JP6968589B2 - Film-forming external preparation - Google Patents
Film-forming external preparation Download PDFInfo
- Publication number
- JP6968589B2 JP6968589B2 JP2017124046A JP2017124046A JP6968589B2 JP 6968589 B2 JP6968589 B2 JP 6968589B2 JP 2017124046 A JP2017124046 A JP 2017124046A JP 2017124046 A JP2017124046 A JP 2017124046A JP 6968589 B2 JP6968589 B2 JP 6968589B2
- Authority
- JP
- Japan
- Prior art keywords
- film
- external preparation
- forming external
- container
- weight
- 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.)
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Images
Landscapes
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Closures For Containers (AREA)
- Materials For Medical Uses (AREA)
Description
本発明は、皮膜形成性外用製剤が容器に収容されている外用製品に関する。より具体的には、本発明は、皮膜形成性外用製剤が、樹脂を構成素材として含む容器に収容されている外用製品であって、当該樹脂の変色を抑制できる外用製品に関する。 The present invention relates to an external product in which a film-forming external preparation is contained in a container. More specifically, the present invention relates to an external product in which the film-forming external preparation is contained in a container containing a resin as a constituent material and can suppress discoloration of the resin.
ひび、あかぎれ、さかむけ、切り傷等の皮膚損傷部を細菌の侵入や感染から予防する衛生材料として、絆創膏が知られている。絆創膏は、粘着剤を積層させたテープ基材の中央部にガーゼや吸収パッドが取り付けられたテープ状絆創膏タイプと、使用前は液状を呈するが、皮膚に適用すると皮膜を形成する液体絆創膏に大別される。テープ状絆創膏では、粘着剤が皮膚を刺激したり、剥離時に皮膚に物理的刺激を与えたりするため、皮膚に発赤、かぶれ、痒み等を生じさせることがある。更に、皮膚損傷部位の大きさや形状は、損傷部位や損傷原因等によって種々異なるため、大きさや形状が予め決められているテープ状絆創膏では、皮膚損傷部位を選択的に被覆することができないという欠点もある。これに対して、液体絆創膏とも称されている皮膜形成性外用製剤は、粘着剤を使用しておらず、剥離時の物理的刺激も緩和されており、更に、損傷部位に選択的に塗布することにより損傷部位の大きさや形状に応じた皮膜を形成できるため、テープ状絆創膏の前記欠点を補うものとして注目を浴びている。 Adhesive plasters are known as sanitary materials for preventing skin damage such as cracks, cracks, hangnail, and cuts from bacterial invasion and infection. Adhesive plasters are the tape-shaped adhesive plasters with gauze and absorbent pads attached to the center of the tape base material on which the adhesive is laminated, and the liquid adhesive plasters that are liquid before use but form a film when applied to the skin. Be separated. In tape-shaped adhesive plasters, the adhesive irritates the skin and physically irritates the skin at the time of peeling, which may cause redness, rashes, itching and the like on the skin. Further, since the size and shape of the skin damage site vary depending on the damage site and the cause of the damage, the tape-shaped adhesive plaster having a predetermined size and shape cannot selectively cover the skin damage site. There is also. On the other hand, the film-forming external preparation, which is also called a liquid bandage, does not use an adhesive, the physical irritation at the time of peeling is alleviated, and it is selectively applied to the damaged part. As a result, a film can be formed according to the size and shape of the injured site, and thus it is attracting attention as a supplement to the above-mentioned drawbacks of the tape-shaped adhesive plaster.
従来、皮膜形成性外用製剤では、皮膜形成成分としてニトロセルロースが使用されており、ニトロセルロースを利用した皮膜形成性外用製剤の製剤処方も種々報告されている。例えば、特許文献１には、炭素数１〜４の１価アルコール及び／又はベンジルアルコールと、炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステルと、ニトロセルロースとを所定量含む皮膜形成性外用製剤は、水と接触しても白濁化やゲル化を抑制でき、安定に皮膜を皮膚上で形成可能になることが開示されている。また、特許文献２には、ニトロセルロースと溶剤を含む油性剤と、水溶性高分子を含む水溶液とが油中水型に乳化された皮膚外用剤が、皮膚に対する軟化作用や付着性に優れ、洗浄・除去が容易であることが開示されている。また、特許文献３には、所定量のニトロセルロースとポリビニルピロリドンがアセトン及び低級アルコールの混合溶媒に溶解されている皮膚外用剤が、取り扱いが容易で速乾性に優れていることが開示されている。 Conventionally, nitrocellulose has been used as a film-forming component in a film-forming external preparation, and various formulations of a film-forming external preparation using nitrocellulose have been reported. For example, Patent Document 1 describes an ester of a monohydric alcohol having 1 to 4 carbon atoms and / or a benzyl alcohol, a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms, and nitrocellulose. It is disclosed that a film-forming external preparation containing a predetermined amount of and can suppress white turbidity and gelation even when in contact with water, and can stably form a film on the skin. Further, in Patent Document 2, a skin external preparation in which an oily agent containing nitrocellulose and a solvent and an aqueous solution containing a water-soluble polymer are emulsified into a water-in-oil type has excellent softening action and adhesiveness to the skin. It is disclosed that it is easy to clean and remove. Further, Patent Document 3 discloses that a skin external preparation in which a predetermined amount of nitrocellulose and polyvinylpyrrolidone are dissolved in a mixed solvent of acetone and a lower alcohol is easy to handle and has excellent quick-drying properties. ..
また、従来、皮膜形成性外用製剤を収容する容器として、使用簡便性の観点から、皮膜形成性外用製剤を皮膚に塗布するための塗布部材を備え、当該塗布部材と皮膜形成性外用製剤が接触した状態で容器内に収められているものが知られている。このような容器を構成する塗布部材は通常は樹脂製であるが、容器に収容する皮膜形成性外用製剤が当該樹脂に及ぼす影響については、従来検討されていない。 Further, conventionally, as a container for accommodating the film-forming external preparation, from the viewpoint of ease of use, a coating member for applying the film-forming external preparation to the skin is provided, and the coating member and the film-forming external preparation come into contact with each other. It is known that the product is contained in a container in a closed state. The coating member constituting such a container is usually made of a resin, but the influence of the film-forming external preparation contained in the container on the resin has not been studied so far.
本発明者は、皮膜形成性外用製剤の組成が、容器の構成素材として含まれる樹脂（塗布部材等の素材）に及ぼす影響を検討したところ、炭素数１〜４の１価アルコール及び／又はベンジルアルコール、炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル、及びニトロセルロースを含む皮膜形成性外用製剤は、樹脂素材の変色（黄変）を生じさせ、その外観を悪化させるという課題を新たに見出した。 The present inventor examined the influence of the composition of the film-forming external preparation on the resin (material such as a coating member) contained as a constituent material of the container, and found that it was a monohydric alcohol having 1 to 4 carbon atoms and / or benzyl. A film-forming external preparation containing an alcohol, an ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monovalent alcohol having 1 to 5 carbon atoms, and a nitrocellulose causes discoloration (yellowing) of the resin material. We have newly found the problem of deteriorating the appearance.
そこで、本発明の目的は、炭素数１〜４の１価アルコール及び／又はベンジルアルコール、炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル、及びニトロセルロースを含む皮膜形成性外用製剤が容器に収容されている外用製品において、当該容器の構成素材として含まれる樹脂の変色を抑制する技術を提供することである。 Therefore, an object of the present invention is to use a monohydric alcohol having 1 to 4 carbon atoms and / or a benzyl alcohol, an ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms, and nitrocellulose. It is an object of the present invention to provide a technique for suppressing discoloration of a resin contained as a constituent material of a container in an external product containing a film-forming external preparation containing the film.
本発明者は、前記課題を解決すべく鋭意検討を行ったところ、炭素数１〜４の１価アルコール、炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル、及びニトロセルロースと共に、パンテノール類を含む皮膜形成性外用製剤は、容器の構成素材として含まれる樹脂の変色を抑制でき、当該樹脂の外観を安定に維持できることを見出した。 As a result of diligent studies to solve the above problems, the present inventor has made an ester of a monohydric alcohol having 1 to 4 carbon atoms, a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms. , And a film-forming external preparation containing pantenols together with nitrocellulose has been found to be able to suppress discoloration of the resin contained as a constituent material of the container and to maintain the appearance of the resin in a stable manner.
更に、本発明者は、前記組成の皮膜形成性外用製剤は、使用中の皮膜の接着性と使用後の皮膜の剥離性が共に良好になることをも見出した。 Furthermore, the present inventor has also found that the film-forming external preparation having the above composition has good adhesiveness of the film during use and peelability of the film after use.
本発明は、これらの知見に基づいて更に検討を重ねることにより完成したものである。即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． 皮膜形成性外用製剤が容器に収容されている外用製品であって、
前記皮膜形成性外用製剤が、(A)炭素数１〜４の１価アルコール、(B)炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル、(C)ニトロセルロース、及び(D)パンテノール類を含み、
前記容器において、内部に収容した前記皮膜形成性外用製剤と接する領域の少なくとも一部が樹脂で形成されている、外用製品。
項２． 前記容器が、
開口部を有する容器本体と、
前記開口部を着脱自在に閉じるキャップと、
前記キャップに連結され、前記を前記開口に取付けられたとき前記容器の内部空間へ延びるように配置されている、前記皮膜形成性外用製剤を皮膚に塗布するための塗布部材と、
を有する、項１に記載の外用製品。
項３． 前記塗布部材の少なくとも一部が、樹脂で形成されている、項２に記載の外用製品。
項４． 前記樹脂が、ポリオレフィンである、項１〜３のいずれかに記載の外用製品。
項５． 前記樹脂が、ポリプロピレン又はポリエチレンである、項１〜４のいずれかに記載の外用製品。
項６． 前記皮膜形成性外用製剤が、更に(E)可塑剤を含む、項１〜５のいずれかに記載の外用製品。
項７． 前記(E)成分として植物油を０．０５〜１．５重量％含む、項６に記載の外用製品。
項８． 前記植物油がヒマシ油である、項７に記載の外用製品。
The present invention has been completed by further studies based on these findings. That is, the present invention provides the inventions of the following aspects.
Item 1. An external product in which a film-forming external preparation is contained in a container.
The film-forming external preparation comprises (A) an ester of a monohydric alcohol having 1 to 4 carbon atoms, (B) an ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms, and (C). Contains nitrocellulose and (D) pantenols,
An external product in which at least a part of a region in contact with the film-forming external preparation contained therein is formed of a resin in the container.
Item 2. The container
The container body with an opening and
With a cap that detachably closes the opening,
A coating member for applying the film-forming external preparation to the skin, which is connected to the cap and is arranged so as to extend into the internal space of the container when the said is attached to the opening.
Item 1. The external product according to Item 1.
Item 3. Item 2. The external product according to Item 2, wherein at least a part of the coating member is made of resin.
