KR101771364B1 - Pharmaceutical composition for the prevention or treatment of lung cancer comprising sanggenol Q - Google Patents
Pharmaceutical composition for the prevention or treatment of lung cancer comprising sanggenol Q Download PDFInfo
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- KR101771364B1 KR101771364B1 KR1020160091399A KR20160091399A KR101771364B1 KR 101771364 B1 KR101771364 B1 KR 101771364B1 KR 1020160091399 A KR1020160091399 A KR 1020160091399A KR 20160091399 A KR20160091399 A KR 20160091399A KR 101771364 B1 KR101771364 B1 KR 101771364B1
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- lung cancer
- sanggenol
- pharmaceutical composition
- treatment
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Abstract
Description
본 발명은 폐암의 예방 또는 치료용 약학적 조성물에 관한 것이다. The present invention relates to a pharmaceutical composition for preventing or treating lung cancer.
우리나라 사람들에게 가장 많이 발생하는 암은 위암, 대장암, 폐암, 갑상선암, 간암이다. 국가 암 발생 통계를 기초로 살펴보면 평생 암에 걸릴 확률이 남성은 3명 중 1명, 여성은 4명 중 1명으로 분석되는 등 암 발생에 대한 위험이 높아지고 있다. 특히 폐암의 경우, 산업화에 따른 대기오염의 악화와 함께 흡연자의 증가, 특히 청소년과 여성들의 흡연 증가 추세로 볼 때 폐암 환자는 더욱 많아질 것으로 예상된다. 미국의 경우도 암 관련 사망 가운데 남녀 모두에게 폐암은 가장 흔한 원인이다. The most common cancer in Korea is gastric cancer, colorectal cancer, lung cancer, thyroid cancer, and liver cancer. Based on national cancer incidence statistics, the risk of developing cancer is increasing, as one in three men and one in four women are diagnosed with a lifetime cancer risk. Especially, in the case of lung cancer, it is expected that the number of lung cancer patients will be increased in view of the deterioration of air pollution caused by industrialization, and the increase of smokers, especially the increase of smoking among adolescents and women. In the United States, lung cancer is the most common cause of cancer-related deaths for both men and women.
주요 형태의 폐암은 소세포 폐암(SCLC) 및 비소세포 폐암(NSCLC)이다. 소세포 폐암(SCLC)은 신속히 성장하는 유형의 폐암이다. 이는 비소세포 폐암보다 훨씬 더 빨리 퍼진다. 소세포 암종(연맥 세포 암), 혼합 소세포/대세포 암종 및 복합 소세포 암종의 3가지 상이한 유형의 소세포 폐암이 존재한다. 대부분의 소세포 폐암은 연맥 세포 유형이다. 비소세포 폐암(NSCLC)은 가장 흔한 유형의 폐암이다. 선암, 편평상피세포암(squamous cell acrcinoma) 및 대세포암(large-cell carcinoma)의 3가지 형태의 NSCLC가 존재한다. 선암은 폐말초 부위에서 주로 발생하고, 여성 또는 비흡연자에게서도 잘 발생하며, 크기가 작아도 전이가 되어 있는 경우가 많고, 최근 그의 발생 빈도가 증가하는 추세에 있다. 다음으로, 편평상피세포암은 주로 폐 중심부에서 발견되고, 주로 기관지 내강으로 자라 기관지를 막는 증상을 나타내며, 남성에게 흔하고, 흡연과 밀접하게 관련된 것으로 알려져 있다. 대세포암은 폐표면 근처(폐 말초)에서 주로 발생하고, 절반 가량은 큰 기관지에서 발생하며, 전체 폐암의 4 내지 10% 정도를 차지하고, 세포 크기가 대체적으로 크며, 그 중 일부는 빠르게 증식 및 전이되는 경향이 있어 다른 비소세포폐암에 비해 예후가 나쁜 것으로 알려져 있다. 폐암에 대한 통상의 치료는 완화 처치, 수술, 화학요법 및 방사선요법을 포함한다. The major forms of lung cancer are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Small cell lung cancer (SCLC) is a rapidly growing type of lung cancer. It spreads much faster than non-small cell lung cancer. There are three different types of small cell lung cancer: small cell carcinoma (ochocardiocarcinoma), mixed small cell / large cell carcinoma and multiple small cell carcinoma. Most small cell lung cancer is ovarian cell type. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. There are three types of NSCLC: adenocarcinoma, squamous cell acinoma, and large-cell carcinoma. Adenocarcinoma occurs mainly in the lung peripheral region, occurs well in women or nonsmokers, and is often metastasized even when the size is small. Recently, the incidence of adenocarcinoma is increasing. Next, squamous cell carcinoma is found mainly in the central lung, and it is known to grow up to the lumen of the bronchial tree, blocking the airway, is common to men, and is closely related to smoking. Large cell carcinomas occur predominantly in the lungs near the lungs (peripheral lungs), about half in large bronchi, accounting for 4 to 10% of all lung cancers, with generally large cell size, It is known that the prognosis is worse than other non - small cell lung cancer. Conventional treatments for lung cancer include palliative care, surgery, chemotherapy, and radiation therapy.
