KR101789518B1 - Composition for improving skin aging and wrinkle comprising Scutellaria baicalensis and Raphanus sativus mixed extract as effective component - Google Patents
Composition for improving skin aging and wrinkle comprising Scutellaria baicalensis and Raphanus sativus mixed extract as effective componentInfo
- Publication number
- KR101789518B1 KR101789518B1 KR1020150168333A KR20150168333A KR101789518B1 KR 101789518 B1 KR101789518 B1 KR 101789518B1 KR 1020150168333 A KR1020150168333 A KR 1020150168333A KR 20150168333 A KR20150168333 A KR 20150168333A KR 101789518 B1 KR101789518 B1 KR 101789518B1
- Authority
- KR
- South Korea
- Prior art keywords
- composition
- skin
- lotion
- cosmetic composition
- cream
- Prior art date
Links
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Abstract
본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 조성물에 관한 것으로, 상세하게는 황금 및 나복자 추출물을 3.5~4.5:6.5~5.5 중량비로 혼합한 혼합추출물이 자외선 조사에 의한 세포 손상을 억제하며, MMP-1의 발현을 현저하게 억제한다. 본 발명의 조성물은 화장료, 건강기능식품 및 약학 조성물로 사용할 수 있으며, 특히, 한의학에서 분류하는 사상체질 중에서 태음인의 피부 주름 개선 효과가 탁월한 효과가 있는 것이다. The present invention relates to a composition for improving skin wrinkles and antioxidants comprising a mixture of gold and nevus mixed extract as an active ingredient. More specifically, the present invention relates to a composition for improving skin wrinkles and antioxidation, which comprises a mixture of gold and nevus extract at a ratio of 3.5 to 4.5: , And significantly inhibits the expression of MMP-1. The composition of the present invention can be used as a cosmetic composition, a health functional food and a pharmaceutical composition, and is particularly effective in improving the skin wrinkles of taeumin in sasang constitution classified by oriental medicine.
Description
본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 노화 및 주름 개선용 조성물에 관한 것으로, 상세하게는 3.5~4.5:6.5~5.5의 중량비로 혼합한 황금 추출물과 나복자 추출물을 유효성분으로 함유하는 피부 노화 및 주름개선용 조성물에 관한 것이다. The present invention relates to a composition for improving skin aging and wrinkles containing an extract of gold and napalmum as an active ingredient. More specifically, the present invention relates to a composition for skin aging and wrinkle improvement, which comprises a gold extract and a nigella extract mixed at a weight ratio of 3.5 to 4.5: To a composition for improving skin aging and wrinkles.
피부는 외부환경의 자극으로부터 체내의 기관들을 보호해주며, 체온조절 등의 생체 항상성 유지에 중요한 역할을 한다. 이러한 피부는 여러 가지 내외적 요인에 의해서 노화가 발생되며, 크게 유전적 원인에 의한 내인성 노화와 환경적 원인에 의한 외인성 노화로 구분된다. 이 중, 광노화는 자외선(ultraviolet; UV)에 의한 노화를 의미한다. 최근 환경오염으로 인한 오존층 파괴는 자외선의 양을 증가시켰고 이에 따라 광노화에 대한 연구가 주목되고 있다(Wang SQ et al., 2010, Dermatol. Ther. 23(1):31-47). 광노화 된 피부에서는 거칠어짐, 탄력 손실, 주름 발생 및 불규칙한 색소 침착 등과 같은 외관상의 특징이 관찰되며, 이 중 광노화의 주된 연구 분야는 피부 주름의 변화에 대한 것이다. 상기 광노화에 의한 피부 주름 형성에 관해 피부의 주요 구성성분인 콜라겐(collagen)의 합성, 분해 및 수분 함유량 등의 기초적인 생리 대사 변화에 대한 연구 결과가 다수 보고되고있다(Brenneisen et al., 2002, Ann. N. Y. Acad. Sci., 973:31-43). 특히 자외선에 의해 활성 산소종(reactive oxygen species) 생성이 증가되고 피부의 효소적, 비효소적 항산화 방어체계가 붕괴되어 콜라겐의 분해 증가 및 생합성을 감소시켜 진피층 내의 콜라겐이 현저하게 감소된다(Bickers DR, Athar M, 2006, J. Invest. Dermatol., 126(12):2565-2575). 상기 콜라겐 감소에 중요한 영향을 미치는 것은 콜라겐 분해 효소(MMPs; matrix metalloproteinases)로, 이는 세포외기질(extracellular matrix)과 기저막(basement membrane)의 분해에 관여한다. 상기 효소는 자외선에 의해 활성이 증가되며 이를 억제함으로써 자외선에 의해 유도되는 피부 두께 증가 및 주름 형성이 감소된다는 연구 결과들이 보고되어 있다(Inomata S et al., 2003, J. Invest. Dermatol., 120(1):128-134). 따라서 광노화의 예방 및 치료를 위해서는 MMPs를 조절하는 것이 효과적인 방법으로 알려져 있다. Skin protects the organs in the body from external stimuli and plays an important role in the maintenance of body homeostasis, such as body temperature control. Such skin is aged by various internal and external factors and is divided into endogenous aging by genetic cause and exogenous aging by environmental cause. Among them, photoaging refers to aging by ultraviolet (UV). Recently, the destruction of the ozone layer due to environmental pollution has increased the amount of ultraviolet rays, and accordingly, research on photoaging has been attracting attention (Wang SQ et al., 2010, Dermatol. Ther. 23 (1): 31-47). In the photoaged skin, appearance characteristics such as roughness, loss of elasticity, wrinkles and irregular pigmentation are observed. Among them, the main research field of photoaging is the change of the skin wrinkles. There have been many reports on the basic physiological metabolism changes such as synthesis, degradation, and moisture content of collagen, which is a major constituent of skin, in the formation of skin wrinkles by photoaging (Brenneisen et al., 2002, Ann. NY Acad. Sci., 973: 31-43). Particularly, ultraviolet rays increase the production of reactive oxygen species, collapse of enzymatic and non-enzymatic antioxidant defenses of skin, decrease collagen decomposition and biosynthesis, and decrease collagen in the dermis (Bickers DR , Athar M, 2006, J. Invest. Dermatol., 126 (12): 2565-2575). Important collagen degradation factors are matrix metalloproteinases (MMPs), which are involved in the degradation of extracellular matrix and basement membrane. Studies have been reported that the enzyme increases activity by ultraviolet rays and inhibits it, thereby increasing skin thickness and wrinkling induced by ultraviolet light (Inomata S et al., 2003, J. Invest. Dermatol., 120 (1): 128-134). Therefore, it is known that effective control of MMPs is required for prevention and treatment of photoaging.
한편, 황금(Scutellaria baicalensis)은 꿀풀과(Labiatae)에 속한 다년생 본초인 황금을 의미하며, 특히 황금의 뿌리를 거피하여 건조한 것을 의미할 수 있으나, 황금의 뿌리, 줄기, 입, 꽃 또는 종자 등 부위에 제한되지 않는다. 황금은 제습열, 지혈 등의 효능이 있어 고혈압, 유행성 뇌척수막염의 치료에 사용되어 왔다. 지금까지 밝혀진 약리작용으로는 항균, 항염증, 항알러지, 이뇨, 고지혈증 개선, 장관운동 억제 작용 등이 알려져 있다.On the other hand, gold (Scutellaria baicalensis) means perennial primordium, belonging to Lamiaceae, and may mean dry by peeling the roots of gold. However, it can be a part of the roots, stems, . Gold has been used for the treatment of hypertension and epidemic meningitis due to its efficacy of moisturizing and hemostatic. Anti-bacterial, anti-inflammatory, anti-allergic, diuretic, improvement of hyperlipemia and inhibition of intestinal motility are known pharmacological actions so far.
또한, 나복자는 십자화과에 속한 식물로 무(Raphanus sativus L.)의 여문 종자이다. 말린 종자는 타원형이거나 둥근 난형과 비슷한데 조금 편평하며 길이는 약 3mm, 너비는 2.5mm이다. 표면은 적갈색이며 한쪽에 세로 홈이 몇 개 있고 한쪽 끝에 밑씨가 있다. 밑씨는 갈색이고 둥근 점 모양으로 도드라져 있다. 확대경으로 관찰하면 씨 전체에 그물무늬가 촘촘히 있다. 질은 단단하고 쪼개면 황백색 혹은 누런 알맹이가 보이고 알맹이에 정유가 있다. 여름과 가을에 종자가 여물면 포기를 베어 햇볕에 말렸다가 손으로 비벼 씨를 빼내어, 잡물을 제거한 후 햇볕에 말린 후 한약재로 사용한다 (중약대사전, 김창민 외, pp.715, 1997). 나복자에는 항균물질이 들어 있어 포도상구균과 대장균에 대하여 뚜렷한 억제 작용을 하고 동심성, 백선균 등의 피부 진균에 대한 항진균작용 등의 약리작용을 가지고 있다. 그리고 기가 치밀어 오르는 증세를 치료하고 호흡을 가라앉히며 소화를 돕고 가래를 삭히는 효능이 있으며 해수로 인한 기관지 천식, 식적기체(食積氣滯), 가슴이 답답하고 더부룩한 증상, 이질에 의한 이급후중을 치료하는데 나복자가 처방된다(중약대사전, 김창민 외, pp.716-718, 1997). 근래에 들어, 나복자 추출물 또는 일부 구성 성분이 강력한 항돌연변이 활성, 항균, 항고혈압 및 항염작용을 나타내는 것으로 보고된 바 있다.In addition, the nematode is a plant belonging to the cruciferous family, and is a free-flowing seed of radish (Raphanus sativus L.). Dried seeds are elliptical or round like ovate, slightly flat, about 3mm in length, and 2.5mm in width. The surface is reddish brown, with several vertical grooves on one side and a base on one side. The undergrowth is brown and has a round dot shape. When viewed with a magnifying glass, there is a net pattern on the whole seed. The vagina is firm, and it has a yellowish white or yellow grain and a refined oil. In summer and autumn, when the seeds are dried, they are dried in the sun and then scraped off by hand. The dried seeds are then dried in the sun and used as medicinal herbs (Chinese medicinal herb, Kim Chang Min et al., Pp.715, 1997). Nebulizers contain antimicrobial substances, which have a clear inhibitory action against Staphylococcus aureus and Escherichia coli, and have pharmacological actions such as antifungal action against dermatophytes such as concentric and pseudomonas. It has the effect of treating the symptom that the giga is growing up, calming down the breath, assisting the digestion and removing the phlegm, and the bronchial asthma caused by seawater, the gastric gas (食品 气 滯), the bumpy and bloated symptom, It is prescribed for the treatment of nausea (Chinese medicines, Kim Changmin et al., Pp.716-718, 1997). Recently, it has been reported that the nevus extract or some of its components exhibit strong antimutagenic activity, antibacterial, antihypertensive and anti-inflammatory actions.
