KR100847222B1 - Phase change skin beauty patch with increased absorption - Google Patents
Phase change skin beauty patch with increased absorption Download PDFInfo
- Publication number
- KR100847222B1 KR100847222B1 KR1020070000870A KR20070000870A KR100847222B1 KR 100847222 B1 KR100847222 B1 KR 100847222B1 KR 1020070000870 A KR1020070000870 A KR 1020070000870A KR 20070000870 A KR20070000870 A KR 20070000870A KR 100847222 B1 KR100847222 B1 KR 100847222B1
- Authority
- KR
- South Korea
- Prior art keywords
- skin
- drug
- layer
- patch
- waxes
- Prior art date
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Images
Classifications
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- D—TEXTILES; PAPER
- D05—SEWING; EMBROIDERING; TUFTING
- D05C—EMBROIDERING; TUFTING
- D05C11/00—Devices for guiding, feeding, handling, or treating the threads in embroidering machines; Machine needles; Operating or control mechanisms therefor
- D05C11/08—Thread-tensioning arrangements
- D05C11/10—Guides, e.g. resilient
Landscapes
- Engineering & Computer Science (AREA)
- Textile Engineering (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
본 발명은 피부 미백, 슬리밍, 주름 개선, 주름 증가 억제, 노화 방지, 아토피 개선 등의 효과를 나타내는 유효물질을 효과적으로 전달하기 위한 피부 미용 패치에 관한 것으로, 배면층, 접착층, 체온 또는 마찰에 의해 액화되는 약물층 및 해제 라이너를 포함하거나; 또는 배면층, 체온 또는 마찰에 의해 액화되는 약물·접착 복합층 및 해제 라이너를 포함하는 본 발명의 피부 미용 패치제는 약물을 함유하는 약물층 혹은 약물·접착 복합층이 부착 전에는 고형이지만 부착 후에 체온 또는 마찰에 의해 액화되어 피부에 대한 투과성이 높게 되어 약물의 신속한 흡수와, 이에 따른 신속한 효과 발현이 가능하고 사용이 편리하다.The present invention relates to a skin cosmetic patch for effectively delivering an effective substance exhibiting the effects of skin whitening, slimming, wrinkle improvement, wrinkle increase inhibition, anti-aging, atopic improvement, etc., which is liquefied by a back layer, an adhesive layer, body temperature or friction. Or includes a drug layer and a release liner; Or the skin cosmetic patch of the present invention comprising a backing layer, a drug-adhesive composite layer liquefied by body temperature or friction, and a release liner, the drug-containing drug layer or the drug-adhesive composite layer containing the drug is solid before attachment but not after body attachment. Alternatively, the liquid is liquefied by friction, and thus the permeability to the skin is high, so that the rapid absorption of the drug and the rapid effect expression can be achieved and it is convenient to use.
상변이, 피부 미용 패치, 미백, 슬리밍, 주름 개선, 노화 방지, 아토피 개선. Phase change, skin beauty patch, whitening, slimming, wrinkle improvement, anti aging, atopic improvement.
Description
도 1은 본 발명의 일 실시예에 따른 피부 미용 패치의 모식적 측단면도,1 is a schematic side cross-sectional view of a skin care patch according to an embodiment of the present invention,
도 2는 본 발명의 다른 실시예에 따른 피부 미용 패치의 모식적 측단면도.Figure 2 is a schematic side cross-sectional view of a skin care patch according to another embodiment of the present invention.
본 발명은 피부 미용 패치에 관한 것으로, 부착 전에는 고형이지만 부착 후에 체온, 피부와의 마찰에 의해 액상으로 변화하여 피부 미백, 슬리밍, 주름 개선, 주름 증가 억제, 노화 방지, 아토피 개선 등의 효과를 나타내는 유효물질을 효과적으로 전달하기 위한 패치 제형에 관련된다.The present invention relates to a skin care patch, which is solid before application but changes to a liquid state by body temperature and friction with the skin after application, resulting in skin whitening, slimming, wrinkle improvement, wrinkle increase inhibition, anti-aging, atopic improvement, etc. It relates to patch formulations for effectively delivering an active substance.
경피로 약물을 전달하는 방법은 멤브레인 제어 시스템(Membrane controlled system), 접착제 분산형 시스템(Adhesive dispersion type system), 매트릭스 확산 제어 시스템(Matrix diffusion controlled system), 및 미소-저장소 용출 제어 시스템(Micro-reservoir dissolution controlled system)의 4 가지로 크게 나눌 수 있다.Methods for delivering drugs transdermally include membrane controlled systems, adhesive dispersion type systems, matrix diffusion controlled systems, and micro-reservoir systems. It can be divided into four types of dissolution controlled system.
멤브레인 제어 시스템(Membrane controlled system)에서는 약물 저장층이 통 상 알루미늄 도포된 플라스틱과 같은 불투과성 막과 투과속도를 조절하는 고분자막(방출제어막) 사이에 둘러싸여 있으며, 약물 저장층 내에는 약물이 고분자 매트릭스 내에 균일하게 분포되어 있거나, 점도가 높은 액상에 용해 혹은 현탁되어 있고, 방출 제어막을 통해 방출된다. 방출 제어막은 투과율이 잘 알려진 미세한 다공성 구조를 갖거나, 또는 갖지 않을 수도 있다. 방출 제어막의 외부는 약물과 상용성을 가지며 피부 발적과 같은 과민 반응을 일으키지 않는 압력 감응형 접착제(Pressure sensitive adhesive)를 사용하여 피부에 잘 부착될 수 있는 구조를 지닌다. 이러한 형태로 제작된 제품에는 협심증 치료제인 Ciba사의 Transderm-Nitro®, 진토제로 사용되고 있는 Transderm-Scop®, 고협압 치료에 사용되는 Boehringer Ingelheim사의 Catapress-TTS® 등이 있다.In the membrane controlled system, the drug storage layer is usually surrounded by an impermeable membrane such as aluminum-coated plastic and a polymer membrane (emission control membrane) that controls the permeation rate. It is uniformly distributed in the inside, or is melt | dissolved or suspended in the liquid phase with high viscosity, and is discharged through a release control film | membrane. The emission control membrane may or may not have a fine porous structure with known permeability. The exterior of the release control membrane has a structure that is compatible with the drug and adheres well to the skin using a pressure sensitive adhesive that does not cause hypersensitivity reactions such as skin redness. Products manufactured in this form include Ciba Transderm-Nitro ® , an angina drug, Transderm-Scop ® , which is used as an anti-nausea agent, and Catapress-TTS ® , Boehringer Ingelheim, which is used for high-pressure therapy.