Item 4. Item 6. The external product according to any one of Items 1 to 3, wherein the resin is a polyolefin.
Item 5. Item 6. The external product according to any one of Items 1 to 4, wherein the resin is polypropylene or polyethylene.
Item 6. Item 2. The external product according to any one of Items 1 to 5, wherein the film-forming external preparation further contains (E) a plasticizer.
Item 7. Item 6. The external product according to Item 6, which contains 0.05 to 1.5% by weight of vegetable oil as the component (E).
Item 8. Item 2. The external product according to Item 7, wherein the vegetable oil is castor oil.
本発明の外用製品では、皮膜形成性外用製剤を収容している容器の構成素材として含まれる樹脂の変色を抑制できるので、優れた外観を維持することができる。 In the external product of the present invention, discoloration of the resin contained as a constituent material of the container containing the film-forming external preparation can be suppressed, so that an excellent appearance can be maintained.
また、本発明の外用製品で使用される皮膜形成性外用製剤は、皮膚への皮膜の接着性が良好であり、しかも使用後に皮膚から皮膜を剥がし易くなっているので、使用者の利便性を向上させることができる。更に、本発明の外用製品で使用される皮膜形成性外用製剤における好適な一態様では、皮膚上に形成した皮膜からパンテノール類の放出を促進することができるので、パンテノール類の薬理作用（創傷修復作用等）を効果的に発揮させることもできる。 In addition, the film-forming external preparation used in the external product of the present invention has good adhesion of the film to the skin, and the film can be easily peeled off from the skin after use, which is convenient for the user. Can be improved. Furthermore, in a preferred embodiment of the film-forming external preparation used in the external product of the present invention, the release of panthenol from the film formed on the skin can be promoted, so that the pharmacological action of the panthenol () It can also effectively exert a wound repair effect).
本発明の外用製品は、皮膜形成性外用製剤が容器に収容されている外用製品であって、当該皮膜形成性外用製剤が、炭素数１〜４の１価アルコール（以下、(A)成分と表記することもある）、炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル（以下、(B)成分と表記することもある）、ニトロセルロース（以下、(C)成分と表記することもある）、及びパンテノール類（以下、(D)成分と表記することもある）を含み、且つ、当該容器において、内部に収容した前記皮膜形成性外用製剤と接する領域の少なくとも一部が樹脂で形成されていることを特徴とする。以下、本発明の外用製品について詳述する。 The external product of the present invention is an external product in which a film-forming external preparation is contained in a container, and the film-forming external preparation is a monohydric alcohol having 1 to 4 carbon atoms (hereinafter referred to as a component (A)). (Sometimes referred to as), ester of monocarboxylic acid having 2 to 4 carbon atoms and monohydric alcohol having 1 to 5 carbon atoms (hereinafter, may be referred to as component (B)), nitrocellulose (hereinafter, (hereinafter, may be referred to as a component). C) component) and pantenols (hereinafter, may be referred to as component (D)) are contained, and in the container, it is in contact with the film-forming external preparation contained therein. It is characterized in that at least a part of the region is formed of a resin. Hereinafter, the external product of the present invention will be described in detail.
皮膜形成性外用製剤
［(A)炭素数１〜４の１価アルコール］
本発明で使用される皮膜形成性外用製剤は、溶剤として炭素数１〜４の１価アルコールを含有する。
Film-forming external preparation [(A) monohydric alcohol with 1 to 4 carbon atoms]
The film-forming external preparation used in the present invention contains a monohydric alcohol having 1 to 4 carbon atoms as a solvent.
炭素数１〜４の１価アルコールの種類については、特に制限されないが、例えば、メタノール、エタノール、ｎ−プロパノール、イソプロパノール、ｎ−ブタノール、ｓｅｃ−ブタノール、イソブタノール、ｔｅｒｔ-ブタノール等が挙げられる。 The type of monohydric alcohol having 1 to 4 carbon atoms is not particularly limited, and examples thereof include methanol, ethanol, n-propanol, isopropanol, n-butanol, sec-butanol, isobutanol, and tert-butanol.
これらの１価アルコールの中でも、好ましくは炭素数２〜４の１価アルコール、更に好ましくはエタノール、イソプロパノール、及びｎ−ブタノール、特に好ましくはエタノール、及びイソプロパノールが挙げられる。とりわけ、イソプロパノールは、容器の構成素材として含まれる樹脂の変色を顕著にする傾向があるが、本発明では、皮膜形成性外用製剤にイソプロパノールが含まれていても、当該樹脂の変色を効果的に抑制することができる。 Among these monohydric alcohols, monohydric alcohols having 2 to 4 carbon atoms are preferable, ethanol, isopropanol and n-butanol are preferable, and ethanol and isopropanol are particularly preferable. In particular, isopropanol tends to make the discoloration of the resin contained as a constituent material of the container remarkable, but in the present invention, even if isopropanol is contained in the film-forming external preparation, the discoloration of the resin is effectively performed. It can be suppressed.
これらの１価アルコールは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These monohydric alcohols may be used alone or in combination of two or more.
皮膜形成性外用製剤における(A)成分の含有量については、特に制限されないが、例えば、(A)成分の総量で１０〜７０重量％、好ましくは１５〜６５重量％、更に好ましくは１８〜６０重量％、特に好ましくは２５〜６０重量％が挙げられる。 The content of the component (A) in the film-forming external preparation is not particularly limited, but for example, the total amount of the component (A) is 10 to 70% by weight, preferably 15 to 65% by weight, and more preferably 18 to 60%. By weight%, particularly preferably 25 to 60% by weight.
［(B)炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル］
本発明で使用される皮膜形成性外用製剤は、溶剤として、更に炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステルを含有する。「炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル」とは、炭素数２〜４のモノカルボン酸１分子と炭素数１〜５の１価アルコール１分子がエステル結合した化合物である。
[(B) Ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms]
The film-forming external preparation used in the present invention further contains an ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms as a solvent. "Ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monovalent alcohol having 1 to 5 carbon atoms" means one molecule of a monocarboxylic acid having 2 to 4 carbon atoms and one molecule of a monohydric alcohol having 1 to 5 carbon atoms. Is an ester-bonded compound.
前記エステルを構成する炭素数２〜４のモノカルボン酸の種類については、特に制限されないが、例えば、酢酸、乳酸、プロピオン酸、酪酸等が挙げられる。これらのモノカルボン酸の中でも、好ましくは、炭素数２又は３のモノカルボン酸、更に好ましくは、酢酸、乳酸が挙げられる。 The type of monocarboxylic acid having 2 to 4 carbon atoms constituting the ester is not particularly limited, and examples thereof include acetic acid, lactic acid, propionic acid, butyric acid and the like. Among these monocarboxylic acids, a monocarboxylic acid having 2 or 3 carbon atoms is preferable, and acetic acid and lactic acid are more preferable.
また、前記エステルを構成する炭素数１〜５の１価アルコールの種類については、特に制限されないが、例えば、メタノール、エタノール、ｎ−プロパノール、イソプロパノール、ｎ−ブタノール、ｓｅｃ−ブタノール、イソブタノール、ｔｅｒｔ-ブタノール、ベンジルアルコール、１−ペンタノール、３−メチル−１−ブタノール、２−メチル−１−ブタノール、２，２ジメチル−１−プロパノール、２−ペンタノール、３−メチル−２−ブタノール、３−ペンタノール、２−メチル−２−ブタノールが挙げられる。これらのアルコールの中でも、好ましくは、メタノール、エタノール、ｎ−プロパノール、イソプロパノール、ｎ−ブタノール、１−ペンタノール、ベンジルアルコール、更に好ましくはエタノール、ｎ−プロパノール、イソプロパノール、ｎ−ブタノール、１−ペンタノールが挙げられる。 The type of monohydric alcohol having 1 to 5 carbon atoms constituting the ester is not particularly limited, and is, for example, methanol, ethanol, n-propanol, isopropanol, n-butanol, sec-butanol, isobutanol, tert. -Butanol, benzyl alcohol, 1-pentanol, 3-methyl-1-butanol, 2-methyl-1-butanol, 2,2dimethyl-1-propanol, 2-pentanol, 3-methyl-2-butanol, 3 -Pentanol and 2-methyl-2-butanol can be mentioned. Among these alcohols, preferred are methanol, ethanol, n-propanol, isopropanol, n-butanol, 1-pentanol, benzyl alcohol, and more preferably ethanol, n-propanol, isopropanol, n-butanol, 1-pentanol. Can be mentioned.
前記エステルとして、具体的には、酢酸メチル、酢酸エチル、酢酸プロピル（酢酸ｎ−プロピル）、酢酸イソプロピル、酢酸ブチル（酢酸ｎ−ブチル）、酢酸ｓｅｃ−ブチル、酢酸イソブチル、酢酸ペンチル（酢酸１−ペンチル）、乳酸エチル、乳酸ブチル、酢酸イソアミル（酢酸３−メチルブチル）、酪酸エチル、プロピオン酸エチル等が挙げられる。これらの中でも、好ましくは、酢酸エチル、酢酸ブチル、乳酸エチル；更に好ましくは、酢酸エチル、酢酸ブチルが挙げられる。 Specific examples of the ester include methyl acetate, ethyl acetate, propyl acetate (n-propyl acetate), isopropyl acetate, butyl acetate (n-butyl acetate), sec-butyl acetate, isobutyl acetate, and pentyl acetate (1-propyl acetate). Pentil), ethyl lactate, butyl lactate, isoamyl acetate (3-methylbutyl acetate), ethyl butyrate, ethyl propionate and the like can be mentioned. Among these, ethyl acetate, butyl acetate and ethyl lactate are preferable; and ethyl acetate and butyl acetate are more preferable.
これらのエステルは、１種を単独で使用してもよく、また２種以上を組み合わせて使用してもよい。例えば、沸点が異なる２種以上のエステルを組み合わせて使用することにより、本発明の皮膜形成性外用製剤の皮膜形成速度を適宜調節することもできる。例えば、沸点が１００℃未満の上記エステル（例えば、酢酸エチル）と、沸点が１００℃以上の上記エステル（例えば、酢酸ブチル）を併用し、沸点が１００℃未満の上記エステルの比率を高く設定すると、皮膜形成速度を早くすることができ、沸点が１００℃未満の上記エステルの比率を低く設定すると、皮膜形成速度を遅くすることができる。 These esters may be used alone or in combination of two or more. For example, by using two or more kinds of esters having different boiling points in combination, the film-forming rate of the film-forming external preparation of the present invention can be appropriately adjusted. For example, when the above ester having a boiling point of less than 100 ° C. (for example, ethyl acetate) and the above ester having a boiling point of 100 ° C. or higher (for example, butyl acetate) are used in combination, the ratio of the above ester having a boiling point of less than 100 ° C. is set high. The film formation rate can be increased, and if the ratio of the ester having a boiling point of less than 100 ° C. is set low, the film formation rate can be decreased.