상기와 같은 폐암이 조기에 진단될 경우에는, 약물치료 및 방사선 치료등을 통해 회복될 수 있으나, 일정 수준으로 병증이 악화된 경우에는 수술을 통해 병변을 제거하고, 약물치료 및 방사선 치료등을 통한 치료를 수행하게 된다. 그런데, 아직까지는 폐암의 치료에 사용될 수 있도록 공인된 약물은 이레사 등을 비롯한 몇가지로 제한되어 있어 환자에게 적합한 치료를 수행하기 어렵고, 이들 치료제는 무시할 수 없는 수준의 부작용을 나타낸다는 단점이 있어, 수술 이후의 치료성공율이 저조한 실정이다. 이러한 단점을 극복하기 위하여, 부작용을 줄일 수 있는 복합 천연물로부터 유래된 치료제를 개발하려는 노력이 계속되고 있으나, 이들 천연물 유래 치료제는 치료효과가 우수하지 못하다는 근본적인 단점이 해소되지 않고 있다. When lung cancer is diagnosed at an early stage, it can be recovered through drug therapy or radiation therapy. However, if the disease progresses to a certain level, the lesion is removed through surgery, and medication and radiation therapy Treatment is performed. However, since the drugs approved to be used for the treatment of lung cancer are limited to a few drugs including Iressa and the like, it is difficult to perform appropriate treatment for patients, and these drugs have disadvantages in that they exhibit negligible levels of side effects. The subsequent success rate of treatment is poor. In order to overcome these disadvantages, attempts have been made to develop therapeutic agents derived from complex natural substances that can reduce side effects. However, the fundamental drawback of these therapeutic agents derived from natural products has not been solved.
이에 따라 보다 안전하면서 효과적으로 폐암을 치료할 수 있는 제제의 개발이 필요한 실정이다. Therefore, it is necessary to develop a formulation that can treat lung cancer more safely and effectively.
본 발명자들은 안전하면서 효과적으로 폐암을 치료할 수 있는 치료제를 개발하기 위하여, 연구를 진행하던 중 상백피 추출물로부터 분리하여 얻어진 상게놀 Q(sanggenol Q)가 폐암의 예방 및 치료에 현저한 효과가 있음을 확인하고 본 발명을 완성하였다. The inventors of the present invention confirmed that sanggenol Q obtained from the extract of Mulberry bark extract had a remarkable effect on the prevention and treatment of lung cancer in order to develop a therapeutic agent capable of treating safe and effective lung cancer, Thereby completing the invention.
본 발명은 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물을 제공하고자 한다. The present invention is to provide a pharmaceutical composition for preventing or treating lung cancer comprising sanggenol Q.
또한, 본 발명은 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 개선용 건강기능식품을 제공하고자 한다. The present invention also provides a health functional food for preventing or ameliorating lung cancer comprising sanggenol Q.
상기의 목적을 달성하기 위하여, 본 발명은 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물을 제공한다. In order to achieve the above object, the present invention provides a pharmaceutical composition for preventing or treating lung cancer comprising sanggenol Q.
이하, 본 명세서에 대하여 더욱 상세하게 설명한다.Hereinafter, the present invention will be described in more detail.
본 명세서에서 어떤 부분이 어떤 구성요소를 "포함" 한다고 할 때, 이는 특별히 반대되는 기재가 없는 한 다른 구성요소를 제외하는 것이 아니라 다른 구성 요소를 더 포함할 수 있는 것을 의미한다. Whenever a component is referred to as "comprising ", it is to be understood that the component may include other components as well, without departing from the scope of the present invention.
본 명세서에서 상기 "예방"이란 상기 약학적 조성물의 투여로 폐암을 억제 또는 지연시키는 모든 행위를 의미한다. 또한, 상기 "치료"란 상기 약학적 조성물의 투여로 폐암의 증세가 호전되거나 이롭게 변경하는 모든 행위를 의미한다.As used herein, the term "prevention" means any action that inhibits or delays lung cancer by administration of the pharmaceutical composition. The term "treatment" as used herein means all the actions of improving or alleviating symptoms of lung cancer by the administration of the pharmaceutical composition.
본 명세서에서 폐암이란 폐에 발생한 암을 의미하며, 소세포 폐암(SCLC) 및 비소세포 폐암(NSCLC)일 수 있으며, 상기 소세포 폐암 및 비소세포 폐암은 전술한 바와 같다. In the present specification, lung cancer means lung cancer, and may be small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), and the small cell lung cancer and non-small cell lung cancer are as described above.
본 발명의 상기 상게놀 Q(sanggenol Q)는 하기 화학식 1로 표시되는 화합물을 의미한다. The sanggenol Q of the present invention means a compound represented by the following general formula (1).
[화학식 1][Chemical Formula 1]
상기 상게놀 Q는 상백피(Morus alba L.)로부터 분리하거나 상업적으로 구매하여 사용될 수 있다. The Sangenol Q can be isolated from Morus alba L. or purchased commercially.
본 명세서에서 상백피는 뽕나무 또는 동속 식물의 뿌리껍질로 만든 약재로서 상백피는 폐열로 인한 해수, 천식을 치료하며 이뇨 작용이 있다. 급성신우염, 허약성부종에 쓰이고 혈압강하 작용이 있으며 코피와 각혈에도 사용한다. 또한 유행성 간염 등에도 쓰인다. 약리작용은 진해, 이뇨, 혈압강하, 진정, 진통, 해열, 진경, 항균작용 등이 보고되었다. 상백피(Morus alba L.)는 물베르린, 물베르로크로벤, 시클로물베르린 등과 쿠마린 유도체인 스코폴레틴, 움벨리페론, 트리테르페노이드인 아미린, 베툴린산 등을 주요성분으로 포함하며 진정작용, 진해작용, 항균작용, 항염작용, 항산화효과 등이 우수한 약재로 알려져 있다. In the present specification, the term "bark bark" refers to a medicinal substance made of the root bark of mulberry or an inbred plant. The bark bark treats seawater and asthma caused by waste heat and has a diuretic effect. It is used for acute pyelonephritis, weakness edema, hypotensive effect, and also for nosebleed and blood. It is also used for epidemic hepatitis. The pharmacological action was reported to be Jinhae, diuretic, hypotension, sedation, analgesia, fever, epidermal and antimicrobial effects. Morus alba L. contains main ingredients such as water berlin, water verrucroven, cyclo water berlin and coumarin derivatives such as scopoletin, umbelliferone, triterpenoid aminoline and betulinic acid. , Vinegar action, antibacterial action, anti-inflammatory action, antioxidant effect and is known as a good medicine.