한편, 사상의학은 이제마 선생이 임상관찰을 통하여 성격, 체형, 생리, 병리 외형과 정신 심리 및 전 우주에 이르기까지 4가지 분류라는 틀을 통하여 인식하였고 이것을 질병의 예방, 치료 및 철학으로 이론화 체계화하였다. 사상의학에서는 체질은 한 번 타고나면 불변하는 것으로 보며, 특질이나 기질, 성격 적성 등을 결정하는 특성에 따라 태양인, 태음인, 소양인, 소음인의 4가지 타입으로 분류하고, 각기 체질에 따른 음식과 섭생 등으로 질병을 미리 예방할 수도 있고 병이 났을 때는 각자의 체질에 따라 치료법이 다르다. 따라서 같은 화장품, 식품 또는 약물일지라도 체질에 따라 유익할 수 있고 해로울 수도 있는 것이다. 이러한 사상체질 중에서 태음인은 간이 크고 폐가 작으며 허리 부위의 형세가 성장하여 서 있는 자세가 굳건하다. 반면에 목덜미 기세가 약하다. 키가 큰 것이 보통이고 작은 사람은 드물다. 대개는 살이 쪘고 체격이 건실하며 간혹 수척한 사람도 있으나 골격만은 건실하다. 성격은 꾸준하고 침착하며 무슨 일이든 시작한 일, 맡은 일을 이루어 성취하는 데 장점이 있으며 어느 곳에서나 잘 적응하는 재간이 있다. 태음인은 땀구멍이 잘 통하여 땀이 잘 나오면 건강하다. 호흡기와 순환기 기능이 약해서 심장병·고혈압·중풍·천식 등에 걸리기 쉽고 지방질이 많은 식품은 좋지 않다. On the other hand, Sasang medicine recognized through the clinical observation four types of classification ranging from personality, body shape, physiology, pathological appearance, psychological psychology and whole universe, and systematized it as prevention, treatment and philosophy of disease . In Sasang Medicine, the constitution is regarded as invariable once it is burned. It is classified into four types according to the characteristics that determine characteristics, temperament, personality aptitude, etc., such as Taenin, Taeinin, Soyangin, and Soeumin. The disease can be prevented in advance, and when sick, the treatment is different according to each constitution. Therefore, even the same cosmetics, food or medicines may be beneficial and harmful depending on the constitution. Among these sasang constitution, Taeumin has a large liver, a small lung, and a standing posture is growing. On the other hand, the neck is weak. Tall is common and little is rare. Most of them are fat, their physique is strong, and sometimes they are thin, but only the skeleton is strong. Personality is steady and calm, and it has the advantage of accomplishing what you start, what you do, and there is a good adaptation everywhere. Taeumin is good when sweat comes out well through the pores well. The respiratory and circulatory functions are weak, so it is easy to get heart disease, hypertension, paralysis, asthma, etc. and the food with high fat is not good.
상기 황금 또는 나복자 추출물의 피부 주름 개선 또는 피부 노화 관련 기술로는 한국공개특허 제2009-0092095호에 미세염증억제작용, 항산화작용 및 주름완화작용을 갖는 황금추출물 및 아카시아추출물, 또는 굴피나무열매추출물을 함유하는 화장료 조성물에 관한 기술에 대하여 개시되어 있고, 한국공개특허 제2010-0038797호에 황련, 황금, 황백, 연교, 금은화 및 치자의 복합 생약 추출물을 유효성분으로 함유하는 피부 노화방지 및 주름 개선용 피부 외용 약학 조성물 및 화장료 조성물에 대하여 개시되어 있으며, 한국공개특허 제2013-0069034호에 안전하면서도 피부 주름 개선 효과가 뛰어난 나복자 추출 분획을 포함하는 주름 개선용 조성물에 대하여 개시되어 있으나, 본 발명의 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 화장료 조성물에 대해서는 언급된 바 없다. As a technique related to skin wrinkle improvement or skin aging of the golden or nevus extract, Korean Patent Publication No. 2009-0092095 discloses a gold extract and an acacia extract or an extract of Aspergillus oryzae having a microinflammatory, antioxidant and wrinkle- And Korean Patent Publication No. 2010-0038797 discloses a composition for preventing skin aging and improving wrinkles containing an extract of a complex herbal medicine extract of Huanglian, golden, yellowtail, persimmon, ginger, and gardenia as an active ingredient. Korean Patent Laid-Open Publication No. 2013-0069034 discloses a composition for improving wrinkles containing an extract of Nebulizers which is safe and has an excellent effect of improving skin wrinkles, And an anti-wrinkle agent containing an extract of the nematode as an active ingredient The bar does not comment on for a cosmetic composition.
본 발명은 상기와 같은 요구에 의해 도출된 것으로서, 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 조성물에 관한 것으로, 상세하게는 황금 및 나복자 추출물을 3.5~4.5:6.5~5.5 중량비로 혼합한 혼합추출물은 자외선 조사에 의한 세포 손상을 억제하며, MMP-1의 발현을 현저하게 억제하고, 특히 태음인에게 주름개선 효과가 있다는 것을 확인함으로써, 본 발명을 완성하였다.The present invention relates to a composition for improving skin wrinkles and an anti-aging composition containing gold and nappy mixed extract as an active ingredient. More specifically, The present inventors completed the present invention by confirming that the mixed extracts mixed at a weight ratio inhibit cell damage by ultraviolet irradiation, remarkably suppress the expression of MMP-1, and particularly have a wrinkle-reducing effect on taeumin.
상기 목적을 달성하기 위하여, 본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 화장료 조성물을 제공한다.In order to achieve the above object, the present invention provides a cosmetic composition for improving skin wrinkles and anti-aging comprising, as an active ingredient, a mixture of golden and nappy mixed extracts.
또한, 본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 건강기능식품 조성물을 제공한다.In addition, the present invention provides a health functional food composition for improving skin wrinkles and anti-aging, which contains, as an active ingredient, a mixture of golden and nappy mixed extracts.
또한, 본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 약학 조성물을 제공한다.The present invention also provides a pharmaceutical composition for improving skin wrinkles and an anti-aging composition comprising a mixture of gold and nappy mixed extracts as an active ingredient.
본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 조성물에 관한 것으로, 상세하게는 황금 및 나복자 추출물을 3.5~4.5:6.5~5.5 중량비로 혼합한 혼합추출물은 자외선 조사에 의한 세포 손상을 억제하며, MMP-1의 발현을 현저하게 억제한다. 황금 및 나복자 추출물의 혼합비가 3.5~4.5:6.5~5.5 중량비인 경우, 다른 혼합비로 혼합하거나, 황금 추출물 또는 나복자 추출물을 단독으로 사용하는 경우보다 효과적으로 자외선 조사에 의한 세포 손상을 억제하며, MMP-1의 발현을 현저하게 억제하는 것이다. 본 발명의 유효성분은 한의학에서 분류하는 사상체질 중 태음인에게 피부 주름 개선 효과가 탁월한 효과가 있는 것으로 태음인의 화장료 조성물, 건강기능식품조성물 및 약학조성물로 유용하게 사용할 수 있다. The present invention relates to a composition for improving skin wrinkles and antioxidants comprising a mixture of gold and nevus mixed extract as an active ingredient. More specifically, the present invention relates to a composition for improving skin wrinkles and antioxidation, comprising a mixture of gold and nevus extract at a ratio of 3.5 to 4.5: , And significantly inhibits the expression of MMP-1. In the case where the mixture ratio of gold and nuggets extract is 3.5 to 4.5: 6.5-5.5 by weight, it is more effective to inhibit cell damage by ultraviolet irradiation and to inhibit MMP-1 Is significantly suppressed. The active ingredient of the present invention has an excellent effect of improving skin wrinkles among taeumin among sasang constitution classified by oriental medicine, and can be effectively used as cosmetic composition, health functional food composition and pharmaceutical composition of taeumin.
도 1은 본 발명의 황금 및 나복자 혼합 추출물의 혼합비(중량비)에 따른 세포 생존률을 확인하기 위하여, HaCaT 세포(사람 각질형성 세포주)에 24시간 동안 각각의 시료를 농도별(100㎍/㎖ 및 200㎍/㎖)로 희석하여 처리하고 자외선(UV Crosslinker, Ultra Lum)을 30분간 조사한 후, MTS 어세이를 수행한 결과이다.
