KR102019676B1 - Compositions for prevention or treatment of benign prostatic hyperplasia comprising a sialyllactose - Google Patents
Compositions for prevention or treatment of benign prostatic hyperplasia comprising a sialyllactose Download PDFInfo
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- KR102019676B1 KR102019676B1 KR1020180013570A KR20180013570A KR102019676B1 KR 102019676 B1 KR102019676 B1 KR 102019676B1 KR 1020180013570 A KR1020180013570 A KR 1020180013570A KR 20180013570 A KR20180013570 A KR 20180013570A KR 102019676 B1 KR102019676 B1 KR 102019676B1
- Authority
- KR
- South Korea
- Prior art keywords
- prostate
- group
- disease
- preventing
- composition
- Prior art date
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- 206010004446 Benign prostatic hyperplasia Diseases 0.000 title claims abstract description 49
- 208000004403 Prostatic Hyperplasia Diseases 0.000 title claims abstract description 49
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- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 229940033203 vitamin b6 0.5 mg Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
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Abstract
본 발명은 시아릴락토오스를 포함하는 전립선 비대 질환 예방 또는 조성물에 관한 것으로서, 더욱 상세하게는 시아릴락토오스를 포함하는 전립선 비대 질환 예방 또는 치료용 약학적 조성물, 전립선 비대 질환 예방 또는 개선용 식품 조성물 및 의약외품 조성물에 관한 것이다. 본 발명에 따른 시아릴락토오스는 전립선 비대 감소 효과, 전립선 무게 감소 효과를 가지고 있어, 전립선 비대 질환을 예방, 치료 또는 개선할 수 있는 의약품, 기능성 식품, 의약외품의 제조에 유용하게 사용할 수 있다. 또한 전립선 비대 질환으로 인한 빈뇨, 야간빈뇨, 복압배뇨, 요흐름 속도 감소, 단축뇨, 배뇨 후 요점적 등의 증상을 완화시킬 수 있다.The present invention relates to a prostate hypertrophy disease prevention or composition comprising a cyaryl lactose, more specifically a pharmaceutical composition for preventing or treating prostate hypertrophy disease comprising a siary lactose, a food composition for preventing or improving prostate hypertrophy disease and It relates to a quasi-drug composition. Cyaryllactose according to the present invention has a prostatic hypertrophy effect, a prostate weight reduction effect, can be useful in the manufacture of medicines, functional foods, quasi-drugs that can prevent, treat or improve the prostate hypertrophy disease. In addition, symptoms such as frequent urination, night urination, abdominal urination, decreased urine flow rate, shortening urine, and urinary discharge after urination may be alleviated.
Description
본 발명은 시아릴락토오스를 포함하는 전립선 비대 질환 예방 또는 조성물에 관한 것으로서, 더욱 상세하게는 시아릴락토오스를 포함하는 전립선 비대 질환 예방 또는 치료용 약학적 조성물, 전립선 비대 질환 예방 또는 개선용 식품 조성물 및 의약외품 조성물에 관한 것이다.The present invention relates to a prostate hypertrophy disease prevention or composition comprising a cyaryl lactose, more specifically a pharmaceutical composition for preventing or treating prostate hypertrophy disease comprising a siary lactose, a food composition for preventing or improving prostate hypertrophy disease and It relates to a quasi-drug composition.
전립선은 섭호선으로 불리기도 하며 수컷 포유류동물의 생식계통에서 주요한 기관 중의 하나이고, 외분비선에 속한다. 또한 전립선의 주요한 기능은 전립선액의 분비와 저장이고 사람의 경우 전립선은 골반강의 저부에 위치하며 구체적으로 방광의 하방, 요도의 상방, 치골의 후방, 직장의 전방에 위치한다.The prostate gland, also called the subsynthetic gland, is one of the major organs in the reproductive system of male mammals and belongs to the exocrine gland. In addition, the main function of the prostate gland is secretion and storage of prostate fluid. In humans, the prostate gland is located at the bottom of the pelvic cavity. Specifically, the prostate gland is located below the bladder, above the urethra, behind the pubic bone and in front of the rectum.
전립선 비대증은 우리나라 남성의 50세 이후 발병이 급격히 일어나는 남성질환으로 최근 우리나라에서 전립선비대증 질환자의 증가율이 년 20%를 상회할 정도로 가파른 증가를 하고 있다. 이 질환의 경우 전립선이행대 부분의 평활근(smooth cell)과 상피세포(epithelial)의 과도한 증식으로 야기되며, 빈뇨, 야간빈뇨, 배뇨 시작의 지연 및 방뇨력의 감퇴 현상을 보인다. 또한 가끔씩 회음부의 불쾌감이나 중압감, 하복부의 긴장감을 느끼는 증상들이 시간이 경과함에 따라 자극 증상 및 배뇨 증상이 심해지고 갑자기 소변을 보지 못하게 되는 경우도 생긴다. 이후 전립선 비대가 더 심해지게 되면 배뇨량이 더욱 감소하고 잔뇨량은 늘어나게 되며 신장에 무리한 영향을 주는 경우까지 이를 수 있다.Prostatic hyperplasia is a male disease that occurs rapidly after 50 years of age in Korea, and the rate of increase of prostate hyperplasia in Korea has recently increased rapidly, exceeding 20% a year. The disease is caused by excessive proliferation of smooth and epithelial cells in the prostate transitional zone, showing frequent urination, nocturia, delayed onset of urination, and a decline in urination. Occasionally, the symptoms of discomfort or pressure in the perineum and tension in the lower abdomen can cause severe irritation, urination, and sudden urination. If the prostate enlargement becomes more severe, the amount of urination decreases further and the amount of residual urine increases, which may lead to excessive effects on the kidneys.
전립선 비대의 한 가지 기전은 남성호르몬인 테스토스테론(testosterone, T)과 디하이드로테스토스테론(dihydrotestosterone, DHT)이 관련되어 있다고 알려져 있다. 치료 물질로는 5αRD의 활성을 억제하는 5αRD 저해제(inhibitor)가 전립선약물치료의 큰 축을 담당하고 있으며, 전립선 치료제로 개발되어 있는 피나스테라이드(Finasteride)의 경우가 5αRD type2를 억제하는 것으로 혈청(serum)에서 70%, 전립선에서 90%정도 억제할 수 있다고 알려져 있다. One mechanism of enlarged prostate is known to be related to the male hormone testosterone (T) and dihydrotestosterone (DHT). As a therapeutic substance, 5αRD inhibitors that inhibit the activity of 5αRD play a major role in the treatment of prostate drugs, while finasteride, which is developed as a prostate drug, inhibits 5αRD type2 in serum. It is known to inhibit 70% and 90% of the prostate gland.
이러한 전립선 비대 질환은 남성, 특히 중노년 남성의 신체건강에 있어서 중요한 질환이며, 건강 관리와 유지를 위해 전립선 비대 질환을 효과적으로 예방, 개선 또는 치료할 수 있는 방안이 필요한 실정이다.The enlarged prostate disease is an important disease in physical health of men, especially middle-aged men, and there is a need for a method for effectively preventing, improving or treating an enlarged prostate for health care and maintenance.
한편, 모유 올리고당 중 시아릴락토오스(sialyllactose)는 장에 존재하는 세균 활성에 영향을 주는 항염증 특성을 가지고 있으며, 장내의 유용한 세균이 잘 성장할 수 있도록 도와준다는 보고가 있는 물질이다(Izquierdo-Useros N et al., PlosBiol, 2012, 10). 또한 시아릭락토오스는 모유 내 존재하므로 복용에 대한 부작용이 이미 검증되어 다양한 기능에 관한 연구가 진행 중이다.Meanwhile, siaryllactose in breast milk oligosaccharides has anti-inflammatory properties that affect bacterial activity in the intestine and has been reported to help the growth of useful bacteria in the intestine (Izquierdo-Useros N). et al., Plos Biol, 2012, 10). In addition, since cyal lactose is present in breast milk, the side effects of taking it have already been verified and various functions are being studied.
