation, the liquid or semi-solid composition preferably contains water. Here, the content of water in the composition is not particularly limited, but is preferably 1% by mass or more with respect to the total mass of the composition from the viewpoint of safety during use of the pharmaceutical preparation and discoloration suppressing action. It is more preferably 5% by mass or more, further preferably 10 to 90% by mass, further preferably 20 to 70% by mass, and particularly preferably 30 to 50% by mass.
また、本発明においては、医薬製剤の使用感の観点から、液状又は半固形状の組成物が、低級アルコールを含有するのが好ましい。ここで、「低級アルコール」とは、炭素数1〜6の直鎖又は分岐鎖の1価のアルコールを意味し、具体的には例えば、エタノール、イソプロパノール、n−プロパノール等が挙げられ、エタノール、イソプロパノール及びこれらの混合物が好ましい。ここで、組成物中の低級アルコールの含有量は、特に限定されないが、医薬製剤の使用感や変色抑制作用の観点から、組成物全質量に対し5質量%以上であるのが好ましく、10〜90質量%であるのがより好ましく、15〜70質量%であるのがさらに好ましく、20〜50質量%であるのが特に好ましい。 Further, in the present invention, from the viewpoint of the usability of the pharmaceutical preparation, it is preferable that the liquid or semi-solid composition contains a lower alcohol. Here, the "lower alcohol" means a linear or branched monohydric alcohol having 1 to 6 carbon atoms, and specific examples thereof include ethanol, isopropanol, n-propanol and the like. Isopropanol and mixtures thereof are preferred. Here, the content of the lower alcohol in the composition is not particularly limited, but is preferably 5% by mass or more, preferably 5% by mass or more, based on the total mass of the composition, from the viewpoint of the usability of the pharmaceutical preparation and the effect of suppressing discoloration. It is more preferably 90% by mass, further preferably 15 to 70% by mass, and particularly preferably 20 to 50% by mass.
本発明においては、医薬製剤の使用時の安全性、使用感の観点から、液状又は半固形状の組成物が、水及び低級アルコールの両者を共に含有するのが好ましい。組成物が、水又は低級アルコールの少なくとも一方を含有する組成物(特に水及び低級アルコールの両者を共に含有する組成物)の場合であっても、変色が抑制されたものとなる。 In the present invention, from the viewpoint of safety and usability when using a pharmaceutical preparation, it is preferable that the liquid or semi-solid composition contains both water and a lower alcohol. Even when the composition is a composition containing at least one of water and a lower alcohol (particularly a composition containing both water and a lower alcohol), discoloration is suppressed.
本発明において、液状又は半固形状の組成物には、医薬成分として、前記以外の薬物、例えば、鎮痛成分、抗炎症成分、抗ヒスタミン成分、殺菌成分、収れん・保護成分、血行促進成分、温感成分、局所麻酔成分、鎮咳剤、ノスカピン類、気管支拡張剤、去痰剤、催眠鎮静剤、ビタミン類、胃粘膜保護剤、制酸剤、抗コリン剤、生薬類、漢方処方等からなる群より選ばれる1種又は2種以上を含んでいてもよい。 In the present invention, the liquid or semi-solid composition may contain other drugs as pharmaceutical components, such as analgesic components, anti-inflammatory components, antihistamine components, bactericidal components, astringent / protective components, blood circulation promoting components, and warming components. Select from the group consisting of sensory ingredients, local anesthetic ingredients, antitussives, noscapines, bronchial dilators, sputum, hypnotic sedatives, vitamins, gastric mucosa protectants, antacids, anticholinergic agents, crude drugs, Chinese herbal prescriptions, etc. It may contain one kind or two or more kinds.
鎮痛成分としては、例えば、アスピリン、アスピリンアルミニウム、アセトアミノフェン、イソプロピルアンチピリン、イブプロフェン、エテンザミド、サザピリン、サリチルアミド、サリチル酸、サリチル酸エチレングリコール、サリチル酸グリコール、サリチル酸ナトリウム、サリチル酸メチル、チアラミド塩酸塩、ラクチルフェネチジン等が挙げられる。
抗炎症成分としては、例えば、グアイアズレンスルホン酸ナトリウム、グリチルリチン酸及びその誘導体並びにそれらの塩類(例えば、グリチルリチン酸二カリウム、グリチルリチン酸モノアンモニウム等)、グリチルレチン酸、セアプローゼ、セミアルカリプロティナーゼ、セラペプターゼ、プロクターゼ、プロナーゼ、ブロメライン等が挙げられる。
Examples of analgesic ingredients include aspirin, aspirin aluminum, acetaminophen, isopropylantipyrine, ibuprofen, etenzamid, sazapyrin, salicylamide, salicylic acid, ethylene glycol salicylate, glycol salicylate, sodium salicylate, methyl salicylate, thialamide hydrochloride, and lactylphenetidine. And so on.
Examples of anti-inflammatory components include sodium gualenate sulfonate, glycyrrhizic acid and its derivatives, and salts thereof (for example, dipotassium glycyrrhizinate, monoammonium glycyrrhizinate, etc.), glycyrrhetinic acid, seapronase, semi-alkali proteinase, therapeptase, proctase, etc. Pronase, bromeline and the like can be mentioned.
抗ヒスタミン成分としては、例えば、アゼラスチン塩酸塩、アリメマジン酒石酸塩、イソチペンジル塩酸塩、イプロヘプチン塩酸塩、エバスチン、エピナスチン塩酸塩、エメダスチンフマル酸塩、オキサトミド、カルビノキサミンジフェニルジスルホン酸塩、カルビノキサミンマレイン酸塩、クレマスチンフマル酸塩、d−クロルフェニラミンマレイン酸塩、dl−クロルフェニラミンマレイン酸塩、ケトチフェンフマル酸塩、ジフェテロール塩酸塩、ジフェテロールリン酸塩、ジフェニルピラリン塩酸塩、ジフェニルピラリンテオクル酸塩、ジフェンヒドラミン塩酸塩、ジフェンヒドラミンサリチル酸塩、ジフェンヒドラミンタンニン酸塩、セチリジン塩酸塩、トリプロリジン塩酸塩、トリペレナミン塩酸塩、トンジルアミン塩酸塩、フェキソフェナジン、フェネタジン塩酸塩、プロメタジン塩酸塩、プロメタジンメチレン二サリチル酸塩、ベポタスチンベシル酸塩、ホモクロルシクリジン塩酸塩、メキタジン、メトジラジン塩酸塩、メブヒドロリンナパジシル酸塩等が挙げられる。 Examples of the antihistamine component include azerastin hydrochloride, alimemazine tartrate, isotipendyl hydrochloride, iproheptin hydrochloride, evastin, epinastine hydrochloride, emedastin fumarate, oxatomide, carbinoxamine diphenyldisulfonate, and carbinoxamine. Maleate, Cremastine Fumarate, d-Chlorpheniramine Maleate, dl-Chlorpheniramine Maleate, Ketotiphenfumarate, Diffeterol Hydrochloride, Diffeterol Phosphate, Diphenylpyraline Hydrochloride, Diphenylpyraline Theocrulate, diphenhydramine hydrochloride, diphenhydramine salicylate, diphenhydramine tannate, cetilidine hydrochloride, triprolidine hydrochloride, tryperenamine hydrochloride, tonzilamine hydrochloride, hexofenazine, phenetazine hydrochloride, promethazine hydrochloride, promethazine methylenedi Examples thereof include salicylate, bepotastine besilate, homochlorcyclidine hydrochloride, mequitazine, metodilazine hydrochloride, mebuhydrolinnapadisylate and the like.
殺菌成分としては、例えば、塩化ベンザルコニウム等が挙げられる。収れん・保護成分としては、例えば、酸化亜鉛等が挙げられる。血行促進成分としては、酢酸トコフェロール、ニコチン酸ベンジル、ヘパリン類似物質、ポリエチレンスルホン酸ナトリウム等が挙げられる。局所麻酔成分としては、例えば、リドカイン、チョウジ油、ベラドンナエキス等が挙げられる。 Examples of the bactericidal component include benzalkonium chloride and the like. Examples of the astringent / protective component include zinc oxide and the like. Examples of the blood circulation promoting component include tocopherol acetate, benzyl nicotinate, heparinoid, sodium polyethylene sulfonate and the like. Examples of the local anesthetic component include lidocaine, clove oil, belladonna extract and the like.
鎮咳剤としては、例えば、アロクラミド塩酸塩、エプラジノン塩酸塩、カルベタペンタンクエン酸塩、クロペラスチン塩酸塩、クロペラスチンフェンジゾ酸塩、ジブナートナトリウム、ジメモルファンリン酸塩、チペピジンクエン酸塩、チペピジンヒベンズ酸塩等が挙げられる。 Antitussives include, for example, allocramid hydrochloride, epradinone hydrochloride, carbetapentanetanate, cloperastine hydrochloride, cloperastin fendizoate, dibunato sodium, dimemorphan phosphate, tipepidin citrate, etc. Examples thereof include tipepidin hibenzate.
ノスカピン類としては、例えば、ノスカピン塩酸塩、ノスカピン等が挙げられる。
気管支拡張剤としては、例えば、トリメトキノール塩酸塩、フェニレフリン塩酸塩、メトキシフェナミン塩酸塩等が挙げられる。
Examples of noscapines include noscapine hydrochloride, noscapine and the like.
Examples of the bronchodilator include trimetokinol hydrochloride, phenylephrine hydrochloride, methoxyphenamine hydrochloride and the like.
去痰剤としては、例えば、アンモニア・ウイキョウ精、塩化アンモニウム等が挙げられる。 Examples of the sputum-removing agent include ammonia / fennel spirit, ammonium chloride and the like.
催眠鎮静剤としては、例えば、アリルイソプロピルアセチル尿素やブロムワレリル尿素等が挙げられる。
ビタミン類としては、例えば、ビタミンB1、ビタミンB2、ビタミンB5、ビタミンB6、ビタミンB12、ビタミンC、ヘスペリジン及びその誘導体並びにそれらの塩類等(例えば、チアミン、チアミン塩化物塩酸塩、チアミン硝化物、ジセチアミン塩酸塩、セトチアミン塩酸塩、フルスルチアミン、フルスルチアミン塩酸塩、オクトチアミン、シコチアミン、チアミンジスルフィド、ビスイブチアミン、ビスベンチアミン、プロスルチアミン、ベンフォチアミン、リボフラビン、リボフラビンリン酸エステル、リボフラビン酪酸エステル、リン酸リボフラビンナトリウム、パンテノール、パンテチン、パントテン酸ナトリウム、ピリドキシン塩酸塩、ピリドキサールリン酸エステル、シアノコバラミン、メコバラミン、アスコルビン酸、アスコルビン酸ナトリウム、アスコルビン酸カルシウム、ヘスペリジン等)が挙げられる。
Examples of the hypnotic sedative include allylisopropylacetylurea and bromvalerylurea.
