KR20220129789A - Composition Comprising Cimifugin for Wound Healing - Google Patents
Composition Comprising Cimifugin for Wound Healing Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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Abstract
Description
본 발명은 시미푸긴을 포함하는 상처 치료용 조성물에 관한 것이다.The present invention relates to a composition for treating wounds comprising simipugin.
우리 몸에서 피부는 여러 가지 기능을 담당하고 있으며, 그 중에서도 가장 중요한 기능은 외부로부터 우리의 몸을 보호하는 장벽 역할이라고 할 수 있다. 피부의 정상적인 구조가 파괴된 상태를 창상 혹은 상처라고 한다. 이와 같이 피부가 상처를 입게 되면 상처 부위가 노출되어 외부 균의 침입을 받을 수 있다. 따라서, 신속한 상처치료가 되어야 추가 감염(infection)을 막을 수 있고 또한, 그로 인한 과도한 염증반응(inflammation)을 막을 수 있다. 과도한 염증반응은 상처치유 기간을 연장시킬 뿐 아니라 흉터의 원인이 되기도 한다.In our body, the skin is in charge of various functions, and the most important function among them is the role of a barrier that protects our body from the outside. A condition in which the normal structure of the skin is destroyed is called a wound or wound. When the skin is injured in this way, the wound site is exposed and can be invaded by external bacteria. Therefore, it is possible to prevent additional infection and also to prevent excessive inflammatory reaction (inflammation) resulting therefrom only when the wound is treated promptly. Excessive inflammatory response not only prolongs the healing period but also causes scarring.
상처치유(wound healing)란 임상적으로 피부가 완전하게 봉합되는 것을 의미하며, 만성상처(chronic wound)가 아닌 일반적인 상처는 대략 3-14일 안에 완전히 치유된다. 상처치유는 각질세포(keratinocyte), 섬유아세포 (fibroblast), 혈관내피세포(endothelial cell), 대식세포(macrophage), 혈소판(platelet) 등 여러 종류의 세포가 상호작용하면서 조절하는 복잡한 과정으로 이루어진다.Wound healing means that the skin is completely sutured clinically, and normal wounds that are not chronic wounds heal completely within about 3-14 days. Wound healing consists of a complex process controlled by interaction of several types of cells, such as keratinocytes, fibroblasts, endothelial cells, macrophages, and platelets.
스테로이드제제는 면역억제를 통하여 피부염증을 조절해주지만, 각질형성세포의 증식을 억제하거나, 세포증식을 억제함으로써 상처치유를 지연시킨다. 이와 같이, 스테로이드제 등으로 인하여 상처 치료가 지연되면 2차 감염 등 다른 위험이 증가하게 되므로, 상처치료제의 개발은 여전히 필요한 실정이다.Steroids control skin inflammation through immunosuppression, but delay wound healing by inhibiting the proliferation of keratinocytes or inhibiting cell proliferation. As such, when wound treatment is delayed due to steroids, etc., other risks such as secondary infection increase, so the development of a wound treatment agent is still necessary.
일 양상은 시미푸긴(Cimifugin)을 포함하는 상처 치료용 약학적 조성물을 제공하는 것이다. One aspect is to provide a pharmaceutical composition for the treatment of wounds comprising simifugin (Cimifugin).
다른 양상은 시미푸긴(Cimifugin)을 포함하는 상처 치료 촉진용 의약외품 조성물을 제공하는 것이다. Another aspect is to provide a quasi-drug composition for promoting wound healing comprising Cimifugin.
일 양상은 시미푸긴(Cimifugin)을 포함하는 상처 치료용 약학적 조성물을 제공하는 것이다. One aspect is to provide a pharmaceutical composition for the treatment of wounds comprising simifugin (Cimifugin).
상기 시미푸긴은 중국의 약초인 방풍에 포함되어 있는 성분으로, 하기 화학식과 같은 물질일 수 있다. The simipugin is a component included in the Chinese herbal medicine, windbreak, and may be a substance represented by the following chemical formula.
