KR100692173B1 - Health functional food having an energetic and sturdy action - Google Patents
Health functional food having an energetic and sturdy action Download PDFInfo
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- KR100692173B1 KR100692173B1 KR1020050024130A KR20050024130A KR100692173B1 KR 100692173 B1 KR100692173 B1 KR 100692173B1 KR 1020050024130 A KR1020050024130 A KR 1020050024130A KR 20050024130 A KR20050024130 A KR 20050024130A KR 100692173 B1 KR100692173 B1 KR 100692173B1
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- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K73/00—Drawn nets
- A01K73/02—Trawling nets
- A01K73/06—Hauling devices for the headlines
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K77/00—Landing-nets for fishing; Landing-spoons for fishing
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K80/00—Harvesting oysters, mussels, sponges or the like
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65H—HANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
- B65H75/00—Storing webs, tapes, or filamentary material, e.g. on reels
- B65H75/02—Cores, formers, supports, or holders for coiled, wound, or folded material, e.g. reels, spindles, bobbins, cop tubes, cans, mandrels or chucks
- B65H75/18—Constructional details
- B65H75/30—Arrangements to facilitate driving or braking
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Environmental Sciences (AREA)
- Animal Husbandry (AREA)
- Biodiversity & Conservation Biology (AREA)
- Marine Sciences & Fisheries (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
본 발명의 신장활성과 항피로, 강정, 강장, 성기능 개선용 건강기능식품은 누에건조엑스 5∼60 중량%, 산수유건조엑스 1∼40 중량%, 사상자건조엑스 1∼10 중량%, 토사자건조엑스 1∼10 중량%, 천궁건조엑스 1∼10 중량%, 녹용분말 1∼20 중량%, 원지건조엑스 1∼10 중량%, 오미자건조엑스 1∼10 중량 %, 계피건조엑스 1∼10 중량% 및 우슬건조엑스 1∼10 중량%를 함유한 조성물이다.Health functional foods for improving kidney activity and anti-fatigue, gangjeong, tonic, sexual function of the present invention is silkworm dry extract 5 ~ 60% by weight, dry corn milk extract 1 ~ 40% by weight, casualty dry extract 1 ~ 10% by weight, earth and sand dry extract 1 to 10% by weight, 1 to 10% by weight of Cheongung dried extract, 1 to 20% by weight of antler powder, 1 to 10% by weight of dry ground extract, 1 to 10% by weight of Omija dried extract, 1 to 10% by weight of cinnamon dried extract and A composition containing 1 to 10% by weight of dried dried extract.
누에건조엑스, 강장강정 및 성기능 개선용 건강기능식품.Silkworm dry extract, tonic tonic and health functional food for improving sexual function.
Description
본 발명은 신장활성과 항피로, 강정, 강장, 성기능 개선용 건강기능식품에 관한 것이다. The present invention relates to renal activity and anti-fatigue, gangjeong, tonic, health functional food for improving sexual function.
성은 인류의 시대변천에 따른 사회문화의 반영인 바, 스트레스 시대인 지금은 누구나 성기능 장애에 걸릴 가능성을 지니고 있다.Sex is a reflection of the social culture of the changing times of humanity, and now everyone in the stressful age has the potential to suffer sexual dysfunction.
성기능 장애란 남녀생식기의 기능과 관련된 질환을 통칭하는 것으로 가장 흔한 것이 발기부전과 조루이다.Sexual dysfunction is a generic term for diseases related to the functions of the male and female genital organs. The most common are erectile dysfunction and premature ejaculation.
발병빈도를 보면 대체로 남자 40대는 10 %에서, 50대는 20 %에서, 60대는 30 %에서, 70대는 50 %에서 그리고 80대는 80 %에서 발기부전이 오게 되어 우리나라에도 줄잡아 약 62만명이 이것으로 고민하고 있는 것으로 추측된다.In terms of incidence, erectile dysfunction usually occurs in 10% of men in their 40s, 20% in their 50s, 30% in their 60s, 50% in their 70s, and 80% in their 80s. It seems to be troubled.
발기부전이란 성교무능증, 성교불능증 등의 의미를 포괄하는 말로써 각종 원인으로 음경이 발기되지 않거나 발기되더라도 질내에 삽입할 수 없을 정도의 강직도를 유지하여 성교를 할 수 없는 상태를 말한다.Erectile dysfunction is a term encompassing the meanings of sexual dysfunction, impotence, etc. It means a state in which the penis is not erected or erected due to various reasons, and maintains the degree of stiffness that cannot be inserted into the vagina to prevent sexual intercourse.
그 원인은 매우 다양한 것으로 보고되고 있으며, 크게 심인성 원인과 기질적인 원인으로 구분하여 치료한다.The causes are reported to be very diverse, and largely divided into psychogenic causes and organic causes to treat.
1) 주로 심인성 원인으로는 계속되는 피곤과 스트레스, 인스턴트식품의 과다복용 및 기타 환경호르몬 등에 노출되는 것이 주원인으로 이는 정신과적인 성치료가 필요하며, 정신요법(우울증 등)의 성공률은 약 70 % 정도로 보고되고 있다.1) The main causes of psychogenicity are exposure to continuous fatigue and stress, overdose of instant foods, and other environmental hormones. This requires psychological sexual treatment, and the success rate of psychotherapy (depression, etc.) is reported to be about 70%. It is becoming.
2) 기질적 원인으로는 혈관이나 신경계 등의 이상(당뇨병, 고혈압, 심장병, 동맥경화증 등 치료제의 복용), 성호르몬 계통의 이상, 수술 또는 부상 등에 의해서도 발기부전을 일으키는 주요 원인이다.2) The organic causes include vascular or nervous system abnormalities (diabetes, hypertension, heart disease, arteriosclerosis, etc.), sex hormones, erectile dysfunction, and other causes.
이들의 치료는 내과적 또는 수술적인 요법이 적용된다. 이러한 치료방법으로는 약물요법과 진공발기유발기구의 사용, 자가주사발기법, 혈관수술 및 음경보형물 삽입 등의 방법이 있으나, 약물요법을 제외하고는 사용시의 번거로움이나 부작용 등의 이유 때문에 점차 경구적인 약물이나 도포제를 선호하고 있는 실정이다.Their treatment is applied by medical or surgical therapy. These treatments include drug therapy, the use of vacuum-induced devices, self-injection techniques, vascular surgery, and penile implants.However, with the exception of drug therapy, they gradually become oral due to the inconvenience and side effects of use. Preferred drugs or coatings are preferred.
한의학에서는 발기부전이 양위 또는 음위의 범주로 인식되며, 이에 대한 치료의 역사도 매우 오래되었다.In oriental medicine, erectile dysfunction is recognized as a categorical or categorical category, and the history of treatment for this is very long.
발기부전이란 <내경편, 內經篇>에 처음으로 "음위()", "이종불수(弛縱不收)", "종근종(宗筋縱)"등으로 기재되었으며, <화제국방, 和劑局方>에서는 양사불거(陽事不擧)라 칭하였으며, <경악전서, 景岳全書>에서는 양위()라 칭하였다.Erectile dysfunction is the first in <internal diameter, 內 經 篇> ) "," Heteroimpairment (弛 縱 不 收) "," 종 종종 (宗 筋 縱) ", etc., and in the <Hwagbang Defense, 和 劑 局 方> called both companies bulge (陽 事 不 擧), In <Amazement, 景 岳 全書> It was called).
이에 대한 치료의 역사도 매우 오래되었다. 한의학적 치료방법은 주로 약물 요법과 침구요법으로 대별된다. 최근 보고들은 이러한 방법에 의한 치료가 매우 효과적임을 보고하고 있다.The history of treatment has been very long. Chinese medical treatment is mainly divided into drug therapy and acupuncture. Recent reports have reported that this method of treatment is very effective.
그러나, 혈관성, 내분비성 및 신경성 원인으로 인한 발기부전의 치료에는 제한적인 경우도 있어 새로운 치료방법에 대한 연구가 필요한 실정이다. 또한 비수술적인 치료방법을 선호하는 추세로 볼 때 한의학적인 치료방법의 개발이나 치료효과의 제고에 대한 연구가 필요하다 하겠다.However, the treatment of erectile dysfunction due to vascular, endocrine, and neurological causes is limited, and thus, a new treatment method is required. In addition, as the preference for non-surgical treatment methods is needed, studies on the development of oriental medicine treatment methods and improvement of treatment effects are necessary.
최근 발기부전 치료제로 각광받는 비아그라의 경우 최초의 경구용 치료제이며, 기존의 약과는 달리 성적 자극이 있어야 발기가 되며 당뇨, 척추손상환자, 노인 남성에게도 효과가 있는 장점이 있다. 하지만, 두통, 소화불량, 코막힘, 시각장애 등의 부작용이 있으며, 성행위 1시간전에 복용해야 하는 번거로움이 있다.In the case of Viagra, which is recently spotlighted as an erectile dysfunction treatment agent, it is the first oral therapeutic agent, and unlike conventional medicine, it is necessary to have sexual stimulation to have an erection, and it is effective in diabetes, spinal cord injury patients, and elderly men. However, there are side effects such as headache, indigestion, nasal congestion, and visual impairment, and there is a hassle to take 1 hour before sexual activity.
한편, 국내에서 개발된 조루병 치료제인 에스에스크림 등은 인삼, 당귀 등의 추출물로 만든 국소 도포제로 조루병 치료에서 많은 효과가 있는 것으로 확인되었다. 하지만 본 에스에스크림 등은 국소 마취효과와 국소 혈액순환 증진효과로써 발기부전 효과가 있는 것으로 확인되고 있기 때문에 근본적인 치료효과를 기대 할 수 없는 실정이다.Meanwhile, escrim, which is a treatment for premature ejaculation, which has been developed in Korea, is a topical coating agent made of extracts of ginseng and tangui. However, since ES cream is found to have an erectile dysfunction effect as a local anesthetic effect and a local blood circulation enhancement effect, the fundamental therapeutic effect cannot be expected.
신장 및 성기능 장애와 무기력증 등은 근본적으로 비장과 신장을 정상화 및 강화시켜 근원치료를 하여야만 회복된다. 그렇지 않고 외부적인 약물분사나 각성제 복용 등으로 일시적인 치료현상으로는 당장 해결이 될지 모르나 차츰 약물효과가 떨어지면 회복할 수 없는 상태에 이르게 된다.Renal and sexual dysfunction and lethargy are fundamentally restored by normalizing and strengthening the spleen and kidneys and treating them. Otherwise, temporary treatment may be solved immediately due to external drug injections or stimulants, but if the drug effects gradually decrease, it will lead to an unrecoverable condition.
따라서, 본 발명자들은 수십년 동안 사회적인 관심과 발기부전 치료제의 부작용을 최소화하고 성기능 개선효과(성호르몬의 생성), 전립선 개선효과, 정력온신작용 및 항피로작용이 탁월한 제품을 개발하기 위하여 연구한 결과, 간ㆍ신을 보호하거나 혹은 보양하는 작용을 가진 녹용, 오미자, 우슬, 누에가루, 산수유, 원지, 토사자, 사상자등 한약재와 기를 순환시켜 혈액을 원활하게 하는 천궁, 계피등 한약재로 구성된 제품인 본 발명품을 개발하게 되었다.Therefore, the present inventors have researched for decades to develop products that are excellent in minimizing the side effects of social attention and erectile dysfunction drugs and improving sexual function (production of sex hormones), improving prostate, energetic oncogenic and anti-fatigue effects. The present invention is a product consisting of Chinese medicine such as antler, schisandra chinensis, hyssop, silkworm powder, cornus, raw paper, earthenware, casualty, etc., which circulates and protects the liver, gods, Developed.
따라서, 본 발명은 각성제등 합성의약품을 전혀 가하지 않고 성기능 부전시 근본적 치료가 가능하고, 부작용이 덜한 천연생약성분을 함유하며, 신체의 건강유지에도 보조효과를 거둘 수 있는 신장활성과 항피로, 강정, 강장작용 및 성기능 개선작용을 갖는 건강기능식품을 제공하고자 하는 것이다.Therefore, the present invention is capable of fundamental treatment during sexual dysfunction without adding any synthetic drugs such as stimulants, containing natural herbal ingredients with less side effects, and renal activity and anti-fatigue, gangjeong, which can have a secondary effect on maintaining the health of the body. To provide health functional foods with tonic action and sexual function improving action.