Examples of vitamins include vitamin B 1 , vitamin B 2 , vitamin B 5 , vitamin B 6 , vitamin B 12 , vitamin C, hesperidin and derivatives thereof, and salts thereof (for example, thiamine, thiamine chloride hydrochloride, etc.). Thiamine nitrate, disetiamine hydrochloride, setothiamine hydrochloride, flusultiamine, flusultiamine hydrochloride, octothiamine, sicothamine, thiamine disulfide, bisibuchiamine, bisbenchamine, prosultiamine, benfothamine, riboflavin, riboflavin phosphorus Acid ester, riboflavin butyrate, sodium riboflavin phosphate, pantenol, pantetin, sodium pantothenate, pyridoxine hydrochloride, pyridoxal phosphate ester, cyanocobalamine, mecobalamine, ascorbic acid, sodium ascorbate, calcium ascorbate, hesperidin, etc.) Be done.
胃粘膜保護剤としては、例えば、ゲファルナート、セトラキサート塩酸塩、ソファルコン、テプレノン、メチルメチオニンスルホニウムクロリド等が挙げられる。
制酸剤としては、例えば、アミノ酢酸、ケイ酸アルミン酸マグネシウム、ケイ酸マグネシウム、合成ケイ酸アルミニウム、合成ヒドロタルサイト、酸化マグネシウム、ジヒドロキシアルミニウムアミノアセテート、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、乾燥水酸化アルミニウムゲル、水酸化アルミニウム・炭酸マグネシウム混合乾燥ゲル、水酸化アルミニウム・炭酸水素ナトリウムの共沈生成物、水酸化アルミニウム・炭酸カルシウム・炭酸マグネシウムの共沈生成物、水酸化マグネシウム、水酸化マグネシウム・硫酸アルミニウムカリウムの共沈生成物、炭酸マグネシウム、炭酸水素ナトリウム、沈降炭酸カルシウム、メタケイ酸アルミン酸マグネシウム、無水リン酸水素カルシウム、リン酸水素カルシウム、烏賊骨、石決明、ボレイ等が挙げられる。
Examples of the gastric mucosa protective agent include gefarnate, cetraxate hydrochloride, sofalcone, teprenone, methylmethionine sulfonium chloride and the like.
Examples of the acid suppressant include aminoacetic acid, magnesium aluminate silicate, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, dihydroxyaluminum aminoacetate, magnesium hydroxide, magnesium hydroxide, aluminum hydroxide gel, and dried. Aluminum hydroxide gel, aluminum hydroxide / magnesium carbonate mixed dry gel, aluminum hydroxide / sodium hydrogen carbonate co-precipitated product, aluminum hydroxide / calcium carbonate / magnesium carbonate co-precipitated product, magnesium hydroxide, magnesium hydroxide・ Co-precipitated products of potassium aluminum sulfate, magnesium carbonate, sodium hydrogen carbonate, precipitated calcium carbonate, magnesium aluminometasilicate, anhydrous calcium hydrogen phosphate, calcium hydrogen phosphate, pirate bones, stone determination, volley, etc. ..
抗コリン薬としては、例えば、オキシフェンサイクリミン塩酸塩、ジサイクロミン塩酸塩、メチキセン塩酸塩、チペピジウム臭化物、メチルベナクチジウム臭化物、ピレンゼピン塩酸塩、ヨウ化イソプロパミド、ヨウ化ジフェニルピペリジノメチルジオキソラン等が挙げられる。 Examples of anticholinergic agents include oxyphencyclimine hydrochloride, dicyclamine hydrochloride, methixene hydrochloride, tipepidium bromide, methylbenactidium bromide, pirenzepine hydrochloride, isopropamide iodide, diphenylpiperidinomethyldioxolane iodide and the like. Can be mentioned.
生薬類としては、例えば、アカメガシワ(赤芽柏)、アセンヤク(阿仙薬)、アルニカ、インヨウカク(淫羊霍)、ウイキョウ(茴香)、ウコン(鬱金)、エンゴサク(延胡索)、オウゴン(黄岑)、オウセイ(黄精)、オウバク(黄柏)、オウヒ(桜皮)、オウレン(黄連)、オンジ(遠志)、ガジュツ(我朮)、カノコソウ(鹿子草)、カミツレ、カロニン(か楼仁)、キキョウ(桔梗)、キョウニン(杏仁)、クコシ(枸杞子)、クコヨウ(枸杞葉)、ケイガイ(荊芥)、ケイヒ(桂皮)、ケツメイシ(決明子)、ゲンチアナ、ゲンノショウコ(現証拠)、コウカ(紅花)、コウブシ(香附子)、ゴオウ(牛黄)、ゴミシ(五味子)、サイシン(細辛)、サンシシ(山梔子)、サンショウ(山椒)、シオン(紫苑)、ジコッピ(地骨皮)、シコン(紫根)、シャクヤク(芍薬)、ジャコウ(麝香)、シャジン(沙参)、シャゼンシ(車前子)、シャゼンソウ(車前草)、獣胆(ユウタン(熊胆)を含む)、ショウキョウ (生姜)、ジリュウ(地竜)、シンイ(辛夷)、セイヨウトチノキ、セキサン(石蒜)、セネガ、センキュウ(川きゅう)、ゼンコ(前胡)、センブリ(千振)、ソウジュツ(蒼朮)、ソウハクヒ(桑白皮)、ソヨウ(蘇葉)、タイサン(大蒜)、チクセツニンジン(竹節人参)、チンピ(陳皮)、トウキ(当帰)、トコン(吐根)、ナンテンジツ(南天実)、ニンジン(人参)、バイモ(貝母)、バクモンドウ(麦門冬)、ハンゲ(半夏)、バンコウカ(番紅花)、ハンピ(反鼻)、ビャクシ(白し)、ビャクジュツ(白朮)、ブクリョウ(茯苓)、ボタンピ(牡丹皮)、ヨウバイヒ(楊梅皮)、ロクジョウ(鹿茸)等の生薬及びこれらの抽出物(エキス、チンキ、乾燥エキス等)等が挙げられる。 Examples of crude drugs include red bud wrinkles (red buds), asenyaku (Asenyaku), Arnica, tincture (innocent sheep), uikyo (scented scent), corn (depressed gold), engosaku (extended ginger), ogong (yellow ginger), and ausei (yellow sardine). Yellow spirit), Oubaku (Huang Kashiwa), Ouhi (Cherry bark), Ouren (Huangren), Onji (Distant), Gajutsu (Ginger), Kanokosou (Kagokusa), Kamitsure, Karonin (Karoujin), Kikyo (Kikyou) , Kyonin (Apricot), Kukoshi (Tincture), Kukoyo (Tincture leaf), Keigai (Tincture), Keihi (Chenpi), Ketsumeishi (Chenpi), Gentiana, Gennoshoko (Present evidence), Kouka (Red flower), Kobushi (Koubushi) ), Goou (Beef Yellow), Gomishi (Gomiko), Saishin (Spicy), Sanshishi (Sanjoko), Sansho (Sansho), Zion (Shien), Jikoppi (Chenpi), Shikon (Purple Root), Shakuyaku (Crude Drug) , Jakou (Musuka), Shajin (Sasan), Shazenshi (Car front child), Shazensou (Car front grass), Beast ginger (including Yutan (Kuma gall)), Ginger (Ginger), Jiryu (Chenpi), Shini ( Spicy), Tincture, Sexan (Ishibuki), Senega, Senkyu (Kawakyu), Zenko (Maekhu), Senburi (Senburi), Soujutsu (Aoi), Souhakuhi (Kuwashirohide), Soyo (Suha), Taisan (Ginger), Chikusetsu carrot (Takebushi ginger), Chinpi (Chenpi), Touki (Toki), Tokon (Vomiting root), Nantenjitsu (Nantenmi), Carrot (Ginger), Baimo (Ginger), Bakumondou (Wheat gate) Winter), Hange (half-summer), Bankouka (bankohana), Hanpi (anti-nose), Byakushi (white), Byakujutsu (white extract), Bukuryo (茯 蓓), Buttonpi (peony skin), Youbaihi (yang plum skin), Rokujo Examples thereof include crude drugs such as (ginger mushroom) and extracts thereof (extracts, tinctures, dried extracts, etc.).
漢方処方としては、例えば、ケイシトウ(桂枝湯)、コウソサン(香蘇散)、サイコケイシトウ(柴胡桂枝湯)、ショウサイコトウ(小柴胡湯)、バクモンドウトウ(麦門冬湯)、ハンゲコウボクトウ(半夏厚朴湯)等が挙げられる。 Chinese cinnamon prescriptions include, for example, cinnamon (Keishito), Kososan (Kososan), Psychokeisito (Saiko Keishito), Shosaikoto (Shosaikoto), Bakumondoto (Mai Men Dong Tang), and Hange. Examples include Sho-saiko-to (Hangekobokuto).
また、本発明において、液状又は半固形状の組成物には、医薬製剤の剤形、投与方法等に応じて医薬品分野、化粧品分野等において用いられる添加物を配合してもよい。こうした添加物としては、例えば、ゲル化剤、多価アルコール、油脂類、乳化剤、可溶化剤、pH調整剤、抗酸化剤、軟化剤、増粘剤、保湿剤、防腐剤、安定化剤、経皮吸収促進剤、矯味剤・甘味剤、テルペン類等が挙げられる。 Further, in the present invention, the liquid or semi-solid composition may contain additives used in the pharmaceutical field, cosmetics field, etc., depending on the dosage form, administration method, etc. of the pharmaceutical preparation. Such additives include, for example, gelling agents, polyhydric alcohols, fats and oils, emulsifiers, solubilizers, pH regulators, antioxidants, softeners, thickeners, moisturizers, preservatives, stabilizers, etc. Examples thereof include transdermal absorption promoters, flavoring agents / sweeteners, and terpenes.