도 2는 본 발명의 황금 및 나복자 혼합 추출물의 혼합비(중량비)에 따른 MMP-1의 발현량을 확인한 결과이다.
도 3은 레플리카 분석에서 사용되는 주름 파라미터의 정의 및 다이어그램이다.
도 4는 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 육안으로 평가한 결과를 나타낸 것이다.
도 5는 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 레플리카의 Rt(Skin roughness) 파라미터로 분석한 결과이다.
도 6은 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 레플리카의 Rm(Maximum roughness) 파라미터로 분석한 결과이다.
도 7은 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 레플리카의 Rz(Average roughness) 파라미터로 분석한 결과이다.
도 8은 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 레플리카의 Rp(Smoothness depth) 파라미터로 분석한 결과이다.
도 9는 중량비가 4:6인 황금 및 나복자 혼합 추출물을 함유하는 제품을 사용한 시험군과 대조군 사이의 주름 개선 효과를 레플리카의 Ra(Arithmetic Average roughness) 파라미터로 분석한 결과이다. 1 is a graph showing the cell viability of HaCaT cells (human keratinocyte cell line) for 24 hours in order to determine the cell viability according to the mixing ratio (weight ratio) of the golden and nephellium mixed extract of the present invention. (UV Crosslinker, Ultra Lum) for 30 minutes and then subjected to MTS assay.
FIG. 2 shows the results of confirming the expression level of MMP-1 according to the mixing ratio (weight ratio) of the golden and nappy mixed extract of the present invention.
3 is a definition and a diagram of the wrinkle parameters used in the replica analysis.
Fig. 4 shows the visual evaluation of the wrinkle-improving effect between the test group and the control group using the product containing the gold and napalmus mixture extract having a weight ratio of 4: 6.
FIG. 5 shows the results of analysis of the wrinkle-improving effect between the test group and the control group using a product containing a mixture of gold and nevus mixed extracts having a weight ratio of 4: 6, using the Rt (skin roughness) parameter of the replica.
FIG. 6 shows the results of analysis of the wrinkle-improving effect between the test group and the control group using a product containing a mixture of gold and nematode mixed extracts having a weight ratio of 4: 6, using the Rm (maximum roughness) parameter of the replica.
FIG. 7 shows the results of analyzing the wrinkle-improving effect between the test group and the control group using the product containing the gold / napkin mixture extract having the weight ratio of 4: 6, using the Rz (Average roughness) parameter of the replica.
FIG. 8 shows the results of analyzing the wrinkle-improving effect between the test group and the control group using a product containing a mixture of gold and nappa mixed extracts having a weight ratio of 4: 6, using the Rp (smoothness depth) parameter of the replica.
FIG. 9 shows the results of analysis of the wrinkle-improving effect between the test group and the control group using a product containing a mixture of gold and nevus mixed extracts having a weight ratio of 4: 6, using an Arithmetic Average Roughness (Ra) parameter of the replica.
본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 화장료 조성물에 관한 것이다.The present invention relates to a cosmetic composition for improving skin wrinkles and antioxidants, which contains, as an active ingredient, a mixture of golden and nappy mixed extracts.
상기 황금 및 나복자 추출물은 물, C1~C4의 저급알코올, 프로필렌글리콜, 에틸아세트산, 부틸렌글리콜, 글리세린, 에테르 및 클로로포름 중에서 선택된 하나 이상의 용매를 이용하여 추출한 것이 바람직하고, 더 바람직하게는 열수 추출하는 것이나, 이에 한정하지 않는다. The golden and nevus extracts are preferably extracted using at least one solvent selected from the group consisting of water, C 1 -C 4 lower alcohol, propylene glycol, ethyl acetate, butylene glycol, glycerin, ether and chloroform, But is not limited thereto.
상기 황금 및 나복자 추출물의 혼합비는 3.5~4.5:6.5~5.5 중량비인 것이 바람직하지만, 이에 한정하지 않으며, 상기 3.5~4.5:6.5~5.5 중량비로 혼합하는 경우, 단독으로 사용하거나 또는 다른 중량비로 혼합하는 것에 비해 주름개선 효과가 탁월하다. The mixing ratio of the gold and nevus extracts is preferably in the range of 3.5 to 4.5: 6.5 to 5.5, but is not limited thereto. In the case of mixing in the ratio of 3.5 to 4.5: 6.5 to 5.5, the mixture may be used singly or mixed at a different weight ratio The effect of wrinkle improvement is superior to that of.
상기 화장료 조성물은 사상체질 중에서 태음인용인 것을 특징으로 하며, 본 발명에서의 태음인 여부는 SCAT 프로그램(한국공개특허 제2012-0034475호, JH DO. et.al 2012, Development of an intefrated Sasang constitution diagnoisis method using face, body shape, voice, and questionnaire information 12:85)을 이용한 체질 판별하거나 한의사에 의해 진단받는 것이 바람직하다. The cosmetic composition of the present invention is characterized in that it is a taenum in the sasang constitution. Whether or not it is a taiko in the present invention is determined by the SCAT program (Korea Patent Publication No. 2012-0034475, JH DO et al 2012, Development of an intefrated Sasang constitution diagnostic method using face, body shape, voice, and questionnaire information 12:85) or to be diagnosed by Oriental medicine.
태음인은 이제마 선생이 임상관찰을 통하여 성격, 체형, 생리, 병리 외형과 정신 심리 및 전 우주에 이르기까지 4가지 분류(태양, 태음, 소양, 소음)라는 틀을 통하여 질병 예방, 치료 및 철학으로 이론화 체계화한 사상의학으로 분류한 기준에 의거하여 허리의 서 있는 기세가 왕성하지만, 뇌추의 기세는 약한 자를 의미한다. 상기 뇌추는 머리, 뒷목덜미, 어깨 등을 의미한다. 또한 체격이 건실하며, 살이 찐 사람이 많지만 수척한 사람도 있고, 소음인(少陰人)과는 체형이 유사하지만, 소음인에 비해 태음인의 체격이 더 큰 편이며 피부가 더 단단하다. 하지만 체격이 큰 소음인도 있으므로 단지 외형만으로 체질을 감별하는 것은 한계가 있으므로, 평소에 나타나는 증상, 맥(脈) 등을 종합적으로 고려해서 감별하는 것이 바람직하다.Tae In-in is a theorist who teaches the theories of disease prevention, treatment, and philosophy through the framework of four categories (sun, lunar, lute, noise) through the clinical observation through personality, body shape, physiology, pathological appearance, psychology, Based on criteria classified as systematic ideological medicine, the standing force of the waist is strong, but the momentum of the brain is weak. The brain weights refer to the head, back neck, shoulder, and the like. In addition, there are many people who are physically strong, many are fat, but some are gentle, and similar in shape to the noise (shiny inhabitants), but the Taeumin has a larger physique and stronger skin than the noise. However, since there is a noise of a large physique, there is a limit to distinguishing the constitution from only the outer shape. Therefore, it is desirable to discriminate the symptom, the pulse (pulse), etc.,
상기 화장료 조성물은 MMP-1의 발현을 저해함으로써 피부의 노화 방지 및 피부 주름개선에 효과가 있는 것이다. The above-mentioned cosmetic composition inhibits the expression of MMP-1, thereby being effective in preventing skin aging and improving skin wrinkles.
본 발명의 일 구현 예에 따른 화장료 조성물에 있어서, 상기 피부 주름 개선 및 항노화용 화장료 조성물은 피부외용 연고, 크림, 유연화장수, 영양화장수, 팩, 에센스, 헤어토닉, 샴푸, 린스, 헤어 컨디셔너, 헤어 트리트먼트, 젤, 스킨로션, 스킨소프너, 스킨토너, 아스트린젠트, 로션, 밀크로션, 모이스처 로션, 영양로션, 마사지 크림, 영양크림, 모이스처 크림, 핸드 크림, 파운데이션, 영양에센스, 선스크린, 비누, 클렌징폼, 클렌징로션, 클렌징크림, 바디 로션 및 바디 클렌저로 이루어지는 군으로부터 선택된 어느 하나의 제형을 가질 수 있으나, 이에 제한되지 않는다. 이들 각 제형으로 이루어진 화장료 조성물은 그 제형의 제제화에 필요하고 적절한 각종의 기제와 첨가물을 함유할 수 있으며, 이들 성분의 종류와 양은 당업자에 의해 용이하게 선정될 수 있다.In the cosmetic composition according to an embodiment of the present invention, the cosmetic composition for improving skin wrinkles and anti-aging may be at least one selected from the group consisting of ointment for external use, cream, softening water, nutritional lotion, pack, essence, hair tonic, shampoo, Skin lotion, skin toner, astringent, lotion, milk lotion, moisturizing lotion, nutrition lotion, massage cream, nutritional cream, moisturizing cream, hand cream, foundation, nutrition essence, sunscreen, soap, cleansing But are not limited to, any one form selected from the group consisting of a foam, a cleansing lotion, a cleansing cream, a body lotion and a body cleanser. The cosmetic composition comprising each of these formulations may contain various bases and additives necessary for formulation of the formulation, and the kinds and amounts of these ingredients can be easily selected by those skilled in the art.