본 발명의 신장활성과 항피로, 강정, 강장, 성기능 개선용 건강기능식품은 누에건조엑스 5∼60 중량%, 산수유건조엑스 1∼40 중량%, 사상자건조엑스 1∼10 중량%, 토사자건조엑스 1∼10 중량%, 천궁건조엑스 1∼10 중량%, 녹용분말 1∼20 중량%, 원지건조엑스 1∼10 중량%, 오미자건조엑스 1∼10 중량 %, 계피건조엑스 1∼10 중량% 및 우슬건조엑스 1∼10 중량%를 함유한 조성물이고,Health functional foods for improving kidney activity and anti-fatigue, gangjeong, tonic, sexual function of the present invention is silkworm dry extract 5 ~ 60% by weight, dry corn milk extract 1 ~ 40% by weight, casualty dry extract 1 ~ 10% by weight, earth and sand dry extract 1 to 10% by weight, 1 to 10% by weight of Cheongung dried extract, 1 to 20% by weight of antler powder, 1 to 10% by weight of dry ground extract, 1 to 10% by weight of Omija dried extract, 1 to 10% by weight of cinnamon dried extract and It is a composition containing 1 to 10% by weight of dried mushroom extract,
그의 제조방법은 누에건조엑스 5∼60 중량%와, 산수유건조엑스 1∼40 중량%, 사상자건조엑스 1∼10 중량%, 토사자건조엑스 1∼10 중량%, 천궁건조엑스 1∼10 중량%, 원지건조엑스 1∼10 중량%, 오미자건조엑스 1∼10 중량%, 계피건조엑기스 1∼10 중량% 및 우슬건조엑스 1∼10 중량%를 균질하게 혼합한후 녹용분말 1∼20 중량%를 첨가함을 특징으로 하는 신장활성과 항피로, 강정, 강장, 성기능 개선용 건강기능식품을 제조함을 특징으로 한다.The manufacturing method is 5 to 60% by weight of silkworm dry extract, 1 to 40% by weight of dry corn extract, 1 to 10% by weight of casualty dry extract, 1 to 10% by weight of earth and sand dry extract, 1 to 10% by weight of dry cloth extract, 1-10% by weight of dry ground extract, 1-10% by weight of Schisandra chinensis extract, 1-10% by weight of cinnamon dry extract, and 1-10% by weight of dried dew extract, and then add 1-20% by weight of antler powder. It is characterized by the manufacture of health functional foods for improving kidney activity and anti-fatigue, gangjeong, tonic, sexual function.
본 발명의 사용하는 생약원료를 구체적으로 설명하면 다음과 같다.When explaining the herbal ingredients used in the present invention in detail.
본 발명에서 사용하는 주성분인 누에건조엑스는 누에(Bombyx mori Linne) 수번데기를 분말화한다음 60 % 에탄올로 추출하고, 농축건조(동결건조)시켜 얻어진 동물성 생약으로, 옛부터 발기부전 및 남성력증진등의 효과가 있는 것으로 알려져 있다. Silkworm dry extract, the main ingredient used in the present invention, is an animal herbal medicine obtained by pulverizing silkworm (Bombyx mori Linne) pupa and extracted with 60% ethanol and concentrated to dryness (freeze-drying). It is known that there is effect such as enhancement.
산수유건조엑스는 층층나무과(Cornaceae)에 속하는 산수유나무(Cornus officialis siebold et Zuccarini)의 익은 열매인 산수유(Corni Fructus)를 따서 씨를 제거한 과실의 추출건조엑스로, 주성분으로는 능금산, 주석산, 몰식자산등 유기산과 배당체등이 들어있고, 한방에서는 자양, 강장, 수렴약으로 사용하고 있으며, 양기부족에도 사용하고 있는 생약이다.Cornus dried extract is an extract and dried extract of fruits removed from Cornus Fructus, a ripe fruit of Cornus officialis siebold et Zuccarini, belonging to the Cornaceae family. And glycosides, etc., is used as a nourishing, tonic, astringent medicine in herbal medicine, and is also used as a herbal medicine for lack of yang.
사상자건조엑스는 미나리과(Umbelliferae)에 속하는 사상자(Torilis japonica) 나무의 열매인 사상자(Torilis Fructus)과실의 추출건조엑스로, 주성분으로는 카디넨(Cadinene), 토릴렌(Torilene)등의 정유성분이 함유되어 있으며, 온신, 수렴성 소염작용이 있는 것으로 알려져 있는 식물생약이다.Casualty dry extract is an extract drying extract of Tolis Fructus, a fruit of the Torilis japonica tree, belonging to the Umbelliferae, and its essential ingredients include essential oils such as Cadinene and Torilene. It is a plant herb that is known to have whole body and astringent anti-inflammatory effect.
토사자건조엑스는 메꽃과(Convolvulaceae)에 속하는 실새삼(Cuscuta chinensis Lamarck)의 씨(Cuscutae Semen)의 추출건조엑스로, 수지등의 배당체를 함유하며, 한방에서는 강정, 강장약으로서 음위, 유정등에 사용되는 생약이다. Tosa Drying Extract is an extract drying extract of Cuscutae Semen of Cucuta chinensis Lamarck belonging to the Convolvulaceae family. It contains glycosides such as resin, and is used as a tablet or tonic in oriental medicine and oil wells. It is a herbal medicine.
천궁건조엑스는 미나리과(Umbelliferae)에 속하는 천궁(Cnidium officinale Makino)의 근경(Cnidii Rhizoma)을 그대로 또는 잔뿌리를 제거한 근경의 추출건조엑스로, 주성분으로 정유인 크니디움락톤(Cnidiumlactone), 크니디움산(Cnidiumic acid) 및 세다노인산(Sedanoic acid)등이 함유되어 있으며, 한방에서는 보혈강장, 온성정혈 및 진통약으로 부인병등에 널리 사용되는 식물생약이다.Cnidium Rhizoma from the root of the Cnidium officinale Makino belonging to the Umbelliferae is extracted or dried root extract with the roots removed.The main components are Cnidiumlactone and Knidium acid. Cnidiumic acid) and Sedanoic acid are contained, and herbal medicines are widely used in women's diseases such as hematopoietic tonic, febrile blood donation and analgesic.
녹용분말(Cervi cornu pantotrichum powder)은 사슴과(Cervidae)에 속하는 매화록(Cervus nippon Temminck) 또는 마록(Cervus elaphus Linne)의 털이밀생되고 골질화되지 않은 어린뿔(유각)을 분말로 한 것으로, 한방에서는 강장, 보기혈, 강정, 원근골, 진통등에 널리사용되고 있는 동물생약이다.Deer antler powder (Cervi cornu pantotrichum powder) is a powder from the hairy, unosteophilized young horns of the plum (Cervus nippon Temminck) or Marok (Cervus elaphus Linne) belonging to Cervidae. Esau is an animal medicine widely used in tonic, boho blood, gangjeong, perspective bone, and pain.
원지건조엑기스는 원지과(Polygalaceae)에 속하는 원지(Polygala tenuifolia Willdenow)의 뿌리(Polygalae Radix)를 추출하여 얻은 건조엑스로, 주성분으로 사포닌인 테누이게닌 A(tenuigenin A), 테누이게닌 B(tenuigenin B)등이 함유되어 있으며, 그밖에 지방유, 폴리갈리톨(polygalitol), 온시신(onsicin), 수지등을 함유하며, 거담약으로 기관지염, 천식등에 쓰이고, 한방에서는 강장, 강정, 진정약으로 사용되고 있는 생약이다.Dried extract extracted from the root of Polygala tenuifolia Willdenow (Polygalae Radix) belonging to the Polygalaceae family. The dry extract is the main ingredient of saponin, tenuigenin A, and tenuigenin B. ), And other fatty oils, polygalitol, onsicin, resin, etc. It is an expectorant used for bronchitis, asthma, and is used as a tonic, gangjeong, and sedative in Chinese medicine. to be.
오미자건조엑스는 목란과(Magnoliaceae)에 속하는 오미자(Maximowiczia chinensis Ruprecht var. typica Nakai 또는 Schizandra chinensis Baillon) 나무의 익은열매(Maximowiziae Fructus)의 추출건조엑스로, 주성분으로는 사과산(malic acid), 주석산(tartaric acid)등의 유기산과 리그난 화합물로 슈잔드린(schizandrin)이 알려져 있으며, 당, 점액질이 많고, 한방에서는 수렴, 진해, 자양강장약등으로 사용되고 있는 생약이다.Schisandra chinensis extract is an extract and dried extract of Maximo wiziae Fructus from the tree of the genus Maximimowiczia chinensis Ruprecht var. Typica Nakai or Schizandra chinensis Baillon belonging to the Magnoliaceae. Schizandrin is known as an organic acid and lignan compound such as tartaric acid, and is a herb that is rich in sugar, mucus, and used in herbal medicine as astringent, Jinhae, and nourishment tonic.
계피건조엑스는 녹나무과(Lauraceae)에 속하는 계피나무(Cinnamomum Cassia Blume 또는 C. zeylanicum Nees)의 줄기 및 가지의 껍질을 벗기어 코르크층을 다소 제거해서 말린 계피(Cassiae Cortex)의 건조엑스로, 주성분으로 정유성분인 신나믹알데히드(Cinnamic aldehyde), 신나밀아세테이트(Cinnamyl acetate), 신나믹산(계피산, Cinnamic acid)등이 주성분이고, 그밖에 유기산, 탄닌, 전분, 수지, 점액, 자당(mannitol) 및 광물성 물질등이 함유되어 있으며, 한방에서는 방향성건위, 발한, 해열, 수렴약등으로 쓰이며, 계피유의 원료가 된다.Dry cinnamon is a dry extract of dried cassia (Cassiae Cortex) by removing the cork layer by peeling stems and branches of Cinnamomum Cassia Blume or C. zeylanicum Nees belonging to the family Lauraceae. Cinnamic aldehyde, cinnamyl acetate, cinnamic acid (cinnamic acid, Cinnamic acid) are essential ingredients, and organic acids, tannins, starches, resins, mucus, mannitol and minerals It is used as a fragrant dry, sweating, antipyretic, astringent medicine, etc., and it is a raw material of cinnamon oil.
우슬건조엑스는 비름과(Amarantaceae)에 속하는 쇠무릅(Achyranthes japonica Nakai)의 뿌리인 우슬(Achyranthis Radix)의 건조엑스로, 사포닌을 함유하며, 가수분해하면 올레아노린산(oleanolic acid) 및 글루쿠론산(glucuronic acid)과 유사한 작용을 갖는 화합물이 추출되며, 최근에는 변태성 호르몬이 확인되었고(에크디스테론, 이노코스테론), 한방에서는 정혈, 이뇨약으로 월경불순, 각기병 등에 사용하며, 통경약으로도 사용하고 또한 동물의 성자극제로 사용되고 있는 식물생약이다.Dry dried extract of Achyranthis Radix, the root of Achyranthes japonica Nakai, belonging to the Amarantaceae, contains saponin and, when hydrolyzed, oleanolic acid and glucurin Compounds with a similar action to glucuronic acid have been extracted, and recently, metamorphic hormones have been identified (ecdysterone, incoosterone), and herbal medicines are used for menstruation, diuretics, dysmenorrhea, dysmenorrhea, etc. It is also a plant herb that is also used as a sex stimulant in animals.
이상과 같이, 본 발명의 온신 및 강장작용과 성기능 개선작용을 갖는 건강기능식품 조성물은 2종의 동물성생약과 8종의 식물성생약으로 구성된 것으로, 함유된 동식물생약의 여러 약리활성을 갖는 유효성분의 복합적인 작용에 기인하여 일반적인 항피로, 강장, 강정 작용은 물론 온신작용, 성기능 증진효과가 기대되는 건강기능식품이다. As described above, the health functional food composition having the warmth and tonic action and sexual function improving action of the present invention is composed of two animal medicines and eight vegetable medicines, and contains an active ingredient having various pharmacological activities of the contained plant and herbal medicines. Due to the complex action, general anti-fatigue, tonic, gangjeong action, as well as whole body action, sexual function enhancement effect is expected.
본 발명에 따라 관용의 방법으로 제조된 제형에는 파우더, 과립, 정제, 캅셀제, 액제, 현탁제 또는 환제가 속하며, 분말(파우더)제제는 1 일 2∼3 회, 1 회 1.5∼4 g을 복용하고, 캅셀제는 1 일 2∼4 회, 1 회 420 mg 캅셀을 5∼6 캅셀씩 복용하며, 환제인 경우에는 1 일 1∼2 회 복용, 1 회 15∼20 환을 복용한다.Powders, granules, tablets, capsules, liquids, suspensions or pills belong to the formulations prepared by the conventional method according to the present invention, and the powder (powder) preparation is taken 1.5 to 4 g 2 to 3 times a day. The capsules are taken 2 to 4 times a day, 5 to 6 capsules of 420 mg capsules once a day, and in case of pills, 1 to 2 times a day and 15 to 20 pills once.
이하 본 발명의 실시예, 제제예, 처방예 및 실험예를 기재한다.Hereinafter, examples, formulation examples, prescription examples and experimental examples of the present invention will be described.
본 발명의 처방에서 "%"는 특별한 사정이 없는 한 중량%를 의미한다."%" In the prescription of the present invention means% by weight unless otherwise specified.