ゲル化剤としては、例えば、カルボキシビニルポリマー等のアクリル酸系高分子;ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、エチルセルロース等の水溶性あるいは水膨潤性のセルロース系高分子;ポリビニルアルコール;ポリビニルピロリドン等が挙げられる。
多価アルコールとしては、例えば、グリセリン、エチレングリコール、プロピレングリコール、1,3−ブチレングリコール、マクロゴール、ポリプロピレングリコール等が挙げられる。
油脂類としては、例えば、スクワラン、パラフィン、流動パラフィン、軽質流動パラフィン、ワセリン等の炭化水素類;ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル等の脂肪酸エステル類;べへニルアルコール、ラウリルアルコール、ミリスチルアルコール、セチルアルコール、ステアリルアルコール、イソステアリルアルコール、オレイルアルコール等の高級アルコール類;ベヘニン酸、ラウリン酸、ミリスチン酸、ステアリン酸、イソステアリン酸、オレイン酸等の高級脂肪酸;カルナウバロウ、鯨ロウ、セラック、ホホバ油、ミツロウ、サラシミツロウ、モンタンロウ、ラノリン、精製ラノリン、還元ラノリン等のロウ類;シリコーン油等が挙げられる。
Examples of the gelling agent include acrylic acid-based polymers such as carboxyvinyl polymers; water-soluble or water-swellable cellulosic polymers such as hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, and ethyl cellulose; polyvinyl alcohol; Polyvinylpyrrolidone and the like can be mentioned.
Examples of the polyhydric alcohol include glycerin, ethylene glycol, propylene glycol, 1,3-butylene glycol, macrogol, polypropylene glycol and the like.
Examples of fats and oils include hydrocarbons such as squalane, paraffin, liquid paraffin, light liquid paraffin, and vaseline; fatty acid esters such as isopropyl myristate and octyldodecyl myristate; behenyl alcohol, lauryl alcohol, and myristyl alcohol. Higher alcohols such as cetyl alcohol, stearyl alcohol, isostearyl alcohol, and oleyl alcohol; higher fatty acids such as behenic acid, lanolinic acid, myristic acid, stearic acid, isostearic acid, and oleic acid; Rows such as honeydew, sardine honeydew, monttan wax, lanolin, refined lanolin, reduced lanolin; silicone oil and the like can be mentioned.
乳化剤としては、例えば、プロピレングリコールモノ脂肪酸エステル、エチレングリコールモノ脂肪酸エステル、グリセリンモノ脂肪酸エステル、ポリグリセリン脂肪酸エステル、ソルビタン脂肪酸エステル、ショ糖脂肪酸エステル、メチルグルコシド脂肪酸エステル、アルキルポリグルコシド等の多価アルコール脂肪酸エステル又は多価アルコールアルキルエーテル;ポリオキシエチレンアルキルエーテル、ポリオキシエチレンアルキルフェニルエーテル、ポリオキシエチレンフィトステロール、ポリオキシエチレンフィトスタノール、ポリオキシエチレンポリオキシプロピレンアルキルエーテル等のポリオキシエチレンエーテル;ポリオキシエチレンモノ脂肪酸エステル、ポリエチレングリコールジ脂肪酸エステル、ポリオキシエチレングリセリン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンソルビトール脂肪酸エステル、ポリオキシエチレンメチルグルコシド脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンヒマシ油、ポリオキシエチレン植物油、ポリオキシエチレンアルキルエーテル脂肪酸エステル、ポリオキシエチレンポリオキシプロピレングリコール等のエーテルエステル等の非イオン性界面活性剤又はラウリル硫酸ナトリウム、セチル硫酸ナトリウムなどのイオン性界面活性剤などが挙げられる。
可溶化剤としては、例えば、上記の乳化剤として例示した非イオン性界面活性剤又はイオン性界面活性剤に加え、グリセリン、流動パラフィン、クロタミトン、マクロゴール等が挙げられる。
Examples of the emulsifier include polyhydric alcohols such as propylene glycol mono fatty acid ester, ethylene glycol mono fatty acid ester, glycerin mono fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, sucrose fatty acid ester, methyl glucoside fatty acid ester, and alkyl polyglucoside. Fatty acid ester or polyhydric alcohol alkyl ether; polyoxyethylene ether such as polyoxyethylene alkyl ether, polyoxyethylene alkyl phenyl ether, polyoxyethylene phytosterol, polyoxyethylene phytostanol, polyoxyethylene polyoxypropylene alkyl ether; polyoxyethylene ether; Ethylene mono fatty acid ester, polyethylene glycol di fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitol fatty acid ester, polyoxyethylene methyl glucoside fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene Nonionic surfactants such as castor oil, polyoxyethylene vegetable oil, polyoxyethylene alkyl ether fatty acid esters, ether esters such as polyoxyethylene polyoxypropylene glycol, or ionic surfactants such as sodium lauryl sulfate and sodium cetyl sulfate. And so on.
Examples of the solubilizer include glycerin, liquid paraffin, crotamitone, macrogol, and the like, in addition to the nonionic surfactant or ionic surfactant exemplified as the emulsifier described above.
pH調整剤としては、例えば、クエン酸、クエン酸ナトリウム、無水クエン酸、リンゴ酸、マレイン酸、コハク酸、フマル酸、酒石酸、酒石酸ナトリウム、乳酸、乳酸カルシウム、乳酸ナトリウム、酢酸、酢酸ナトリウム、氷酢酸等の有機酸又はその塩;塩酸、硫酸、リン酸、リン酸水素ナトリウム、リン酸二水素カリウム、リン酸二水素ナトリウム、炭酸ナトリウム、炭酸水素ナトリウム等の無機酸又はその塩;水酸化ナトリウム、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム等の水酸化アルカリ;トリエタノールアミン、ジエタノールアミン、ジイソプロパノールアミン等のアミン類等が挙げられる。
抗酸化剤としては、例えば、亜硫酸ナトリウム、アスコルビン酸、亜硫酸水素ナトリウム、亜硫酸ナトリウム、エデト酸ナトリウム、エリソルビン酸、塩酸システイン、クエン酸、トコフェロール、酢酸トコフェロール、大豆レシチン、没食子酸プロピル等が挙げられる。
軟化剤としては、例えば、アラントイン、アーモンド油、オリブ油、グリセリン、流動パラフィン、スクワラン、スクワレン、精製ラノリン、中鎖脂肪酸トリグリセリド、ナタネ油、ヒマシ油、プロピレングリコール、ポリブテン等が挙げられる。
増粘剤としては、例えば、ポリビニルピロリドン、カルボキシメチルセルロース、コロイド性ケイ酸アルミニウム、キサンタンガム、ローカストビーンガム、トラガントガム、グァーガム、ゼラチン、アラビアゴム、アルギン酸、アルブミン等が挙げられる。
保湿剤としては、ヒアルロン酸ナトリウム、グリセリン、1,3−ブチレングリコール、プロピレングリコール、尿素、ショ糖、エリスリトール、ソルビトール等が挙げられる。
防腐剤としては、例えば、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸イソプロピル、パラオキシ安息香酸ブチル、パラオキシ安息香酸イソブチル、パラオキシ安息香酸ベンジル、安息香酸ナトリウム、安息香酸、安息香酸ベンジル、塩化ベンザルコニウム、塩化セチルピリジニウム、塩化ベンゼトニウム、アミノエチルスルホン酸等が挙げられる。
安定化剤としては、例えば、アジピン酸、アスコルビン酸、亜硫酸ナトリウム、亜硫酸水素ナトリウム、塩化ナトリウム、硬化油、システイン等が挙げられる。
経皮吸収促進剤としては、例えば、アジピン酸ジイソプロピル等の脂肪酸エステル類が挙げられる。
矯味剤・甘味剤としては、例えば、アセスルファムカリウム、ステビア、ソーマチン、スクラロース、パノース、トレハロース、エリスリトール、ラクチトール、還元パラチノース、カップリングシュガー、フラクトオリゴ糖、ガラクトオリゴ糖、乳果オリゴ糖、イソマルトオリゴ糖、パラチノースオリゴ糖、ラフィノース、アスパルテーム、果糖、キシリトール、黒砂糖、サッカリン若しくはその塩、ソルビトール、乳糖、白糖、ハチミツ、ブドウ糖、マルチトール、マルトース、マンニトール、水アメ等が挙げられる。
Examples of the pH adjuster include citric acid, sodium citrate, anhydrous citric acid, malic acid, maleic acid, succinic acid, fumaric acid, tartrate acid, sodium tartrate, lactic acid, calcium lactate, sodium lactate, acetic acid, sodium acetate, and ice. Organic acids such as acetic acid or salts thereof; inorganic acids such as citric acid, sulfuric acid, phosphoric acid, sodium hydrogen phosphate, potassium dihydrogen phosphate, sodium dihydrogen phosphate, sodium carbonate, sodium hydrogen carbonate or the like; sodium hydroxide , Alkyl hydroxide such as potassium hydroxide, calcium hydroxide, magnesium hydroxide; amines such as triethanolamine, diethanolamine, diisopropanolamine and the like can be mentioned.
Examples of the antioxidant include sodium sulfite, ascorbic acid, sodium hydrogen sulfite, sodium sulfite, sodium edetate, erythorbic acid, cysteine hydrochloride, citric acid, tocopherol, tocopherol acetate, soybean lecithin, propyl gallate and the like.
Examples of the softening agent include allantoin, almond oil, olive oil, glycerin, liquid paraffin, squalane, squalene, refined lanolin, medium chain fatty acid triglyceride, rapeseed oil, castor oil, propylene glycol, polybutene and the like.
Examples of the thickener include polyvinylpyrrolidone, carboxymethyl cellulose, colloidal aluminum silicate, xanthan gum, locust bean gum, tragant gum, guar gum, gelatin, arabic gum, alginic acid, albumin and the like.
Examples of the moisturizer include sodium hyaluronate, glycerin, 1,3-butylene glycol, propylene glycol, urea, sucrose, erythritol, sorbitol and the like.
Examples of preservatives include methyl paraoxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, isopropyl paraoxybenzoate, butyl paraoxybenzoate, isobutyl paraoxybenzoate, benzyl paraoxybenzoate, sodium benzoate, benzoic acid, and benzoic acid. Examples thereof include benzyl acid acid, benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, aminoethylsulfonic acid and the like.
Examples of the stabilizer include adipic acid, ascorbic acid, sodium sulfite, sodium hydrogen sulfite, sodium chloride, hydrogenated oil, cysteine and the like.
