KR20050047579A - Bone disease drug composition using herb medicines - Google Patents
Bone disease drug composition using herb medicines Download PDFInfo
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- KR20050047579A KR20050047579A KR1020030081309A KR20030081309A KR20050047579A KR 20050047579 A KR20050047579 A KR 20050047579A KR 1020030081309 A KR1020030081309 A KR 1020030081309A KR 20030081309 A KR20030081309 A KR 20030081309A KR 20050047579 A KR20050047579 A KR 20050047579A
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- bone
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- present
- osteoporosis
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- Medicines Containing Plant Substances (AREA)
Abstract
본 발명은 혼합생약재를 이용한 골질환 예방 및 치료용 약제 조성물에 관한 것으로서, 더욱 상세하게는 방풍, 우슬, 오가피, 두충 및 금모구척을 일정 비율 혼합하여 만성 골질환(골다공증, 류마티스 관절염)과 퇴행성 골질환에 관련된 골세포 증식과, 분화유도에 골형성 및 골조직의 분해를 억제함으로써 골질환의 예방 및 치료에 매우 효과적인 약제 조성물 및 건강식품에 관한 것이다.The present invention relates to a pharmaceutical composition for preventing and treating bone diseases using a mixed herbal medicine, and more specifically, to prevent chronic bone disease (osteoporosis, rheumatoid arthritis) and degenerative bone by mixing a certain ratio of windproof, dew, organopi, tongchung and umbilical cord. The present invention relates to a pharmaceutical composition and health food which is very effective in preventing and treating bone diseases by inhibiting bone cell proliferation and differentiation-induced bone formation and bone tissue degradation.
Description
본 발명은 혼합생약재를 이용한 골질환 예방 및 치료용 약제 조성물에 관한 것으로서, 더욱 상세하게는 방풍, 우슬, 오가피, 두충 및 금모구척을 일정 비율 혼합하여 만성 골질환(골다공증, 류마티스 관절염)과 퇴행성 골질환에 관련된 골세포 증식과, 분화유도에 골형성 및 골조직의 분해를 억제함으로써 골질환의 예방 및 치료에 매우 효과적인 약제 조성물 및 건강식품에 관한 것이다.The present invention relates to a pharmaceutical composition for preventing and treating bone diseases using a mixed herbal medicine, and more specifically, to prevent chronic bone disease (osteoporosis, rheumatoid arthritis) and degenerative bone by mixing a certain ratio of windproof, dew, organopi, tongchung and umbilical cord. The present invention relates to a pharmaceutical composition and health food which is very effective in preventing and treating bone diseases by inhibiting bone cell proliferation and differentiation-induced bone formation and bone tissue degradation.
뼈는 단단하기만 한 조직이 아니고, 일생동안 지속적으로 변화하는 활동적인 조직이다. 육안으로는 뼈는 외부의 피질골(치밀골)과 내부의 소주골(해면골, 스폰지뼈)로 구분하는데, 피질골은 물리적인 강도가 강하여 신체를 보호하고 지지하는 역할을 하고, 소주골은 충격을 흡수하거나 칼슘의 변화를 일정하게 유지하는 역할을 주로 한다. 뼈가 성장이 중단된 후에도 오래된 뼈는 파괴되어 없어지고(골흡수) 새로운 뼈가 없어진 곳을 메우는 고정(골형성)이 일생동안 반복되며 이러한 현상을 뼈의 재형성이라 한다. 골흡수와 골형성이 균형을 이루어야 골의 정상적인 형태가 유지되고 혈액 속의 칼슘농도가 일정하게 유지되는데 혈액에 칼슘이 부족하게 되면 이를 보충하기 위하여 골흡수가 증가되어 뼈의 칼슘을 혈액으로 방출하게 되며, 골흡수가 지속되면 뼈가 약해지게 되어 골다공증이 발생한다. Bones are not just hard tissues, but active tissues that change continuously throughout life. In the naked eye, bone is divided into external cortical bone (dense bone) and internal small bone (spongy bone, sponge bone). Cortical bone has a strong physical strength to protect and support the body, and the small bone absorbs shock Mainly plays a role in keeping calcium changes constant. Even after the bone has stopped growing, the old bone is destroyed and lost (bone absorption), and the fixation (bone formation) that fills in the place where the new bone is missing is repeated throughout life. This phenomenon is called bone remodeling. Bone resorption and bone formation must be balanced to maintain the normal shape of the bone and maintain a constant calcium concentration in the blood. When calcium is deficient in the blood, bone resorption is increased to compensate for this. If bone resorption persists, bones become weak and osteoporosis occurs.
골다공증은 총골량이 줄어들어 작은 충격에도 쉽게 골절이 생기는 일종의 노화현상으로 누구나 나이가 들면 피할 수 없으나, 특히 폐경기 이후 여성들에게 빈발하며, 갑상선, 부갑상선의 기능항진, 만성 신부전 및 부신피질호르몬의 투여에 의하여 발생되기도 한다. 의학적으로는 뼈의 콜라겐과 칼슘이 모두 감소되어 뼈의 강도가 약해진 것이며 골다공증이 생기면 골의 양이 감소되어 가벼운 사고에 의해서도 골절이 발생함으로써, 특히 여성에게서 골반골절 및 척추골절은 치명적이라 할 수 있겠다. 골반골절이 일어나게 되면 1년 내에 30%의 환자가 사망하며 척추골절로 숨질 확률은 골반골절보다 1.4배 높은 것으로 밝혀졌고, 세계적으로 매년 120만 명의 여성이 골다공증으로 인한 골절을 경험하고 있다. 이러한 심각성 때문에 미국을 비롯한 선진각국은 일찍부터 골다공증의 원인 규명 및 치료제 개발에 많은 노력을 기울이고 있으며, 우리나라도 현재 많은 과학자들이 관심을 가지고 연구를 진행하고 있다. 골다공증에 의한 골절의 위험도를 결정하는 가장 중요한 요소는 골밀도이기에 골밀도의 측정은 매우 중요하다 Osteoporosis is a kind of aging phenomenon in which bone fracture is easily caused by a small impact due to a decrease in total bone mass, and it can not be avoided by anyone as it ages. It can also occur. Medically, both bone collagen and calcium are reduced and bone strength is weakened. When osteoporosis occurs, the amount of bone is reduced and fractures occur even by minor accidents. Especially, pelvic fractures and vertebral fractures are fatal in women. . When pelvic fractures occur, 30% of patients die within a year, and the probability of dying from vertebral fractures is 1.4 times higher than that of pelvic fractures, and 1.2 million women worldwide suffer from osteoporosis. Because of this seriousness, developed countries, including the United States, have made great efforts to identify the causes of osteoporosis and to develop therapeutics from early on. Many Korean scientists are currently conducting research with interest. The most important factor in determining the risk of fracture due to osteoporosis is bone density, so the measurement of bone density is very important.
골밀도의 변화는 소주골의 골밀도는 폐경 전에 비해 폐경 후에 약 3배 가량 빠르게 소실되며 폐경 직후는 1년에 5% 이상 소실된다. 폐경 후에는 여성의 골밀도가 급격히 감소하여 남녀간의 차이가 더욱 심하며 남성의 경우 최대 골밀도의 20 ∼ 30% 소실되고 여성의 경우는 40 ∼ 50% 소실된다.Changes in bone mineral density of the bones of the small bones are lost about three times faster after menopause than in menopause, and after menopause, more than 5% is lost in a year. After menopause, the bone density of women decreases rapidly, and the difference between men and women is more severe. In men, 20-30% of the maximum bone density is lost and in women, 40-50%.
최근 골다공증 치료제 개발 동향은 칼시토닌(calcitonin) 주사법, 에스트로겐 대체치료법, 비포스로네이트(biphosphonate) 섭취 등이 있다. 상기와 같은 방법은 효과도 만족스럽지 못하며, 투여방법 및 투여량의 문제, 부작용 등이 문제시되고 있다. Recent developments in the treatment of osteoporosis include calcitonin injection, estrogen replacement therapy, and biphosphonate intake. Such a method is also unsatisfactory in effect, the problem of the administration method and dosage amount, side effects and the like have been a problem.