실시예 : 복합생약 추출물의 제조(파우더)Example: Preparation of Complex Herbal Extract (Powder)
제법 1 대량생산 - 복합생약 추출물의 제조(파우더) Preparation Method 1 Mass Production- Preparation of Complex Herbal Extract (Powder)
① 하기 표1에 기재된 처방생약 중, 누에는 1 차로 95 % 에탄올 8 배량으로 5 시간 추출하고, 2 차는 50 % 에탄올 5 배량으로 3 시간 추출하여 감압농축기에서 에탄올을 회수하여 누에엑스 40 ㎏을 얻는다. ① In the herbal medicines listed in Table 1 below, silkworms were first extracted with 8% of 95% ethanol for 5 hours, and secondary extracts were extracted with 5% of 50% ethanol for 3 hours to recover ethanol in a reduced pressure concentrator to obtain 40 kg of silkworm extract. .
② 하기처방의 기타(잔여 녹용, 천궁 등 9가지 생약)한약재는 추출기에 넣고 70 ℃의 정제수 8 배량을 넣어 6 시간 추출하여 여과한 다음, 여액을 감압농축기에 넣고 농축하여 468 ㎏을 얻는다.② Other herbal medicines (remaining antler, Cheongung, etc.) of the following prescription are put in an extractor, put 8 times the amount of purified water at 70 ℃ and extracted for 6 hours, filtered, and the filtrate is put in a vacuum condenser and concentrated to obtain 468 ㎏.
③ 누에엑스 40 ㎏과 농축액 468 ㎏을 합하여 진공건조시켜 분말(파우더) 108.35 ㎏을 얻었다(파우더 1 ㎏은 원생약 9.23 ㎏에 해당함).③ 40 kg of silkworm extract and 468 kg of the concentrated solution were dried in vacuo to obtain 108.35 kg of powder (powder) (1 kg of powder corresponds to 9.23 kg of crude medicine).
표 1 (처방) Table 1 (Prescription)
참고로, 표 1 처방에 따른 본 발명품(파우더)에 함유된 단백질과 아미노산함량을 성분분석하여 하기 표 2에 기재하였다. For reference, the protein and amino acid content contained in the present invention (powder) according to the Table 1 formulation is analyzed in Table 2 below.
표 2 파우더의 단백질과 아미노산 함량. Table 2 Protein and Amino Acid Content in Powders.
* : 필수아미노산을 가리킴*: Indicates essential amino acid
분석기기 : 가스클로마토그래피(Gas chromatograph)Analyzer: Gas Chromatograph
제법 2 : 파우더제제(복합생약의 추출물의 제조, 진공건조) Preparation method 2 : powder formulation (preparation of extract of complex herbal medicine, vacuum drying)
① 제법 1의 표 1 처방생약 및 량을 준수하되, 누에는 90 % 에탄올 8 배량으로 5시간 추출하고, 2차로 60 % 에탄올 5 배량으로 3시간 추출하여 여과하고 여액을 감압 농축기에 넣고 60 ℃이하에서 농축하여 누에 엑스 40 ㎏을 얻는다.① In accordance with the prescription 1 and the amount of prescription medicines in Table 1 of the formula 1, silkworms are extracted with 8% of 90% ethanol for 5 hours, secondly with 60% ethanol 5 times for 3 hours, filtered, and the filtrate is put in a vacuum concentrator under 60 ℃. Concentrate on to obtain silkworm x 40 kg.
② 녹용을 분쇄하여 가루로 하고, 얻어진 분말 25 ㎏을 80 메쉬체로 거른 후 멸균처리 하여 녹용분말을 얻는다.② Grind the antler to powder, filter 25 kg of the powder obtained by 80 mesh sieve and sterilize to obtain antler powder.
③ 정선된 기타 생약재(제법 1, 표 1 처방참조)를 차례대로 추출기에 넣고 정제수 8 배량으로 5시간 추출한 다음, 2차로 정제수 5 배량으로 3시간 추출하여, 합한 추출액을 60 ℃이하에서 감압농축하여 엑스 472.60 ㎏을 얻는다.③ Selected herbal medicines (see Formulation 1, Table 1) in turn into the extractor, extracted with 8 times purified water for 5 hours, and then extracted with 5 times purified water for 3 hours. The combined extracts are concentrated under reduced pressure below 60 ℃. Gain 472.60 kg.
④ 누에엑스(40 ㎏)와 기타 생약재엑스(472.60 ㎏)를 진공건조기에서 60 ℃이하로 건조시킨다.④ Dry silkworm extract (40 ㎏) and other herbal extracts (472.60 ㎏) below 60 ° C in a vacuum dryer.
⑤ ④에서 얻은 엑스건조 파우더 108.16 ㎏과 ②의 녹용분말 24.5 ㎏을 혼합하여 균질한 파우더 132.66 ㎏을 얻었다.(파우더 1 ㎏은 원생약 7.54 ㎏에 해당함)108.16 kg of the x-dried powder obtained in ④ and 24.5 kg of antler powder of ② were mixed to obtain 132.66 kg of homogeneous powder. (1 kg of powder corresponds to 7.54 kg of crude medicine)
참고적으로, 하기에 추가 처방예 1 내지 10을 기재한다.For reference, further Prescription Examples 1 to 10 are described below.
처방예 1Prescription Example 1
누 에 : Bombyx mori Linne 전충 60 %Silkworms: Bombyx mori Linne shock 60%
산수유 : Cornus officinalis Sied Et Zucc 열매 7 %Cornus: Cornus officinalis Sied Et Zucc Berries 7%
사상자 : Torilis japonica Decandolle 열매 5 %Casualty: Torilis japonica Decandolle Berries 5%
토사자 : Cuscuta chinensis Lamarck 종자 3 %Earthenware: Cuscuta chinensis Lamarck Seed 3%
천 궁 : Cnidium officinale Makino 뿌리 2 %Celestial Arch: Cnidium officinale Makino Root 2%
녹 용 : Cervus nippon Temminck 뿔 5 %Antler: Cervus nippon Temminck Horns 5%
원 지 : Polygala tenuifolia Willdenow 뿌리 5 %Origin: Polygala tenuifolia Willdenow Root 5%
오미자 : Schizandra chinensis Baillon 열매 3 %Schizandra chinensis Baillon berries 3%
계 피 : Cinnamomum zeylanicum Nees 수피 5 %Cinnamon: Cinnamomum zeylanicum Nees Bark 5%
우 슬 : Achyranthes japonica Nakai 뿌리 5 %Dew: Achyranthes japonica Nakai root 5%
처방예 2Prescription Example 2
누 에 : Bombyx mori Linne 전충 50 %Silkworm: Bombyx mori Linne 50%
산수유 : Cornus officinalis Sied Et Zucc 열매 11 %Cornus: Cornus officinalis Sied Et Zucc Fruit 11%
사상자 : Torilis japonica Decandolle 열매 2 %Casualty: Torilis japonica Decandolle Berries 2%
토사자 : Cuscuta chinensis Lamarck 종자 6 %Earthenware: Cuscuta chinensis Lamarck Seed 6%
천 궁 : Cnidium officinale Makino 뿌리 3 %Celestial: Cnidium officinale Makino root 3%
녹 용 : Cervus nippon Temminck 뿔 8 %Antler: Cervus nippon Temminck Horns 8%
원 지 : Polygala tenuifolia Willdenow 뿌리 2 %Origin: Polygala tenuifolia Willdenow Root 2%
오미자 : Schizandra chinensis Baillon 열매 4 %Schizandra chinensis Baillon berries 4%
계 피 : Cinnamomum zeylanicum Nees 수피 6 %Cinnamon: Cinnamomum zeylanicum Nees Bark 6%
우 슬 : Achyranthes japonica Nakai 뿌리 8 %Dew: Achyranthes japonica Nakai root 8%
처방예 3Prescription Example 3
누 에 : Bombyx mori Linne 전충 40 %Silkworm: Bombyx mori Linne worm 40%
산수유 : Cornus officinalis Sied Et Zucc 열매 20 %Cornus: Cornus officinalis Sied Et Zucc Fruit 20%
사상자 : Torilis japonica Decandolle 열매 3 %Casualty: Torilis japonica Decandolle Fruit 3%
토사자 : Cuscuta chinensis Lamarck 종자 5 %Earthenware: Cuscuta chinensis Lamarck Seed 5%
천 궁 : Cnidium officinale Makino 뿌리 4 %Celestial: Cnidium officinale Makino root 4%
녹 용 : Cervus nippon Temminck 뿔 10 %Antler: Cervus nippon Temminck Horns 10%
원 지 : Polygala tenuifolia Willdenow 뿌리 3 %Origin: Polygala tenuifolia Willdenow Root 3%
오미자 : Schizandra chinensis Baillon 열매 7 %Schizandra chinensis Baillon berries 7%
계 피 : Cinnamomum zeylanicum Nees 수피 2 %Cinnamon: Cinnamomum zeylanicum Nees Bark 2%
우 슬 : Achyranthes japonica Nakai 뿌리 6 %Dew: Achyranthes japonica Nakai root 6%
처방예 4Prescription Example 4
누 에 : Bombyx mori Linne 전충 15 %Silkworms: Bombyx mori Linne 15%
산수유 : Cornus officinalis Sied Et Zucc 열매 26 %Cornus: Cornus officinalis Sied Et Zucc Fruit 26%
사상자 : Torilis japonica Decandolle 열매 10 %Casualties: Torilis japonica Decandolle Berries 10%
토사자 : Cuscuta chinensis Lamarck 종자 4 %Earthenware: Cuscuta chinensis Lamarck Seed 4%
천 궁 : Cnidium officinale Makino 뿌리 10 %Celestial: Cnidium officinale Makino root 10%
녹 용 : Cervus nippon Temminck 뿔 15 %Antler: Cervus nippon Temminck Horns 15%
원 지 : Polygala tenuifolia Willdenow 뿌리 4 %Origin: Polygala tenuifolia Willdenow Root 4%
오미자 : Schizandra chinensis Baillon 열매 5 %Schizandra chinensis Baillon berries 5%
계 피 : Cinnamomum zeylanicum Nees 수피 4 %Cinnamon: Cinnamomum zeylanicum Nees Bark 4%
우 슬 : Achyranthes japonica Nakai 뿌리 7 %Dew: Achyranthes japonica Nakai root 7%
처방예 5Prescription Example 5
누 에 : Bombyx mori Linne 전충 10 %Silkworms: Bombyx mori Linne 10%
산수유 : Cornus officinalis Sied Et Zucc 열매 40 %Cornus: Cornus officinalis Sied Et Zucc Fruit 40%
사상자 : Torilis japonica Decandolle 열매 7 %Casualty: Torilis japonica Decandolle Fruit 7%
토사자 : Cuscuta chinensis Lamarck 종자 2 %Earthenware: Cuscuta chinensis Lamarck Seed 2%
천 궁 : Cnidium officinale Makino 뿌리 6 %Celestial: Cnidium officinale Makino root 6%
녹 용 : Cervus nippon Temminck 뿔 20 %Deer Antler: Cervus nippon Temminck Horn 20%
원 지 : Polygala tenuifolia Willdenow 뿌리 7 %Origin: Polygala tenuifolia Willdenow Root 7%
오미자 : Schizandra chinensis Baillon 열매 2 %Schizandra chinensis Baillon berries 2%
계 피 : Cinnamomum zeylanicum Nees 수피 3 %Cinnamon: Cinnamomum zeylanicum Nees Bark 3%
우 슬 : Achyranthes japonica Nakai 뿌리 3 %Dew: Achyranthes japonica Nakai root 3%
처방예 6Prescription Example 6
누 에 : Bombyx mori Linne 전충 28 %Silkworms: Bombyx mori Linne shock 28%
산수유 : Cornus officinalis Sied Et Zucc 열매 10 %Cornus: Cornus officinalis Sied Et Zucc Fruit 10%
사상자 : Torilis japonica Decandolle 열매 6 %Casualties: Torilis japonica Decandolle Berries 6%
토사자 : Cuscuta chinensis Lamarck 종자 9 %Earthenware: Cuscuta chinensis Lamarck Seed 9%
천 궁 : Cnidium officinale Makino 뿌리 7 %Celestial: Cnidium officinale Makino root 7%
녹 용 : Cervus nippon Temminck 뿔 2 %Antler: Cervus nippon Temminck Horns 2%
원 지 : Polygala tenuifolia Willdenow 뿌리 10 %Origin: Polygala tenuifolia Willdenow Root 10%
오미자 : Schizandra chinensis Baillon 열매 8 %Schizandra chinensis Baillon berries 8%
계 피 : Cinnamomum zeylanicum Nees 수피 10 %Cinnamon: Cinnamomum zeylanicum Nees Bark 10%
우 슬 : Achyranthes japonica Nakai 뿌리 10 %Dew: Achyranthes japonica Nakai root 10%