前記エステルの好適な例として、酢酸エチルと酢酸ブチルを組み合わせて使用し、酢酸エチル１００重量部当たり、酢酸ブチルを５〜５０重量部、好ましくは７〜４０重量部、更に好ましくは１〜３０重量部となる比率を充足させることが挙げられる。このような比率で酢酸エチルと酢酸ブチルを併用することにより、皮膚に塗布した際に適度な皮膜形成速度で、皮膜を形成させることが可能になる。 As a preferred example of the ester, ethyl acetate and butyl acetate are used in combination, and butyl acetate is 5 to 50 parts by weight, preferably 7 to 40 parts by weight, more preferably 1 to 30 parts by weight, per 100 parts by weight of ethyl acetate. Satisfying the ratio of parts can be mentioned. By using ethyl acetate and butyl acetate in combination at such a ratio, it becomes possible to form a film at an appropriate film forming rate when applied to the skin.
皮膜形成性外用製剤における(B)成分の含有量については、特に制限されず、(B)成分の種類や備えさせるべき皮膜形成速度等に応じて適宜設定すればよいが、例えば、該製剤の総量当たり、２５〜６５重量％、好ましくは２５〜６０重量％、更に好ましくは３５〜５５重量％が挙げられる。 The content of the component (B) in the film-forming external preparation is not particularly limited, and may be appropriately set according to the type of the component (B), the film formation rate to be provided, and the like. 25 to 65% by weight, preferably 25 to 60% by weight, more preferably 35 to 55% by weight, based on the total amount.
皮膜形成性外用製剤において、(A)成分に対する(B)成分の比率については、前述する両成分の各含有量を充足する範囲で適宜設定すればよいが、例えば、(A)成分１００重量部当たり、(B)成分が２０〜１０００重量部、好ましくは４０〜６００重量部、更に好ましくは４０〜５００重量部、特に好ましくは４０〜３５重量部、より一層好ましくは６０〜１８重量部が挙げられる。 In the film-forming external preparation, the ratio of the component (B) to the component (A) may be appropriately set within a range that satisfies each content of both components described above. For example, 100 parts by weight of the component (A). The component (B) is 20 to 1000 parts by weight, preferably 40 to 600 parts by weight, more preferably 40 to 500 parts by weight, particularly preferably 40 to 35 parts by weight, and even more preferably 60 to 18 parts by weight. Be done.
［(C)ニトロセルロース］
本発明で使用される皮膜形成性外用製剤は、ニトロセルロースを含有する。ニトロセルロースは、皮膚上で形成される皮膜の基剤としての役割を果たす。
[(C) Nitrocellulose]
The film-forming external preparation used in the present invention contains nitrocellulose. Nitrocellulose serves as a base for the film formed on the skin.
本発明に使用されるニトロセルロースは、皮膚上で皮膜を形成できる限り、その分子量、窒素含有量等については、特に制限されない。 The nitrocellulose used in the present invention is not particularly limited in its molecular weight, nitrogen content and the like as long as it can form a film on the skin.
また、本発明で使用される皮膜形成性外用製剤では、ニトロセルロースとして、ピロキシリンを使用することもできる。ピロキシリンとは、ニトロセルロースが溶媒に潤されているものであり、具体的には、ニトロセルロース７０重量％程度とイソプロパノール３０重量％程度の混合物が挙げられる。本発明において、(C)成分として、市販されているピロキシリンを使用することもできる。市販されているピロキシリンとしては、具体的には、Ｔ．Ｎ．Ｃ．Ｉｎｄｕｓｔｒｉａｌ Ｃｏ．，Ｌｔｄ製のＲＳ １／３２ ｓｅｃ、ＲＳ １／１６ ｓｅｃ、ＲＳ １／８ ｓｅｃ、ＲＳ １／８ Ｌ ｓｅｃ、ＲＳ １／８ Ｈ ｓｅｃ、ＲＳ １／４ ｓｅｃ、ＲＳ １／４ Ｈ ｓｅｃ、ＲＳ １／２ ｓｅｃ、ＲＳ １ ｓｅｃ、ＲＳ ５〜６ ｓｅｃ、ＲＳ １０〜１５ ｓｅｃ、ＲＳ １５〜２０ ｓｅｃ、ＲＳ ３０〜４０ ｓｅｃ、ＲＳ ６０〜８０ ｓｅｃ、ＲＳ １２０ ｓｅｃ、ＲＳ １５０ ｓｅｃ、ＲＳ ３００ ｓｅｃ、ＲＳ ５００ ｓｅｃ、ＲＳ ８００ ｓｅｃ、ＲＳ １２００ ｓｅｃ、ＲＳ ２０００ ｓｅｃ；Ｋｏｒｅａ ＣＮＣ Ｌｔｄ製のＲＳ １／１６、ＲＳ １／８、ＲＳ１／４、ＲＳ １／２、ＲＳ １、ＲＳ ２、ＲＳ ５、ＲＳ ７、ＲＳ ２０、ＲＳ ６０、ＲＳ １２０、ＲＳ ５００、ＲＳ １０００、ＲＳ ２０００等が挙げられる。これらは、１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。なお、本発明において、ニトロセルロースとしてピロキシリンを使用する場合には、ピロキシリンに内在する炭素数１〜４の１価アルコールは、前記(A)成分の一部を構成することになる。 Further, in the film-forming external preparation used in the present invention, pyroxylin can also be used as the nitrocellulose. Pyroxylin is a solvent in which nitrocellulose is moistened, and specific examples thereof include a mixture of about 70% by weight of nitrocellulose and about 30% by weight of isopropanol. In the present invention, commercially available pyroxylin can also be used as the component (C). Specific examples of commercially available pyroxylin include T.I. N. C. Industrial Co. , Ltd made RS 1/32 sec, RS 1/16 sec, RS 1/8 sec, RS 1/8 L sec, RS 1/8 H sec, RS 1/4 sec, RS 1/4 H sec, RS 1/2 sec, RS 1 sec, RS 5-6 sec, RS 10-15 sec, RS 15-20 sec, RS 30-40 sec, RS 60-80 sec, RS 120 sec, RS 150 sec, RS 300 sec , RS 500 sec, RS 800 sec, RS 1200 sec, RS 2000 sec; RS 1/16, RS 1/8, RS 1/4, RS 1/2, RS 1, RS 2, RS 5, manufactured by Korea CNC Ltd. Examples thereof include RS 7, RS 20, RS 60, RS 120, RS 500, RS 1000, RS 2000 and the like. These may be used alone or in combination of two or more. In the present invention, when pyroxylin is used as the nitrocellulose, the monohydric alcohol having 1 to 4 carbon atoms contained in the pyroxylin constitutes a part of the component (A).
皮皮膜形成性外用製剤における(C)成分の含有量は、皮膚上で皮膜を形成可能であることを限度として、特に制限されないが、例えば、３．５〜１４重量％、好ましくは５．６〜１１．２重量％（ニトロセルロース７０重量％とイソプロパノール３０重量％の混合物であるピロキシリンを使用する場合、当該ピロキシリン含有量として、５〜２０重量％、好ましくは８〜１６重量％）が挙げられる。 The content of the component (C) in the skin film-forming external preparation is not particularly limited as long as the film can be formed on the skin, but is, for example, 3.5 to 14% by weight, preferably 5.6. ~ 11.2% by weight (when pyroxylin, which is a mixture of 70% by weight of nitrocellulose and 30% by weight of isopropanol, is used, the pyroxylin content is 5 to 20% by weight, preferably 8 to 16% by weight). ..
［(D)パンテノール類］
本発明で使用される皮膜形成性外用製剤は、パンテノール類を含有する。前記(A)〜(C)成分を含有する皮膜形成性外用製剤は、容器の構成素材として含まれる樹脂の変色を引き起こすが、本発明では、皮膜形成性外用製剤にパンテノール類が含まれることによって当該樹脂の変色を抑制することができる。また、本発明で使用される皮膜形成性外用製剤が、前記(A)〜(C)成分と共に、パンテノール類を含むことにより、使用中の皮膜の皮膚への接着性を良好にしつつ、使用後に皮膜を皮膚から剥離し易くすることも可能になる。
[(D) Panthenol]
The film-forming external preparation used in the present invention contains panthenol. The film-forming external preparation containing the components (A) to (C) causes discoloration of the resin contained as the constituent material of the container. In the present invention, the film-forming external preparation contains panthenol. Therefore, discoloration of the resin can be suppressed. Further, the film-forming external preparation used in the present invention contains pantenols together with the above-mentioned components (A) to (C), so that the film being used can be used while improving the adhesiveness to the skin. It will also be possible to facilitate the later peeling of the film from the skin.
本発明において、パンテノール類とは、パンテノール、その誘導体、及びそれらの塩を指す。パンテノール類として、具体的には、パンテノール、パントテニルエチルエーテル、パントテン酸アルカリ土類金属塩（例えばカルシウム塩等）、パントテン酸アルカリ金属塩（例えばナトリウム塩等）、アセチルパントテニルエチルエーテル等が挙げられる。 In the present invention, panthenol refers to panthenol, its derivative, and salts thereof. Specific examples of pantenols include pantenol, pantothenyl ethyl ether, pantothenic acid alkaline earth metal salt (for example, calcium salt, etc.), pantothenic acid alkali metal salt (for example, sodium salt, etc.), acetylpantothenyl ethyl ether, and the like. Can be mentioned.
これらのパンテノール類の中でも、容器の構成素材として含まれる樹脂の変色をより一層効果的に抑制させるという観点から、好ましくはパンテノールが挙げられる。また、パンテノールは、使用中の皮膜の接着性と使用後の皮膜の剥離性をより一層良好にするという観点からも好適である。 Among these panthenol types, panthenol is preferably mentioned from the viewpoint of more effectively suppressing discoloration of the resin contained as a constituent material of the container. Panthenol is also suitable from the viewpoint of further improving the adhesiveness of the film during use and the peelability of the film after use.
これらのパンテノール類は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These panthenol types may be used alone or in combination of two or more.
皮膜形成性外用製剤における(D)成分の含有量は、使用するパンテノール類の種類等に応じて適宜設定すればよいが、例えば、０．０５〜１０重量％が挙げられる。容器の構成素材として含まれる樹脂の変色をより一層効果的に抑制させるという観点から、(D)成分の含有量として、好ましくは０．０５〜８重量％、更に好ましくは０．１〜７．５重量％、より好ましくは１〜５重量％、特に好ましくは３〜７．５重量％が挙げられる。(D)成分の含有量が前記範囲を満たすことによって、使用中の皮膜の接着性と使用後の皮膜の剥離性をより一層良好にすることも可能になる。 The content of the component (D) in the film-forming external preparation may be appropriately set according to the type of panthenol to be used and the like, and examples thereof include 0.05 to 10% by weight. From the viewpoint of more effectively suppressing discoloration of the resin contained as the constituent material of the container, the content of the component (D) is preferably 0.05 to 8% by weight, more preferably 0.1 to 7. 5% by weight, more preferably 1 to 5% by weight, and particularly preferably 3 to 7.5% by weight. When the content of the component (D) satisfies the above range, it is possible to further improve the adhesiveness of the film during use and the peelability of the film after use.