접착제 분산형 시스템(Adhesive dispersion type system)은 앞에서 언급한 멤브레인 제어 시스템(Membrane controlled system)을 간소화한 형태로, 약물 저장층을 완전히 둘러싸는 대신 약물을 고무계, 아크릴계, 실리콘계 등의 접착제에 직접 분산시켜 제조하고 불투과성 지지층에 용액을 캐스팅(casting) 또는 핫 멜트(hot melt) 법을 이용하여 단층 또는 다층으로 도포한다. 또는, 약물 저장층의 상부에 일정한 투과도를 갖는 약물이 없는 얇은 접착제 막을 이용하여 제조할 수도 있다.The adhesive dispersion type system is a simplified form of the membrane controlled system mentioned above. Instead of completely enclosing the drug storage layer, the adhesive is dispersed directly in an adhesive such as rubber, acrylic or silicone. The solution is applied to the impermeable support layer in a single layer or multiple layers using a casting or hot melt method. Alternatively, it may be prepared using a thin adhesive film free of drugs having a constant permeability on top of the drug storage layer.
매트릭스 확산 제어 시스템(Matrix diffusion controlled system)은 약물을 친수성 혹은 친유성 고분자 매트릭스에 분산시킨 약물 저장층을 만들고, 불투과성 플라스틱으로 이루어진 장치 안에 반대 방향으로 확산을 방지하기 위해 들어 있는 폐쇄 기판(occlusive base plate)에 부착시켜 제조한다. 앞에서 언급되었던 다른 두 시스템과는 달리, 접착제가 표면 전체에 도포되지 않고, 약물이 분산된 매트릭스 가장자리에 도포되어 있다. 이러한 형태로 개발된 제제는 Key사의 Nitro-Dur®가 있다.The matrix diffusion controlled system creates a drug storage layer in which the drug is dispersed in a hydrophilic or lipophilic polymer matrix and contains an occlusive base contained in the device of impermeable plastic to prevent diffusion in the opposite direction. It is prepared by attaching to a plate). Unlike the other two systems mentioned previously, the adhesive is not applied to the entire surface, but to the drug matrix on the dispersed matrix edge. Formulations developed in this form include Nitro-Dur ® from Key.
미소-저장소 용출 제어 시스템(Micro-reservoir dissolution controlled system)형 제제는 멤브레인 제어 시스템(Membrane controlled system)과 접착제 분산형 시스템(Adhesive dispersion type system)의 복합체라고 할 수 있다. 먼저 약물을 수용성 고분자의 수용액에 현탁시킨 후, 약물 현탁액을 지용성 고분자에 기계적 힘으로 유리되지 않는 미세한 약물 저장층 입자를 분산시켜 제조한다. 이렇게 열역학적으로 불안한 분산계는 즉시 고분자 사슬을 가교시킴으로써 안정화를 이루며 일정 두께의 고분자 디스크로 만들어지고, 이러한 약물이 들어 있는 고분자 디스크를 점착제 패드(pad) 중앙에 부착시켜 완성한다. 이러한 형태로 개발된 제제로는 협심증 치료에 사용하는 Searle사의 Nitrodisc®가 있다.The micro-reservoir dissolution controlled system type preparation is a complex of membrane controlled system and adhesive dispersion type system. The drug is first suspended in an aqueous solution of a water-soluble polymer, and then the drug suspension is prepared by dispersing fine drug storage layer particles that are not liberated by mechanical force in the fat-soluble polymer. The thermodynamically unstable dispersion system is stabilized by crosslinking polymer chains immediately and is made of a polymer disk having a certain thickness, and is completed by attaching a polymer disk containing such a drug to the center of an adhesive pad. Formulations developed in this form include Searle Nitrodisc ® for the treatment of angina pectoris.
이상에서 언급된 전통적인 경피 흡수 시스템은 약물을 장시간 방출하여 유효 혈중 농도를 지속적으로 유지할 수 있으며, 반감기가 짧은 약물에 사용할 수 있다는 장점을 갖는다. 그러나, 이들 시스템에서는 약물의 흡수 지연 등으로 인해 신속한 약물 전달에 많은 한계가 있을 뿐 아니라, 피부 흡수 효율을 높이기 위해 고농도의 약물을 사용할 경우 제제 상에서 약물이 결정화되는 단점이 있다.The conventional transdermal absorption system mentioned above has the advantage that the drug can be released for a long time to maintain an effective blood concentration, and can be used for a drug having a short half-life. However, in these systems, there are many limitations to rapid drug delivery due to delayed absorption of the drug, etc., and there is a disadvantage in that the drug crystallizes on the formulation when a high concentration of drug is used to increase skin absorption efficiency.
이상과 같은 종래의 경피 흡수 시스템의 문제점을 고려하여, 본 발명에서는 피부에 부착하여 미백, 슬리밍, 주름 개선, 노화 방지, 아토피 개선의 효과를 얻도록 된 제제로서, 약물의 피부 투과 속도가 빠르고 사용이 편리한 피부 미용 패치를 제공하는 것을 목적으로 한다.In consideration of the problems of the conventional transdermal absorption system as described above, in the present invention, as a preparation to obtain the effect of whitening, slimming, wrinkle improvement, anti-aging, atopic improvement by adhering to the skin, the skin penetration rate of the drug is used quickly It aims to provide this convenient skin care patch.
상기 목적을 달성하기 위한 본 발명의 피부 미용 패치는,The skin care patch of the present invention for achieving the above object,
피부에 부착하는 패치형 제제로서, 배면층, 접착층, 체온 또는 마찰에 의해 액화되는 약물층 및 해제 라이너를 포함하는 피부 미용 패치제; 또는A patch-like preparation for adhering to skin, comprising: a skin cosmetic patch comprising a backing layer, an adhesive layer, a drug layer liquefied by body temperature or friction, and a release liner; or
피부에 부착하는 패치형 제제로서, 배면층, 체온 또는 마찰에 의해 액화되는 약물·접착 복합층 및 해제 라이너를 포함하는 피부 미용 패치제인 것을 특징으로 한다.It is a patch-form preparation which adheres to skin, It is a skin cosmetic patch containing a back layer, the drug adhesive layer liquefied by body temperature or friction, and a release liner.
본 발명은 경피를 이용하여 피부 미백, 슬리밍, 주름 개선, 노화 방지, 아토피 개선 등에 효과 있는 유효물질을 전달하기 위한 패치 제형에 관한 것으로, 약물이 침투할 수 없는 최상의 배면층과, 바깥쪽으로 피부와 직접 접촉하여 부착력을 주고 안쪽으로는 약물을 함유하는 약물·접착 복합층, 또는 접착층과 약물층을 갖고, 제거 가능한 해제 라이너를 포함하며, 여기에서 약물이 함유되어 있는 부분은 체온에 의해 액화되거나, 마찰에 의한 졸-겔의 변화를 이용하여 약물이 함유되어 있는 부분이 액화되는 것을 특징으로 한다.The present invention relates to a patch formulation for delivering an effective substance that is effective for skin whitening, slimming, wrinkle improvement, anti-aging, atopic dermatitis, etc. It has an adhesive-adhesive composite layer or a drug-adhesive composite layer containing a drug, or an adhesive layer and a drug layer, and includes a removable release liner, in which the drug-containing part is liquefied by body temperature, It is characterized in that the part containing the drug is liquefied using the sol-gel change by friction.
