JP2017160170A - External composition - Google Patents
External composition Download PDFInfo
- Publication number
- JP2017160170A JP2017160170A JP2016048015A JP2016048015A JP2017160170A JP 2017160170 A JP2017160170 A JP 2017160170A JP 2016048015 A JP2016048015 A JP 2016048015A JP 2016048015 A JP2016048015 A JP 2016048015A JP 2017160170 A JP2017160170 A JP 2017160170A
- Authority
- JP
- Japan
- Prior art keywords
- composition
- water
- external
- swellable powder
- iron oxide
- 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.)
- Granted
Links
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- 239000000843 powder Substances 0.000 claims abstract description 125
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- 238000000034 method Methods 0.000 claims abstract description 15
- 230000001747 exhibiting effect Effects 0.000 claims abstract description 11
- 230000000087 stabilizing effect Effects 0.000 claims abstract description 5
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 129
- 239000002628 heparin derivative Substances 0.000 claims description 46
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- 238000011105 stabilization Methods 0.000 claims description 8
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical class OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 abstract 1
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- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 3
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Abstract
Description
本発明は、外用組成物に関する。 The present invention relates to a composition for external use.
従来、外用組成物にサラサラ感を与えるために、また、テカリやべたつき感を抑えるために、非水膨潤性の粉体（以下、粉体とも記す）を用いた外用組成物が多く知られている。この様な粉体は比重が大きい場合が多い。そのため、粉体を添加した水性分散系の外用組成物では、外用組成物中の粉体の分散安定性が不十分となり、粉体が沈降したり、ケーキングを起こしたりするという問題があった。 Conventionally, many external compositions using non-water-swellable powders (hereinafter also referred to as powders) have been known in order to give the external compositions a smooth feeling and to suppress shine and stickiness. Yes. Such powder often has a large specific gravity. Therefore, the aqueous dispersion external composition to which the powder is added has a problem that the dispersion stability of the powder in the external composition becomes insufficient, and the powder settles or causes caking.
そこで、粉体を添加した水性分散系の外用組成物に、更に高分子を添加して粘度を上げて、粉体の分散安定性を向上させる方法が提案されている（特許文献１）。しかし、粉体の分散安定性を向上させるために、高分子の添加量を増加させていくと、却って外用組成物の使用時にべたつきが生じ、使用感が悪化したり、サラサラ感やテカリを十分に抑制できなかったりするという問題があった。 In view of this, a method has been proposed in which a polymer is further added to an aqueous dispersion external composition to which powder is added to increase the viscosity, thereby improving the dispersion stability of the powder (Patent Document 1). However, if the amount of the polymer added is increased in order to improve the dispersion stability of the powder, on the contrary, stickiness occurs when using the composition for external use, and the feeling of use deteriorates, and the smoothness and shine are sufficient. There was a problem that it could not be suppressed.
また、近年、粉体表面を疎水化処理した粉体を配合した外用組成物も知られている。この様な粉体は、肌上での耐水性が高く、塗布後は、肌から組成物が取れ難い特性を有する。そのため、ことから、外用組成物に疎水化処理した粉体を配合することで、塗布時の使用感と共に塗布後の特性に優れたものとすることができる。 In recent years, an external composition containing a powder whose surface has been hydrophobized is also known. Such powder has high water resistance on the skin, and has a characteristic that it is difficult to remove the composition from the skin after application. Therefore, by blending the hydrophobized powder into the composition for external use, it is possible to achieve excellent post-application characteristics as well as the feeling of use at the time of application.
さて、その様な粉体であっても、乳化組成物において分散安定化させることには解決すべき課題を有しており、特に、油相中で粉体を安定に分散させることが重要とされている。そのために、乳化組成物に配合する種々の分散安定化剤の検討が行われている。 Even with such a powder, there is a problem to be solved for stabilizing the dispersion in the emulsion composition, and it is particularly important to stably disperse the powder in the oil phase. Has been. Therefore, various dispersion stabilizers to be blended in the emulsion composition have been studied.
分散安定化剤として、例えばポリオキシアルキレン変性ポリシロキサン、両末端シリコーン化グリセリン、アクリル変性シリコーン等が知られている。しかし、これら成分は非イオン性界面活性剤でもあり、HLBのバランスが崩れた場合等で転相し易く、乳化安定性に悪影響を与える場合があった。また、複数の粉体を配合する場合に、乳化組成物中で十分な安定性を確保できないといった問題があった。 As a dispersion stabilizer, for example, polyoxyalkylene-modified polysiloxane, both-ends silicone-modified glycerin, acrylic-modified silicone and the like are known. However, these components are also nonionic surfactants, and are liable to phase inversion when the HLB balance is lost, which may adversely affect the emulsion stability. Moreover, when mix | blending several powder, there existed a problem that sufficient stability could not be ensured in an emulsion composition.
従って、外用組成物中で非水膨潤性の粉体の分散安定性について改良の余地があった。 Therefore, there is room for improvement in the dispersion stability of the non-water-swellable powder in the external composition.
本発明は、非水膨潤性の粉体を含有しながらも、当該粉体の分散安定性が向上された外用組成物を提供することを目的とする。 An object of the present invention is to provide a composition for external use which contains a non-water-swellable powder and has improved dispersion stability of the powder.
また、本発明は、非水膨潤性の粉体を含む外用組成物において、当該粉体の分散安定化法を提供することを目的とする。 Another object of the present invention is to provide a method for stabilizing the dispersion of an external composition containing a non-water-swellable powder.
本発明者らは、上記課題を解決するために鋭意検討を重ねていたところ、非水膨潤性の粉体を含む流動性を呈する外用組成物に対して、ヘパリン類似物質を組み合わせることによって、流動性を呈する外用組成物において非水膨潤性の粉体の分散安定性を向上できることを見出した。 The inventors of the present invention have made extensive studies in order to solve the above-described problems. As a result, a combination of a heparin-like substance and a fluid composition for external use including a non-water-swellable powder can be used. It has been found that the dispersion stability of a non-water-swellable powder can be improved in an external composition exhibiting properties.
また、本発明者らは、上記検討の過程で、ヘパリン類似物質、更には常温で固体の油性成分を配合すると、非水膨潤性の粉体の発色性（鮮やかさ）も向上させることができることも見出した。 In addition, the present inventors can improve the color developability (brightness) of non-water-swellable powders by blending heparin-like substances and further solid oily components at room temperature during the above examination process. I also found.
本発明は、これらの知見に基づいて完成したものであり、下記の実施形態を有するものである。 The present invention has been completed based on these findings and has the following embodiments.
項１．
ヘパリン類似物質及び非水膨潤性の粉体を含み、25℃で流動性を呈する外用組成物。
Item 1.
An external composition comprising a heparin-like substance and a non-water-swellable powder and exhibiting fluidity at 25 ° C.
項２．
前記ヘパリン類似物質の含有量が0.001〜10重量%である前記項１に記載の外用組成物。
Item 2.
Item 2. The composition for external use according to Item 1, wherein a content of the heparin-like substance is 0.001 to 10% by weight.
項３．
更に酸化鉄を含む前記項１又は２に記載の外用組成物。
Item 3.
Item 3. The composition for external use according to Item 1 or 2, further comprising iron oxide.
項４．
更に常温で固体の油性成分を含む前記項１〜３のいずれかに記載の外用組成物。
Item 4.
Item 4. The composition for external use according to any one of Items 1 to 3, further comprising an oily component that is solid at normal temperature.
項５．
Ｂ型粘度計を用いて、25℃で測定した際における粘度が20,000mPa・s〜2,000,000mPa・sである前記項１〜４のいずれかに記載の外用組成物。
Item 5.
Item 5. The composition for external use according to any one of Items 1 to 4, which has a viscosity of 20,000 mPa · s to 2,000,000 mPa · s when measured at 25 ° C. using a B-type viscometer.
項６．
非水膨潤性の粉体を含む外用組成物中に、ヘパリン類似物質を併存させることを特徴とする、外用組成物中の非水膨潤性の粉体の分散安定化法。
Item 6.
A method for stabilizing the dispersion of a non-water swellable powder in an external composition, wherein a heparin-like substance coexists in the external composition containing the non-water swellable powder.
項７．
更に常温で固体の油性成分を含む前記項６に記載の分散安定化法。
Item 7.
Item 7. The dispersion stabilization method according to Item 6, further comprising an oily component that is solid at normal temperature.
本発明の外用組成物は、流動性を呈し、非水膨潤性の粉体が含有されているにもかかわらず、ヘパリン類似物質が組み合わせて含有されているので、当該粉体の分散安定性が向上している。本発明の流動性を呈する外用組成物は、非水膨潤性の粉体やその他の成分の偏りを著しく低減でき、各成分の効果のばらつき等を効果的に解消することができる。 Although the composition for external use of the present invention exhibits fluidity and contains a non-water-swellable powder, it contains a combination of heparin-like substances, so that the dispersion stability of the powder is low. It has improved. The composition for external use exhibiting the fluidity of the present invention can remarkably reduce the non-swellable powder and other components, and can effectively eliminate variations in the effects of the components.
