KR20110074116A - Composition for wound healing and preparation method thereof - Google Patents
Composition for wound healing and preparation method thereof Download PDFInfo
- Publication number
- KR20110074116A KR20110074116A KR1020090130989A KR20090130989A KR20110074116A KR 20110074116 A KR20110074116 A KR 20110074116A KR 1020090130989 A KR1020090130989 A KR 1020090130989A KR 20090130989 A KR20090130989 A KR 20090130989A KR 20110074116 A KR20110074116 A KR 20110074116A
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- South Korea
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- composition
- wound healing
- water
- film
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
본 발명은 피부에 도포시 공기와 접촉하면서 서서히 굳어 막을 형성할 수 있는 상처치유용 조성물 및 이의 제조방법에 관한 것으로, 보다 구체적으로는, 항균 및 항염 작용을 갖는 활성 성분 0.1∼25중량%, 수용성 막 형성 고분자 물질 10∼40중량%, 비수용성 막 형성 고분자 물질 1∼20중량%, 가소제 1∼10중량%, 유화제 1∼10중량%, 첨가제 0.1∼10중량%, 및 용제 10∼70중량%로 구성되는 조성물로서, 피부 도포시 두께가 상대적으로 매우 얇은 막을 형성하여 이물감이 거의 없고, 주성분인 활성 성분을 지속적으로 방출할 수 있도록 도와주며, 외부의 마찰 및 자극에 대응하여 피부를 보호함으로써, 상처치유 및 조직회복 기능을 갖는 조성물 및 이의 제조 방법에 관한 것이다.The present invention relates to a wound healing composition and a method for preparing the same, which may gradually solidify while contacting air when applied to the skin, and more specifically, 0.1 to 25% by weight of an active ingredient having antibacterial and anti-inflammatory action, and water-soluble. 10 to 40% by weight of film-forming polymer material, 1 to 20% by weight of water-insoluble film-forming polymer material, 1 to 10% by weight of plasticizer, 1 to 10% by weight of emulsifier, 0.1 to 10% by weight of additive, and 10 to 70% by weight of solvent The composition is composed of a relatively thin thickness when applying the skin, there is almost no foreign body feeling, helps to continuously release the active ingredient as a main component, by protecting the skin against external friction and irritation, A composition having a wound healing and tissue repair function and a method for producing the same.
상처치유, 소독, 조직회복, 막형성, 막 Wound healing, disinfection, tissue recovery, membrane formation, membrane
Description
본 발명은 피부에 도포시 공기와 접촉하면서 신속히 굳어 막을 형성할 수 있는 상처치유용 조성물 및 이의 제조방법에 관한 것으로, 보다 구체적으로는, 항균 및 항염 작용을 갖는 활성 성분 0.1∼25중량%, 수용성 막 형성 고분자 물질 10∼40중량%, 비수용성 막 형성 고분자 물질 1∼20중량%, 가소제 1∼10중량%, 유화제 1∼10중량%, 첨가제 0.1∼10중량%, 및 용제 10∼70중량%로 구성되는 조성물로서, 피부 도포시 두께가 상대적으로 매우 얇은 막을 형성하여 이물감이 거의 없고, 주성분인 활성 성분을 지속적으로 방출할 수 있도록 도와주며, 외부의 마찰 및 자극에 대응하여 피부를 보호함으로써, 상처치유 및 조직회복 기능을 갖는 조성물 및 이의 제조 방법에 관한 것이다.The present invention relates to a wound healing composition and a method for preparing the same, which can rapidly solidify in contact with air when applied to the skin, and more specifically, 0.1 to 25% by weight of an active ingredient having antibacterial and anti-inflammatory action, and water-soluble. 10 to 40% by weight of film-forming polymer material, 1 to 20% by weight of water-insoluble film-forming polymer material, 1 to 10% by weight of plasticizer, 1 to 10% by weight of emulsifier, 0.1 to 10% by weight of additive, and 10 to 70% by weight of solvent The composition is composed of a relatively thin thickness when applying the skin, there is almost no foreign body feeling, helps to continuously release the active ingredient as a main component, by protecting the skin against external friction and irritation, A composition having a wound healing and tissue repair function and a method for producing the same.
일반적으로, 창상, 외상 등과 같은 피부의 상처를 효율적으로 치료하기 위해서, 병원에서는 드레싱을 사용한다. 상처치유를 위한 드레싱은 소독 능력, 적당한 습기 유지능력, 부착 및 제거 능력, 상처의 보호 능력, 항균 능력, 항염 능력, 드레싱 장비의 무독성 등이 중요하다.In general, dressings are used in hospitals to efficiently treat wounds of the skin such as wounds, traumas, and the like. Dressings for wound healing are important for disinfection, proper moisture retention, adhesion and removal, wound protection, antimicrobial, anti-inflammatory and nontoxicity of dressing equipment.
지금까지는 상처치유 및 조직회복을 위해서 보통 약제학적 연고나 크림을 바르고, 그 위에 상처 보호용 가아제와 반창고를 접착시키거나 전용 보호밴드를 접착시킴으로써 약물과 상처를 보호하면서 상처를 치유하는 방법이 널리 사용되어져 왔다. 그러나 이러한 상처치유 방법은 약물 도포 및 접착 후 일정 시간이 지나면 외부의 마찰 등에 의하여 소실되거나, 하루에도 몇 번씩 갈아줘야 하는 불편함이 있었으며, 외관상으로도 문제가 있었다.Until now, it has been widely used to heal wounds by applying pharmaceutical ointments or creams for wound healing and tissue recovery, and by attaching a wound protective gauze and bandage on them or by attaching a special protective band. come. However, the wound healing method was lost due to external friction after a certain time after application and adhesion of the drug, or had to be changed several times a day, and there was a problem in appearance.