구체적으로, 본 발명의 패치 제형은 다음과 같은 구성을 갖는다:Specifically, the patch formulation of the present invention has the following configuration:
a) 약물 불투과성의 배면층;a) drug impermeable backing layer;
b) 피부와 직접 접촉하여 부착력을 주고, 안쪽으로는 약물을 함유하는 약물·접착 복합층; 및b) a drug-adhesive composite layer which is in direct contact with skin to give adhesion and contains a drug therein; And
c) 제거 가능한 해제 라이너 층을 포함하거나, 또는c) comprises a removable release liner layer, or
a) 약물 불투과성의 배면층;a) drug impermeable backing layer;
b-1) 배면층 아래의 접착층;b-1) an adhesive layer under the back layer;
b-2) 약물을 함유하고 있는 약물층; 및b-2) a drug layer containing the drug; And
c) 제거 가능한 해제 라이너 층을 포함한다.c) a removable release liner layer.
여기에서, 약물·접착 복합층과 약물층은 단층 혹은 2 층 이상의 구조를 가질 수 있는데, 약물층을 여러 층으로 제조하고 약물의 농도 구배를 이용하여 흡수를 촉진시킬 수 있다.Here, the drug-adhesive composite layer and the drug layer may have a single layer or a structure of two or more layers. The drug layer may be prepared in several layers and the absorption may be promoted by using a concentration gradient of the drug.
본 발명의 패치 제형을 구성하는 층 중에서 가장 특징적인 부분은 약물을 함유하는 약물층 혹은 약물·접착 복합층으로, 체온에 의해 액화되거나 마찰에 의해 액화되는 특성을 갖는다. 즉, 기존 패치 제형과는 달리 약물을 함유하고 있는 약물층과 약물·접착 복합층의 약물 매트릭스는 체온 혹은 마찰에 의해 액화되므로 피부에 대한 투과성이 높아져서 약물의 신속한 흡수와, 이에 따른 신속한 효과 발현이 가능하고 사용이 편리하다.The most characteristic part of the layers constituting the patch formulation of the present invention is a drug layer or drug-adhesive composite layer containing a drug, which has a property of liquefying by body temperature or liquefying by friction. In other words, unlike the existing patch formulation, the drug matrix of the drug layer and the drug-adhesive composite layer containing the drug is liquefied by body temperature or friction, so that the permeability to the skin is increased, so that the rapid absorption of the drug and the rapid effect expression are thus achieved. It is possible and convenient to use.
본 발명의 패치 제형에서 사용되는 체온에 의해 액화되는 약물층 매트릭스의 기제로는 카카오지, 글리세로젤라틴, Witepsol, 라우린(laurin)지 등의 좌제 기제류, 세틸 에스테르(cetyl ester) 왁스, 미세결정형(microcrystalline) 왁스, 비-유 화(non-emulsifying) 왁스, 백색 왁스(white wax), 황색 왁스(yellow wax) 등의 왁스류, 온도에 의해 졸-겔 변화를 갖는 폴록사머(poloxamer)류, 폴리(N-이소프로필아크릴아미드)(Poly(N-isopropylacrylamide))의 유도체, 폴리(N-사이클로프로필메타크릴아미드)(Poly(N-cyclopropylmethacrylamide))의 유도체, 디아세톤 아크릴아미드(diacetone acrylamide)와 하이드록시에틸 아크릴레이트(hydroxyethyl acrylate)의 공중합체도 사용할 수 있으며, 이들을 단독 혹은 혼합물로 사용할 수 있다. 또한 용융점 조절을 위하여 폴리에틸렌 클리콜, 프로필렌 글리콜 등의 폴리올을 첨가할 수 있다.Bases of the drug layer matrix liquefied by body temperature used in the patch formulation of the present invention include suppository bases such as cacao butter, glycerogelatin, Witepsol, laurin paper, cetyl ester wax, fine Waxes such as crystalline waxes, non-emulsifying waxes, white waxes and yellow waxes, and poloxamers having sol-gel changes with temperature , Derivative of poly (N-isopropylacrylamide), derivative of poly (N-cyclopropylmethacrylamide), derivative of poly (N-cyclopropylmethacrylamide), diacetone acrylamide And copolymers of hydroxyethyl acrylate may be used, and these may be used alone or in a mixture. In addition, polyols such as polyethylene glycol and propylene glycol may be added to control the melting point.
마찰에 의해 약물 매트릭스가 액체로 변하는 구성도 사용 가능하다. 이 경우 피부에 적용 후 마사지나 미세한 움직임에 의해 액화되므로 약물의 흡수가 증가한다. 이때 사용가능한 구성물로는 디메티콘(dimethicone)류, 사이클로메티콘(cyclomethicone) 혹은 이들을 기본 구조로 하는 공중합체, 디메티콘 코폴리올 크로스폴리머 디메티콘을 단독 혹은 혼합물로 사용할 수 있으며, 점도 조절을 위하여 폴리비닐알콜(polyvinyl alcohol), 폴록사머(poloxamer), 폴리비닐피롤리돈(polyvinyl pyrrolidone), 폴리비닐피롤리돈-비닐아세테이트 공중합체(polyvinyl pyrrolidone/vinyl acetate copolymer), 하이드록시프로필 셀룰오스(hydroxypropyl cellulose), 하이드록시프로필메틸 셀룰로오스(hydroxypropylmethyl cellulose), 하이드록시에틸 셀룰로오스(hydroxyethyl cellulose), 하이드록시프로필에틸 셀룰로오스(hydroxypropylethyl cellulose), 폴리옥스(polyox), 카르복시메틸 셀룰로오스(carboxymethyl cellulose), 카르복시프로필 셀룰로오스(carboxypropyl cellulose)와 이의 염으로 된 폴리머, 잔탄 검(xanthan gum), 카라게난 검(carrageenan gum), 알지네이트 검(alginate gum), 카라얀 검(karayan gum), 아라비아 검(arabic gum)과 이의 염 유도체, 젤라틴(gelatin), 폴리아크릴산(polyacrylic acid), 카보폴(carbopol), 폴리쿼터니움-11(polyquaternium-11), 폴리쿼터니움-39(polyquaternium-39), 폴리알킬비닐에테르-말레인산 공중합체(PVM/MA copolymer) 등의 고분자를 단독 혹은 혼합물로 첨가할 수 있다.It is also possible to use a configuration in which the drug matrix is turned into a liquid by friction. In this case, the absorption of the drug increases because it is liquefied by massage or fine movement after application to the skin. The constituents that can be used include dimethicones, cyclomethicone or copolymers having a basic structure thereof, and dimethicone copolyol crosspolymer dimethicone alone or as a mixture. Polyvinyl alcohol, poloxamer, polyvinyl pyrrolidone, polyvinylpyrrolidone / vinyl acetate copolymer, hydroxypropyl cellulose ), Hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropylethyl cellulose, polyox, carboxymethyl cellulose, carboxypropyl cellulose Xanthan gum, a polymer of cellulose and its salts xanthan gum, carrageenan gum, alginate gum, Karayan gum, arabic gum and its salt derivatives, gelatin, polyacrylic acid, carbo Polymers such as carbopol, polyquaternium-11, polyquaternium-39, and polyalkylvinylether-maleic acid copolymers (PVM / MA copolymer) may be added alone or in a mixture. can do.