아리아드 제약회사(Ariad Pharmaceuticals, Inc, cambridge, MA, USA)는 골다공증을 신호전달을 저해하는 경구투여용 약품개발을 연구하는 회사로서, 최근 Src SH2 도메인에 결합하는 저분자 물질의 개발을 하고 있다. Ariad Pharmaceuticals, Inc., cambridge, Mass., USA, is a researcher working on oral medications that inhibit osteoporosis signaling. Recently, Ariad Pharmaceuticals, Inc., Cambridge, Mass., USA, has developed a small molecule that binds to the Src SH2 domain.
또한, 악시스 제약회사(Axys Pharmaceuticals, Inc, San Francisco)는 Merk 와 Co와 공동으로 카텝신(Cathepsin) K를 저해하는 저분자량 물질을 개발하고 있다. 카텝신 K는 조공세포(osteoclast)가 분비하는 시스테인 프로테아제로서 이는 골다공증의 중요한 효소이다. 카텝신 K의 분자입체구조를 결정하고 효소활성부위에 결합하는 저해제 물질을 개발하였다.In addition, Axys Pharmaceuticals, Inc, San Francisco, in collaboration with Merk and Co, is developing a low molecular weight substance that inhibits Catepsin K. Cathepsin K is a cysteine protease secreted by osteoblasts and is an important enzyme in osteoporosis. Inhibitors have been developed that determine the molecular stereostructure of cathepsin K and bind to the enzyme active site.
또한, 에스트로겐 수용체 조절인자를 변형시킨 물질이 Pfizer, Inc(New York City, USA)에서 현재 2단계 임상 시험 중에 있다. 드롤록시펜(Droloxifene)이라는 이 약은 뼈에 중요한 랄록시펜(raloxifene) (Evista)을 개선한 것이다. 이런 에스트로겐 수용체 조절 물질들은 뼈, 심장, 유방에도 작용이 있으나 방광 등에는 상관이 없다.In addition, substances modifying estrogen receptor modulators are currently in Phase 2 clinical trials at Pfizer, Inc. (New York City, USA). This drug, called Droloxifene, is an improvement on raloxifene (Evista), which is important for bones. These estrogen receptor modulators also work on the bones, heart, and breast, but not on the bladder.
새로운 치료제인 OPG(Osteoprotegerin)는 우리의 뼈가 매 7년에서 14년 사이에 새로운 골격으로 재구성된다. 그러나, 질병이나 퇴행성의 경우 이러한 균형이 깨지며 뼈는 생성되는 것보다 제거되는 것이 더 많다. 암젠(Thousand Oaks, CA, USA)사는 뼈의 파괴와 보호를 담당하는 2개의 단백질을 발견하였는데 뼈를 보호하는 것은 OPG이며, 이 유전자는 정상에서는 모두 가지고 있으나 정상생쥐에 이 유전자수를 늘리면 뼈강도가 강해진다.Osteoprotegerin (OPG), a new treatment, reconstitutes our bones into new skeletons every seven to fourteen years. However, in the case of disease or degeneration, this balance is broken and bone is more removed than is produced. Thousand Oaks, CA, USA, found two proteins responsible for bone destruction and protection. OPG protects bones, and all of these genes are present in normal mice. Becomes stronger.
미국에서의 항골흡수 치료법은 골다공증을 예방하고 치료하는데 쓰이는데 Osteomark NTx 세럼은 미국에서 조골세포에 의한 골흡수가 된 상태를 진단하는 시약이다. In the United States, anti-bone resorption therapy is used to prevent and treat osteoporosis. Osteomark NTx serum is a reagent for diagnosing osteoporosis by osteoblasts in the United States.
상기와 같은 치료방법 및 치료제가 지속적으로 연구되고 있긴 하지만, 위장관, 간, 신장 등의 부작용에 대한 개선은 아직 만족스럽지 못하였다.Although the above treatment methods and therapeutic agents have been continuously studied, improvement of side effects such as gastrointestinal tract, liver, kidney and the like has not been satisfactory.
따라서, 부작용이 없고, 골다공증을 비롯한 골질환 치료제로서 한약재의 이용이 절실한 상태이다.Therefore, there is no side effect, and there is an urgent need for the use of herbal medicines for the treatment of bone diseases including osteoporosis.
이에, 본 발명자들은 골다공증, 류마치스성 관절염, 퇴행성 관절염, 허리, 목의 디스크질환에 사용될 수 있는 한방제제에 관하여 오랜 연구를 한 결과, 방풍, 우슬, 오가피, 두충 및 금모구척 추출물이 만성 골질환(골다공증, 류마티스 관절염)과 퇴행성 골질환에 관련하여 골세포 증식과, 분화유도에 골형성 및 골조직의 분해를 억제함으로써 골질환의 예방 및 치료에 매우 효과적임을 알게 됨으로써 본 발명을 완성하게 되었다.Accordingly, the present inventors have conducted a long study on herbal preparations that can be used for osteoporosis, rheumatoid arthritis, degenerative arthritis, waist and neck disc diseases, and as a result, windbreaks, dew, cucumber skin, worms and umbilical cord extracts have chronic bone disease ( Osteoporosis, rheumatoid arthritis) and degenerative bone diseases related to osteoblast proliferation and differentiation induce osteoporosis by inhibiting the formation of bone tissue by inhibiting the osteoporosis was found to be very effective in the prevention and treatment of the disease was completed.
따라서, 본 발명은 방풍, 우슬, 오가피, 두충 및 금모구척 추출물을 유효성분으로 함유하는 골질환 예방 및 치료용 약제 조성물 또는 건강식품을 제공하는데 그 목적이 있다. Accordingly, an object of the present invention is to provide a pharmaceutical composition or health food for preventing and treating bone diseases, which contains a windproof, dew, agar, worms and chamomile extract as an active ingredient.
본 발명은 방풍, 우슬, 오가피, 두충 및 금모구척 추출물을 유효성분으로 함유하는 골질환 예방 및 치료용 약제 조성물을 그 특징으로 한다.The present invention is characterized in that the pharmaceutical composition for preventing and treating bone diseases, which contains the wind-proof, hyssop, scabies, worms and chamomile extracts as active ingredients.
또한, 상기 추출물을 함유하는 건강식품을 포함한다.In addition, it includes a health food containing the extract.
이와 같은 본 발명을 더욱 상세히 설명하면 다음과 같다.Referring to the present invention in more detail as follows.
본 발명은 방풍, 우슬, 오가피, 두충 및 금모구척을 일정 비율 혼합하여 만성 골질환(골다공증, 류마티스 관절염)과 퇴행성 골질환에 관련된 골세포 증식과, 분화유도에 골형성 및 골조직의 분해를 억제함으로써 골질환의 예방 및 치료에 매우 효과적인 약제 조성물에 관한 것이다.The present invention by mixing a certain ratio of wind, dew, agar, worms and gold moths by inhibiting the proliferation of bone cells associated with chronic bone diseases (osteoporosis, rheumatoid arthritis) and degenerative bone diseases, and osteogenic and differentiation of bone tissue in differentiation The present invention relates to a pharmaceutical composition which is very effective for the prevention and treatment of bone diseases.