처방예 7Prescription Example 7
누 에 : Bombyx mori Linne 전충 5 %Silkworm: Bombyx mori Linne 5%
산수유 : Cornus officinalis Sied Et Zucc 열매 38 %Cornus: Cornus officinalis Sied Et Zucc Fruit 38%
사상자 : Torilis japonica Decandolle 열매 8 %Casualties: Torilis japonica Decandolle Berries 8%
토사자 : Cuscuta chinensis Lamarck 종자 10 %Earthenware: Cuscuta chinensis Lamarck seed 10%
천 궁 : Cnidium officinale Makino 뿌리 5 %Celestial: Cnidium officinale Makino root 5%
녹 용 : Cervus nippon Temminck 뿔 12 %Antler: Cervus nippon Temminck Horns 12%
원 지 : Polygala tenuifolia Willdenow 뿌리 8 %Origin: Polygala tenuifolia Willdenow Root 8%
오미자 : Schizandra chinensis Baillon 열매 10 %Schizandra chinensis Baillon berries 10%
계 피 : Cinnamomum zeylanicum Nees 수피 2 %Cinnamon: Cinnamomum zeylanicum Nees Bark 2%
우 슬 : Achyranthes japonica Nakai 뿌리 2 %Dew: Achyranthes japonica Nakai root 2%
처방예 8Prescription Example 8
누 에 : Bombyx mori Linne 전충 55 %Silkworms: Bombyx mori Linne shock 55%
산수유 : Cornus officinalis Sied Et Zucc 열매 1 %Cornus: Cornus officinalis Sied Et Zucc Fruit 1%
사상자 : Torilis japonica Decandolle 열매 4 %Casualty: Torilis japonica Decandolle Fruit 4%
토사자 : Cuscuta chinensis Lamarck 종자 10 %Earthenware: Cuscuta chinensis Lamarck seed 10%
천 궁 : Cnidium officinale Makino 뿌리 5 %Celestial: Cnidium officinale Makino root 5%
녹 용 : Cervus nippon Temminck 뿔 6 %Antler: Cervus nippon Temminck Horns 6%
원 지 : Polygala tenuifolia Willdenow 뿌리 8 %Origin: Polygala tenuifolia Willdenow Root 8%
오미자 : Schizandra chinensis Baillon 열매 6 %Schizandra chinensis Baillon berries 6%
계 피 : Cinnamomum zeylanicum Nees 수피 1 %Cinnamon: Cinnamomum zeylanicum Nees Bark 1%
우 슬 : Achyranthes japonica Nakai 뿌리 4 %Dew: Achyranthes japonica Nakai root 4%
처방예 9Prescription Example 9
누 에 : Bombyx mori Linne 전충 8 %Silkworms: Bombyx mori Linne worms 8%
산수유 : Cornus officinalis Sied Et Zucc 열매 30 %Cornus: Cornus officinalis Sied Et Zucc Fruit 30%
사상자 : Torilis japonica Decandolle 열매 9 %Casualty: Torilis japonica Decandolle Fruit 9%
토사자 : Cuscuta chinensis Lamarck 종자 5 %Earthenware: Cuscuta chinensis Lamarck Seed 5%
천 궁 : Cnidium officinale Makino 뿌리 8 %Celestial Arch: Cnidium officinale Makino Root 8%
녹 용 : Cervus nippon Temminck 뿔 13 %Antler: Cervus nippon Temminck Horns 13%
원 지 : Polygala tenuifolia Willdenow 뿌리 6 %Origin: Polygala tenuifolia Willdenow Root 6%
오미자 : Schizandra chinensis Baillon 열매 3 %Schizandra chinensis Baillon berries 3%
계 피 : Cinnamomum zeylanicum Nees 수피 9 %Cinnamon: Cinnamomum zeylanicum Nees Bark 9%
우 슬 : Achyranthes japonica Nakai 뿌리 9 %Dew: Achyranthes japonica Nakai root 9%
처방예 10Prescription Example 10
누 에 : Bombyx mori Linne 전충 28 %Silkworms: Bombyx mori Linne shock 28%
산수유 : Cornus officinalis Sied Et Zucc 열매 14 %Cornus: Cornus officinalis Sied Et Zucc Fruit 14%
사상자 : Torilis japonica Decandolle 열매 7 %Casualty: Torilis japonica Decandolle Fruit 7%
토사자 : Cuscuta chinensis Lamarck 종자 7 %Earthenware: Cuscuta chinensis Lamarck Seed 7%
천 궁 : Cnidium officinale Makino 뿌리 10 %Celestial: Cnidium officinale Makino root 10%
녹 용 : Cervus nippon Temminck 뿔 2.5 %Antler: Cervus nippon Temminck Horn 2.5%
원 지 : Polygala tenuifolia Willdenow 뿌리 7 %Origin: Polygala tenuifolia Willdenow Root 7%
오미자 : Schizandra chinensis Baillon 열매 7.5 %Schizandra chinensis Baillon berries 7.5%
계 피 : Cinnamomum zeylanicum Nees 수피 10 %Cinnamon: Cinnamomum zeylanicum Nees Bark 10%
우 슬 : Achyranthes japonica Nakai 뿌리 7 %Dew: Achyranthes japonica Nakai root 7%
(제조)상기 추가 처방예 1-10은 제법 1 또는 2에 따른다.(Manufacturing) The said additional prescription example 1-10 is based on the manufacturing method 1 or 2.
추가 제제예Additional formulation example
제제예 1 환제의 제조 Formulation Example 1 Preparation of Pills
제법 1의 추출물 - 120 ㎎Extract of Preparation 1-120 mg
옥수수전분 - 30 ㎎ Corn starch-30 mg
멸균증류수 - 적량 Sterile Distilled Water-Proper
상기의 성분을 혼합하고 통상의 환제 제조방법으로 0.35 ㎝ 지름으로 성형한다.The above components are mixed and molded into a 0.35 cm diameter by a conventional pill manufacturing method.
제제예 2 환제의 제조 Formulation Example 2 Preparation of Pills
제법 1의 추출물 - 120 ㎎Extract of Preparation 1-120 mg
옥수수전분 - 30 ㎎ Corn starch-30 mg
멸균증류수 - 적량 Sterile Distilled Water-Proper
장뇌삼 - 적량 Camphor-Good
산삼 배양근 - 적량 Wild Ginseng Culture Root-Appropriate
솔잎 - 적량 Pine Needle-Correct
제제 1과 동일한 방법으로 제조한다.Prepared in the same manner as in Formulation 1.
제제예 3 정제의 제조 Formulation Example 3 Preparation of Tablet
제법 2의 추출물 - 100 ㎎ Extract of Preparation 2-100 mg
유당 - 50 ㎎ Lactose-50 mg
전분 - 30 ㎎ Starch-30 mg
스테아린산마그네슘 - 적량Magnesium Stearate-Correct
상기의 성분을 혼합하고 통상의 정제 제조방법에 따라서 타정하여 정제로 제조한다.The above components are mixed and compressed into tablets according to a conventional tablet production method.
제제예 4 정제의 제조 Formulation Example 4 Preparation of Tablet
제법 2의 추출물 - 100 ㎎ Extract of Preparation 2-100 mg
유당 - 50 ㎎ Lactose-50 mg
전분 - 30 ㎎ Starch-30 mg
스테아린산마그네슘 - 적량Magnesium Stearate-Correct
아가리크스 버섯 - 적량 Agaricus Mushroom-Proper
상황버섯 - 적량 Situation Mushroom-Proper
인삼 - 적량 Ginseng-Appropriate
제제예 3과 동일한 방법으로 제조한다.It is prepared in the same manner as in Formulation Example 3.
제제예 5 캡슐의 제조 Formulation Example 5 Preparation of Capsule
제법 1의 추출물 - 100 ㎎ Extract of Preparation 1-100 mg
유당 - 40 ㎎ Lactose-40 mg
전분 - 40 ㎎ Starch-40 mg
스테아린산마그네슘 - 적량Magnesium Stearate-Correct
탈크 - 2 ㎎ Talc-2 mg
상기 성분을 혼합하고 통상의 캡슐 제조방법에 따라서 젤라틴캡슐에 충전하여 캡슐로 제조한다.The ingredients are mixed and filled into gelatin capsules according to a conventional capsule manufacturing method to prepare capsules.
제제예 6 캡슐의 제조 Formulation Example 6 Preparation of Capsules
제법 1의 추출물 - 100 ㎎ Extract of Preparation 1-100 mg
유당 - 40 ㎎ Lactose-40 mg
전분 - 40 ㎎ Starch-40 mg
스테아린산마그네슘 - 적량Magnesium Stearate-Correct
탈크 - 2 ㎎ Talc-2 mg
차가 버섯 - 적량 Chaga Mushroom-Proper
제제 5와 동일한 방법으로 제조한다.Prepared in the same manner as in Preparation 5.
제제예 7 액제의 제조 Formulation Example 7 Preparation of Liquid
제법 1의 추출물 - 1000 ㎎Extract of Preparation 1-1000 mg
설탕 - 40 g Sugar-40 g
이성화당 - 40 g Isomerized sugar-40 g
레몬향 - 적량 Lemon Scent-Correct
정제수를 가하여 120 ㎖로 맞추었다.Purified water was added to adjust the volume to 120 ml.
통상의 액제의 제조방법에 따라 상기의 성분을 혼합한 다음, 갈색병이나 파우치에 충전하고 멸균시켜 액제를 제조한다.The above components are mixed according to a conventional method for preparing a liquid, and then filled into a brown bottle or a pouch and sterilized to prepare a liquid.
제제예 8 액제의 제조 Formulation Example 8 Preparation of Liquid
제법 1의 추출물 - 1000 ㎎Extract of Preparation 1-1000 mg
설탕 - 40 g Sugar-40 g
이성화당 - 40 g Isomerized sugar-40 g
레몬향 - 적량 Lemon Scent-Correct
인삼파우더 - 적량 Ginseng Powder-Appropriate
솔잎 - 적량 Pine Needle-Correct
제제예 7과 동일한 방법으로 제조한다.It is prepared in the same manner as in Formulation Example 7.
제제예 9 건강식품의 제조 Formulation Example 9 Preparation of Health Food
제법 1의 추출물 - 1000 ㎎ Extract of Preparation 1-1000 mg
비타민A 아세테이트 - 60 ㎍Vitamin A Acetate-60 μg
비타민 E - 0.5 ㎎ Vitamin E-0.5 mg
비타민 B1 - 0.12 ㎎ Vitamin B1-0.12 mg
비타민 B2 - 0.10 ㎎ Vitamin B2-0.10 mg
비타민 B6 - 0.6 ㎎ Vitamin B6-0.6 mg
비타민 B12 - 0.3 ㎍ Vitamin B12-0.3 μg
비타민 C - 8 ㎎ Vitamin C-8 mg
비노틴 - 8 ㎎ Vinotin-8 mg
니코틴산아미드 - 1.4 ㎎ Nicotinamide-1.4 mg
엽산 - 30 ㎍ Folic acid-30 μg
황산제1철 - 1.60 ㎎ Ferrous Sulfate-1.60 mg
산화아연 - 0.72 ㎎ Zinc Oxide-0.72 mg
제1인산칼슘 - 10 ㎎ Calcium monophosphate-10 mg
제2인산칼슘 - 50 ㎎ Dicalcium Phosphate-50 mg
구연산칼슘 - 80 ㎎ Calcium Citrate-80 mg
탄산칼슘 - 50 ㎎ Calcium Carbonate-50 mg
염화마그네슘 - 20 ㎎ Magnesium chloride-20 mg
상황버섯 - 적량 Situation Mushroom-Proper
산삼배양근 - 적량 Wild Ginseng Root-Appropriate
홍삼 - 적량 Red Ginseng-Correct
아가리크스버섯 - 적량 Agaricus Mushroom-Proper
상기의 비타민 및 미네랄 혼합물의 조성비는 건강식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하다.Although the composition ratio of the said vitamin and mineral mixture was mixed and consisted with the component suitable for a health food in a preferable Example, you may change the compounding ratio arbitrarily.
통상의 건강식품 제조 방법에 따라 상기의 성분을 혼합한 다음 과립을 제조하고 통상의 방법에 따라 건강식품 조성물 제조에 사용한다.The above ingredients are mixed according to a conventional health food preparation method, and then granules are prepared and used for preparing a health food composition according to a conventional method.
제제예 10 과립제의 제조 Formulation Example 10 Preparation of Granules
제법 2의 추출물 - 100 ㎎ Extract of Preparation 2-100 mg
유당 - 40 ㎎ Lactose-40 mg
전분 - 40 ㎎ Starch-40 mg
스테아린산마그네슘 - 적량 Magnesium Stearate-Correct
탈크 - 2 ㎎ Talc-2 mg
관용의 방법으로 과립제를 제조한다.Granules are prepared by conventional methods.
제제예 11 과립제의 제조 Formulation Example 11 Preparation of Granules
제법 2의 추출물 - 100 ㎎ Extract of Preparation 2-100 mg
유당 - 40 ㎎ Lactose-40 mg
전분 - 40 ㎎ Starch-40 mg
상어연골 - 12 ㎎ Shark Cartilage-12 mg
스테아린산마그네슘 - 적량 Magnesium Stearate-Correct
탈크 - 2 ㎎ Talc-2 mg
관용의 방법으로 과립제를 제조한다.Granules are prepared by conventional methods.