상기 상처는 외부의 압력 등에 의한 피부 상피조직의 온전함이 파괴되는 것을 나타내는 의미로서, 창상(創傷)이라고도 할 수 있다. 상기 상처의 종류로는 찰과상, 타박상, 열상, 칼날에 의한 절창, 자창(刺創), 할창(割創), 총창(銃創), 폭창, 교창(咬創) 등이 있으나, 이에 제한되지 않는다.The wound means that the integrity of the skin epithelial tissue is destroyed by external pressure, etc., and may also be referred to as a wound (創傷). The types of wounds include, but are not limited to, abrasions, bruises, lacerations, cuts by a knife, cuts, spears, spears, spears, spears, and the like.
일 구체예에 따르면, 상기 상처는 스테로이드제로 인하여 상처치유가 지연된 상처일 수 있다. 상기 스테로이드제제로 인하여 지연된 상처는 스테로이드제제가 각질형성세포의 증식을 억제하거나, 세포증식을 억제함으로써 지연되는 것일 수 있다. 상기 상처치유가 지연된 상처는 스테로이드제를 사용하여 상처가 지연된 것일 수 있고, 스테로이드제를 지속하여 사용하고 있어 상처 치유의 지연이 진행되고 있는 상처일 수 있다. According to one embodiment, the wound may be a wound in which wound healing is delayed due to a steroid agent. The wound delayed due to the steroid agent may be delayed by the steroid agent inhibiting the proliferation of keratinocytes or inhibiting cell proliferation. The wound in which the wound healing is delayed may be a wound in which the wound is delayed by using a steroid, or a wound in which the wound healing is delayed due to the continuous use of the steroid.
일 구체예에 따르면, 상기 스테로이드제는 부신피질호르몬제, 남성호르몬제, 여성호르몬제일 수 있으나, 예를 들면 부신피질호르몬제 일 수 있다. 상기 부신피질호르몬제는 항염증 효과 및 면역억제효과를 가지는 약물로, 발적, 부종, 열감, 압통 등의 증상을 현저히 감소시킬 수 있는 제제일 수 있으며, 신체의 면역기능이 저하되어 세균 감염이 잘 유발되거나 악화되는 부작용이 나타날 수 있다. 상기 부신피질호르몬제는 덱타메타손, 히드로코르티손, 프레드니솔론, 베타메타손일 수 있으나, 이에 제한되지 않는다.According to one embodiment, the steroid agent may be a corticosteroid agent, a male hormone agent, or a female hormone agent, but may be, for example, a corticosteroid agent. The adrenocortical hormone agent is a drug having an anti-inflammatory effect and an immunosuppressive effect, and may be an agent that can significantly reduce symptoms such as redness, edema, heat, tenderness, etc. Side effects may be induced or exacerbated. The corticosteroid agent may be dextamthasone, hydrocortisone, prednisolone, or betamethasone, but is not limited thereto.
일 실시예에 따르면, 스테로이드제를 처리한 상처의 경우, 상처치유가 되지 않았으며, 스테로이드제를 처리한 상처에 시미푸긴을 사용한 경우 스테로이드제만 처리한 상처 대비 현저히 상처치유가 진행되는 것을 확인하였다. According to one embodiment, in the case of wounds treated with steroids, wound healing did not occur, and when simipugin was used for wounds treated with steroids, it was confirmed that wound healing progressed significantly compared to wounds treated with only steroids. .
상기 '상처 치료'는 상처치유와 동등한 의미일 수 있으며, 파괴된 피부의 상피조직이 온전해지는 모든 과정을 포함하는 의미이다.The 'wound treatment' may have the same meaning as wound healing, and includes all processes in which the epithelial tissue of the destroyed skin is intact.
한편, 본 발명의 약학적 조성물은 각각 통상의 방법에 따라 다양한 형태로 제형화하여 사용될 수 있다. 예컨대, 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽 등의 경구형 제형으로 제형화할 수 있고, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. 다만, 본 발명의 조성물은 상처 치료라는 목적상 피부 외용제의 형태로 제공되는 것일 수 있다. 예를 들면, 액제, 연고제, 크림제, 로션제, 스프레이제, 패취제, 겔제 또는 에어로졸제 등의 피부 외용제의 형태로 사용될 수 있다.On the other hand, the pharmaceutical composition of the present invention can be formulated in various forms according to a conventional method, respectively, and used. For example, it may be formulated in oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, and syrups, and may be formulated in the form of external preparations, suppositories, and sterile injection solutions. However, the composition of the present invention may be provided in the form of a skin external preparation for the purpose of wound treatment. For example, it may be used in the form of external preparations for skin, such as liquids, ointments, creams, lotions, sprays, patches, gels, or aerosols.