방풍은 산형과에 속한 다년생 초본인 방풍(防風)(Ledebouriella seseloides WOLFF)의 뿌리 및 뿌리줄기를 건조한 것으로, 뿌리에 정유, 만니톨, 고미배당체, 다당류 및 유기산 등이 함유되어 있다. 방풍 과실에 함유된 정유성분 중에는 피넨(pinene), 리모넨(limonene), 팔미트산(palmitic acid), 비사볼렌(bisabolene) 등 약 66종의 화학 성분이 분리되어 있고, 쿠마린(coumarin)류에는 임페라토린(imperatorin), 펠롭테린(phellopterin), 레데보리엘롤(ledebouriellol)이 있으며 다당류에는 사포스니코반(saposhnikovan) A, B, C가 있다. 약리작용으로는 해열, 진통, 소염 작용이 있고 소염 작용, 항경련 작용, 평활근이완 작용이 있으며 항균 작용이 있다. 본 발명에서는 방풍의 함량을 10 ∼ 20 중량% 사용함으로써 효과를 극대화시키며, 그 함량이 10 중량% 미만일 경우에는 효과가 미비한 문제점이 있으며, 20 중량%를 초과하면 경제적이지 못하다.Windproof is dried root and root stem of perennial herb, Ledebouriella seseloides WOLFF, which contains essential oil, mannitol, high glycoside, polysaccharide and organic acid. Among the essential oils contained in the wind-proof fruit, about 66 chemical components such as pinene, limonene, palmitic acid and bisabolene are separated, and coumarins have impera Imperatorin, pelletopterin, and ledebouriellol, and the polysaccharides include saposhnikovan A, B, and C. Pharmacological action is antipyretic, analgesic, anti-inflammatory action, anti-inflammatory action, anti-convulsion action, smooth muscle relaxation action, and antibacterial action. In the present invention, to maximize the effect by using the content of the windproof 10 to 20% by weight, when the content is less than 10% by weight there is a problem that the effect is insufficient, if it exceeds 20% by weight is not economical.
비름과에 속하는 우슬(Achyranthis Bidentatae Radix)은 우리나라에서는 쇠무릎(Achyranthes japonica NAKAI)의 뿌리를 건조한 것으로, 올레놀릭계 사포닌과 스테로이드계 이노코스테론, 엑다이스테론(ecdysterone) 등의 성분이 함유되어 있고 예로부터 뿌리를 우슬이라 하여 고혈압, 류마티스, 관절통 같은 울혈의 치료제 및 이뇨제, 강장제로 사용되고있다. 생약에 대한 성분의 연구로는 최근에 우슬 뿌리에서 올레아닉산의 글루투로나이드 사포닌을 분리하여 구조 결정을 한 바 있고, 세포독성이 있는 사포닌으로서 아카이란토사이드(Achyranthosides) A, B와 글루투로나이드 사포닌인 아카이란토사이드 C, D를 분리하여 구조 결정을 하였다. 우슬의 생물학적 활성에 관한 연구로는 항염증, 항산화 간 보호, 항알레르기, 항암작용 등이 다양하게 보고되었다. 본 발명에서의 우슬의 유효 함량은 15 ∼ 35 중량%이며, 15 중량% 미만일 경우에는 효과가 미비하고, 35 중량% 초과할 경우에는 미비한 출혈이 있는 문제점이 있다.Achyranthis Bidentatae Radix belonging to the amaranth family is dried root of Achyranthes japonica NAKAI in Korea, and it contains olenolic saponin, steroidal inoosterone, and ecdysterone. Root from the root is called as a treatment for congestion such as hypertension, rheumatism, arthralgia, diuretics, tonic. In the study of the ingredients of herbal medicine, recently, the structure determination by separating the olenic acid gluturonide saponin from the root of the dew is a cytotoxic saponin Achyranthosides A, B and glue Acarantotosides C and D, which are turonide saponins, were separated and structured. There are various reports on the biological activity of hyaluronic acid, including anti-inflammatory, antioxidant liver protection, anti-allergic and anticancer activity. In the present invention, the effective content of the dew is 15 to 35% by weight, when less than 15% by weight is ineffective, and when it exceeds 35% by weight there is a problem that there is insufficient bleeding.
오갈피나무과에 속하는 오가피(Acanthopanacis Cortex)는 맛이 맵고 쓰며 따뜻한 성질을 갖고 있고 간경(刊經), 신경(神經)에 작용하여 풍습을 없애고 기를 돋우며 정수를 불러준다고 알려져 있다. 이를 장복하면 신체의 기를 높여주고 위를 보해 주고 정신을 맑게 해주며 허리 척추가 쑤시는 통증에 좋은 효과를 보인다. 오가피에는 오가피 배당체이고 리그난 를리코시드류인 아칸토시드 A, B, C, D와 면역성을 높여주는 수용체 다당체가 있다. 잎에는 지사노사이드(Chiisanoside)가 있어 약리적 기능을 갖고 있으며, 뿌리에서는 오가피 배당체 뿐만 아니라 시렁긴(Sylrgin), 쿠마린 배당체가 있다. 다우코스테린 이 함유되어 있으며, 메틸살리실알데히드 등의 정유성분과 탄닌, 필미틴산, 리놀렌산, 비타민 A, B, 시린가레지놀 등도 함유되어 있다. 시린가레지놀은 간장해에서 오는 S-Got, S-Gpt의 비정상적인 상승을 정상치로 빠른 속도로 회복시켜주고 동물의 생명을 연장시켜주며, 투여약물의 생체내의 대사능력을 항진시켜준다. 본 발명에서 오가피의 유효 함량은 5 ∼ 20 중량%이며, 5 중량% 미만이면 효과가 미비하며, 20 중량% 초과하면 발열이 일어나는 문제점이 있다.Ogapi (Acanthopanacis Cortex), belonging to the Agalaceae family, is known for its taste, bitterness, warm properties, acting on the liver, nerves, and nerves to remove customs, nourish, and clarify essence. If you wear it, it will help your body feel up, support your stomach, clear your mind, and have a good effect on the pain in your lumbar spine. Ogapi contains the agapi glycoside and lignan lycosides acantosides A, B, C, D and receptor polysaccharides that enhance immunity. The leaves have a pharmacological function with cysanosides, and the roots contain not only the ogapi glycosides but also the silrgin and coumarin glycosides. It contains Dowsterin, and contains essential oils such as methylsalicylaldehyde and tannins, pilmitnic acid, linolenic acid, vitamins A, B, and cyringareginol. Syringareginol restores abnormal levels of S-Got and S-Gpt from the liver to normal levels rapidly, prolongs animal life, and enhances the metabolism of the drug in vivo. In the present invention, the effective amount of Ogapi is 5 to 20% by weight, the effect is insufficient if less than 5% by weight, there is a problem that heat generation exceeds 20% by weight.
두충나무과에 속하는 두충(Eucommiae Cortex)은 간신을 보하고 근골을 튼튼하게 하며, 오래 먹으면 몸이 가벼워지면서 늙지 않게 된다고 전해지는 한약재로서 많은 양의 교질과 칼륨, 결정성 고무질, 구타페르카가 함유되어 있으며 고혈압, 소아마비 후유증, 습관성 유산 등에 유효한 것으로 알려져 있다. 성분으로는 주로 리그난류(lignan), 이리도이드류(Iridoids)가 있다. 그 외에 에리쓰로(erythro) 및 쓰레오-구아이아실글리세롤(threo-guaiacylglycerol), 울모프레놀(ulmoprerol), 노나코산(nonacosan) 등이 있고 약리작용으로는 혈압강하. 항고지혈, 진정 및 진통작용, 소염작용, 세망내피계탐식 작용(reticuloendothelial phagocytic function), 이뇨 효과 등이 있다. 본 발명에서는 이의 유효 함량이 5 ∼ 30 중량%이며, 5 중량% 미만이면 효과가 미비하며, 30 중량% 초과하면 경제적이지 못하다.Eucommiae Cortex, which belongs to the genus Camellia family, is a herb that is said to protect the liver, strengthen the musculature, and to make the body lighter and less old after long eating.It contains a large amount of collagen, potassium, crystalline rubber, and gutta-percha. It is known to be effective in hypertension, polio sequelae, and habitual miscarriage. The constituents are mainly lignans and iridoids. In addition, there are erythro and threo-guaiacylglycerol, ulmopreol, and nonacosan, and pharmacological action lowers blood pressure. Antihyperlipidemia, sedative and analgesic, anti-inflammatory, reticuloendothelial phagocytic function, and diuretic effect. In the present invention, the effective content thereof is 5 to 30% by weight, the effect is insignificant if less than 5% by weight, it is not economical if it exceeds 30% by weight.