상처치유를 위한 드레싱은 과거에는 천연 재료등을 응용하였으나, 점차 발전하면서 고분자 물질을 이용하게 되었으며, 1962년 윈터(Winter)등이 상처를 습윤한 상태로 유지시킬 때, 흉터가 없이 빨리 치유되고, 통증도 감소시킨다는 사실을 발표한 후에는, 병원 등에서도 상처를 습윤한 상태로 치료하는 방법을 사용하게 되었다. 최근에는 3M등에서 습윤한 상태로 상처를 유지하여 회복시키는 제품을 출시하였는데, 이는 외부의 마찰 및 샤워 등에도 비교적 안전하고, 외관상 보기에도 잘 보이지 않는 장점을 지니고 있으나, 제품 자체가 두꺼워 튀어나와 보이는 문제가 있고, 소독 작용이 떨어져 이미 염증이 시작된 상처에는 사용할 수 없는 단점이 있다.In the past, dressings for wound healing were applied with natural materials, but gradually developed, using polymer materials. In 1962, when Winter kept the wounds wet, healed quickly without scars. After announcing that it also reduces pain, hospitals and others have used a method of treating wounds in wet conditions. Recently, we have launched a product that maintains and repairs wounds in a wet state, such as 3M, which is relatively safe against external friction and showers, and has an invisible appearance, but the product itself protrudes out of view. There is a disadvantage that can not be used for wounds that have already begun because the disinfection action is off.
이에, 본 발명자들은 이러한 단점들을 극복하고자 약물 도포를 손쉽게 하고, 별도의 가아제나 보호 밴드를 사용하지 않으면서도 항균 및 항염 작용을 발휘하며, 과거의 방법과 비교하여 지속시간이 연장된 막 형태의 상처치유 및 조직회복기능을 갖는 기능성 조성물 및 이의 제조방법에 대하여 연구하게 되었다.In order to overcome these drawbacks, the present inventors can easily apply the drug, exhibit antimicrobial and anti-inflammatory action without using a separate gauze or protective band, and have a wound in the form of a prolonged duration compared to the past methods. Functional compositions having healing and tissue repair functions and methods for preparing the same have been studied.
특히, 이러한 신규의 상처치유 및 조직회복 기능을 갖는 조성물을 제조하기 위해서는 항균 및 항염 작용을 갖는 활성 성분의 선별, 이러한 활성 성분을 효율적으로 피부에 전달할 수 있는 고분자의 선정 및 제형 개발, 및 피부에 적용시 막 내의 활성 성분이 신속하고, 지속적으로 상처에 전달되어야 하는 필요조건을 모두 만족할 수 있도록 설계하는 것이 매우 중요하다.In particular, in order to prepare a composition having a new wound healing and tissue repair function, the selection of active ingredients with antibacterial and anti-inflammatory action, the selection of polymers and formulations that can effectively deliver these active ingredients to the skin, and to the skin It is very important that the application is designed so that the active ingredient in the membrane satisfies all of the requirements that must be delivered quickly and continuously to the wound.
본 발명은 상기한 바와 같은 종래 기술의 문제점을 해결하기 위한 것으로서, 본 발명의 목적은 피부에 도포시 공기와 접촉하면서 신속히 굳어 막을 형성할 수 있는 상처치유 및 조직회복 기능을 갖는 조성물 및 이의 제조방법을 제공하는 것이다.The present invention is to solve the problems of the prior art as described above, an object of the present invention is a composition having a wound healing and tissue recovery function that can be quickly solidified in contact with air when applied to the skin and a method for manufacturing the same To provide.
상기와 같은 목적을 달성하기 위하여, 본 발명에 의한 조성물은 항균 및 항염 작용을 갖는 활성 성분 0.1∼25중량%, 수용성 막 형성 고분자 물질 10∼40중량%, 비수용성 막 형성 고분자 물질 1∼20중량%, 가소제 1∼10중량%, 유화제 1∼10중량%, 첨가제 0.1∼10중량%, 및 용제 10∼70중량%를 포함하는 것을 특징으로 한다.In order to achieve the above object, the composition according to the present invention is 0.1 to 25% by weight of the active ingredient having antibacterial and anti-inflammatory action, 10 to 40% by weight of the water-soluble film-forming polymer material, 1 to 20% by weight of the water-insoluble film-forming polymer material %, 1 to 10% by weight of plasticizer, 1 to 10% by weight of emulsifier, 0.1 to 10% by weight of additive, and 10 to 70% by weight of solvent.
본 발명에 의한 상기 조성물은, 피부 도포시 두께가 상대적으로 매우 얇은 막을 형성하여 이물감이 거의 없고, 주성분인 활성 성분을 지속적으로 방출할 수 있도록 도와주며, 외부의 마찰 및 자극에 대응하여 피부를 보호함으로써, 상처치유 및 조직회복 기능을 갖는 것을 특징으로 한다.The composition according to the present invention forms a relatively thin film when the skin is applied, has almost no foreign matter, helps to continuously release the active ingredient as a main ingredient, and protects the skin against external friction and irritation. It is characterized by having a wound healing and tissue recovery function.
본 발명자들은 상기 조성물을 피부에 도포한 결과, 막을 형성하는 고분자 물 질과 활성 성분이 균일하게 혼합되어 신속히 막을 형성함을 확인하였으며, 1회 적용으로 약 72시간 효과를 지속할 수 있는 특징을 지님도 확인하였다. 나아가, 활성 성분으로서 항균, 항염 및 면역강화 효능을 갖는 것으로 알려져 있는 백리향, 금은화, 포공영, 황백, 울금, 녹두, 에키나시아 추출물 등으로부터 선택된 적어도 1종 이상의 천연물질 또는 화학물질을 함유한 조성물을 사람의 피부에 적용하여 상처부위에서 소독작용을 위한 항균, 항염 및 면역 강화 효과를 확인함으로써 본 발명을 완성하였다.As a result of applying the composition to the skin, the inventors have confirmed that the polymer and the active ingredient forming the film are uniformly mixed to form a film quickly, and have a feature that can last about 72 hours with a single application. Also confirmed. Furthermore, a composition containing at least one natural or chemical substance selected from thyme, gold, silver, pogongyoung, yellow white, turmeric, mung bean, echinacea extract, etc., which are known to have antimicrobial, anti-inflammatory and immunopotentiating efficacy as active ingredients The present invention was completed by confirming the antibacterial, anti-inflammatory and immune enhancing effect for disinfection in the wound area.