Examples of the transdermal absorption promoter include fatty acid esters such as diisopropyl adipate.
Examples of flavoring agents and sweeteners include assesulfam potassium, stevia, somatin, sucralose, panose, trehalose, erythritol, lactitol, reduced palatinose, coupling sugar, fructo-oligosaccharide, galactooligosaccharide, milk fruit oligosaccharide, isomalto-oligosaccharide, and palatinose. Examples thereof include oligosaccharides, raffinose, aspartame, fructose, xylitol, brown sugar, saccharin or a salt thereof, sorbitol, lactose, sucrose, honey, glucose, martitol, maltose, mannitol, water candy and the like.
テルペン類としては、例えば、イソボルネオール、イロン、オシメン、カルベオール、カルボタナセトン、カルボメントン、カルボン、カレン、カロン、カンフェン、カンフル、ゲラニオール、サビネン、サフラナール、シクロシトラール、シトラール、シトロネラール、シトロネル酸、シトロネロール、シネオール、シメン、シルベストレン、チモール、イソツジョール、ツジョン、テルピネオール、テルピネン、テルピノレン、トリシクレン、ネロール、ピネン、ピノカンフェオール、ピノール、ピペリテノン、フェランドラール、フェランドレン、フェンチェン、フェンチルアルコール、ペリリルアルコール、ペリルアルデヒド、ボルネオール、ミルセン、メントール、メントン、ヨノール、ヨノン、リナロール、リモネン等が挙げられる。 Examples of terpenes include isobornole, iron, osimene, carbeol, carbotanaceton, carbomenton, carboxylic, kalen, karon, camphene, camphor, geraniol, sabinene, safranal, cyclocitral, citral, citronellal, citronellic acid, citronellal and cineol. , Simen, sylvestren, timole, isotsjor, tsujeong, terpineol, terpinene, terpinene, tricyclene, nerol, pinene, pinocampeol, pinol, piperitenon, ferlandral, ferlandren, fenchen, fentyl alcohol, perylyl alcohol, Examples thereof include perylaldehyde, borneol, milsen, menthol, menthon, yonor, yonon, linalool and limonene.
テルペン類を含む精油としては、例えば、アニス油、イランイラン油、イリス油、ウイキョウ油、オレンジ油、カナンガ油、カミツレ油、カヤプト油、カラウェー油、クベブ油、グレープフルーツ油、ケイヒ油、コリアンダー油、サフラン油、サンショウ油、シソ油、シトリオドラ油、シトロネラ油、ショウキョウ油、ショウズク油、樟脳油、ジンジャーグラス油、スペアミント油、セイヨウハッカ油、ゼラニウム油、ダイウイキョウ油、チョウジ油、テレビン油、トウヒ油、ネロリ油、バジル油、ハッカ油、パルマローザ油、ピメント油、プチグレン油、ベイ油、ペニローヤル油、ヘノポジ油、ベルガモット油、ボアドローズ油、ホウショウ油、マジョラン油、マンダリン油、メリッサ油、ユーカリ油、ライム油、ラベンダー油、リナロエ油、レモン油、レモングラス油、ローズ油、ローズマリー油、ローマカミツレ油等が挙げられる。 Essential oils containing terpenes include, for example, anis oil, ylang ylang oil, iris oil, uikyo oil, orange oil, cananga oil, chamomile oil, kayapto oil, caraway oil, kubeb oil, grapefruit oil, kehi oil, coriander oil, etc. Saffron oil, sansho oil, perilla oil, citriodora oil, citronella oil, ginger oil, ginger oil, ginger oil, spearmint oil, peppermint oil, geranium oil, daiuikyo oil, chow oil, television oil, tohi Oil, neroli oil, basil oil, peppermint oil, palmarosa oil, piment oil, petitgrain oil, bay oil, peniroyal oil, henoposi oil, bergamot oil, boadrose oil, peppermint oil, majoran oil, mandarin oil, melissa oil, eucalyptus oil, Examples thereof include lime oil, lavender oil, linaroe oil, lemon oil, lemongrass oil, rose oil, rosemary oil, and Roman chamomile oil.
本発明において、液状又は半固形状の組成物の製造方法は特に限定されず、配合する成分の種類や量、組成物の性状、容器の形状、医薬製剤の剤形、投与経路や用途等に応じて、例えば第十六改正日本薬局方 製剤総則等に記載の公知の方法により製造することができる。 In the present invention, the method for producing a liquid or semi-solid composition is not particularly limited, and the type and amount of the components to be blended, the properties of the composition, the shape of the container, the dosage form of the pharmaceutical preparation, the administration route, the application, etc. Accordingly, for example, it can be produced by a known method described in the 16th revised Japanese Pharmacopoeia General Regulations for Formulation.
<ポリオレフィン系樹脂製容器>
本発明において、「容器」とは、液状又は半固形状の組成物を直接的に収容する包装体を意味する。容器の形状は、液状又は半固形状の組成物を収容可能であることを限度として特に限定されず、組成物の性状、医薬製剤の剤形、投与経路や用途等に応じて適宜検討して決定すればよい。
このような容器の形状としては、例えば、エアゾール剤用容器、ポンプスプレー剤用容器、ボトル容器(より詳細には例えば、スポンジ状の塗布部材(ヘッド)を備えるボトル容器、ロールオン容器やジャーボトル容器など)、チューブ容器、点眼容器等が挙げられる。なお、これらの容器はいずれも公知であり、公知の方法により製造すればよく、また、市販品を用いてもよい。
<Polyolefin-based resin container>
In the present invention, the "container" means a package that directly contains a liquid or semi-solid composition. The shape of the container is not particularly limited as long as it can accommodate a liquid or semi-solid composition, and is appropriately examined according to the properties of the composition, the dosage form of the pharmaceutical preparation, the administration route, the application, and the like. You just have to decide.
Examples of the shape of such a container include a container for an aerosol agent, a container for a pump spray agent, and a bottle container (more specifically, for example, a bottle container provided with a sponge-like coating member (head), a roll-on container, and a jar bottle container. Etc.), tube containers, eye drop containers, etc. All of these containers are known and may be manufactured by a known method, or commercially available products may be used.
本発明において、容器としては、医薬製剤の取り扱いや使用時の便宜等の観点から、以下の(1)又は(2):
(1) スポンジ状の塗布部材を備えるボトル容器のように、容器本体と塗布部材とを備え、前記容器本体に収容された組成物を前記塗布部材に含浸させて使用する容器;
(2) チューブ容器のように、柔軟性を有する容器本体と、吐出口とを備えてなる容器;
が好ましく、(1)の態様の容器が特に好ましい。
In the present invention, as the container, the following (1) or (2):
(1) A container provided with a container body and a coating member, such as a bottle container having a sponge-like coating member, and used by impregnating the coating member with the composition contained in the container body;
(2) A container having a flexible container body and a discharge port, such as a tube container;
Is preferable, and the container of the aspect (1) is particularly preferable.
[(1)容器本体と塗布部材とを備え、前記容器本体に収容された組成物を前記塗布部材に含浸させて使用する容器]
斯かる態様の容器の場合、容器本体に収容された組成物を塗布部材に含浸・保持させて、前記塗布部材を被塗布部に接触させることにより、組成物を塗布することができる。この場合において、容器本体と塗布部材は、それぞれ独立の部材として作製してから容器本体に塗布部材を装着してもよく、一体的に成型してもよい。
なお、塗布部材としては、液状又は半固形状の組成物を含浸・保持可能な構成であればよく、例えばスポンジ状のような多孔質の部材や刷毛状の部材等が挙げられる。
[(1) A container provided with a container body and a coating member, and used by impregnating the coating member with the composition contained in the container body]
In the case of a container of such an embodiment, the composition can be applied by impregnating and holding the composition contained in the container body in the coating member and bringing the coating member into contact with the portion to be coated. In this case, the container body and the coating member may be manufactured as independent members, and then the coating member may be attached to the container body or integrally molded.
The coating member may have a structure capable of impregnating and holding a liquid or semi-solid composition, and examples thereof include a porous member such as a sponge and a brush-like member.
このような容器としては例えば、容器本体の口部に塗布部材を備え、前記容器本体に収容された組成物を前記塗布部材に含浸させて使用する容器が挙げられる。
より詳細な具体例としては例えば、口部を有する容器本体と、前記口部に装着された、多孔質(スポンジ状など)の塗布部材とを備えてなる容器等が挙げられる。この場合、容器本体に収容された組成物を、孔径・空隙率等が適宜調整された多孔質の塗布部材に含浸・保持させた後、当該塗布部材を被塗布部に接触させることによって、組成物を被塗布部に塗布することができる。
また、別の具体例としては例えば、口部を有する容器本体と、前記口部に装着された、刷毛状の塗布部材とを備えてなる容器等が挙げられる。この場合、容器本体に収容された組成物を、毛の長さ・間隔等が適宜調整された刷毛に含浸・保持させた後、当該塗布部材を被塗布部に接触させることによって、組成物を被塗布部に塗布することができる。
Examples of such a container include a container in which a coating member is provided at the mouth of the container body and the coating member is impregnated with the composition contained in the container body.
More detailed specific examples include, for example, a container body having a mouth portion and a container provided with a porous (sponge-like or the like) coating member attached to the mouth portion. In this case, the composition contained in the container body is impregnated and held in a porous coating member whose pore size, porosity, etc. are appropriately adjusted, and then the coating member is brought into contact with the coated portion to form a composition. An object can be applied to the portion to be coated.
Further, as another specific example, for example, a container body having a mouth portion and a container provided with a brush-like coating member attached to the mouth portion and the like can be mentioned. In this case, the composition contained in the container body is impregnated and held in a brush whose hair length, spacing, etc. are appropriately adjusted, and then the coated member is brought into contact with the portion to be coated to obtain the composition. It can be applied to the part to be coated.