금모구척(Cibotium barometz(LINNE)J.SMITH)은 방각궐과의 여러해살이풀로서, 간신(肝腎)이 허약해서 허리가 아프고 잘 서지 못하거나, 또는 다리와 무릎이 연약해지는 증상에 탁월한 효과가 있고, 풍습(風濕)이 침범해서 일어나는 요통, 관절염, 하체무력증에 사용되며, 신장 기능 감퇴로 소변을 참지 못하고 성 기능이 감퇴되거나, 여자의 경우 백대하가 지속적으로 흐를 때에 녹용(鹿茸)을 배합하여 사용하면 효력이 뛰어나다. 이의 성분으로는 탄닌, 전분 등이 함유되어 있다. 항균 지혈작용을 나타낸다. 본 발명에서는 이의 유효함량이 10 ∼ 20 중량%이며, 10 중량% 미만으로 사용할 경우에는 효과가 미비하게 나타나며, 20 중량%를 초과할 경우에는 경제적이지 못하다.Cibotium barometz (LINNE) J. SMITH is a perennial herb with a stag beetle, and has excellent effects on the symptoms of weakness and weakness of the waist, weak legs, and weak legs and knees. It is used for low back pain, arthritis, lower limb asthenia caused by the invasion of wind, and it is impaired by renal function. Excellent effect Its components include tannins, starches and the like. It shows antibacterial hemostatic action. In the present invention, the effective content thereof is 10 to 20% by weight, the effect is insignificant when used in less than 10% by weight, it is not economical when it exceeds 20% by weight.
한편, 상기 생약재 외에 구판, 당귀, 홍화자, 육계, 구기자, 약콩, 고비, 오적골, 숙지황, 적두, 익모초 및 속 중에서 1 종 이상을 함유할 수 있으며, 바람직한 함량은 20 ∼ 55 중량%이다. 이의 함량이 20 중량% 미만이면 효과가 미비하며, 55 중량%를 초과할 경우에는 경제적이지 못하다.On the other hand, in addition to the herbal medicine may contain one or more of Gupan, Angelica, safflower, broiler, goji berry, medicinal beans, ferns, five red bones, ripening sulfur, red beans, motherwort and genus, the preferred content is 20 to 55% by weight. If the content thereof is less than 20% by weight, the effect is insignificant, and if it exceeds 55% by weight, it is not economical.
한편, 상기한 생약재들을 다음과 같은 방법에 의하여 단순 추출하거나, 보다 활성이 우수한 혼합생약재 추출물을 효율적으로 분리하는 과정을 더욱 상세히 살펴보면 다음과 같다.On the other hand, the herbal extracts described above by the following method, or look at in more detail the process of efficiently separating the more excellent mixed herbal extracts as follows.
상기에서 제시된 혼합생약재를 물, 저급 알코올(바람직하게는 메탄올, 에탄올, 부탄올), 초산에틸, 방향족 탄화수소 또는 염소화탄화수소에 넣고, 100 ∼ 130 ℃에서 6 ∼ 10 시간동안 중탕하고 여과 추출한다. 이때 수용액의 사용량은 혼합생약재 부피의 2 ∼ 5 배 정도가 적당하다. The mixed herbal medicines described above are placed in water, lower alcohols (preferably methanol, ethanol, butanol), ethyl acetate, aromatic hydrocarbons or chlorinated hydrocarbons, and then hot-water filtered at 100-130 ° C. for 6-10 hours. At this time, the amount of the aqueous solution is preferably about 2 to 5 times the volume of the mixed herbal medicines.
상기에서 분리된 추출액을 40 ∼ 60 ℃의 조건 하에서 감압 농축한 후, 가열 또는 동결건조하여 추출액을 분말 상태로 만든다. The extract thus separated is concentrated under reduced pressure under the conditions of 40 to 60 ° C., and then heated or lyophilized to make the extract liquid.
한편, 상기 생약성분은 각각 분말화하거나, 또는 각각 단독으로 추출하여 엑기스를 얻고 이들 엑기스를 혼합하거나 또는 필요한 생약성분을 합하고 함께 추출하여도 좋다.On the other hand, the herbal ingredients may be powdered or extracted alone, respectively, to obtain extracts, and these extracts may be mixed, or the necessary herbal ingredients may be combined and extracted together.
상기에서 얻어진 혼합생약재 추출물에 대하여 조골세포 증식 효과 및 골밀도 등을 확인한 결과, 다음 실시예에서 나타나는 바와 같이 우수한 효과를 나타내었다. 따라서, 본 발명은 상기 추출방법에 의해서 얻어진 혼합생약재 추출물을 유효성분으로 함유하는 골질환 예방 및 치료용 의약품 또는 건강식품으로 사용 가능하다.As a result of confirming the osteoblast proliferation effect and bone density with respect to the mixed herbal medicine extract obtained above, as shown in the following examples showed an excellent effect. Therefore, the present invention can be used as a medicine or health food for preventing and treating bone diseases containing the mixed herbal medicine extract obtained by the extraction method as an active ingredient.
의약품으로 제조시, 본 발명의 혼합생약재 추출물은 임상 투여시에 경구 또는 비경구로 투여가 가능하며 일반적인 의약품 제제의 형태로 제공될 수 있다.When prepared as a pharmaceutical, the mixed herbal extract of the present invention may be administered orally or parenterally during clinical administration and may be provided in the form of a general pharmaceutical formulation.
본 발명의 혼합생약재 추출물은 실제 임상 투여시에 경구 또는 비경구의 여러 가지 제형으로 투여될 수 있는데, 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 제조된다.The mixed herbal extract of the present invention may be administered in various oral or parenteral formulations during actual clinical administration, and when formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, etc. that are commonly used. It is prepared using.
경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캅셀제 등이 포함되며, 이러한 고형제제는 리그난과 락톤 화합물 및 그의 유도체에 적어도 하나 이상의 부형제, 예를 들면 전분, 칼슘 카보네이트, 수크로스 또는 락토오스, 젤라틴 등을 섞어 조제된다. 또한, 단순한 부형제 이외에 마그네슘 스트레이트, 탈크 같은 윤활제들도 사용된다. 경구투여를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 액체 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다.Solid form preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, which form at least one excipient such as starch, calcium carbonate, sucrose or lactose in lignans and lactone compounds and derivatives thereof. Mixed with gelatin. In addition to simple excipients, lubricants such as magnesium straight and talc are also used. Liquid preparations for oral administration include suspensions, solvents, emulsions, and syrups. In addition to the commonly used simple diluents, water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have.
비경구 투여를 위한 제제에는 멸균된 수용액, 비수용성 용제, 현탁제, 유제, 동결건조제, 좌제가 포함된다. 비수용성제, 현탁용제로는 프로필렌글리콜, 폴리에틸렌글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔, 마크로골, 트윈 61, 카카오지, 라우린지, 글리세롤젤라틴 등이 사용될 수 있다.Formulations for parenteral administration include sterile aqueous solutions, water-insoluble solvents, suspensions, emulsions, lyophilizers, suppositories. As the non-aqueous and suspending solvent, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate, and the like can be used. As the base of the suppository, utopsol, macrogol, tween 61, cacao butter, laurin butter, glycerol gelatin and the like can be used.