이하 본 발명을 자세히 설명한다.Hereinafter, the present invention will be described in detail.
본 발명에 따른 막 조성물은 항균 및 항염 작용을 갖는 활성 성분 0.1∼25중량%, 수용성 막 형성 고분자 물질 1∼40중량%, 비수용성 막 형성 고분자 물질 1∼20중량%, 가소제 1∼10중량%, 유화제 1∼10중량%, 첨가제 0.1∼10중량%, 및 용제 10∼70중량%로 구성되는 조성물로서, 피부에 도포시 상술한 막 형성 고분자 물질과 활성 성분이 균일하게 혼합된 막을 형성할 수 있다.The membrane composition according to the present invention comprises 0.1 to 25% by weight of the active ingredient having antibacterial and anti-inflammatory action, 1 to 40% by weight of the water-soluble film-forming polymer material, 1 to 20% by weight of the water-insoluble film-forming polymer material, and 1 to 10% by weight of the plasticizer. , 1 to 10% by weight of an emulsifier, 0.1 to 10% by weight of an additive, and 10 to 70% by weight of a solvent, which can form a film in which the above-mentioned film-forming polymer substance and the active ingredient are uniformly mixed when applied to the skin. have.
본 발명의 조성물은 통상 액제 형태로 제조되어 피부에 도포시 공기와 접촉하여 상처치유 및 조직회복 기능을 갖는 기능성 막을 형성하는 것을 특징으로 한다. 이러한 막의 두께는 특별히 한정될 필요는 없으나 이물감 등을 고려할 때, 0.01∼1.0mm의 두께가 바람직할 수 있다.The composition of the present invention is usually prepared in the form of a liquid, characterized in that in contact with the air when applied to the skin to form a functional film having a wound healing and tissue recovery function. The thickness of the film need not be particularly limited, but in consideration of foreign matters, a thickness of 0.01 to 1.0 mm may be preferable.
또한, 일반적으로 이와 유사한 조성물들은 비교적 단기간만 존속하고 자연스럽게 피부로부터 제거되는 것이 대부분이지만, 본 발명에 따른 조성물은 1회 적용으로 약 3일간 효과를 지속시킬 수 있는 것을 특징으로 한다.In addition, while similar compositions generally last only relatively short periods of time and are naturally removed from the skin, the compositions according to the invention are characterized in that they can last about 3 days in a single application.
본 발명에 따른 조성물에 함유될 수 있는 활성 성분의 예들에는 항균, 항염 및 면역강화 효능을 갖는 공지된 물질, 예컨대 백리향, 금은화, 포공영, 황백, 울금, 녹두, 에키나시아 추출물 등으로부터 선택된 적어도 1종 이상의 천연물질 및 화학물질이 포함된다. 본 발명의 조성물은 피부에 도포시 상처 부위에 막을 형성한 후, 이들 활성 성분들이 신속하고, 지속적으로 상처 부위에 효율적으로 전달될 수 있도록 한다.Examples of active ingredients which may be contained in the compositions according to the invention include at least one or more selected from known substances having antimicrobial, anti-inflammatory and immunopotentiating efficacy, such as thyme, gold and silver, pogongyoung, yellowish white, turmeric, mung bean, echinacea extract and the like. Natural substances and chemicals are included. The composition of the present invention forms a film on the wound site when applied to the skin, and then allows these active ingredients to be delivered quickly and continuously to the wound site efficiently.
본 발명에 따른 상처치유용 조성물 중 상술한 활성 성분의 함량은 막 형성액 기준으로 0.1∼25중량%, 바람직하게는 1∼15중량%이다. 그러나, 이러한 활성 성분의 함량은 본 발명에 있어서 절대적인 것은 아니며, 활성 성분이 약제인 경우에는, 1회 투여량이 본 발명의 1투여 제제 단위 내에서 0.1∼10중량%, 바람직하게는 0.1∼5중량% 범위일 수도 있다.The content of the above-mentioned active ingredient in the wound healing composition according to the present invention is 0.1 to 25% by weight, preferably 1 to 15% by weight, based on the film forming liquid. However, the content of such active ingredients is not absolute in the present invention, and when the active ingredient is a medicament, a single dose is 0.1 to 10% by weight, preferably 0.1 to 5% by weight in the dosage unit of the present invention. It can also be in the% range.