실험예Experimental Example
실험예 1 (제제에 대한 안정성 실험) Experimental Example 1 (Stability Test for Preparation)
샘플 : 제법 2의 캅셀충진전 파우더Sample: Capsule filling powder of Preparation 2
실험기간 : 가속실험 2001. 03. 18 - 2001. 09. 17Experiment period: Acceleration experiment 2001. 03. 18-2001. 09. 17
실온실험 2001. 03. 18 - 2004. 03. 17 Room temperature experiment 2001. 03. 18-2004. 03. 17
실험기기 : HPLC, 항온항습기 등Experimental equipment: HPLC, constant temperature and humidity
실험자료 및 조건 : 제법 2의 캅셀충진전 파우더Test data and condition: Powder before capsule filling of Preparation 2
LOT NO : 000306, 000308, 000310 LOT NO: 000306, 000308, 000310
① 가속실험 : 37 ℃ ∼ 40 ℃, 75 %RH, 6 개월 ① Accelerated test: 37 ℃ ~ 40 ℃, 75% RH, 6 months
② 실온실험 : 36 개월 ② Room temperature experiment: 36 months
실험항목 및 표준 : Experiment Items and Standards:
성상 : 특수한 냄새와 맛이 있는 흑갈색의 파우더 Appearance: Dark brown powder with special smell and taste
확인 : 누에, 산수유, 사상자, 토사자, 천궁, 녹용, 원지, 오미자, 계피, 우슬 Check: silkworm, cornus, casualty, earth and sand, celestial, antler, grass, schizandra, cinnamon, dew
수분 : 10 %이하 Moisture: 10% or less
정량 : 계피산(cinnamic acid) 및 슈잔드린(schizandrin) 100 % 이상 함유. Quantification: Contains more than 100% of cinnamic acid and schizandrin.
실험결과 : 가속실험과 실온실험에 근거하여 본 제품을 밀봉상태에서 가속조건에서 6 개월, 실온에서 3 년동안 보존하여도 성상이나 품질면에서 영향과 변화가 없었다.(표 3, 표 4 참조)Experimental results: Based on the accelerated test and room temperature test, there was no effect or change in properties and quality even if the product was stored for 6 months under accelerated conditions and 3 years at room temperature under sealed conditions (see Table 3 and Table 4).
표 3 가속조건 실험표(진공건조) Table 3 Accelerated Condition Test Table (Vacuum Dry)
표 4 실온조건실험표(진공건조) Table 4 room temperature test table (vacuum dry)
실험예 2 (본 발명품 파우더의 온신정력작용에 대한 실험) Experimental Example 2 ( Experiment on the warm-up force action of the powder of the present invention)
1. 실험재료1. Experimental Materials
1.1 실험동물 : 비스타랫트(wistar rat), 건강한 숫놈 마우스를 사용하였으며, 모두 ○○대학의학원 실험 동물과에서 제공(실험동물 합격증 10-1022호) 받은 것이다. 1.1 Experimental Animals: Wistar rats and healthy male mice were used, and all were provided by the Department of Laboratory Animals, University of ○○ Medical School (Certificate of Experimental Animals 10-1022).
실험동물은 기능학실험중심의 동물사육실에서 사육과 실험을 진행하였다.The experimental animals were reared and experimented in the animal breeding room of the functional experimental center.
동물을 1 주일간 환경적응 시킨후 온도 22±3 ℃, 상대습도 50±10 %, 환기 10 회/일, 낮에는 자연 태양광, 밤에는 형광등하에서 사육하였다.Animals were allowed to acclimate for one week, and then reared under temperature 22 ± 3 ° C, relative humidity 50 ± 10%, ventilation 10 times / day, natural sunlight during the day and fluorescent lamp at night.
1.2 약품 : 본 발명품 파우더는 한국국일무약(주)에서 제공받았고(제법 2, 진공건조제법), 오자연종환(五子衍宗丸), 역시 국일무약(주)에서 제공받았으며, 하이드로코티손(hydrocortisone), 에스트라디올(estradiol)와 프로게스테론 및 알코올등은 모두 원료상에서 구입하였다. 본 발명품의 파우더는 건조파우더를 의미한다. 1.2 Medicine: The powder of the present invention was provided by Korea Kuk-il Pharmaceutical Co., Ltd. (Preparation 2, vacuum drying method), Oh Natural Jong-hwan (五 子 衍 宗 丸), also provided by Kukil Chemical Co., Ltd., hydrocortisone, Estradiol, progesterone and alcohol were all purchased from the raw materials. Powder of the present invention means a dry powder.
참고로, 오자연종환은 동의보감에 기재되어 그 처방이나 효능은 옛부터 알려져 왔으며, 중국에서는 발매중인 제품으로 구기자, 복분자, 차전자, 토사자, 오미자로 구성된 강정제이다.For reference, Oh Natural Jonghwan is described in Dongbobogam and its prescription and efficacy have been known since ancient times, and it is a product that is on sale in China. It is a gangjeongja composed of wolfberry, bokbunja, tea, earthenware, and schisandra.
1.3 기기 : GB-204 형 분석천평(스위스제조) 1.3 Instrument: GB-204 Type Analysis Cheonpyeong
1.4 통계분석 : SPSS10 소프트웨어를 사용하여 분석, 계량자료는 t-검사, 계수자 료는 X2-검사로 각군을 비교하였다. 1.4 Statistical Analysis: Each group was analyzed using SPSS10 software, t-test for quantitative data and X 2 -test for counting data.
2. 실험방법과 결과2. Experimental method and result
2.1 본발명품 파우더의 성년거세마우스 부성생식기관과 신장 무게에 대한 영향. 2.1 Effect of Invention Powder on Adult Germouse Paragonal Tract and Kidney Weight.
체중 25∼30 g 인 건강성년숫놈 마우스(mouse) 50 마리를 취하여 그중 10 마리는 정상대조군, 그외 40 마리는 에텔경도마취하 규칙적으로 소독하고 양측 고환을 적출하고 임의로 모형군, 본 발명품 파우더(제법 2, 이하 동일함) 2.30 g/kg 군, 본 발명품 파우더 1.15 g/kg 군과 오자연종환 3.9 g/kg의 양성약물군등 4개군으로 나누어 각군에 10 마리씩 분배하였다. Take 50 healthy male mice 25 to 30 g in weight, 10 of which are normal controls, 40 others are regularly sterilized under ether hardness anesthesia, and both testicles are removed. 2, the same as below) divided into four groups, 2.30 g / kg group, 1.15 g / kg group of the present invention powder and a positive drug group of 3.9 g / kg of Oh Natural Bell ring was divided into 10 groups to each group.
수술후 다음날부터 위내투약을 시작하여 매일 1 회씩 연속 15 일간 투약하였다. Intragastric administration was started from the next day after surgery and was administered once daily for 15 consecutive days.
최종 투약 한시간후 탈경추방법으로 치사하고 동물의 체중, 개복후 포피선, 전립선-정낭선, 항문거근(levator ani muscle)과 신장을 취하여 즉시 무게를 측정하였다. 그 결과 본 발명품 파우더 2.30 g/kg 군과 1.15 g/kg 군, 양성약물군은 모형군에 비교하여 모두 성년 거세마우스의 전립선-정낭선의 무게를 증가시켰고(각 P<0.05), 동시에 본 발명품 파우더 2.30 g/kg과 1.15 g/kg 군은 모두 양성약물군보다 증가폭이 컸다. 본 발명품 파우더 2.30 g/kg 군, 1.15 g/kg 군과 양성약물군은 모형군에 비교하여 모두 성년 거세마우스의 포피선의 무게를 증가시켰고(따로, P<0.001, P<0.01, P<0.05), 그중 본 발명품 파우더 2.30 g/kg 군과 1.15 g/kg 군이 더욱 뚜렷하였다. One hour after the final dose, the animals were lethal by the cervical spine method and weighed immediately by taking the animal's weight, the open foreskin, the prostate-spermatocardium, the levator ani muscle and the kidneys. As a result, the invention powder 2.30 g / kg group, 1.15 g / kg group, and the positive drug group all increased the weight of prostate-sperm gland of adult castration mice (P <0.05) and at the same time, the invention powder 2.30 Both g / kg and 1.15 g / kg groups showed a greater increase than the positive drug group. 2.30 g / kg group powder, 1.15 g / kg group and the positive drug group of the present invention increased the weight of the skin of adult castration mice in comparison with the model group (P <0.001, P <0.01, P <0.05), Among them, the 2.30 g / kg group and 1.15 g / kg group of the inventive powder were more distinct.
본 발명품 파우더 2.30 g/kg 군과 1.15 g/kg 군은 모형군에 비교하여 모두 성년 거세마우스의 항문거근과 신장의 무게를 뚜렷이 증가시켰으며(따로 P<0.05, P<0.001), 동시에 양성약물군보다 훨씬 컸다. 이 결과는 본 발명품 파우더는 성년 거세마우스의 부성생식기관 및 신장무게에 대한 작용이 양성약물군보다 강하다는 것을 제시한다.(표 5 참조)Powder 2.30 g / kg group and 1.15 g / kg group of the present invention significantly increased the weight of the anal muscles and kidneys of adult castration mice (P <0.05, P <0.001) compared to the model group. It was much bigger than. This result suggests that the powder of the present invention has a stronger action on paternal reproductive organs and kidney weight of adult castration mice than the positive drug group (see Table 5).
표 5 본 발명품 파우더(제법 2)의 성년 거세마우스 부성생식기관과 신장무게에 대한 영향.(±s) Table 5 Effects of the powder of the present invention (Preparation 2) on adult castration mouse paternal reproductive organs and kidney weight. ± s)
모형군과의 비교 *P<0.05, **P<0.01, ***P<0.001;Comparison with model group * P <0.05, ** P <0.01, *** P <0.001;
2.2 본 발명품 파우더의 어린 거세랫트(rat) 부성생식기관과 신장 무게에 대한 영향. 2.2 Effect of Invention Powders on Young Rat Rat Reproductive Tract and Kidney Weight.
체중 50∼80 g인 건강한 어린 숫놈랫트(rat) 50 마리를 취하여 그중 10 마리는 정상대조군, 그외 40 마리는 에텔경도마취하 규칙적으로 소독하고 양측 고환을 적출하였다. 거세랫트를 임의로 모형군, 본 발명품 파우더(제법 2, 이하 동일함) 1.8 g/kg 군, 본 발명품 파우더 0.9 g/kg 군과 오자연종환 2.7 g/kg의 양성약물군등 4개군으로 나누어 각군에 10 마리씩 분배하였다. 수술후 다음날부터 위내투약을 시작하여 매일 1 회씩 연속적으로 15 일간 투약하였다.Fifty healthy young male rats weighing 50-80 g were taken, ten of which were normal controls, and 40 others were regularly sterilized under Etel hardness anesthesia and bilateral testes were extracted. The gusset rats were randomly divided into four groups, such as model group, 1.8 g / kg group of the present invention powder (the same as the manufacturing method 2), 0.9 g / kg group of the present invention powder, and 2.7 g / kg of OTC species group. Ten animals were distributed. Intragastric administration was started from the next day after surgery and was administered once daily for 15 consecutive days.
최종투약 한시간후 탈경추방법으로 치사하고 동물의 체중을 측정하고, 개복후 포피선, 전립선-정낭선, 항문거근과 신장을 취하여 즉시 무게를 측정하였다. 그결과 본발명품 파우더 1.8 g/kg 군, 0.9 g/kg 군과 양성약물군은 모형군에 비교하여 모두 어린 거세랫트(rat)의 전립선-정낭선의 무게를 증가시켰으며, (각각 P<0.01, P<0.05, P<0.005), 동시에 본 발명품 1.8g/kg 군과 0.9 g/kg 군은 양성약물군보다 증가폭이 컷다. 본 발명품 1.8 g/kg 군과 0.9 g/kg 군은 모형군과 양성 약물군에 비교하여 모두 어린 거세랫트의 포피선의 무게를 증가시켰고(각각 P<0.01, P<0.05), 동시에 양성약물군보다 증가폭이 컷다.One hour after the final dose, the animals were lethal and weighed. The weight of the animals was measured immediately after taking the foreskin, prostate-spermatozoa, anal root and kidney. As a result, the present invention powder 1.8 g / kg group, 0.9 g / kg group and positive drug group increased the weight of the prostate-sperm gland of the young rats (P <0.01, P respectively) <0.05, P <0.005), at the same time the 1.8g / kg group and 0.9 g / kg group of the present invention is less incremental than the positive drug group. The 1.8 g / kg group and the 0.9 g / kg group of the present invention increased the weight of the foreskin of the young gusset rats (P <0.01, P <0.05, respectively) compared to the model group and the positive drug group, and at the same time, the increase was greater than the positive drug group. Cut.