斯かる態様の容器は、塗布部材に組成物を含浸・保持させて使用するため、例えば医薬製剤が外用塗布剤である場合において被塗布部で液ダレの問題が生じにくい、塗布部材を直接に被塗布部に接触させて使用することで手指が汚れない、あるいは塗布部材の形状・大きさ等を調整することで簡易に組成物を塗布する領域を柔軟に調整可能である、などのメリットを有する。しかしながら、塗布部材において組成物が含浸・保持されるため組成物に変色が生じた場合には塗布部材全体にわたって変色が生じることになる。そのため、例えば医薬製剤の使用時など、塗布部材を外部に露出させた場合において、外観上特に変色が目立つこととなる。しかるところ、本発明によれば組成物の変色が抑制されるため、斯かる外観上の問題を解決して前記のメリットを十二分に享受できる、という優れた効果を有する。なお、斯かる態様の容器の場合、容器本体及び塗布部材が共にポリオレフィン系樹脂製であるのが特に好ましい。
なお、斯かる容器は、収容する組成物が、例えば液状の組成物や低粘性の半固形状の組成物である場合に特に好適に採用できる。
Since the container of such an embodiment is used by impregnating and holding the composition in the coating member, for example, when the pharmaceutical preparation is an external coating agent, the problem of liquid dripping does not easily occur in the coated portion, and the coating member is directly applied. There are merits such as that the fingers do not get dirty by using it in contact with the part to be coated, or that the area to which the composition is applied can be easily adjusted by adjusting the shape and size of the coating member. Have. However, since the composition is impregnated and retained in the coated member, if the composition is discolored, the discoloration occurs over the entire coated member. Therefore, when the coated member is exposed to the outside, for example, when a pharmaceutical preparation is used, discoloration is particularly noticeable in appearance. However, according to the present invention, since discoloration of the composition is suppressed, there is an excellent effect that such an appearance problem can be solved and the above-mentioned merits can be fully enjoyed. In the case of the container of such an embodiment, it is particularly preferable that both the container body and the coating member are made of a polyolefin resin.
In addition, such a container can be particularly preferably adopted when the composition to be accommodated is, for example, a liquid composition or a low-viscosity semi-solid composition.
斯かる態様の容器は公知であり、例えば、特許第5570089号公報等に開示されている。また、本発明においては、斯かる態様の容器として市販品を用いてもよく、このような市販品としては例えば、塗布部材として低密度ポリエチレン製の連通多孔質体であるMAPS((株)イノアックコーポレーション)を用いた容器等が挙げられる。 Containers of such an embodiment are known and are disclosed, for example, in Japanese Patent No. 5570809. Further, in the present invention, a commercially available product may be used as the container of such an embodiment, and such a commercially available product is, for example, MAPS Co., Ltd., which is a communicating porous body made of low-density polyethylene as a coating member. Examples include containers using (corporation).
[(2)柔軟性を有する容器本体と、吐出口とを備えてなる容器]
斯かる態様の容器の場合、柔軟性を有する容器本体を押圧すること等により容器内部に圧を加え、容器内部に収容された組成物を吐出口から吐出させることによって、組成物を被塗布部に塗布することができる。なお、斯かる態様の容器において吐出口は容器に予め設けられていなくともよく、使用開始前に容器に穿孔等して吐出口を設ける構成としてもよく、斯かる態様の容器も「柔軟性を有する容器本体と、吐出口とを備えてなる容器」に包含される。
[(2) A container provided with a flexible container body and a discharge port]
In the case of a container of such an embodiment, pressure is applied to the inside of the container by pressing the flexible container body or the like, and the composition contained in the container is discharged from the discharge port, whereby the composition is applied to the portion to be coated. Can be applied to. In addition, in the container of such an embodiment, the discharge port does not have to be provided in advance in the container, and the container may be provided with a discharge port by perforating the container before the start of use. It is included in "a container having a container body and a discharge port".
斯かる態様の容器は、単純な構造であるため製造コストが低い、容器本体を押圧すること等により吐出口から組成物を吐出させて使用するため容器内の組成物が汚染されない、などのメリットを有する。
なお、斯かる態様の容器は、収容する組成物が、例えば粘性の高い半固形状の組成物である場合に特に好適に採用できる。
Since the container of such an embodiment has a simple structure, the manufacturing cost is low, and the composition in the container is not contaminated because the composition is discharged from the discharge port by pressing the container body or the like. Has.
The container of such an embodiment can be particularly preferably adopted when the composition to be contained is, for example, a highly viscous semi-solid composition.
斯かる態様の容器は公知であり、例えば、特許第5302550号公報、特許第5525135号公報等に開示されている。また、本発明においては、斯かる態様の容器として市販品を用いてもよい。 Containers of such an embodiment are known, and are disclosed in, for example, Japanese Patent No. 5302550, Japanese Patent No. 5525135, and the like. Further, in the present invention, a commercially available product may be used as the container of such an embodiment.
本発明において、「ポリオレフィン系樹脂」は特に限定されず、単一種のモノマーの重合体(ホモポリマー)であっても、複数種のモノマーの共重合体(コポリマー)であってもよい。また、コポリマーである場合、その重合様式は特に限定されず、ランダム重合でもブロック重合でもよい。さらに、その立体規則性(タクティシティー)は特に限定されない。
このようなポリオレフィン系樹脂としては、具体的には例えば、ポリエチレン(より詳細には例えば、低密度ポリエチレン(直鎖状低密度ポリエチレンを含む)、高密度ポリエチレン、中密度ポリエチレンなど)、ポリプロピレン、環状ポリオレフィン、ポリ(4−メチルペンテン)、ポリテトラフルオロエチレン、エチレン・プロピレン共重合体、エチレン・α−オレフィン共重合体、エチレン・アクリル酸共重合体、エチレン・メタクリル酸共重合体、エチレン・酢酸ビニル共重合体、エチレン・アクリル酸エチル共重合体等が挙げられ、本発明においては、これらの1種又は2種以上を組み合わせて使用できる。
本発明において、ポリオレフィン系樹脂としては、変色抑制作用の観点から、ポリエチレン、ポリプロピレン、環状ポリオレフィンが好ましく、ポリエチレン、ポリプロピレンが特に好ましい。
なお、本発明において、「ポリオレフィン系樹脂製」とは、その材質の少なくとも一部にポリオレフィン系樹脂を含んでいることを意味し、例えば、ポリオレフィン系樹脂と他の樹脂との2種以上の樹脂の混合体(ポリマーアロイ)も「ポリオレフィン系樹脂製」に含まれる。
In the present invention, the "polyolefin-based resin" is not particularly limited, and may be a polymer of a single type of monomer (homopolymer) or a copolymer of a plurality of types of monomers (copolymer). Further, in the case of a copolymer, the polymerization mode is not particularly limited, and random polymerization or block polymerization may be used. Furthermore, its stereoregularity (tacticity) is not particularly limited.
Specific examples of such polyolefin-based resins include polyethylene (more specifically, for example, low-density polyethylene (including linear low-density polyethylene), high-density polyethylene, medium-density polyethylene, etc.), polypropylene, and cyclic resin. Polyolefin, poly (4-methylpentene), polytetrafluoroethylene, ethylene / propylene copolymer, ethylene / α-olefin copolymer, ethylene / acrylic acid copolymer, ethylene / methacrylic acid copolymer, ethylene / acetic acid Examples thereof include vinyl copolymers, ethylene / ethyl acrylate copolymers, and the like, and in the present invention, one or a combination of two or more of these can be used.
In the present invention, the polyolefin-based resin is preferably polyethylene, polypropylene or cyclic polyolefin, and particularly preferably polyethylene or polypropylene, from the viewpoint of suppressing discoloration.
In the present invention, "made of a polyolefin-based resin" means that at least a part of the material contains a polyolefin-based resin. For example, two or more kinds of resins, a polyolefin-based resin and another resin, are used. (Polymer alloy) is also included in "made of polyolefin resin".
本発明において、「ポリオレフィン系樹脂製容器」とは、容器において、その内部に収容された液状又は半固形状の組成物と接する部分の少なくとも一部(好適には、通常の保存時において組成物と接する部分の10%以上、より好適には、通常の保存時において組成物と接する部分の30%以上、特に好適には、通常の保存時において組成物と接する部分の全体)が「ポリオレフィン系樹脂製」である「容器」を意味する。従って、例えば液状又は半固形状の組成物と接する層(容器の最内層)の少なくとも一部にポリオレフィン系樹脂の層を設け、その外側に他の材質の樹脂やアルミニウム箔等の素材を積層等させてなる容器も、「ポリオレフィン系樹脂製容器」に該当する。
このような、複数種の素材を積層等させてなる容器としては、具体的には例えば、ポリオレフィン系樹脂で構成された層を最内層とし、その外側に直接あるいは他の層を介してアルミニウム箔を積層し、さらにその外側に必要に応じて任意に他の層を積層してなるラミネートフィルム製の容器等が挙げられる。
In the present invention, the "polyolefin-based resin container" refers to at least a part (preferably, the composition during normal storage) of the container in contact with the liquid or semi-solid composition contained therein. 10% or more of the portion in contact with the composition, more preferably 30% or more of the portion in contact with the composition during normal storage, particularly preferably the entire portion in contact with the composition during normal storage) is "polyolefin-based". It means "container" which is "made of resin". Therefore, for example, a polyolefin-based resin layer is provided on at least a part of the layer (innermost layer of the container) in contact with the liquid or semi-solid composition, and other materials such as resin and aluminum foil are laminated on the outside thereof. The container to be used also falls under the category of "polyolefin resin container".
As a container formed by laminating a plurality of types of materials as described above, specifically, for example, a layer made of a polyolefin resin is used as the innermost layer, and an aluminum foil is provided on the outer side of the container directly or via another layer. Examples thereof include a container made of a laminated film, which is formed by laminating the above-mentioned materials and further laminating other layers on the outside thereof, if necessary.
なお、本発明において、液状又は半固形状の組成物の、容器への収容手段は特に限定されず、容器の形状や組成物の性状等に応じて、常法により充填等すればよく、これにより本発明の医薬製剤が製造できる。 In the present invention, the means for accommodating the liquid or semi-solid composition in the container is not particularly limited, and the composition may be filled by a conventional method according to the shape of the container, the properties of the composition, and the like. Therefore, the pharmaceutical preparation of the present invention can be produced.
<医薬製剤>
本発明において、「医薬製剤」の投与方法・適用方法は特に限定されず、経口及び経皮、経膣等の非経口が挙げられる。本発明においては、液状又は半固形状の組成物の特性(患部の位置、形状や範囲に応じて柔軟に必要な量だけ塗布等することが可能である点)から、非経口が好ましく、経皮投与が特に好ましい。
<Pharmaceutical product>
In the present invention, the administration method and application method of the "pharmaceutical preparation" are not particularly limited, and examples thereof include oral, transdermal, and parenteral such as transvaginal. In the present invention, parenteral is preferable because of the characteristics of the liquid or semi-solid composition (the point that it can be flexibly applied in a required amount according to the position, shape and range of the affected area). Skin administration is particularly preferred.