또한, 본 발명에 따른 상처치유용 조성물 중 막을 형성하면서 상술한 활성 성분을 담지하는 성분인 수용성 막 형성 고분자 물질의 예들에는, 이에 한정되는 것은 아니나, 폴리아크릴산 나트륨(sodium polyacrylate), 아크릴레이트 폴리머(acrylate polymer), 아크릴레이트 공중합체(acrylate copolymer), 알킬 올레핀산(alkyl olefinic acid), 알킬 올레핀산 에스테르 공중합체(alkyl olefinic acid ester copolymer), 아미드/올레핀산(amide/olefinic acid), 아미드/올레핀산 공중합체(amide/olefinic acid copolymer), 폴리비닐아세테이트(polyvinyl acetate), 폴리비닐피롤리돈(polyvinylpyrrolidone), 비닐피롤리돈-비닐아세테이트 공중합체(vinylpyrrolidone-vinylacetate copolymer), 히드록시알킬셀룰로오 스(hydroxyalkyl cellulose), 알킬셀룰로오스(alkyl cellulose), 카르복시비닐폴리머(Carboxyvinyl polymer, Carbopol®) 또는 이들의 혼합물로부터 선택되는 적어도 1종의 물질이 포함될 수 있다.In addition, examples of the water-soluble film-forming polymer material that is a component that carries the active ingredient described above while forming a film in the wound healing composition according to the present invention include, but are not limited to, sodium polyacrylate, acrylate polymer ( acrylate polymer, acrylate copolymer, alkyl olefinic acid, alkyl olefinic acid ester copolymer, amide / olefinic acid, amide / olefin Amide / olefinic acid copolymer, polyvinyl acetate, polyvinylpyrrolidone, vinylpyrrolidone-vinylacetate copolymer, hydroxyalkyl cellulose switch (hydroxyalkyl cellulose), alkyl cellulose (alkyl cellulose), carboxyvinyl polymer (carboxyvinyl polymer, Carbopol ®) or mixtures thereof It may comprise a material of at least one member selected from.
본 발명에 따른 상처치유용 조성물은 더욱 바람직하게는 폴리아크릴산나트륨, 히드록시알킬셀룰로오스, 알킬셀룰로오스, 카르복시비닐폴리머 등을 포함할 수 있다. 상술한 수용성 막 형성 고분자 물질들은 알약을 안정적으로 유지할 수 있도록 약제학적 코팅 물질로서 통상적으로 사용되는 성분이나, 본원발명에서는 피부에 도포시 피부 친화적이면서 활성 성분의 흡수를 돕는 작용을 하는 막을 형성하는 역할을 한다.The wound healing composition according to the present invention may more preferably include sodium polyacrylate, hydroxyalkyl cellulose, alkyl cellulose, carboxyvinyl polymer and the like. The above-mentioned water-soluble film-forming polymer materials are components commonly used as pharmaceutical coating materials to stably maintain a pill, but in the present invention, when applied to the skin, they form a film that acts as a skin-friendly and helps to absorb the active ingredient. Do it.
상술한 수용성 막 형성 고분자 물질은 조성물 전체 중량을 기준으로 10∼40중량%, 바람직하게는 10∼30중량%으로 포함되는 것이 바람직하다. 수용성 막 형성 고분자 물질이 10중량% 미만이면, 막을 형성하기가 어려울 수 있으며, 30중량%를 초과하면, 필름형성액이 그 상태를 유지하기가 어렵다.The water-soluble film-forming polymer material described above is preferably contained in 10 to 40% by weight, preferably 10 to 30% by weight based on the total weight of the composition. If the water-soluble film-forming polymer material is less than 10% by weight, it may be difficult to form a film. If the water-soluble film-forming polymer material is more than 30% by weight, it is difficult for the film forming liquid to maintain its state.
또한, 본 발명에 따른 상처치유용 조성물 중 막을 형성하면서 상술한 활성 성분을 담지하는 성분인 비수용성 막 형성 고분자 물질의 예들에는, 이에 한정되는 것은 아니나, 히드록시프로필메틸셀룰로오스 프탈레이트(Hydroxypropylmethylcellulose phthalate), 폴리에틸렌글리콜 6000(Polyethyleneglycol 6000), 메타크릴레이트 공중합체(Metacrylate copolymer), 셀룰로오스아세테이트 프탈레이트(Cellulose acetate phthalate), 셀 룰로오스아세테이트 부틸레이트(Cellulose acetate butylate), 히드록시프로필메틸셀룰로오스 석시네이트(Hydroxypropylmethylcellulose succinate), 폴리비닐아세테이트 프탈레이트(Polyvinyl acetate phthalate), 셀룰로오스아세테이트 트리멜리테이트(Cellulose acetate trimellitate), 카르복시메틸셀룰로오스(Carboxymethylcellulose), 쉘락(Shellac), 옥수수단백추출물(Zein) 및 키틴, 키틴산, 대두단백, 소맥단백, 한천, 카라기난, 펙틴, 옥수수 전분, 감자 전분, 밀 전분, 쌀 전 분등의 전분류 또는 이들의 혼합물로부터 선택되는 적어도 1종의 물질이 포함될 수 있다.In addition, examples of the water-insoluble film-forming polymer material that is a component that carries the active ingredient described above while forming a film in the wound healing composition according to the present invention include, but are not limited to, hydroxypropylmethylcellulose phthalate, Polyethyleneglycol 6000, methacrylate copolymer, cellulose acetate phthalate, cellulose acetate butylate, hydroxypropylmethylcellulose succinate , Polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethylcellulose, shellac, corn protein extract (Zein) and chitin, chitin, soy protein, At least one substance selected from starch such as wheat protein, agar, carrageenan, pectin, corn starch, potato starch, wheat starch, rice starch, or mixtures thereof may be included.
본 발명에 따른 상처치유용 조성물은 더욱 바람직하게는 히드록시프로필메틸셀룰로오스 프탈레이트 등을 포함할 수 있다. 상술한 비수용성 막 형성 고분자 물질들은 통상적으로 알약을 코팅하는 용도로 많이 사용되는 성분이나, 본원발명에서는 피부의 pH인 4.5∼6.5에서 비교적 안정하게 막을 형성하는 역할을 한다.The wound healing composition according to the present invention may more preferably include hydroxypropylmethylcellulose phthalate and the like. The above-mentioned non-aqueous film-forming polymer materials are components commonly used for coating pills, but in the present invention, they serve to form a film relatively stably at 4.5 to 6.5, which is the pH of the skin.