본 발명품 파우더 1.8 g/kg 군과 0.9 g/kg 군은 모형군과 양성약물군에 비교하여 모두 어린 거세랫트의 신장의 무게를 증가시켰는데, 그중 본 발명품 1.8 g/kg 군이 모형군에 비하여 뚜렷하였다(P<0.05). 이상의 경과는 본 발명품의 어린 거세랫트의 부성생식기관 및 신장무게에 대한 작용이 양성약물군보다 우월하다는 것을 보여주는 것이다. (표 6참조)In the present invention powder 1.8 g / kg group and 0.9 g / kg group increased the weight of the kidneys of young geese rats compared to the model group and the positive drug group, of which the 1.8 g / kg group of the present invention is clearer than the model group (P <0.05). The above process shows that the young germination rats of the present invention have a superior effect on the reproductive organs and kidney weight than the positive drug group. (See Table 6)
표 6 본 발명품 파우더(제법 2)의 미성년 거세랫트(rat)부성생식기관과 신장 무게에 대한 영향.(±s) Table 6 Effects of powder of the present invention (Preparation 2) on the reproductive organs and renal weight of the young rats. ± s)
모형군과의 비교 *P<0.05, **P<0.01Comparison with model group * P <0.05, ** P <0.01
2.3 본 발명품 파우더의 하이드로코티손(hydrocortisone)으로 조성한 양허(陽虛, lack of vital energy)모델마우스 면역기관, 신장과 고환무게에 대한 영향. 2.3 Insufficient lack of vital energy model mice made from hydrocortisone powder of the present invention Mouse immune organs, effects on kidney and testicle weight.
건강한 숫놈마우스 50 마리를 취하여 그중 10 마리는 정상대조군, 그외 40 마리는 각군 10마리씩 임의로 4 개군으로 나누었다. 모형군과 투약군 마우스는 모두 하이드로코티손(hydrocortisone) 25 mg/kg량으로 하루 1 회씩 10 일간 연속 주사하였다. 정상대조군과 모형군은 같은량의 음료수 급여를 투입하고, 약물군은 본 발명품파우더(제법 2, 이하 동일함) 2.30 g/kg, 1.15 g/kg, 양성약물군인 오자연종환 3.9 g/kg을 하루 1 회씩 15 일간 연속적으로 경구 투약하였다. 최종투약 한시간후 탈경추방법으로 치사하고 동물의 체중을 측정하고, 개복후, 흉선, 부신, 신장과 고환을 취하여 즉시 무게를 측정하였다. 그결과 본 발명품 파우더 2.30 g/kg 군과 1.15 g/kg 군은 모형군과 양성약물군에 비교하여 모두 양허모델마우스의 흉선무게가 증가되고, 그중 본 발명품 2.3 g/kg 투여군이 더 뚜렷하였으며(P<0.05), 본 발명품 파우더 2.3 g/kg 군, 1.15 g/kg 군과 양성약물군은 모형군에 비하여 모두 양허모델마우스의 신장무게를 중가시켰는데 그중 본 발명품 2.3 g/kg 군과 양성약물군의 증가가 뚜렷하였다. (각 P<0.05)Fifty healthy male mice were taken, 10 of which were divided into four groups, 10 of which were normal controls and 10 of each group. Both the model and dosing mice received a continuous injection of 25 mg / kg of hydrocortisone once daily for 10 days. The normal control group and the model group are fed the same amount of drink, the drug group is 2.30 g / kg, 1.15 g / kg of the powder of the invention (Method 2, hereinafter), 3.9 g / kg of O natural species, a positive drug group per day Oral dosing was performed once daily for 15 days. One hour after the last dose, the animals were lethal by the cervical spine method, and the animals were weighed. As a result, the weight of the thymus of the concealed model mice was increased in the 2.30 g / kg group and the 1.15 g / kg group of the inventive group, and the 2.3 g / kg administration group of the present invention was more prominent (P). <0.05), the present invention powder 2.3 g / kg group, 1.15 g / kg group and the positive drug group all increased the weight of the derailed model mouse compared to the model group, among which the increase of the 2.3 g / kg group and the positive drug group of the present invention Was clear. (Each P <0.05)
이 결과는, 본 발명품의 양허모델마우스 흉선에 대한 작용이 양성약물군 보다 우월하다는 것을 보여준다.(표 7참조)This result shows that the action of the inventive model on the thymus thymus is superior to the positive drug group (see Table 7).
표 7 본 발명품 파우더(제법 2)의 하이드로코티손(hydrocortisone)으로 조성한 양허(陽虛)모델마우스 면역기관, 신장과 고환무게에 대한 영향.(±s) Table 7 Effects of Yang model mouse immune organs, kidneys and testicle weight, prepared with hydrocortisone of powder (Invention 2) of the present invention. ± s)
모형군과의 비교 *P<0.05Comparison with model group * P <0.05
2.4 본 발명품 파우더의 정상숫놈랫트(rat)의 부성생식기관과 고환과 신장무게에 대한 영향. 2.4 Effect of Powder of the Invention on the Normal Reproductive Tract and Testicles and Kidney Weight of Rats.
건강한 숫놈랫트(rat) 40 마리(180∼200 g)를 취하여 임의로 대조군, 본 발명품 파우더(제법 2, 이하 동일함) 1.8 g/kg 군, 본 발명품 파우더 0.9 g/kg 군과 오자연종환 2.7 g/kg의 양성약물군등 각군에 10 마리씩 4 개군으로 나누었다. 매일 1 회 15 일간 연속투약 하였다. 최종 투약 1 시간후 체중을 측정하고, 개복후 포피선, 전립선-정낭선, 항문거근, 고환과 신장을 취하여 무게를 측정하였다.Take 40 healthy rats (180-200 g) and randomly control, 1.8 g / kg group of the present invention powder (the same as Preparation 2, below), 0.9 g / kg group of the present invention powder and 2.7 g of Oh-Nang Jong-hwan. Each group was divided into 4 groups, 10 animals per kg / kg positive drug group. The dose was administered once daily for 15 days. One hour after the final dose, the body weight was measured, and the weight was measured after taking the foreskin, prostate-sperm gland, anus muscles, testicles and kidneys.
실험결과, 본 발명품 파우더 1.8 g/kg 군과 0.9 g/kg 군은 대조군과 양성약물군에 비교하여 모두 정상숫놈랫트의 전립선-정낭선, 포피선과 고환의 무게를 증가시켰는데, 그중 본 발명품 파우더 1.8 g/kg 군이 모두 뚜렷하였다.(각 P<0.05)As a result, the present invention powder 1.8 g / kg group and 0.9 g / kg group increased the weight of prostate-sperm gland, foreskin and testes of normal male rats compared to the control group and the positive drug group, among which the invention powder 1.8 All g / kg groups were clear (each P <0.05).
이 결과는 본 발명품의 정상숫놈랫트의 부성생식기관 및 고환무게에 대한 작용이 양성 약물군에 비하여 우월함을 보여 주었다.(표 8참조)The results showed that the normal male rats of the present invention had a superior effect on the female reproductive organs and testicular weight compared to the positive drug group (see Table 8).
표 8 본 발명품 파우더(제법 2)의 정상숫놈 랫트(rat)의 부성생식기관, 고환과 신장 무게에 대한 영향.(±s) Table 8 Influence on the paternal reproductive organs, testis and kidney weight of normal male rats of the inventive powder (Preparation 2). ± s)
대조군과의 비교 *P<0.05Comparison with Control * P <0.05
2.5 본 발명품 파우더의 숫놈랫트(rat)의 포착 및 교배능력에 대한 영향. 2.5 Influence on the Capturing and Crossing Capability of Male Rats of the Invention Powder.
성년 숫놈랫트(rat) 40 마리를 취하여 임의로 정상대조군, 본 발명품 파우더(제법 2, 이하 동일함) 1.8 g/kg 군, 본 발명품 파우더 0.9 g/kg 군과 오자연종환 2.7 g/kg의 양성약물군등 각군에 10 마리씩 4 개군으로 나누었다. 이상의 각군 랫트(rat)에 매일 1 회 연속 15 일간 위내투약을 진행하였다. 따로 체중이 250∼300 g 되는 성년 암컷랫트(rat) 40 마리를 취하여 먼저 소디움 펜토바비탈(Sodium Pentobarbital ; 0.6 %, 9 ㎖/kg)로 복강주사마취후 요배부 양쪽 1.5 cm 부위를 절개하고 양쪽 난소를 적출한후 페니실린 2 만단위/kg 량으로 매일 1 회씩 연속 5 일간 수술후 근육주사하였다. 수술 2 주일후 암놈과 숫놈 랫트(rat)의 교배실험을 진행하였다. 실험 48 시간전에 암놈랫트(rat)에 에스트라디올(estradiol)(20 ㎍/마리) 근육주사하고, 교배 4 시간전에 또 프로게스테론(progesterone, 500 ㎍/마리) 근육주사하였다. 숫놈랫트(rat) 최종약물투입일 저녁 매 숫놈랫트(rat)를 단독으로 50×35×25 cm 크기의 비닐통에 넣고 5 분간 환경 적용시킨 후 암놈랫트(rat)한마리씩을 넣고 20 분간 숫놈랫트(rat)가 암놈랫트(rat)에 포착회수 및 포착잠복기(암놈랫트(rat)를 넣어서부터 숫놈랫트(rat)가 제1차 암놈랫트(rat)를 포착할때까지의 시간), 사정회수와 사정잠복기(암놈랫트(rat)를 넣어서부터 숫놈랫트(rat)가 제1차 사정할때까지의 시간)등을 관찰기록하였다. 그런후에 각군, 각항의 지표 및 포착률(%)과 사정률(%)을 계산 하였다. 실험결과는 본 발명품 파우더 1.8 g/kg 군, 본 발명품 파우더 0.9 g/kg 군은 대조군과 양성약물군에 비교하여 모두 포착잠복기가 현저히 단축되고, 포착률(%)과 사정회수가 증가 되었는데 그중 본 발명품 파우더 1.8 g/kg 군이, 대조군에 비하여 현저히 증가되었다.(각각 P<0.05, P,<0.05, P<0.01)40 male male rats were randomly taken and treated as the normal control group, 1.8 g / kg group of the present invention powder (the same method 2, hereinafter), 0.9 g / kg group of the present invention powder, and 2.7 g / kg of OJH 2.7 g / kg group. Each group was divided into four groups of 10 horses. In each group of rats, gastric administration was performed once daily for 15 consecutive days. Separately, 40 adult female rats weighing 250-300 g were taken first, followed by intraperitoneal anesthesia with sodium pentobarbital (0.6%, 9 ml / kg). After ovarian extraction, penicillin 20,000 units / kg was administered once daily for 5 consecutive days after intramuscular injection. Two weeks after the operation, the female and male rats were mated. Female rats were injected with estradiol (20 μg / mol) 48 hours before the experiment, and progesterone (500 μg / mol) was injected intramuscularly 4 hours before mating. In the evening of the last rat injection, each male rat is placed in a 50 × 35 × 25 cm plastic container alone for 5 minutes, and then one female rat is added and the male rat is placed for 20 minutes. The number of times the rat catches and catches the latencies of the female rats (the time from when the female rats catch the first rat to the rats), the number of times and the ejaculation. The incubation period (the time from the insertion of a female rat to the first ejaculation of a male rat) was observed and recorded. Then, each group, the index of each term, and the capture rate (%) and ejaculation rate (%) were calculated. Experimental results show that the present invention powder 1.8 g / kg group, the invention powder 0.9 g / kg group significantly reduced the capture latency, and increased the capture rate (%) and the number of assessments compared to the control group and the positive drug group, among which the invention powder The 1.8 g / kg group was significantly increased compared to the control group (P <0.05, P, <0.05, P <0.01, respectively).
또한, 본 발명품 파우더 1.8 g/kg 군, 0.9 g/kg 군과 양성약물군은 대조군에 비교하여 모두 사정율이 증가되었는데(각각 P<0.01, P<0.05, P<0.05), 본 발명품 1.8 g/kg 군의 사정율은 양성약물군을 훨씬 초과하였다.In addition, the present invention powder 1.8 g / kg group, 0.9 g / kg group and the positive drug group all increased the ejaculation rate compared to the control group (P <0.01, P <0.05, P <0.05 respectively), the present invention 1.8 g / The ejaculation rate of the kg group far exceeded the positive drug group.
이 결과는, 본 발명품의 랫트의 교배능력에 대한 작용이 양성약물군보다 강하다는 것을 제시하는 것이다.(표 9참조)This result suggests that the action of the present invention on the mating ability of rats is stronger than that of the positive drug group (see Table 9).