상백피는 뽕나무(Morus alba L.) 및 동속 근녹식물 근피의 코르크층을 제거한 것으로, 겨울에 뿌리를 캐내 깨끗이 씻어 신선할 때 코르크층을 벗겨내고 세로로 갈라서 나무망치로 두드려 목부와 피부를 분리시켜 백피만 취한 것이다. 맛은 달고, 성질은 차다. 상백피는 동양의약에서 당뇨병 치료제, 이뇨제, 진토제, 설사제등에 사용되어져 왔다(Giaccia A. et al. Nat Rev Drug Disc 2; 803-811, 2003). 성분으로는 프레닐레이트 플라보노이드(prenylated flavonoid), 벤조퓨란(benzofuran), 페놀(phenol)계 화합물등 수종의 화합물로서 이들 화합물들이 COX-1, COX-2, 그리고 산화질소(NO) 생성저해효과 등 다양한 생물활성이 보고되었다. 주요 생리활성 성분으로는 움벨리페론(Umbelliferone), 멜베로크로멘(mulberrochromene), 시클로멜베린(cyclomulberrin), 시클로멀베로크로맨(cyclomulberrochromene)등이 함유되어 있으며, 아세틸콜린(acetyl choline)과 작용이 유사한 항염성분이 함유되어 있다. Morus alba L. and Morus alba L. Remove the cork layer from the root of the root of the plant. In the winter, wash the roots cleanly, and when it is fresh, peel off the layer of cork, cut it vertically and cut it with a wooden hammer, It is only taken. The taste is sweet and the quality is cold. Alcoholic beverages have been used in oriental medicine for the treatment of diabetes, diuretics, pills and diarrhea (Giaccia A. et al. Nat Rev Drug Disc 2; 803-811, 2003). These compounds include several compounds such as prenylated flavonoid, benzofuran, and phenol compounds. These compounds inhibit COX-1, COX-2, and nitric oxide (NO) production Various biological activities have been reported. The major physiologically active ingredients include Umbelliferone, Mulberrochromene, Cyclomulberrin, Cyclomulberrochromene, etc., and it acts with acetylcholine This similar anti-inflammatory component is contained.
본 발명에서의 상게놀 Q는 상백피 추출 및 분리를 통해서 얻어질 수 있으며, 상기 상백피의 추출 및 분리는 당업계에서 사용되는 방법을 이용할 수 있으며, 이를 한정하지 않는다. Sangenol Q in the present invention can be obtained through extraction and separation of bark extract, and extraction and separation of the bark extract can be performed by methods used in the art, but are not limited thereto.
본 명세서에서 상기 추출은 천연물로부터 활성성분을 분리하는 것을 의미하며, 물, 유기 용매 또는 이의 혼합용매를 이용하는 추출 과정으로 추출물을 획득할 수 있으며, 상기 추출물은 추출액, 이의 건조 분말 또는 이를 이용하여 제형화된 모든 형태를 포함할 수 있다. Herein, the extraction refers to the separation of an active ingredient from a natural product, and an extract can be obtained by an extraction process using water, an organic solvent or a mixed solvent thereof, and the extract can be obtained by using an extract, a dry powder thereof, It can include all forms that have been formalized.
예컨대, 본 발명의 상백피의 추출 용액은 물 또는 유기 용매를 이용하여 추출될 수 있다. 유기용매로는 저급 알콜, 아세톤, 클로로포름, 메틸렌클로라이드, 에테르, 에틸아세테이트, 헥산 등을 예시할 수 있다. 저급알콜로는 메탄올, 에탄올, 프로판올 및 부탄올을 예시할 수 있으며, 에탄올이 가장 바람직하다.For example, the extract solution of the plant extract of the present invention can be extracted with water or an organic solvent. Examples of the organic solvent include lower alcohols, acetone, chloroform, methylene chloride, ether, ethyl acetate, hexane and the like. As the lower alcohol, methanol, ethanol, propanol and butanol can be mentioned, and ethanol is most preferable.
본 발명의 약학적 조성물은 상기 폐암의 예방 또는 치료용 약학적 조성물의 전체 중량에 대하여 상게놀 Q(sanggenol Q)의 함량은 0.1 중량% 내지 90 중량%를 포함할 수 있으나, 이에 한정되지 않는다. The pharmaceutical composition of the present invention may include, but is not limited to, 0.1 to 90% by weight of sanggenol Q based on the total weight of the pharmaceutical composition for preventing or treating lung cancer.
본 발명의 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물에서 상기 폐암 예방 또는 치료는 폐암 세포 사멸 촉진에 의한 것이다.In the pharmaceutical composition for preventing or treating lung cancer comprising sanggenol Q of the present invention, prevention or treatment of lung cancer is caused by promotion of lung cancer cell death.