本発明の外用組成物は、各成分の分散安定性が良好であり、非水膨潤性の粉体が沈降せず、ケーキング現象を抑えることができる。 The composition for external use of the present invention has good dispersion stability of each component, non-swellable powder does not settle, and can suppress the caking phenomenon.
また、本発明の外用組成物では、ヘパリン類似物質、更にはマイクロクリスタリンワックス等の常温で固体の油性成分を配合すると、非水膨潤性の粉体の分散安定性に加えて、酸化鉄を配合した場合の発色性（鮮やかさ）を向上させることもできる。従って、外用組成物を皮膚に塗布したときの、その外観を改善すること（鮮やかさを際立たせること）もできる。 In addition, in the composition for external use of the present invention, when a solid oil component such as a heparin-like substance and a microcrystalline wax is blended at room temperature, iron oxide is blended in addition to the dispersion stability of the non-water-swellable powder. The color developability (brightness) can be improved. Therefore, when the composition for external use is applied to the skin, the appearance can be improved (the vividness can be emphasized).
これらの効果は、外用組成物の品質の向上に繋がる。 These effects lead to an improvement in the quality of the composition for external use.
(1)外用組成物
本発明の外用組成物は、25℃で流動性を呈し、ヘパリン類似物質及び非水膨潤性の粉体を含む。
(1) External Composition The external composition of the present invention exhibits fluidity at 25 ° C. and contains a heparin-like substance and a non-water-swellable powder.
以下、本発明の外用組成物の流動性と、それに含まれる各成分について説明する。 Hereinafter, the fluidity of the composition for external use of the present invention and each component contained therein will be described.
本発明の外用組成物には、水相のみからなる水性組成物、並びに水相と油相とを混合して得られる乳化組成物が含まれる。 The composition for external use of the present invention includes an aqueous composition comprising only an aqueous phase and an emulsified composition obtained by mixing an aqueous phase and an oil phase.
(1-1)流動性の定義
本発明の流動性を呈する外用組成物とは、液状から半固形状の組成物を示す。好ましくは水の配合量が10重量%以上であり、より好ましくは20重量%以上を含む組成物を示す。
(1-1) Definition of fluidity The composition for external use exhibiting the fluidity of the present invention refers to a liquid to semi-solid composition. A composition containing preferably 10% by weight or more of water, more preferably 20% by weight or more is shown.
前記液状とは、常温（15℃〜25℃）で流動性が高く、粘度が低い状態を示す。液状の外用組成物として、具体的には、液剤、ローション剤、乳剤、懸濁剤等が好ましい。その液状の外用組成物の粘度は、1mPa・s〜20,000mPa・s程度であることが好ましい。 The liquid state indicates a state where the fluidity is high and the viscosity is low at room temperature (15 ° C. to 25 ° C.). Specifically, liquid preparations, lotions, emulsions, suspensions and the like are preferable as the liquid external composition. The viscosity of the liquid external composition is preferably about 1 mPa · s to 20,000 mPa · s.
従来、液状の組成物では、非水膨潤性粉体を分散させることが難しかった。本発明においては、液状の組成物であっても、ヘパリン類似物質を配合することで、容易に非水膨潤性粉体の分散安定性を向上させることができ、この向上率は高い。 Conventionally, in a liquid composition, it has been difficult to disperse non-water-swellable powder. In the present invention, even if it is a liquid composition, the dispersion stability of the non-water-swellable powder can be easily improved by adding a heparin-like substance, and this improvement rate is high.
前記半固形状とは、常温（15℃〜25℃）で流動性がややある状態を示す。半固形状とは、固体とは異なり、スティック状化粧品等の一定の形状を示さず、指で触れると形状が変わり平面に塗布できるものを示す。具体的には、軟膏剤、クリーム剤、ゲル剤、ゼリー剤、懸濁剤、乳剤等が好ましい。その半固形状の外用組成物の粘度は、得られる組成物における分散安定性をより向上させられることから、20,000mPa・s〜2,000,000mPa・s程度であることが好ましく、50,000mPa・s〜1,000,000mPa・sであることがより好ましい。 The semi-solid state indicates a state where the fluidity is somewhat at room temperature (15 ° C. to 25 ° C.). The semi-solid form is different from a solid, and does not show a fixed shape such as a stick-like cosmetic product, but shows a shape that can be applied to a flat surface when touched with a finger. Specifically, ointments, creams, gels, jellies, suspensions, emulsions and the like are preferable. The viscosity of the semisolid external composition is preferably about 20,000 mPa · s to 2,000,000 mPa · s, since the dispersion stability in the resulting composition can be further improved, and 50,000 mPa · s to 1,000,000. mPa · s is more preferable.
前記粘度は、1日間静置させたサンプルを、Ｂ型粘度計を用いて、25℃にて測定される。例えば、東機産業株式会社製のRB-85L粘度計（単一円筒形回転粘度計）で、ローター番号M4のローターを使用して測定することができる。そのときの回転数は、サンプル粘度に応じて0.3rpm〜60rpmの間で調節する。例えば、10,000 mPa・s程度以下のときは60rpm、10,000 mPa・s〜50,000 mPa・s程度のときは12rpm、50,000 mPa・s〜400,000mPa・s程度のときは1.5rpm、400,000 mPa・s〜2,000,000 mPa・s程度のときは0.3rpmで測定する。なお、粘度は測定開始から30秒後の値を採用する。 The viscosity is measured at 25 ° C. using a B-type viscometer on a sample that was allowed to stand for 1 day. For example, it can be measured with a RB-85L viscometer (single cylindrical rotational viscometer) manufactured by Toki Sangyo Co., Ltd., using a rotor with a rotor number of M4. The rotation speed at that time is adjusted between 0.3 rpm and 60 rpm according to the sample viscosity. For example, 60 rpm when the speed is about 10,000 mPa · s or less, 12 rpm when the speed is about 10,000 mPa · s to 50,000 mPa · s, 1.5 rpm when the speed is about 50,000 mPa · s to 400,000 mPa · s, 400,000 mPa · s to 2,000,000 When it is about mPa · s, measure at 0.3 rpm. The viscosity is 30 seconds after the start of measurement.
本発明の流動性を呈する外用組成物が、液状である場合、常温での粘度が1mPa・s〜20,000mPa・sであることが好ましい。 When the composition for external use exhibiting the fluidity of the present invention is in a liquid state, the viscosity at room temperature is preferably 1 mPa · s to 20,000 mPa · s.
本発明の流動性を呈する外用組成物が、半固形状である場合、常温での粘度が20,000mPa・s〜2,000,000mPa・sであることが好ましく、50,000mPa・s〜1,000,000mPa・sであることがより好ましい。 When the composition for external use exhibiting the fluidity of the present invention is semi-solid, the viscosity at normal temperature is preferably 20,000 mPa · s to 2,000,000 mPa · s, and preferably 50,000 mPa · s to 1,000,000 mPa · s. It is more preferable.
(1-2) 非水膨潤性の粉体
本発明の外用組成物は、非水膨潤性の粉体を含む。非水膨潤性の粉体は、外用組成物をコンシーラー様の医薬品やファンデーション等の化粧料として用いた場合に、皮膚に対して、サラサラ感を与えたり、テカリやべたつき感を抑えたりするために機能すると共に、後述する酸化鉄と組み合わせた場合、発色性（鮮やかさ）の調整剤としても機能する。
(1-2) Non-water-swellable powder The composition for external use of the present invention comprises a non-water-swellable powder. Non-water-swellable powder is used to give a smooth feel to the skin and to prevent shine and stickiness when the composition for external use is used as a cosmetic such as a concealer-like drug or foundation. In addition to functioning, when combined with iron oxide, which will be described later, it also functions as an adjuster of color developability (brightness).
非水膨潤性の粉体の種類は特に限定されず、併用する添加物や剤によって適宜選定することができる。 The kind of non-water-swellable powder is not particularly limited, and can be appropriately selected depending on the additive or agent used together.
非水膨潤性の粉体として、カオリン系粘土鉱物、パイロフィライト系粘土鉱物、雲母系粘土鉱物、緑泥石系粘土鉱物、焼成粘土鉱物、ゼオライト系粘土鉱物、（下記酸化鉄以外の）金属酸化物、デンプン等を好ましく用いることができる。 Non-water-swellable powders such as kaolin clay minerals, pyrophyllite clay minerals, mica clay minerals, chlorite clay minerals, calcined clay minerals, zeolitic clay minerals, and metal oxides (other than iron oxide below) Products, starch and the like can be preferably used.
カオリン系粘土鉱物として、例えばカオリナイト、ハロイサイト、ナクライト、デッカイト、クリソタイル等を好ましく用いることができる。 As kaolin clay minerals, for example, kaolinite, halloysite, nacrite, decaite, chrysotile and the like can be preferably used.
パイロフィライト系粘土鉱物として、タルク、パイロフィライト等を好ましく用いることができる。タルクは、光沢、使用感等の調整に使うことができる。 As the pyrophyllite clay mineral, talc, pyrophyllite and the like can be preferably used. Talc can be used to adjust gloss, feel, etc.