표 9 본 발명품 파우더(제법 2)의 랫트(rat)의 포착 및 교배능력에 대한 영향.(±s) Table 9 Influence on the capturing and mating ability of the rat of the inventive powder (Preparation 2). ± s)
대조군과의 비교 *P<0.05, **P<0.01Comparison with Control * P <0.05, ** P <0.01
3. 결론 3. Conclusion
이상의 실험결과로부터 볼 때, 1) 본 발명품 파우더(제법 2, 이하 동일함)는 모형군과 양성약물군에 비교하여 모두 거세마우스의 전립선-정낭선, 포피선, 항문거근과 신장의 무게를 뚜렷이 증가시켰고, 2) 또한 본 발명품 파우더는 모형군과 양성약물군에 비교하여 모두 어린 거세랫트(rat)의 전립선-정낭선, 포피선과 신장의 무게를 증가시켰다. 3) 하이드로코티손(hydrocortisone)으로 조성한 양허(陽虛, lack of vital energy)모델마우스에서 모형군과 양성약물군에 비교하여 모두 흉선의 무게를 증가시켰고, 4) 본 발명품 파우더는 대조군과 양성약물군에 비교하여 모두 정산 숫놈 랫트의 전립선-정낭선, 포피선과 고환의 무게를 증가시켰는데, 그중에서는 1.8 g/kg을 투여군이 더욱 뚜렷하였으며, 5)랫트(rat)의 교배실험에서는 본 발명품 파우더는 대조군과 양성약물군에 비교하여 모두 숫놈랫트의 포착잠복기가 현저히 단축되고, 포착률과 사정회수가 증가되었고, 본 발명품의 사정율은 양성약물군을 훨씬 초과하였다.From the above experimental results, 1) the powder of the present invention (the same as Preparation 2, below) significantly increased the weight of the prostate-sperm gland, the foreskin, the anus muscles and the kidneys of castration mice compared to the model group and the benign drug group. 2) In addition, the powder of the present invention increased the weight of the prostate-sperm gland, foreskin, kidney and kidney of both young rats compared to the model group and the positive drug group. 3) The weight of the thymus was increased in both the lack of vital energy model mice prepared with hydrocortisone compared to the model group and the positive drug group, and 4) the powder of the present invention was compared with the control group and the positive drug group. In all male rats, the weight of the prostate-sperm gland, foreskin and testicle was increased, among which the group administered 1.8 g / kg was more pronounced. 5) In the rat mating experiment, the powder of the invention was compared with the control group. Compared with the positive drug group, all male rats had significantly shortened the latencies of trapping, increased the capture rate and the number of times of ejaculation, and the ejaculation rate of the present invention far exceeded the positive drug group.
이상의 실험결과로부터 본 발명품 파우더는 거세한 동물의 부성생식기관과 신장의 무게를 증가시켰고, 하이드로코티손으로 조성한 양허모델마우스의 면역 기관의 무게를 증가시켰으며, 숫놈랫트의 교배능력을 증강시킬 수 있음을 보여주었으며, 이들 작용은 모두 양성약물군인 오자연종환의 작용을 초과하였다.From the above test results, the powder of the present invention increased the weight of the parental reproductive organs and kidneys of castrated animals, increased the weight of the immune organs of the model mice with hydrocortisone, and could increase the mating capacity of male rats. All of these actions exceeded the action of Oh Natural Bell, a positive drug group.
따라서, 본 발명품은 남성호르몬양 작용이 있고, 신장작용의 강화는 물론, 항피로, 강장 및 강장작용을 갖는 건강기능식품으로 손색이 없는 제품임이 입증되었다.Therefore, the present invention has a male hormone-like action, as well as strengthening the kidney action, as well as anti-fatigue, tonic and tonic has been proved to be a good product as a health functional food.
그러나 이들의 작용기전은 앞으로 더욱 진일보적인 연구를 계속해야할 것이다.However, their mechanism of action will continue to be further researched.
실험예 3 (본 발명품의 항피로작용에 대한 실험) Experimental Example 3 ( Experiment on Anti-Fatigue Action of the Invention)
1. 실험재료1. Experimental Materials
1.1 실험동물 : 건강한 숫놈 마우스를 ○○ 대학의학원 실험동물과에서 제공(실험동물 합격증 10-1022호)받았다. 실험동물은 기능학실험중심의 동물 사육실에서 사육과 실험을 진행하였다. 동물을 1주일간 환경적응 시킨후 온도 22±3 ℃ 상대습도 50±10 %, 환기 10 회/일, 낮에는 자연태양광, 밤에는 형광등하에서 사육하였고 고체사료와 음료수 급여를 충분히 공급하였다. 1.1 Experimental Animals: A healthy male mouse was provided by the Laboratory Animals Department of the University Medical Center (No. 10-1022). The experimental animals were reared and experimented in the animal breeding room of the functional experimental center. After the animals were acclimated for one week, the animals were kept at a temperature of 22 ± 3 ℃, relative humidity of 50 ± 10%, ventilation 10 times / day, daylight during daylight, and fluorescent lamps at night.
1.2 약품 : 본 발명품 파우더(제법 2)는 한국국일무약에서 제공받았다. 1.2 Medicine: The powder of the present invention (Preparation 2) was provided by KKD.
1.3 기기 : GB-24 형 분석천평(스위스제조); 722형 스펙트로포토미터(spectrophotometer) 1.3 instrument: GB-24 type analytical balance (manufactured in Switzerland); 722 type spectrophotometer
1.4 통계분석 : SPSS10 소프트웨어를 사용하여 분석, 계량자료는 t-검사, 계수자료는 X2 -검사로 각군지간을 비교하였다. 1.4 Statistical Analysis: SPSS10 software was used to analyze the t-tests for quantitative data and X 2 -test for counting data.
2. 실험방법과 결과2. Experimental method and result
2.1 본 발명품의 마우스 상압에서 산소결핍인내능력에 대한 영향. 2.1 Influence on Oxygen Deficiency Endurance Ability in Mouse Atmospheric Pressure of the Invention.
체중 20±2 g 인 건강한 숫놈마우스를 임의로 각군 15 마리씩 총 45마리를 본 발명품 파우더(제법 2, 이하 동일함) 2.30 g/Kg, 1.15 g/kg 용량군과 대조군(음료수 급여)등 3개 군으로 설정하였다. 약물을 하루 1회씩 경구 투여하여 30 일간 계속하였다. 최종투여 1 시간 후 한 마리씩 먼저 20 g의 생석회를 넣은 (CO2 를 흡수) 125 ㎖ 용 입구 큰 유리병에 넣고 병마개를 닫고 와세린으로 밀봉한후 동물을 넣어서부터 사망 하기 전까지의 시간 즉, 생존시간을 측정하였다. 약물군과 대조군을 비교하여본 결과, 본 발명의 파우더 2.30 g/kg 군과 1.15 g/kg군의 마우스 산소결핍인내성 생존시간을 모두 연장시켰는바 그중 2.30 g/kg 용량군이 더욱 뚜렷하였다.(표 10 참조)A total of 45 healthy male mice weighing 20 ± 2 g (15 mice each) were randomly selected from three groups: 2.30 g / Kg, 1.15 g / kg dose group and control group (drinking water). Set to. The drug was administered orally once a day for 30 days. One hour after the last dose, each animal was first placed in a 125 ml inlet vial with 20 g of quicklime (absorbed CO 2 ), closed with a cap, sealed with wasserine, and survived from death to the animal. The time was measured. As a result of comparing the drug group and the control group, the mice's oxygen deficiency endurance survival time of the 2.30 g / kg group and the 1.15 g / kg group of the present invention were extended, and the 2.30 g / kg dose group was more distinct. 10)
표 10 본 발명품 파우더(제법 2) 마우스 상압에서 산소결핍인내성에 대한 영향.(±s) Table 10 Effect of Inventive Powder (Preparation 2) on Oxygen Deprivation Tolerability at Normal Pressure of Mice. ± s)
대조군과 비교, *P<0.05Compared to control, * P <0.05
2.2 본 발명품의 마우스 하중유영(負重遊泳)능력에 대한 영향. 2.2 Influence on the Mouse Load Sliding Capacity of the Invention.
체중 20±2 g인 건강한 숫놈마우스를 임의로 각군 15마리씩 총 45마리를 본 발명품 파우더(제법 2, 이하 동일함) 2.30 g/kg, 1.15 g/kg 의 2 개용량군과 대조군(음료수 급여)등 3 개 군으로 설정하였다. 약물을 하루 1 회씩 경구 투여하여 30 일간 계속하였다. 최종 투여 1 시간 후 매 마우스 꼬리근부에 체중 10 %의 부하를 달고 수온이 26±1 ℃, 물의 깊이 22 cm인 물탱크(유영조 : 50 cm×40 cm×35 cm)안에 넣고 마우스의 유영지속시간 즉, 마우스를 물에 넣어서부터 물밑에 가라앉아 6 초내에 다시 수면에 솟구치지 못할 때까지의 시간을 기록한다. 그 결과 약물군을 대조군에 비교하여 보면 2.30 g/kg, 1.15 g/kg 용량군의 하중 유영지속시간이 모두 연장되었는데, 그중 2.30 g/kg군 용량군이 더 뚜렷하였다. (P<0.05)(표 11를 참조)A total of 45 healthy male mice with a body weight of 20 ± 2 g are selected from 15 groups in each group. 2.30 g / kg of the present invention powder (the same as in Preparation Process 2), 2.30 g / kg, 1.15 g / kg of two dose groups and the control group (drinks) Three groups were set. The drug was administered orally once a day for 30 days. One hour after the last dose, each mouse's tail muscle is loaded with a 10% weight and placed in a water tank with a water temperature of 26 ± 1 ° C and a depth of 22 cm (swimming tank: 50 cm × 40 cm × 35 cm). That is, the time from when the mouse is submerged in water to sink to the bottom and cannot rise again in 6 seconds is recorded. As a result, when comparing the drug group with the control group, the load swimming durations of the 2.30 g / kg and 1.15 g / kg dose groups were all extended, and the 2.30 g / kg group was more distinct. (P <0.05) (See Table 11)
표 11 본 발명품 파우더(제법 2)의 마우스 하중유영(負重遊泳)능력에 대한 영향. (±s) Table 11 Influence on the mouse load swimming ability of the powder of the present invention (Manufacturing Method 2). ( ± s)
대조군과 비교, *P<0.05Compared to control, * P <0.05
2.3 본 발명품의 마우스 저온에서의 인내능력에 대한 영향. 2.3 Effect of the Invention on Endurance at Mouse Low Temperature.
체중 20±2 g 인 건강한 숫놈마우스를 임의로 매군 15 마리씩 총 45마리를 본 발명품(제법 2, 이하 동일함) 2.30 g/㎏, 1.15 g/㎏ 2 개 용량군과 대조군(음료수 급여)등 3 개 군으로 설정하였다. 약물을 하루 1 회씩 경구 투여하여 30 일간 계속하였다. 최종투여 1 시간 후 각기 -6±1 ℃인 냉장고에 80 분간 방치하고 각군 생존율을 기록하였다. 그 결과 약물투여군과 대조군사이에 현저한 차이가 없었다.(표 12 참조)A total of 45 healthy male mice each weighing 20 ± 2 g were randomly selected, and a total of 45 mice were collected. Three dogs of the present invention (Formula 2 and below) 2.30 g / kg, 1.15 g / kg, 2 dose groups and a control group (drinking water) It was set as a group. The drug was administered orally once a day for 30 days. After 1 hour of final administration, each group was left in a refrigerator at -6 ± 1 ° C. for 80 minutes and the survival rate of each group was recorded. As a result, there was no significant difference between the drug group and the control group (see Table 12).
표 12 본 발명품 파우더(제법 2)의 마우스 저온에서의 인내성에 대한 영향. TABLE 12 Effect of Inventive Powder (Manufacturing 2) on Endurance at Mouse Low Temperature.
2.4 본 발명품의 마우스 유영 45분후 혈청젖산함량에 대한 영향. 2.4 Effect on Serum Lactic Acid Content After 45 Minutes of Mouse Streaming of the Invention.
체중 20±2 g 인 건강한 숫놈마우스를 임의로 매군 15 마리씩 총 45마리를 발명품 파우더(제법 2, 이하 동일함) 2.30 g/kg, 1.15 g/kg 의 2개 용량군과 대조군(음료수 급여)등 3개 군으로 설정하였다. 약물을 하루 1회씩 경구 투여하여 30일간 계속하였다. 최종 투여 1 시간 후 매 마우스를 수온이 30±1 ℃, 물의 깊이 22 cm인 물탱크(유영조 ; 50 cm×40 cm×35 cm)안에 넣고 45 분간 유영시킨 후 꺼내어 즉시 눈가에서 채혈하여 원심분리기(2000 회전/min)로 혈청을 분리한 후 722형 스펙트로포토미터(spectrophotometer)로 혈청젖산(lactic acid) 함량을 측정하였다. 그 결과 본 발명품 파우더 2.30 g/kg과 1.15 g/kg 군의 혈청젖산함량이 대조군보다 훨씬 적으며, 그중 2.30 g/kg 용량군이 훨씬 뚜렷하였다.(표 13 참조)A total of 45 healthy male mice, each weighing 20 ± 2 g, were randomly selected for a total of 45 dogs.Inventive powder (Form 2, the same) 2.30 g / kg, 1.15 g / kg 2 dose groups and control group (drinking water) 3 The dogs were set up. The drug was administered orally once a day for 30 days. One hour after the final administration, each mouse was placed in a water tank (water tank; swimming pool; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C. and a depth of 22 cm for 45 minutes. The serum was separated at 2000 revolutions per minute and the serum lactic acid content was measured with a 722 spectrophotometer. As a result, the serum lactate content of the 2.30 g / kg and 1.15 g / kg group of the powder of the present invention was much lower than that of the control group, and the 2.30 g / kg dose group was much more prominent (see Table 13).