구체적으로 본 발명의 상게놀 Q(sanggenol Q)를 포함하는 약학적 조성물은 pro-apoptotic 단백질을 활성화한다. 예컨대, PARP, cleaved caspase 3의 단백질들의 발현은 증가되는 반면, 프로카스파제(procaspase) 8, 프로카스파제(procaspase) 9, XIAP, BAD 및 Bcl-2는 상게놀 Q(sanggenol Q)에 의하여 발현이 감소된다. 또한, 본 발명의 상게놀 Q를 포함하는 약학적 조성물은 암의 전이에 관여하는 헤지호그 신호와 관련된 유전자인 Shh 및 SUFU의 발현을 억제하는 반면, 종양 억제와 관련된 PTCH-1, PTCH-2 및 GLI의 발현을 증가시킨다. Specifically, a pharmaceutical composition comprising sanggenol Q of the present invention activates a pro-apoptotic protein. For example, the expression of proteins of PARP and cleaved caspase 3 is increased while that of procaspase 8, procaspase 9, XIAP, BAD and Bcl-2 is increased by expression of sanggenol Q . In addition, the pharmaceutical composition comprising Sangenol Q of the present invention inhibits the expression of Shh and SUFU, genes associated with hedgehog signals involved in cancer metastasis, while PTCH-1, PTCH-2 and 0.0 > GLI < / RTI >
따라서, 본 발명의 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물은 폐암의 세포 사멸 촉진을 이용하여 폐암의 예방 및/또는 치료에 우수한 효과를 나타낼 수 있다. Accordingly, the pharmaceutical composition for preventing or treating lung cancer including sanggenol Q of the present invention can exert an excellent effect for prevention and / or treatment of lung cancer by promoting apoptosis of lung cancer.
본 발명의 상게놀 Q(sanggenol Q)를 포함하는 폐암의 예방 또는 치료용 약학적 조성물은 약학적 조성물이다. The pharmaceutical composition for preventing or treating lung cancer comprising sanggenol Q of the present invention is a pharmaceutical composition.
본 발명의 약학적 조성물은 약효를 증가시키지는 않으나 약학적 조성물에 통상 사용되어 냄새, 맛, 시각 등을 향상시킬 수 있는 성분을 추가로 포함할 수 있다. 또한, 본 발명의 약학적 조성물은 약학적으로 허용 가능한 첨가제를 추가적으로 포함할 수 있다. 약학적으로 허용 가능한 첨가제는 예컨대, 전분, 젤라틴화 전분, 미결정셀룰로오스, 유당, 포비돈, 콜로이달실리콘디옥사이드, 인산수소칼슘, 락토스, 만니톨, 엿, 아라비아고무, 전호화전분, 옥수수전분, 분말셀룰로오스, 히드록시프로필셀룰로오스, 오파드라이, 전분글리콜산나트륨, 카르나우바 납, 합성규산알루미늄, 스테아린산, 스테아린산마그네슘, 스테아린산알루미늄, 스테아린산칼슘, 백당, 덱스트로스, 소르비톨 및 탈크 등이 있으나, 이를 한정하지 않는다. 추가로, 상기 약학적 조성물은 단독 사용하거나 기존에 사용된 폐암에 대한 예방 또는 치료 활성을 가지는 물질을 포함할 수 있다.The pharmaceutical composition of the present invention does not increase the drug efficacy but may further include components that are commonly used in pharmaceutical compositions and can improve odor, taste, and visual appearance. In addition, the pharmaceutical composition of the present invention may further comprise a pharmaceutically acceptable additive. Pharmaceutically acceptable additives include, for example, starch, gelatinized starch, microcrystalline cellulose, lactose, povidone, colloidal silicon dioxide, calcium hydrogen phosphate, lactose, mannitol, gum, arabic gum, pregelatinized starch, cornstarch, powdered cellulose, But are not limited to, hydroxypropylcellulose, opaques, sodium starch glycolate, carnauba wax, synthetic aluminum silicate, stearic acid, magnesium stearate, aluminum stearate, calcium stearate, white sugar, dextrose, sorbitol and talc. In addition, the pharmaceutical composition may contain a substance that has a prophylactic or therapeutic activity against lung cancer used alone or in a conventional manner.
본 발명의 상기 약학적 조성물은 약학적으로 허용 가능한 담체를 포함하고 경구 또는 비경구용의 인체 또는 수의용으로 제형화될 수 있다. 본 발명의 약학적 조성물을 제제화하는 경우 충진제, 증량제, 결합제, 습윤제, 붕해제 및 계면활성제 등의 희석제 또는 부형제를 사용할 수 있다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제 및 캡슐제 등이 포함되며, 이러한 고형제제는 본 발명의 화합물을 포함하는 약학적 조성물에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(Calcium carbonate), 수크로스(Sucrose) 또는 락토오스(Lactose) 및 젤라틴 등을 섞어 조제할 수 있다. 또한 단순한 부형제 이외에 마그네슘, 스티레이트, 탈크 같은 윤활제를 사용할 수 있다. 경구를 위한 액상제제로는 현탁제, 내용액제, 유제 및 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물 및 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제 및 보존제 등이 포함될 수 있다. 비경구투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제제 및 좌제가 포함된다. 비수성용제 및 현탁용제로는 프로필렌글리콜(Propylene glycol), 폴리에틸렌 글리콜 및 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다.The pharmaceutical composition of the present invention comprises a pharmaceutically acceptable carrier and may be formulated for oral or parenteral administration for human or veterinary use. When the pharmaceutical composition of the present invention is formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants may be used. Solid form preparations for oral administration include tablets, pills, powders, granules and capsules, which may be prepared by mixing the pharmaceutical composition comprising the compound of the present invention with at least one excipient such as starch, calcium carbonate Calcium carbonate, Sucrose or Lactose, and Gelatin. In addition to simple excipients, lubricants such as magnesium, styrene, and talc may be used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions and syrups, and various excipients such as wetting agents, sweetening agents, fragrances and preservatives in addition to commonly used simple diluents such as water and liquid paraffin . Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations and suppositories. Examples of non-aqueous solvents and suspensions include vegetable oils such as propylene glycol, polyethylene glycol and olive oil, injectable esters such as ethyl oleate, and the like. Examples of suppository bases include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like.