또한, 약물 매트릭스 내에는 약물의 피부 투과성을 높이기 위한 흡수 촉진제(enhancer)를 사용할 수 있으며, 이때 사용 가능한 흡수 촉진제로는 탄소수 9∼22 사이의 알칸 및 알켄(alkanes and alkenes) 등의 탄화수소(hydrocarbon)류, 에탄올, 메탄올, 라우릴알콜(lauryl alcohol) 등의 알코올류, 폴리에틸렌 글리콜(polyethylene glycol), 프로필렌 글리콜(propylene glycol) 등의 폴리올류, 라우린산(lauric acid), 미리스틴산(myristic acid), 스테아린산(stearic acid), 올레인산(oleic acid) 등의 지방산류 및 유도체 IPM, 글리세릴 모노라우레이트(glyceryl monolaurate), 글리세릴 모노올레이트(glyceryl monooleate), 글리세릴 모노카프릴레이트(glyceryl monocaprylate), 에틸올레이트(ethyloleate), 에틸데카노에이트(ethyldecanoate) 등의 에스테르류, N,N-디메틸아미노아세테이트(N,N-dimethylamino acetate), 1-(N,N-디메틸아미노)-2-프로판올 데카노에이트(1-(N,N-dimethylamino)-2-propanol decanoate) 등의 알킬 아미노 에스테르류(alkyl amino esters), Azone®, 디메틸포름아미드(dimethylformamide), 데메틸아세트아미드(demethylacetamide) 등의 아미드(amide)류, PEG2 올레아민(oleamine), 페네틸아민 (phenethylamine), 스테아릴아민(stearylamine), 트리에틸아민(triethylamine), 도데실아민(dodecylamine) 등의 아민(amine)과 이들의 염류, 카바크롤(carvacrol), 티몰(thymol), 아네톨(anethole) 등의 방향족 화합물류, DMSO, n-데실메틸 설폭사이드(n-decylmethyl sulfoxide) 등의 설폭사이드(sulfoxide)류, β-CD, HP-β-CD 등의 사이클로덱스트린(cyclodexrin)류, α-테르펜(terpene), p-멘탄(menthane), d-리모넨(limonene), 디펜텐(dipentene), 멘톨(menthol) 등의 테르펜류(terpenes), N-메틸-피롤리돈(N-methyl-pyrrolidone; NMP), 1-에틸 피롤리돈(1-ethyl pyrrolidone), 1-부틸 피롤리돈(1-butyl pyrrolidone) 등의 피롤리돈(pyrrolidone)과 이미다졸(imidazole) 유도체류를 단독 혹은 혼합하여 사용할 수 있다.In addition, an absorption enhancer (enhancer) may be used in the drug matrix to increase the skin permeability of the drug. In this case, absorption accelerators usable may include hydrocarbons such as alkanes and alkenes having 9 to 22 carbon atoms. Alcohols such as ethanol, methanol, lauryl alcohol, polyols such as polyethylene glycol, propylene glycol, lauric acid, myristic acid ), Fatty acids and derivatives such as stearic acid and oleic acid, IPM, glyceryl monolaurate, glyceryl monooleate, glyceryl monocaprylate ), Esters such as ethyloleate, ethyldecanoate, N, N-dimethylamino acetate, 1- (N, N-dimethylamino) -2- F Alkyl amino esters such as ropanol decanoate (1- (N, N-dimethylamino) -2-propanol decanoate), Azone®, dimethylformamide, demethylacetamide Amines such as amides such as amide, PEG2 oleamine, phenethylamine, stearylamine, triethylamine, dodecylamine, and the like Salts, aromatic compounds such as carvacrol, thymol, anethole, sulfoxides such as DMSO, n-decylmethyl sulfoxide, β- Cyclodexrins such as CD and HP-β-CD, terpenes such as α-terpene, p-menthane, d-limonene, dipentene and menthol Terpenes, N-methyl-pyrrolidone; Pyrrolidone and imidazole derivatives such as NMP), 1-ethyl pyrrolidone, and 1-butyl pyrrolidone. Can be.
이들 흡수 촉진제의 함량은 약물층 전체 중량 대비 0.001∼10 %까지 사용 가능하며, 0.01∼5 % 범위가 바람직하다.The content of these absorption accelerators may be used in an amount of 0.001 to 10% based on the total weight of the drug layer, and preferably 0.01 to 5%.
배면층(Backing layer)의 역할은 약물을 피부쪽 한 방향으로만 전달시키고, 물리적, 화학적인 접촉으로부터 내부(접착층, 약물층)를 보호하는 역할을 하거나, 제품의 형태를 유지하는 데 도움을 준다. 이러한 특성을 잘 나타내기 위해서 사용 가능한 물질로는 폴리 비닐 아세테이트, 에틸 셀룰로오즈, 폴리 메틸 메타크릴레이트, 메타크릴로일 에틸 베타인-메타크릴레이트 공중합체(methacryloyl ethyl betain/methacylate copolymer, Yukaformer; 제조 회사 Mitsubishi), 메타크릴산 공중합체(methacrylic acid copolymers; Eudragit L 100, Eudragit L 125, Eudragit L 100-55, Eudragit L 30D-55), 아미노알킬 메타크릴레이트 공중합체(aminoalkyl methacrylate copolymers; Eudragit E 100, Eudragit E 125, Eudragit RL 100, Eudragit RL 30D), 셀룰로오즈 아세테이트 프탈레이트, 폴리비닐피롤리돈-비닐아세테이트 공중합체(polyvinyl pyrrolidone/vinyl acetate copolymer), 하이드록시프로필 셀룰오스(hydroxypropyl cellulose), 하이드록시프로필메틸 셀룰로오스(hydroxypropylmethyl cellulose), 하이드록시에틸 셀룰로오스(hydroxyethyl cellulose), 하이드록시프로필에틸 셀룰로오스(hydroxypropylethyl cellulose), 폴리에틸렌 테레프탈레이트, 폴리에틸렌, 폴리프로필렌, 폴리비닐 클로라이드 등의 고분자류, 실리콘 매트릭스, 우레탄 매트릭스, 고무, 알루미늄 호일과 같은 금속 호일류 및 폴리머-금속 조성물류, 부직포 등의 직물류 등을 사용할 수 있으며, 이들을 단독 혹은 혼합물로 사용할 수 있다. 또한, 용매를 이용한 캐스팅(casting) 방법 혹은 핫 멜트(hot melt) 법으로도 제조가 가능하다.The role of the backing layer is to deliver the drug in one direction towards the skin, to protect the interior (adhesive layer, drug layer) from physical and chemical contact, or to help maintain the shape of the product. . Materials that can be used to demonstrate these properties include polyvinyl acetate, ethyl cellulose, poly methyl methacrylate, methacryloyl ethyl betaine / methacylate copolymer, Yukaformer; Mitsubishi), methacrylic acid copolymers (Eudragit L 100, Eudragit L 125, Eudragit L 100-55, Eudragit L 30D-55), aminoalkyl methacrylate copolymers (Eudragit E 100, Eudragit E 125, Eudragit RL 100, Eudragit RL 30D), cellulose acetate phthalate, polyvinylpyrrolidone / vinyl acetate copolymer, hydroxypropyl cellulose, hydroxypropylmethyl Hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl Polymers such as hydroxypropylethyl cellulose, polyethylene terephthalate, polyethylene, polypropylene, polyvinyl chloride, metal foils such as silicone matrix, urethane matrix, rubber, aluminum foil, and fabrics such as polymer-metal compositions and nonwoven fabrics Etc. can be used and these can be used individually or in mixture. In addition, the present invention may also be manufactured by a casting method using a solvent or a hot melt method.