雲母系粘土鉱物として、四角雲母（マイカ）、絹雲母（セリサイト）、白雲母（マスコバイト）、金雲母（フロゴバイト）、合成雲母、紅雲母（リチア雲母）、黒雲母（バイオタイト）等を好ましく用いることができる。 As mica-based clay minerals, square mica (mica), sericite (sericite), muscovite (mascobite), phlogopite (phlogobite), synthetic mica, red mica (lithia mica), biotite, biotite, etc. It can be preferably used.
緑泥石系粘土鉱物として、クロライト等を好ましく用いることができる。 As the chlorite clay mineral, chlorite or the like can be preferably used.
焼成粘土鉱物として、焼成雲母、焼成タルク、焼成セリサイト等を好ましく用いることができる。 As the calcined clay mineral, calcined mica, calcined talc, calcined sericite and the like can be preferably used.
ゼオライト系粘土鉱物として、天然ゼオライト、合成ゼオライト等を好ましく用いることができる。 As zeolite clay minerals, natural zeolite, synthetic zeolite and the like can be preferably used.
金属酸化物として、酸化亜鉛（亜鉛華）、酸化チタン、酸化アルミニウム、シリカ等を好ましく用いることができる。酸化チタン等は、白色顔料として用いることができる。酸化チタン、酸化亜鉛等の超微粒子は、紫外線の防御にも使うことができる。酸化チタン被覆雲母（雲母チタン）は、真珠光沢顔料として使うことができる。酸化チタンは、化粧料では、紫外線散乱剤として、日焼け止め、ファンデーション等として用いることが可能である。 As the metal oxide, zinc oxide (zinc flower), titanium oxide, aluminum oxide, silica and the like can be preferably used. Titanium oxide or the like can be used as a white pigment. Ultrafine particles such as titanium oxide and zinc oxide can also be used for ultraviolet protection. Titanium oxide-coated mica (titanium mica) can be used as a pearlescent pigment. Titanium oxide can be used in cosmetics as a UV scattering agent, sunscreen, foundation, and the like.
デンプンとして、コーンスターチ、馬鈴薯デンプン等を好ましく用いることができる。 As starch, corn starch, potato starch or the like can be preferably used.
非水膨潤性の粉体は、その用途に合わせて、１種単独で使用しても良く、２種以上を組み合わせて使用しても良い。 The non-water-swellable powder may be used alone or in combination of two or more depending on the application.
非水膨潤性の粉体の粒径や形状も制限されず、従来公知の非水膨潤性の粉体を目的に応じて適宜用いることができる。非水膨潤性の粉体の粒径として0.01〜20μm程度が好ましく、0.1〜10μm程度がより好ましい。非水膨潤性の粉体の粒径はレーザー回析等で測定することが可能である。非水膨潤性の粉体の形状として粉末状が好ましい。 The particle diameter and shape of the non-water-swellable powder are not limited, and any conventionally known non-water-swellable powder can be used appropriately according to the purpose. The particle size of the non-water-swellable powder is preferably about 0.01 to 20 μm, more preferably about 0.1 to 10 μm. The particle size of the non-water swellable powder can be measured by laser diffraction or the like. As the shape of the non-water-swellable powder, powder is preferable.
本発明の外用組成物に非水膨潤性の粉体を添加する場合、非水膨潤性の粉体の含有量（2種以上を併用する場合は合計量）は、併用するヘパリン類似物質の含有量や、下記酸化鉄の種類や含有量等によって適宜選定することができる。本発明の外用組成物中の非水膨潤性の粉体の含有量は、1〜35重量%程度が好ましく、1〜30重量%程度がより好ましく、1〜25重量%程度が更に好ましい。 When a non-water-swellable powder is added to the composition for external use of the present invention, the content of the non-water-swellable powder (the total amount when two or more types are used in combination) is the content of the heparin-like substance used in combination. It can be appropriately selected depending on the amount and the type and content of the following iron oxide. The content of the non-water-swellable powder in the external composition of the present invention is preferably about 1 to 35% by weight, more preferably about 1 to 30% by weight, and further preferably about 1 to 25% by weight.
前記非水膨潤性の粉体の含有量は、本発明の外用組成物が水性組成物又は水相と油相とを混合して得られる乳化組成物（クリーム等）である場合に適用できる。 The content of the non-water-swellable powder can be applied when the external composition of the present invention is an aqueous composition or an emulsified composition (such as a cream) obtained by mixing an aqueous phase and an oil phase.
本発明の外用組成物を、皮膚用とする場合に、その適用する皮膚の色に合わせて、下記酸化鉄の含有量に合わせて、非水膨潤性の粉体の中でも白色顔料の種類や含有量を適宜選択することができる。 When the composition for external use of the present invention is for skin, according to the color of the skin to which it is applied, the content and the content of white pigment among non-water-swellable powders according to the content of the following iron oxide The amount can be appropriately selected.
本発明の外用組成物中の非水膨潤性の粉体及び酸化鉄の含有量（合計量）は、上記同様の理由から、1〜40重量%程度が好ましく、1〜35重量%程度がより好ましく、1〜30重量%程度が更に好ましい。 The content (total amount) of the non-water-swellable powder and iron oxide in the external composition of the present invention is preferably about 1 to 40% by weight, more preferably about 1 to 35% by weight for the same reason as above. Preferably, about 1 to 30% by weight is more preferable.
尚、非水膨潤性の粉体には属しない成分として、水膨潤性粘土鉱物がある。水膨潤性粘土鉱物として、例えば、スメクタイト属の層状ケイ酸塩鉱物、バーミキュライト系等が挙げられる。更に具体的には、モンモリロナイト、サポナイト、ヘクトライト、ヘラクライト、バイデライト、ノントロナイト、バーミキュライト、ベントナイト等が挙げられる。これら水膨潤性粘土鉱物は、本発明の外用組成物で使用する非水膨潤性の粉体には属しない成分であるが、本発明の効果を妨げない範囲で、適宜含有させてもよい。 A component that does not belong to the non-water-swellable powder is a water-swellable clay mineral. Examples of water-swellable clay minerals include layered silicate minerals belonging to the genus smectite, vermiculite and the like. More specifically, examples include montmorillonite, saponite, hectorite, heraclite, beidellite, nontronite, vermiculite, bentonite and the like. These water-swellable clay minerals are components that do not belong to the non-water-swellable powder used in the composition for external use of the present invention, but may be appropriately contained as long as the effects of the present invention are not hindered.
(1-3)酸化鉄
本発明の外用組成物は、前記非水膨潤性の粉体に加えて、更に酸化鉄を含むことが好ましい。酸化鉄は、本発明の外用組成物をコンシーラー様の医薬品やファンデーション等の化粧料として用いた場合に、皮膚に対して、発色に必要な着色剤として機能する。組成物に非水膨潤性の粉体が配合されている場合、酸化鉄を配合しても組成物が十分に発色しない（組成物がくすんだ色になる）場合があるが、酸化鉄をヘパリン類似物質と併用することで、酸化鉄の分散安定性も向上させることができるだけでなく、組成物の発色性（鮮やかさ）を向上させることができる。
(1-3) Iron oxide The external composition of the present invention preferably further contains iron oxide in addition to the non-water-swellable powder. Iron oxide functions as a colorant necessary for color development on the skin when the composition for external use of the present invention is used as a cosmetic such as a concealer-like drug or foundation. When a non-water-swellable powder is blended in the composition, the composition may not sufficiently develop color even if iron oxide is blended (the composition becomes dull in color). By using together with the similar substance, not only the dispersion stability of iron oxide can be improved, but also the color developability (brightness) of the composition can be improved.
酸化鉄として、赤酸化鉄（三二酸化鉄、ベンガラ）、黄酸化鉄、黄色三二酸化鉄、黒酸化鉄等を用いることが好ましい。 As iron oxide, it is preferable to use red iron oxide (iron sesquioxide, bengara), yellow iron oxide, yellow iron sesquioxide, black iron oxide, or the like.
酸化鉄は、その用途に合わせて、1種単独で使用しても良く、2種以上を組み合わせて使用しても良い。 Iron oxides may be used alone or in combination of two or more depending on the application.
酸化鉄の粒径や形状も制限されず、従来公知の酸化鉄を目的に応じて適宜用いることができる。酸化鉄の粒径として0.01〜10μm程度が好ましく、0.1〜1μm程度がより好ましく、0.1〜0.8μmが更に好ましい。酸化鉄の粒径はレーザー回析等で測定することが可能である。酸化鉄の形状として粉末状が好ましい。 The particle diameter and shape of the iron oxide are not limited, and conventionally known iron oxide can be appropriately used depending on the purpose. The particle size of iron oxide is preferably about 0.01 to 10 μm, more preferably about 0.1 to 1 μm, and still more preferably 0.1 to 0.8 μm. The particle size of iron oxide can be measured by laser diffraction or the like. The shape of iron oxide is preferably powder.