본 발명의 약학적 조성물은 목적하는 방법에 따라 경구 투여하거나 비경구 투여할 수 있으며, 비경구 투여시 피부 외용 또는 복강내주사, 직장내주사, 피하주사, 정맥주사, 근육 내 주사 또는 흉부 내 주사 주입방식을 선택하는 것이 바람직하다. The pharmaceutical composition of the present invention may be administered orally or parenterally in accordance with the desired method, and may be administered orally, parenterally or intraperitoneally, rectally, subcutaneously, intravenously, intramuscularly, It is preferable to select the injection method.
본 발명의 상기 약학적 조성물은 개체에 투여하여 폐암을 예방 또는 치료할 수 있다. 본 발명에서 사용된 용어, "개체"는 폐암 또는 이의 직, 간접적 원인에 의해 유발된 질환을 가지고 있으며, 본 발명의 상기 약학적 조성물을 투여하여 증상이 호전될 수 있는 질환을 가진 인간을 포함한 말, 양, 돼지, 염소, 개 등의 포유동물을 의미하나, 바람직하게는 인간을 의미한다. The pharmaceutical composition of the present invention can be administered to an individual to prevent or treat lung cancer. The term "individual" as used in the present invention refers to a disease caused by lung cancer or a direct or indirect cause thereof, and includes a human having a disease in which symptoms can be alleviated by administering the pharmaceutical composition of the present invention , Sheep, pigs, goats, dogs and the like, preferably humans.
본 발명에서 사용된 용어, "투여"는 어떠한 적절한 방법으로 개체에 본 발명의 약학적 조성물을 도입하는 것을 의미한다. 투여 경로는 목적 조직에 도달할 수 있는 한 어떠한 일반적인 경로를 통하여 경구 또는 비경구 투여될 수 있다. 또한, 본 발명의 약학적 조성물이 표적 세포로 이동할 수 있도록 하는 임의의 장치에 의해 투여될 수 있다.As used herein, the term "administering" means introducing a pharmaceutical composition of the invention into a subject by any suitable method. The route of administration may be oral or parenteral administration via any conventional route so long as it can reach the target tissue. In addition, the pharmaceutical composition of the present invention may be administered by any device that allows it to migrate to a target cell.
본 발명의 약학적 조성물은 약학적으로 유효한 양으로 투여한다. 본 발명에서 사용된 용어, 약학적으로 유효한 양은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효 용량 수준은 환자의 체중, 성별, 연령, 건강상태, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출 비율, 치료 기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 약학적 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있다. 단일 또는 다중 투여될 수 있다. 상기 요소를 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 당업자에 의해 용이하게 결정될 수 있으며, 일반적으로 환자의 체중에 따른 투여량은 1일 0.001 mg/kg 내지 100 mg/kg이고, 바람직하게는 0.01 mg/kg 내지 30mg/kg 투여할 수 있으며, 1일 1회 내지 6회 투여하는 것이 바람직하다. The pharmaceutical composition of the present invention is administered in a pharmaceutically effective amount. The term, pharmaceutically effective amount, as used herein, means an amount sufficient to treat a disease at a reasonable benefit / risk ratio applicable to medical treatment, and an effective dosage level will vary with the weight, sex, age, , The activity of the drug, the sensitivity to the drug, the time of administration, the route of administration and rate of release, the duration of the treatment, factors including co-administered drugs, and other factors well known in the medical arts. The pharmaceutical composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. May be administered singly or multiply. It is important to take into account all of the factors mentioned above and to administer the amount in which the maximum effect can be obtained in a minimal amount without adverse effect, and it can be easily determined by those skilled in the art. Generally, the dose according to the patient's body weight is 0.001 mg / kg to 100 mg / kg, preferably 0.01 mg / kg to 30 mg / kg, and is preferably administered once to six times a day.
본 발명의 약학적 조성물은 폐암 예방 또는 치료를 위하여 단독으로, 또는 수술, 방사선 치료, 호르몬 치료, 화학 치료 및 생물학적 반응 조절제를 사용하는 방법들과 병용하여 사용할 수 있다.The pharmaceutical composition of the present invention may be used alone or in combination with methods for the prevention or treatment of lung cancer or using surgery, radiation therapy, hormone therapy, chemotherapy and biological response modifiers.
또한, 본 발명은 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 개선용 건강기능식품을 제공한다. In addition, the present invention provides a health functional food for preventing or ameliorating lung cancer comprising sanggenol Q.
상기 폐암 예방 또는 개선용 건강기능식품은 본 발명의 상게놀 Q(sanggenol Q)를 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다. The health functional food for preventing or ameliorating lung cancer may be used as it is, or may be used together with other food or food ingredients, and suitably used according to a conventional method.