本発明の皮膜形成性外用製剤において、(C)成分と(D)成分の比率については、前述する各成分の含有量に基づいて定まるが、例えば、(C)成分１００重量部当たり、(D)成分が０．１〜３００重量部が挙げられる。容器の構成素材として含まれる樹脂の変色をより一層効果的に抑制させるという観点から、(C)成分１００重量部当たり、(D)成分が、好ましくは１〜２００重量部、更に好ましくは５〜１００重量部が挙げられる。C)成分と(D)成分の比率が前記範囲を満たすことによって、使用中の皮膜の接着性と使用後の皮膜の剥離性をより一層良好にすることも可能になる。 In the film-forming external preparation of the present invention, the ratio of the component (C) to the component (D) is determined based on the content of each component described above, and is, for example, (D) per 100 parts by weight of the component (C). ) The component is 0.1 to 300 parts by weight. From the viewpoint of more effectively suppressing discoloration of the resin contained as the constituent material of the container, the component (D) is preferably 1 to 200 parts by weight, more preferably 5 to 5 parts by weight per 100 parts by weight of the component (C). 100 parts by weight is mentioned. When the ratio of the component (C) to the component (D) satisfies the above range, it is possible to further improve the adhesiveness of the film during use and the peelability of the film after use.
［(E)可塑剤］
本発明で使用される皮膜形成性外用製剤は、皮膚上に形成させる皮膜に対して、良好な柔軟性を付与するために、必要に応じて、可塑剤（以下、(E)成分と表記することもある）を含んでいてもよい。
[(E) Plasticizer]
The film-forming external preparation used in the present invention is, if necessary, a plasticizer (hereinafter referred to as “component (E)) in order to impart good flexibility to the film formed on the skin. May include).
本発明で使用される可塑剤としては、薬学的に許容できるものであれば、特に制限されないが、例えば、植物油、炭素数５〜２２のモノ、ジ又はトリカルボン酸と炭素数１〜９の１価アルコールのエステル、テルペノイド、多価アルコール、グリセリン脂肪酸エステル、鉱物油、ポリエーテル、ポリエステル等が挙げられる。 The plasticizer used in the present invention is not particularly limited as long as it is pharmaceutically acceptable, but for example, vegetable oil, mono, di or tricarboxylic acid having 5 to 22 carbon atoms and 1 of 1 to 9 carbon atoms. Examples thereof include esters of valence alcohols, terpenoids, polyhydric alcohols, glycerin fatty acid esters, mineral oils, polyethers, polyesters and the like.
植物油としては、具体的には、ヒマシ油、綿実油、大豆油、ゴマ油、アルモンド油、ウイキョウ油、トウモロコシ油、オリブ油、オレンジ油、カミツレ油、ケイヒ油、小麦麦芽油、サフラワー油、シソ油、シトロネラー油、ショウキョウ油、スペアミント油、コメ油、チョウジ油、ツバキ油、テレビン油、トウヒ油、ナタネ油、ハッカ油、ヒマラヤスギ油、ヒマワリ油、ベルガモット油、ヤシ油、ユーカリ油、ラッカセイ油、ラベンダー油、卵黄油、レモン油、ローズ油、ロート油、ローマカミツレ油等が挙げられる。これらの植物油は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of vegetable oils include castor oil, cottonseed oil, soybean oil, sesame oil, almond oil, sardine oil, corn oil, olive oil, orange oil, chamomile oil, kehi oil, wheat germ oil, safflower oil, and perilla oil. , Citronella oil, ginger oil, spare mint oil, rice oil, butterfly oil, camellia oil, television oil, peppermint oil, rapeseed oil, peppermint oil, sunflower oil, sunflower oil, bergamot oil, palm oil, eucalyptus oil, lacquer oil, Examples include lavender oil, egg yolk oil, lemon oil, rose oil, funnel oil, and Roman chamomile oil. These vegetable oils may be used alone or in combination of two or more.
炭素数５〜２２のモノ、ジ又はトリカルボン酸と炭素数１〜９の１価アルコールのエステルとしては、具体的には、パルミチン酸イソプロピル、ミリスチン酸イソプロピル、ステアリン酸イソプロピル、リノール酸エチル、リノール酸イソプロピル、フタル酸ジメチル、フタル酸ジエチル、フタル酸ジプロピル、フタル酸ジブチル、フタル酸ジオクチル、アジピン酸ジイソブチル、アジピン酸ジイソプロピル、アジピン酸ジイソノニル、アジピン酸ジオクチル、セバシン酸ジエチル、セバシン酸ジイソプロピル、セバシン酸ジブチル、クエン酸トリエチル、クエン酸トリブチル、クエン酸アセチルトリブチル等が挙げられる。これらのエステルは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of the ester of a mono, di or tricarboxylic acid having 5 to 22 carbon atoms and a monovalent alcohol having 1 to 9 carbon atoms include isopropyl palmitate, isopropyl myristate, isopropyl stearate, ethyl linoleate, and linoleic acid. Isopropyl, dimethyl phthalate, diethyl phthalate, dipropyl phthalate, dibutyl phthalate, dioctyl phthalate, diisobutyl adipate, diisopropyl adipate, diisononyl adipate, dioctyl adipate, diethyl sevacinate, diisopropyl sevacinate, dibutyl sevacinate, Examples thereof include triethyl citrate, tributyl citrate, and acetyltributyl citrate. These esters may be used alone or in combination of two or more.
テルペノイドとしては、具体的には、カンフル、メントール、ボルネオール、シネオール、アネトール、リモネン、オイゲノール、ゲラニオール、ハッカ油等が挙げられる。これらのテルペノイドは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of the terpenoid include camphor, menthol, borneol, cineole, anethole, limonene, eugenol, geraniol, and mentha oil. These terpenoids may be used alone or in combination of two or more.
多価アルコールとしては、具体的には、プロピレングリコール、グリセリン、ソルビトール等が挙げられる。これらの多価アルコールは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of the polyhydric alcohol include propylene glycol, glycerin, sorbitol and the like. These polyhydric alcohols may be used alone or in combination of two or more.
グリセリン脂肪酸エステルとしては、具体的には、モノステアリン酸グリセリル、モノオレイン酸グリセリン、モノミリスチン酸グリセリン、ラウリン酸デカグリセリル、中鎖脂肪酸トリグリセリド等が挙げられる。これらのグリセリン脂肪酸エステルは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of the glycerin fatty acid ester include glyceryl monostearate, glycerin monooleate, glycerin monomyristate, decaglyceryl laurate, and medium-chain fatty acid triglyceride. These glycerin fatty acid esters may be used alone or in combination of two or more.
鉱物油としては、具体的には、流動パラフィン、ワセリン等が挙げられる。これらの鉱物油は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Specific examples of the mineral oil include liquid paraffin and petrolatum. These mineral oils may be used alone or in combination of two or more.
ポリエーテルとしては、具体的には、ポリエチレングリコール等が挙げられる。 Specific examples of the polyether include polyethylene glycol and the like.
ポリエステルとしては、具体的には、アジピン酸ポリエステル等が挙げられる。 Specific examples of the polyester include polyester adipic acid and the like.
これらの可塑剤の中でも、好ましくは、植物油、及びテルペノイド、更に好ましくは、ヒマシ油、及びカンフルが挙げられる。とりわけ、可塑剤として植物油（特に、ヒマシ油）を０．０５〜１．５重量％の含有量を満たす範囲で含有させる場合には、皮膚上で皮膜を形成させた際に、皮膜からのパンテノール類の放出を促進でき、パンテノール類の薬理作用（創傷修復作用等）を効果的に発揮させることが可能になる。特に、このような所定量の植物油（特に、ヒマシ油）と、テルペノイド(特に、カンフル)とを併用することによって、皮膜からのパンテノール類の放出をより一層効果的に促進させることができる。 Among these plasticizers, vegetable oils and terpenoids are preferable, and castor oil and camphor are more preferable. In particular, when vegetable oil (particularly castor oil) is contained as a plasticizer in a range satisfying the content of 0.05 to 1.5% by weight, the pan from the film is formed when the film is formed on the skin. The release of tenors can be promoted, and the pharmacological action (wound repair action, etc.) of panthenol can be effectively exerted. In particular, by using such a predetermined amount of vegetable oil (particularly castor oil) in combination with terpenoids (particularly camphor), the release of panthenol from the film can be promoted even more effectively.
これらの可塑剤は、１種を単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These plasticizers may be used alone or in combination of two or more.
本発明で使用される可塑剤の好適な例として、植物油とテルペノイドの組み合わせ、特にヒマシ油とカンフルの組み合わせが挙げられる。植物油とテルペノイドを組み合わせて使用する場合、これらの比率については、特に制限されないが、例えば、植物油１００重量部当たり、テルペノイドが０．１〜１０００００重量部、好ましくは１０〜３０００重量部、更に好ましくは５０〜２０００重量部、特に好ましくは１００〜１０００重量部が挙げられる。 Preferable examples of the plasticizers used in the present invention include combinations of vegetable oils and terpenoids, especially castor oil and camphor. When the vegetable oil and the terpenoid are used in combination, these ratios are not particularly limited, but for example, 0.1 to 100,000 parts by weight of the terpenoid, preferably 10 to 3000 parts by weight, more preferably per 100 parts by weight of the vegetable oil. 50 to 2000 parts by weight, particularly preferably 100 to 1000 parts by weight.
本発明の皮膜形成性外用製剤において、(E)成分を含有させる場合、その含有量については、特に制限されないが、例えば、総量で０．０１〜２０重量％、好ましくは０．０５〜１０重量％が挙げられる。 When the component (E) is contained in the film-forming external preparation of the present invention, the content thereof is not particularly limited, but for example, the total amount is 0.01 to 20% by weight, preferably 0.05 to 10% by weight. % Is mentioned.
より具体的には、植物油を使用する場合であれば、本発明の皮膜形成性外用製剤における植物油の含有量として、通常０．０１〜１０重量％、好ましくは０．０５〜１０重量％が挙げられる。 More specifically, when vegetable oil is used, the content of vegetable oil in the film-forming external preparation of the present invention is usually 0.01 to 10% by weight, preferably 0.05 to 10% by weight. Be done.