本発明において、医薬製剤の剤形は、容器に収容された組成物が液状又は半固形状である限りにおいて特に限定されるものではなく、その利用目的等に応じて、例えば、第十六改正日本薬局方 製剤総則等に記載の剤形から適宜選択できる。こうした剤形としては、具体的には例えば、皮膚等に適用する製剤(外用液剤、スプレー剤、軟膏剤、クリーム剤、ゲル剤等)、経口投与する製剤(経口液剤、シロップ剤、経口ゼリー剤等)などの、第十六改正日本薬局方 製剤総則に記載の剤形が挙げられる。
本発明において医薬製剤としては、外用液剤、スプレー剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形であるのが好ましく、リニメント剤、ローション剤、外用エアゾール剤、ポンプスプレー剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形であるのがより好ましく、ローション剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形であるのが特に好ましい。
In the present invention, the dosage form of the pharmaceutical preparation is not particularly limited as long as the composition contained in the container is in a liquid or semi-solid state, and for example, the sixteenth amendment is made according to the purpose of use thereof. It can be appropriately selected from the dosage forms described in the Japanese Pharmacopoeia General Regulations for Formulation. Specific examples of such dosage forms include preparations applied to the skin and the like (external liquids, sprays, ointments, creams, gels, etc.) and orally administered preparations (oral liquids, syrups, oral jelly). Etc.), etc., and the dosage forms described in the 16th Amendment of the General Regulations for Pharmaceutical Formulations of the Japanese Pharmacy.
In the present invention, the pharmaceutical preparation is preferably in a dosage form selected from the group consisting of external liquids, sprays, ointments, creams and gels, and liniments, lotions, external aerosols, pump sprays, etc. The dosage form selected from the group consisting of ointments, creams and gels is more preferable, and the dosage form selected from the group consisting of lotions, ointments, creams and gels is particularly preferable.
本発明の医薬製剤は、NSAIDの一種であるロキソプロフェン又はその塩を含有することから、医療用医薬品やOTC医薬品として用いることができ、具体的には例えば外用消炎鎮痛剤;解熱鎮痛薬、総合感冒薬(かぜ薬)等の内服薬;等として有用である。 Since the pharmaceutical preparation of the present invention contains loxoprofen, which is a kind of NSAID, or a salt thereof, it can be used as a medical drug or an OTC drug. It is useful as an internal medicine such as a medicine (cold medicine); etc.
次に、「方法」の態様の発明について以下に説明する。
本発明は、次の成分(A)及び(B):
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物を、ポリオレフィン系樹脂製容器に収容する工程を含む、組成物の変色の抑制方法にも関する。
斯かる態様の発明において、成分(A)を配合する工程、成分(B)を配合する工程、及び組成物をポリオレフィン系樹脂製容器に収容する工程の順序は特に限定されず、成分(A)及び(B)を含有する液状又は半固形状の組成物がポリオレフィン系樹脂製容器に収容された状態が直接的又は間接的に作出されればよい。
なお、斯かる態様の発明において、各種文言の意義、各成分の配合量等は全て「医薬製剤」について説明したのと同様である。
Next, the invention of the aspect of the "method" will be described below.
In the present invention, the following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
It also relates to a method for suppressing discoloration of the composition, which comprises a step of accommodating the liquid or semi-solid composition containing the above in a polyolefin-based resin container.
In the invention of such an embodiment, the order of the step of blending the component (A), the step of blending the component (B), and the step of accommodating the composition in the polyolefin resin container is not particularly limited, and the step of blending the component (A) is not particularly limited. The state in which the liquid or semi-solid composition containing (B) and (B) is contained in a polyolefin-based resin container may be directly or indirectly created.
In the invention of such an aspect, the meanings of various words, the blending amount of each component, and the like are all the same as those described for the "pharmaceutical preparation".
本明細書は、以上の実施形態に関連して、例えば以下に例示される発明を開示するが、これらに何ら限定されるものではない。
[1] 次の成分(A)及び(B):
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物が、ポリオレフィン系樹脂製容器に収容されてなる、医薬製剤。
[2] 成分(A)が、ロキソプロフェンナトリウム水和物である、[1]記載の医薬製剤。
[3] 成分(B)が、トウガラシ、トウガラシ末、トウガラシ軟エキス、トウガラシ乾燥エキス、カプサイシン及びノナン酸バニリルアミド(ノニル酸ワニリルアミド)よりなる群から選ばれる1種以上である、[1]又は[2]記載の医薬製剤。
[4] 成分(B)が、トウガラシ軟エキス及びノナン酸バニリルアミド(ノニル酸ワニリルアミド)よりなる群から選ばれる1種以上である、[1]又は[2]記載の医薬製剤。
The present specification discloses, for example, the inventions exemplified below in relation to the above embodiments, but is not limited thereto.
[1] The following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
A pharmaceutical preparation in which a liquid or semi-solid composition containing the above is contained in a polyolefin-based resin container.
[2] The pharmaceutical preparation according to [1], wherein the component (A) is loxoprofen sodium hydrate.
[3] The component (B) is at least one selected from the group consisting of capsicum, capsicum powder, capsicum soft extract, capsicum dried extract, capsaicin and nonanoic acid vanillylamide (nonyl acid vanillylamide), [1] or [2]. ] Described pharmaceutical preparation.
[4] The pharmaceutical preparation according to [1] or [2], wherein the component (B) is at least one selected from the group consisting of soft pepper extract and vanillylamide nonanoic acid (vanillylamide nonamic acid).
[5] 組成物が、水を更に含有するものである、[1]〜[4]のいずれか記載の医薬製剤。
[6] 組成物が、低級アルコールを更に含有するものである、[1]〜[5]のいずれか記載の医薬製剤。
[7] 低級アルコールが、エタノール及びイソプロパノールよりなる群から選ばれる1種以上である、[6]記載の医薬製剤。
[8] ポリオレフィン系樹脂が、ポリエチレン及びポリプロピレンよりなる群から選ばれる1種以上である、[1]〜[7]のいずれか記載の医薬製剤。
[9] 容器が、エアゾール剤用容器、ポンプスプレー剤用容器、ボトル容器、チューブ容器又は点眼容器である、[1]〜[8]のいずれか記載の医薬製剤。
[10] 容器が、以下の(1)又は(2):
(1) 容器本体と塗布部材とを備え、前記容器本体に収容された組成物を前記塗布部材に含浸させて使用する容器;
(2) 柔軟性を有する容器本体と、吐出口とを備えてなる容器;
である、[1]〜[8]のいずれか記載の医薬製剤。
[11] 容器が、スポンジ状の塗布部材を備えるボトル容器、又はチューブ容器である、[1]〜[8]のいずれか記載の医薬製剤。
[12] 外用液剤、スプレー剤、軟膏剤、クリーム剤、ゲル剤、経口液剤、シロップ剤及び経口ゼリー剤よりなる群から選ばれる剤形である、[1]〜[11]のいずれか記載の医薬製剤。
[13] 外用液剤、スプレー剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形である、[1]〜[11]のいずれか記載の医薬製剤。
[14] リニメント剤、ローション剤、エアゾール剤、ポンプスプレー剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形である、[1]〜[11]のいずれか記載の医薬製剤。
[15] ローション剤、軟膏剤、クリーム剤及びゲル剤よりなる群から選ばれる剤形である、[1]〜[11]のいずれか記載の医薬製剤。
[5] The pharmaceutical preparation according to any one of [1] to [4], wherein the composition further contains water.
[6] The pharmaceutical preparation according to any one of [1] to [5], wherein the composition further contains a lower alcohol.
[7] The pharmaceutical preparation according to [6], wherein the lower alcohol is one or more selected from the group consisting of ethanol and isopropanol.
[8] The pharmaceutical preparation according to any one of [1] to [7], wherein the polyolefin-based resin is at least one selected from the group consisting of polyethylene and polypropylene.
[9] The pharmaceutical preparation according to any one of [1] to [8], wherein the container is a container for an aerosol agent, a container for a pump spray agent, a bottle container, a tube container or an eye drop container.
[10] The container is the following (1) or (2):
(1) A container provided with a container body and a coating member, and used by impregnating the coating member with the composition contained in the container body;
(2) A container provided with a flexible container body and a discharge port;
The pharmaceutical preparation according to any one of [1] to [8].
[11] The pharmaceutical preparation according to any one of [1] to [8], wherein the container is a bottle container or a tube container provided with a sponge-like coating member.
[12] The dosage form according to any one of [1] to [11], which is a dosage form selected from the group consisting of external liquids, sprays, ointments, creams, gels, oral liquids, syrups and oral jellies. Pharmaceutical product.
[13] The pharmaceutical preparation according to any one of [1] to [11], which is a dosage form selected from the group consisting of external liquids, sprays, ointments, creams and gels.
[14] The pharmaceutical preparation according to any one of [1] to [11], which is a dosage form selected from the group consisting of a liniment agent, a lotion agent, an aerosol agent, a pump spray agent, an ointment agent, a cream agent and a gel agent.
[15] The pharmaceutical preparation according to any one of [1] to [11], which is a dosage form selected from the group consisting of lotions, ointments, creams and gels.
[16] 次の成分(A)及び(B):
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物を、ポリオレフィン系樹脂製容器に収容する工程を含む、組成物の変色の抑制方法。
[17] 成分(A)が、ロキソプロフェンナトリウム水和物である、[16]記載の方法。
[18] 成分(B)が、トウガラシ、トウガラシ末、トウガラシ軟エキス、トウガラシ乾燥エキス、カプサイシン及びノナン酸バニリルアミド(ノニル酸ワニリルアミド)よりなる群から選ばれる1種以上である、[16]又は[17]記載の方法。
[19] 成分(B)が、トウガラシ軟エキス及びノナン酸バニリルアミド(ノニル酸ワニリルアミド)よりなる群から選ばれる1種以上である、[16]又は[17]記載の方法。
[16] The following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
A method for suppressing discoloration of a composition, which comprises a step of accommodating a liquid or semi-solid composition containing the above in a polyolefin-based resin container.
[17] The method according to [16], wherein the component (A) is loxoprofen sodium hydrate.
[18] The component (B) is at least one selected from the group consisting of capsicum, capsicum powder, capsicum soft extract, capsicum dried extract, capsaicin and nonanoic acid vanillylamide (nonyl acid vanillylamide), [16] or [17]. ] The method described.