본 발명에 따른 유효성분의 제제 내 함유량은 체내에서의 활성 성분의 흡수도, 불활성화율, 배설속도, 사용자의 연령, 성별 및 상태 등에 따라 적절히 선택할 수 있다. 본 발명의 혼합생약재 추출물의 경우, 3000 ∼ 6000 ㎎/㎏이고, 바람직하게는 4000 ∼ 5000 ㎎/㎏이며, 하루 1 ∼ 3회 투여할 수 있다.The content in the preparation of the active ingredient according to the present invention can be appropriately selected depending on the absorbency, inactivation rate, excretion rate, age, sex and condition of the user in the body. In the case of the mixed herbal medicine extract of the present invention, it is 3000 to 6000 mg / kg, preferably 4000 to 5000 mg / kg, and can be administered 1 to 3 times a day.
또한, 본 발명은 혼합생약재 추출물을 유효성분으로 하는 만성 골질환(골다공증, 류마티스 관절염)과 퇴행성 골질환에 관련하여 골세포 증식과 분화유도에 골형성 및 골조직의 분해를 억제함으로써 골질환의 예방 및 치료에 매우 효과적인 건강식품을 포함한다.In addition, the present invention prevents bone disease by inhibiting bone formation and bone tissue degradation in osteoblast proliferation and differentiation in association with chronic bone disease (osteoporosis, rheumatoid arthritis) and degenerative bone disease as an active ingredient mixed herbal medicines Contains health foods that are very effective in treatment.
건강식품이란, 상기 혼합생약재 추출물을 일반 식품에 첨가하거나, 캅셀화, 분말화, 현탁액 등으로 제조한 식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기복용시 발생할 수 있는 부작용 등이 없는 장점이 있다.The health food is a food prepared by adding the mixed herbal medicine extract to a general food, or capsules, powdered, suspensions, etc., and when ingesting it, has a specific effect on health, but unlike a general medicine It has the advantage that there is no side effect that can occur during long-term use of the drug as a raw material.
이하, 본 발명은 다음 실시예에 의거하여 더욱 상세히 설명하겠는바, 본 발명이 이에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail based on the following examples, but the present invention is not limited thereto.
실시예 1Example 1
방풍 150 g, 우슬 200 g, 오가피 150 g, 두충 300 g, 금모구척 200 g을 증류수(또는 정제수)로 2 ∼ 5배의 부피로 배합하고 환류조건하에서 8시간 열을 가한 다음 여과하여 여액을 제조하고 이를 감압농축하여 100 ㎖ 되게 한 후 동결건조시켜서 약 150 g의 동결건조중량을 얻었다.Windproof 150 g, 200 g of dew, 150 g of Ogapi, 300 g of Tobacco, 200 g of Geumgucheokgi were mixed in distilled water (or purified water) in a volume of 2 to 5 times, heated under reflux for 8 hours, and filtered to prepare a filtrate. The resultant was concentrated under reduced pressure to 100 ml and lyophilized to obtain a freeze-dried weight of about 150 g.
실시예 2Example 2
방풍 100 g, 우슬 200 g, 오가피 100 g, 두충 100 g, 금모구척 100 g, 구판50 g, 당귀 150 g, 홍화자 200 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를 얻었다.Wind-proof 100 g, 200 g of dew, 100 g of Ogapi, 100 g of Tofu, 100 g of Jingu gukcheok, 50 g of old plate, 150 g of Angelica, and 200 g of safflower were extracted with water in the same manner as in Example 1 to obtain an extract.
실시예 3Example 3
방풍 100 g, 우슬 150 g, 오가피 50 g, 두충 50 g, 금모구척 100 g, 육계 50 g, 구기자 50 g, 약콩 50 g, 고비 100 g, 홍화자 300 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를 얻었다.Windproof 100 g, 150 g of dew, 50 g of Ogapi, 50 g of Tofu, 100 g of broiled chicken, 100 g of broiler, 50 g of wolfberry, 50 g of medicinal beans, 100 g of fern, 300 g of safflower with water in the same manner as in Example 1 above It extracted and obtained the extract.
실시예 4Example 4
방풍 150 g, 우슬 250 g, 오가피 100 g, 두충 100 g, 금모구척 200 g, 오적골 100 g, 고비 100 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를 얻었다.Wind-proof 150 g, 250 g of dew, 100 g of Ogapi, 100 g of Tofu, 200 g of Gold Mochumcheok, 100 g of Ohjeolgol and 100 g of Gobi were extracted in the same manner as in Example 1 to obtain an extract.
실시예 5Example 5
방풍 150 g, 우슬 250 g, 오가피 100 g, 두충 50 g, 금모구척 200 g, 구판 50 g, 숙지황 50 g, 적두 150 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를 얻었다.Wind 150g, dew 250g, 100g of Ogapi, 50g of Tofu, 200g of Jingu gukcheok, 50g of old plate, 50g of sucrose and red ginseng were extracted with water in the same manner as in Example 1 to obtain an extract.
실시예 6Example 6
방풍 100 g, 우슬 150 g, 오가피 200 g, 두충 100 g, 금모구척 200 g, 홍화자 200 g, 숙지황 50 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를었다.Windproof 100 g, dew 150 g, Ogapi 200 g, tofu 100 g, Jingu Gucheok 200 g, safflower 200 g, Sukji sulfur 50 g was extracted with water in the same manner as in Example 1 to extract.
실시예 7 Example 7
방풍 150 g, 우슬 150 g, 오가피 100 g, 두충 200 g, 금모구척 100 g, 고비 50 g, 익모초 50 g, 속 50 g, 숙지황 50 g을 상기 실시예 1과 같은 방법으로 물로 추출하여 엑기스를었다.Windproof 150 g, 150 g of dew, 100 g of Ogapi, 200 g of Tofu, 100 g of Goldfish guchu 100 g, Gobi 50 g, motherwort vinegar 50 g, genus 50 g, 50 g of sucrose and sulfur extract in the same manner as in Example 1 It was.
실험예 1: 조골세포 증식 분석Experimental Example 1: Osteoblast proliferation assay
1) 조골세포의 세포 배양 1) Cell Culture of Osteoblasts
뼈의 구성 성분인 조골세포와 유사한 성질을 나타내는 MG-63 세포주 및 HOS-TE85 세포주를 서울대학교 의과대학 암 연구소의 한국 세포주은행으로부터 분양 받아 실험에 사용하였다.The MG-63 cell line and HOS-TE85 cell line, which had similar properties to osteoblasts, a component of bone, were distributed from the Korea Cell Line Bank of Seoul National University College of Medicine.
MG-63은 10% FBS, 페니실린 100 U/㎖, 스트렙토마이신 100 ㎍/㎖를 포함하는 DMEM 배지[Gibco BRL,미국]를 사용하였으며, HOS-TE85 세포주도 같은 배지조건을 사용하여 습식 조건에서 37 ℃로 5% CO2를 포함하는 배양기(incubator)에서 배양하였다. 배지는 1주일에 3회 교환하였고, 1주일에 1회 계대배양하였다.MG-63 used DMEM medium [Gibco BRL, USA] containing 10% FBS, penicillin 100 U / ml, streptomycin 100 [mu] g / ml, and HOS-TE85 cell line was subjected to wet conditions using 37 Incubation was carried out in an incubator containing 5% CO 2 at ° C. The medium was changed three times a week and subcultured once a week.
2) 추출물 농도에 따른 세포증식 실험; MTT 실험 2) cell proliferation experiment according to the extract concentration; MTT Experiment
상기 1)에서 배양한 MG-63와 HOS-TE85 세포주를 96 웰 플레이트에 접종하고, 본 발명의 혼합 생약재 추출물을 건조약재당 1 ㎍/㎖의 농도가 되도록 각 농도별로 6개의 웰에 첨가하였다. 대조군으로 추출물을 첨가하지 않은 것으로 사용하였고 MG-63 세포주 및 HOS-TE85 세포주에서의 비교군으로서는 현재 골다공증 치료제로 주로 사용되고 있는 리비알(Livial)을 사용하였다. The MG-63 and HOS-TE85 cell lines cultured in 1) were inoculated into 96 well plates, and the mixed herbal extract of the present invention was added to 6 wells at each concentration so as to have a concentration of 1 μg / ml per dry medicine. As a control, no extract was added, and as a comparison group in the MG-63 cell line and the HOS-TE85 cell line, Livial, which is currently mainly used as a therapeutic agent for osteoporosis, was used.