이러한 시아릴락토오스를 류마티스관절염 환자에 투여하여 IgG 변화에 따른 자가면역질환 치료효과를 확인하거나 시아릴락토오스의 퇴행성관절염에 대한 예방 및 치료효과를 확인한 문헌은 존재하나, 시아릴락토오스의 전립선 비대 질환 개선효과를 확인한 연구는 아직 없는 실정이다.Although there is a literature reviewing the administration of cyaryllactose to patients with rheumatoid arthritis to confirm the autoimmune disease treatment effect according to the IgG change or the prevention and treatment effect of cyaryllactose for degenerative arthritis, the improvement of prostatic hypertrophy disease of cyaryllactose There is no research to confirm the effect.
이에 본 발명자들은 전립선 비대 질환을 효율적으로 예방 및 치료할 수 있는 신규 물질을 찾고자 연구한 결과, 시아릴락토오스(sialyllactose)의 전립선 비대 감소 효과 및 전립선 무게 감소 효과를 확인함으로써 본 발명을 완성하게 되었다.Accordingly, the present inventors have studied to find a novel substance that can effectively prevent and treat prostatic hypertrophy disease. As a result, the present inventors have completed the present invention by confirming the effect of reducing the prostate hypertrophy and the weight of the prostate gland by sialyllactose.
따라서 본 발명의 목적은, 시아릴락토오스를 포함하는 전립선 비대 질환 예방 또는 치료용 약학적 조성물, 전립선 비대 질환 예방 또는 개선용 식품 조성물 및 의약외품 조성물을 제공하는 것이다.Accordingly, an object of the present invention is to provide a pharmaceutical composition for preventing or treating prostatic hypertrophy disease, including a cyaryllactose, a food composition for preventing or improving prostate hypertrophy disease, and a quasi-drug composition.
상기 목적을 달성하기 위하여, 본 발명은 시아릴락토오스(Sialyllactose) 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 치료용 약학적 조성물을 제공한다.In order to achieve the above object, the present invention provides a pharmaceutical composition for preventing or treating prostatic hypertrophy disease, comprising siaryllactose (Sialyllactose) or a pharmaceutically acceptable salt thereof as an active ingredient.
또한 본 발명은 시아릴락토오스를 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 개선용 식품 조성물을 제공한다.In another aspect, the present invention provides a food composition for preventing or ameliorating prostatic hypertrophy disease, comprising siarylactose as an active ingredient.
또한 본 발명은 시아릴락토오스를 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 개선용 의약외품 조성물을 제공한다.In another aspect, the present invention provides a quasi-drug composition for preventing or ameliorating prostate hyperplasia, comprising siarylactose as an active ingredient.
본 발명에 따른 시아릴락토오스는 전립선 비대 감소 효과, 전립선 무게 감소 효과를 가지고 있어, 전립선 비대 질환을 예방, 치료 또는 개선할 수 있는 의약품, 기능성 식품, 의약외품의 제조에 유용하게 사용할 수 있다. 또한 전립선 비대 질환으로 인한 빈뇨, 야간빈뇨, 복압배뇨, 요흐름 속도 감소, 단축뇨, 배뇨 후 요점적 등의 증상을 완화시킬 수 있다.Cyaryllactose according to the present invention has a prostatic hypertrophy effect, a prostate weight reduction effect, can be useful in the manufacture of medicines, functional foods, quasi-drugs that can prevent, treat or improve the prostate hypertrophy disease. In addition, symptoms such as frequent urination, night urination, abdominal urination, decreased urine flow rate, shortening urine, and urinary discharge after urination may be alleviated.
도 1은 시알산(Sialic acid) 및 시아릴락토오스(α2,3-sialyllactose 및 α2,6-sialyllactose)의 구조를 나타낸 도이다.
도 2는 시아릴락토오스의 전립선 비대 감소 효과를 확인보기 위해 실험군에서 절제한 전립선 조직의 크기를 확인한 결과를 나타낸 도이다.
도 3은 시아릴락토오스의 전립선 무게 감소 효과를 확인하기 위해 전립선 무게와 상대적 전립선 무게 비율을 측정한 결과를 나타낸 도이다.
도 4는 시아릴락토오스의 체중 당 전립선 무게(PW/BW) 비율 감소 효과를 확인하기 위해 체중 당 전립선 무게(PW/BW) 비율을 측정한 결과를 나타낸 도이다.1 is a diagram illustrating the structure of sialic acid and sialic lactose (α2,3-sialyllactose and α2,6-sialyllactose).
Figure 2 is a view showing the results of confirming the size of the prostate tissue excised in the experimental group to determine the effect of reducing the prostate hypertrophy of siaryl lactose.
Figure 3 is a diagram showing the results of measuring the ratio of the prostate weight and relative prostate weight in order to confirm the effect of reducing the prostate weight of cyaryllactose.
Figure 4 is a view showing the result of measuring the weight of the prostate weight (PW / BW) per weight in order to confirm the effect of reducing the weight of the prostate weight (PW / BW) per weight of siaryl lactose.
본 발명은 시아릴락토오스(Sialyllactose) 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 치료용 약학적 조성물을 제공한다.The present invention provides a pharmaceutical composition for preventing or treating prostatic hypertrophy disease, comprising siarylacactose or a pharmaceutically acceptable salt thereof as an active ingredient.
상기 “시아릴락토오스”는 시알릴올리고당(sialyloligosaccharide)에 속하는 물질이다. 구체적으로, 상기 시알릴올리고당은 다양한 글리코시드 결합으로 존재하며, 보다 일반적으로 α(2,3) 또는 α(2,6) 갈락토오스(또는 락토오스)로 존재한다. 이와 같은 시알로시드(sialoside)의 기능은 올리고당 부분의 구조적 이질성(structural heterogeneity)에 따라 다양해진다. 올리고당의 기본적인 빌딩 블럭(building block)은 5종의 단당류(monosaccharide), 즉 D-글루코오스(Glc), D-갈락코오스(Gal), N-아세틸글루코사민(GlcNAc), L-푸코오스(Fuc) 및 시알산(N-아세틸-뉴라민산, Neu5Ac)이며, 락토오스 또는 폴리락토사민이 α2,3 또는 α2,6 결합에 의해 시알릴화될 수 있다.Said "cyaryl lactose" is a substance belonging to sialyloligosaccharides. Specifically, the sialyl oligosaccharides are present in various glycoside bonds, and more commonly in α (2,3) or α (2,6) galactose (or lactose). The function of such sialosides varies according to the structural heterogeneity of the oligosaccharide moiety. The basic building blocks of oligosaccharides are five monosaccharides: D-glucose (Glc), D-galaccose (Gal), N-acetylglucosamine (GlcNAc), L-fucose (Fuc) and Sialic acid (N-acetyl-neuraminic acid, Neu5Ac), and lactose or polylactosamine can be sialylated by α2,3 or α2,6 bonds.
본 발명의 시아릴락토오스는 비환원말단에 시알산이 붙은 올리고당으로 주로 포유동물 젖에 존재하며, 소량이지만 요에도 포함되어 있는 물질이다. 또한 본 발명의 시아릴락토오스는 3’-시아릴락토오스(α-NeuNAc-(2→3)-β-D-Gal-(1→4)-D-Glc, α2,3-sialyllactose), 6’-시아릴락토오스(α-NeuNAc-(2→6)-β-D-Gal-(1→4)-D-Glc, α2,6-sialyllactose), 또는 이들의 혼합물일 수 있으며, 바람직하게는 6’-시아릴락토오스일 수 있다. 상기 3’-시아릴락토오스 및 6’-시아릴락토오스의 화학구조식은 C23H38NO19Na이며 모유에 많이 함유되어 있는 천연 유래의 단일화합물(single compound)이자 구조이성질체이다. 또한 상기 6’-시아릴락토오스는 세포 인식 및 면역 반응을 포함한 다양한 세포 경로에 관여하는 당단백질 및 당지질의 중요한 성분이다.Siarylactose of the present invention is an oligosaccharide with sialic acid attached to the non-reducing end thereof, which is mainly present in mammalian milk and is contained in urine in small amounts. In addition, the cyaryllactose of the present invention is 3'-cyaryllactose (α-NeuNAc- (2 → 3) -β-D-Gal- (1 → 4) -D-Glc, α2,3-sialyllactose), 6 ' -Ciarylactose (α-NeuNAc- (2 → 6) -β-D-Gal- (1 → 4) -D-Glc, α2,6-sialyllactose), or mixtures thereof, preferably 6 '-Cyaryllactose. The chemical structural formulas of 3'-cyaryllactose and 6'-cyaryllactose are C 23 H 38 NO 19 Na and are naturally occurring single compounds and structural isomers contained in mother's milk. The 6'-cyaryllactose is also an important component of glycoproteins and glycolipids involved in various cellular pathways, including cell recognition and immune responses.