상술한 비수용성 막 형성 고분자 물질은 본 발명의 조성물 내에서 외부의 마찰과 손실에 대응하여 막 내의 활성 성분을 외부로부터 보호하는 역할과 막이 지속적인 효과를 발휘할 수 있도록 하는 역할을 하며 그 함량은 조성물 전체 중량을 기준으로 1∼20중량%, 바람직하게는 1∼10중량%이다. 비수용성 막 형성 고분자 물질이 1중량% 미만이면, 막을 형성하기가 어려울 수 있으며, 10중량%을 초과하면, 필름형성액이 그 상태를 유지하기가 어렵다.The water-insoluble film-forming polymer material described above serves to protect the active ingredient in the membrane from the outside in response to external friction and loss in the composition of the present invention and to allow the membrane to exert a lasting effect, and the content of the whole composition 1 to 20% by weight, preferably 1 to 10% by weight, based on the weight. If the water-insoluble film-forming polymer material is less than 1% by weight, it may be difficult to form a film, and if it exceeds 10% by weight, it is difficult for the film forming liquid to maintain its state.
또한, 본 발명에 따른 상처치유용 조성물에는 부드러운 느낌을 주기 위한 가소제가 사용될 수 있는데, 이러한 가소제로서는, 이에 한정되는 것은 아니나, 프로 필렌글리콜(Propylene glycol), 부틸렌글리콜(Butylene glycol), 폴리에틸렌글리콜 1500(Polyethylene glycol 1500), 솔비톨(D-Sorbitol solution) 또는 이들의 혼합물로부터 선택되는 적어도 1종의 물질이 사용될 수 있다.In addition, the wound healing composition according to the present invention may be used as a plasticizer to give a soft feeling, such plasticizers, but is not limited to these, propylene glycol, butylene glycol, polyethylene glycol At least one material selected from 1500 (polyethylene glycol 1500), sorbitol (D-Sorbitol solution) or a mixture thereof may be used.
본 발명에 따른 상처치유용 조성물 중 상술한 가소제의 함량은 막 형성액 기준으로 1∼10중량%, 바람직하게는 1∼5중량%이다.The content of the above-described plasticizer in the wound healing composition according to the present invention is 1 to 10% by weight, preferably 1 to 5% by weight, based on the film forming liquid.
또한, 본 발명에 따른 상처치유용 조성물 내에서 활성 성분과 막 형성액과의 유화를 위해 유화제가 사용될 수 있으며, 이러한 유화제로서는, 이에 한정되는 것은 아니나, 소르비탄모노라우레이트(스판 20®(Span 20®)), 소르비탄모노팔미테이트(스판 40®(Span 40®)), 소르비탄모노스테아레이트(스판 60®(Span 60®)), 소르비탄모노올레이트(스판 80®(Span 80®)), 폴리옥시에틸렌소르비탄모노라우레이트(트윈 20®(Tween 20®)), 폴리옥시에틸렌소르비탄모노팔미테이트(트윈 40®(Tween 40®)), 폴리옥시에틸렌소르비탄모노스테아레이트(트윈60®(Tween 60®)), 폴리옥시에틸렌소르비탄모노올레이트(트윈 80®(Tween 80®)) 등의 비이온 계면활성제 중에서 선택되는 적어도 1종의 물질을 사용할 수 있다.In addition, an emulsifier may be used for emulsification of the active ingredient and the film-forming liquid in the wound healing composition according to the present invention. Such emulsifiers include, but are not limited to, sorbitan monolaurate (span 20 ® (Span 20 ® )), sorbitan monopalmitate (span 40 ® (Span 40 ® )), sorbitan monostearate (span 60 ® (Span 60 ® )), sorbitan monooleate (span 80 ® (Span 80 ®) )), polyoxyethylene sorbitan monolaurate (tween 20 ® (tween 20 ®)) , polyoxyethylene sorbitan monopalmitate (tween 40 ® (tween 40 ®)) , polyoxyethylene sorbitan monostearate ( tween 60 ® (tween 60 ®)) , polyoxyethylene sorbitan monooleate can be used at least one kind of material selected from non-ionic surfactants such as (tween 80 ® (tween 80 ®)) .
본 발명에 따른 조성물 중 상술한 유화제의 함량은 조성물 전체 중량을 기준으로 1∼10중량%, 바람직하게는 1∼5중량%이다.The content of the above-mentioned emulsifier in the composition according to the present invention is 1 to 10% by weight, preferably 1 to 5% by weight, based on the total weight of the composition.
또한, 본 발명에 따른 상처치유용 조성물 내에서 사용될 수 있는 첨가제는, 이에 한정되는 것은 아니나, pH조절제, 안정화제, 항산화제, 착색제 등을 사용할 수 있다.In addition, the additive that can be used in the wound healing composition according to the present invention is not limited thereto, and pH adjusting agents, stabilizers, antioxidants, coloring agents, and the like may be used.
본 발명에 따른 조성물 중 상술한 첨가제의 함량은 조성물 전체 중량을 기준으로 0.1∼10중량%, 바람직하게는 0.1∼5중량%이다.The content of the above-mentioned additives in the composition according to the present invention is 0.1 to 10% by weight, preferably 0.1 to 5% by weight based on the total weight of the composition.
또한, 본 발명에 따른 상처치유용 조성물 내에서 사용될 수 있는 용제는, 이에 한정되는 것은 아니나, 용제의 휘발성 및 잔류시 초래할 수 있는 유기 용제의 문제점 등을 고려하여, 약제학적으로 피부에 사용할 수 있는 물, 유기용제 또는 이의 혼합물을 사용할 수 있다.In addition, the solvent that can be used in the composition for wound healing according to the present invention is not limited thereto, but considering the volatility of the solvent and the problems of the organic solvent that may be caused when remaining, etc. Water, organic solvents or mixtures thereof can be used.