상기에서 세포주를 37 ℃ 배양기에서 3일간 배양하고, 여기에 MTT(3-(4,5-dimethylthiazol-2-YL)-2,5-diphenyltetrazolium bromid; Triazoly Blue)를 0.05 mg/㎖ 농도로 가하여 같은 조건에서 4시간 더 배양하였다. 생성된 포르마잔(formazan) 결정을 DMSO로 용해시켜 엘리자 리더(ELISA reader)로 550 nm에서의 흡광도를 측정하였다.The cell line was incubated for 3 days in an incubator at 37 ° C., and MTT (3- (4,5-dimethylthiazol-2-YL) -2,5-diphenyltetrazolium bromid; Triazoly Blue) was added at a concentration of 0.05 mg / ml. Incubated further 4 hours under conditions. The resulting formazan crystals were dissolved in DMSO and absorbance at 550 nm was measured with an ELISA reader.
세포 증식율(%)은 추출물을 첨가하지 않은 대조군 웰의 흡광도에 대한 추출물 첨가 웰의 흡광도의 비(%)로서 계산하였다.Cell growth rate (%) was calculated as the ratio (%) of absorbance of the extract added wells to the absorbance of the control wells without the extract.
그 결과, 본 발명의 혼합생약재 추출물은 MG-63과 같은 조골세포 유사 세포에 대한 우수한 증식률을 나타내었다[도 1]. 종래 골다공증 치료제로 사용되고 있는 리비알에 비하여 조골세포 증식률이 더 우수하였음을 확인하였다[도 2]. 또한, 본 발명의 혼합생약재 추출물은 HOS-TE85와 같은 조골세포 유사 세포에 대해서도 우수한 증식률을 나타내었다. 따라서, 본 발명의 혼합생약재 추출물은 골다공증 치료 또는 예방과 관련된 약물 및 건강 식품에 유용하게 사용될 수 있음을 확인하였다.As a result, the mixed herbal extract of the present invention showed an excellent proliferation rate for osteoblast-like cells such as MG-63 [Fig. 1]. It was confirmed that osteoblast proliferation rate was superior to that of Rivial, which is conventionally used as a treatment for osteoporosis [FIG. 2]. In addition, the mixed herbal extract of the present invention showed excellent proliferation rate for osteoblast-like cells such as HOS-TE85. Therefore, it was confirmed that the mixed herbal extract of the present invention can be usefully used for drugs and health foods related to the treatment or prevention of osteoporosis.
본 발명의 혼합생약재 추출물이 조골세포의 증식에 미치는 알아본 결과 조골세포에 대하여 우수한 증식 효과가 있음을 확인하였다. 또한, 종래 골다공증 치료제로 사용되어 있는 리비알에 비하여 조골세포 증식률이 더 우수하였다.As a result of examining the effect of the mixed herbal medicine extract of the present invention on the proliferation of osteoblasts, it was confirmed that there is an excellent proliferative effect on the osteoblasts. In addition, the osteoblast proliferation rate was higher than that of the rivial, which is conventionally used as a therapeutic agent for osteoporosis.
실험예 2: 골다공증 모델의 동물 실험 난소 적출 흰쥐에 대한 동물 실험Experimental Example 2: Animal Experiment of Osteoporosis Model Animal Experiment on Ovariectomized Rat
골다공증 억제 효과를 관찰하기 위해서 폐경기 이후 타입 I 골다공증이 발생하는 SD(Sprague-Dawley)계 암컷 흰쥐를 난소적출 실험하고 소주골의 면적의 변화를 측정하였다. 실험재료로는 10주령 체중 200 ∼ 220 g 정도의 흰쥐 암컷을 사용하고 양쪽 난소 적출술을 실시하는데 정상군은 난소 적출을 제외한 모든 수술을 행한 그룹이며, 대조군은 상기 실시예 1의 엑기스를 투여하지 않고, 투여군은 실시예 1의 엑기스를 3000 mg/kg을 1일 1회 경구투여하여 10주 동안 사육하였다.In order to observe the inhibitory effect of osteoporosis, SD (Sprague-Dawley) female rats undergoing postmenopausal type I osteoporosis were examined for ovarian extraction and the changes in the area of the minor bone were measured. As a test material, 10-week-old female rats having a body weight of 200-220 g were subjected to bilateral ovarian extraction. The normal group was a group that performed all operations except ovarian extraction. The control group was not administered the extract of Example 1 above. , The administration group was raised for 10 weeks by oral administration of 3000 mg / kg once a day extract of Example 1.
1) 약물 투여에 의한 체중 및 조직 무게의 변화측정 1) Measurement of changes in body weight and tissue weight by drug administration
상기 방법에 의해 난소가 적출된 후 약물이 투여된 실험 동물의 체중을 매주 측정하고 일정기간 투여 후 조직 무게를 측정하여 난소 적출을 제외한 모든 수술을 행한 정상군 및 난소를 적출하여 본페로니 다중비교법(boneferroni multiple comparison method)으로 약물 투여를 하지 않은 대조군의 체중 및 조직 무게와 비교하였다[표 1].After the ovary was extracted by the above method, the weight of the experimental animal to which the drug was administered was measured weekly, and the tissue weight was measured after a certain period of time to extract the normal group and the ovaries which performed all operations except ovarian extraction. (boneferroni multiple comparison method) was compared with the weight and tissue weight of the control group not administered drug [Table 1].
그 결과, 약물 투여시 대조군과 비교하여 체중의 변화와 조직의 무게의 차이가 없었다. 즉, 체중의 변화나 조직무게의 변화를 나타낼 만큼 큰 호르몬의 변화는 없는 것으로 간주되어 본 발명의 추출물은 안전한 약물로 사료된다. As a result, there was no difference in body weight and tissue weight when compared with the control group. That is, it is considered that there is no hormonal change that is large enough to show a change in body weight or tissue weight, so the extract of the present invention is considered to be a safe drug.
2) 병리조직학적 관찰 2) Histopathological observation
채취한 대퇴 골조직을 10% 포르마린 용액에 고정한 수 포름산 os에서 탈회를 실시하였다. 골조직의 관찰 부위를 수술칼로 절단한 뒤 20 ∼ 100% 알코올과 아세톤에 이르는 단계 별 탈수 과정을 거쳐 자일렌으로 수세하고 파라핀 포매를 실시하였다. 파라핀 포매된 골조직을 마이크롬으로 5 ㎛로 절단하고 헤마톡실린 및 에오신(hematoxyline and eosin, H&E) 염색과 고모리(gomori) 염색을 실시하고, 광학 현미경으로 확인하였다[도 3].The collected femoral bone tissue was demineralized in aqueous formic acid os fixed in 10% formarin solution. Observation sites of bone tissue were cut with a surgical knife, washed with xylene, and paraffin embedded through dehydration processes ranging from 20 to 100% alcohol and acetone. Paraffin-embedded bone tissue was cut to 5 μm with micron, hematoxylin and eosin (H & E) staining and gomori staining were performed, and confirmed with an optical microscope [FIG. 3].
3) 형태계측학적 분석 3) Morphometric Analysis
각 군이 경골에서 다음과 같은 방법에 의해 형태계측학적 분석을 실시하였다. 광학 현미경내의 메타뷰 프로그램을 이용하여 경골 내에서 각 소주골(trabecular)의 면적을 자동적으로 계산하고 이것으로 소주골의 면적을 구하였다. 각 경골의 근위부에서 성장판의 직하부의 부분 중 가로변의 길이가 성장판 길이의 약 2/3 정도의 길이로 기준 면적 2×106 ㎛2인 직사각형 내부의 골소주의 개수를 구한 다음 평균 면적에 개수를 곱하여 각각의 골 표본의 소주골 면적을 구한 후 통계처리하였다[도 4].Each group was subjected to morphometric analysis in the tibia by the following method. Using the meta-view program in the optical microscope, the area of each trabecular in the tibia was automatically calculated, and the area of the minor bone was obtained from this. In the proximal tibia of each of the number of the following average area of the length of the straight portion of the lower portion of the growth plate obtained for the number of roadside inside the reference area 2 × 10 6 ㎛ 2 to a length of about 2/3 of the growth plate length rectangular trabeculae By multiplying the small bone area of each bone sample was statistically processed [Fig. 4].