본 발명의 화장료 조성물의 제형이 페이스트, 크림 또는 겔인 경우에는 담체 성분으로서 동물섬유, 식물섬유, 왁스, 파라핀, 전분, 트라가칸트, 셀룰로오스 유도체, 폴리에틸렌 글리콜, 실리콘, 벤토나이트, 실리카, 탈크 또는 산화아연 등이 이용될 수 있다.When the formulation of the cosmetic composition of the present invention is a paste, a cream or a gel, an animal fiber, a plant fiber, a wax, a paraffin, a starch, a tragacanth, a cellulose derivative, a polyethylene glycol, a silicone, a bentonite, Etc. may be used.
본 발명의 화장료 조성물의 제형이 파우더 또는 스프레이인 경우에는 담체 성분으로서 락토스, 탈크, 실리카, 알루미늄 히드록시드, 칼슘 실리케이트 또는 폴리아미드 파우더가 이용될 수 있고, 특히 스프레이인 경우에는 추가적으로 클로로플루오로히드로카본, 프로판-부탄 또는 디메틸 에테르와 같은 추진체를 포함할 수 있다.When the formulation of the cosmetic composition of the present invention is a powder or a spray, lactose, talc, silica, aluminum hydroxide, calcium silicate or polyamide powder may be used as a carrier component. Especially, in the case of a spray, Propellants such as carbon, propane-butane or dimethyl ether.
본 발명의 화장료 조성물의 제형이 용액 또는 유탁액의 경우에는 담체 성분으로서 용매, 용매화제 또는 유탁화제가 이용되고, 예컨대 물, 에탄올, 이소프로판올, 에틸 카보네이트, 에틸 아세테이트, 벤질 알코올, 벤질 벤조에이트, 프로필렌글리콜, 1,3-부틸글리콜 오일, 글리세롤 지방족 에스테르, 폴리에틸렌 글리콜 또는 소르비탄의 지방산 에스테르가 있다.When the formulation of the cosmetic composition of the present invention is a solution or an emulsion, a solvent, a solvent or an emulsifier is used as a carrier component, and examples thereof include water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, Glycol, 1,3-butyl glycol oil, glycerol aliphatic ester, polyethylene glycol or fatty acid esters of sorbitan.
본 발명의 화장료 조성물의 제형이 현탁액인 경우에는 담체 성분으로서 물, 에탄올 또는 프로필렌 글리콜과 같은 액상 희석제, 에톡실화 이소스테아릴 알코올, 폴리옥시에틸렌 소르비톨 에스테르 및 폴리옥시에틸렌 소르비탄 에스테르와 같은 현탁제, 미소결정성 셀룰로오스, 알루미늄 메타히드록시드, 벤토나이트, 아가 또는 트라칸트 등이 이용될 수 있다.When the formulation of the cosmetic composition of the present invention is a suspension, a carrier such as water, a liquid diluent such as ethanol or propylene glycol, a suspension such as ethoxylated isostearyl alcohol, polyoxyethylene sorbitol ester and polyoxyethylene sorbitan ester, Microcrystalline cellulose, aluminum metahydroxide, bentonite, agar or tracant, etc. may be used.
본 발명의 화장료 조성물의 제형이 계면-활성제 함유 클렌징인 경우에는 담체 성분으로서 지방족 알코올 설페이트, 지방족 알코올 에테르설페이트, 설포숙신산 모노에스테르, 아세티오네이트, 이미다졸리늄 유도체, 메틸타우레이트, 사르코시네이트, 지방산 아미드 에테르 설페이트, 알킬아미도베타인, 지방족 알코올, 지방산 글리세리드, 지방산 디에탄올아미드, 식물성 유, 리놀린 유도체 또는 에톡실화 글리세롤 지방산 에스테르 등이 이용될 수 있다.When the formulation of the cosmetic composition of the present invention is an interfacial-active agent-containing cleansing, the carrier component may include aliphatic alcohol sulfate, aliphatic alcohol ether sulfate, sulfosuccinic acid monoester, acethionate, imidazolinium derivative, methyltaurate, sarcosinate , Fatty acid amide ether sulfate, alkylamidobetaine, aliphatic alcohol, fatty acid glyceride, fatty acid diethanolamide, vegetable oil, linolenic derivative or ethoxylated glycerol fatty acid ester.
본 발명의 화장료 조성물은 형광물질, 살진균제, 굴수성 유발물질, 보습제, 방향제, 방향제 담체, 단백질, 용해화제, 당 유도체, 일광차단제, 비타민, 식물 추출물 등을 포함하는 부형제를 추가로 함유할 수 있다.The cosmetic composition of the present invention may further contain an excipient including a fluorescent substance, a fungicide, a hygroscopic substance, a moisturizer, a fragrance, a fragrance carrier, a protein, a solubilizer, a sugar derivative, a sunscreen, a vitamin, .
또한, 본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 건강기능식품 조성물에 관한 것이다.The present invention also relates to a health functional food composition for improving skin wrinkles and anti-aging, which comprises a mixture of gold and nappy mixed extracts as an active ingredient.
상기 황금 및 나복자 추출물의 혼합비는 3.5~4.5:6.5~5.5 중량비인 것이 바람직하지만 이에 한정하지 않으며, 사상체질 중에서 태음인용인 것이 특징이다. Preferably, the mixing ratio of the golden and nepheline extracts is 3.5 to 4.5: 6.5-5.5 by weight, but is not limited thereto.
본 발명의 건강기능식품 조성물을 식품첨가물로 사용하는 경우, 상기 건강기능식품 조성물을 그대로 첨가하거나 다른 식품 또는 식품성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다. 유효 성분의 혼합양은 그의 사용 목적(예방 또는 개선)에 따라 적절하게 사용될 수 있다. 일반적으로, 식품 또는 음료의 제조시 본 발명의 건강기능식품 조성물은 원료에 대하여 15 중량부 이하, 바람직하게는 10 중량부 이하의 양으로 첨가된다. 그러나 건강을 목적으로 하는 장기간의 섭취의 경우에는 상기 양은 상기 범위 이하일 수 있으며, 안전성 면에서 아무런 문제가 없기 때문에 유효성분은 상기 범위 이상의 양으로 사용될 수 있다.When the health functional food composition of the present invention is used as a food additive, the health functional food composition may be added as it is, or may be used together with other food or food ingredients, and suitably used according to a conventional method. The amount of the active ingredient to be mixed can be suitably used depending on the purpose of use (prevention or improvement). Generally, the health functional food composition of the present invention is added in an amount of not more than 15 parts by weight, preferably not more than 10 parts by weight based on the raw material, when the food or beverage is produced. However, in the case of long-term intake intended for health, the amount may be less than the above range, and since there is no problem in terms of safety, the active ingredient may be used in an amount of more than the above range.
상기 건강기능식품의 종류에 특별한 제한은 없다. 상기 건강기능식품 조성물을 첨가할 수 있는 식품의 예로는 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차 드링크제, 알콜 음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 건강식품을 모두 포함한다.There is no particular limitation on the kind of the health functional food. Examples of the foods to which the health functional food composition can be added include dairy products including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen and other noodles, gums, ice cream, soups, Drinks, alcoholic beverages, and vitamin complexes, all of which include health foods in a conventional sense.
또한, 본 발명의 건강기능식품 조성물은 식품, 특히 기능성 식품으로 제조될 수 있다. 본 발명의 기능성 식품은 식품 제조 시에 통상적으로 첨가되는 성분을 포함하며, 예를 들어, 단백질, 탄수화물, 지방, 영양소 및 조미제를 포함한다. 예컨대, 드링크제로 제조되는 경우에는 유효성분 이외에 천연 탄수화물 또는 향미제를 추가 성분으로서 포함시킬 수 있다. 상기 천연 탄수화물은 모노사카라이드(예컨대, 글루코오스, 프럭토오스 등), 디사카라이드(예컨대, 말토스, 수크로오스 등), 올리고당, 폴리사카라이드(예컨대, 덱스트린, 시클로덱스트린 등), 또는 당알코올(예컨대, 자일리톨, 소르비톨, 에리쓰리톨 등)인 것이 바람직하다. 상기 향미제는 천연 향미제(예컨대, 타우마틴, 스테비아 추출물 등)와 합성 향미제(예컨대, 사카린, 아스파르탐 등)를 이용할 수 있다.In addition, the health functional food composition of the present invention can be produced as a food, particularly a functional food. The functional food of the present invention includes components that are ordinarily added in food production, and includes, for example, proteins, carbohydrates, fats, nutrients, and seasonings. For example, in the case of a drink, a natural carbohydrate or a flavoring agent may be included as an additional ingredient in addition to the active ingredient. The natural carbohydrate may be selected from the group consisting of monosaccharides (e.g., glucose, fructose, etc.), disaccharides (e.g., maltose, sucrose, etc.), oligosaccharides, polysaccharides (e.g., dextrin, cyclodextrin, For example, xylitol, sorbitol, erythritol, etc.). The flavoring agent may be a natural flavoring agent (e.g., tau Martin, stevia extract, etc.) and a synthetic flavoring agent (e.g., saccharin, aspartame, etc.).
상기 건강기능식품 조성물 이외에 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산음료에 사용되는 탄산화제 등을 더 함유할 수 있다. 이러한 상기 첨가되는 성분의 비율은 크게 중요하진 않지만 본 발명의 건강기능식품 조성물 100 중량부에 대하여, 0.01 내지 0.1 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above health functional food composition, it is also possible to use various nutrients, vitamins, electrolytes, flavors, colorants, pectic acids and salts thereof, alginic acid and its salts, organic acids, protective colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, A carbonating agent used in beverages, and the like. Although the ratio of the above-mentioned ingredients is not critical, it is generally selected in the range of 0.01 to 0.1 part by weight based on 100 parts by weight of the health functional food composition of the present invention.