본 명세서에서 상기“기능 식품”이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조 및 가공한 식품을 의미하며, 본 명세서의 상기“기능”이란 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적인 작용으로 보건 용도에 유용한 효과를 의미할 수 있다. The term " functional food " as used herein means a food prepared and processed by using raw materials or ingredients having useful functions in the human body. The " function " Which may be useful for health use.
상기 식품의 종류에는 특별한 제한은 없다. 상기 상게놀 Q(sanggenol Q)를 첨가할 수 있는 식품의 예로는 각종 스프, 음료수, 차, 드링크제, 알코올음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 건강식품을 모두 포함할 수 있다. 상기 외에 본 발명의 상게놀 Q(sanggenol Q)는 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그 밖에 본 발명의 건강기능식품은 천연 과일주스, 과일주스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 혼합하여 사용할 수 있다. There is no particular limitation on the kind of the food. Examples of foods to which sanggenol Q can be added include various soups, beverages, tea, drinks, alcoholic beverages and vitamin complexes, and may include all health foods in a conventional sense. In addition to the above, sanggenol Q of the present invention can be used in various forms such as various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloid thickening agents, Preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. In addition, the health functional food of the present invention may contain flesh for the production of natural fruit juice, fruit juice drink and vegetable drink. These components may be used independently or in combination.
본 발명에 따른 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물은 폐암 세포에서 카스파제 3 및 카스파제 9를 활성시키고, PARP(poly-ADP ribose polymerase) 절단을 촉진하며, Bcl-2, XIAP 및 Bad를 억제시켜 우수한 폐암 치료 및 예방 효과를 갖는다. The pharmaceutical composition for prevention or treatment of lung cancer comprising sanggenol Q according to the present invention activates caspase 3 and caspase 9 in lung cancer cells, promotes poly (ADP ribose polymerase) cleavage, Bcl-2, XIAP and Bad, thereby having excellent lung cancer treatment and prevention effect.
도 1은 상게놀 Q(sanggenol Q)의 농도에 따른 폐암세포 사멸효과를 나타낸 도이다.
도 2A는 상게놀 Q(sanggenol Q)의 처리에 따른 세포 사멸 단백질의 발현 변화이고, 도 2B는 상계놀 Q의 처리에 따른 세포 사멸을 TUNEL analysis로 측정하여 나타낸 도이다.
도 3은 상게놀 Q(sanggenol Q)의 처리에 따른 헤지호그 신호(hedgehog signal)와 관련된 유전자의 발현 변화를 나타낸 도이다.
도 4는 상게놀 Q(sanggenol Q)의 처리에 따른 세포 사멸(apoptosis)의 세포 변화와 Sub-G1기의 변화를 나타낸 도이다.1 is a graph showing lung cancer cell killing effect according to the concentration of sanggenol Q. Fig.
FIG. 2A shows the expression of apoptotic protein according to treatment with sanggenol Q, and FIG. 2B shows apoptosis following treatment with Sanguinol Q by TUNEL analysis.
FIG. 3 is a graph showing the expression of a gene related to a hedgehog signal according to the treatment of sanggenol Q. FIG.
FIG. 4 is a graph showing changes in cell and sub-G1 phase of apoptosis following treatment with sanggenol Q. FIG.
이하, 본 명세서를 구체적으로 설명하기 위해 실시예를 들어 상세하게 설명하기로 한다. 그러나, 본 명세서에 따른 실시예들은 여러 가지 다른 형태로 변형될 수 있으며, 본 명세서의 범위가 아래에서 기술하는 실시예들에 한정되는 것으로 해석되지 않는다. 본 명세서의 실시예들은 당업계에서 평균적인 지식을 가진 자에게 본 명세서를 보다 완전하게 설명하기 위해 제공되는 것이다.Hereinafter, the present invention will be described in detail by way of examples with reference to the drawings. However, the embodiments according to the present disclosure can be modified in various other forms, and the scope of the present specification is not construed as being limited to the embodiments described below. Embodiments of the present disclosure are provided to more fully describe the present disclosure to those of ordinary skill in the art.
<상게놀 Q의 추출 및 분리><Extraction and Separation of Sangenol Q>
M. alba(뽕나무) 의 뿌리를 건조하여 만든 가루를 80% 메탄올로 상온에서 24시간 추출하였다(68L x 3). 여과지를 이용하여 여과한 후 진공 회전 증발기를 통해 농축하였다. The dried powder of M. alba (mulberry) was extracted with 80% methanol at room temperature for 24 hours (68 L x 3). Filtered through filter paper, and concentrated via a vacuum rotary evaporator.
남겨진 농축액을 물 2L를 이용하여 부유시키고 ethyl acetate (EtOAc, 2L x 2) 그리고 normal-butanol(n-BuOH, 1.8L x 3)를 이용하여 연속하여 추출하였다. 농축액은 물과 유기층으로 제각기 EtOAc fraction (MRE, 580g), n-BuOH fraction (MRB, 114g), 그리고 H2O fraction (MRW, 1006g) 으로 구분되었다. EtOAc 층은 이산화규소 관 크로마토그래피에 의해 Sanggenol Q를 비롯한 41층으로 분리되었다(MRE1 to MRE41).The remaining concentrate was suspended in 2 L of water and extracted successively with ethyl acetate (EtOAc, 2 L x 2) and normal-butanol (n-BuOH, 1.8 L x 3). The concentrate was partitioned into EtOAc fraction (MRE, 580 g), n-BuOH fraction (MRB, 114 g) and H 2 O fraction (MRW, 1006 g) The EtOAc layer was separated into 41 layers, including Sanggenol Q, by silicon dioxide tube chromatography (MRE1 to MRE41).