[19] The method according to [16] or [17], wherein the component (B) is at least one selected from the group consisting of a soft pepper extract and vanillylamide nonanoic acid (vanillylamide nonamic acid).
[20] 組成物が、水を更に含有するものである、[16]〜[19]のいずれか記載の方法。
[21] 組成物が、低級アルコールを更に含有するものである、[16]〜[20]のいずれか記載の方法。
[22] 低級アルコールが、エタノール及びイソプロパノールよりなる群から選ばれる1種以上である、[21]記載の方法。
[23] ポリオレフィン系樹脂が、ポリエチレン及びポリプロピレンよりなる群から選ばれる1種以上である、[16]〜[22]のいずれか記載の方法。
[24] 容器が、エアゾール剤用容器、ポンプスプレー剤用容器、ボトル容器、チューブ容器又は点眼容器である、[16]〜[23]のいずれか記載の方法。
[25] 容器が、以下の(1)又は(2):
(1) 容器本体と塗布部材とを備え、前記容器本体に収容された組成物を前記塗布部材に含浸させて使用する容器;
(2) 柔軟性を有する容器本体と、吐出口とを備えてなる容器;
である、[16]〜[23]のいずれか記載の方法。
[26] 容器が、スポンジ状の塗布部材を備えるボトル容器、又はチューブ容器である、[16]〜[23]のいずれか記載の方法。
[20] The method according to any one of [16] to [19], wherein the composition further contains water.
[21] The method according to any one of [16] to [20], wherein the composition further contains a lower alcohol.
[22] The method according to [21], wherein the lower alcohol is at least one selected from the group consisting of ethanol and isopropanol.
[23] The method according to any one of [16] to [22], wherein the polyolefin-based resin is at least one selected from the group consisting of polyethylene and polypropylene.
[24] The method according to any one of [16] to [23], wherein the container is a container for an aerosol agent, a container for a pump spray agent, a bottle container, a tube container, or an eye drop container.
[25] The container is the following (1) or (2):
(1) A container provided with a container body and a coating member, and used by impregnating the coating member with the composition contained in the container body;
(2) A container provided with a flexible container body and a discharge port;
The method according to any one of [16] to [23].
[26] The method according to any one of [16] to [23], wherein the container is a bottle container or a tube container provided with a sponge-like coating member.
以下に実施例を挙げて本発明を詳細に説明するが、本発明はこれら実施例に何ら限定されるものではない。 Hereinafter, the present invention will be described in detail with reference to examples, but the present invention is not limited to these examples.
[試験例1]保存試験 その1
表1に示す成分及び分量を含有する液状の組成物を調製し、ポリエチレン製又はガラス製の容器に収容して、それぞれ実施例1、比較例1、2の医薬製剤とした。
得られた各種の医薬製剤を、80℃の暗所に1週間保存し、3日間保存後及び1週間保存後の変色(黄変)の有無を目視により評価した。なお、結果は、変色が生じなかったものを○、変色が生じたものを×として評価した。
結果を表1に示す。
[Test Example 1] Preservation test 1
A liquid composition containing the components and amounts shown in Table 1 was prepared and contained in a polyethylene or glass container to prepare the pharmaceutical preparations of Example 1 and Comparative Examples 1 and 2, respectively.
The obtained various pharmaceutical preparations were stored in a dark place at 80 ° C. for 1 week, and the presence or absence of discoloration (yellowing) after storage for 3 days and 1 week was visually evaluated. The results were evaluated as ◯ for those without discoloration and x for those with discoloration.
The results are shown in Table 1.
比較例1(ポリエチレン製容器収容)と比較例2(ガラス製容器収容)との対比より、組成物をポリエチレン製の容器に収容することにより3日間保存後の変色が抑制され多少の変色抑制作用が発揮されるものの、その作用は十分では無く、1週間保存後には変色が生じることが確認された。
一方、実施例1(トウガラシ軟エキス配合、ポリエチレン製容器収容)と比較例1(ポリエチレン製容器収容)との対比より、組成物にさらにトウガラシ軟エキスを配合したうえでポリエチレン製の容器に収容することによって、1週間保存後の変色も抑制され、十分な変色抑制作用が発揮されることが確認された。
From the comparison between Comparative Example 1 (containing in a polyethylene container) and Comparative Example 2 (accommodating in a glass container), by accommodating the composition in a polyethylene container, discoloration after storage for 3 days was suppressed and a slight discoloration suppressing action was performed. However, its action was not sufficient, and it was confirmed that discoloration occurred after storage for 1 week.
On the other hand, in comparison with Example 1 (combined with capsicum soft extract, contained in a polyethylene container) and Comparative Example 1 (contained in a polyethylene container), the composition is further blended with the capsicum soft extract and then contained in a polyethylene container. As a result, it was confirmed that discoloration after storage for one week was also suppressed and a sufficient discoloration suppressing effect was exhibited.
以上の試験結果より、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物に、さらにトウガラシ又はその抽出物を含有せしめ、かつ、これをポリオレフィン系樹脂製の容器に収容することにより、高温保存時における変色を抑制できることが明らかとなった。 Based on the above test results, a liquid or semi-solid composition containing loxoprofen or a salt thereof is further impregnated with capsicum or an extract thereof, and the temperature is increased by storing the pepper in a container made of a polyolefin resin. It was clarified that discoloration during storage can be suppressed.
[試験例2]保存試験 その2
表2に示す成分及び分量を含有する液状の組成物を調製し、ポリエチレン製又はガラス製の容器に収容して、それぞれ実施例2、比較例3、4の医薬製剤とし、試験例1と同様の方法により80℃の暗所に3日間及び1週間保存した後の変色の有無を評価した。
結果を表2に示す。
[Test Example 2] Preservation test 2
A liquid composition containing the components and amounts shown in Table 2 was prepared and contained in a polyethylene or glass container to prepare pharmaceutical formulations of Examples 2, Comparative Examples 3 and 4, respectively, as in Test Example 1. The presence or absence of discoloration after storage in a dark place at 80 ° C. for 3 days and 1 week was evaluated by the above method.
The results are shown in Table 2.
以上の試験結果より、トウガラシ軟エキスに代えてノナン酸バニリルアミドを含有せしめた場合にも、同様に高温保存時における変色の抑制が確認された。 From the above test results, it was confirmed that discoloration was similarly suppressed during high-temperature storage even when pelargonic acid vanillylamide was contained instead of the soft pepper extract.
[試験例3]保存試験 その3
表3に示す成分及び分量を含有する液状の組成物を調製し、ポリエチレン製の容器に収容して実施例3の医薬製剤とし、試験例1と同様の方法により80℃の暗所に1週間保存した後の変色の有無を評価した。
結果を表3に示す。
[Test Example 3] Preservation test No. 3
A liquid composition containing the components and amounts shown in Table 3 was prepared, contained in a polyethylene container to form the pharmaceutical preparation of Example 3, and placed in a dark place at 80 ° C. for 1 week by the same method as in Test Example 1. The presence or absence of discoloration after storage was evaluated.
The results are shown in Table 3.
以上の試験結果より、低級アルコールとしてイソプロパノールに代えてエタノールを用いた場合でも、同様に高温保存時における変色の抑制が確認された。 From the above test results, it was confirmed that even when ethanol was used instead of isopropanol as the lower alcohol, discoloration was similarly suppressed during high-temperature storage.
以上の試験例1〜3の結果より、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物に、さらにトウガラシ軟エキス、ノナン酸バニリルアミドに代表されるトウガラシ又はその抽出物を含有せしめ、かつ、ポリオレフィン系樹脂製の容器に収容することにより、高温保存時における変色を抑制できることが明らかとなった。 Based on the results of Test Examples 1 to 3 above, the liquid or semi-solid composition containing loxoprofen or a salt thereof is further impregnated with a soft and chili pepper extract, a capsicum typified by nonanoic acid vanillylamide, or an extract thereof. , It was clarified that discoloration during high temperature storage can be suppressed by storing in a container made of polyolefin resin.
[試験例4]保存試験 その4
表4に示す成分及び分量を含有する液状の組成物を調製し、ポリエチレン製又はガラス製の容器に収容して、それぞれ実施例4、比較例5、6又は参考例1の医薬製剤とし、試験例1と同様の方法により80℃の暗所に2週間保存した後の変色の有無を評価した。
結果を表4に示す。
[Test Example 4] Preservation test No. 4
A liquid composition containing the components and amounts shown in Table 4 was prepared and contained in a polyethylene or glass container to prepare the pharmaceutical preparations of Example 4, Comparative Examples 5, 6 or Reference Example 1, respectively, for testing. The presence or absence of discoloration after storage in a dark place at 80 ° C. for 2 weeks was evaluated by the same method as in Example 1.
The results are shown in Table 4.
比較例5と、参考例1(ロキソプロフェン非配合)との対比より、80℃2週間の保存後において確認された変色は、ロキソプロフェンを液状の組成物に配合したことに起因するものであることが確認された。
そして、実施例4と、比較例5(ガラス製容器収容)、比較例6(ノナン酸バニリルアミド非配合)との対比より、液状の組成物にさらにノナン酸バニリルアミドを配合し、かつ、ポリエチレン製の容器に収容することにより、斯かる変色を抑制できることが確認された。
From the comparison between Comparative Example 5 and Reference Example 1 (without loxoprofen), the discoloration confirmed after storage at 80 ° C. for 2 weeks may be due to the addition of loxoprofen to the liquid composition. confirmed.
Then, by comparing Example 4 with Comparative Example 5 (contained in a glass container) and Comparative Example 6 (without pelargonic acid vanillylamide), the liquid composition was further blended with pelargonic acid vanillylamide and made of polyethylene. It was confirmed that such discoloration can be suppressed by containing the mixture in a container.
[試験例5]保存試験 その5
表5に示す成分及び分量を含有する液状の組成物を調製し、ポリプロピレン製の容器に収容して実施例5、6の医薬製剤とし、試験例1と同様の方法により80℃の暗所に2週間保存した後の変色の有無を評価した。
結果を表5に示す。
[Test Example 5] Preservation test No. 5
A liquid composition containing the components and amounts shown in Table 5 was prepared, contained in a polypropylene container to prepare the pharmaceutical preparations of Examples 5 and 6, and placed in a dark place at 80 ° C. by the same method as in Test Example 1. The presence or absence of discoloration after storage for 2 weeks was evaluated.
The results are shown in Table 5.