또한, 본 발명은 황금 및 나복자 혼합 추출물을 유효성분으로 함유하는 피부 주름 개선 및 항노화용 약학 조성물에 관한 것이다. 상기 황금 및 나복자 추출물의 혼합비는 3.5~4.5:6.5~5.5 중량비인 것이 바람직하지만 이에 한정하지 않으며, 사상체질 중에서 태음인용인 것이 특징이다.The present invention also relates to a pharmaceutical composition for improving skin wrinkles and anti-aging, which contains, as an active ingredient, a mixture of golden and nappy mixed extracts. Preferably, the mixing ratio of the golden and nepheline extracts is 3.5 to 4.5: 6.5-5.5 by weight, but is not limited thereto.
본 발명의 약학 조성물은 유효성분 이외에 약학적으로 허용되는 담체를 포함할 수 있으며, 이러한 담체는 제제 시에 통상적으로 이용되는 것으로서, 락토스, 덱스트로스, 수크로스, 솔비톨, 만니톨, 전분, 아카시아 고무, 인산 칼슘, 알기네이트, 젤라틴, 규산 칼슘, 미세결정성 셀룰로스, 폴리비닐피롤리돈, 셀룰로스, 물, 시럽, 메틸 셀룰로스, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일 등을 포함하나, 이에 한정되는 것은 아니다. 본 발명의 약학적 조성물은 상기 성분들 이외에 윤활제, 습윤제, 감미제, 향미제, 유화제, 현탁제, 보존제 등을 추가로 포함할 수 있다. 적합한 약학적으로 허용되는 담체 및 제제는 레밍턴의 약학적 과학(Remington's Pharmaceutical Sciences, 19th ed., 1995)에 상세히 기재되어 있다.The pharmaceutical composition of the present invention may contain a pharmaceutically acceptable carrier in addition to the active ingredient. Such a carrier is usually used at the time of formulation, and includes lactose, dextrose, sucrose, sorbitol, mannitol, starch, Calcium carbonate, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and minerals Oils, and the like, but are not limited thereto. The pharmaceutical composition of the present invention may further contain a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, etc., in addition to the above components. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington's Pharmaceutical Sciences, 19th ed., 1995.
본 발명에 따른 약학 조성물의 적합한 투여량은 제제화 방법, 투여 방식, 환자의 연령, 체중, 성, 병적 상태, 음식, 투여 시간, 투여 경로, 배설 속도 및 반응 감응성과 같은 요인들에 의해 다양하게 처방될 수 있다. 한편, 본 발명의 약학 조성물의 투여량은 바람직하게는 1일 당 0.0001 내지 100mg/kg(체중)이다.The appropriate dosage of the pharmaceutical composition according to the present invention may vary depending on such factors as the formulation method, the administration method, the patient's age, body weight, sex, pathological condition, food, administration time, administration route, excretion rate, . On the other hand, the dosage of the pharmaceutical composition of the present invention is preferably 0.0001 to 100 mg / kg (body weight) per day.
본 발명의 약학 조성물은 경구 또는 비경구로 투여할 수 있으며, 비경구 투여의 경우, 피부에 국소적으로 도포, 정맥 내 주입, 피하 주입, 근육 주입, 복강 주입, 경피 투여 등으로 투여할 수 있다.The pharmaceutical composition of the present invention may be administered orally or parenterally. In the case of parenteral administration, the composition may be administered topically to the skin, intravenously, subcutaneously, intramuscularly, intraperitoneally, or transdermally.
본 발명의 약학 조성물에 포함되는 유효성분의 농도는 치료 목적, 환자의 상태, 필요기간 등을 고려하여 결정할 수 있으며 특정 범위의 농도로 한정되지 않는다.The concentration of the active ingredient contained in the pharmaceutical composition of the present invention can be determined in consideration of the purpose of treatment, the condition of the patient, the period of time required, etc., and is not limited to a specific range of concentration.
본 발명의 약학 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 약학적으로 허용되는 담체 또는 부형제를 이용하여 제제화함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기 내에 내입시켜 제조될 수 있다. 이때 제형은 주사제, 크림, 패취, 분무제, 연고제, 경고제, 로션제, 리니멘트제, 파스타제 및 카타플라스마제 중에서 선택된 어느 하나의 제형으로 제조될 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.
The pharmaceutical composition of the present invention may be manufactured in a unit dosage form by formulating it using a pharmaceutically acceptable carrier or excipient according to a method which can be easily carried out by those having ordinary skill in the art to which the present invention belongs Into a capacity container. The formulations may be formulated into any one of the formulations selected from injectables, creams, patches, sprays, ointments, alerts, lotions, liniments, pastes and cataplasms, and may additionally contain dispersing or stabilizing agents have.
이하, 실시예를 이용하여 본 발명을 더욱 상세하게 설명하고자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로 본 발명의 범위가 이들에 의해 제한되지 않는다는 것은 당해 기술분야에서 통상의 지식을 가진 자에게 있어 자명한 것이다.
Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are merely illustrative of the present invention and that the scope of the present invention is not limited thereto.
[재료 및 방법][Materials and Methods]
1. 한약재 추출물의 제조1. Preparation of herb extracts
한약재는 광명당으로부터 구입하였고, 각 시료는 5.5±0.3℃의 온도 및 55±5%의 습도를 유지하는 약재보관용 냉장고에서 보관하였다. 황금 및 나복자 추출물은 황금 및 나복자 각각의 총 중량에 대하여 10배량에 해당되는 물을 첨가하여 3시간씩 2회 환류냉각 추출하고, 여과지를 이용하여 얻어진 여액을 감압농축기로 용매를 제거함으로써 추출물을 제조하였다.
Herbal medicines were purchased from Kwangmyong, and each sample was stored in a medicinal storage refrigerator maintained at a temperature of 5.5 ± 0.3 ° C and a humidity of 55 ± 5%. The extracts of gold and nasopharyngeae were prepared by adding water corresponding to 10 times the total weight of each of gold and nasopharynx and refluxing and cooling for 2 hours for 3 hours. The filtrate obtained by using filter paper was subjected to removal of solvent with a vacuum concentrator to prepare an extract Respectively.
2. 세포실험2. Cell experiments
1) 세포배양1) Cell culture
HaCaT 세포(사람 각질형성 세포주)는 Dulbecco's Modified Eagle Medium (DMEM, Gibco)에 10% 소태아 혈청(Fetal bovine serum;FBS, Gibco)과 1% 페니실린-스트렙토마이신(penicillin-streptomycin;PS, Gibco)이 함유된 배지에서 37℃, 5% CO2 조건에서 배양하였다.
HaCaT cells were incubated with 10% fetal bovine serum (FBS, Gibco) and 1% penicillin-streptomycin (PS, Gibco) in Dulbecco's Modified Eagle Medium (DMEM, Gibco) in the culture medium containing the cells were cultured at 37 ℃, 5% CO 2 condition.
2) 세포생존률 분석2) Cell survival analysis
HaCaT 세포(사람 각질형성 세포주)에 24시간 동안 각각의 시료를 농도별로 희석하여 처리하고 자외선(UV Crosslinker, Ultra Lum)을 20 mJ/cm2 의 세기로 30분간 조사한 후, MTS 어세이(CellTiter Aqueous One Solution Cell proliferation assay kit, 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophynyl)-2H-tetrazolium, inner salt; MTS, Promega Co. Madison, WI, USA) 기법으로 세포 생존능을 490nm에서 마이크로플레이트 리더(Molecular Devices, Sunnyvale, CA, USA) 로 측정하여 시험하였다.
HaCaT cells (human keratinocyte cell line) were diluted with each sample for 24 hours and irradiated with ultraviolet light (UV Crosslinker, Ultra Lum) at an intensity of 20 mJ / cm 2 After 30 minutes of irradiation, the cells were treated with MTS assay (CellTiter Aqueous One Solution Cell proliferation assay kit, 3- (4,5-dimethylthiazol-2-yl) -5- (3-carboxymethoxyphenyl) -2- cell viability was measured at 490 nm using a microplate reader (Molecular Devices, Sunnyvale, Calif., USA) using a tetrazolium, inner salt, MTS, Promega Co. Madison,
3) MMP-1의 발현량 분석3) Analysis of expression level of MMP-1
UV 조사 후, MMP-1(matrix metalloproteinases-1)의 발현량을 측정하기 위하여 5×104의 HaCaT 세포를 배양하였고, 제조사의 지시에 따라 ELISA 키트(R&D Systems, Inc., Minneapolis, MN, USA)를 이용하여 MMP-1의 발현량을 측정하였다. After UV irradiation, 5 × 10 4 HaCaT cells were cultured to measure the expression level of MMP-1 (matrix metalloproteinases-1). ELISA kit (R & D Systems, Inc., Minneapolis, ) Was used to measure the expression level of MMP-1.
상세하게는 96웰 플레이트에 HaCaT 세포를 도말한 후, 본 발명의 황금 및 나복자 혼합추출물을 다양한 혼합비율별로 처리하였다. 이후, 자외선(UV) 조사하고, 배양물의 상등액을 수집하고 13,000rpm으로 5분 동안 원심분리하였다. 이후 상등액을 취해 ELISA 키트를 이용한 형광 어세이를 수행하여 MMP-1의 발현량을 정량분석하였다.