本発明の外用組成物中の酸化鉄の含有量（2種以上を併用する場合は合計量）は、併用するヘパリン類似物質の含有量や、前記非水膨潤性の粉体の種類や含有量等によって適宜選定することができる。本発明の外用組成物中の酸化鉄の含有量は、0.01〜8重量%程度が好ましく、0.1〜5重量%程度がより好ましく、1〜3重量%程度が更に好ましい。 The content of iron oxide in the composition for external use of the present invention (the total amount when two or more types are used in combination) is the content of the heparin-like substance used in combination, the type and content of the non-water-swellable powder It can be selected as appropriate. The content of iron oxide in the external composition of the present invention is preferably about 0.01 to 8% by weight, more preferably about 0.1 to 5% by weight, and still more preferably about 1 to 3% by weight.
前記酸化鉄の含有量は、本発明の外用組成物が水性組成物又は水相と油相とを混合して得られる乳化組成物（クリーム等）である場合に適用できる。 The iron oxide content can be applied when the external composition of the present invention is an aqueous composition or an emulsified composition (such as a cream) obtained by mixing an aqueous phase and an oil phase.
本発明の外用組成物を皮膚用とする場合に、その適用する皮膚の色に合わせて、上記非水膨潤性の粉体の含有量に合わせて、酸化鉄の種類や含有量を適宜選択することができる。 When the composition for external use of the present invention is used for skin, the type and content of iron oxide are appropriately selected in accordance with the content of the non-water-swellable powder according to the color of the applied skin. be able to.
(1-4)ヘパリン類似物質
本発明の外用組成物に含まれるヘパリン類似物質は、ムコ多糖の多硫酸エステルであり、日本薬局方外医薬品規格(1993)に収載されているものを使用することが好ましい。
(1-4) Heparin-like substance The heparin-like substance contained in the composition for external use of the present invention is a mucopolysaccharide polysulfate ester, which is listed in the Japanese Pharmacopoeia Standards for Pharmaceuticals (1993). Is preferred.
ヘパリン類似物質は、本発明の外用組成物をコンシーラー様の医薬品やファンデーション等の化粧料として用いた場合に、皮膚の保湿作用や血行促進作用を有する。外用組成物にヘパリン類似物質を配合することで、皮膚のバリア機能を回復し、肌の潤いを取り戻し、外的刺激から保護する作用（保湿作用）、皮膚の新陳代謝を活性化、肌再生を促す作用（血行促進作用）、皮膚の炎症を抑え、荒れた肌を正常な状態へ導く作用（抗炎症作用）が期待できる。 The heparin-like substance has a skin moisturizing action and a blood circulation promoting action when the composition for external use of the present invention is used as a cosmetic such as a concealer-like drug or a foundation. By adding a heparin-like substance to the composition for external use, it restores the skin barrier function, regains skin moisture, protects it from external stimuli (moisturizing effect), activates skin metabolism, and promotes skin regeneration. It is expected to have an action (blood circulation promoting action), an action that suppresses skin inflammation and leads to rough skin to a normal state (anti-inflammatory action).
本発明の外用組成物中のヘパリン類似物質の含有量は、併用する非水膨潤性の粉体の種類や含有量等によって適宜選定することができ、0.0005〜10重量%程度が好ましく、0.001〜10重量%程度がより好ましい。 The content of the heparin-like substance in the composition for external use of the present invention can be appropriately selected depending on the type and content of the non-water-swellable powder used together, and is preferably about 0.0005 to 10% by weight, preferably 0.001 to About 10% by weight is more preferable.
本発明の外用組成物中のヘパリン類似物質の含有量は通常0.001〜5重量%程度が好ましく、0.01〜5重量%程度がより好ましく、0.05〜3重量%が更に好ましい。 The content of the heparin-like substance in the external composition of the present invention is usually preferably about 0.001 to 5% by weight, more preferably about 0.01 to 5% by weight, and still more preferably 0.05 to 3% by weight.
本発明の外用組成物が水性組成物である場合、ヘパリン類似物質の含有量は通常0.001〜5重量%程度が好ましく、0.01〜5重量%程度がより好ましく、0.05〜3重量％が更に好ましい。 When the composition for external use of the present invention is an aqueous composition, the content of the heparin-like substance is usually preferably about 0.001 to 5% by weight, more preferably about 0.01 to 5% by weight, and still more preferably 0.05 to 3% by weight.
本発明の外用組成物が水相と油相とを混合して得られる乳化組成物（クリーム等）である場合、ヘパリン類似物質の含有量は通常0.05〜2重量%程度が好ましく、0.1〜1重量%程度がより好ましい。 When the composition for external use of the present invention is an emulsion composition (cream or the like) obtained by mixing an aqueous phase and an oil phase, the content of heparin-like substance is usually preferably about 0.05 to 2% by weight, preferably 0.1 to 1 More preferred is about wt%.
本発明の外用組成物中のヘパリン類似物質と非水膨潤性の粉体（2種以上を併用する場合は合計量）との配合比は、ヘパリン類似物質1重量部に対して、非水膨潤性の粉体を0.001〜16,000重量部程度配合することが好ましく、非水膨潤性の粉体を0.02〜5,000重量部程度配合することがより好ましく、非水膨潤性の粉体を0.2〜1,000重量部程度配合することが更に好ましく、非水膨潤性の粉体を0.2〜500重量部程度配合することが特に好ましく、非水膨潤性の粉体を0.5〜200重量部程度配合することが最も好ましい。 The mixing ratio of the heparin-like substance and the non-water-swellable powder (total amount when two or more kinds are used in combination) in the composition for external use of the present invention is non-water-swelled relative to 1 part by weight of the heparin-like substance. It is preferable to mix about 0.001 to 16,000 parts by weight of the non-swellable powder, more preferably about 0.02 to 5,000 parts by weight of the non-water swellable powder, and 0.2 to 1,000 parts by weight of the non-water swellable powder. More preferably, about 0.2 to 500 parts by weight of non-water swellable powder is blended, and most preferably about 0.5 to 200 parts by weight of non-water swellable powder is blended. .
本発明の外用組成物に非水膨潤性の粉体に加えて酸化鉄が含まれる場合、外用組成物中のヘパリン類似物質と、非水膨潤性の粉体及び酸化鉄の合計量（2種以上を併用する場合は合計量）との配合比は、ヘパリン類似物質1重量部に対して、非水膨潤性の粉体及び酸化鉄を合計量として0.001〜16,000重量部程度配合することが好ましく、非水膨潤性の粉体及び酸化鉄を合計量として0.2〜5,000重量部程度配合することがより好ましく、非水膨潤性の粉体及び酸化鉄を0.2〜1,000重量部程度配合することが更に好ましく、非水膨潤性の粉体及び酸化鉄を0.2〜500重量部程度配合することが特に好ましく、非水膨潤性の粉体及び酸化鉄を0.5〜200重量部程度配合することが最も好ましい。 When the external composition of the present invention contains iron oxide in addition to the non-water-swellable powder, the total amount of the heparin-like substance in the composition for external use, the non-water-swellable powder and iron oxide (two types) The combined ratio with the total amount in the case of using the above in combination is preferably about 0.001 to 16,000 parts by weight of the total amount of non-water-swellable powder and iron oxide per 1 part by weight of the heparin-like substance. More preferably, the total amount of non-water-swellable powder and iron oxide is about 0.2 to 5,000 parts by weight, and the amount of non-water-swellable powder and iron oxide is about 0.2 to 1,000 parts by weight. Preferably, about 0.2 to 500 parts by weight of the non-water-swellable powder and iron oxide are particularly preferably blended, and most preferably about 0.5 to 200 parts by weight of the non-water-swellable powder and iron oxide are blended.
本発明の外用組成物では、ヘパリン類似物質と非水膨潤性の粉体（及び酸化鉄）が前記配合割合で配合されることにより、非水膨潤性の粉体（及び酸化鉄）の分散安定性を更に向上させることができる。その結果、流動性を呈する外用組成物における非水膨潤性の粉体（及び酸化鉄）等の成分の偏りを著しく低減できる。 In the composition for external use of the present invention, the heparin-like substance and the non-water-swellable powder (and iron oxide) are blended at the above-mentioned blending ratio, whereby the dispersion stability of the non-water-swellable powder (and iron oxide) is stabilized. The property can be further improved. As a result, the bias of components such as non-water-swellable powder (and iron oxide) in the external composition exhibiting fluidity can be significantly reduced.
本発明の外用組成物では、更にヘパリン類似物質が前記配合割合で配合されることにより、ヘパリン類似物質による角質水分保持増強作用や抗炎症作用（血行障害の改善作用）を良好に発現することができる。 In the composition for external use of the present invention, when the heparin-like substance is further blended at the above-mentioned blending ratio, the heparin-like substance can enhance the keratin water retention enhancing action and the anti-inflammatory action (the blood circulation disorder improving action) well. it can.
(1-5)水性成分
本発明の外用組成物は、水相のみからなる場合であっても良い。また、外用組成物を乳化組成物とする場合の水相とすることもの可能である。乳化組成物は、水相と油相から形成される。
(1-5) Aqueous component The composition for external use of the present invention may comprise only an aqueous phase. Moreover, it can be set as the water phase in the case of making an external composition into an emulsion composition. The emulsified composition is formed from an aqueous phase and an oil phase.