또한, 각각의 제형에 따라 약학적으로 허용 가능한 담체, 예컨대 완충제, 보존제, 무통화제, 가용화제, 등장제, 안정화제, 기제, 부형제, 윤활제 등 당업계에 공지된 담체를 추가로 포함하여 제조할 수 있다. 예컨대, 상처 부위에 국부적으로 사용되는 피부 외용제인 경우에는 통상적인 첨가제, 예를 들어 보존제, 의약 침투를 보조하는 용매, 연고 및 크림의 경우 연화제 등을 포함할 수 있으며, 에탄올 또는 올레일 알코올과 같은 통상적 담체를 함유할 수 있다. In addition, according to each dosage form, a pharmaceutically acceptable carrier, such as a buffer, preservative, analgesic agent, solubilizer, isotonic agent, stabilizer, base, excipient, lubricant, etc., may be prepared by further including a carrier known in the art. can For example, in the case of an external preparation for skin used locally on a wound site, it may include conventional additives, for example, a preservative, a solvent to aid drug penetration, and an emollient in the case of ointments and creams, such as ethanol or oleyl alcohol. It may contain conventional carriers.
또한, 본 발명의 약학적 조성물에는, 상처 치료에 일반적으로 사용되는 화합물, 예컨대 항생제, 피부 치료용 조제, 마취제 및 진통제 등을 추가로 포함할 수 있다. 이는, 각각의 제형에 따라 약간씩 변화될 수 있으며, 바람직하게는 피부 외용제의 형태로 제공되는 경우에 포함될 수 있으나, 이에 제한되는 것은 아니다. 일반적으로, 상처부위의 감염을 방지하거나 감염으로 인한 상처의 악화를 방지하기 위하여 상처부위에 항생제, 항균제 등의 약제를 공급할 수 있고, 또한 통증의 완화를 위하여 국소 마취제 및 진통제 등을 공급할 수 있다. 다양한 기능성 약제들을 함유시켜 공급함으로써, 사용상의 편리성을 도모하고, 효율적인 상처치유에 도움이 되는 환경을 조성함으로써 상처치유 효과를 더욱 향상시킬 수 있다.In addition, the pharmaceutical composition of the present invention may further include a compound commonly used for wound treatment, such as antibiotics, skin treatment preparations, anesthetics and analgesics. This may vary slightly depending on each formulation, and may preferably be included when provided in the form of an external preparation for skin, but is not limited thereto. In general, in order to prevent infection of the wound site or to prevent deterioration of the wound due to infection, drugs such as antibiotics and antibacterial agents may be supplied to the wound site, and a local anesthetic and analgesic may be supplied to relieve pain. By containing and supplying various functional drugs, it is possible to promote convenience in use and to further improve the wound healing effect by creating an environment conducive to effective wound healing.
한편, 본 발명의 약학적 조성물은 약학적으로 유효한 양으로 투여한다. 본 발명의 용어 "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분하며 부작용을 일으키지 않을 정도의 양을 의미하며, 유효용량 수준은 환자의 건강상태, 상처의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 방법, 투여 시간, 투여 경로 및 배출 비율, 치료기간, 배합 또는 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다.On the other hand, the pharmaceutical composition of the present invention is administered in a pharmaceutically effective amount. As used herein, the term "pharmaceutically effective amount" refers to an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and not to cause side effects, and the effective dose level depends on the patient's health condition, The type of wound, severity, drug activity, sensitivity to drug, administration method, administration time, administration route and rate of excretion, duration of treatment, factors including drugs used in combination or concomitantly, and other factors well known in the medical field. can
다른 양상은 시미푸긴(Cimifugin)을 포함하는 상처 치료 촉진용 의약외품 조성물을 제공하는 것이다. Another aspect is to provide a quasi-drug composition for promoting wound healing comprising Cimifugin.
상기 시미푸긴, 상처, 및 시미푸긴의 상처 치료 효능에 대해서는 상기 설명한 바와 같으며, 본 발명의 조성물은 상처의 치료 또는 개선 목적으로 의약외품에 첨가될 수 있다. The simipugin, wounds, and wound healing efficacy of simipugin are as described above, and the composition of the present invention may be added to quasi-drugs for the purpose of treating or improving wounds.