Specifically, HaCaT cells were plated on a 96-well plate, and then the golden and napalmia mixed extracts of the present invention were treated at various mixing ratios. Then, ultraviolet (UV) irradiation was performed, and the supernatant of the culture was collected and centrifuged at 13,000 rpm for 5 minutes. The supernatant was then subjected to fluorescent assay using an ELISA kit to quantitatively analyze the expression level of MMP-1.
3. 인체적용시험3. Human body application test
본 시험은 헬싱키 선언(Declaration of Helsinki)에 근거한 윤리규정, 인체적용 시험가이드라인[식품의약품안전처, 2011.12 제정] 및 관련 규정에 따라 실시하였다(시험코드: DEF-HSWIT001(2)-15036, IRB승인번호: 제1-220777-A-N-02호-DICN15031).
This test was carried out in accordance with the Declaration of Helsinki Code of Ethics, the Guidelines for Applicability to the Body [Food and Drug Administration, Dec. 2011] and related regulations (Test Code: DEF-HSWIT001 (2) -15036, IRB Approval number: 1-220777-AN-02-DICN15031).
1) 시험 목적1) Purpose of examination
본 시험은 주름이 생성되기 시작하거나 이미 생성된 30세 이상의 태음인 여성을 대상으로 12주간 시험제품을 사용하게 하여 주름개선 효과 및 피부 안전성을 평가하기 위함이다.
The purpose of this test is to evaluate the wrinkle reduction effect and skin safety by using the test product for 12 weeks for women who are already 30 years old or older and have already started to produce wrinkles.
2) 시험 제품2) Test products
- 제품명: KIOM SY(2015SY 1-1)- Product: KIOM SY (2015SY 1-1)
- 시험군(A): 0.4g의 황금 추출물 및 0.6g의 나복자 추출물의 혼합물 1% 함유Test group (A): 1% of a mixture of 0.4 g of golden extract and 0.6 g of nevus extract
- 대조군(B): 황금 및 나복자 추출물의 미함유- Control group (B): unspiked of golden and nepheline extracts
- 제품의 성상: 크림- Appearance: Cream
- 제품의 보관: 실온 보관- Storage of products: Storage at room temperature
- 제품의 유효 성분: 0.4g의 황금 추출물 및 0.6g의 나복자 추출물의 혼합물 1% - active ingredient of the product: a mixture of 0.4 g of golden extract and 0.6 g of nevus extract 1%
- 제품의 사용 방법: 12주 동안 1일 2회 세안 후 스킨 다음 단계에서 제품 A와 B를 안면 좌, 우측 정해진 눈가 부위에 바르고 흡수시키게 하였다. 피험자는 이중맹검법과 무작위 배정에 따라 두 그룹으로 나누어 A그룹은 좌측에 시험군(제품 A), 우측에 대조군(제품 B)을 사용하게 하고, B그룹은 좌측에 대조군(제품 B), 우측에 시험군(제품 A)을 사용하게 하였다.
- How to use the product: After cleansing twice a day for 12 weeks, skin A and B are applied on the left and right sides of the eye. Subjects were divided into two groups according to double blind method and random assignment. Group A had the test group on the left side (product A) and control group (product B) on the right side. Group B had the control group on the left side (product B) The test group (product A) was used.
3) 시험 방법3) Test method
모든 피험자는 방문 시마다 시험부위를 세척한 다음에 항온항습실(22±2℃, 50±5%)에 입실하였으며, 30분 동안 안정을 취한 후 시험에 참여하였다.All subjects visited the temperature and humidity chamber (22 ± 2 ° C, 50 ± 5%) after washing the test site at each visit and took the test after stabilization for 30 minutes.
평가는 제품 사용 전과 사용 후 각 시점(4주, 8주, 12주)에서 육안평가, 피부 주름 파라미터 측정, 피험자에 의한 설문평가 및 시험자의 관찰과 문진을 통해 피부 안전성을 평가하였다.
The evaluation of skin safety was made by visual evaluation, skin wrinkle parameter measurement, questionnaire evaluation by the subjects, observations and interviews of the subjects at each time point (4 weeks, 8 weeks, 12 weeks) before and after use of the product.
① 피험자 선정① Selection of subjects
피부 임상 시험 전 SCAT 프로그램(한국공개특허 제2012-0034475호, JH DO. et.al 2012, Development of an intefrated Sasang constitution diagnoisis method using face, body shape, voice, and questionnaire information 12:85)을 이용한 체질 판별이 된 임상 대상자 선정 절차에 따라 선별하였다. The constitution using the SCAT program before skin clinical trial (Korea Patent Publication No. 2012-0034475, JH DO. Et.al 2012, Development of an intefrated Sasang constitutional diagnosis method using face, body shape, voice, and questionnaire information 12:85) And the selection was made according to the procedure for selecting clinical subjects.
본 시험은 30~65세의 태음인 여성을 모집하였으며, 모집결과, 피험자 선정 기준에 부합하고 제외 기준에 부합하지 않는 태음인 여성 피험자 22명이 모집되었으며, 이들의 연령은 43~58세(평균 연령 49.05±3.77세)로 분포하였다.In this study, we recruited women who were taekwondo aged between 30 and 65. We recruited 22 women who did not meet the exclusion criterion. The age of the subjects was 43 ~ 58 years 3.77 years).
피부 주름은 더마프로 피부과학연구소의 SOP(standard operating procedure)에 따라 주름이 생성되기 시작하거나 이미 생성된 피험자를 대상으로 시험의 목적과 방법, 기대 효능과 이상반응을 설명하여 참여 의사를 보이는 자는 시험 참가 동의서를 작성하고 시험에 참여하도록 하였다.Skin wrinkles can be measured by examining the purpose and method of the test, expected efficacy and adverse reactions of subjects who have already begun to produce wrinkles according to the standard operating procedure (SOP) of Derma Pro skin science institute, I made a participation agreement and participated in the test.
태음인 인자 판별을 위해 시험 시작 전, 체질량 지수(BMI) 측정(Inbody 330, Biospace, Korea), 신체 둘레 측정, 사진촬영 및 사상체질 진단 설문평가를 진행하였고, 한국한의학 연구원의 사상체질 진단 프로그램(SCAT, Sasang Constitutional Analysis Tool)을 이용하여 태음인을 선정하였다.BMI (Inbody 330, Biospace, Korea), body circumference measurement, photographing, and sasang constitutional questionnaire evaluation were conducted before the start of the test. , Sasang Constitutional Analysis Tool).
- 체질을 대략 분류할 수 있는 설문문항 2-3개를 이용하여 임상 대상자 1차 필터링 시행하였다. - We performed the first-order filtering of clinical subjects using 2-3 questionnaires to roughly classify the constitution.
- 1차 필터링된 피험자를 대상으로 SCAT를 통하여 체질을 진단하였으며, 본 발명에 따르는 태음인 체질인 자를 선정하였다. - Primary screened subjects were screened for their constitution through SCAT, and the constitutional elements according to the present invention were selected.
- 피부 임상 기준 인원인 20명을 초과한 24명(20명+4명)를 최종 임상 시험 피험자로 선정하였다.- Twenty-four patients (20 +4) who exceeded 20 clinical criteria were selected as the final clinical trial subjects.
선정 과정에서 피험자마다 계산된 태음(TE), 소음(SE), 소양(SY) 체질 값 중 가장 높은 체질값(max(TE,SE,SY))과 두 번째로 높은 체질값(median(TE,SE,SY))의 차이가 큰 순서대로 정렬해서 태음인으로 판단된 24명을 선정하였다. The highest constitution (max (TE, SE, SY)) and the second highest constitution (median (TE, SE) SE, SY)) were selected in order of greatest difference.
[피험자 선정기준][Subject selection criteria]
하기에 기재한 바와 같은 조건에 부합되는 지원자를 시험 대상군으로 선정하였다. Candidates who meet the conditions described below were selected as test subjects.
- 30세 이상의 태음인으로 주 시험자의 판단에 따라 시험부위에 주름이 있는 자 - Those who are over 30 years old and have a wrinkle on the examination area as judged by the state tester.
- 피부질환을 포함하는 급, 만성 신체 질환이 없는 건강한 자- Healthy person who does not have acute and chronic physical illness including skin disease
- 시험에 앞서 시험의 목적, 내용 등에 대해 충분히 설명을 듣고 자발적으로 서면 동의서에 서명한 지원자- Applicants who voluntarily signed a written agreement before he / she has fully explained the purpose and contents of the examination prior to the examination
- 시험기간 동안 추적 관찰이 가능한 자
- Those who can follow up during the test
[피험자 제외기준][Subjects excluded]
하기에 기재된 항목에 해당되는 지원자는 시험 대상군에서 제외하였다.Applicants who fall under the items listed below are excluded from the test subjects.
- 임신, 수유 중 또는 6개월 이내에 임신을 계획하고 있는 경우- If you plan to become pregnant during pregnancy, lactation, or within 6 months.
- 피부질환의 치료를 위해 스테로이드가 함유된 피부 외형제를 1개월 이상 사용한 경우- For the treatment of skin diseases, the use of steroid-containing skin contour for over a month
- 동일한 시험에 참가한 뒤 6개월이 경과 되지 않은 경우- If six months have passed since you participated in the same test
- 민감성, 과민성 피부를 가진 경우- If you have sensitive, sensitive skin
- 시험부위에 점, 여드름, 홍반, 모세혈관 확장 등의 피부 이상 소견이 있는 경우- If there is skin abnormalities such as dots, acne, erythema, capillary dilatation on the test site
- 시험시작 3개월 이내에 시험부위에 동일 또는 유사한 화장품 또는 의약품을 사용한 경우- Using the same or similar cosmetics or medicines in the test site within 3 months of the start of the test
- 시험부위에 시술(박피술, 보톡스, 기타 피부관리 등)을 받거나 6개월 이내 계획한 경우- If you are receiving treatment (such as peeling, botox, other skin care) on the test site or planning within 6 months
- 만성 소모성 질환이 있는 경우 (천식, 당뇨, 고혈압 등)- In the case of chronic wasting disease (asthma, diabetes, hypertension, etc.)