以上の試験結果より、ポリオレフィン系樹脂製容器としてポリエチレン製容器に代えてポリプロピレン製容器を用いた場合でも、同様に高温保存時における変色の抑制が確認された。 From the above test results, it was confirmed that even when a polypropylene container was used instead of the polyethylene container as the polyolefin-based resin container, discoloration was similarly suppressed during high-temperature storage.
[試験例6]保存試験 その6
実施例1、3の医薬製剤に収容されているのと同一の液状の組成物を調製し、これを、容器において塗布部材として用いられる、低密度ポリエチレン製の連通多孔質体(MAPS:(株)イノアックコーポレーション)に含浸させた後、80℃の暗所に1週間保存したが、いずれの組成物においても明らかな変色は認められなかった。
[Test Example 6] Preservation test No. 6
A communication porous body (MAPS: Co., Ltd .) made of low-density polyethylene, which is used as a coating member in a container by preparing the same liquid composition as contained in the pharmaceutical preparations of Examples 1 and 3. ) Inoac Corporation) and then stored in a dark place at 80 ° C. for 1 week, but no obvious discoloration was observed in any of the compositions.
製造例1(ローション剤)
常法により、下記表6に記載の成分及び分量(g)を100g中に含有する液状の組成物(処方例1〜8)を製造し、ポリプロピレン製の容器本体の口部にスポンジ状のポリウレタン製塗布部材を装着したボトル容器に収容し、それぞれ製造例1−1〜1−8の医薬製剤(ローション剤)とした。
Production Example 1 (lotion agent)
A liquid composition (formulation examples 1 to 8) containing the components and amounts (g) shown in Table 6 below in 100 g is produced by a conventional method, and sponge-like polyurethane is formed on the mouth of a polypropylene container body. The product was housed in a bottle container equipped with a coating member, and used as a pharmaceutical preparation (lotion agent) of Production Examples 1-1 to 1-8, respectively.
製造例2(ローション剤)
常法により、上記表6に記載の成分及び分量(g)を100g中に含有する液状の組成物(処方例1〜8)を製造し、ポリエチレン製の容器本体の口部にスポンジ状の低密度ポリエチレン製塗布部材(MAPS:(株)イノアックコーポレーション)を装着したボトル容器に収容し、それぞれ製造例2−1〜2−8の医薬製剤(ローション剤)とした。
Production Example 2 (lotion agent)
A liquid composition (formulation examples 1 to 8) containing the components and the amount (g) shown in Table 6 above in 100 g is produced by a conventional method, and a sponge-like low density polyethylene container body is provided at the mouth. It was housed in a bottle container equipped with a coating member made of density polyethylene (MAPS: Inoac Corporation), and used as a pharmaceutical preparation (lotion agent) of Production Examples 2-1 to 2-8, respectively.
製造例3(ローション剤)
常法により、下記表7に記載の成分及び分量(g)を100g中に含有する液状の組成物(処方例9〜16)を製造し、ポリプロピレン製の容器本体の口部にスポンジ状のポリウレタン製塗布部材を装着したボトル容器に収容し、それぞれ製造例3−1〜3−8の医薬製剤(ローション剤)とした。
Production Example 3 (lotion agent)
A liquid composition (formulation examples 9 to 16) containing the components and amounts (g) shown in Table 7 below in 100 g is produced by a conventional method, and sponge-like polyurethane is formed on the mouth of a polypropylene container body. The product was housed in a bottle container equipped with a coating member, and used as a pharmaceutical preparation (lotion agent) of Production Examples 3-1 to 3-8, respectively.
製造例4(ローション剤)
常法により、上記表7に記載の成分及び分量(g)を100g中に含有する液状の組成物(処方例9〜16)を製造し、ポリエチレン製の容器本体の口部にスポンジ状の低密度ポリエチレン製塗布部材(MAPS:(株)イノアックコーポレーション)を装着したボトル容器に収容し、それぞれ製造例4−1〜4−8の医薬製剤(ローション剤)とした。
Production Example 4 (lotion agent)
A liquid composition (formulation examples 9 to 16) containing the components and the amount (g) shown in Table 7 above in 100 g is produced by a conventional method, and a sponge-like low density polyethylene container body is formed at the mouth. It was housed in a bottle container equipped with a coating member made of density polyethylene (MAPS: Inoac Corporation), and used as a pharmaceutical preparation (lotion agent) of Production Examples 4-1 to 4-8, respectively.
製造例5(ゲル剤)
常法により、下記表8に記載の成分及び分量(g)を100g中に含有する半固形状の組成物(処方例17〜24)を製造し、低密度ポリエチレン製のフィルムを最内層としてその外側(中間層)にアルミニウム箔、さらにその外側に低密度ポリエチレン製のフィルムを積層したラミネートフィルム製のチューブ容器(ラミネートチューブ)に収容し、それぞれ製造例5−1〜5−8の医薬製剤(ゲル剤)とした。
Production Example 5 (Gel agent)
A semi-solid composition (Formulation Examples 17 to 24) containing the components and amounts (g) shown in Table 8 below in 100 g is produced by a conventional method, and the film made of low-density polyethylene is used as the innermost layer. The pharmaceutical preparations of Production Examples 5-1 to 5-8 are housed in a tube container (laminated tube) made of a laminated film in which an aluminum foil is laminated on the outer side (intermediate layer) and a low-density polyethylene film is laminated on the outer side thereof. Gel agent).
製造例6(軟膏剤)
常法により、下記表9に記載の成分及び分量(g)を100g中に含有する半固形状の組成物(処方例25〜32)を製造し、高密度ポリエチレン製のフィルムを最内層としてその外側(中間層)にポリエチレンテレフタレート製のフィルム、さらにその外側に高密度ポリエチレン製のフィルムを積層したラミネートフィルム製のチューブ容器(ラミネートチューブ)に収容し、それぞれ製造例6−1〜6−8の医薬製剤(軟膏剤)とした。
Production Example 6 (ointment)
A semi-solid composition (Formulation Examples 25 to 32) containing the components and amounts (g) shown in Table 9 below in 100 g is produced by a conventional method, and the film made of high-density polyethylene is used as the innermost layer. It is housed in a tube container (laminated tube) made of a laminated film in which a polyethylene terephthalate film is laminated on the outer side (intermediate layer) and a high-density polyethylene film is laminated on the outer side thereof. It was used as a pharmaceutical preparation (ointment).
製造例7(クリーム剤)
常法により、下記表10に記載の成分及び分量(g)を100g中に含有する半固形状の組成物(処方例33〜40)を製造し、低密度ポリエチレン製のフィルムを最内層としてその外側(中間層)にナイロン製のフィルム、さらにその外側に低密度ポリエチレン製のフィルムを積層したラミネートフィルム製のチューブ容器(ラミネートチューブ)に収容し、それぞれ製造例7−1〜7−8の医薬製剤(クリーム剤)とした。
Production Example 7 (Cream)
A semi-solid composition (Formulation Examples 33 to 40) containing the components and amounts (g) shown in Table 10 below in 100 g is produced by a conventional method, and a film made of low-density polyethylene is used as the innermost layer. It is housed in a tube container (laminated tube) made of a laminated film in which a nylon film is laminated on the outer side (intermediate layer) and a low-density polyethylene film is laminated on the outer side thereof. It was prepared as a preparation (cream).
製造例8(経口液剤)
常法により、下記表11に記載の成分及び分量(mg)を30mL中に含有する液状の組成物(処方例41〜48)を製造し、ポリプロピレン製のボトル容器に収容し、それぞれ製造例8−1〜8−8の医薬製剤(経口液剤)とした。
Production Example 8 (oral solution)
A liquid composition (Formulation Examples 41 to 48) containing the components and amounts (mg) shown in Table 11 below in 30 mL is produced by a conventional method, and is contained in a polypropylene bottle container, and each of them is produced in Production Example 8. It was prepared as a pharmaceutical preparation (oral solution) of -1 to 8-8.
本発明によれば、ロキソプロフェン又はその塩を含有する液状又は半固形状の組成物の、高温保存時における変色を抑制できる。したがって、保存安定性に優れた、ロキソプロフェン又はその塩を含有する医薬を提供することができ、医薬品産業等において好適に利用できる。 According to the present invention, discoloration of a liquid or semi-solid composition containing loxoprofen or a salt thereof at high temperature storage can be suppressed. Therefore, it is possible to provide a drug containing loxoprofen or a salt thereof, which has excellent storage stability, and can be suitably used in the pharmaceutical industry and the like.
Claims (1)
(A)ロキソプロフェン又はその塩;
(B)トウガラシ又はその抽出物;
を含有する液状又は半固形状の組成物を、ポリオレフィン系樹脂製容器に収容する工程を含む、組成物の変色の抑制方法。 The following components (A) and (B):
(A) Loxoprofen or a salt thereof;
(B) Capsicum or its extract;
A method for suppressing discoloration of a composition, which comprises a step of accommodating a liquid or semi-solid composition containing the above in a polyolefin-based resin container.
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WO2014002599A1 (en) * | 2012-06-25 | 2014-01-03 | 興和株式会社 | Crude-drug-containing pharmaceutical composition |
JP2014224110A (en) * | 2013-04-25 | 2014-12-04 | 第一三共ヘルスケア株式会社 | Loxoprofen-containing external preparation composition |
JP2015098469A (en) * | 2013-10-16 | 2015-05-28 | 興和株式会社 | Pharmaceutical composition comprising chili pepper |
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WO2014002599A1 (en) * | 2012-06-25 | 2014-01-03 | 興和株式会社 | Crude-drug-containing pharmaceutical composition |
JP2014224110A (en) * | 2013-04-25 | 2014-12-04 | 第一三共ヘルスケア株式会社 | Loxoprofen-containing external preparation composition |
JP2015098469A (en) * | 2013-10-16 | 2015-05-28 | 興和株式会社 | Pharmaceutical composition comprising chili pepper |
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医薬品インタビューフォーム ロキソプロフェンNA外用ポンプスプレー1%「TCK」, vol. 2015年2月改訂(第1版), JPN6017010920, February 2015 (2015-02-01), JP, pages 1 - 16, ISSN: 0004955865 * |
医薬品インタビューフォーム ロキソプロフェンNA外用ポンプスプレー1%「YD」, vol. 2015年6月改訂(第3版), JPN6017010918, June 2015 (2015-06-01), JP, pages 1 - 30, ISSN: 0004955866 * |
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