배면층에는 여러 가소제(plasticizer)를 첨가하여 사용하는 것이 가능하다. 위에서 언급된 가소제인 프로필렌 글리콜(propylene glycol), 글리세린(glycerin), 폴리에틸렌 글리콜(polyethylene glycol) 외에, 사용되는 용매에 따라 더 많은 종류의 가소제를 사용할 수 있고, 피마자유(caster oil), 수소화 피마자유(hydrogenated caster oil)도 사용할 수 있다.Various plasticizers can be added and used for a back layer. In addition to the above-mentioned plasticizers propylene glycol, glycerine, polyethylene glycol, more plasticizers can be used depending on the solvent used, caster oil, hydrogenated castor oil (hydrogenated caster oil) can also be used.
접착층은 피부에 접착하기 쉽도록 압력 감응형 접착제로 제조될 수 있다. 이 때 사용 가능한 접착제로는 폴리디메틸실록산(polydimethylsiloxane) 등의 실리콘류, 폴리아크릴레이트와 같은 아크릴계 접착제, 폴리이소부틸렌(polyisobutylene) 계열의 접착체 등이 있다.The adhesive layer may be made of a pressure sensitive adhesive to facilitate adhesion to the skin. At this time, the adhesive may be silicone such as polydimethylsiloxane, acrylic adhesive such as polyacrylate, polyisobutylene-based adhesive or the like.
해제 라이너 층은 피부에 접착하기 전에 제거된다. 이들은 층이 이웃한 압력 감응형 접착층으로부터 쉽게 벗겨지는 물질로 제조된다. 해제 라이너 층은 실리콘, 혹은 불소가 첨가된 하이드로카본과 같은 물질로 코팅된 폴리에스테르와 같은 약물 비투과성 폴리머를 이용하여 제조 가능하다. 또한 포장재의 블리스터 안에 직접 부착이 가능하다.The release liner layer is removed before adhering to the skin. They are made of a material whose layers easily peel off from neighboring pressure sensitive adhesive layers. The release liner layer may be prepared using a drug impermeable polymer such as polyester coated with a material such as silicone or hydrocarbons with added fluorine. It can also be attached directly into the blister of the packaging.
약물층이나 약물·접착 복합층에는 약물의 용해도 증진을 위해 계면활성제가 첨가될 수 있다. 계면활성제로는 도큐세이트 나트륨(docusate sodium), 유화 왁스(emulsifying wax), 자가 유화 글리세릴 모노올레이트(self emulsifying glyceryl monooleate), 라우릴황산나트륨(sodium lauryl sulfate) 등의 음이온 계면활성제류, 염화벤제토니움(benzethonium chloride), 세트리미드(cetrimide), 유화 왁스(emulsifying wax) 등의 양이온 계면활성제류, 부틸파라벤(butylparaben), 프로필파라벤(propylparaben), 에틸파라벤(ethylparaben), 메틸파라벤(methylparaben), 글리세릴 모노올레이트(glyceryl monooleate), 폴리옥시에틸렌 알킬 에스테르(polyoxyethylene alkyl ester), 폴리옥시에틸렌 캐스터 오일(polyoxyethylene castor oil) 유도체, 폴리옥시에틸렌 소르비탄 지방산 에스테르(polyoxyethylene sorbitan fatty acid ester), 폴리옥시에틸렌 스테아레이트(polyoxyethylene stearate), 폴리소르베이트(polysorbate), 소르빈산(sorbic acid), 소르비탄 에스테르(sorbitan ester) 등의 비이온성 계면활성제류를 단독 혹은 혼합 사용할 수 있다.In the drug layer or drug-adhesive composite layer, a surfactant may be added to enhance the solubility of the drug. Surfactants include anionic surfactants such as docusate sodium, emulsifying wax, self emulsifying glyceryl monooleate, sodium lauryl sulfate, benzyl chloride Cationic surfactants such as tonium (benzethonium chloride), cetrimide and emulsifying wax, butylparaben, propylparaben, ethylparaben, methylparaben and methylparaben Glyceryl monooleate, polyoxyethylene alkyl esters, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, poly Oxyethylene stearate, polysorbate, sorbic acid, sorbitan ester A non-ionic surfactant acids, such as (sorbitan ester) may be used alone or in combination.
또한, 약물층에는 노화 방지, 피부 미백, 슬리밍, 주름 개선, 아토피 개선 등의 효과를 나타내기 위해서 다음과 같은 약물을 포함할 수 있다:In addition, the drug layer may include the following drugs to exhibit the effects of anti-aging, skin whitening, slimming, wrinkle improvement, atopic dermatitis, etc .:
아토피 개선을 위해서는 연근 분말, 메밀 분말, 양파 분말, N-스테아로일-파이토스핑고신(N-stearoyl-phytosphingosine), 백급(Bletilla striata REICHB. fil.), 자소(Perilla ocymoides), 에키나시아(Echinacea purpurea), 발효대두 추출물, 손바닥 선인장 추출물, 파네솔, 하수오, 시엽, 일라이트의 추출물, 영지버섯, 유근피, 감초, 백복령, 백지마, 백년초, 진피, 지실 추출물, 카테킨 등을 단독 혹은 혼합물로 사용할 수 있다. 이들의 함량은 약물층 중량 대비 0.001 내지 30 % 범위에 있을 수 있고, 0.01 내지 10 % 범위가 바람직하다.To improve atopy, lotus root powder, buckwheat powder, onion powder, N-stearoyl-phytosphingosine, Bletilla striata REICHB. Fil., Perilla ocymoides, Echinacea purpurea, Fermented soybean extract, palm cactus extract, panesol, sewage, leaflet, extract of illite, ganoderma lucidum, yugeunpi, licorice, baekbokyeong, Baekjima, baeknyeoncho, dermis, fruit extract, catechin and the like can be used alone or in a mixture. Their content may be in the range of 0.001 to 30% by weight of the drug layer, preferably 0.01 to 10%.