또한 본 발명의 시아릴락토오스는 이의 유도체를 포함할 수 있다. 상기 “유도체”는 상기 시아릴락토오스의 작용기를 도입, 치환, 산화, 환원 등에 의해서 모체의 구조와 성질을 대폭적으로 변화시키지 않는 한도에서 변화시킨 화합물을 의미한다. 이러한 작용기의 종류에는 제한이 없으며, 예컨대 각각 독립적으로 히드록시기, 페녹시기, 티에닐기, 푸릴기, 피리딜기, 시클로헥실기, 알킬알코올기, 알킬디알코올기, 또는 치환 또는 비치환된 페닐로 치환 또는 비치환된 C1 내지 C20의비사이클릭 탄화수소기; 히드록시기, 히드록시메틸기, 메틸기, 또는 아미노기로 치환 또는 비치환된 C3 내지 C30의 사이클릭 탄화수소기; 또는 당 잔기를 포함할 수 있으나, 이에 제한되는 것은 아니다.In addition, the siarylactose of the present invention may include a derivative thereof. The "derivative" refers to a compound in which the functional group of the siarylactose is changed to the extent that the structure and properties of the parent are not significantly changed by introduction, substitution, oxidation, or reduction. There is no limitation in the kind of such functional groups, and for example, each independently substituted with a hydroxy group, a phenoxy group, a thienyl group, a furyl group, a pyridyl group, a cyclohexyl group, an alkyl alcohol group, an alkyldialcohol group, or a substituted or unsubstituted phenyl; Unsubstituted C1 to C20 bicyclic hydrocarbon group; C3 to C30 cyclic hydrocarbon group unsubstituted or substituted with a hydroxy group, a hydroxymethyl group, a methyl group, or an amino group; Or a sugar moiety, but is not limited thereto.
상기 "당 잔기"란 다당류 분자로부터 1개의 수소 원자가 제거된 기를 의미하며, 따라서 예를 들어 단당류 또는 올리고당으로부터 유래된 잔기를 의미할 수 있다. 상기 “치환된”은 별도의 정의가 없는 한, 작용기 중 하나 이상의 수소 원자가 할로겐(F, Cl, Br 또는 I), 히드록시기, 니트로기, 시아노기, 이미노기(=NH, =NR, R은 C1 내지 C10의 알킬기이다), 아미노기(-NH2,-NH(R'), -N(R")(R"'), R',R",R"'은 각각 독립적으로 탄소수 C1 내지 C10의 알킬기이다), 아미디노기, 히드라진기, 히드라존기, 카르복시산기, C1 내지 C20의 알킬기, C6 내지 C30의 아릴기, C3 내지 C30의 시클로알킬기, C3 내지 C30의 헤테로아릴기, 또는 C2 내지 C30의 헤테로시클로알킬기로 치환되는 것을 의미한다.The "sugar residue" refers to a group in which one hydrogen atom has been removed from a polysaccharide molecule, and thus may mean, for example, a residue derived from a monosaccharide or oligosaccharide. Unless otherwise defined, the term "substituted" means that at least one hydrogen atom of the functional group is halogen (F, Cl, Br or I), hydroxy group, nitro group, cyano group, imino group (= NH, = NR, R is C1 To a C10 alkyl group), an amino group (-NH2, -NH (R '), -N (R ") (R"'), R ', R ", R"' are each independently a C1 to C10 alkyl group Amidino group, hydrazine group, hydrazone group, carboxylic acid group, C1 to C20 alkyl group, C6 to C30 aryl group, C3 to C30 cycloalkyl group, C3 to C30 heteroaryl group, or C2 to C30 hetero It is meant to be substituted with a cycloalkyl group.
본 발명의 용어 "약학적으로 허용가능한 염"이란, 화합물이 투여되는 유기체에 심각한 자극을 유발하지 않고 화합물의 생물학적 활성과 물성들을 손상시키지 않는 화합물의 제형을 의미한다. 상기 약학적 염은, 약학적으로 허용되는 음이온을 함유하는 무독성 산부가염을 형성하는 산, 예를 들어, 염산, 황산, 질산, 인산, 브롬화수소산, 요오드화수소산 등과 같은 무기산, 타타르산, 포름산, 시트르산, 아세트산, 트리클로로아세트산, 트리플로로아세트산, 글루콘산, 벤조산, 락트산, 푸마르산, 말레인산, 살리신산 등과 같은 유기 카본산, 메탄설폰산, 에탄술폰산, 벤젠설폰산, p-톨루엔설폰산 등과 같은 설폰산 등에 의해 형성된 산부가염이 포함된다. 예를 들어, 약학적으로 허용되는 카르복실산 염에는, 리튬, 나트륨, 칼륨, 칼슘, 마그네슘 등에 의해 형성된 금속염 또는 알칼리 토금속 염, 라이신, 아르지닌, 구아니딘 등의 아미노산 염, 디시클로헥실아민, N-메틸-D-글루카민, 트리스(히드록시메틸) 메틸아민, 디에탄올아민, 콜린 및 트리에틸아민 등과 같은 유기염 등이 포함된다.As used herein, the term "pharmaceutically acceptable salt" means a formulation of a compound that does not cause severe irritation to the organism to which the compound is administered and does not impair the biological activity and properties of the compound. The pharmaceutical salts include acids that form non-toxic acid addition salts containing pharmaceutically acceptable anions, for example inorganic acids such as hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, hydrobromic acid, hydroiodic acid, and the like, tartaric acid, formic acid, citric acid Sulfonic acids such as acetic acid, trichloroacetic acid, trichloroacetic acid, gluconic acid, benzoic acid, lactic acid, organic carbonic acid such as fumaric acid, maleic acid, salicylic acid, methanesulfonic acid, ethanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, etc. Acid addition salts formed by phonic acid or the like. For example, pharmaceutically acceptable carboxylic acid salts include metal salts or alkaline earth metal salts formed by lithium, sodium, potassium, calcium, magnesium, amino acid salts such as lysine, arginine, guanidine, dicyclohexylamine, N Organic salts such as -methyl-D-glucamine, tris (hydroxymethyl) methylamine, diethanolamine, choline and triethylamine and the like.
또한 상기 시아릴락토오스는 전립선 무게 감소 효과를 나타낼 수 있으며, 전립선 비대 감소 효과를 나타낼 수 있다. 따라서 본 발명의 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는 약학적 조성물을 이용하면, 전립선 비대 질환의 예방, 개선 또는 치료 효과를 나타낼 수 있고, 전립선 비대 질환으로 인한 빈뇨, 야간빈뇨, 복압배뇨, 요흐름 속도 감소, 단축뇨, 배뇨 후 요점적 등의 증상을 완화시킬 수 있다. 또한 본 발명의 시아릴락토오스는 모유 내 존재하며 복용에 대한 부작용이 이미 검증된 물질이므로 의약 또는 식품 용도로 유용하게 사용할 수 있다.In addition, the siaryl lactose may exhibit a prostate weight reduction effect, and may exhibit a prostate hypertrophy effect. Therefore, by using the pharmaceutical composition containing the siarylactose of the present invention or a pharmaceutically acceptable salt thereof as an active ingredient, it can exhibit the effect of preventing, improving or treating prostatic hypertrophy, Symptoms such as nocturia, abdominal urination, decreased urinary flow rate, shortening of urine, and urine dropping after urination can be alleviated. In addition, the siarylactose of the present invention is present in breast milk and has been proven to have side effects of taking it, and thus may be usefully used for medicine or food.