特に、植物油の含有量が０．０５〜１．５重量％を満たしている場合には、皮膚上で皮膜を形成させた際に、皮膜からのパンテノール類の放出を促進でき、パンテノール類の薬理作用（創傷修復作用等）を効果的に発揮させることが可能になる。皮膜からのパンテノール類の放出をより一層効果的に促進させるという観点から、発明の皮膜形成性外用製剤における植物油の含有量として、更に好ましくは０．１〜１．５重量％、特に好ましくは０．１〜１重量％が挙げられる。 In particular, when the content of the vegetable oil is 0.05 to 1.5% by weight, the release of panthenol from the film can be promoted when the film is formed on the skin, and the panthenol can be promoted. It becomes possible to effectively exert the pharmacological action (wound repair action, etc.) of. From the viewpoint of more effectively promoting the release of panthenol from the film, the content of the vegetable oil in the film-forming external preparation of the present invention is more preferably 0.1 to 1.5% by weight, particularly preferably. 0.1 to 1% by weight can be mentioned.
また、テルペノイドを使用する場合であれば、本発明の皮膜形成性外用製剤におけるテルペノイドの含有量として、通常０．０１〜１０重量％、好ましくは０．０５〜１０重量％、更に好ましくは０．１〜８重量％、特に好ましくは１〜８重量％が挙げられる。 When a terpenoid is used, the content of the terpenoid in the film-forming external preparation of the present invention is usually 0.01 to 10% by weight, preferably 0.05 to 10% by weight, and more preferably 0. 1 to 8% by weight, particularly preferably 1 to 8% by weight.
皮膜形成性外用製剤において、(E)成分を含有させる場合、(C)成分と(E)成分の比率については、特に制限されず、前述する両成分の各含有量を充足する範囲で適宜設定すればよいが、例えば、(C)成分１００重量部当たり、(E)成分が０．００１〜５００重量部が挙げられる。 When the component (E) is contained in the film-forming external preparation, the ratio of the component (C) to the component (E) is not particularly limited and is appropriately set as long as the contents of both components described above are satisfied. However, for example, 0.001 to 500 parts by weight of the component (E) may be mentioned per 100 parts by weight of the component (C).
より具体的には、植物油を使用する場合であれば、(C)成分１００重量部当たり、植物油が０．００３〜５００重量部が挙げられる。特に、皮膜からのパンテノール類の放出をより一層効果的に促進させるという観点から、(C)成分１００重量部当たり、植物油が、好ましくは０．７〜４０重量部、更に好ましくは１〜２０重量部、特に好ましくは１〜１３重量部が挙げられる。 More specifically, when vegetable oil is used, 0.003 to 500 parts by weight of vegetable oil may be mentioned per 100 parts by weight of the component (C). In particular, from the viewpoint of more effectively promoting the release of panthenol from the film, vegetable oil is preferably 0.7 to 40 parts by weight, more preferably 1 to 20 parts by weight per 100 parts by weight of the component (C). By weight, particularly preferably 1 to 13 parts by weight.
また、テルペノイドを使用する場合であれば、(C)成分１００重量部当たり、テルペノイドが、０．００３〜５００重量部、好ましくは１〜５０重量部、更に好ましくは５〜２０重量部が挙げられる。 When a terpenoid is used, the amount of the terpenoid is 0.003 to 500 parts by weight, preferably 1 to 50 parts by weight, and more preferably 5 to 20 parts by weight per 100 parts by weight of the component (C). ..
［(F)ベンジルアルコール］
本発明で使用される皮膜形成性外用製剤は、溶剤として、更にベンジルアルコール（以下、(F)成分と表記することもある）を含んでいてもよい。
[(F) Benzyl alcohol]
The film-forming external preparation used in the present invention may further contain benzyl alcohol (hereinafter, may be referred to as component (F)) as a solvent.
皮膜形成性外用製剤において、(F)成分を含有させる場合、その含有量については、特に制限されないが、例えば、０．０１〜７０重量％、好ましくは０．１〜２０重量％、更に好ましくは０．５〜１０重量％が挙げられる。 When the component (F) is contained in the film-forming external preparation, the content thereof is not particularly limited, but is, for example, 0.01 to 70% by weight, preferably 0.1 to 20% by weight, more preferably. 0.5 to 10% by weight is mentioned.
本発明の皮膜形成性外用製剤において、(F)成分を含有させる場合、(A)成分と(F)成分の比率については、特に制限されず、前述する両成分の各含有量を充足する範囲で適宜設定すればよいが、例えば、(A)成分１００重量部当たり、(F)成分が５〜２００重量部、好ましくは５〜１２５重量部、より好ましくは５〜７７重量部、更に好ましくは６〜５６重量部が挙げられる。 When the component (F) is contained in the film-forming external preparation of the present invention, the ratio of the component (A) to the component (F) is not particularly limited, and the range in which each content of both components described above is satisfied. For example, per 100 parts by weight of the component (A), the component (F) is 5 to 200 parts by weight, preferably 5 to 125 parts by weight, more preferably 5 to 77 parts by weight, still more preferably. 6 to 56 parts by weight can be mentioned.
［その他の成分］
本発明で使用される皮膜形成性外用製剤は、本発明の効果を妨げない範囲で、必要に応じて、水、アセトン、エチルメチルケトン、ジエチルエーテル等の溶剤を更に含んでいてもよい。但し、(A)成分、(B)成分、及び(F)成分以外の溶剤は、皮膜の外観等に悪影響を及ぼすことがあるため、(A)及び(B)成分以外の溶剤を配合する場合には、かかる特性を考慮する必要がある。更に、ジエチルエーテルは、揮発性の高さに起因する発火性から製造上の取り扱いに注意が必要であり、また、保存中の乾燥による固化、特有の匂い等の原因にもなり得るので、ジエチルエーテルを配合する場合には、このような特性に配慮することが求められる。皮膜形成性外用製剤における(A)及び(B)成分以外の溶剤の含有量としては、例えば、４重量％以下程度、特に２重量％以下程度であることが望ましい。
[Other ingredients]
The film-forming external preparation used in the present invention may further contain a solvent such as water, acetone, ethyl methyl ketone and diethyl ether, if necessary, as long as the effect of the present invention is not impaired. However, solvents other than the components (A), (B), and (F) may adversely affect the appearance of the film, so when a solvent other than the components (A) and (B) is mixed. It is necessary to consider such characteristics. Furthermore, since diethyl ether requires careful handling in manufacturing due to its high volatility and is ignitable, it can also cause solidification due to drying during storage, a peculiar odor, and the like. When blending ether, it is required to consider such characteristics. The content of the solvent other than the components (A) and (B) in the film-forming external preparation is preferably, for example, about 4% by weight or less, particularly about 2% by weight or less.
更に、本発明で使用される皮膜形成性外用製剤は、本発明の効果を妨げない範囲で、必要に応じて、(D)成分以外の薬効成分を含んでいてもよい。このような薬効成分としては、例えば、抗炎症剤、局所麻酔剤、鎮痛剤、抗ヒスタミン剤、殺菌剤、抗真菌剤、ビタミン類、保湿剤、美白剤、組織修復剤、皮膚保護剤、角質軟化剤、局所刺激剤、鎮痒剤、収斂剤、紫外防御剤、シリコンゲル、生薬エキス、アミノ酸類、ミネラル類等が挙げられる。 Further, the film-forming external preparation used in the present invention may contain a medicinal ingredient other than the ingredient (D), if necessary, as long as the effect of the present invention is not impaired. Examples of such medicinal ingredients include anti-inflammatory agents, local anesthetics, painkillers, antihistamines, bactericides, antifungal agents, vitamins, moisturizers, whitening agents, tissue remodeling agents, skin protectants, and keratin softeners. , Local stimulants, antipruritic agents, astringents, ultraviolet protective agents, silicon gels, crude drug extracts, amino acids, minerals and the like.
また、本発明で使用される皮膜形成性外用製剤は、本発明の効果を妨げない範囲で、必要に応じて、増粘剤、緩衝剤、キレート剤、抗酸化剤、安定化剤、乳化剤、防腐剤、香料、清涼化剤、着色剤、分散剤、流動化剤、粘稠化剤、増粘剤、吸着剤、保湿剤、湿潤剤、防湿剤、帯電防止剤等の添加剤を含んでいてもよい。 In addition, the film-forming external preparation used in the present invention contains thickeners, buffers, chelating agents, antioxidants, stabilizers, emulsifiers, as necessary, as long as it does not interfere with the effects of the present invention. Includes additives such as preservatives, fragrances, refreshing agents, coloring agents, dispersants, fluidizing agents, thickening agents, thickeners, adsorbents, moisturizers, wetting agents, moisturizing agents, antistatic agents, etc. You may.
［皮膜形成性外用製剤の製造方法］
本発明で使用される皮膜形成性外用製剤は、前記(A)〜(D)成分、及び必要に応じて、前記(E)成分、(F)成分、他の溶剤、薬効成分、添加剤等を所望量混合することにより調製される。
[Manufacturing method of film-forming external preparation]
The film-forming external preparation used in the present invention includes the above-mentioned (A) to (D) components, and if necessary, the above-mentioned (E) component, (F) component, other solvents, medicinal properties, additives, etc. Is prepared by mixing the desired amount.
容器
本発明の外用製品では、前記皮膜形成性外用製剤を収容する容器として、内部に収容している前記皮膜形成性外用製剤と接する領域の少なくとも一部が樹脂で形成されている容器を使用する。樹脂は、前記(A)〜(C)を含む皮膜形成性外用製剤と接触した状態になると変色（黄変）が、本発明の製品では、皮膜形成性外用製剤が更に前記(D)成分を含むことにより、当該樹脂の変色を抑制することが可能になっている。
Container In the external product of the present invention, as the container for accommodating the film-forming external preparation, a container in which at least a part of the region in contact with the film-forming external preparation is formed of resin is used. .. The resin discolors (yellows) when it comes into contact with the film-forming external preparation containing (A) to (C), and in the product of the present invention, the film-forming external preparation further contains the component (D). By including it, it is possible to suppress discoloration of the resin.
［容器の構成部材］
本発明で使用される容器の構造については、特に制限されないが、少なくとも、開口部を有する容器本体と、当該開口部を着脱自在に閉じるキャップとを有していればよい。
[Container components]
The structure of the container used in the present invention is not particularly limited, but at least a container body having an opening and a cap for detachably closing the opening may be provided.
前記容器本体は、開口部と内部空間を有し、当該内部空間が前記皮膜形成性外用製剤を収容する機能を果たす。 The container body has an opening and an internal space, and the internal space functions to accommodate the film-forming external preparation.
また、前記キャップは、前記容器本体の開口部を着脱自在に閉じるように構成され、使用時には取り外され、保管時には前記容器本体の開口部に取り付けられた状態になる。 Further, the cap is configured to detachably close the opening of the container body, is removed during use, and is attached to the opening of the container body during storage.