- 그 외 주 시험자의 판단으로 시험이 곤란하다고 판단되는 경우
- In the case where it is determined that the test is difficult due to the judgment of the other state tester
[피험자 제한사항] [Subject Limitations]
피험자는 시험제품 이외의 기능성 화장품 혹은 의약품과의 혼용을 금하도록 하였고, 시험제품 외에 사용하는 기초 화장품은 기능성 성분이 없는 스킨, 로션만을, 메이크업 화장품은 베이스 메이크업(파운데이션, 파우더), 펜슬, 립스틱만을 사용하도록 하였으며, 선 크림 제품은 외출 시 반드시 사용하도록 하였다. 그리고, 방문(측정)시에는 색조 화장은 하지 않고 방문하도록 하였다.
The test subjects were prohibited from mixing with functional cosmetics other than the test products or medicines. In addition to the test products, the basic cosmetics to be used were skins without lotion, lotion only, makeup cosmetics with base makeup (foundation, powder), pencil, lipstick , And sun cream products should be used when going out. At the time of visit (measurement), it was visited without making a color tone.
[피험자 수 및 이에 대한 근거][Number of Subjects and Basis]
피험자 수는 기능성 화장품의 유효성 평가를 위한 가이드라인(2003, 2005), 화장품 표시, 광고 실증을 위한 시험방법 가이드라인(2013)에 준하여 20명 이상을 선정하여 시험을 시행하였다.
The number of subjects was 20 or more according to the guidelines for evaluating the effectiveness of functional cosmetics (2003, 2005), and the test method guidelines for cosmetics labeling and advertising demonstration (2013).
② 피부 주름의 육안 평가② Visual evaluation of skin wrinkles
육안 평가는 양측 눈가의 주름 상태에 대해 주름평가 기준에 의거 2인의 시험자가 일정한 조명하에 독립적으로 평가하였다. 각 평가 시점마다 주름 상태의 등급을 10단계(0.5점 단위) 로 기록하고, 시험자 2인의 평균값을 분석하였다(표 1).The naked eye evaluation was based on the wrinkle evaluation criteria for the wrinkle state of both eyes, and the two testers were independently evaluated under constant illumination. At each evaluation point, the degree of wrinkle condition was recorded in 10 steps (0.5 point unit) and the average value of the two testees was analyzed (Table 1).
③ 레플리카를 이용한 피부 주름 파라미터 평가③ Evaluation of skin wrinkle parameter using replica
피부 주름은 각 평가시점에서 Visioline? VL650 (C+K, Germany)을 이용하여 피부 레플리카 이미지를 분석하여 평가하였다. 이 측정기기는 제작한 SILFLO 레플리카를 기기내의 frame 에 장착하고, 레플리카에 35°의 각도로 빛을 투과시켜 이미지를 촬영한다. 촬영된 이미지는 녹색으로 그림자가 마크되며, 자동적으로 수치화하여 5가지의 주름 파라미터 [Rt(Skin roughness), Rm(Maximum roughness), Rz(Average roughness), Rp(Smoothness depth), Ra(Arithmetic Average roughness)]를 분석하였다.
Skin wrinkles were measured at each evaluation point by Visioline? VL650 (C + K, Germany) was used to analyze and evaluate skin replica images. This measuring instrument mounts the produced SILFLO replica on a frame in the instrument and records the image by transmitting light at an angle of 35 ° to the replica. The photographed image is marked with a shadow of green and is automatically digitized to form five wrinkle parameters Rt (Skin roughness), Rm (Maximum roughness), Rz (Average roughness), Rp (Smoothness depth) ) Was analyzed.
④ 사진 촬영④ Photography
각 평가 시점에서 안면 피부 촬영장치(VISIA? CR, Canfield, USA)를 이용하여 안면 좌, 우 측면을 촬영하였다.
At each evaluation point, the facial left and right side were photographed using a facial skin imaging device (VISIA? CR, Canfield, USA).
⑤ 피험자에 의한 설문평가⑤ Questionnaire evaluation by subject
제품의 효능에 관한 설문은 제품 사용 4주, 8주, 12주 후 평가시점에서 피험자로 하여금 5점 척도(1, 전혀 그렇지 않다; 2, 그렇지 않은 편이다; 3. 차이가 없다; 4. 그런 편이다; 5. 매우 그렇다)로 설문을 작성하도록 하였다. 또한 제품 사용성에 관한 설문은 제품 사용 12주 후 평가시점에서 5단계 척도(1, 전혀 좋지 않다; 2, 좋지 않은 편이다; 3, 보통이다; 4, 좋은 편이다; 5, 매우 좋다)로 실시하여, 피험자들이 작성한 긍정적인 답변(4, 좋은 편이다; 5, 매우 좋다)을 분석하였다.
The questionnaire on the efficacy of the product was used to assess the effect of the product on the 5-point scale (1, not at all, 2, not at all) at the 4, 8, 5. Very well) asked to complete the questionnaire. In addition, the questionnaire on product usability was conducted at 12 weeks after the product was used, at the 5-step scale (1, not at all good, 2, bad, 3, moderate, 4, good, 5, very good). (4, good; 5, very good).
⑥ 피부 안전성 평가⑥ Skin safety evaluation
제품 사용 4주, 8주, 12주 후 시점에서 문진과 시험자의 관찰을 통해 주관적 피부 자극감과 객관적 피부 자극을 평가하였다.
Subjective skin irritation and objective skin irritation were assessed by the interviewer and the examiner at 4, 8, and 12 weeks after use of the product.
4) 통계분석4) Statistical analysis
모든 데이터는 SPSS 패키지 프로그램(IBM, USA)을 이용하여 통계적 유의성을 검증하였으며, 육안평가의 경우 시험자 간 신뢰도 분석으로 ICC(Intraclass correlation coefficient) 분석을 수행하고, ICC 값이 0.8 이상이면 시험자 간의 신뢰도를 인정하여 시험자의 평균값을 적용하여 분석하였다. 또한 정규성은 첨도 (kurtosis)와 왜도(skewness)를, 사전 동질성은 paired t-테스트를 통해 검증하였다. All data were analyzed using the SPSS package program (IBM, USA). ICC (Intraclass correlation coefficient) analysis was performed by the interlaboratory reliability analysis for visual evaluation. And the mean value of the tester was applied. In addition, kurtosis and skewness were examined for normality and paired t-test for pre-homogeneity.
동일 피험자에게서 반복 측정한 데이터에 존재하는 상호의존성(교호작용), 군간 비교 및 시점별 전 후 변화를 확인하기 위해 반복측정 분산분석법(Repeated Measures ANOVA)을 적용하였다. 설문평가 분석 시 효능에 관한 설문평가는 두 군의 비모수적 평균 값을 비교하기 위해 Mann-Whitney U-테스트를 이용하였고, 제품 사용성 설문평가는 카이-스퀘어 테스트(Chi-Square test)를 이용하여 분석하였다. 각 통계학적 유의수준은 p 값이 0.05 미만인 것을 유의한 것으로 하였다.
Repeated Measures ANOVA was applied to identify interdependence, inter-group comparisons, and post-event changes in the repeated measures data from the same subjects. For the questionnaire evaluation, the Mann-Whitney U-test was used to compare the non-parametric mean values of the two groups, and the Chi-square test was used to evaluate the product usability questionnaire. Respectively. Each statistical significance level was p <0.05.
실시예Example 1. One. 황금Gold 및 And 나복자Napkin 추출물의 혼합물 제조 Preparation of a mixture of extracts
상기 [재료 및 방법]에 기재한 바와 같이 황금 및 나복자 추출물을 제조하여, 황금:나복자의 중량비가 1:9, 2:8, 3:7, 4:6, 5:5, 6:4, 7:3, 8:2 및 9:1이 되도록 혼합하여 혼합 추출물을 각각 제조하였다. The gold and nodule extracts were prepared as described in [Materials and Methods] above, and the weight ratio of gold: napkin was 1: 9, 2: 8, 3: 7, 4: 6, 5: 5, 6: 4, 7 : 3, 8: 2 and 9: 1, respectively, to prepare mixed extracts.
이후, 실시예에서는 본 실시예 1에서 제조한 혼합추출물을 이용하여 세포 생존률 및 MMP-1 발현량을 분석하였으며, 효과가 가장 우수한 혼합 추출물을 선정하여 태음인 22명을 대상으로 주름 개선효과를 분석하였다.
In the following examples, the cell survival rate and the amount of MMP-1 expression were analyzed using the mixed extracts prepared in Example 1, and the effect of improving wrinkles was analyzed in 22 Taeyumin .