그 결과, 난소 적출한 대조군은 정상군에 비해 소주골의 면적이 82%나 감소되었으며, 이는 골다공증이 유발되었음을 나타낸 것이다. 또한, 난소 적출로 인한 소주골 면적은 혼합생약재 추출물의 투여로 증가되었는데 정상군에 비하여 낮았으나(*; p<0.05, **p<0.01), 대조군에 비해서는 유의성있게 증가하였다.As a result, the control group extracted from the ovary was reduced by 82% of the area of the subcetabular bone compared to the normal group, indicating that osteoporosis was induced. In addition, the area of osseous bone due to ovarian extraction was increased by the administration of mixed herbal extract, which was lower than the normal group ( * ; p <0.05, ** p <0.01), but significantly increased compared to the control group.
본 발명의 혼합생약재 추출물의 투여는 대조군에 비해 약 89.8%정도 소주골의 면적을 증가시켰다. 따라서, 본 발명의 혼합 생약재 추출물은 골다공증의 예방 및 치료에 효과적으로 사용될 수 있음을 알 수 있다.Administration of the mixed herbal medicine extract of the present invention increased the area of the small bones by about 89.8% compared to the control group. Therefore, it can be seen that the mixed herbal medicine extract of the present invention can be effectively used for the prevention and treatment of osteoporosis.
실험예 3: 흰쥐에 대한 경구투여 급성 독성실험Experimental Example 3: Oral Acute Toxicity in Rats
8주령의 특정병원체부재(specific pathogen-free, SPF) SD계 흰쥐를 사용하여 급성 독성실험을 실시하였다. 그룹당 5마리씩의 흰쥐에 본 발명의 혼합 생약재 추출물을 각각 0.5% 메틸셀룰로오즈 용액에 현탁하여 1 g/kg/mL의 용량으로 1회 단회 경구투여 하였다. 시험 물질 투여 후 동물의 폐사여부, 임상증상, 체중의 변화를 관찰하고 혈액검사와 혈액생화학적 검사를 실시하였으며, 부검하여 육안으로 복강장기와 흉강장기의 이상여부를 관찰하였다.Acute toxicity test was performed using 8-week-old specific pathogen-free (SPF) SD rats. In five rats per group, the mixed herbal medicine extract of the present invention was suspended in 0.5% methylcellulose solution and administered once orally at a dose of 1 g / kg / mL. After administration of the test substance, mortality, clinical symptoms, and changes in body weight were observed, blood tests and blood biochemical tests were performed, and necropsy was performed to observe abdominal and thoracic organ abnormalities.
그 결과, 시험물질을 투여한 모든 동물에서 특기할 만한 임상증상이나 폐사된 동물은 없었으며, 체중변화, 혈액검사, 혈액생화학 검사, 부검소견 등에서도 독성변화는 나타내지 않았다(LD50 9000 mg/kg 이상)As a result, there were no clinical symptoms or deaths in all animals treated with the test substance, and no toxicity change was observed in weight change, blood test, blood biochemistry test, autopsy findings (LD 50 9000 mg / kg). More than)
실험예 4: 경골의 골밀도와 골함량의 측정Experimental Example 4 Measurement of Bone Mineral Density and Bone Content of Tibia
10주간의 사육후 Lunar사의 rat전용 골밀도 측정기인 PIXIMUS를 이용하여 경골의 골밀도(bone mineral denxity, BMD)와 골무기질함량(bone mineral contents, BMC)을 측정하였다. 골함량의 단위는 g으로 나타내었고, 골밀도는 g/cm2로 나타내었다[표 2]. 본 발명의 추출물 투여군의 경골의 골밀도와 골무기질 함량은 골무기질 함량은 0.307375(g)과 골밀도는 0.183838(g/cm2)으로서 대조군의 골무기질 함량 0.263818(g)과 골밀도는 0.175891(g/cm2)보다 높은 경향을 보였다. 경골 골밀도를 체중으로 나눈 값이 대조군에서 0.727961(g/cm2)이며, 본 발명의 추출물 투여군의 경골 골밀도를 체중으로 나눈 값이 0.800333(g/cm2) 높아 본 발명의 추출물 투여군이 골밀도를 높이는데 효과적임을 알 수 있었다.After 10 weeks of breeding, bone mineral denxity (BMD) and bone mineral contents (BMC) of tibia were measured using PIXIMUS, Lunar's rat BMD. The unit of bone content is expressed in g, and the bone density is expressed in g / cm 2 [Table 2]. The bone mineral density and bone mineral content of the tibia of the extract-administered group of the present invention is 0.307375 (g) and bone density is 0.183838 (g / cm 2 ) as the bone mineral content 0.263818 (g) and bone density 0.175891 (g / cm) of the control group. 2 ) tended to be higher than that. The tibial bone density divided by weight is 0.727961 (g / cm 2 ) in the control group, the tibial bone density divided by the weight of the extract-administered group of the present invention is 0.800333 (g / cm 2 ) as high as the extract administration group of the present invention increases bone density It was found to be effective.
제조예 1: 분말 및 캅셀제의 제조Preparation Example 1 Preparation of Powder and Capsule
본 발명의 혼합생약재 추출물 10 ㎎을 락토오스 14.8 ㎎, 결정성 셀룰로오스 3 ㎎, 마그네슘 스테아레이트 0.2 ㎎과 함께 섞었다. 혼합물을 적당한 장치를 사용하여 No.5 젤라틴 캅셀에 채웠다.10 mg of the mixed herbal extract of the present invention was mixed with 14.8 mg of lactose, 3 mg of crystalline cellulose, and 0.2 mg of magnesium stearate. The mixture was filled into No. 5 gelatin capsules using a suitable apparatus.
상기 분말 및 캅셀제의 구성성분은 다음과 같다.The components of the powder and the capsules are as follows.
혼합생약재 추출물 · ·········· 10 ㎎Mixed Herbal Extracts ·········· 10 mg
락토오스 ··················14.8 ㎎Lactose ····················· 14.8 mg
결정성 셀룰로오스··············· 3 ㎎Crystalline cellulose 3 mg
마그네슘 스테아레이트 ·········· 0.2 ㎎Magnesium Stearate 0.2 mg
제조예 2 : 주사액제의 제조Preparation Example 2 Preparation of Injection Solution
본 발명의 혼합생약재 추출물 10 ㎎, 만니톨 180 ㎎, Na2HPO4ㆍ12H2O 26 ㎎ 및 증류수 2974 ㎎을 혼합하여 주사제를 제조하였다. 상기 용액을 병에 넣고 20 ℃에서 30분간 가열하여 멸균 처리하였다.10 mg of the mixed herbal extract of the present invention, mannitol 180 mg, Na 2 HPO 4 12H 2 O 26 mg and distilled water 2974 mg was prepared to inject. The solution was placed in a bottle and heated at 20 ° C. for 30 minutes for sterilization.