前記キャップには、塗布部材が取り付けられていることが望ましい。このように塗布部材が取り付けられていると、前記皮膜形成性外用製剤の皮膚への塗布を簡便に行うことが可能になる。前記塗布部材は、前記キャップを前記開口に取付けられたとき、前記容器の内部空間へ延びるように配置されていればよい。前記塗布部材の構成については、特に制限されないが、前記皮膜形成性外用製剤を皮膚に塗布する塗布部と、当該塗布部と前記キャップとを連結する軸部とによって構成されていればよい。前記塗布部の形状については、前記皮膜形成性外用製剤を皮膚に塗布し得る形状である限り、特に制限されないが、前記軸部の軸方向に伸びる複数の毛で形成された刷毛部であることが好ましい。 It is desirable that a coating member is attached to the cap. When the coating member is attached in this way, the film-forming external preparation can be easily applied to the skin. The coating member may be arranged so as to extend into the internal space of the container when the cap is attached to the opening. The structure of the coating member is not particularly limited, but may be limited to that of a coating portion for applying the film-forming external preparation to the skin and a shaft portion for connecting the coating portion and the cap. The shape of the coating portion is not particularly limited as long as it is a shape that allows the film-forming external preparation to be applied to the skin, but it is a brush portion formed of a plurality of hairs extending in the axial direction of the shaft portion. Is preferable.
また、本発明で使用される容器は、前記容器本体と、必要に応じて塗布部材が取り付けられているキャップに加えて、前記容器の開口に取付けられ、前記容器の内部空間に連通するように形成された中栓を有していてもよい。当該中栓を設けることによって、前記塗布部材の塗布部に付着した前記皮膜形成性外用製剤を扱くことができ、皮膚に塗布する皮膜形成性外用製剤の量を調節し易くなる。 Further, the container used in the present invention is attached to the opening of the container in addition to the container body and the cap to which the coating member is attached, if necessary, so as to communicate with the internal space of the container. It may have a formed inner plug. By providing the inner plug, the film-forming external preparation adhering to the coating portion of the coating member can be handled, and the amount of the film-forming external preparation to be applied to the skin can be easily adjusted.
図１に本発明で使用される容器の好適な例の断面図を示す。図１では、キャップ２が容器本体１の開口部から取り外された状態が図示されている。図１に示す容器では、容器本体１の開口部に中栓３が取り付けられている。また、図１に示す容器では、キャップ２に塗布部材４が取り付けられ、塗布部材４は、キャップ２を容器本体１の開口に取付けられたとき、容器本体１の内部空間へ延びるように配置されている。また、図１に示す容器において、塗布部材４は、塗布部（刷毛部）４１と、塗布部４１保持してキャップに連結している軸部４２によって構成されている。
FIG. 1 shows a cross-sectional view of a suitable example of the container used in the present invention. FIG. 1 shows a state in which the cap 2 is removed from the opening of the container body 1. In the container shown in FIG. 1, the inner plug 3 is attached to the opening of the container body 1. Further, in the container shown in FIG. 1, the coating member 4 is attached to the cap 2, and the coating member 4 is arranged so as to extend into the internal space of the container body 1 when the cap 2 is attached to the opening of the container body 1. ing. Further, in the container shown in FIG. 1, the coating member 4 is composed of a coating portion (brush portion) 41 and a shaft portion 42 holding the
［容器の構成素材］
本発明で使用される容器は、内部に収容した前記皮膜形成性外用製剤と接する領域の少なくとも一部が樹脂で形成されていればよい。具体的には、前記容器本体、前記キャップ、必要に応じて設けられる前記塗布部材、及び必要に応じて設けられる前記中栓の内、少なくとも１つの構成部材において、前記皮膜形成性外用製剤と接する領域の少なくとも一部が樹脂で形成されていればよい。ここで、「皮膜形成性外用製剤と接する領域」とは、容器に前記皮膜形成性外用製剤を収容した状態で、容器に正立させた際に容器内で前記皮膜形成性外用製剤が接触する領域だけでなく、容器を横向き及び逆立にした際に容器内で前記皮膜形成性外用製剤が接触する領域を包含する。即ち、前記皮膜形成性外用製剤と接する領域は、前記容器本体の場合は内部空間を形成する内壁表面、前記キャップの場合は容器本体の開口部と対向する壁面、前記塗布部材の場合はその表面、及び、前記中栓の場合は前記容器本体に取り付けられた際に内部空間で露出している部分の表面が、該当する。
[Container material]
In the container used in the present invention, at least a part of the region in contact with the film-forming external preparation contained therein may be formed of resin. Specifically, at least one of the container body, the cap, the coating member provided as needed, and the inner plug provided as needed is in contact with the film-forming external preparation. It suffices that at least a part of the region is made of resin. Here, the "region in contact with the film-forming external preparation" means that the film-forming external preparation comes into contact with the film-forming external preparation in the container when the film-forming external preparation is placed upright in the container. It includes not only the region but also the region to which the film-forming external preparation comes into contact in the container when the container is turned sideways and upside down. That is, the region in contact with the film-forming external preparation is the surface of the inner wall forming the internal space in the case of the container body, the wall surface facing the opening of the container body in the case of the cap, and the surface thereof in the case of the coating member. In the case of the inner plug, the surface of the portion exposed in the internal space when attached to the container body corresponds to the case.
本発明で使用される容器において、皮膜形成性外用製剤と接する領域を樹脂で形成するには、容器の所定構成部材を樹脂で形成することが望ましいが、樹脂以外の素材を基材として成形し、所定の領域に樹脂をコートしたものであってもよい。例えば、容器本体の場合であれば、金属製の容器本体の内壁面に樹脂をコートしたものであってもよく、またキャップの場合であれば、金属製のキャップにおいて容器本体の開口部と対向する壁面部分に樹脂をコートしたものであってもよい。 In the container used in the present invention, in order to form the region in contact with the film-forming external preparation with resin, it is desirable to form the predetermined constituent members of the container with resin, but the container is molded using a material other than resin as a base material. , A resin may be coated on a predetermined area. For example, in the case of the container body, the inner wall surface of the metal container body may be coated with resin, and in the case of the cap, the metal cap faces the opening of the container body. The wall surface portion to be covered with resin may be coated.
本発明で使用される容器において、収容した前記皮膜形成性外用製剤と接する領域は、一部又は全部が樹脂で形成されていればよい。収容した前記皮膜形成性外用製剤と接する領域の一部を樹脂で形成する場合には、当該領域の他の部分は、金属、ガラス等の素材で形成されていればよい。即ち、容器の構成部材の内、一部の構成部材が樹脂製であり、他の構成部材が他の素材（金属、ガラス等）製のものであってもよく、一つ構成部材において、樹脂製と他の素材（金属、ガラス等）製のものが組み合わされていてもよい。例えば、キャップ及び塗布部材が樹脂で形成され、容器本体が炭素材（金属、ガラス等）で形成されたものであってもよい。また、例えば、塗布部材において、塗布部を樹脂製且つ軸部を他の素材（金属、ガラス等）製にして、塗布部材の一部を樹脂製にしたものであってもよい。 In the container used in the present invention, the region in contact with the film-forming external preparation contained therein may be partially or wholly formed of resin. When a part of the region in contact with the contained film-forming external preparation is formed of a resin, the other portion of the region may be formed of a material such as metal or glass. That is, among the constituent members of the container, some of the constituent members may be made of resin, and the other constituent members may be made of other materials (metal, glass, etc.). A combination of plastic and other materials (metal, glass, etc.) may be used. For example, the cap and the coating member may be made of resin, and the container body may be made of a carbon material (metal, glass, etc.). Further, for example, in the coating member, the coating portion may be made of resin and the shaft portion may be made of another material (metal, glass, etc.), and a part of the coating member may be made of resin.
本発明で使用される容器の好適な一態様として、容器本体と、塗布部材が取り付けられているキャップとを有し、当該塗布部材の少なくとも一部が樹脂製であるもの（以下、態様Ａと表記する）が挙げられる。 As a preferred embodiment of the container used in the present invention, a container body and a cap to which a coating member is attached are provided, and at least a part of the coating member is made of resin (hereinafter referred to as aspect A). Notation).
態様Ａにおける塗布部材としては、塗布部又は軸部のいずれか少なくとも一方が樹脂製であればよいが、好ましくは塗布部及び軸部の双方が樹脂製のものが挙げられる。態様Ａにおける容器本体は、樹脂製又は他の素材のいずれであってもよいが、容器に堅牢性を備えさせるために、金属製であることが好ましい。態様Ａにおけるキャップは、樹脂製又は他の素材のいずれであってもよいが、樹脂製であることが好ましい。また、中栓は通常は樹脂製であるので、態様Ａに前記中栓を取り付ける場合には、当該中栓も樹脂で形成される。 As the coating member in the aspect A, at least one of the coating portion and the shaft portion may be made of resin, but preferably, both the coating portion and the shaft portion are made of resin. The container body in aspect A may be made of resin or other material, but is preferably made of metal in order to provide the container with robustness. The cap in aspect A may be made of resin or other material, but is preferably made of resin. Further, since the inner plug is usually made of resin, when the inner plug is attached to the aspect A, the inner plug is also made of resin.
本発明で使用される容器において、皮膜形成性外用製剤と接触する領域の少なくとも一部の構成素材となる樹脂の種類については、特に制限されず、例えば、ポリプロピレン、ポリエチレン等のポリオレフィン樹脂；ポリエチレンテレフタレート、ポリブチレンテレフタレート等のポリエステル樹脂；ナイロン等のポリアミド樹脂等が挙げられる。 In the container used in the present invention, the type of resin that is a constituent material of at least a part of the region in contact with the film-forming external preparation is not particularly limited, and is, for example, a polyolefin resin such as polypropylene or polyethylene; polyethylene terephthalate. , Polybutylene terephthalate and other polyester resins; and examples include polyamide resins such as nylon.
これらの樹脂の中でも、ポリオレフィン（特にポリプロピレン）は、前記(A)〜(C)を含む皮膜形成性外用製剤と接触した状態になると顕著な変色（黄変）を生じさせ易い特性があるが、本発明では、ポリオレフィン（特にポリプロピレン）を皮膜形成性外用製剤と接触する領域に使用しても、変色（黄変）を効果的に抑制することができる。このような本発明の効果を鑑みれば、前記樹脂として、好ましくはポリオレフィン、更に好ましくはポリプロピレンが挙げられる。 Among these resins, polyolefins (particularly polypropylene) have the property of easily causing remarkable discoloration (yellowing) when they come into contact with the film-forming external preparations containing (A) to (C). In the present invention, discoloration (yellowing) can be effectively suppressed even when a polyolefin (particularly polypropylene) is used in a region in contact with a film-forming external preparation. In view of such effects of the present invention, examples of the resin include polyolefins, more preferably polypropylene.