실시예Example 2. 2. 황금Gold 및 And 나복자Napkin 혼합 추출물에 대한 세포 Cells for mixed extracts 생존률Survival rate 분석 analysis
상기 실시예 1에서 제조한 1:9, 2:8, 3:7, 4:6, 5:5, 6:4, 7:3, 8:2 및 9:1의 중량비가 되도록 혼합한 황금 및 나복자 혼합 추출물을 각각 HaCaT 세포(사람 각질형성 세포주)에 24시간 동안 처리하고, 자외선(UV Crosslinker, Ultra Lum)을 30분간 조사한 후, MTS 어세이를 수행한 결과, 도 1에 개시한 바와 같이, 황금 및 나복자 혼합 추출물의 혼합비에 따라 세포 생존률이 다르게 나타났으며, 자외선 조사에 의해 세포 생존률이 55.3%로 감소하였고, 혼합비가 4:6인 황금 및 나복자 혼합 추출물 100㎍/㎖을 처리한 경우, 세포 생존률이 94.1%이고, 200㎍/㎖을 처리한 경우, 세포 생존률이 112.8%로 나타났다.The weight ratio of the gold and silver particles prepared in Example 1 to be mixed at a weight ratio of 1: 9, 2: 8, 3: 7, 4: 6, 5: 5, 6: 4, 7: 3, 8: As shown in FIG. 1, when the crude extracts were treated with HaCaT cells (human keratinocyte) for 24 hours and irradiated with ultraviolet light (UV Crosslinker, Ultra Lum) for 30 minutes, The survival rate was decreased to 55.3% by ultraviolet irradiation. When 100 ㎍ / ㎖ of mixed extracts of gold and napalm were treated with 4: 6 mixture ratio, The cell viability was 94.1%, and when treated with 200 μg / ml, the cell viability was 112.8%.
한편, 황금 추출물을 단독으로 처리한 경우, 세포 생존률은 55.1~57.6%이었으며, 나복자 추출물을 단독 처리하였을 경우, 세포 생존률은 31.6~34.6%로 나타났다(도 1).
On the other hand, the cell survival rate was 55.1 ~ 57.6% when the gold extract was treated alone, and the cell survival rate was 31.6 ~ 34.6% when the extract was treated alone (Fig. 1).
실시예Example 3. 3. 황금Gold 및 And 나복자Napkin 혼합 추출물의 Mixed extract MMPMMP -1의 발현량에 대한 효과-1 on the expression level
콜라겐 분해 효소(MMPs; matrix metalloproteinases)는 세포외기질(extracellular matrix)과 기저막(basement membrane)의 분해에 관여함으로써, 콜라겐 감소에 영향을 미치는 효소이다. Collagen degradation enzymes (MMPs) are involved in the degradation of the extracellular matrix and basement membrane, thereby affecting collagen degradation.
본 실시예 3에서는 콜라겐 감소에 중요한 영향을 미치는 콜라겐 분해 효소(MMPs; matrix metalloproteinases)의 발현량의 변화를 분석함으로써, 본 발명의 유효성분인 황금 및 나복자 추출물의 혼합물의 주름개선 효과가 있는지 여부를 확인하였다. In Example 3, the change in the amount of expression of collagenase (MMPs), which has an important influence on collagen reduction, is analyzed to determine whether or not a wrinkle-improving effect of a mixture of gold and napalmia extracts Respectively.
도 2에 개시한 바와 같이, 자외선을 조사하지 않은 세포에서는 MMP-1의 발현량이 매우 낮았으나, 자외선 조사에 의해 MMP-1의 발현이 현저하게 증가하였다는 것을 확인할 수 있었고, 본 발명의 황금 및 나복자 추출물을 비율별로 혼합하여 처리한 경우 MMP-1의 발현량이 현저하게 감소하였다. 특히, 황금 추출물 대 나복자 추출물이 4:6의 비율로 혼합된 경우, 거의 자외선을 조사하지 않았을 때와 거의 동일하게 MMP-1이 발현되고 있음을 확인함으로써, 본 발명의 유효성분은 주름개선에 효과가 있을 것으로 판단하였다.
As shown in FIG. 2, although the expression level of MMP-1 was extremely low in cells not irradiated with ultraviolet rays, it was confirmed that the expression of MMP-1 was remarkably increased by ultraviolet irradiation, The expression of MMP-1 was remarkably decreased when the crude extract was mixed at a ratio of 1: 1. In particular, when the extract of golden and larvae was mixed at a ratio of 4: 6, it was confirmed that MMP-1 was expressed almost in the same manner as when almost no ultraviolet light was irradiated. Thus, .
실시예Example 4. 4:6의 중량비로 혼합한 4. Mixed in a weight ratio of 4: 6 황금Gold 및 And 나복자Napkin 혼합 추출물을 포함하는 시험제품을 이용한 임상 시험 Clinical trials with test products containing mixed extracts
본 실시예 4에서는 상기 실시예 2 및 3의 결과를 바탕으로, 가장 효과가 우수한 4:6의 중량비로 혼합한 황금 및 나복자 혼합 추출물을 포함하는 시험제품을 제조하고, 이를 22명의 태음인에게 적용하는 임상시험을 실시하였다. In Example 4, based on the results of Examples 2 and 3, a test product containing a mixture of gold and nevus mixed extracts at a weight ratio of 4: 6, which is most effective, was prepared and applied to 22 taeeumin Clinical trials were conducted.
본 시험은 제외기준 및 선정기준에 준하는 43~58세의 여성 피험자 총 24명이 참여하였으나 2명(#12:개인사정, #13; 추적관찰 실패)이 탈락하여 총 22명(평균 50.43±3.92세)의 피험자가 시험 종료 시까지 전 과정을 성실히 수행하였다. 피험자의 피부 특성은 설문에 의해 조사하였다.A total of 24 female subjects aged 43-58 years who participated in the exclusion and selection criteria participated in the study. Two subjects (# 12: personal assessment, # 13; failure to follow up) were withdrawn and a total of 22 subjects (mean 50.43 ± 3.92 years ) Performed satisfactorily until the end of the study. The subjects' skin characteristics were investigated by questionnaire.
22명 중에서 그룹 A는 본 발명의 유효성분인 4:6의 황금 및 나복자 혼합 추출물을 함유하는 시험군이고, 그룹 B는 대조군으로 본 발명의 유효성분을 함유하지 않은 제품을 사용한 그룹이다. 하기 표 2 내지 4에 임상 시험에 참여한 시험군(A)와 대조군(B)의 정보, 피부타입 및 피부 상태를 개시하였다.Among the 22 groups, Group A is a test group containing a gold and napalmia mixed extract of 4: 6 which is an active ingredient of the present invention, and Group B is a group using a product containing no active ingredient of the present invention as a control group. Tables 2 to 4 below provide information on the test group (A) and the control group (B) participating in the clinical trial, skin type and skin condition.
(Skin type)Skin type
(Skin type)
(Surface)Surface condition
(Surface)
(Thickness)thickness
(Thickness)
(Duration of UV exposure)UV exposure time
(Duration of UV exposure)
(Sleeping hours)Sleep time
(Sleeping hours)
(Smoking)Smoking
(Smoking)
(Irritability)Stimulation sensitivity
(Irritability)
(Stinging)Sting sensitivity
(Stinging)
(Adverse reaction)Adverse experience
(Adverse reaction)
1) 피부 주름의 육안평가 분석1) Visual evaluation of skin wrinkles
본 실시예에서는 상기한 바와 같이 제품을 적용 전과 적용 4주 후, 8주 후, 12주 후에 시험군과 대조군의 피부를 육안 평가 비교하였으며, 그 결과 8주 후 시점에서부터 시험군이 대조군에 비해 눈가 주름이 유의하게 개선되었음을 확인하였다(표 5 및 도 4).In this example, the skin of the test group and the control group were compared before and 8 weeks after application and after 12 weeks of application, and as a result, after 8 weeks, Wrinkles were significantly improved (Table 5 and Fig. 4).
*: p값이 0.05 미만인 경우, 시험군과 대조군 사이에 유의하게 차이가 있다는 것을 의미한다.
*: If the p value is less than 0.05, it means that there is a significant difference between the test group and the control group.
2) 레플리카를 이용한 피부 주름 파라미터 분석2) Analysis of skin wrinkle parameters using replica
Rt 및 Rm 파라미터는 제품 사용 4주 이후 시점부터 시험군이 대조군에 비해 유의하게 개선되었음을 확인하였고(표 6, 도 5 및 도 6), Rz 및 Rp 파라미터는 제품 사용 8주 이후 시점부터 시험군이 대조군에 비해 유의하게 개선되었음을 확인하였으며(표 6, 도 7 및 도 8), Ra 파라미터는 제품 사용 12주 시점부터 시험군이 대조군에 비해 유의하게 개선되었음을 확인하였다(표 6 및 도 9) . The Rt and Rm parameters were significantly improved in the test group from the 4th week after the product use (Table 6, FIG. 5 and FIG. 6) (Table 6, Fig. 7 and Fig. 8). It was confirmed that the Ra parameter was significantly improved in the test group from the 12th week of use of the product compared to the control group (Table 6 and Fig. 9).
*: p값이 0.05 미만인 경우이고, 시험군과 대조군 사이에 유의하게 차이가 있다는 것을 의미한다.
*: p value less than 0.05, meaning that there is a significant difference between the test group and the control group.
3) 피부 안전성 평가3) Skin safety evaluation
본 시험기간 동안 모든 피험자에게서 피부 이상반응은 관찰되지 않았다. 따라서 본 발명의 유효성분은 독성 또는 부작용이 없는 것으로 판단하였다(표 7).No skin adverse events were observed in all subjects during the study period. Therefore, it was judged that the active ingredient of the present invention had no toxicity or side effects (Table 7).
자극감
(Subjective irritation)Subjective
Irritability
(Subjective irritation)
자극
(Objective
Irritation)Objective
Stimulation
(Objective
Irritation)
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