JP7301536B2 - external composition - Google Patents
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Description
本発明は、ヘパリン類似物質を含有する外用組成物に関する。より具体的には、本発明は、低温条件下でもヘパリン類似物質の析出が抑制されており、優れた製剤安定性を備える外用組成物に関する。 The present invention relates to a topical composition containing a heparinoid. More specifically, the present invention relates to a composition for external use in which precipitation of heparin-like substances is suppressed even under low-temperature conditions and which has excellent formulation stability.
従来、ヘパリン類似物質は、コンドロイチン多硫酸等の多硫酸化ムコ多糖であり、保湿作用、抗炎症作用、血行促進作用等が知られており、しかも副作用が少ないことから、外用組成物の有効成分として用いられている（例えば、特許文献１参照）。 Conventionally, heparin-like substances are polysulfated mucopolysaccharides such as chondroitin polysulfate, which are known to have moisturizing action, anti-inflammatory action, blood circulation promoting action, etc., and have few side effects. (see, for example, Patent Document 1).
また、外用組成物は、寒冷地や冬季における保管・流通の際に、低温条件下に晒されることがあるため、低温条件でも優れた製剤安定性を有していることが求められている。 In addition, external compositions are required to have excellent formulation stability even under low-temperature conditions, since they may be exposed to low-temperature conditions during storage and distribution in cold regions or in winter.
一方、ヘパリン類似物質には、低温条件での安定性に乏しく、一旦溶解させても低温条件下で保存すると、析出し易いという欠点がある。このようなヘパリン類似物質の析出は、外用組成物の外観性状の悪化を招くだけでなく、ヘパリン類似物質による所期の薬効を減じることにもなるので、ヘパリン類似物質を含む外用組成物では、ヘパリン類似物質の析出を抑制し、優れた製剤安定性を備えさせることが求められている。しかしながら、従来、ヘパリン類似物質を含有する外用組成物において、低温条件下でのヘパリン類似物質の析出を抑制させる技術については十分に検討されていない。 On the other hand, heparin-like substances have the drawback that they are poor in stability under low-temperature conditions and tend to precipitate when stored under low-temperature conditions even if they are dissolved once. Such deposition of a heparinoid not only worsens the external appearance of the composition for external use, but also reduces the intended efficacy of the heparinoid. It is required to suppress the precipitation of heparin analogues and provide excellent formulation stability. However, conventionally, in a composition for external use containing a heparinoid, a technique for suppressing precipitation of the heparinoid under low-temperature conditions has not been sufficiently studied.
本発明の目的は、ヘパリン類似物質を含有する外用組成物において、低温条件下で保存しても、ヘパリン類似物質の析出を抑制できる製剤技術を提供することである。 An object of the present invention is to provide a formulation technology capable of suppressing deposition of a heparinoid substance even when stored under low temperature conditions in a composition for external use containing a heparinoid substance.
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、ヘパリン類似物質、イノシトール、及び水を含む外用組成物は、低温条件下でもヘパリン類似物質の析出を抑制でき、優れた製剤安定性を具備できることを見出した。本発明は、かかる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。 The present inventors conducted intensive studies to solve the above problems, and found that an external composition containing a heparinoid, inositol, and water can suppress precipitation of the heparinoid even under low-temperature conditions, and has excellent formulation stability. I found that I can possess the sexuality. The present invention has been completed through further studies based on such findings.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． ヘパリン類似物質、イノシトール、及び水を含有する、外用組成物。
項２． イノシトールの含有量が０．１～９重量％である、項１に記載の外用組成物。
項３． ヘパリン類似物質及び水を含む外用組成物においてヘパリン類似物質の析出を抑制する方法であって、
外用組成物中で、ヘパリン類似物質、イノシトール、及び水を共存させる、ヘパリン類似物質の析出抑制方法。
That is, the present invention provides inventions in the following aspects.
Section 1. A topical composition comprising a heparinoid, inositol, and water.
Section 2. Item 2. The composition for external use according to Item 1, wherein the content of inositol is 0.1 to 9% by weight.