상기 '상처 치료 촉진'은 상처치유 촉진과 동일한 의미일수 있으며, 파괴된 피부의 상피조직이 온전해지는 모든 과정이 촉진되는 것을 포함하는 의미이다.The 'promoting wound healing' may have the same meaning as accelerating wound healing, and includes promoting all processes in which the epithelial tissue of the destroyed skin is intact.
상기 '의약외품'은 사람이나 동물의 질병을 치료, 경감, 처치 또는 예방할 목적으로 사용되는 섬유, 고무제품 또는 이와 유사한 것, 인체에 대한 작용이 약하거나 인체에 직접 작용하지 아니하며, 기구 또는 기계가 아닌 것과 이와 유사한 것, 감염병 예방을 위하여 살균, 살충 및 이와 유사한 용도로 사용되는 제제 중 하나에 해당하는 물품으로서, 사람이나 동물의 질병을 진단, 치료, 경감, 처치 또는 예방할 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것 및 사람이나 동물의 구조와 기능에 약리학적 영향을 줄 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것을 제외한 물품을 의미한다.The above 'quasi-drugs' refer to fibers, rubber products, or the like, which are used for the purpose of treating, alleviating, treating or preventing diseases of humans or animals, have weak effects on the human body or do not directly act on the human body, and are not instruments or machines. Items similar to those used for sterilization, insecticide and similar purposes for the prevention of infectious diseases , refers to items other than instruments, machines, or devices, which are not machines or devices, and items used for the purpose of pharmacologically affecting the structure and function of humans or animals.
본 발명의 조성물을 의약외품 첨가물로 사용할 경우, 상기 조성물을 그대로 첨가하거나 다른 의약외품 또는 의약외품 성분과 함께 사용할 수 있고, 통상적인 방법에 따라 적절하게 사용할 수 있다. 유효성분의 혼합량은 사용 목적에 따라 적합하게 결정될 수 있다.When the composition of the present invention is used as a quasi-drug additive, the composition may be added as it is or used together with other quasi-drugs or quasi-drug ingredients, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be suitably determined according to the purpose of use.
본 발명의 의약외품 조성물은 이에 제한되지는 않으나, 바람직하게는 소독청결제, 샤워폼, 구강 청정제(가그린), 물티슈, 세제비누, 핸드워시, 가습기 충진제, 마스크, 연고제 또는 필터충진제일 수 있다.The quasi-drug composition of the present invention is not limited thereto, but preferably disinfectant cleaner, shower foam, mouth freshener (Gagreen), wet tissue, detergent soap, hand wash, humidifier filler, mask, ointment or filter filler.
본 발명에 따른 시미푸긴을 포함하는 조성물을 사용할 경우, 상처 치료 효능이 뛰어나므로, 상처 치료를 위한 피부 외용제를 비롯한 의약품 등에 적용되어 사용될 수 있을 것이다.When the composition containing simipugin according to the present invention is used, since it has excellent wound healing efficacy, it may be applied to and used in pharmaceuticals, including external preparations for wound treatment.
도 1은 각 처리군의 상처를 사진으로 확인한 데이터이다.
도 2는 각 처리군의 상처 크기를 그래프로 나타낸 데이터이다.1 is data confirming the wounds of each treatment group with a photograph.
2 is a graph showing the wound size of each treatment group.
이하 하나 이상의 구체예를 실시예를 통해 보다 상세하게 설명한다. 그러나, 이들 실시예는 하나 이상의 구체예를 예시적으로 설명하기 위한 것으로 본 발명의 범위가 이들 실시예에 한정되는 것은 아니다. Hereinafter, one or more specific embodiments will be described in more detail through examples. However, these examples are for illustrative purposes of one or more embodiments, and the scope of the present invention is not limited to these examples.
실시예 1. 스테로이드 및 시미푸긴 준비Example 1. Steroid and Simipugin Preparation
상처에 스테로이드를 처리하기 위하여, 아세톤에 덱사메타손(Dexamethasone, (DEX), sigma Aldrich, Korea)을 0.1% 로 희석하여 준비하였다. 농도에 따른 상처 치료 정도를 확인하기 위하여, 바세린 50μg에 시미푸긴(Cimifugin, Chemfaces, Korea)을 0.01% 또는 0.1%로 희석하여 준비하였다. In order to treat the wound with steroids, dexamethasone (DEX), sigma Aldrich, Korea) was diluted to 0.1% in acetone and prepared. In order to check the degree of wound healing according to the concentration, it was prepared by diluting simifugin (Cimifugin, Chemfaces, Korea) to 0.01% or 0.1% in 50 μg of vaseline.