本発明で使用される容器において、皮膜形成性外用製剤と接触する領域に設けられる樹脂部分は、１種の樹脂で形成されていてもよく、２種以上の樹脂で形成されていてもよい。例えば、容器本体とキャップの双方を樹脂製にする場合であれば、容器本体とキャップがそれぞれ異なる樹脂で形成されていてもよい。また、塗布部材を樹脂製にする場合であれば、塗布部と軸部が、同一の樹脂で形成されていてもよく、またそれぞれ異なる樹脂で形成されていてもよい。塗布部材の好適な一例として、塗布部がポリアミド系樹脂で形成され、軸部がオレフィン樹脂で形成されているものが挙げられる。 In the container used in the present invention, the resin portion provided in the region in contact with the film-forming external preparation may be formed of one type of resin or two or more types of resin. For example, if both the container body and the cap are made of resin, the container body and the cap may be made of different resins. Further, when the coating member is made of resin, the coating portion and the shaft portion may be formed of the same resin or may be formed of different resins. As a preferable example of the coating member, there is a case where the coating portion is formed of a polyamide resin and the shaft portion is formed of an olefin resin.
外用製品の使用方法
本発明の外用製品に収容されている皮膜形成性外用製剤は、粘性のある液状を呈するが、皮膚に塗布すると、前記(A)成分及び(B)成分が揮散して、(C)成分による皮膜が形成される。本発明の外用製品に収容されている皮膜形成性外用製剤は、外用医薬製剤（即ち、液体絆創膏）として使用することができる。具体的には、本発明の外用製品は、ひび、あかぎれ、さかむけ、小さな切り傷等の皮膚損傷部に塗布することにより、当該皮膚損傷部位に皮膜を形成させて、細菌、汚れ、水等から当該皮膚損傷部位を保護するための医薬製品として使用できる。
How to use the external product The film-forming external preparation contained in the external product of the present invention exhibits a viscous liquid, but when applied to the skin, the components (A) and (B) are volatilized. A film is formed by the component (C). The film-forming external preparation contained in the external product of the present invention can be used as an external pharmaceutical preparation (that is, a liquid bandage). Specifically, the external product of the present invention is applied to a skin-damaged part such as a crack, a crack, a hangnail, or a small cut to form a film on the skin-damaged part to prevent bacteria, dirt, water, etc. It can be used as a pharmaceutical product for protecting the skin damage site.
本発明の外用製品を使用して、皮膜形成性外用製剤を皮膚に塗布する方法については、特に制限されないが、例えば、本発明の外用製品の容器に前記塗布部材が取り付けられている場合には、当該塗布部材を使用して皮膜形成性外用製剤を皮膚に塗布すればよい。 The method of applying the film-forming external preparation to the skin using the external product of the present invention is not particularly limited, but for example, when the application member is attached to the container of the external product of the present invention. , The film-forming external preparation may be applied to the skin using the application member.
以下に、実施例等に基づいて本発明を詳細に説明するが、本発明はこれらによって限定されるものではない。なお、以下の実施例及び比較例において、ニトロセルロース源として、ピロキシリン（ニトロセルロース：イソプロピルアルコールの重量比が７：３）を使用した。 Hereinafter, the present invention will be described in detail based on examples and the like, but the present invention is not limited thereto. In the following Examples and Comparative Examples, pyroxylin (nitrocellulose: isopropyl alcohol weight ratio: 7: 3) was used as the nitrocellulose source.
試験例１
表１及び２に示す組成の皮膜形成性外用製剤を調製した。具体的には(A)成分、(D)成分、及び(E)成分を攪拌混合し、これに（C）成分を添加して分散させた後、(B)成分を加えて均一に攪拌溶解して目的の皮膜形成性外用製剤を得た。各皮膜形成性外用製剤１０ｍｌを下記容器１及び２に収容し、キャップを取り付けて、５０℃、７５％ＲＨの雰囲気で２０日間保管した。なお、保管は容器を正立させた状態で行ったため、保管中は、キャップ及び中栓は皮膜形成性外用製剤と接触していない状態になっている。
（容器１）
図１に示す構造の容器。
容器本体：内径１５ｍｍ、容積１５ｍｌの金属製の容器本体。
キャップ：ポリプロピレン製のキャップ
塗布部材：ナイロン製の塗布部及びポリプロピレン製の軸部からなる塗布部材。
中栓：ポリプロピレン製の中栓
（容器２）
図１に示す構造の容器。
容器本体：内径１５ｍｍ、容積１５ｍｌの金属製の容器本体。
キャップ：ポリプロピレン製のキャップ
塗布部材：ナイロン製の塗布部及びポリエチレン製の軸部からなる塗布部材。
中栓：ポリプロピレン製の中栓
Test Example 1
A film-forming external preparation having the composition shown in Tables 1 and 2 was prepared. Specifically, the components (A), (D), and (E) are stirred and mixed, the component (C) is added and dispersed, and then the component (B) is added and uniformly stirred and dissolved. Then, the desired film-forming external preparation was obtained. 10 ml of each film-forming external preparation was housed in the following containers 1 and 2, capped, and stored at 50 ° C. and 75% RH for 20 days. Since the container was stored upright, the cap and inner plug were not in contact with the film-forming external preparation during storage.
(Container 1)
A container having the structure shown in FIG.
Container body: A metal container body with an inner diameter of 15 mm and a volume of 15 ml.
Cap: Polypropylene cap coating member: A coating member composed of a nylon coating portion and a polypropylene shaft portion.
Inner stopper: Polypropylene inner stopper (container 2)
A container having the structure shown in FIG.
Container body: A metal container body with an inner diameter of 15 mm and a volume of 15 ml.
Cap: Polypropylene cap coating member: A coating member composed of a nylon coating portion and a polyethylene shaft portion.
Inner plug: Polypropylene inner plug
２０日間保管後に、キャップを取り外して、塗布部材に付加している皮膜形成性外用製剤を拭き取った後に、塗布部材の外観を目視にて確認した。皮膜形成性外用製剤を容器に収容せずに２０日間保管した後の塗布部材の色を「１点」とし、容器１を使用した場合には、変色（黄変）が認められた比較例１の２０日間保管した後の塗布部材の色を「１０点」、容器２を使用した場合には、変色（黄変）が認められた比較例３の２０日間保管した後の塗布部材の色を「１０点」として、変色の程度を評点化した。なお、それぞれの条件で１０回の試験を行い、各条件での評点の平均値を求めた。 After storage for 20 days, the cap was removed, and the film-forming external preparation attached to the coating member was wiped off, and then the appearance of the coating member was visually confirmed. Comparative Example 1 in which discoloration (yellowing) was observed when the container 1 was used, with the color of the coated member as "1 point" after storing the film-forming external preparation for 20 days without storing it in the container. The color of the coated member after being stored for 20 days was "10 points", and when the container 2 was used, the color of the coated member after being stored for 20 days in Comparative Example 3 in which discoloration (yellowing) was observed. The degree of discoloration was scored as "10 points". The test was performed 10 times under each condition, and the average value of the scores under each condition was obtained.
得られた結果を表１及び２に示す。イソプロパノール、酢酸エチル、及びニトロセルロースを含み、パンテノールを含まない皮膜形成性外用製剤を容器１及び２に収容して保管すると、ポリプロピレン製及びポリエチレン製の塗布部材の黄変が認められた（比較例１及び３）。特に、ポリプロピレン製の塗布部材の場合には、ポリエチレン製に比べて黄変が著しくなっていた。また、このような黄変は、皮膜形成性外用製剤にヒマシ油を配合しても、改善できなかった（比較例２及び４）。これに対して、イソプロパノール、酢酸エチル、及びニトロセルロースと共に、パンテノールを配合した皮膜形成性外用製剤を使用した場合には、ポリプロピレン製及びポリエチレン製の塗布部材の黄変を効果的に抑制できていた（実施例１〜１０）。特にパンテノールが３〜５重量％である場合には、黄変を抑制する効果がより一層顕著に奏されていた（実施例２〜５及び７〜１０）。参考のために、実施例２及び比較例１において、保管後の塗布部材の軸部の外観を撮影した写真を図２に示す。 The results obtained are shown in Tables 1 and 2. When the film-forming external preparations containing isopropanol, ethyl acetate, and nitrocellulose but not panthenol were stored in containers 1 and 2, yellowing of the polypropylene and polyethylene coating members was observed (comparative). Examples 1 and 3). In particular, in the case of the coated member made of polypropylene, yellowing was remarkable as compared with the case made of polyethylene. Moreover, such yellowing could not be improved even if castor oil was added to the film-forming external preparation (Comparative Examples 2 and 4). On the other hand, when a film-forming external preparation containing panthenol together with isopropanol, ethyl acetate, and nitrocellulose was used, yellowing of polypropylene and polyethylene coated members could be effectively suppressed. (Examples 1 to 10). In particular, when the amount of panthenol was 3 to 5% by weight, the effect of suppressing yellowing was more remarkable (Examples 2 to 5 and 7 to 10). For reference, FIG. 2 shows photographs of the appearance of the shaft portion of the coated member after storage in Example 2 and Comparative Example 1.
試験例２
表３に示す各皮膜形成性外用製剤について、皮膚への皮膜の接着性、及び皮膚から皮膜の剥離性について評価した。なお、表３に示す参考例１〜５、比較参考例１及び２の皮膜形成性外用製剤は、それぞれ、実施例１〜５（実施例６〜１０）、比較例１及び２（比較例３及び４）で使用した皮膜形成性外用製剤と同一である。
Test Example 2
For each film-forming external preparation shown in Table 3, the adhesiveness of the film to the skin and the peelability of the film from the skin were evaluated. The film-forming external formulations of Reference Examples 1 to 5 and Comparative Reference Examples 1 and 2 shown in Table 3 are Examples 1 to 5 (Examples 6 to 10) and Comparative Examples 1 and 2 (Comparative Example 3), respectively. It is the same as the film-forming external preparation used in 4).
各皮膜形成性外用製剤の約０．０５ｇを手の甲のＭＰ関節部（約１ｃｍ2）に塗布して皮膜を形成させた。塗布してから２時間、通常の生活を送った後に、皮膜と皮膚の接着状態を観察し、皮膜を皮膚から剥離させた。その際に、下記判定基準に従って、皮膜の接着性と剥離性について評点化した。本試験は６名の被験者によって行い、各被験者が判定した評点の平均値を算出した。
＜皮膜の接着性の判定基準＞
５：皮膜が端部までしっかりと接着している。
４：皮膜の端部が少し剥がれている。
３：皮膜の端部が剥がれている。
２：皮膜の半分位の領域が剥がれている。
１：皮膜の殆どの領域が剥がれている。
＜皮膜の剥離性の判定基準＞
５：剥がし易い。
４：やや剥がし易い。
３：どちらともいえない。
２：やや剥がし難い。
１：剥がし難い。
About 0.05 g of each film-forming external preparation was applied to the MP joint (about 1 cm 2 ) on the back of the hand to form a film. After living a normal life for 2 hours after application, the adhesion between the film and the skin was observed, and the film was peeled off from the skin. At that time, the adhesiveness and peelability of the film were scored according to the following criteria. This test was conducted by 6 subjects, and the average value of the scores judged by each subject was calculated.