본 발명에 따른 조성물 중 상술한 용제의 함량은 조성물 전체 중량을 기준으로 10∼70중량%, 바람직하게는 20∼60중량%이다.The content of the above-mentioned solvent in the composition according to the present invention is 10 to 70% by weight, preferably 20 to 60% by weight based on the total weight of the composition.
이하, 상기한 성분들을 이용하여 본 발명에 따른 상처치유용 조성물을 제조하는 방법에 관하여 기술하기로 한다.Hereinafter, a method for preparing a wound healing composition according to the present invention using the above components will be described.
본 발명에 따른 상처치유용 조성물의 제조 방법은, a) 에탄올, 정제수 등 수용성 고분자 물질을 용해시킬 수 있는 용제에 수용성 고분자 및 상술한 기능성을 부여하는 활성 성분을 투입하고, 상기 활성 성분의 용해도에 따라 유화제 및 첨가제를 첨가하여 용해하는 단계, b) 별도의 용기에 비수용성 고분자 물질, 가소제 및 첨가제를 상기 용제에 첨가하여 용해하는 단계, 및 c) 상기 a) 및 b) 단계에서 제조된 용액을 혼합하는 단계를 포함하며, 이를 통해 점성이 있는 상처치유 및 조직회복 기능을 갖는 기능성 막 형성액을 수득하는 것을 특징으로 한다.In the method for preparing a wound healing composition according to the present invention, a) a water-soluble polymer and an active ingredient imparting the above-mentioned functionality to a solvent capable of dissolving a water-soluble polymer such as ethanol and purified water are added to the solubility of the active ingredient. Dissolving by adding an emulsifier and an additive according to the present invention; b) adding and dissolving the non-aqueous polymer material, a plasticizer and an additive to the solvent in a separate container, and c) dissolving the solution prepared in steps a) and b). It comprises the step of mixing, it is characterized in that to obtain a functional film forming solution having a viscous wound healing and tissue repair function.
일반적으로, 막 형성액의 점도가 높을 경우에는 유동성이 적기 때문에 피부 에 도포시 흘러내리지 않고, 적용 부위에 정확하게 적용할 수 있으므로, 막 형성액의 점도를 일정하게 유지시킬 필요가 있다. 따라서, 본 발명에 따른 조성물의 점도는 이에 한정되는 것은 아니나, 약 1,000∼3,000 cps 정도가 적당하다.In general, when the viscosity of the film forming liquid is high, the fluidity is low, so that it can be applied accurately to the application site without flowing down upon application to the skin. Therefore, it is necessary to keep the viscosity of the film forming liquid constant. Therefore, the viscosity of the composition according to the present invention is not limited to this, about 1,000 to 3,000 cps is suitable.
상술한 바와 같이 본 발명은, As described above, the present invention,
첫째, 상처부위의 피부에 도포시 막을 형성하여 피부의 상처를 효과적으로 보호하고, 항균 및 항염 작용을 통해 상처를 지속적으로 치유하고 회복시키며, 1회 적용으로 약 72시간 효과를 지속할 수 있는 상처치유용 조성물을 제공하며,First, it forms a film when applied to the skin of the wound area, effectively protects the wound of the skin, continuously heals and recovers the wound through antibacterial and anti-inflammatory action, and heals the wound that can last about 72 hours with one application. Providing a composition for
둘째, 활성 성분의 막 형성 기제에 대한 용해를 최적화하여 제조 효율성을 현저히 향상시킨 상기 조성물의 제조방법을 제공한다.Second, there is provided a method for preparing the composition, which significantly improves the production efficiency by optimizing the dissolution of the active ingredient into the film forming base.
이하 본 발명의 바람직한 실시예를 상세히 설명하기로 한다. 이에 앞서, 본 명세서 및 청구범위에 사용된 용어나 단어는 통상적이거나 사전적인 의미로 한정해서 해석되어서는 아니되며, 발명자는 그 자신의 발명을 가장 최선의 방법으로 설명하기 위해 용어의 개념을 적절하게 정의할 수 있다는 원칙에 입각하여 본 발명의 기술적 사상에 부합하는 의미와 개념으로 해석되어야만 한다.Hereinafter, a preferred embodiment of the present invention will be described in detail. Prior to this, terms or words used in the specification and claims should not be construed as having a conventional or dictionary meaning, and the inventors should properly explain the concept of terms in order to best explain their own invention. Based on the principle that can be defined, it should be interpreted as meaning and concept corresponding to the technical idea of the present invention.
따라서, 본 명세서에 기재된 도면 및 실시예에 도시된 구성은 본 발명의 가장 바람직한 일 실시예에 불과할 뿐이고 본 발명의 기술적 사상을 모두 대변하는 것은 아니므로, 본 출원시점에 있어서 이들을 대체할 수 있는 다양한 균등물과 변형예들이 있을 수 있음을 이해하여야 한다.Therefore, the configuration shown in the drawings and the embodiments described herein are only one of the most preferred embodiments of the present invention and do not represent all of the technical spirit of the present invention, various modifications that can be replaced at the time of the present application It should be understood that there may be equivalents and variations.
<실시예 1 내지 6 및 비교실시예><Examples 1 to 6 and Comparative Examples>
본 발명에 따른 조성물을 다음과 같은 제조 방법으로 제조하였다.The composition according to the present invention was prepared by the following preparation method.
1) 필름형성액 I의 제조1) Preparation of Film Forming Solution I
에탄올, 정제수 등 수용성 고분자 물질을 용해시킬 수 있는 용해제에 수용성 고분자인 폴리아크릴산 나트륨과 상술한 기능성을 부여하는 활성 성분을 투입하고, 활성 성분의 용해성에 따라 유화제와 안정화제인 피로아황산나트륨을 첨가한 후, 뭉치지 않도록 잘 저어주었다.Sodium polyacrylate, which is a water-soluble polymer, and an active ingredient for imparting the above-mentioned functionality are added to a dissolving agent capable of dissolving water-soluble high molecular substances such as ethanol and purified water. Stir well to avoid clumping.