실시예 2. 상처 치료 확인 Example 2. Confirmation of wound healing
모든 동물 실험은 동국대학교 실험동물운영위원회 승인 프로토콜(승인번호 IACUC-2017-015) 하에 실험을 수행하였으며, 실험동물은 5주령 수컷 BALB/c 마우스(코아텍, 서울)를 사용하였다. 마우스는 6 마리씩 4 그룹(대조군, 스테로이드 처리군, 스테로이드 및 시미푸긴 0.01% 처리군, 스테로이드 및 시미푸긴 0.1% 처리군)으로 무작위로 나누어 실험 하였다. All animal experiments were carried out under the protocol approved by the Dongguk University Laboratory Animal Steering Committee (approval number IACUC-2017-015), and 5-week-old male BALB/c mice (Coatec, Seoul) were used as experimental animals. Mice were randomly divided into 4 groups of 6 mice each (control group, steroid treatment group, steroid and simipugin 0.01% treatment group, steroid and simipugin 0.1% treatment group).
상처 재생 실험을 위하여, 각 그룹의 마우스 등을 면도한 후 직경 5mm 생검펀치(Kai Group, Seki, Japan)로 피부 결손을 만들었다. 실시예 1에서 준비한 덱사메타손을 대조군을 제외한 모든 그룹의 상처에 같은 양으로 14일간 매일 도포하였다. 또한, 스테로이드 및 시미푸긴 0.1% 또는 0.01% 처리군에는 희석한 시미푸긴을 각 상처에 같은 양으로 14일간 매일 도포하였다. 상처의 크기는 피부를 결손 시킨 당일, 7일째, 14일째에 측정하여 평균으로 계산하였다. For the wound regeneration experiment, after shaving the back of each group of mice, skin defects were made with a 5 mm diameter biopsy punch (Kai Group, Seki, Japan). Dexamethasone prepared in Example 1 was applied daily for 14 days in the same amount to the wounds of all groups except the control group. In addition, in the steroid and simipugin 0.1% or 0.01% treatment groups, diluted simipugin was applied to each wound in the same amount every day for 14 days. The size of the wound was measured on the day of skin defect, on the 7th, and on the 14th, and calculated as an average.
그 결과, 도 1 및 도 2에서 보이는 바와 같이, 대조군의 상처의 크기는 7일차부터 눈에 띄게 작아져 14일차에는 약 1.5 mm 정도로 현저히 작아지는 것을 확인하였다. 반면, 스테로이드를 처리한 군들은 7일차까지는 큰 변화가 나타나지 않았으나, 14일차에는 시미푸긴을 처리한 군의 상처가 스테로이드만 처리한 군의 상처 대비 현저히 작아지는 것을 확인하였다. As a result, as shown in FIGS. 1 and 2 , it was confirmed that the size of the wound in the control group became noticeably smaller from the 7th day and significantly decreased to about 1.5 mm on the 14th day. On the other hand, the steroid-treated group did not show any significant change until the 7th day, but on the 14th day, it was confirmed that the wounds of the simipugin-treated group were significantly smaller than the wounds of the steroid-treated group.
Claims (5)
A pharmaceutical composition for wound treatment comprising Cimifugin.
상기 상처는 스테로이드제로 인하여 상처치유가 지연된 상처인,
상처 치료용 약학적 조성물.
The method of claim 1,
The wound is a wound in which wound healing is delayed due to steroids,
A pharmaceutical composition for the treatment of wounds.
상기 스테로이드제는 부신피질호르몬제, 남성호르몬제, 여성호르몬제인,
상처 치료용 약학적 조성물.
3. The method of claim 2,
The steroid is a corticosteroid, male hormone, female hormone,
A pharmaceutical composition for the treatment of wounds.
상기 조성물은 액제, 연고제, 크림제, 로션제, 스프레이제, 패취제, 겔제 또는 에어로졸제인 것을 특징으로 하는,
상처 치료용 약학적 조성물.
The method of claim 1,
The composition is characterized in that it is a liquid, ointment, cream, lotion, spray, patch, gel or aerosol agent,
A pharmaceutical composition for the treatment of wounds.
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