<실시예 1. 폐암 세포의 배양 및 세포 생존력 분석> ≪ Example 1: Culture and cell viability of lung cancer cells >
폐암 세포의 배양Culture of lung cancer cells
H460, A549 및 H1299 세포를 ATCC (American type culture collection: rockville, MD)에서 구입하여 (열비활성화)소태아혈청(FBS), 2 mM 글루타민, 100 U/mL 페니실린 및 100 μg/mL 스트랩토마이신이 첨가된 RPMI 1640 배지에서 5% C02에서 배양하였다. Fetal serum (FBS), 2 mM glutamine, 100 U / mL penicillin and 100 μg / mL streptomycin were purchased from ATCC (American Type Culture Collection: Rockville, MD) the addition of RPMI 1640 medium and incubated in 5% C0 2.
세포의 생존력 분석Cell viability analysis
세포 생존력 분석을 위하여 H460, A549 및 H1299 세포를 70%로 배양 하고, 각각 다른 농도의 상게놀 Q(sanggenol Q)로 처리하여 24시간 동안 추가 배양을 수행하고, MTT 분석법을 이용하여 세포 생존률을 측정하였다. For cell viability analysis, H460, A549 and H1299 cells were cultured in 70%, treated with different concentrations of sanggenol Q for 24 hours, and cell viability was measured using MTT assay Respectively.
도 1은 상게놀 Q(sanggenol Q)의 농도에 따른 폐암세포주인 H460, A549 및 H1299의 사멸효과를 나타낸 도이고, 도 2B는 TUNEL analysis를 통하여 confocal microscopy로 폐암 세포주인 H460가 사멸 되는 것을 형광 물질로 확인한 도이다. FIG. 1 shows the killing effect of lung cancer cell lines H460, A549 and H1299 according to the concentration of sanggenol Q, and FIG. 2B shows the killing of H460, a lung cancer cell line, by confocal microscopy through TUNEL analysis. As shown in Fig.
도 1 및 2에서 확인할 수 있는 바와 같이, 상게놀 Q(sanggenol Q)의 농도 및 처리 시간에 따라 폐암 세포주의 생존 능력(viability)이 감소하는 것을 확인할 수 있었다. 상게놀 Q(sanggenol Q)를 포함하는 폐암 예방 또는 치료용 약학적 조성물은 폐암 세포의 생존능력을 저하시켜, 폐암의 치료 및 예방 효과를 갖는 것을 알 수 있었다. As can be seen from Figs. 1 and 2, viability of the lung cancer cell line was decreased according to the concentration of sanggenol Q and the treatment time. The pharmaceutical composition for prevention or treatment of lung cancer including sanggenol Q has lowered the survival ability of lung cancer cells and has a therapeutic and preventive effect on lung cancer.
<실시예 2. 단백질 측정을 위한 웨스턴 블롯(westem blot) 분석>Example 2. Western blot analysis for protein determination < RTI ID = 0.0 >
세포 배양 후 상게놀 Q(sanggenol Q)를 첨가하고, 24시간 동안 추가 배양을 수행하고, 세포를 PBS로 세척한 다음 용균(lysis) 용액(20 mM 자당, 1 mM EDTA, 20 μM Tris-Cl, pH7.2, 1 mM DTT, 1O mM KCl, 1.5 mM MgCl2, 5 μg/mL 펩스타틴 A, 10 μg/ml 류펩틴 및 2 μg /mL 아프로티닌)을 첨가하여 용리시켰다. 원심 분리 후 상등액을 수집하여 단백질 농도를 측정한 후 30 μg을 함유한 분취액을 bio-rad 단백질 분석키트를 이용하여 SDS-폴리아크릴아마이드 겔 상에서 분리하고 지시된 1차 항체를 포옥시다아제 공액화 2차 항체를 이용하여 PARP, 카스파제(caspase) 3, 8, 9, bc1-2, XIAP, Bad, Shh, PTCH-1, PTCH-2, SUFU, GLI 및 actin 을 ECL검출 시스템으로 분석하였다. After incubation, sanggenol Q was added and further incubated for 24 hours. Cells were washed with PBS and lysed (20 mM sucrose, 1 mM EDTA, 20 μM Tris-Cl, pH 7.2, 1 mM DTT, 10 mM KCl, 1.5 mM MgCl 2 , 5 μg / mL pepstatin A, 10 μg / ml leupeptin and 2 μg / mL aprotinin). After centrifugation, the supernatant was collected and the protein concentration was measured. The aliquot containing 30 μg was separated on SDS-polyacrylamide gel using a bio-rad protein assay kit, and the indicated primary antibody was conjugated to the
도 2A는 웨스턴 블롯 방법으로 상게놀 Q(sanggenol Q)의 처리에 따른 세포 사멸 단백질의 발현 변화(2A)를 나타낸 도이다. 2A shows the expression (2A) of the apoptosis protein according to the treatment with sanggenol Q by the Western blot method.
도 2의 결과를 보면, 세포 사멸(Apoptosis)과 관련된 분열된 카스파제(Cleaved caspase) 3과 PARP는 증가하는 반면, 프로카스파제(procaspase) 9, XLAP, Bad는 감소되는 것을 확인할 수 있었다. 2 shows that cleaved caspase 3 and PARP associated with apoptosis are increased while that of procaspase 9, XLAP and Bad is decreased.