Item 3. A method for suppressing deposition of a heparinoid in an external composition containing a heparinoid and water, comprising:
A method for suppressing precipitation of a heparinoid, comprising coexisting a heparinoid, inositol, and water in a composition for external use.
本発明によれば、流通や保管の段階で低温に晒されても、ヘパリン類似物質が安定に溶解した状態を保持でき、ヘパリン類似物質による所期の薬効を安定に維持させることが可能になる。 According to the present invention, even when exposed to low temperatures during distribution and storage, the heparin analogue can be maintained in a stable dissolved state, and the intended efficacy of the heparin analogue can be stably maintained. .
１．外用組成物
本発明の外用組成物は、ヘパリン類似物質、イノシトール、及び水を含有することを特徴とする。以下、本発明の外用組成物について詳述する。
1. Composition for external use The composition for external use of the present invention is characterized by containing a heparin analogue, inositol, and water. The composition for external use of the present invention is described in detail below.
［ヘパリン類似物質］
本発明の外用組成物は、ヘパリン類似物質を含む。ヘパリン類似物質とは、コンドロイチン多硫酸等の多硫酸化ムコ多糖であり、保湿作用、抗炎症作用、血行促進作用等を有することが知られている公知の薬剤である。
[Heparin-like substance]
The topical composition of the present invention contains a heparinoid. Heparin-like substances are polysulfated mucopolysaccharides such as chondroitin polysulfate, and are known drugs known to have moisturizing, anti-inflammatory, and blood circulation promoting effects.
本発明で使用されるヘパリン類似物質の由来については、特に制限されないが、例えば、ムコ多糖類を多硫酸化することにより得られたもの、食用獣の組織（例えば、ウシやブタ等の気管軟骨を含む肺臓）から抽出したもの等が挙げられる。本発明の外用組成物では、ヘパリン類似物質として、日本薬局方外医薬品規格に収戴されているヘパリン類似物質が好適に使用される。 The origin of the heparin-like substance used in the present invention is not particularly limited, but examples include those obtained by polysulfating mucopolysaccharides, tissues of edible animals (e.g., tracheal cartilage of bovine, porcine, etc.). (including lungs), and the like. In the composition for external use of the present invention, as the heparinoid substance, a heparinoid substance included in the Japanese Pharmaceutical Standards outside the Pharmacopoeia is preferably used.
本発明の外用組成物におけるヘパリン類似物質の含有量については、製剤形態等に応じて適宜設定すればよいが、例えば、０．０１～１重量％、好ましくは０．０５～０．５重量％、更に好ましくは０．１～０．４重量％が挙げられる。 The content of the heparin analogue in the composition for external use of the present invention may be appropriately set according to the form of the formulation, etc., and is, for example, 0.01 to 1% by weight, preferably 0.05 to 0.5% by weight. , and more preferably 0.1 to 0.4% by weight.
［イノシトール］
本発明の外用組成物は、更にイノシトールを含む。イノシトールは、低温条件下での保存によって生じるヘパリン類似物質の析出を抑制する役割を果たす。
[Inositol]
The topical composition of the present invention further contains inositol. Inositol plays a role in suppressing precipitation of heparin analogues caused by storage under low temperature conditions.
イノシトールとは、シクロヘキサンの各炭素上の水素原子が１つずつ水酸基に置き換わったシクロヘキサンヘキサオールである。 Inositol is cyclohexanehexaol in which one hydrogen atom on each carbon of cyclohexane is replaced with a hydroxyl group.
本発明の外用組成物におけるイノシトールの含有量としては、例えば、０．１～９重量％が挙げられる。イノシトールを７重量％以上含む場合には、低温条件下での保存によって生じるヘパリン類似物質の析出を抑制できるが、イノシトール自体が析出する傾向が現れる。そのため、低温条件下での保存によって生じるヘパリン類似物質の析出を効果的に抑制しつつ、イノシトール自体の析出も抑制するという観点から、本発明の外用組成物におけるイノシトールの含有量として、好ましくは０．１～６重量％、更に好ましくは２～６重量％が挙げられる。 The content of inositol in the topical composition of the present invention is, for example, 0.1 to 9% by weight. When the inositol content is 7% by weight or more, precipitation of heparin-like substances caused by storage under low-temperature conditions can be suppressed, but inositol itself tends to precipitate. Therefore, from the viewpoint of effectively suppressing the deposition of heparin-like substances caused by storage under low-temperature conditions and also suppressing the deposition of inositol itself, the content of inositol in the composition for external use of the present invention is preferably 0. .1 to 6% by weight, more preferably 2 to 6% by weight.