피부 미백 물질로는 아르부틴(arbutin), 코지산(kojic acid), 셀리나(selina), 비타민 C, 피토클리어 EL-1(phytoclear EL-1), PaSSO3Ca(calcium D-pantetheine-S-sulfonate), 트레티노인(tretinoin), 글루타치온(glutatione), 아스코르빈산(ascorbic acid), 대두 추출물(soybean extract), 이구사 추출물, 이르고, 해조류 추출물, 조개류 추출물, 약초 추출물, 버섯 추출물, 자금우과(Myrsinaceae) 식물 엠벨리아(Embelia javanica DC.)의 추출물, 란과 심바듐 속 식물로부터 얻어지는 추출물, 해바라기 종자 추출물, 젖산(lactic acid), 레티노인산(retinoic acid), 리놀레인산(linoleic acid), 글리콜산(glycolic acid), 나이아신아미드(niacinamide), 레시틴(lecithins), 네오글리코프로테인(neoglycoproteins), LG106W, 루시놀(rucinol), 태반 추출물(placenta extract), 엘라직산(ellagic acid), 카밀레 추출물(chamomile extract), t-AMCHA(trans-4-(aminomethyl)cyclohexane carboxylic acid), AA-2G(vit-c-glu), 3-에톡시-비타민 C, 닥나무 추출물, 유용성 감초 추출물, 반하, 상지, 상황 추출물, 코질 카페이트 (kojyl caffeate), 비타민 C-PGM, 하이드로퀴논 등을 단독 혹은 혼합물로 사용할 수 있다. 이들의 함량은 약물층 중량 대비 0.001 내지 30 % 범위로 될 수 있고, 0.01 내지 10 % 범위가 바람직하다.Skin whitening agents include arbutin, kojic acid, selina, vitamin C, phytoclear EL-1, PaSSO3Ca (calcium D-pantetheine-S-sulfonate), Tretinoin, Glutathione, Ascorbic Acid, Soybean Extract, Igusa Extract, Irgo, Algae Extract, Shellfish Extract, Herbal Extract, Mushroom Extract, Myrsinaceae Plant Embelli Extracts of Embelia javanica DC., Extracts from plants of the genus Ran and simbadium, sunflower seed extract, lactic acid, retinoic acid, linoleic acid, glycolic acid Niacinamide, lecithin, neoglycoproteins, LG106W, rucinol, placenta extract, ellagic acid, chamomile extract, t-AMCHA (trans-4- (aminomethyl) cyclohexane carboxyl ic acid), AA-2G (vit-c-glu), 3-ethoxy-vitamin C, mulberry extract, oil-soluble licorice extract, halves, upper extremity, situation extract, kojyl caffeate, vitamin C-PGM, Hydroquinone and the like can be used singly or in mixture. Their content may range from 0.001 to 30% by weight of the drug layer, preferably from 0.01 to 10%.
노화 방지 물질로는 아스코르빈산(ascorbic acid; Vit C), 베타-카로틴(β-carotene; pro-Vit A), 토코페롤(tocopherol; Vit E), 이소플라본(isoflavone; genistein), 레스베라트롤(resveratrol), 피크노게놀(pycnogenol), SOD(superoxide dismutase), 카탈라제(catalase), 알파-리포산(α-lipoic acid), 셀레니움(selenium), 코엔자임 Q10(coenzyme Q10), 알파-하이드록시산(α-hydroxy acids), 루이보스 발효 추출물, 유근피 추출물, 탄닌, 장목 추출물 등을 단독 혹은 혼합물로 사용할 수 있다. 이들의 함량은 약물층 중량 대비 0.001 내지 30 % 범위로 될 수 있고, 0.01 내지 10 % 범위가 바람직하다.Ascorbic acid (Vit C), beta-carotene (pro-Vit A), tocopherol (Vit E), isoflavone (genistein), resveratrol Pycnogenol, superoxide dismutase (SOD), catalase, alpha-lipoic acid, selenium, coenzyme Q10, alpha-hydroxy acid acids), rooibos fermented extract, rhizome extract, tannin, lumberjack extract, etc. may be used alone or in a mixture. Their content may range from 0.001 to 30% by weight of the drug layer, preferably from 0.01 to 10%.
슬리밍, 즉 체중 감소 효과를 나타내기 위한 물질로는 카페인(caffeine), 리포산(lipoic acid), 테오필린(theophylline), 데아닌(theanine), 제니스테인(genistein), 카르니틴(L-carnitine), 센텔라 아시아티카, 러스커스, 퓨커스, 아이비, 호스체스트넛, 고투콜라 추출물, 플라보노이드, 커피 추출물, 콜라 추출물, 해초 추출물, 버섯 추출물, 테오브로민, 테오필린초산, 아미노필린, 운카리아 토멘토사, 카테킨 등을 단독 혹은 혼합물로 사용할 수 있다. 이들의 함량은 약물층 중량 대비 0.001 내지 30 % 범위로 될 수 있고, 0.01 내지 10 % 범위가 바람직하다.Slimming, weight-reducing substances include caffeine, lipoic acid, theophylline, theanine, genistein, L-carnitine, Centella Asia Tica, Ruscus, Fucus, Ivy, Horse Chestnut, Gotu Kola Extract, Flavonoids, Coffee Extract, Cola Extract, Seaweed Extract, Mushroom Extract, Theobromine, Theophylline Acetate, Aminophylline, Uncaria Tomentosa, Catechin, etc. Can be used as Their content may range from 0.001 to 30% by weight of the drug layer, preferably from 0.01 to 10%.
주름 개선을 위한 물질로는 메디민 A(Medimin A), EGCG, angelic complex, 페오니플로린(paeoniflorin), 비타민 C, 비타민 E, DPHP, 우르솔산(ursolic acid), 레티놀(retinol), 폴리에톡실화 레틴아미드, 레티닐 팔미테이트, 7-DHC(7-dehydrocholesterol), 아데노신, 카이네틴(Kinetin), 빈랑자 추출물, 옥타좀, 베툴린, 당귀, 숙지황, 천궁, 질려자, 하수오, 황기, 형개, 감초, 백작약의 혼합 식물 추출물, 진세노사이드, 예덕나무 추출물, 베르게닌, 매생이 추출물, 패장, 호장근, 파고지, 고삼 추출물, 장뇌삼 추출물, 목백일홍 추출물, 전호 추출물, 파슬리 추출물, 빈랑자(Areca catechu L.) 추출물, 현미 추출물, 유근피 추출물 등을 단독 혹은 혼합물로 사용할 수 있다. 이들의 함량은 약물층 중량 대비 0.001 내지 30 % 범위로 될 수 있고, 0.01 내지 10 % 범위가 바람직하다.Medications for improving wrinkles include Medimin A, EGCG, angelic complex, paeoniflorin, vitamin C, vitamin E, DPHP, ursolic acid, retinol, polyethoxylation Retinamide, retinyl palmitate, 7-DHC (7-dehydrocholesterol), adenosine, kinetin, betel extract, octasome, betulin, donkey, succinct, celestial organ, tired person, sewage, astragalus, mold , Botanical extracts of licorice, earl pear, ginsenosides, prickly pear extract, bergenin, falconus extract, package, rye root, pagoji, red ginseng extract, camphor ginseng extract, crape myrtle extract, rhubarb extract, parsley extract, betel nut catechu L.) extract, brown rice extract, and root extract may be used alone or as a mixture. Their content may range from 0.001 to 30% by weight of the drug layer, preferably from 0.01 to 10%.