2) 필름형성액 II의 제조2) Preparation of Film Forming Solution II
별도의 용기에 카보폴 940과 정제수, 에탄올, 디에틸렌글리콜모노에틸에테르, 트리에탄올아민을 넣어서 완전 용해시켰다. 완전 용해 후 다시 에틸셀룰로오스와 프로필렌글리콜을 첨가하여 완전 용해시켰다.In a separate container, Carbopol 940, purified water, ethanol, diethylene glycol monoethyl ether, and triethanolamine were completely dissolved. After complete dissolution, ethylcellulose and propylene glycol were added again to dissolve completely.
3) 혼합3) mixed
상기 필름형성액 II에 필름형성액 I의 용액을 천천히 넣으면서 혼합하였다. 혼합시 뭉치지 않고, 활성 성분이 잘 혼합되도록 약 30분간 교반하였다.The film-forming liquid I was slowly mixed into the film-forming liquid I. Stir for about 30 minutes so that the active ingredients are well mixed without mixing.
4) 물성 평가4) Property evaluation
통상의 점도 측정 방법에 따라 완성된 필름형성액의 점도를 측정하였다. 실시예의 경우, 약 1,000∼3,000 cps 범위의 점도값을 나타내었다.The viscosity of the completed film forming liquid was measured according to the usual viscosity measuring method. For the examples, viscosity values in the range of about 1,000 to 3,000 cps are shown.
상술한 방법으로 제조된 본 발명의 조성물을 아래의 표 1에 나타내었다. 표 1의 단위는 중량%이다.The composition of the present invention prepared by the above method is shown in Table 1 below. The units in Table 1 are by weight.
Raw material name
실시예compare
Example
오스 프탈레이트Hydroxypropylmethylcellulose
Osphthalate
<< 실험예Experimental Example 1> 항균 효과 평가 1> Antibacterial effect evaluation
1. 천연물의 추출방법1. Extraction method of natural products
건조생약재를 파쇄하여 분말화한 것 100g에 메탄올(80%) 1000ml를 가하여 상온에서 4∼5일간 침적하여 2회 반복 추출하고, 여과한 후, 그 여과액을 감압 증류하여 농축하고 다시 동결 건조하여 건조 엑기스의 최종 산물을 분말형태로 얻었다.1000 g of methanol (80%) was added to 100 g of powdered and dried powdered medicinal herbs, and the mixture was immersed at room temperature for 4-5 days, extracted twice. After filtration, the filtrate was concentrated by distillation under reduced pressure and lyophilized again. The final product of the dry extract was obtained in powder form.
2. 시험방법2. Test method
상기 추출물을 이용하여 본 발명의 막 형성액의 제조방법에 따라 상기 실시예1∼6 및 비교실시예 조성물을 제조한 후, 본 발명의 천연 추출물의 항균 효과를 측정하기 위하여 항균력 평가(MIC)를 진행하였으며, 스태필로코커스 아우레우스(S. mutans) 및 클렙시엘라 뉴모니아(K. pneumoniae) 2종에 대한 항균 활성을 다음의 단계별 희석법으로 평가하였다. 2종의 균을 액체 배지 상태로 37℃에서 배양하고, UV 흡광분석계로 균수를 측정한 후 적당한 농도로 희석하였다. 플레이트의 각 웰(well)에 단계별로 희석하여 넣고 다시 37℃에서 배양한 후, 600 nm에서 흡광도를 측정하여 미생물의 생장 정도를 판별하고, 이 결과를 표 2에 나타내었다. 판별 방법으로는 MIC 평가를 수행하였다. 아래 TCN(Triclosan)은 항균제로 사용되는 대표적인 물질이며 하기 DMSO(Dimethyl sulfoxide)는 실험시 희석에 사용되는 용매이다. After the preparation of the Examples 1 to 6 and Comparative Example compositions according to the method for producing a film forming solution of the present invention using the extract, to evaluate the antimicrobial effect of the natural extract of the present invention (MIC) was the advances, Staphylococcus aureus (S. mutans) and keulrep City antibacterial activity against two kinds of Elah pneumoniae (K. pneumoniae) were evaluated in the next step of dilution. Two bacteria were cultured at 37 ° C. in a liquid medium, and the bacterial counts were measured using a UV absorbance analyzer, and then diluted to an appropriate concentration. Diluted into each well of the plate step by step and incubated again at 37 ℃, and then measured the absorbance at 600 nm to determine the growth of microorganisms, the results are shown in Table 2. MIC evaluation was performed as a discrimination method. TCN (Triclosan) below is a representative material used as an antimicrobial agent and the following DMSO (dimethyl sulfoxide) is a solvent used for dilution in the experiment.
*TCN : Triclosan, 대표적인 항균 성분 * TCN: Triclosan, representative antibacterial ingredient
**DMSO : Dimethyl sulfoxide, 용매** DMSO: Dimethyl sulfoxide, solvent
표 2에 의하면, 본 발명의 상처치유 및 조직회복 기능을 갖는 기능성 막 형성액에 사용되는 6가지의 추출물은 항균제로 사용되는 TCN과 비교해서는 약간 떨어지지만, 무처리 시료인 DMSO 처리시료에 대비하여 우수한 항균효과를 나타내었다.According to Table 2, the six extracts used in the functional membrane-forming liquid having wound healing and tissue repair functions of the present invention are slightly inferior to TCN used as an antimicrobial agent, but compared to the DMSO-treated sample which is an untreated sample. It showed excellent antibacterial effect.