本発明の外用組成物は、水を含むことが好ましい。水の種類は、特に制限されない。例えば、精製水、蒸留水、イオン交換水、滅菌水、生理食塩水、及び海洋深層水等を、制限なく使用することができる。好ましくは精製水である。 The external composition of the present invention preferably contains water. The type of water is not particularly limited. For example, purified water, distilled water, ion exchange water, sterilized water, physiological saline, deep ocean water and the like can be used without limitation. Preferably it is purified water.
本発明の外用組成物における水の含有量は、1〜95重量%程度が好ましく、10〜90重量%程度がより好ましく、20〜80重量%程度が更に好ましい。 The content of water in the external composition of the present invention is preferably about 1 to 95% by weight, more preferably about 10 to 90% by weight, and still more preferably about 20 to 80% by weight.
本発明の外用組成物は、多価アルコールを含むことが好ましい。例えば炭素数2〜6で酸素数2〜3の多価アルコールを用いることが好ましい。多価アルコールとして、エチレングリコール、ジエチレングリコール、プロピレングリコール、1,3-プロパンジオール、ジプロピレングリコール、1,3-ブチレングリコール、1,2-ペンタンジオール、1,2-ヘキサンジオール、3-メチル-1,3-ブタンジオール、グリセリン、ソルビトール等を用いることがより好ましい。中でもプロピレングリコール、ジプロピレングリコール、1,3-ブチレングリコール、1,2-ペンタンジオールを用いることが特に好ましい。多価アルコールは１種単独で使用しても良く、2種以上を組み合わせて使用しても良い。 The external composition of the present invention preferably contains a polyhydric alcohol. For example, it is preferable to use a polyhydric alcohol having 2 to 6 carbon atoms and 2 to 3 oxygen atoms. As polyhydric alcohols, ethylene glycol, diethylene glycol, propylene glycol, 1,3-propanediol, dipropylene glycol, 1,3-butylene glycol, 1,2-pentanediol, 1,2-hexanediol, 3-methyl-1 It is more preferable to use 3-butanediol, glycerin, sorbitol or the like. Among these, it is particularly preferable to use propylene glycol, dipropylene glycol, 1,3-butylene glycol, or 1,2-pentanediol. A polyhydric alcohol may be used individually by 1 type, and may be used in combination of 2 or more type.
外用組成物における多価アルコールの含有量は、1〜10重量%程度が好ましく、2〜5重量%程度がより好ましい。 The content of the polyhydric alcohol in the external composition is preferably about 1 to 10% by weight, more preferably about 2 to 5% by weight.
(1-6)油性成分
本発明の外用組成物は、常温（25℃）で液体の油性成分を含むことが好ましい。これにより、本発明の外用組成物を水相と油相とを混合して得られる乳化組成物とすることができる。
(1-6) Oily Component The composition for external use of the present invention preferably contains an oily component that is liquid at room temperature (25 ° C.). Thereby, the composition for external use of this invention can be made into the emulsion composition obtained by mixing an aqueous phase and an oil phase.
常温で液体の油性成分として、医薬品、医薬部外品、化粧品、飲食品等の分野において許容されるものであれば特に制限されない。例えば、常温で液体の脂肪族アルコール等を用いることが好ましい。常温で液状の油性成分として、ヘキシルデカノール、オクチルドデカノール、デシルテトラデカノール、オレイルアルコール、ラウリルアルコール等の液体アルコールを用いることが好ましい。ヘキシルデカノール、オクチルドデカノール等の液体アルコールを用いることがより好ましく、ヘキシルデカノールを用いることが更に好ましい。 The oily component that is liquid at room temperature is not particularly limited as long as it is acceptable in the fields of pharmaceuticals, quasi drugs, cosmetics, foods and drinks, and the like. For example, it is preferable to use an aliphatic alcohol that is liquid at room temperature. It is preferable to use liquid alcohols such as hexyl decanol, octyldodecanol, decyl tetradecanol, oleyl alcohol, and lauryl alcohol as the oily component that is liquid at room temperature. It is more preferable to use liquid alcohols such as hexyl decanol and octyl decanol, and it is more preferable to use hexyl decanol.
常温で液体の油性成分として、また、シリコーン油、鉱物油、植物油、液状ロウ類やエステル油を用いることが好ましい。 It is preferable to use silicone oil, mineral oil, vegetable oil, liquid waxes and ester oils as the oily component which is liquid at normal temperature.
常温で液体の油性成分は1種単独で使用しても良く、2種以上を組み合わせて使用しても良い。 Oily components that are liquid at room temperature may be used alone or in combination of two or more.
外用組成物中の常温で液体の油性成分の含有量は、1〜30重量%程度が好ましく、5〜20重量%程度がより好ましく、7〜15重量%程度が更に好ましい。外用組成物中の常温で液体の油性成分がこの含有量で含まれることで、その乳化状態が安定化され、長期に亘り良好な乳化状態を維持することができる。 The content of the oily component that is liquid at room temperature in the external composition is preferably about 1 to 30% by weight, more preferably about 5 to 20% by weight, and still more preferably about 7 to 15% by weight. When the oily component that is liquid at room temperature in the composition for external use is contained in this content, the emulsified state is stabilized, and a good emulsified state can be maintained over a long period of time.
本発明の外用組成物は、更に常温（25℃）で固体の油性成分を含むことが好ましい。これにより、本発明の外用組成物を乳化組成物とした場合に、非水膨潤性の粉体や酸化鉄等の分散性をより向上させることができるだけでなく、発色性（鮮やかさ）も向上させることができる。常温で固体の油性成分は、外用組成物をコンシーラー様の医薬品やファンデーション等の化粧料として用いた場合に基剤として機能する。 The composition for external use of the present invention preferably further contains an oily component that is solid at ordinary temperature (25 ° C.). Thereby, when the composition for external use of the present invention is an emulsified composition, not only can the dispersibility of non-water-swellable powder, iron oxide, etc. be improved, but also the color developability (brightness) is improved. Can be made. The oily component that is solid at room temperature functions as a base when the composition for external use is used as a cosmetic such as a concealer-like drug or foundation.
常温で固体の油性成分として、医薬品、医薬部外品、化粧品、飲食品等の分野において許容されるものであれば特に制限されない。例えば、常温で固体のアルコールを用いることが好ましい。 The oily component that is solid at room temperature is not particularly limited as long as it is acceptable in the fields of pharmaceuticals, quasi drugs, cosmetics, foods and drinks, and the like. For example, it is preferable to use alcohol that is solid at room temperature.
常温で固体の油性成分として、ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、オレイン酸、ベヘン酸等の脂肪酸、ミツロウ、カルバナロウ、ラノリン、ラノリンエステル、キャンデリラワックス等のロウ類、セトステアリルアルコール、ステアリルアルコール、セタノール（セチルアルコール）、ミリスチルアルコール、イソステアリルアルコール、ベヘニルアルコール、ラノリンアルコール等の固体アルコールを用いることが好ましい。セトステアリルアルコール、ステアリルアルコール、セタノール（セチルアルコール）、ベヘニルアルコール等の固体アルコールを用いることがより好ましい。 As an oily component that is solid at room temperature, fatty acids such as lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, behenic acid, beeswax, carnauba wax, lanolin, lanolin ester, waxes such as candelilla wax, cetostearyl alcohol, It is preferable to use solid alcohols such as stearyl alcohol, cetanol (cetyl alcohol), myristyl alcohol, isostearyl alcohol, behenyl alcohol, and lanolin alcohol. It is more preferable to use solid alcohols such as cetostearyl alcohol, stearyl alcohol, cetanol (cetyl alcohol), and behenyl alcohol.
常温で固体の油性成分として、マイクロクリスタリンワックス、α-オレフィンオリゴマー、ゲル化炭化水素、セレシンワックス、固形パラフィン、ワセリン等の炭化水素油を用いることが好ましい。中でもマイクロクリスタリンワックスを用いることが好ましい。 As oil components that are solid at room temperature, hydrocarbon oils such as microcrystalline wax, α-olefin oligomer, gelled hydrocarbon, ceresin wax, solid paraffin, and petroleum jelly are preferably used. Among them, it is preferable to use microcrystalline wax.
常温で固体の油性成分は1種単独で使用しても良く、2種以上を組み合わせて使用しても良い。 Oily components that are solid at room temperature may be used singly or in combination of two or more.
本発明の外用組成物中の常温で固体の油性成分の含有量は、0.5〜30重量%程度が好ましく、1〜20重量%程度がより好ましく、2〜18重量%程度が更に好ましい。外用組成物中の常温で固体の油性成分がこの含有量で含まれることで、その乳化状態が安定化され、長期に亘り良好な乳化状態を維持することができる。また、外用組成物中の非水膨潤性の粉体や酸化鉄料等の分散性をより向上させることができ、更には発色性（鮮やかさ）も向上させることができる。 The content of the oily component that is solid at room temperature in the external composition of the present invention is preferably about 0.5 to 30% by weight, more preferably about 1 to 20% by weight, and still more preferably about 2 to 18% by weight. When the oily component that is solid at room temperature in the composition for external use is contained in this content, the emulsified state is stabilized, and a good emulsified state can be maintained over a long period of time. Moreover, the dispersibility of the non-water-swellable powder or iron oxide in the composition for external use can be further improved, and the color developability (brightness) can also be improved.