도 1은 본 발명의 일 실시예에 따른 피부 미용 패취의 모식적 측단면도이고, 도 2는 본 발명의 다른 실시예에 따른 피부 미용 패취의 모식적 측단면도이다. 도 1은 배면층, 접착층, 약물층, 그리고 해제 라이너의 4 층으로 구성되는 본 발명의 패취를 보여주고, 도 2는 배면층, 약물·접착 복합층, 그리고 해제 라이너의 3 층으로 구성되는 본 발명의 패취를 보여준다.1 is a schematic side cross-sectional view of a skin care patch according to an embodiment of the present invention, Figure 2 is a schematic side cross-sectional view of a skin care patch according to another embodiment of the present invention. 1 shows a patch of the invention consisting of four layers of a backing layer, an adhesive layer, a drug layer, and a release liner, and FIG. 2 is a bone consisting of three layers of a backing layer, a drug / adhesive composite layer, and a release liner. The patch of the invention is shown.
이하, 본 발명의 바람직한 실시예를 통해 본 발명을 더욱 구체적으로 설명한다. 단, 이들 실시예는 본 발명의 이해를 돕기 위한 예시일 뿐, 본 발명의 범위가 이들만으로 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail with reference to preferred embodiments of the present invention. However, these examples are only illustrative to aid the understanding of the present invention, and the scope of the present invention is not limited thereto.
실시예Example 1 One
다음과 같은 조성으로 피부 미백 패치를 제조하였다:Skin whitening patches were prepared with the following composition:
(1) 약물층 제조 용액(1) drug layer preparation solution
아르부틴(arbutin) 1 %Arbutin 1%
디메티콘(dimethicone) 3.5 %Dimethicone 3.5%
사이클로디메티콘(cyclodimethicone) 6 %Cyclodimethicone 6%
폴리에틸렌 글리콜(polyethylene glycol) 3 %Polyethylene glycol 3%
폴리비닐 피롤리돈(polyvinyl pyrrolidone) 4 % Polyvinyl pyrrolidone 4%
디메티콘 코폴리올 크로스폴리머 디메티콘 1 %Dimethicone Copolyol Crosspolymer Dimethicone 1%
스테아린산(stearic acid) 0.1 %Stearic acid 0.1%
정제수를 가하여 100 %로 하였다.Purified water was added to make 100%.
(2) 접착층 제조 용액(2) Adhesive layer manufacturing solution
실리콘(silicone) 35 %Silicone 35%
헵탄 또는 에틸 아세테이트(heptane or ethyl acetate) 65 %Heptane or ethyl acetate 65%
아르부틴을 물에 용해시킨 다음 폴리비닐 피롤리돈을 가하여 점증시킨 후 디메티콘, 사이클로디메티콘, 디메티콘코폴리올 크로스폴리머 디메티콘, 폴리에틸렌 글리콜, 스테아린산을 가하여 젤 상의 약물층 용액을 제조하였다.Arbutin was dissolved in water and then increased by adding polyvinyl pyrrolidone, and then dimethicone, cyclodimethicone, dimethicone copolyol crosspolymer dimethicone, polyethylene glycol, stearic acid were added to prepare a drug layer solution on the gel.
접착층은 실리콘을 헵탄 혹은 에틸 아세테이트 용액에 가하여 젤 상의 접착층 용액을 제조하였다.The adhesive layer added silicone to heptane or ethyl acetate solution to prepare an adhesive layer solution on the gel.
배면층은 다우 코닝사에서 제조된 실리콘 매트릭스를 구입하여 사용하였다.The back layer was used by purchasing a silicon matrix manufactured by Dow Corning Corporation.
배면층 위에 접착층 용액을 가하여 캐스팅(casting) 후 건조하였다. 다음에, 약물층을 캐스팅한 후 건조하여 미백 패치를 제조하였다.The adhesive layer solution was added to the back layer, and cast and dried. Next, the drug layer was cast and dried to prepare a whitening patch.
실시예Example 2 2
다음과 같은 조성으로 슬리밍 패치를 제조하였다:Slimming patches were prepared with the following composition:
(1) 약물층 제조 용액(1) drug layer preparation solution
리포산(lipoic acid) 3 %Lipoic acid 3%
테오필린(theophylline) 2 %Theophylline 2%
카카오지 85 %Kakaoji 85%
폴리에틸렌 글리콜(polyethylene glycol) 3 %Polyethylene glycol 3%
정제수를 가하여 100 %로 하였다.Purified water was added to make 100%.
(2) 접착층 제조 용액(2) Adhesive layer manufacturing solution
폴리아크릴레이트(polyacrylate) 22 %Polyacrylate 22%
에탄올 78 %Ethanol 78%
(3) 배면층 제조 용액(3) back layer manufacturing solution
에틸 셀룰로오스 25 %Ethyl cellulose 25%
글리세린(Glycerin) 5 %Glycerin 5%
에탄올 70 %Ethanol 70%
리포산과 테오필린을 카카오지, 폴리에틸렌 글리콜, 정제수에 넣고 용융시켜 디스크 형태의 약물층을 제조하였다.Lipoic acid and theophylline were dissolved in cacao butter, polyethylene glycol, and purified water to prepare a disk-type drug layer.
배면층은 에틸 셀룰로오스와 글리세린을 에탄올에 녹여 캐스팅하여 필름으로 제조하고, 접착층은 에탄올에 녹인 폴리아크릴레이트를 배면층 위에 캐스팅하여 제조하였다. 이후, 약물층을 접착층 위에 라미네이션하여 슬리밍 패치를 제조하였다.The back layer was prepared by melting ethyl cellulose and glycerin in ethanol and casting the film, and the adhesive layer was prepared by casting polyacrylate dissolved in ethanol on the back layer. Thereafter, the drug layer was laminated on the adhesive layer to prepare a slimming patch.
실시예Example 3 3
다음과 같은 조성으로 아토피 개선 패치를 제조하였다:Atopy improvement patches were prepared with the following composition:
(1) 약물층 제조 용액(1) drug layer preparation solution
카테킨 2 %Catechin 2%
디메티콘(dimethicone) 6 %Dimethicone 6%
사이클로디메티콘(cyclodimethicone) 2 %Cyclodimethicone 2%
디메티콘 코폴리올 크로스폴리머 디메티콘 8 %Dimethicone Copolyol Crosspolymer Dimethicone 8%
프로필렌 글리콜 1 %Propylene Glycol 1%
카보폴 1 %Cabopol 1%
DMSO 0.01 %DMSO 0.01%
정제수를 가하여 100 %로 하였다.Purified water was added to make 100%.