<실험예 2> 기질 금속단백질분해효소 활성 억제 효과 측정Experimental Example 2 Measurement of Inhibitory Effect of Substrate Metalloproteinase Activity
본 발명의 천연 추출물의 기질 금속 단백질분해효소 활성 억제 효과를 다음과 같은 방법으로 평가하였다. 기질 금속 단백질분해효소, 평가시료(백리향, 금은화, 포공영, 황백, 울금, 녹두 추출물) 또는 억제제(N-이소부틸-N-(4-메톡시페닐설폰일)-글리실 하이드록사믹산, NNGH) 및 완충용액(PBS)을 넣어 반응액을 제조하고, 37℃에서 1시간 동안 방치하였다. 보정(calibration)하여 블랭크(blank)를 설정한 뒤, 최종적으로 형광 표지된 기질을 각 웰에 넣고, 20분동안 1분 간격으로 형광의 크기를 측정하였다. 비교 시료로 사용한 기질 금속단백질분해효소 저해제의 활성 억제 정도를 기준으로 평가 시료의 효과를 측정하였으며, 그 결과를 하기 표 3에 나타내었다.The inhibitory effect of the substrate metal protease activity of the natural extract of the present invention was evaluated by the following method. Substrate metalloproteinases, test samples (thyme, sterling silver, pogongyoung, sulfur white, turmeric, mung bean extract) or inhibitors (N-isobutyl-N- (4-methoxyphenylsulfonyl) -glycile hydroxamic acid, NNGH) And a buffer solution (PBS) was added to prepare a reaction solution, and left for 1 hour at 37 ℃. After setting the blank by calibration, the fluorescently labeled substrate was finally put in each well, and the size of the fluorescence was measured at 1 minute intervals for 20 minutes. The effect of the evaluation sample was measured based on the degree of activity inhibition of the substrate metalloproteinase inhibitor used as a comparative sample, and the results are shown in Table 3 below.
효소 활성(V/ min ) MMP-1
Enzyme Activity (V / min )
( NNGH 와의 상대값 ) % Inhibition
(With NNGH Relative value )
(상기 MMP-1 이라는 항목은 효소 활성을 나타내며, 효소활성의 수치가 낮을수록 억제율(%)이 높아 항염효과가 좋은 것을 의미함)(The term MMP-1 indicates an enzyme activity. The lower the value of the enzyme activity, the higher the inhibition rate (%), which means that the anti-inflammatory effect is good.)
상기 표 3에 나타난 바와 같이 본 발명의 상처치유 및 조직회복기능을 갖는 기능성 막 형성액에서 활성 성분으로 사용되는 백리향, 금은화, 포공영, 황백, 울금, 녹두 추출물은 모두 기질 금속 단백질분해효소의 활성을 억제하는 효과를 나타내었다.As shown in Table 3, all of the thyme, gold, silver, pogongyoung, baekbaek, turmeric, and mung bean extracts used as active ingredients in the functional film-forming liquid having wound healing and tissue repair functions of the present invention all exhibit the activity of substrate metalloproteinases. Inhibitory effect was shown.
<< 실험예Experimental Example 3> 막의 3> membrane 부착성Adhesion (( 손실율Loss rate ) 평가) evaluation
상기 실시예 및 비교실시예에서 제조한 상처치유 및 조직회복 기능을 갖는 기능성 막 형성액의 부착성을 알아보기 위하여 아래와 같이 실험하였다. 깨끗한 유리표면에 상기 막을 도포하였다. 약 20분후 막의 건조가 완료되면, 1차로 막 표면에 물을 흘려 보내면서 수분에 의한 막의 손실율을 측정하고, 2차로 솔을 이용하여 가볍게 문지르면서 마찰에 의한 막의 손실율을 측정하였다. 그 결과를 아래 표 4에 기재하였다.In order to examine the adhesion of the functional film-forming solution having the wound healing and tissue recovery functions prepared in Examples and Comparative Examples was tested as follows. The film was applied to a clean glass surface. After about 20 minutes of drying of the membrane, the loss rate of the membrane due to moisture was measured while first flowing water to the surface of the membrane, and the loss ratio of the membrane due to friction was measured while lightly rubbing with a brush. The results are shown in Table 4 below.
상기 표 4에 의하면, 본 발명의 조성물에 의해 생성된 막의 수분에 의한 손실율은 1% 이하로, 부착성이 매우 좋은 것을 알 수 있고, 솔에 의해 가볍게 마찰을 가해도 2%를 초과하지 않아, 일상생활에서 막이 소실될 가능성은 매우 적음을 알 수 있다. According to Table 4, the loss rate by moisture of the film produced by the composition of the present invention is 1% or less, it can be seen that the adhesion is very good, do not exceed 2% even if lightly rubbed with a brush, It is very unlikely that membranes will be lost in everyday life.
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CN102961467A (en) * | 2012-12-06 | 2013-03-13 | 河北神威药业有限公司 | Medicine composition capable of clearing heat and removing toxicity and preparation method of stock solution thereof |
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CN102961467A (en) * | 2012-12-06 | 2013-03-13 | 河北神威药业有限公司 | Medicine composition capable of clearing heat and removing toxicity and preparation method of stock solution thereof |
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KR101253951B1 (en) * | 2013-01-25 | 2013-04-16 | 김현동 | Manufacturing method of plaster for moxibustion sore |
WO2014126370A1 (en) * | 2013-02-13 | 2014-08-21 | Dong-A Pharmaceutical Co.,Ltd | Film-forming pharmaceutical composition for wound healing and method for preparing the same |
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CN103977115A (en) * | 2014-04-28 | 2014-08-13 | 苏燕 | External traditional Chinese medicine preparation for treating trauma and infection, and preparation method thereof |
KR20190106127A (en) * | 2018-03-07 | 2019-09-18 | 단국대학교 천안캠퍼스 산학협력단 | Topical gel comprising fusidicacid with enhanced skin-permeability forming a film on a skin |
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