本発明の外用組成物中の液体の油性成分及び固体の油性成分からなる群から選ばれる少なくとも１種の油性成分の含有量（合計量）は、上記同様の理由から、1〜60重量%程度が好ましく、5〜40重量%程度がより好ましく、10〜35重量%程度が更に好ましい。 The content (total amount) of at least one oily component selected from the group consisting of a liquid oily component and a solid oily component in the composition for external use of the present invention is about 1 to 60% by weight for the same reason as above. Is preferable, about 5 to 40% by weight is more preferable, and about 10 to 35% by weight is more preferable.
(1-7)外用組成物に配合するその他の成分
本発明の外用組成物は、本発明の効果を妨げない範囲で、目的とする薬効成分を配合することもできる。薬効成分としては、特に制限しないが、例えば、ステロイド剤、局所麻酔剤、抗炎症剤、殺菌剤、鎮痒剤、皮膚保護剤、血行促進剤、ビタミン類等を用いることが好ましい。
(1-7) Other components to be blended in composition for external use The composition for external use of the present invention can also be blended with a desired medicinal component as long as the effects of the present invention are not hindered. Although it does not restrict | limit especially as a medicinal ingredient, For example, it is preferable to use a steroid agent, a local anesthetic agent, an anti-inflammatory agent, a disinfectant, an antipruritic agent, a skin protective agent, a blood circulation promoter, vitamins, etc.
本発明の外用組成物には、本発明の効果を妨げない範囲で、更に必要に応じて界面活性剤（モノステアリン酸グリセリン、ポリオキシエチレンベヘニルエーテル等）、増粘剤、安定剤（エデト酸ナトリウム等）、吸収促進剤、吸着剤、充填剤、酸化防止剤、防腐剤（パラオキシ安息香酸メチル、パラオキシ安息香酸プロピル等）、乳化剤、可溶化剤、殺菌剤、保湿剤、pH調整剤、香料、防臭剤、分散剤、顔料等を含有させても良い。 In the composition for external use of the present invention, a surfactant (glyceryl monostearate, polyoxyethylene behenyl ether, etc.), a thickener, and a stabilizer (edetic acid) are added as necessary, as long as the effects of the present invention are not hindered. Sodium, etc.), absorption enhancers, adsorbents, fillers, antioxidants, preservatives (methyl paraoxybenzoate, propyl paraoxybenzoate, etc.), emulsifiers, solubilizers, bactericides, moisturizers, pH adjusters, fragrances Further, a deodorant, a dispersant, a pigment and the like may be contained.
本発明の外用組成物に含まれる非水膨潤性の粉体には属しない成分として、水膨潤性粘土鉱物が有る。水膨潤性粘土鉱物として、例えば、スメクタイト属の層状ケイ酸塩鉱物、バーミキュライト系等が挙げられる。更に具体的には、モンモリロナイト、サポナイト、ヘクトライト、ヘラクライト、バイデライト、ノントロナイト、バーミキュライト、ベントナイト等が挙げられる。本発明の外用組成物には、これら水膨潤性粘土鉱物を、本発明の効果を妨げない範囲で、更に必要に応じて含有させても良い。 As a component not belonging to the non-water-swellable powder contained in the composition for external use of the present invention, there is a water-swellable clay mineral. Examples of water-swellable clay minerals include layered silicate minerals belonging to the genus smectite, vermiculite and the like. More specifically, examples include montmorillonite, saponite, hectorite, heraclite, beidellite, nontronite, vermiculite, bentonite and the like. In the composition for external use of the present invention, these water-swellable clay minerals may be further contained as necessary within a range not impeding the effects of the present invention.
本発明の外用組成物のpHは特に限定されず、使用目的に応じて適宜設定すればよい。例えば外用組成物が皮膚に適用される場合には弱酸性〜中性の範囲内のpHが例示され、皮膚に対する低刺激性等の観点からpH4.5〜7とすることが好ましく、pH4.5〜6.5とすることがより好ましい。 The pH of the composition for external use of the present invention is not particularly limited, and may be set as appropriate according to the purpose of use. For example, when the composition for external use is applied to the skin, a pH within a weakly acidic to neutral range is exemplified, and it is preferably pH 4.5 to 7 from the viewpoint of hypoallergenicity to the skin, pH 4.5 It is more preferable to set to -6.5.
(2)外用組成物の調製方法
本発明の外用組成物は、前述の通りヘパリン類似物質及び非水膨潤性の粉体を混合し、25℃で流動性を呈するものであれば、当業界の通常の方法に従って製造することができる。
(2) Preparation method of external composition As described above, the external composition of the present invention is a mixture of a heparin-like substance and a non-water-swellable powder and exhibits fluidity at 25 ° C. It can be produced according to conventional methods.
外用組成物の調製方法で使用される非水膨潤性の粉体、ヘパリン類似物質、常温で固体の油性成分、酸化鉄、その他の任意の成分等の種類、含有量、配合比等については前述と同様に説明される。 The type, content, blending ratio, etc. of the non-water-swellable powder, heparin-like substance, oily component that is solid at room temperature, iron oxide, and other optional components used in the preparation method of the composition for external use are described above. Will be described in the same manner.
外用組成物の調製では、前記成分を混合し、50〜90℃程度の温度になるように加熱した後、ホモジナイザー、ホモミキサー、攪拌機等の混合機を用いて所定条件で混合することが好ましい。これにより、水相のみからなる水性組成物を調製することができ、又は水相と油相とを混合して乳化することで乳化組成物を調製することができる。 In the preparation of the composition for external use, it is preferable that the above components are mixed and heated to a temperature of about 50 to 90 ° C., and then mixed under a predetermined condition using a mixer such as a homogenizer, a homomixer, or a stirrer. Thereby, the aqueous composition which consists only of an aqueous phase can be prepared, or an emulsion composition can be prepared by mixing and emulsifying a water phase and an oil phase.
ここで、本発明の外用組成物は、25℃で流動性を呈し、液状から半固形状の組成物であれば、その粘度を特に制限するものではない。外用組成物が液状である場合、常温での粘度が1mPa・s〜20,000mPa・sであることが好ましい。外用組成物が半固形状である場合、常温での粘度が20,000mPa・s〜2,000,000mPa・sであることが好ましく、50,000mPa・s〜1,000,000mPa・sであることがより好ましい。 Here, the external composition of the present invention exhibits fluidity at 25 ° C. and is not particularly limited in viscosity as long as it is a liquid to semi-solid composition. When the composition for external use is liquid, the viscosity at normal temperature is preferably 1 mPa · s to 20,000 mPa · s. When the composition for external use is semi-solid, the viscosity at normal temperature is preferably 20,000 mPa · s to 2,000,000 mPa · s, and more preferably 50,000 mPa · s to 1,000,000 mPa · s.
(3)外用組成物中の非水膨潤性の粉体（及び酸化鉄）の分散安定化法
本発明の外用組成物中の非水膨潤性の粉体（追加的に酸化鉄）の分散安定化法は、非水膨潤性の粉体（追加的に酸化鉄）を含む外用組成物中に、ヘパリン類似物質を併存させることを特徴とする。
(3) Dispersion stabilization method of non-water swellable powder (and iron oxide) in external composition Dispersion stability of non-water swellable powder (additional iron oxide) in external composition of the present invention The chemical conversion method is characterized in that a heparin-like substance coexists in a composition for external use containing a non-water-swellable powder (additionally iron oxide).
前記分散安定化法では、前述の常温で固体の油性成分を更に含むことが好ましい。 In the dispersion stabilization method, it is preferable to further include an oily component that is solid at room temperature.
外用組成物の分散安定化法で使用される非水膨潤性の粉体、ヘパリン類似物質、常温で固体の油性成分、酸化鉄その他の任意の成分等の種類、含有量、配合比等については前述と同様に説明される。 About types, contents, blending ratios, etc. of non-water-swellable powders, heparin-like substances, oily components that are solid at room temperature, iron oxide and other optional components used in the dispersion stabilization method of externally used compositions The description is the same as described above.
外用組成物中の非水膨潤性の粉体（追加的に酸化鉄）の分散安定化法は、前述の外用組成物の調製方法に沿って、行うことができる。外用組成物中の非水膨潤性の粉体（追加的に酸化鉄）の分散安定化法では、外用組成物を乳化組成物とする場合には、更に乳化に必要な水及び界面活性剤を使用することが好ましい。水の使用量についても前述の通りである。 The dispersion stabilization method of the non-water-swellable powder (additionally iron oxide) in the external composition can be performed in accordance with the preparation method of the external composition described above. In the dispersion stabilization method of the non-water-swellable powder (additionally iron oxide) in the external composition, when the external composition is an emulsified composition, water and a surfactant necessary for emulsification are further added. It is preferable to use it. The amount of water used is also as described above.