카테킨을 정제수에 녹이고 카보폴을 가하여 점증시킨 다음, 디메티콘, 사이클로디메티콘, 디메티콘 코폴리올 크로스폴리머 디메티콘, 프로필렌 글리콜, DMSO를 가하여 젤 상의 약물층을 제조하였다.The catechin was dissolved in purified water and added to Carbopol and then increased. Then, a dimethicone, cyclodimethicone, dimethicone copolyol crosspolymer dimethicone, propylene glycol, DMSO was added to prepare a drug layer on the gel.
배면층은 우레탄 필름을 구입하여 사용하였고, 접착층은 다우 코닝사에서 구입한 실리콘 접착제를 불소가 첨가된 하이드로카본과 같은 물질로 코팅된 폴리에스테르에 캐스팅하거나 핫 멜팅 방법으로 제조한 후, 두 층을 라미네이션하였다.The back layer was obtained by using a urethane film, and the adhesive layer was cast by Dow Corning Co., Ltd. on a polyester coated with a fluorinated hydrocarbon-like material or manufactured by hot melting, and then laminated by two layers. It was.
라미네이션한 반제품 위에 젤 상의 약물층을 캐스팅하여 아토피 개선 패치를 제조하였다.An atopic improvement patch was prepared by casting a drug layer on the gel onto the laminated semifinished product.
비교예Comparative example 1 내지 3 1 to 3
다음 표 1의 처방에 따라 비교예 1 내지 3의 약물 용액을 제조하고, 각각의 약물 용액을 실시예 1 내지 3의 배면층과 접착층 위에 캐스팅하여, 통상적으로 알 려진 접착제 분산형(adhesive dispersion type; 약물 매트릭스가 액화되지 않는)의 패치를 제조하였다. 효과적인 비교를 위해, 약물층의 두께와 각 약물의 함량은 실시예와 비교예가 동일하도록 조절하였다.The drug solutions of Comparative Examples 1 to 3 were prepared according to the prescription of Table 1, and each drug solution was cast on the back layer and the adhesive layer of Examples 1 to 3, and a known adhesive dispersion type (adhesive dispersion type); Patches of the drug matrix were not liquefied). For effective comparison, the thickness of the drug layer and the content of each drug were adjusted to be the same as in the Examples and Comparative Examples.
효과시험예 1: 흡수 속도 평가 Effect Test Example 1 Evaluation of Absorption Rate
헤어리스 마우스 피부(Hairless mouse skin), 인간 사체(human cadaver) 피부를 36.5 ℃에서 프란츠셀 위에 고정시킨 후 실시예 2 및 3, 비교예 2 및 3의 제제를 공여부(donor department)에 적용시키고, 수용부(receptor) 용액으로는 HEPES 완충 식염수(pH 7.4)를 채워 0, 5, 15, 30, 60, 120 및 240 분간 샘플링하였다. 얻어진 샘플은 LC Mass를 이용하여 분석하였다. 분석된 데이터를 이용하여 약물의 단위 면적당 용출 속도를 계산하였다. 단, 실시예 2와 비교예 2의 경우에는 테오필린의 흡수 속도를 계산하였다. 다음 표 2는 그 결과이다.Hairless mouse skin, human cadaver skin was immobilized on Franz cells at 36.5 ° C. and then the formulations of Examples 2 and 3, Comparative Examples 2 and 3 were applied to the donor department, Receptor solutions were filled with HEPES buffered saline (pH 7.4) and sampled for 0, 5, 15, 30, 60, 120 and 240 minutes. The obtained sample was analyzed using LC Mass. The analyzed data was used to calculate the dissolution rate per unit area of drug. However, in the case of Example 2 and Comparative Example 2, the absorption rate of theophylline was calculated. Table 2 shows the results.
위 표 2에서 보듯이, 실시예 2 및 3의 패치가 비교예 2 및 3의 패치보다 흡수 속도가 높은 것으로 나타났다. 이는 마찰이나 체온에 의해 매트릭스가 액화되는 본 발명에 따른 패치가 통상적으로 알려진 패치에 비해 흡수 속도가 빠른 것을 나타낸다.As shown in Table 2, the patches of Examples 2 and 3 was found to have a higher absorption rate than the patches of Comparative Examples 2 and 3. This indicates that the patch according to the present invention, in which the matrix is liquefied by friction or body temperature, has a faster absorption rate than conventionally known patches.
효과시험예 2: 인체 피부에 대한 미백 효과 Effect Test Example 2 : Whitening Effect on Human Skin
건강한 남자 20 명을 대상으로 피검자의 등 부위에 직경 1.5 ㎝의 구멍 6 개가 뚫린 불투명 테이프를 부착한 뒤, 각 피검자의 최소 홍반량에 1.5∼2 배 정도의 자외선(UVB)을 조사하여 피부의 흑화를 유도하였다. 다음에, 실시예 1 및 비교예 1의 패치를 하루에 1 회, 4 시간씩 피부에 부착하고 1 주, 2 주 및 4 주 후에 크로마미터를 이용하여 피부의 명암을 측정하였다. 효과의 판정은 피부의 명암을 나타내는 L 값을 구하여 결정하였다. 다음 표 3에 그 결과를 나타낸다.Twenty healthy men were attached with an opaque tape with 6 holes of 1.5 cm in diameter on the back of the subject, and then irradiated with 1.5 ~ 2 times of ultraviolet light (UVB) to the minimum amount of erythema of each subject. Induced. Next, the patches of Example 1 and Comparative Example 1 were attached to the skin once a day for 4 hours, and after 1 week, 2 weeks and 4 weeks, the contrast of the skin was measured using a chromameter. The determination of the effect was determined by obtaining an L value representing the contrast of the skin. The results are shown in Table 3 below.
위 표 3에서 보듯이, 실시예 1의 패치가 비교예 1의 패치보다 높은 미백 효과를 보였주었다. 이는 실시예 1의 패치에서 약물층의 매트릭스가 액화되어 신속한 미백 효과 발현을 일으키기 때문인 것으로 사료된다.As shown in Table 3, the patch of Example 1 showed a higher whitening effect than the patch of Comparative Example 1. This is believed to be due to the liquefaction of the matrix of the drug layer in the patch of Example 1 causing rapid whitening effect expression.
이상에서 살펴 본 바와 같이, 본 발명의 패치는 약물을 함유하는 약물층 혹은 약물·접착 복합층이 체온 또는 마찰에 의해 액화되어 피부에 대한 투과성이 높게 되므로, 약물의 신속한 흡수와, 이에 따른 신속한 효과 발현이 가능하고 사용이 편리하다. 따라서, 피부 미용 패치로 이용할 경우 신속한 미백, 주름 개선, 슬리밍, 노화 방지, 아토피 개선 효과를 나타낼 수 있다.As described above, in the patch of the present invention, the drug layer or drug-adhesive composite layer containing the drug is liquefied by body temperature or friction, so that the permeability to the skin is high, so that the rapid absorption of the drug and the rapid effect accordingly Expression is possible and convenient to use. Therefore, when used as a skin care patch can exhibit a rapid whitening, wrinkle improvement, slimming, anti-aging, atopy improvement.
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