本発明の外用組成物において、ヘパリン類似物質とイノシトールの比率については、前記各含有量に応じて定まるが、例えば、ヘパリン類似物質１００重量部当たり、イノシトールが３０～３０００重量部が挙げられる。低温条件下での保存によって生じるヘパリン類似物質の析出をより一層効果的に抑制するという観点から、ヘパリン類似物質１００重量部当たり、イノシトールが好ましくは３０～２０００重量部、更に好ましくは６００～２０００重量部が挙げられる。 In the composition for external use of the present invention, the ratio of the heparin analogue to inositol is determined according to the above-mentioned contents. From the viewpoint of more effectively suppressing precipitation of heparinoids caused by storage under low temperature conditions, inositol is preferably 30 to 2000 parts by weight, more preferably 600 to 2000 parts by weight, per 100 parts by weight of heparinoids. Part is mentioned.
［水］
本発明の外用組成物は、ヘパリン類似物質を溶解させる基剤として水を含む。本発明の外用組成物における水の含有量は、ヘパリン類似物質、イノシトール、及びその他に添加される添加剤や薬理成分以外の残部であればよいが、例えば、１重量％以上、好ましくは５重量％以上、より好ましくは１０重量％以上、更に好ましくは５０重量％以上、６０重量％以上、又は７０重量％以上が挙げられる。また、水の含有量の上限値としては、例えば、９９．８９重量％以下、好ましくは９９．８５重量％以下、更に好ましくは９７．９重量％以下が挙げられる。
[water]
The topical composition of the present invention contains water as a base for dissolving the heparinoid. The content of water in the composition for external use of the present invention may be the balance other than the heparin analogue, inositol, and other additives and pharmacological components added, for example, 1% by weight or more, preferably 5% by weight. % or more, more preferably 10 wt% or more, still more preferably 50 wt% or more, 60 wt% or more, or 70 wt% or more. The upper limit of the water content is, for example, 99.89% by weight or less, preferably 99.85% by weight or less, and more preferably 97.9% by weight or less.
［その他の添加剤］
本発明の外用組成物は、前述する成分に加えて、その製剤形態等に応じて、他の添加剤が含まれていてもよい。
[Other additives]
In addition to the components described above, the composition for external use of the present invention may contain other additives depending on the form of formulation and the like.
本発明の外用組成物に配合し得る添加剤については、特に制限されないが、例えば、多価アルコール（エチレングリコール、１，３－ブチレングリコール、プロピレングリコール、イソプレングリコール、ジエチレングリコール、ジプロピレングリコール、ポリプロピレングリコール、グリセリン等）、１価低級アルコール（エタノール、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、ｔｅｒｔ－ブタノール等）、増粘剤、油分、ｐＨ調節剤、界面活性剤、乳化剤、可溶化剤、防腐剤、保存剤、酸化防止剤、安定化剤、キレート剤、香料、着色料等が挙げられる。これらの添加剤は、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。 Additives that can be blended in the composition for external use of the present invention are not particularly limited. , glycerin, etc.), monohydric lower alcohols (ethanol, propanol, isopropanol, n-butanol, sec-butanol, tert-butanol, etc.), thickeners, oils, pH adjusters, surfactants, emulsifiers, solubilizers, Preservatives, preservatives, antioxidants, stabilizers, chelating agents, perfumes, coloring agents and the like are included. These additives may be used singly or in combination of two or more.
本発明の外用組成物において、これらの添加剤を含有させる場合、その含有量については、使用する添加剤の種類、製剤形態等に応じて適宜設定すればよい。 When these additives are contained in the composition for external use of the present invention, the content thereof may be appropriately set according to the type of additive used, the formulation form, and the like.