상기 전립선 비대 질환은 요로 폐색을 동반한 전립선 비대 질환 또는 혈뇨를 동반한 전립선 비대 질환을 포함할 수 있으며, 이에 제한되지는 않는다. 또한 상기 전립선 비대 질환은 전립선 비대로 인한 빈뇨, 야간빈뇨, 복압배뇨, 요흐름 속도 감소, 단축뇨, 배뇨 후 요점적 등의 증상을 포함할 수 있으며, 이에 제한되지는 않는다.The prostate enlargement disease may include, but is not limited to, an enlarged prostate disease with urinary tract obstruction or an enlarged prostate disease with hematuria. In addition, the enlarged prostate disease may include symptoms such as urination due to enlarged prostate, nocturia, abdominal urination, urinary flow rate reduction, shortening urine, urine dropping, and the like, but is not limited thereto.
또한 상기 전립선 비대 질환은 남성 호르몬인 테스토스테론(testosterone), 이의 활성형인 디하이드로 테스토스테론(dihydrotestosterone, DHT) 및 프로피온산 테스토스테론(testosterone propionate, TP)으로 이루어진 군에서 선택된 1 이상의 물질에 의해 유발된 질환일 수 있고, 바람직하게는 프로피온산 테스토스테론에 의해 유발된 질환일 수 있으며 이에 제한되지는 않는다.In addition, the prostate hypertrophy disease may be a disease caused by one or more substances selected from the group consisting of testosterone (testosterone), an active form thereof, dihydrotestosterone (DHT), and testosterone propionate (TP). It may be, but is not limited to, a disease caused by propionic acid testosterone.
본 발명의 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는 전립선 비대 질환 예방 또는 치료용 약학적 조성물은 약학적 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다. 또한, 약학적 조성물의 제조에는 고체 또는 액체의 제제용 첨가물을 사용할 수 있다. 제제용 첨가물은 유기 또는 무기 중 어느 것이어도 된다.A pharmaceutical composition for preventing or treating prostatic hypertrophy disease comprising the siarylactose of the present invention or a pharmaceutically acceptable salt thereof as an active ingredient further includes suitable carriers, excipients and diluents commonly used in the manufacture of pharmaceutical compositions. can do. In addition, the preparation of the pharmaceutical composition may be used as additives for the preparation of solid or liquid. The additive for preparation may be either organic or inorganic.
부형제로서는 예를 들면 유당, 자당, 백당, 포도당, 옥수수 전분 (corn starch), 전분, 탈크, 소르비트, 결정 셀룰로오스, 덱스트린, 카올린, 탄산칼슘, 이산화규소 등을 들 수 있다. 결합제로서는 예를 들면 폴리비닐알코올, 폴리비닐에테르, 에틸셀룰로오스, 메틸셀룰로오스, 아라비아고무, 트래거캔스 (tragacanth), 젤라틴, 셀락(shellac), 히드록시프로필셀룰로오스, 히드록시프로필메틸셀룰로오스, 구연산칼슘, 덱스트린, 펙틴 (pectin)등을 들 수 있다. 활택제로서는 예를 들면 스테아린산마그네슘, 탈크, 폴리에틸렌글리콜, 실리카, 경화식물유 등을 들 수 있다. 착색제로서는 통상 의약품에 첨가하는 것이 허가되어 있는 것이라면 모두 사용할 수 있다. 이들의 정제, 과립제에는 당의(糖衣), 젤라틴코팅, 기타 필요에 따라 적절히 코팅할 수 있다. 또한, 필요에 따라 방부제, 항산화제 등을 첨가할 수 있다.Examples of excipients include lactose, sucrose, white sugar, glucose, corn starch, starch, talc, sorbet, crystalline cellulose, dextrin, kaolin, calcium carbonate, silicon dioxide and the like. Examples of the binder include polyvinyl alcohol, polyvinyl ether, ethyl cellulose, methyl cellulose, gum arabic, tragacanth, gelatin, shellac, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, calcium citrate, Dextrin, pectin and the like. Examples of the lubricant include magnesium stearate, talc, polyethylene glycol, silica, hardened vegetable oil, and the like. As a coloring agent, if it is normally permitted to add to a pharmaceutical, all can be used. These tablets and granules can be appropriately coated according to sugar, gelatin coating and other needs. Moreover, preservatives, antioxidants, etc. can be added as needed.
또한 본 발명의 약학적 조성물은 당업계에서 통상적으로 제조되는 어떠한 제형으로도 제조될 수 있으며 (예: 문헌[Remington's Pharmaceutical Science, 최신판; Mack Publishing Company, Easton PA), 제제의 형태는 특별히 한정되는 것은 아니나 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있으며, 이에 제한되지는 않는다.In addition, the pharmaceutical composition of the present invention may be prepared in any formulation commonly prepared in the art (e.g., Remington's Pharmaceutical Science, latest edition; Mack Publishing Company, Easton PA), and the form of the formulation is particularly limited. However, it may be used in the form of oral formulations, external preparations, suppositories, and sterile injectable solutions such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, etc. according to conventional methods, but is not limited thereto. .
본 발명의 약학적 유효량은 환자의 상처 종류, 적용부위, 처리회수, 처리시간, 제형, 환자의 상태, 보조제의 종류 등에 따라 변할 수 있다. 사용량은 특별히 한정되지 않지만, 통상 본 발명의 약학 조성물의 일일 유효량을 환자에 적용시 0.00001 내지 10000 μg일 수 있다. 상기 1 일량은 1일에 1회, 또는 적당한 간격을 두고 하루에 2~3회에 나눠 투여해도 되고, 수일(數日) 간격으로 간헐(間歇)투여해도 된다.The pharmaceutically effective amount of the present invention may vary depending on the type of wound, the area of application, the number of treatments, the treatment time, the dosage form, the condition of the patient, the type of adjuvant, and the like. The amount used is not particularly limited, but may generally be 0.00001 to 10000 μg when the daily effective amount of the pharmaceutical composition of the present invention is applied to a patient. The daily dose may be administered once a day or divided into two to three times a day at appropriate intervals, or may be administered intermittently at intervals of several days.
그러나, 본 발명의 약학적 조성물의 상기 사용량은 투여 경로, 환자의 연령, 성별, 체중, 환자의 중증도, 상처 종류, 적용부위, 처리회수, 처리시간, 제형, 환자의 상태, 보조제의 종류 등의 여러 관련 인자에 비추어 결정되는 것이므로 상기 유효량은 어떠한 측면으로든 본 발명의 범위를 제한하는 것으로 이해되어서는 아니 된다.However, the amount of the pharmaceutical composition of the present invention may be used in such a manner as the route of administration, the age, sex, weight of the patient, the severity of the patient, the type of wound, the site of application, the number of treatments, the treatment time, the dosage form, the condition of the patient, the type of supplement, and the like. The effective amount is not to be understood as limiting the scope of the present invention in any aspect because it is determined in view of various related factors.
또한 본 발명은 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 개체에 투여하는 단계;를 포함하는, 전립선 비대 질환 예방 또는 치료 방법을 제공한다.In another aspect, the present invention provides a method for preventing or treating prostatic hypertrophy disease, comprising the step of administering siarylactose or a pharmaceutically acceptable salt thereof to a subject.