本発明の分散安定化方法によれば、後述する実施例に示すように、外用組成物中で、非水膨潤性の粉体（追加的に酸化鉄）の分散安定性を向上できる。従って、本発明によれば、外用組成物における成分の偏りを著しく低減でき、効果のばらつきなどを効果的に解消することができ、また、その外観も改善できる。 According to the dispersion stabilization method of the present invention, the dispersion stability of a non-water-swellable powder (additionally iron oxide) can be improved in a composition for external use, as shown in Examples described later. Therefore, according to the present invention, it is possible to remarkably reduce the unevenness of components in the composition for external use, to effectively eliminate variations in effects, and to improve the appearance.
本発明によれば、非水膨潤性の粉体（追加的に酸化鉄）を含有する外用組成物の品質を著しく向上させることができる。更に乳化組成物とする場合の乳化状態（エマルジョン）を長期に亘って安定に維持することが可能になる。本発明によれば、外用組成物において、非水膨潤性の粉体の分散安定性が向上すると共に、酸化鉄を添加する場合、発色性（鮮やかさ）を向上させることができる。 According to the present invention, the quality of an external composition containing non-water-swellable powder (additionally iron oxide) can be remarkably improved. Furthermore, it becomes possible to maintain the emulsified state (emulsion) stably when used as an emulsified composition over a long period of time. According to the present invention, in the external composition, the dispersion stability of the non-water-swellable powder is improved, and when iron oxide is added, the color developability (brightness) can be improved.
(4)外用組成物の適用対象
本発明の外用組成物の適用対象は制限されず、例えば皮膚（頭皮を含む）が好ましい。外用組成物が皮膚に塗布等して適用されることを目的とする場合には、25℃で流動性を呈することで適用することができれば良く、例えば化粧品、皮膚外用医薬部外品、皮膚外用医薬品等の皮膚に塗布等して適用される形態である限り制限されない。例えば軟膏状、クリーム状、ペースト状、ムース状、ゲル状、ゼリー状、懸濁液状、乳液状、液状等の各種所望の外用剤に適する形態とすることが好ましい。
(4) Subject of application of external composition The subject of application of the external composition of the present invention is not limited, and for example, skin (including scalp) is preferable. When the composition for external use is intended to be applied to the skin, etc., it may be applied by exhibiting fluidity at 25 ° C., for example, cosmetics, quasi-drugs for external use on skin, external use for skin It is not limited as long as it is a form that is applied to the skin of a pharmaceutical product or the like. For example, a form suitable for various desired external preparations such as an ointment, cream, paste, mousse, gel, jelly, suspension, emulsion, and liquid is preferable.
本発明の外用組成物が例えばヒトの皮膚に適用することによって使用される場合、外用組成物を皮膚に適用する量、回数は特に制限されない。例えば含有される生理活性物質の種類や濃度、使用者の年齢、性別、症状の程度、適用形態、期待される程度等に応じて、一日に一回〜数回の頻度で適当量を皮膚（特に症状が生じている部位）に適用することが好ましい。 When the composition for external use of the present invention is used, for example, by applying it to human skin, the amount and frequency of applying the composition for external application to the skin are not particularly limited. For example, depending on the type and concentration of the physiologically active substance contained, the age, sex, symptom level, application form, expected level, etc. of the user, an appropriate amount of skin is applied once to several times a day. It is preferable to apply to (particularly where the symptom is occurring).
本発明の外用組成物は、25℃で流動性を呈し、ヘパリン類似物質と非水膨潤性の粉体（追加的に酸化鉄）とを併用することによって、外用組成物（又は乳化組成物）中において非水膨潤性の粉体（追加的に酸化鉄）の分散安定性が向上される。従って、本発明の外用組成物（又は乳化組成物）では、含有成分の偏りを著しく低減でき、各成分の効果のばらつき等を効果的に解消することができる。それにより、外用組成物の外観も向上される。その結果、非水膨潤性の粉体（追加的に酸化鉄）を含有する外用組成物（又は乳化組成物）の品質を著しく向上させることができる。 The composition for external use of the present invention exhibits fluidity at 25 ° C., and is a composition for external use (or emulsion composition) by using a heparin-like substance and a non-water-swellable powder (additionally iron oxide) in combination. The dispersion stability of the non-water-swellable powder (additionally iron oxide) is improved. Therefore, in the composition for external use (or emulsified composition) of the present invention, the bias of the contained components can be remarkably reduced, and variations in the effects of the components can be effectively eliminated. Thereby, the external appearance of the composition for external use is also improved. As a result, the quality of the external composition (or emulsion composition) containing the non-water-swellable powder (additionally iron oxide) can be remarkably improved.
本発明の外用組成物は、非水膨潤性の粉体（追加的に酸化鉄）の分散が安定化されており、使用時に手にとり易く、展延性が良好であり、ベタツキが少なく、肌になじみ易く、使用感も優れる。本発明の外用組成物は、酸化鉄を添加する場合、発色性（鮮やかさ）を向上させることができる。 The composition for external use of the present invention has a stable dispersion of non-water-swellable powder (additionally iron oxide), is easy to take during use, has good spreadability, has less stickiness, and is good for the skin. It is easy to get used to and has a good feeling of use. The composition for external use of the present invention can improve color development (brightness) when iron oxide is added.
実施例に基づいて、本発明を具体的に説明するが、本発明はこれらのみに限定されるものではない。 The present invention will be specifically described based on examples, but the present invention is not limited to these examples.
(1) 水性組成物
(1-1) 水性組成物（表1〜5）の調製
表1〜5に記載する処方に従って、水性組成物を調製した。
(1) Aqueous composition
(1-1) Preparation of aqueous composition (Tables 1 to 5) According to the formulations described in Tables 1 to 5, aqueous compositions were prepared.
表1又は2の水性組成物では、精製水にヘパリン類似物質を溶解させた後、非水膨潤性の粉体を混合分散させた。 In the aqueous composition of Table 1 or 2, a heparin-like substance was dissolved in purified water, and then a non-water-swellable powder was mixed and dispersed.
表4及び5の水性組成物では、表に記載する各配合成分（ヘパリン類似物質、非水膨潤性の粉体、酸化鉄等）を夫々秤量し、水中で80℃にて加熱して、混合した。その後、40℃以下に冷却して、水性組成物を調製した。 In the aqueous compositions shown in Tables 4 and 5, each of the ingredients listed in the table (heparin-like substance, non-water-swellable powder, iron oxide, etc.) was weighed and heated in water at 80 ° C. for mixing. did. Then, it cooled to 40 degrees C or less, and prepared the aqueous composition.
表1、2及び4に、ヘパリン類似物質及び非水膨潤性の粉体を含む水性組成物の評価結果を示す。表5に、ヘパリン類似物質及び非水膨潤性の粉体に加えて、酸化鉄を含む水性組成物の評価結果を示す。 Tables 1, 2 and 4 show the evaluation results of aqueous compositions containing heparin-like substances and non-water-swellable powders. Table 5 shows the evaluation results of the aqueous composition containing iron oxide in addition to the heparin-like substance and the non-water-swellable powder.
(1-2) 水性組成物における分散安定性
非水膨潤性の粉体の水性組成物中での分散安定性を評価した。
(1-2) Dispersion stability in the aqueous composition The dispersion stability of the non-water-swellable powder in the aqueous composition was evaluated.
評価基準は、次の通りである。 The evaluation criteria are as follows.
◎：使用した非水膨潤性の粉体が均一に水溶液に分散している。
○：使用した非水膨潤性の粉体がほぼ水溶液に分散しているが、壁面に一部ムラが生じている。
△：使用した非水膨潤性の粉体があまり水溶液に分散できず、暫くすると沈殿が生じ、上清の一部が透明になる。
×：使用した非水膨潤性の粉体が水溶液に分散できず、暫くすると沈殿が生じ、上清が透明になる。
A: The non-water swellable powder used is uniformly dispersed in the aqueous solution.
○: The non-water swellable powder used was almost dispersed in the aqueous solution, but some unevenness occurred on the wall surface.
(Triangle | delta): The non-water-swellable powder used cannot be disperse | distributed so much in aqueous solution, precipitation will arise after a while, and a part of supernatant will become transparent.
X: The non-swellable powder used cannot be dispersed in the aqueous solution, and after a while, precipitation occurs and the supernatant becomes transparent.
分散安定性の程度については表3のとおりである。 Table 3 shows the degree of dispersion stability.
(1-3) 水性組成物の粘度
水性組成物の粘度は、1日間静置させたサンプルを、B型粘度計（東機産業株式会社製RB-85L粘度計）で、ローター番号M4のローターを用いて、25℃にて測定した。
(1-3) Viscosity of aqueous composition Viscosity of aqueous composition was measured using a B type viscometer (RB-85L viscometer manufactured by Toki Sangyo Co., Ltd.) Was measured at 25 ° C.
また、測定開始から30秒後の粘度を採用した。 Further, the viscosity 30 seconds after the start of measurement was adopted.
(1-4) 水性組成物の発色性
表5では、ヘパリン類似物質及び非水膨潤性の粉体に加えて、酸化鉄を含む水性組成物の発色性を評価した。
(1-4) Color developability of aqueous composition In Table 5, the color developability of an aqueous composition containing iron oxide in addition to a heparin-like substance and a non-water-swellable powder was evaluated.