［その他の薬理成分］
本発明の外用組成物は、前述する成分に加えて、その用途や製剤形態等に応じて、他の薬理成分が含まれていてもよい。
[Other pharmacological ingredients]
In addition to the components described above, the composition for external use of the present invention may contain other pharmacological components depending on its use, formulation form, and the like.
本発明の外用組成物に配合し得る薬理成分については、特に制限されないが、保湿剤、抗ヒスタミン剤、局所麻酔剤、抗炎症剤、ステロイド剤、殺菌剤、鎮痒剤、皮膚保護剤、血行促進成分、ビタミン類、清涼化剤、アミノ酸等が挙げられる。これらの薬効成分は、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。 The pharmacological ingredients that can be blended in the composition for external use of the present invention are not particularly limited, but include moisturizing agents, antihistamines, local anesthetics, anti-inflammatory agents, steroids, disinfectants, antipruritic agents, skin protective agents, blood circulation promoting ingredients, Examples include vitamins, cooling agents, amino acids, and the like. These medicinal ingredients may be used singly or in combination of two or more.
本発明の外用組成物において、これらの薬理成分を含有させる場合、その含有量については、使用する薬理成分の種類、期待する効果、製剤形態等に応じて適宜設定すればよい。 When these pharmacological ingredients are contained in the composition for external use of the present invention, the content thereof may be appropriately set according to the type of the pharmacological ingredient to be used, the expected effect, the formulation form, and the like.
［製剤形態・使用方法］
本発明の外用組成物は、経皮適用される製剤（外用医薬品、化粧料等）として使用され、とりわけ外用医薬品として好適に使用される。
[Formulation/Method of use]
The external composition of the present invention is used as a transdermal formulation (external medicine, cosmetics, etc.), and is particularly preferably used as an external medicine.
本発明の外用組成物の製剤形態については、経皮適用可能であることを限度として特に制限されず、例えば、液剤（ローション剤、スプレー剤、エアゾール剤、及び乳液剤を含む）、水溶性軟膏剤、油脂性軟膏剤、クリーム剤、フォーム剤、ゲル剤、貼付剤等が挙げられる。これらの中でも、好ましくはクリーム剤、液剤が挙げられる。これらの製剤形態への調製は、第十六改正日本薬局方 製剤総則等に記載の公知の方法に従って、製剤形態に応じた添加剤を用いて製剤化することにより行うことができる。 The formulation form of the composition for external use of the present invention is not particularly limited as long as it can be applied transdermally. preparations, oleaginous ointments, creams, foams, gels, patches and the like. Among these, creams and liquids are preferred. Preparation into these formulations can be carried out according to known methods described in the 16th revision of the Japanese Pharmacopoeia, General Rules for Formulations, etc., using additives appropriate for the formulation.
発明の外用組成物は、ヘパリン類似物質による保湿作用、抗炎症作用、血行促進作用等を発揮できるので、これらの作用が求められる皮膚に好適に適用される。 Since the composition for external use of the invention can exhibit moisturizing action, anti-inflammatory action, blood circulation promoting action, etc. by the heparin analogue, it is preferably applied to the skin where these actions are desired.
２．ヘパリン類似物質の析出抑制方法
本発明は、ヘパリン類似物質及び水を含む外用組成物においてヘパリン類似物質の析出を抑制する方法であって、外用組成物中で、ヘパリン類似物質、イノシトール、及び水を共存させることを特徴とする、ヘパリン類似物質の析出抑制方法を提供する。
2. Method for Suppressing Precipitation of Heparinoids The present invention is a method for suppressing precipitation of heparinoids in a composition for external use containing a heparinoid and water, wherein the composition for external use contains a heparinoid, inositol, and water. Provided is a method for suppressing precipitation of heparinoids, characterized by coexistence.
当該析出抑制方法において、使用するヘパリン類似物質及びイノシトールの配合量、配合される他の成分の種類や配合量、外用組成物の製剤形態等については、前記「１．外用組成物」の場合と同様である。 In the precipitation suppression method, the amounts of the heparinoid and inositol to be used, the types and amounts of other ingredients to be blended, the formulation form of the composition for external use, etc. are the same as in the case of "1. Composition for external use" above. It is the same.