본 발명에 있어서, "개체"란 소, 개, 돼지, 닭, 양, 말, 인간을 포함한 포유동물을 의미하나 이에 제한되는 것은 아니다. 본 발명의 개체는 전립선 비대 질환의 예방 또는 치료를 필요로 하는 환자로 전립선 비대 질환 치료 중인 환자, 전립선 비대 질환 치료를 받은 적이 있는 환자, 전립선 비대 질환 치료를 받을 필요가 있는 환자를 모두 포함하며, 전립선 비대 질환 치료를 위하여 외과적 수술을 시행한 환자 또한 포함될 수 있다.In the present invention, "individual" means a mammal including a cow, a dog, a pig, a chicken, a sheep, a horse, and a human, but is not limited thereto. Subjects of the present invention include all patients who need to prevent or treat prostatic hypertrophy disease, patients who are undergoing prostate hypertrophy disease, patients who have been treated for prostate hypertrophy disease, patients who need to be treated for prostate hypertrophy disease, Patients who have undergone surgical operations to treat an enlarged prostate may also be included.
또한 본 발명의 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염은 이 외 기존의 전립선 비대 질환 치료를 위한 약물 또는 치료방법과 병용하여 처리될 수 있다. 본 발명의 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 병용 처리하는 경우, 이는 전립선 비대 질환 치료를 위한 다른 약물 또는 치료방법과 동시에 또는 순차적으로 처리될 수 있다. In addition, the siarylactose of the present invention or a pharmaceutically acceptable salt thereof may be treated in combination with other existing drugs or methods for treating prostatic hypertrophy. In the case of the combination treatment of the siarylactose of the present invention or a pharmaceutically acceptable salt thereof, it may be treated simultaneously or sequentially with other drugs or methods for treating prostatic hypertrophy diseases.
또한 본 발명은 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 개선용 식품 조성물을 제공한다.In another aspect, the present invention provides a food composition for preventing or ameliorating prostatic hypertrophy disease, comprising siarylactose or a pharmaceutically acceptable salt thereof as an active ingredient.
본 발명의 “식품”은, 기능성 식품(functional food), 영양 보조제(nutritional supplement), 건강식품(health food) 및 식품 첨가제(food additives) 등의 모든 형태로 제조할 수 있다. 예를 들면, 건강식품으로는 본 발명의 시아릴락토오스를 차, 쥬스 및 드링크의 형태로 제조하여 음용하도록 하거나, 과립화, 캡슐화 및 분말화하여 섭취할 수 있다. 또한, 기능성 식품으로는 음료(알콜성 음료 포함), 과실 및 그의 가공식품(예: 과일통조림, 병조림, 잼, 마말레이드 등), 어류, 육류 및 그 가공식품(예: 햄, 소시지, 콘비프 등), 빵류 및 면류(예: 우동, 메밀국수, 라면, 스파게티, 마카로니 등), 과즙, 각종 드링크, 쿠키, 엿, 유제품(예: 버터, 치츠 등), 식용식물유지, 마가린, 식물성 단백질, 레토르트 식품, 냉동식품, 각종 조미료(예: 된장, 간장, 소스 등) 등에 본 발명의 시아릴락토오스를 첨가하여 제조할 수 있다.The "food" of the present invention can be prepared in all forms such as functional food, nutritional supplement, health food and food additives. For example, as a health food, the siarylactose of the present invention may be prepared in the form of tea, juice, and drink for drinking, or granulated, encapsulated, and powdered. Functional foods also include beverages (including alcoholic beverages), fruits and processed foods (e.g. canned fruit, canned foods, jams, marmalade, etc.), fish, meat and processed foods (e.g. ham, sausages, corned beef, etc.) , Breads and noodles (e.g. udon, soba, ramen, spaghetti, macaroni, etc.), fruit juices, various drinks, cookies, malts, dairy products (e.g. butter, cheats, etc.), edible vegetable oils, margarine, vegetable protein, retort food , Frozen foods, various seasonings (e.g., miso, soy sauce, sauce, etc.) can be prepared by the addition of the siaryl lactose of the present invention.
또한 본 발명은 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 개선용 의약외품 조성물을 제공한다.In another aspect, the present invention provides a quasi-drug composition for preventing or ameliorating prostatic hyperplasia, comprising siarylactose or a pharmaceutically acceptable salt thereof as an active ingredient.
상기 용어 “의약외품”은 인체에 대한 작용이 약하거나 인체에 직접 작용하지 아니한 물품일 수 있으며, 사람이나 동물의 질병을 진단, 치료, 경감, 처치 또는 예방할 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것 또는 사람이나 동물의 구조와 기능에 약리학적 영향을 줄 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것을 제외한 물품을 의미한다.The term “quasi drug” may be an article that has a weak effect on the human body or does not directly affect the human body, and is an apparatus, machine, or device among articles used for diagnosing, treating, alleviating, treating, or preventing a disease of a human or animal. Means any article other than non-apparatus, machinery, or apparatus that is used for the purpose of pharmacologically affecting the structure and function of a person or animal.
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 an quasi-drug additive, the composition may be added as it is or used with other quasi-drugs or quasi-drug components, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be appropriately determined depending on the intended use.
본 발명의 시아릴락토오스 또는 이의 약학적으로 허용 가능한 염을 유효성분으로 포함하는, 전립선 비대 질환 예방 또는 개선용 식품 조성물 또는 의약외품 조성물을 이용하면 전립선 비대 질환의 예방, 개선 또는 치료 효과를 나타낼 수 있다. 또한 전립선 비대 질환으로 인한 빈뇨, 야간빈뇨, 복압배뇨, 요흐름 속도 감소, 단축뇨, 배뇨 후 요점적 등의 증상을 완화시킬 수 있다.When using a food composition or quasi-drug composition for preventing or improving prostate hypertrophy disease, comprising the siarylactose of the present invention or a pharmaceutically acceptable salt thereof as an active ingredient, it may exhibit an effect of preventing, improving or treating prostatic hypertrophy disease. . In addition, symptoms such as frequent urination, night urination, abdominal urination, decreased urine flow rate, shortening urine, and urinary discharge after urination may be alleviated.
이하, 본 발명을 실시예에 의거하여 보다 구체적으로 설명한다. 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로, 본 발명의 요지에 따라 발명의 범위가 이들 실시예에 의해 제한되지 않는다는 것은 당업계에서 통상의 지식을 가진 자에 있어서 자명할 것이다.EMBODIMENT OF THE INVENTION Hereinafter, this invention is demonstrated more concretely based on an Example. The examples are only for illustrating the present invention in more detail, and it will be apparent to those skilled in the art that the scope of the present invention is not limited by these examples according to the gist of the present invention.
실시예 1. 실험재료 및 실험조건 설정Example 1 Experimental Materials and Experimental Conditions
실시예 1-1. 실험재료 구입 및 전처리Example 1-1. Purchase and pretreatment of experimental materials
실험을 위한 동물로는 대한바이오링크(Daejeon, Republic of Korea)에서 6주령 수컷 Wistar rats (200 ± 20 g)을 구입하여 상지대학교의 동물실험윤리위원회에서 정한 실험동물 가이드라인에 따라 사육하였다. 실험을 시작하기 전 1주 동안 적응기간을 둔 후 실험 기간인 6주 동안 사료와 물은 자유롭게 섭취하도록 하였으며 12시간 간격으로 빛을 조절해주는 환경에서 온도 22 ± 2 ℃, 습도 55% ± 9%의 환경을 유지해주었다. 사료와 물은 자유롭게 섭취하도록 하였다. 또한 상기 실험동물은 무작위로 총 5개의 실험군(n=5)으로 구분하였으며, 모든 실험군 동물은 보고된 이전 논문에 따라 거세하고 1주간의 회복기를 가진 뒤 실험에 이용하였다.For the experiments, 6-week-old male Wistar rats (200 ± 20 g) were purchased from Daejeon, Republic of Korea, and were bred according to the guidelines of experimental animals set by the Animal Experimentation Ethics Committee of Sangji University. After 1 week of adaptation, the feed and water were freely consumed for 6 weeks, and the temperature was controlled at a temperature of 22 ± 2 ℃ and a humidity of 55% ± 9% for 12 hours. The environment was maintained. Feed and water were taken freely. In addition, the experimental animals were randomly divided into a total of five experimental groups (n = 5), and all the experimental animals were castrated according to the previous papers reported, and used for experiments after a week of recovery.