評価基準は、次の通りである。 The evaluation criteria are as follows.
◎：使用した酸化鉄（乾燥粉体）より、色が鮮やかになった。
○：使用した酸化鉄（乾燥粉体）と、色の鮮やかさが同程度であった。
△：使用した酸化鉄（乾燥粉体）より、色の鮮やかさがやや低下した。
×：使用した酸化鉄（乾燥粉体）より、色の鮮やかさが著しく低下した。
(Double-circle): The color became brighter than the used iron oxide (dry powder).
○: The vividness of the color was the same as that of the iron oxide (dry powder) used.
(Triangle | delta): The vividness of color fell slightly from the used iron oxide (dry powder).
X: The vividness of the color was significantly reduced from the iron oxide (dry powder) used.
表6に水性組成物の色の鮮やかさの程度を示す。 Table 6 shows the degree of color vividness of the aqueous composition.
(1-5) 結果（実施例1〜7及び比較例1〜5）(1-5) Results (Examples 1 to 7 and Comparative Examples 1 to 5)
水性組成物に、非水膨潤性の粉体を水と混合すると、分散安定性が悪く、沈降してしまった（比較例1〜5）。 When a non-water-swellable powder was mixed with water in an aqueous composition, the dispersion stability was poor and settled (Comparative Examples 1 to 5).
一方、水性組成物に、非水膨潤性の粉体をヘパリン類似物質と共に水と混合した場合、分散安定性が向上し、沈降を抑制することができた（実施例1〜7）。水性組成物では、特に、カオリン及び酸化亜鉛は、ヘパリン類似物質による分散安定性が著しく向上した。 On the other hand, when a non-water-swellable powder was mixed with water together with a heparin-like substance in an aqueous composition, dispersion stability was improved and sedimentation could be suppressed (Examples 1 to 7). In the aqueous composition, in particular, kaolin and zinc oxide have significantly improved dispersion stability due to heparin-like substances.
(1-5) 結果（実施例8、9、比較例6、7及び参考例1）(1-5) Results (Examples 8 and 9, Comparative Examples 6 and 7 and Reference Example 1)
非水膨潤性の粉体を含み、粘度を2,000,000mPa・s以上である流動性のない組成物（水性組成物）とした場合、ヘパリン類似物質を含有しなくても分散安定性を有していた（参考例1）。 When it is a non-flowable composition (aqueous composition) containing non-water-swellable powder and having a viscosity of 2,000,000 mPa · s or more, it has dispersion stability even if it does not contain heparin-like substances. (Reference Example 1).
流動性を有する水性組成物にヘパリン類似物質を配合しないと、非水膨潤性の粉体の分散安定性が悪く、非水膨潤性の粉体が沈降してしまった（比較例6、7）。 If a heparin-like substance was not added to the aqueous composition having fluidity, the dispersion stability of the non-water-swellable powder was poor, and the non-water-swellable powder settled (Comparative Examples 6 and 7). .
一方、流動性を有する水性組成物にヘパリン類似物質を配合することで、非水膨潤性の粉体の分散安定性に優れた組成物を調製することができた（実施例8、9）。 On the other hand, a composition excellent in dispersion stability of a non-water-swellable powder could be prepared by blending a heparin-like substance with an aqueous composition having fluidity (Examples 8 and 9).
(1-6) 結果（実施例10、11、比較例8及び9）(1-6) Results (Examples 10 and 11, Comparative Examples 8 and 9)
水性組成物に着色剤として酸化鉄を含有させた場合、ヘパリン類似物質を含有しないと、分散安定性だけでなく、発色性に劣る結果となった（比較例8、9）。 When iron oxide was contained as a colorant in the aqueous composition, not containing a heparin-like substance resulted in inferior color development as well as dispersion stability (Comparative Examples 8 and 9).
水性組成物に、ヘパリン類似物質を含有させることによって、非水膨潤性の粉体や酸化鉄の分散安定性に加え、酸化鉄の発色性（色の鮮やかさ）に優れた組成物を調製することができた（実施例10、11）。 By adding a heparin-like substance to the aqueous composition, a composition excellent in iron oxide color development (color vividness) in addition to non-water-swellable powder and iron oxide dispersion stability is prepared. (Examples 10 and 11).
水性組成物に、ヘパリン類似物質を含有することで、単に酸化鉄の色が損なわれなかっただけではなく、より鮮やかな色の組成物を調製することができた。 By including a heparin-like substance in the aqueous composition, not only the color of iron oxide was not impaired, but a composition with a brighter color could be prepared.
(2) 乳化組成物
(2-1) 乳化組成物（表7及び8）の調製
表7及び8に記載する処方に従って、乳化組成物を調製した。
(2) Emulsified composition
(2-1) Preparation of Emulsified Composition (Tables 7 and 8) Emulsified compositions were prepared according to the formulations described in Tables 7 and 8.
水相：先ず、表7及び8に記載する各配合成分（ヘパリン類似物質、非水膨潤性の粉体、酸化鉄等）を夫々秤量し、水中で80℃にて加熱して混合し、均一に溶解し、水性組成物を調製した。 Aqueous phase: First, each of the ingredients listed in Tables 7 and 8 (heparin-like substance, non-water swellable powder, iron oxide, etc.) was weighed and mixed by heating at 80 ° C. in water and mixing. And an aqueous composition was prepared.
油相：次に、表7及び8に記載する各配合成分（液体油、固体油等）を夫々秤量し、80℃にて加熱して混合し、均一に溶解し油性組成物を調製した。 Oil phase: Next, each compounding component (liquid oil, solid oil, etc.) described in Tables 7 and 8 was weighed, heated and mixed at 80 ° C., and uniformly dissolved to prepare an oily composition.
油性組成物と水性組成物とを混合し、攪拌しながら40℃以下に冷却して、乳化組成物を調製した。 The oily composition and the aqueous composition were mixed and cooled to 40 ° C. or lower with stirring to prepare an emulsified composition.
表7及び8に、ヘパリン類似物質及び非水膨潤性の粉体に加えて、酸化鉄を含む、乳化組成物（固形油含む）の評価結果を示す。乳化組成物はクリーム状であった。 Tables 7 and 8 show the evaluation results of the emulsion composition (including solid oil) containing iron oxide in addition to the heparin-like substance and the non-water-swellable powder. The emulsified composition was creamy.
(2-2) 乳化組成物の発色性
ヘパリン類似物質及び非水膨潤性の粉体に加えて、酸化鉄を含む乳化組成物の発色性を表5と同じ基準に従い評価した。
(2-2) Color developability of emulsion composition In addition to the heparin-like substance and non-water-swellable powder, the color developability of the emulsion composition containing iron oxide was evaluated according to the same criteria as in Table 5.
(2-3) 乳化組成物の粘度
乳化組成物の粘度は、1日間静置させたサンプルを、B型粘度計（東機産業株式会社製RB-85L粘度計）で、ローター番号M4のローターを用いて、25℃にて測定した。
(2-3) Viscosity of emulsified composition The viscosity of the emulsified composition was measured by using a B-type viscometer (RB-85L viscometer manufactured by Toki Sangyo Co., Ltd.) Was measured at 25 ° C.
また、測定開始から30秒後の粘度を採用した。 Further, the viscosity 30 seconds after the start of measurement was adopted.
(2-4) 結果（実施例12〜16、比較例10及び11）(2-4) Results (Examples 12 to 16, Comparative Examples 10 and 11)
乳化組成物の発色性については、乳化組成物とした場合であっても、ヘパリン類似物質を含有しない場合には、酸化鉄の鮮やかさが十分に発揮されなかった（比較例10、11）。 Regarding the color developability of the emulsion composition, even when the emulsion composition was used, the vividness of iron oxide was not sufficiently exhibited when no heparin-like substance was contained (Comparative Examples 10 and 11).
一方、ヘパリン類似物質を含有する場合には、酸化鉄の鮮やかさが十分に発揮され、発色性の点でより優れた組成物を調製することができた（実施例12〜16）。 On the other hand, in the case of containing a heparin-like substance, the vividness of iron oxide was sufficiently exhibited, and it was possible to prepare compositions that were superior in terms of color developability (Examples 12 to 16).
乳化組成物では、特に、マイクロクリスタリンワックス等の常温で固体の油性成分を含有させることで、その鮮やかさをより際立たせることができた。 In the emulsified composition, the vividness of the emulsified composition can be made more conspicuous by including a solid oily component such as microcrystalline wax at normal temperature.
この様に、本発明によれば、流動性を呈する外用組成物における非水膨潤性の粉体等の成分の偏りを著しく低減でき、外用組成物に含まれる成分の効果のばらつき等を効果的に解消できる。また、本発明の外用組成物を皮膚に塗布したときの、その外観を改善することもできる。これらの効果は外用組成物の品質の向上に繋がる。 As described above, according to the present invention, it is possible to remarkably reduce the unevenness of components such as non-water-swellable powder in the external composition exhibiting fluidity, and to effectively vary the effects of the components contained in the external composition. Can be resolved. Moreover, the external appearance when the composition for external use of this invention is apply | coated to skin can also be improved. These effects lead to an improvement in the quality of the composition for external use.
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