以下に実施例を示して本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。 EXAMPLES The present invention will be described in more detail with reference to examples below, but the present invention is not limited to these.
試験例１
表１に示す組成の外用組成物（液状）を調製した。得られた各外用組成物について、以下の方法で低温サイクル試験を行い、ヘパリン類似物質の析出抑制効果を評価した。
Test example 1
A composition for external use (liquid) having the composition shown in Table 1 was prepared. A low-temperature cycle test was performed on each of the obtained compositions for external use by the following method to evaluate the effect of suppressing the precipitation of heparinoids.
調製直後の外用組成物３０ｍｌを透明ガラス容器（胴径φ３５ｍｍ×高さφ７８ｍｍ）に充填し、低温サイクル試験に供した。低温サイクル試験では、－２０℃の温度条件で開始し、－２０℃から４℃まで昇温し、その後４℃から－２０℃まで降温する温度変化を２４時間かけて行うことを１サイクルとして、合計３日間（３サイクル）行った。低温サイクル試験後の外用組成物の外観を目視にて確認し、ヘパリン類似物質の析出の有無の評価を行った。なお、ヘパリン類似物質が析出すると、キラキラした析出物が液中に分散した状態で観察されるので、当該析出物の分散の有無に基づいて、ヘパリン類似物質の析出の有無を評価した。 30 ml of the composition for external use immediately after preparation was filled in a transparent glass container (body diameter φ35 mm×height φ78 mm) and subjected to a low-temperature cycle test. In the low-temperature cycle test, starting at a temperature condition of -20 ° C., increasing the temperature from -20 ° C. to 4 ° C., and then decreasing the temperature from 4 ° C. to -20 ° C. over 24 hours. A total of 3 days (3 cycles) were performed. The external appearance of the composition for external use after the low-temperature cycle test was visually confirmed, and the presence or absence of precipitation of a heparinoid was evaluated. When the heparinoid precipitated, glittering precipitates were observed dispersed in the liquid, so the presence or absence of precipitation of the heparinoid was evaluated based on the presence or absence of dispersion of the precipitate.
また、前記低温サイクル試験後には、外用組成物におけるイノシトールの析出物の有無も観察した。なお、イノシトールが析出すると、白色の析出物が、沈降した状態で観察される。 After the low-temperature cycle test, the presence or absence of inositol precipitates in the composition for external use was also observed. In addition, when inositol precipitates, a white precipitate is observed in a sedimented state.
また、調製直後の外用組成物は、いずれもヘパリン類似物質及びイノシトールは完全に溶解した状態になっており、澄明な状態であった。 In addition, the external composition immediately after preparation was in a clear state, in which the heparinoid and inositol were completely dissolved.
得られた結果を表１に示す。この結果、イノシトールを含まない場合、低温サイクル試験後には、ヘパリン類似物質の析出の生成が認められた（比較例１）。これに対して、イノシトールを含む場合には、低温サイクル試験後でも、ヘパリン類似物質の析出は認められず、ヘパリンを安定に溶解した状態を維持できていた。特に、イノシトールを０．１～６重量％含む場合には、ヘパリン類似物質の析出の生成を十分に抑制しつつ、イノシトール自体の析出も抑制できており、澄明な外観を安定に維持できていた。 Table 1 shows the results obtained. As a result, when inositol was not contained, precipitation of a heparin-like substance was observed after the low-temperature cycle test (Comparative Example 1). On the other hand, when inositol was contained, precipitation of heparin-like substances was not observed even after the low-temperature cycle test, and heparin could be maintained in a stably dissolved state. In particular, when the inositol content was 0.1 to 6% by weight, the precipitation of the heparin-like substance was sufficiently suppressed, and the precipitation of the inositol itself was also suppressed, and the clear appearance could be stably maintained. .
Claims (4)
外用組成物中で、ヘパリン類似物質、イノシトール、及び水を共存させる、ヘパリン類似物質の析出抑制方法。 A method for suppressing deposition of a heparinoid in an external composition containing a heparinoid and water, comprising:
A method for suppressing precipitation of a heparinoid, comprising coexisting a heparinoid, inositol, and water in a composition for external use.
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