또한, 도 3은 상게놀 Q(sanggenol Q)의 처리에 따른 헤지호그 신호(hedgehog signal)와 관련된 유전자의 발현 변화를 나타낸 도이다. 도 3의 결과를 보면, 상게놀 Q(sanggenol Q)의 투여로 암의 전이에 관여하는 헤지호그 신호와 관련된 유전자인 Shh 및 SUFU를 억제하는 반면, 종양 억제와 관련된 PTCH-1, PTCH-2 및 GLI는 증가시키는 것을 확인할 수 있었다. 3 is a graph showing a change in the expression of a gene related to a hedgehog signal according to treatment with sanggenol Q. Fig. 3 shows that administration of sanggenol Q suppresses Shh and SUFU, which are genes involved in hedgehog signaling involved in cancer metastasis, while PTCH-1, PTCH-2, GLI could be confirmed to increase.
<실시예 3. 세포주기 분석>≪ Example 3: Cell cycle analysis >
세포 배양 후 트립신-EDTA를 이용하여 떼어낸 후 75% Ethanol을 이용해 고정 시켜준 다음 Ethanol을 제거하고 RNase를 1시간 처리하였다. 반응시킨 후 RNase를 제거하고 Propidium Iodide(PI)를 첨가하여 유세포 분석기를 이용하여 세포 주기를 분석하였다. After cell culture, trypsin-EDTA was removed and fixed with 75% ethanol. Ethanol was removed and RNase was treated for 1 hour. After the reaction, RNase was removed and Propidium Iodide (PI) was added to analyze the cell cycle using a flow cytometer.
도 4A는 상게놀 Q(sanggenol Q)의 처리에 따른 세포 사멸(apoptosis)의 세포 변화를 나타낸 도이다. 상기 도 4A의 결과로, 상게놀 Q(sanggenol Q)로 처리하는 경우, 세포 자멸을 일으키는 세포가 증가하는 것을 확인할 수 있었다. 4A is a graph showing cell changes of apoptosis upon treatment with sanggenol Q. Fig. As shown in FIG. 4A, when treated with sanggenol Q, it was confirmed that cells causing apoptosis were increased.
<실시예 4. 세포자멸사 분석>≪ Example 4: Apoptosis analysis >
세포 배양 후 상게놀 Q(sanggenol Q) 를 24시간 처리하여 Annexin V 화합물과 FITC 처리하고 DAPI 용액을 1 mg/ml 을 첨가하여 유세포 분석기를 통해 분석하였다. After cell culture, sanggenol Q was treated with Annexin V compound for 24 hours, treated with FITC, and DAPI solution was added at 1 mg / ml and analyzed by flow cytometry.
도 4B는 상게놀 Q(sanggenol Q)의 처리에 따른 세포의 주기를 분석하였을 때, Sub-G1기의 변화를 나타낸 도이다. 상기 도 4B의 결과로 상게놀 Q(sanggenol Q)로 처리하지 않은 경우(도 4B의 좌측)에 비하여 상게놀 Q(sanggenol Q)로 처리한 경우가 Sub-G1 population을 현저하게 증가시킴을 확인하였다.FIG. 4B is a graph showing a change in the Sub-G1 phase when the cell cycle is analyzed according to the treatment with sanggenol Q. FIG. As a result of FIG. 4B, it was confirmed that the treatment with sanggenol Q significantly increased the sub-G1 population when treated with sanggenol Q (left side of FIG. 4B) .
상기의 결과들을 종합하여 보면, 상게놀 Q(sanggenol Q)로 처리하는 경우, 현저하게 폐암 세포주의 세포 사멸(apoptosis)을 활성화시키고, Survival 단백질의 발현을 감소시키며, Cell Death protein들의 발현을 크게 증가시키는 것을 확인할 수 있다. 따라서, 상게놀 Q(sanggenol Q)를 포함하는 약학적 조성물의 경우 폐암 예방 및 치료에 유리한 효과를 갖는 것을 확인할 수 있다. The above results indicate that treatment with sanggenol Q significantly activates apoptosis of lung cancer cell lines, decreases the expression of Survival protein, significantly increases the expression of cell death proteins . Therefore, it can be confirmed that a pharmaceutical composition containing sanggenol Q has an advantageous effect on prevention and treatment of lung cancer.
Claims (5)
상기 상게놀 Q(sanggenol Q)는 상백피(morus alba)에서 추출 및 분리된 것인 폐암 예방 또는 치료용 약학적 조성물. The method according to claim 1,
Wherein the sanggenol Q is extracted and isolated from morus alba.
상기 폐암 예방 또는 치료는 폐암 세포 사멸 촉진에 의한 것인 폐암 예방 또는 치료용 약학적 조성물. The method according to claim 1,
Wherein the prevention or treatment of lung cancer is by promoting the death of lung cancer cells.
상기 폐암은 소세포 폐암(SCLC) 또는 비소세포 폐암(NSCLC)인 것인 폐암 예방 또는 치료용 약학적 조성물. The method according to claim 1,
Wherein the lung cancer is small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
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Non-Patent Citations (3)
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Archives of Pharmacal Research (20151130), 38(11), pp. 2066-2075 |
Bioorganic & Medicinal Chemistry Letters (20160615), 26(12), pp. 2788-2794 |
Natural Product Research (2015), 29(18), pp. 1711-1718 |
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