<Criteria for film adhesiveness>
5: The film is firmly adhered to the end.
4: The edge of the film is slightly peeled off.
3: The edge of the film is peeled off.
2: About half of the film is peeled off.
1: Most areas of the film are peeled off.
<Criteria for film peelability>
5: Easy to peel off.
4: Slightly easy to peel off.
3: I can't say either.
2: It is a little difficult to peel off.
1: Difficult to peel off.
結果を表３に示す。ニトロセルロースを含む皮膜形成性外用製剤は、いずれも、塗布から２時間後には、しっかりとした皮膜が形成された。但し、パンテノール及び可塑剤（ヒマシ油）を含まない場合には、皮膜の剥離性が悪かった（比較参考例１）。また、可塑剤（ヒマシ油）を含む場合であっても、皮膜の剥離性は改善できていなかった（比較参考例２）。これに対して、パンテノールを含む場合には、皮膜の接着性を良好に維持しつつ、優れた剥離性を有していた（参考例１〜５）。 The results are shown in Table 3. In all of the film-forming external preparations containing nitrocellulose, a firm film was formed 2 hours after application. However, when panthenol and a plasticizer (castor oil) were not contained, the peelability of the film was poor (Comparative Reference Example 1). Further, even when a plasticizer (castor oil) was contained, the peelability of the film could not be improved (Comparative Reference Example 2). On the other hand, when panthenol was contained, it had excellent peelability while maintaining good adhesiveness of the film (Reference Examples 1 to 5).
なお、比較参考例１及び２の皮膜形成性外用製剤では、皮膜を剥離し難く、強い力で剥離することを要したため、剥離後の皮膚は赤みを帯びた状態になっていたが、参考例１〜５の皮膜形成性外用製剤では、皮膜を剥離し易く、剥離後の皮膚状態は正常であった。また、比較参考例１及び２の皮膜形成性外用製剤では、皮膜を剥離し難かったために、剥離中に皮膜が破断されたが、参考例１〜５の皮膜形成性外用製剤では、皮膜を剥離し易く、剥離後の皮膜は、殆ど破断されることなく、形状を維持できていた。参考のため、参考例１、２及び比較参考例１の皮膜形成性外用製剤について、皮膚から剥離した後の皮膜の形状を観察した結果を図３に示す。 In the film-forming external preparations of Comparative Reference Examples 1 and 2, the film was difficult to exfoliate and it was necessary to exfoliate with a strong force, so that the skin after exfoliation was in a reddish state. In the film-forming external preparations 1 to 5, the film was easily peeled off, and the skin condition after peeling was normal. Further, in the film-forming external preparations of Comparative Reference Examples 1 and 2, the film was broken during the peeling because it was difficult to peel off the film, but in the film-forming external preparations of Reference Examples 1 to 5, the film was peeled off. The film was easy to peel off, and the shape of the film after peeling could be maintained with almost no breakage. For reference, FIG. 3 shows the results of observing the shape of the film after peeling from the skin of the film-forming external preparations of Reference Examples 1 and 2 and Comparative Reference Example 1.
試験例４
表４に示す組成の皮膜形成性外用製剤を調製した。具体的には(A)成分、(D)成分、(E)成分、及び(F)成分を攪拌混合し、これに（C）成分を添加して分散させた後、(B)成分を加えて均一に攪拌溶解して目的の皮膜形成性外用製剤を得た。
Test Example 4
A film-forming external preparation having the composition shown in Table 4 was prepared. Specifically, the component (A), the component (D), the component (E), and the component (F) are stirred and mixed, and the component (C) is added and dispersed, and then the component (B) is added. The mixture was uniformly stirred and dissolved to obtain the desired film-forming external preparation.
各皮膜形成性外用製剤について、パドルオーバーディスク法で、パンテノールの放出性について評価した。具体的には、先ず、パドルオーバーディスク（富山産業株式会社製、網１２５μｍ、ＳＵＳ３１６製、Ｄ２４１４）に、皮膜形成性外用製剤約０．１ｇを素早くドーナツ状に塗布し、約２時間風乾した。試験液は３２℃±０．５℃に加温したｐＨ６．０のリン酸塩緩衝液９００ｍｌを用い、毎分５０回転で試験を行った。皮膜形成性外用製剤を塗布したディスク1個をとり、試験を開始し、２分後にベッセル内の試験液を採取し、孔径０．４５μｍ以下のメンブランフィルターでろ過し試料溶液とした。パンテノール標準溶液及び試料溶液２０μｌにつき、高速液体クロマトグラフを用いてパンテノール濃度を測定した。パンテノール標準溶液(０．１、０．２、０．５、１、２及び５μｇ／ｍｌ)のパンテノール濃度とピーク面積から検量線を作成し、以下の式に従ってパンテノール放出率を算出した。 The release property of panthenol was evaluated by the paddle overdisc method for each film-forming external preparation. Specifically, first, about 0.1 g of a film-forming external preparation was quickly applied to a paddle over disk (manufactured by Toyama Sangyo Co., Ltd., net 125 μm, manufactured by SUS316, D2414) in a donut shape, and air-dried for about 2 hours. As the test solution, 900 ml of a phosphate buffer solution having a pH of 6.0 heated to 32 ° C. ± 0.5 ° C. was used, and the test was conducted at 50 rpm. One disc coated with the film-forming external preparation was taken, the test was started, and 2 minutes later, the test solution in the vessel was collected and filtered through a membrane filter having a pore size of 0.45 μm or less to prepare a sample solution. The panthenol concentration was measured using a high performance liquid chromatograph for 20 μl of the panthenol standard solution and the sample solution. A calibration curve was prepared from the panthenol concentration and peak area of the panthenol standard solution (0.1, 0.2, 0.5, 1, 2 and 5 μg / ml), and the panthenol release rate was calculated according to the following formula. ..
WS:標準品採取量(g)
RFs: パンテノール標準溶液に使用したパンテノール標準品の純度(%)
n:サンプリング回
WT:試料採取量(g)[初期重量及び初期重量換算値]
P:パンテノール濃度(%)
WS: Standard product collection amount (g)
RFs: Purity (%) of the Panthenol standard used in the Panthenol standard solution
n: Sampling times
WT: Sampling volume (g) [Initial weight and initial weight conversion value]
P: Panthenol concentration (%)
得られた結果を表４に示す。この結果、パンテノールと共に、０．１〜１．５重量％のヒマシ油を含む皮膜形成性外用製剤では、パンテノールの放出率が向上していた（参考例６〜９）。特に、０．１重量％及び１重量％のヒマシ油を含む場合には、パンテノールの放出率が格段に高まっていた（参考例６及び７）。 The results obtained are shown in Table 4. As a result, the release rate of panthenol was improved in the film-forming external preparation containing 0.1 to 1.5% by weight of castor oil together with panthenol (Reference Examples 6 to 9). In particular, when 0.1% by weight and 1% by weight of castor oil were contained, the release rate of panthenol was remarkably increased (Reference Examples 6 and 7).
１ 容器本体
２ キャップ
３ 中栓
４ 塗布部材
４１ 塗布部
４２ 軸部
1 Container body 2 Cap 3 Inner plug 4
Claims (7)
前記皮膜形成性外用製剤が、(A)炭素数１〜４の１価アルコール、(B)炭素数２〜４のモノカルボン酸と炭素数１〜５の１価アルコールとのエステル、(C)ニトロセルロース、及び(D)パンテノール、その塩、及び／又はアセチルパントテニルエチルエーテルを含み(ただし、ポリエステル及び／又はグリセリルトリベンゾエートを含む場合を除く。)、
前記容器において、内部に収容した前記皮膜形成性外用製剤と接する領域の少なくとも一部がポリオレフィンで形成されている、外用製品。 An external product in which a film-forming external preparation is contained in a container.
The film-forming external preparation is (A) an ester of a monocarboxylic acid having 1 to 4 carbon atoms, (B) an ester of a monocarboxylic acid having 2 to 4 carbon atoms and a monohydric alcohol having 1 to 5 carbon atoms, (C). Includes nitrocellulose and (D) pantenol, salts thereof, and / or acetylpantothenyl ethyl ether (except when polyester and / or glyceryl tribenzoate is included).
An external product in which at least a part of a region in contact with the film-forming external preparation contained therein is formed of polyolefin in the container.
開口部を有する容器本体と、
前記開口部を着脱自在に閉じるキャップと、
前記キャップに連結され、前記開口に取付けられたとき前記容器の内部空間へ延びるように配置されている、前記皮膜形成性外用製剤を皮膚に塗布するための塗布部材を有する、請求項１に記載の外用製品。 The container
The container body with an opening and
With a cap that detachably closes the opening,
Coupled to the cap, is arranged so as to extend into the interior space of said container when mounted in front Symbol opening, the film-forming external preparation having an application member for applying to the skin, to claim 1 The listed external products.
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| FR2718637A1 (en) * | 1994-04-15 | 1995-10-20 | Oreal | Cosmetic composition to be applied to the nail. |
| GB9511939D0 (en) * | 1995-06-13 | 1995-08-09 | Unilever Plc | Alcohol/aqueous nail lacquer |
| US5662891A (en) * | 1995-12-28 | 1997-09-02 | Almell, Ltd. | Nail coating compositon free of aromatic and ketone solvents and formaldehyde resins |
| FR2773067B1 (en) * | 1997-12-29 | 2000-03-03 | Oreal | NITROCELLULOSE VARNISH COSMETIC COMPOSITION CONTAINING A STABILIZING AGENT |
| FR2887751B1 (en) * | 2005-06-29 | 2007-09-14 | Oreal | APPLICATOR AND DEVICE FOR PACKAGING AND APPLICATION COMPRISING SUCH AN APPLICATOR. |
| JP5026030B2 (en) * | 2006-08-30 | 2012-09-12 | 株式会社吉野工業所 | Cosmetic applicator |
| WO2011044008A1 (en) * | 2009-10-08 | 2011-04-14 | Schering-Plough Healthcare Products, Inc. | Low ether composition and delivery apparatus |
| JP5950528B2 (en) * | 2011-09-30 | 2016-07-13 | 小林製薬株式会社 | Film-forming external preparation |
| JP2016175883A (en) * | 2015-03-20 | 2016-10-06 | 合同インキ株式会社 | Nail polish, coating method of nail polish, and nail polish liquid kit |
| JP6775976B2 (en) * | 2016-03-18 | 2020-10-28 | 小林製薬株式会社 | Topical preparation for reducing skin friction |
| JP7048221B2 (en) * | 2017-06-26 | 2022-04-05 | 小林製薬株式会社 | Film-forming external preparation |
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