본 발명의 시아릴락토오스(sialyllactose)는 Carbosynth Ltd. (Berkshire, UK) 에서 구입하였다. 양성대조물질로 사용된 피나스테라이드(finasteride, 5α-환원효소 type 2 억제제)는 Merk & Co., Inc. (White house Station, NJ, USA)에서 구입하였다. 프로피온산 테스토스테론(testosterone propionate) 및 그 밖의 시약들은 Sigma Aldrich (St. Louis, MO, USA)에서 구입하였다.Siaryllactose of the present invention is Carbosynth Ltd. (Berkshire, UK). Finasteride (5α-
실시예 1-2. 실험조건 설정Example 1-2. Experimental condition setting
상기 5개의 군은 실험 조건에 따라 각각 대조군(sharm-operated group, Con군), BPH(benign prostatic hyperplasia) 모델군(BPH군), 피나스테라이드 처리군(finasteride-treated group, Fina군), 0.5 mg/kg 시아릴락토오스 처리군 (Sialyllactose-treated group, Sia 0.5) 및 1.0 mg/kg 시아릴락토오스 처리군 (Sialyllactose-treated group, Sia 1.0)으로 구분하였으며, 이를 표 1에 나타내었다.The five groups were control group (sharm-operated group, Con group), BPH (benign prostatic hyperplasia) model group (BPH group), finasteride-treated group (finasteride-treated group, Fina group), 0.5 mg / It was divided into kg siarylactose-treated group (Saly 0.5) and 1.0 mg / kg sialyllactose-treated group (Sia 1.0), which is shown in Table 1.
(Con group) : 대조군 Con group
(Con group) : Control
(BPH group) : BPH 투여군 BPH group
(BPH group) : BPH administration group
(Fina group) : 피나스테라이드 처리군 Fina County
(Fina group) : finasteride treatment group
10 mg/kg
경구투여(Oral)Finasteride
10 mg / kg
Oral administration
(Sia0.5 group) : 시아릴락토오스 0.5 mg/kg 처리군 Sia0.5 County
(Sia0.5 group) : cyaryllactose 0.5 mg / kg treatment group
0.5 mg/kg
복강투여(Intraperitoneal)Cyaryllactose
0.5 mg / kg
Intraperitoneal
(Sia1.0 group) : 시아릴락토오스 1.0 mg/kg 처리군 Sia1.0 County
(Sia1.0 group) : cyaryllactose 1.0 mg / kg treatment group
1.0 mg/kg
복강투여(Intraperitoneal)Cyaryllactose
1.0 mg / kg
Intraperitoneal
상기 표 1에 나타낸 각 실험군의 실험조건은 다음과 같다. Con군은 전처리(거세)만을 실시한 군이며, BPH군은 테스토스테론 10 mg/kg 을 피하주사 함으로써 전립선 비대를 유도한 군이다. Fina군은 양성대조군으로써 전립선 비대 유발과 피타스테라이드(finasteride)를 경구투여한 군이며, Sia 0.5 및 Sia 1.0군은 전립선 비대 유발과 시아릴락토오스(sialyllactose)를 각각 0.5 mg/kg 및 1.0 mg/kg 복강투여한 군이다.Experimental conditions of each experimental group shown in Table 1 are as follows. The Con group was the only group treated with pretreatment (castration), and the BPH group induced prostate hypertrophy by subcutaneous injection of testosterone 10 mg / kg. The Fina group was a positive control group and induced oral administration of prostatic hypertrophy and phytasteride, and the Sia 0.5 and Sia 1.0 groups provoked an enlarged prostate and siallyllactose 0.5 mg / kg and 1.0 mg / kg, respectively. kg intraperitoneally administered group.
상기 실험에 이용한 실험물질의 상세한 투여 방법 및 투여량은 다음과 같다. 우선 전립선 비대 유발을 위한 테스토스테론의 투여는 실험동물의 거세 후 1주 간의 회복기를 거친 뒤 실시하였다. 구체적으로, Con군을 제외한 BPH군, Fina군, Sia0.5군 및 Sia1.0군에 프로피온산 테스토스테론을 용매(corn oil : EtOH (9:1))에 녹여 10 mg/kg 을 하루에 한번 4주간 피하 주사하여 전립선 비대증을 유도하였다. 피나스테라이드는 용매(PBS : EtOH : Koliphor (18:1:1))에 녹여 10 mg/kg 을 하루에 한번 4주간 경구투여 하였으며, 시아릴락토오스는 물에 녹여 Sia0.5군 및 Sia1.0군에 각각 0.5 mg/kg 및 1 mg/kg의 용량으로 하루에 한번 복강투여 하였다.Detailed administration method and dosage of the test substance used in the experiment is as follows. First, administration of testosterone for prostatic hypertrophy was performed after a week of recovery after castration of experimental animals. Specifically, propionate testosterone was dissolved in a solvent (corn oil: EtOH (9: 1)) in the BPH group, Fina group, Sia0.5 group and Sia1.0 group except Con group, and 10 mg / kg once a day for 4 weeks. Subcutaneous injection induced prostatic hyperplasia. Finasteride was dissolved in a solvent (PBS: EtOH: Koliphor (18: 1: 1)) and 10 mg / kg was administered orally for 4 weeks once a day. Cyaryllactose was dissolved in water and added to Sia0.5 and Sia1.0 groups. Intraperitoneal administration once daily at doses of 0.5 mg / kg and 1 mg / kg, respectively.
상기 모든 실험군의 실험 결과 확인을 위해 6주간의 실험이 끝나는 마지막 날 몸무게를 측정하였으며 모든 실험동물을 12시간 동안 절식시켰다. 다음날 조레틸(Zoletil (Virbac; Carros Cedex, France))을 0.5 ml 투여하여 마취시킨 후 심장천자 방법(cardiac puncture)을 실시하여 심장에서 채혈하였으며, 상기 채혈한 혈액은 분석 전까지 80°C에 보관하였다. 전립선조직은 절제 후 무게를 측정하고, 생리식염수에 씻어낸 후 무게를 측정한 뒤 실험하기 전까지 80°C에 보관하였다.In order to confirm the experimental results of all the experimental groups, the weight was measured on the last day of the end of the 6-week experiment, and all the experimental animals were fasted for 12 hours. The next day, 0.5 ml of Zoletil (Virbac; Carros Cedex, France) was anesthetized, followed by cardiac puncture, and the blood was collected from the heart. The collected blood was stored at 80 ° C until analysis. . Prostate tissue was weighed after resection, washed with physiological saline and weighed and stored at 80 ° C until the experiment.
모든 실험 데이터는 통계분석을 실시하였으며 실험 개체수의 평균 ± 표준 편차 (SD)로 나타내었다. 통계적으로 유의한 것은 ANOVA와 Dunnett의 post hoc test를 사용하여 결정하였으며, 0.05 이하의 P 값은 통계적으로 유의하다고 간주하였다.All experimental data were statistically analyzed and expressed as mean ± standard deviation (SD) of the experimental population. Statistical significance was determined using ANOVA and Dunnett's post hoc test. P values below 0.05 were considered statistically significant.
실시예 2. 시아릴락토오스의 전립선 비대 감소 효과 확인Example 2 Confirmation of the Prostate Hypertrophy Reduction Effect of Siarylactose
시아릴락토오스가 전립선 비대에 미치는 영향을 알아보기 위해 실험군에서 절제한 전립선 조직의 크기를 확인하였으며 이를 도 2에 나타내었다.In order to determine the effect of cyaryllactose on the enlargement of the prostate, the size of the prostate tissue excised in the experimental group was confirmed and shown in FIG. 2.