혼합생약재 추출물 ········ ····· 10 ㎎Mixed medicinal herb extract ············· 10 mg
만니톨 ··················· 180 ㎎Mannitol 180mg
Na2HPO4ㆍ12H2O ·· ············· 26 ㎎Na 2 HPO 4 12H 2 O 26 mg
증류수 ·················· 2974 ㎎Distilled water ················· 2974 mg
제조예 3: 건강식품(정제, 캅셀 또는 음료)의 제조Preparation Example 3 Preparation of Health Food (Tablet, Capsule or Beverage)
1일 복용 기준으로 본 발명의 혼합생약재 추출물 0.2 g, 분말비타민 E, 젖산철, 산화아연, 니코틴산 아미드, 비타민 A, 비타민 B1 및 비타민 B2를 혼합하여 제조하였다.It was prepared by mixing 0.2 g of the mixed herbal extract of the present invention, powdered vitamin E, iron lactate, zinc oxide, nicotinic acid amide, vitamin A, vitamin B1 and vitamin B2 on a daily dose basis.
상기 건강식품의 구성성분은 다음과 같다(사람 1일복용량 기준).The components of the health food is as follows (per person daily dose basis).
혼합생약재 추출물 ·············· 300 mgMixed medicinal herb extract ········· 300 mg
인삼 추출물 ················· 100 mgGinseng Extract ·················· 100 mg
녹차 추출물 ················· 100 mgGreen Tea Extract ················ 100 mg
비타민 C ·················· 100 mg100 mg of vitamin C ·················
분말비타민 E ·············· 120 mgPowdered Vitamin E 120 mg
젖산철 ···················· 2 mg Iron Lactate ... 2 mg
산화아연 ··················· 2 mgZinc Oxide ················ 2 mg
니코틴산아미드 ·················20 mgNicotinamide ... 20 mg
비타민 A ·········· ········ 5 mgVitamin A ... 5 mg
비타민 B1 ··················· 2 mgVitamin B1 2 mg
비타민 B2 ··················· 2 mgVitamin B2 · 2 mg ··········
옥수수전분···················200 mgCorn starch ... 200 mg
스테아린산 마그네슘 ·············· 20 mgMagnesium stearate 20 mg
이상에서 설명한 바와 같이, 본 발명에 따른 혼합생약재 추출물은 조골 세포(osteoblast)를 증식시키고 실험 동물군에서 골밀도를 증가시키고 소주골의 면적을 증가시키는 것으로 나타남으로써 관절염, 골다공증, 디스트 등의 골질환 예방 및 치료에 매우 유용하게 사용될 수 있다. 또한, 독성이 전혀 없으므로 건강 보조 식품으로도 널리 이용될 수 있다.As described above, the mixed herbal medicine extract according to the present invention has been shown to increase osteoblasts, increase bone density in experimental animal groups, and increase the area of small intestinal bone, thereby preventing bone diseases such as arthritis, osteoporosis, and distress. And very useful for treatment. In addition, since it is not toxic at all, it can be widely used as a dietary supplement.
도 1은 본 발명의 혼합생약재 추출물 통해 조골세포와 유사한 여성세포주인 HOS-TE85(a)와 남성세포주인 MG-63(b)에서의 세포증식 효과를 나타낸 것이다.Figure 1 shows the effect of cell proliferation in the female cell line HOS-TE85 (a) and male cell line MG-63 (b) similar to osteoblasts through the mixed herbal extract of the present invention.
도 2는 본 발명의 혼합생약재 추출물과 종래 골다공증 치료제의 조골세포 증식률 비교 결과를 나타낸 것이다.Figure 2 shows the results of comparing the osteoblast proliferation rate of the mixed herbal medicine extract of the present invention and conventional osteoporosis therapeutics.
도 3은 본 발명의 혼합생약재 추출물 대신 동양의 물을 10주간 경구투여한 정상군의 경골사진(A), 본 발명의 혼합생약재 추출물을 투여하지 않은 대조군의 경골사진(B), 본 발명의 혼합생약재 추출물을 10주간 경구투여한 군의 경골사진(C)을 나타낸 것이다.3 is a tibial photograph (A) of the normal group administered orally with oriental water for 10 weeks instead of the mixed herbal medicine extract of the present invention, the tibial photograph (B) of the control group not administered the mixed herbal medicine extract of the present invention, the mixture of the present invention The tibia picture (C) of the group orally administered the herbal extract for 10 weeks is shown.
도 4는 본 발명의 혼합생약재 추출물을 10주간 경구투여한 흰쥐 경골의 소주골 면적의 각 군의 비교 그래프를 나타낸 것이다.Figure 4 shows a comparative graph of each group of the sub-catheter bone area of the rat tibia orally administered 10 minutes of the mixed herbal medicine extract of the present invention.
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WO2006091030A1 (en) * | 2005-02-23 | 2006-08-31 | Oscotec Inc. | A herbal mixture extract of rehmanniae radix preparata and acanthopanacis cortex and a composition comprising the same for prevention and treatment of osteoporosis |
WO2006135121A1 (en) * | 2005-06-17 | 2006-12-21 | Joon Shik Shin | Bone disease drug composition using herb medicines |
WO2007001156A1 (en) * | 2005-06-28 | 2007-01-04 | Jun Sik Shin | Pharmaceutical composition for treating inflammation, pain, arthritis and spinitis, and proliferating osteoblastic cell and method thereof |
WO2009157712A3 (en) * | 2008-06-24 | 2010-03-18 | 헬릭서 | Crude drug composition for cartilage regeneration, pain suppression, and edema suppression |
CN102526261A (en) * | 2012-02-21 | 2012-07-04 | 简福川 | Chinese medicine for treating lumbar vertebra osteoproliferation |
KR101218792B1 (en) * | 2009-10-28 | 2013-01-14 | 조용택 | A beverage composition containing herb medicine extracts and method for preparing the same |
KR101444760B1 (en) * | 2013-08-05 | 2014-09-26 | 동우당제약(주) | A composition for preventing bone metabolism-related diseases and increasing bone function comprising mix extracts of Achyranthes bidentata and Siegesbeckia glabrescens |
KR20160088255A (en) | 2015-01-15 | 2016-07-25 | 경희대학교 산학협력단 | Composition comprising the combined extracts of Schisandra chinensis, Eucommia ulmoides and Lycium barbarum for preventing or treating bone metabolism diseases |
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WO2006091030A1 (en) * | 2005-02-23 | 2006-08-31 | Oscotec Inc. | A herbal mixture extract of rehmanniae radix preparata and acanthopanacis cortex and a composition comprising the same for prevention and treatment of osteoporosis |
US8053001B2 (en) | 2005-02-23 | 2011-11-08 | Oscotec Inc. | Herbal mixture extract of Rehmanniae radix preparata and Acanthopanacis cortex and a composition comprising the same for prevention and treatment of osteoporosis |
WO2006135121A1 (en) * | 2005-06-17 | 2006-12-21 | Joon Shik Shin | Bone disease drug composition using herb medicines |
WO2007001156A1 (en) * | 2005-06-28 | 2007-01-04 | Jun Sik Shin | Pharmaceutical composition for treating inflammation, pain, arthritis and spinitis, and proliferating osteoblastic cell and method thereof |
KR100765813B1 (en) * | 2005-06-28 | 2007-10-10 | 신준식 | Crude drugs for treating inflammation, analgesia and arthritis, and proliferating osteoblastic cell |
WO2009157712A3 (en) * | 2008-06-24 | 2010-03-18 | 헬릭서 | Crude drug composition for cartilage regeneration, pain suppression, and edema suppression |
KR101218792B1 (en) * | 2009-10-28 | 2013-01-14 | 조용택 | A beverage composition containing herb medicine extracts and method for preparing the same |
CN102526261A (en) * | 2012-02-21 | 2012-07-04 | 简福川 | Chinese medicine for treating lumbar vertebra osteoproliferation |
KR101444760B1 (en) * | 2013-08-05 | 2014-09-26 | 동우당제약(주) | A composition for preventing bone metabolism-related diseases and increasing bone function comprising mix extracts of Achyranthes bidentata and Siegesbeckia glabrescens |
KR20160088255A (en) | 2015-01-15 | 2016-07-25 | 경희대학교 산학협력단 | Composition comprising the combined extracts of Schisandra chinensis, Eucommia ulmoides and Lycium barbarum for preventing or treating bone metabolism diseases |
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