도 2에서와 같이, 전립선 비대를 유도하지 않은 Con군과 비교하여 전립선 비대를 유도한 나머지 모든 실험군에서 전립선이 비대해지며 붉어진 혈관을 확인할 수 있었다. 전립선 비대를 유도한 실험군의 결과에서, 전립선 비대만을 유발한 BPH군과 비교하여 양성대조약물인 피나스테라이드를 투여한 Fina군에서 비대해진 전립선의 크기가 줄어들었으며 붉은 빛이 줄어든 것을 육안으로 확인하였다. 또한 시아릴락토오스를 투여한 Sia0.5군 및 Sia1.0군에서도 모두 BPH군과 비교하여 비대해진 전립선의 크기가 줄어들었으며 붉은 빛이 줄어든 것을 육안으로 확인하였다. As shown in Figure 2, compared with the Con group that did not induce prostate hypertrophy, the prostate enlarged and reddened blood vessels in all the experimental groups that induced the prostate enlargement was confirmed. As a result of the experimental group that induced the enlargement of the prostate, it was visually confirmed that the enlarged prostate gland decreased and the reddish color decreased in the Fina group administered with the positive control drug finasteride compared to the BPH group that caused the enlarged prostate. In addition, in the Sia0.5 and Sia1.0 groups administered with cyaryllactose, the size of the enlarged prostate was reduced and the redness was reduced compared to the BPH group.
따라서 본 발명의 시아릴락토오스가 기존에 알려진 전립선 비대증 개선 치료제 성분인 피나스테라이드와 같은 전립선 비대증 개선 효과를 가짐을 확인하였다.Therefore, it was confirmed that the siarylactose of the present invention has an effect of improving prostate hypertrophy, such as finasteride, which is a known ingredient for improving prostate hypertrophy.
실시예 3. 시아릴락토오스의 전립선 무게 감소 효과 확인Example 3 Confirmation of the Prostate Weight Loss Effect of Siarylactose
시아릴락토오스가 전립선 무게에 미치는 영향을 알아보기 위해, 실험동물을 희생시킨 후 즉시 전립선 무게를 측정하였으며, 상대적 전립선 무게 비율(relative prostate ratio)을 다음과 같은 식으로 측정하여 이에 대한 결과를 도 3에 나타내었다. In order to determine the effect of cyaryllactose on the prostate weight, the prostate weight was measured immediately after the sacrifice of the experimental animals, and the relative prostate ratio was measured by the following equation. Shown in
전립선 무게 비율(Relative prostate weight ratio) = prostate weight of the experimental group (BPH, Fina or Sia)/prostate weight of Con.Relative prostate weight ratio = prostate weight of the experimental group (BPH, Fina or Sia) / prostate weight of Con.
도 3의 데이터는 통계분석을 실시하여 실험 개체수의 평균 ± 표준 편차(SD)로 나타내었으며(n=10) 통계처리 데이터는 다음과 같다: ###p <0.001 대 CON군, *p <0.05 및 ***p <0.001 대 BPH군.The data of FIG. 3 was analyzed by the mean ± standard deviation (SD) of the experimental population by statistical analysis (n = 10). Statistical data are as follows: ### p <0.001 vs. CON group, * p <0.05 And *** p <0.001 vs. BPH group.
도 3에서와 같이, 전립선 비대를 유도하지 않은 Con군과 비교하여 전립선 비대를 유도한 나머지 모든 실험군에서 전립선의 무게가 확연히 증가한 것을 확인할 수 있었다. 전립선 비대를 유도한 실험군의 결과에서, 전립선 비대만을 유발한 BPH군과 비교하여 양성대조약물인 피나스테라이드를 투여한 Fina군에서 전립선 무게가 감소한 것을 확인하였다. 또한 시아릴락토오스를 투여한 Sia0.5군 및 Sia1.0군에서도 전립선 비대만을 유발한 BPH군과 비교하여 전립선 무게가 유의성 있게 감소한 것을 확인하였으며, 특히 Sia0.5군의 경우 Fina군과 비교하였을 때도 유의성 있는 전립선 무게 감소를 확인하였다.As shown in FIG. 3, the weight of the prostate gland was significantly increased in all the experimental groups inducing prostate hypertrophy compared to the Con group which did not induce prostate hypertrophy. As a result of the experimental group inducing prostate hypertrophy, the prostate weight was decreased in the Fina group administered with the positive control drug finasteride compared to the BPH group causing the prostate hypertrophy. In addition, in the Sia0.5 and Sia1.0 groups treated with siaryl lactose, the prostate weight was significantly reduced compared to the BPH group that caused the enlargement of the prostate, and especially in the Sia0.5 group, the Fina group was also compared. Significant prostate weight loss was identified.
따라서 본 발명의 시아릴락토오스는 기존에 알려진 전립선 비대증 개선 치료제 성분인 피나스테라이드와 비교하였을 경우에도 더 적은 용량으로 더욱 효과적인 전립선 비대증 개선 효과를 가짐을 확인하였다.Therefore, it was confirmed that the cyaryllactose of the present invention has more effective prostatic hypertrophy improvement effect at a lower dose even when compared to finasteride, which is a known ingredient for improving prostate hypertrophy.
실시예 4. 시아릴락토오스의 체중 당 전립선 무게(PW/BW) 비율 감소 효과 확인Example 4. Confirmation of the effect of reducing the weight of the prostate weight (PW / BW) per weight of the cyaryl lactose
시아릴락토오스가 전립선 무게에 미치는 영향을 알아보기 위해, 체중 당 전립선 무게(PW/BW) 비율을 측정하였으며 이를 도 4에 나타내었다. 도 4의 데이터는 통계분석을 실시하여 실험 개체수의 평균 ± 표준 편차(SD)로 나타내었으며(n=10) 통계처리 데이터는 다음과 같다: ###p <0.001 대 CON군, *p <0.05 및 ***p <0.001 대 BPH군.To determine the effect of cyaryllactose on the weight of the prostate gland, the weight of the prostate gland (PW / BW) per body weight was measured and shown in FIG. 4. The data in FIG. 4 was expressed as mean ± standard deviation (SD) of the experimental population by statistical analysis (n = 10). Statistical data were as follows: ### p <0.001 vs. CON group, * p <0.05 And *** p <0.001 vs. BPH group.
도 4에서와 같이, 전립선 비대만을 유도한 BPH군의 PW/BW 비율은 3.23으로 전립선 비대를 유도하지 않은 Con군과 비교하여 유의성 있게 증가한 것을 확인하였다. 그러나 BPH군과 비교하여 Fina군에서는 PW/BW 비율이 감소한 것을 확인하였으며, 시아릴락토오스를 투여한 Sia0.5군 및 Sia1.0군에서도 전립선 비대만을 유발한 BPH군과 비교하여 PW/BW 비율이 유의성 있게 감소한 것을 확인하였다. 특히 Sia0.5군의 경우 Fina군과 비교하였을 때도 유의성 있는 PW/BW 비율 감소를 확인하였다.As shown in FIG. 4, the PW / BW ratio of the BPH group that induced only prostate hypertrophy was 3.23, which was significantly increased compared to the Con group that did not induce prostate hypertrophy. However, in the Fina group, the PW / BW ratio was decreased compared to the BPH group, and the PW / BW ratio was also increased in the Sia0.5 group and the Sia1.0 group in which cyaryllactose was induced compared to the BPH group that caused the prostate hypertrophy. It was confirmed that the decrease significantly. In particular, the Sia0.5 group showed a significant decrease in the PW / BW ratio compared to the Fina group.
따라서 본 발명의 시아릴락토오스는 기존에 알려진 전립선 비대증 개선 치료제 성분인 피나스테라이드와 비교하였을 경우에도 더 적은 용량으로 더욱 효과적인 전립선 비대증 개선 효과를 가짐을 확인하였다.Therefore, it was confirmed that the cyaryllactose of the present invention has more effective prostatic hypertrophy improvement effect at a lower dose even when compared to finasteride, which is a known ingredient for improving prostate hypertrophy.
제제예 1. 의약품의 제조Formulation Example 1 Preparation of Pharmaceuticals
1.1 산제의 제조1.1 Preparation of Powder
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 200mgSiarylactose or its pharmaceutically acceptable salt 200 mg
유당 100mgLactose 100mg
탈크 10mgTalc 10mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다.The above ingredients are mixed and filled in an airtight cloth to prepare a powder.
1.2 정제의 제조1.2 Preparation of Tablets
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 100mgSiarylactose or a pharmaceutically acceptable salt thereof 100 mg
옥수수전분 100mgCorn Starch 100mg
유당 100mgLactose 100mg
스테아린산 마그네슘 2mg2 mg magnesium stearate
상기의 성분들을 혼합한 후 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다.After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.
1.3 캡슐제의 제조1.3 Preparation of Capsules
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 100mgSiarylactose or a pharmaceutically acceptable salt thereof 100 mg
옥수수전분 100mgCorn Starch 100mg
유당 100mgLactose 100mg
스테아린산 마그네슘 2mg2 mg magnesium stearate
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 정제를 제조한다.According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare tablets.
1.4 주사제의 제조1.4 Preparation of Injections
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 10μg/mlCyaryllactose or a pharmaceutically acceptable salt thereof 10 μg / ml
주사용 멸균 증류수 적량Appropriate sterile distilled water for injection
pH 조절제 적량pH adjuster
통상의 주사제의 제조방법에 따라 1 앰플당(2ml) 상기의 성분 함량으로 제조한다.According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule (2 ml).
1.5 액제의 제조1.5 Preparation of Liquids
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 100mgSiarylactose or a pharmaceutically acceptable salt thereof 100 mg
설탕 20g20 g of sugar
이성화당 20g20 g of isomerized sugar
레몬향 적량Lemon flavor
정제수를 가하여 전체 1,000ml로 맞추었다. 통상의 액제의 제조방법에 따라 상기의 성분을 혼합한 다음, 갈색병에 충전하고 멸균시켜 액제를 제조한다.Purified water was added to adjust the total volume to 1,000 ml. According to the conventional method for preparing a liquid, the above components are mixed, and then filled into a brown bottle and sterilized to prepare a liquid.
제제예 2. 식품의 제조Formulation Example 2 Preparation of Food
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 100mgSiarylactose or a pharmaceutically acceptable salt thereof 100 mg
비타민 혼합물 적량Vitamin mixture proper amount
비타민 A 아세테이트 70 ㎍70 μg of Vitamin A Acetate
비타민 E 1.0 ㎎Vitamin E 1.0 mg
비타민 B1 0.13 ㎎Vitamin B1 0.13 mg
비타민 B2 0.15 ㎎Vitamin B2 0.15 mg
비타민 B6 0.5 ㎎Vitamin B6 0.5 mg
비타민 B12 0.2 ㎍0.2 μg of vitamin B12
비타민 C 10 ㎎Vitamin C 10 mg
비오틴 10 ㎍10 μg biotin
니코틴산아미드 1.7 ㎎Nicotinic Acid 1.7 mg
엽산 50 ㎍Folate 50 ㎍
판토텐산 칼슘 0.5 ㎎Calcium Pantothenate 0.5mg
무기질 혼합물 적량Mineral mixture
황산제1철 1.75 ㎎Ferrous Sulfate 1.75 mg
산화아연 0.82 ㎎Zinc Oxide 0.82 mg
탄제1인산칼륨 15 ㎎Potassium monophosphate 15 mg
제2인산칼슘 55 ㎎Dibasic calcium phosphate 55 mg
구연산칼륨 90 ㎎Potassium Citrate 90 mg
탄산칼슘 100 ㎎
염화마그네슘 24.8 ㎎Magnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 건강기능식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 건강기능식품 제조방법에 따라 상기의 성분을 혼합한 다음, 통상의 방법에 따라 건강기능식품 조성물 제조(예, 영양캔디 등)에 사용할 수 있다.Although the composition ratio of the above-mentioned vitamin and mineral mixtures is a composition that is relatively suitable for the health functional food, the composition is mixed in a preferred embodiment, but the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health functional food manufacturing method. Then, it can be used for the manufacture of the nutraceutical composition (eg, nutrition candy, etc.) according to a conventional method.
제제예 3. 음료의 제조Formulation Example 3 Preparation of Beverage
시아릴락토오스 또는 이의 약학적으로 허용 가능한 염 100mgSiarylactose or a pharmaceutically acceptable salt thereof 100 mg
구연산 1000 ㎎Citric acid 1000 mg
올리고당 100 g100 g oligosaccharides
매실농축액 2 gPlum concentrate 2 g
타우린 1 g1 g of taurine
정제수를 가하여 전체 900 ㎖Add 900 ml of purified water
통상의 건강기능성 음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1시간동안 85℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2ℓ용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 건강기능성 음료 조성물 제조에 사용한다.After mixing the above components in accordance with the conventional method for preparing a health functional beverage, the mixture was heated by stirring at 85 ℃ for about 1 hour, the resulting solution was filtered and obtained in a sterilized 2 L container, sealed and sterilized and then stored in a refrigerator. It is used for the manufacture of the health functional beverage composition of the invention.
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 수요계층, 수요국가, 사용 용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다.Although the composition ratio is a composition suitable for a preferred beverage in a preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, use purpose.
Claims (6)
Siaryllactose (Sialyllactose) or a pharmaceutically acceptable salt thereof as an active ingredient, prostatic hypertrophy disease preventing or treating pharmaceutical composition.
상기 시아릴락토오스는 3’-시아릴락토오스, 6’-시아릴락토오스, 또는 이들의 혼합물인 것을 특징으로 하는, 전립선 비대 질환 예방 또는 치료용 약학적 조성물.
The method of claim 1,
The cyaryl lactose is characterized in that 3'- cyaryllactose, 6'- cyaryllactose, or a mixture thereof, a pharmaceutical composition for preventing or treating prostatic hypertrophy disease.
상기 시아릴락토오스는 전립선 무게를 감소시키는 것을 특징으로 하는, 전립선 비대 질환 예방 또는 치료용 약학적 조성물.
The method of claim 1,
The siaryl lactose is characterized in that to reduce the weight of the prostate, prostatic hypertrophy disease prevention or treatment pharmaceutical composition.
상기 전립선 비대 질환은 요로 폐색을 동반한 전립선 비대 질환 또는 혈뇨를 동반한 전립선 비대 질환을 포함하는 것을 특징으로 하는, 전립선 비대 질환 예방 또는 치료용 약학적 조성물.
The method of claim 1,
The prostatic hypertrophy disease comprises a prostatic hypertrophy disease with urinary tract obstruction or an enlarged prostate disease with hematuria, pharmaceutical composition for preventing or treating prostatic hypertrophy disease.
A functional food composition for preventing or ameliorating prostatic hypertrophy disease comprising siarylactose or a pharmaceutically acceptable salt thereof as an active ingredient.
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WO2012019125A2 (en) | 2010-08-06 | 2012-02-09 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Biomarkers for prostate cancer and methods for their detection |
KR101773067B1 (en) | 2017-05-31 | 2017-08-30 | 아주대학교산학협력단 | Composition for Preventing or Treating Osteoarthritis Comprising 6'-Sialyllactose or Salts Thereof |
KR101773066B1 (en) | 2017-01-23 | 2017-08-30 | 아주대학교산학협력단 | Composition for Preventing or Treating Osteoarthritis Comprising 3'-Siallylactose or Derivatives Thereof |
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WO2012019125A2 (en) | 2010-08-06 | 2012-02-09 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Biomarkers for prostate cancer and methods for their detection |
US20130156813A1 (en) | 2010-08-06 | 2013-06-20 | Jeffrey Gildersleeve | Biomarkers for prostate cancer and methods for their detection |
KR101773066B1 (en) | 2017-01-23 | 2017-08-30 | 아주대학교산학협력단 | Composition for Preventing or Treating Osteoarthritis Comprising 3'-Siallylactose or Derivatives Thereof |
KR101773067B1 (en) | 2017-05-31 | 2017-08-30 | 아주대학교산학협력단 | Composition for Preventing or Treating Osteoarthritis Comprising 6'-Sialyllactose or Salts Thereof |
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