표 13 본 발명품 파우더(제법 2) 마우스 유영 45분후 혈청젖산함량에 대한 영향.(±s) Table 13 Effect of the invention powder (Preparation 2) on serum lactate content after 45 minutes of mouse swimming. ± s)
대조군과 비교, **P<0.05Compared to control, ** P <0.05
2.5 본 발명품의 마우스 유영 45분후 혈청요소질소함량에 대한 영향. 2.5 Effect on Serum Urea Nitrogen Content After 45 Minutes of Mouse Streaming of the Invention.
체중 20±2 g 인 건강한 숫놈마우스를 임의로 매군 15 마리씩 총 45마리를 본 발명품 파우더(제법 2, 이하 동일함) 2.30 g/kg, 1.15 g/kg 의 2 개 용량군과 대조군(음료수 급여)등 3 개군으로 설정하였다. 약물을 하루 1 회씩 경구 투여하여 30일간 계속하였다. 최종투여 1 시간 후 매 마우스를 수온이 30±1 ℃, 물의 깊이 22 cm 인 물탱크(유영조 ; 50 cm×40 cm×35 cm)안에 넣고 45분간 유영시킨 후 꺼내어 즉시로 눈가에서 채혈하여 원심분리기(2000 회전/min)로 혈청을 분리한 후 722 형 스펙트로포토미터(spectrophotometer)로 혈청요소질소함량을 측정하였다. 그 결과 약물투여군과 대조군과는 현저한 차이는 없었다.(표 14 참조)A total of 45 healthy male mice with a body weight of 20 ± 2 g are selected for each group of 15 dogs. Two dose groups of 2.30 g / kg and 1.15 g / kg of the present invention powder (the same as in Formula 2) and the control group (drinks) Three groups were set. The drug was administered orally once a day for 30 days. One hour after the final administration, each mouse was placed in a water tank (water tank; swimming pool; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C and a depth of water of 22 cm for 45 minutes. Serum was isolated at (2000 rpm) and the serum urea nitrogen content was measured with a 722 spectrophotometer. As a result, there was no significant difference between the drug administration group and the control group (see Table 14).
표 14 본 발명품 파우더(제법 2) 마우스 유영후 혈청요소질소함량에 대한 영향.(±s) Table 14 Influence on serum urea nitrogen content after swimming the invention powder (Preparation 2). ± s)
2.6 본 발명품의 마우스 유영 45분후 간장과 근육의 글리코겐(glycogen)함량에 대한 영향. 2.6 Effect on Glycogen Content of Soy and Muscle after 45 Minutes of Mouse Streaming of the Invention.
체중 20±2 g 인 건강한 숫놈마우스를 임의로 매군 15마리씩 총 45마리를 본 발명품 파우더(제법 2, 이하 동일함) 2.30 g/kg, 1.15 g/kg 의 2 개용량군과 대조군(음료수 급여)등 3개 군으로 설정하였다. 약물을 하루 1 회씩 경구 투여하여 30일간 계속하였다. 최종 투여 1 시간 후 각 마우스를 수온이 30±1 ℃, 물의 깊이 22 cm 인 물탱크(유영조 ; 50 cm×40 cm×35 cm)안에 넣고 45분간 유영시킨 후 꺼내어 즉시로 간장과 아래다리 근육을 떼어 내어 조직을 찧어부신후, 아스론컬러방법(anthrone colorimetric method)로 간장과 근육의 글리코겐(glycogen)함량을 측정하였다. 그 결과 본 발명품 2.30 g/kg 과 1.15g/kg의 투여군은 마우스 유영 45분후의 간장의 글리코겐(glycogen)함량이 대조군보다 모두 매우 현저히 높았고, 그중 2.30 g/kg 용량군이 훨씬 뚜렷하였으며(P<0.01), 본 발명품 2.30g/kg, 1.15 g/kg 용량군이 유영 45분후의 근육의 글리코겐(glycogen)함량이 대조군보다 모두 뚜렷히 증가되었는데, 그중 2.30 g/kg 용량군이 훨씬 뚜렷하였다.(P<0.01)(표 15,16 참조)A total of 45 healthy male mice with a body weight of 20 ± 2 g are selected for each group of 15, respectively. 2.30 g / kg, 1.15 g / kg of two dose groups and the control group (drinks) Three groups were set up. The drug was administered orally once a day for 30 days. After 1 hour of final administration, each mouse was placed in a water tank (water tank; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C. and a depth of 22 cm of water. After removal, the tissue was swollen, and the glycogen content of the liver and muscle was measured by an anthrone colorimetric method. As a result, the administration groups of 2.30 g / kg and 1.15 g / kg of the present invention had significantly higher glycogen content in the liver after 45 minutes of mouse swimming than the control group, and the 2.30 g / kg dose group was much more prominent (P < 0.01), 2.30 g / kg, 1.15 g / kg dose group of the present invention significantly increased the glycogen content of the muscle 45 minutes after swimming, compared to the control group, of which the 2.30 g / kg dose group was much more obvious (P <0.01) (see Tables 15 and 16)
표 15 본 발명품 파우더(제법 2)의 마우스 유영 45분후 간장 글리코겐(glycogen)함량에 대한 영향.(±s) Table 15 Effect of Soy Glycogen Content in 45 Minutes of Mouse Streaming of the Invention Powder (Preparation 2). ± s)
대조군과 비교, **P<0.01, *P<0.05Compared to control, ** P <0.01, * P <0.05
표 16 본 발명품 파우더(제법 2)의 마우스 유영 45분후 근육 글리코겐(glycogen) 함량에 대한 영향.(±s) Table 16 Effect of the present invention powder (Preparation 2) on muscle glycogen content after 45 minutes of mouse swimming. ± s)
대조군과 비교, *P<0.05Compared to control, * P <0.05
3. 결론3. Conclusion
본 실험은 동물이 상압에서의 산소결핍인내성, 하중유영(負重遊泳), 저온에 대한 인내성등 실험과, 운동 후 혈청젖산, 혈청요소질소(urea nitrogen) 및 간장과 근육의 글리코겐(glycogen)함량을 측정하여, 본 발명품의 마우스에 대한 항피로작용을 연구하였다.In this experiment, the animal was tested for resistance to oxygen deficiency at normal pressure, endurance under load, endurance to low temperature, and after exercise, serum lactate, serum urea nitrogen, and glycogen content of liver and muscle were examined. By measuring, the anti-fatigue effect on the mouse of the present invention was studied.
그 결과는 30 일간 본 발명품을 투여한 마우스는 산소결핍 인내성과 하중유영중에서의 생존시간을 현저히 연장할수 있었고, 마우스의 간장, 근육 글리코겐(glycogen)의 함량을 증가시켰으며, 유영후 혈청젖산함량을 낮추었다.The results showed that mice treated with the present invention for 30 days could significantly prolong oxygen survival and endurance in load-bearing, increase the liver, muscle glycogen content, and increase serum lactate content after swimming. Lowered.
그러나, 저온에 대한 인내성, 유영 후 혈청요소질소함량등 실험의 결과는 현저한 차이가 보이지 않았다.However, the results of experiments such as endurance to low temperature and serum urea nitrogen content after swimming did not show any significant difference.
실험예 4 (본 발명품 파우더 급성독성실험) Experimental Example 4 (Inventive Powder Acute Toxicity Test)
한국 NITR/SOP/GTX/601-01(1999.12.31) "단회투여독성시험법"에 준하여 급성 독성시험을 하였다.The acute toxicity test was conducted in accordance with the Korean Single Drug Toxicity Test (NITR / SOP / GTX / 601-01).
1. 실험재료1. Experimental Materials
1.1 실험동물 : 1.1 Experimental Animals:
건강한 비스터(wistar)랫트(18~22 g)를 ○○ 대학의학원 실험동물과에서 제공(실험동물합격증 10-1022호)되었으며, 실험동물은 기능학실험중심의 동물사육실에서 사육과 실험을 진행하였다. 동물을 실내온도 23±5 ℃, 상대습도 50±10 ℃, 환기 6∼10 회/일, 낮에는 자연태양광, 밤에는 형광등의 환경에서 사육하였고, 고체사료와 음료수 급여를 충분히 제공하였다. 일반적으로 동물을 일주간 환경적응 시킨 후 시험에 사용하였다. Healthy wistar rats (18-22 g) were provided by the laboratory department of laboratory animals at ○○ University Medical Center (Experimental Animal Pass No. 10-1022), and the experimental animals were raised and tested in the animal laboratory in the functional experimental center. Proceeded. Animals were housed in a room temperature of 23 ± 5 ℃, relative humidity 50 ± 10 ℃, ventilation 6-10 times / day, daylight in the daylight, fluorescent light at night, and provided sufficient solid feed and drink. In general, animals were used for testing after one week of environmental adaptation.
1.2 약품: 1.2 Drugs:
본 발명품의 제법 1에 따른 제품으로 한국국일무약(주)에서 제공된 것이다.It is a product according to the manufacturing method 1 of this invention, and was provided by Kukil Pharmaceutical Co., Ltd.
1.3 투여용량 1.3 Dosage
예비시험을 거쳐 최대투여가능 용량인 60,000 mg/kg 투여군을 최고용량군, 14,406 ㎎/kg 투여군을 최저용량군으로 하고, 0.7을 공비수로 5 개용량군(60,000, 42,000, 29,400, 20,580과 14,406 mg/kg) 및 대조군을 설정하였으며, 투여는 용시조제하여 1회경구투여하였다.After the preliminary test, the maximum dose of 60,000 mg / kg was used as the highest dose group, and the 14,406 mg / kg dose was the lowest dose group, and 0.7 was azeotropic in five dose groups (60,000, 42,000, 29,400, 20,580 and 14,406). mg / kg) and a control group were set, and administration was once administered orally in preparation.
1.4 관찰항목 1.4 Observation Items
1.4.1 일반증상관찰 1.4.1 General symptoms observation
모든 시험동물에 대한 이상증상은 투여당일에는 투여후 1시간에서 6시까지는 매시간, 투여 1일부터 14일까지는 1일 2회씩 일전시간에 관찰하여 14일 동안 일반상태의 변화, 중독증상발현, 사망동물의 유무, 및 시험물질 투여후 시험물질에 의해 나타날 가능성이 있는 증상에 대해 주의하여 관찰하였다. Abnormal symptoms for all test animals were observed every hour from 1 hour to 6 hours after administration on the day of administration and twice a day from 1 to 14 days after administration for 14 days. Careful observation was made about the presence or absence of animals and the symptoms likely to be caused by the test substance after administration of the test substance.
1.4.2 체중측정 1.4.2 Weighing
시험에 사용된 모든 실험동물에 대하여 시험물질 투여당일(0 일), 3, 7, 10, 14일째 체중을 측정하였다.All experimental animals used in the test were weighed on the 3rd, 7th, 10th, and 14th day of administration (Day 0).
1.4.3 부검 1.4.3 Necropsy
시험종료후 생존마우스의 체중을 측정한후 에텔(ether)로 마취하여 방혈치사시킨후, 외관 및 내부장기 이상유무를 육안적으로 상세히 관찰하였다.After completion of the test, the weight of the surviving mice was measured, anesthetized with ether, and bleeding was observed. The appearance and internal organ abnormalities were visually observed in detail.
2. 시험결과2. Test result
2.1 사망동물 및 임상증상의 관찰2.1 Observation of dead animals and clinical symptoms
모든 투여용량군에서 시험기간동안 사망한 동물은 없었다. 또한 시험물질에 의한 독성으로 인정되는 증상도 나타나지 않았다.No animals died during the trial in all dose groups. In addition, no symptoms were recognized as toxic by the test substance.
2.2 체중변화2.2 weight change
모든 투여용량군에서 대조군과 비교하여 유의성있는 체중변화는 보이지 않았 다.There was no significant weight change in all dose groups compared to the control.
2.3 육안적 부검소견2.3 Visual Autopsy Findings
대조군과 모든 투여용량군에서 사망개체는 없었으며, 생존개체에서도 별다른 육안적 이상소견이 관찰되지 않았다.There were no deaths in the control group and all dose groups, and no gross abnormalities were observed in the surviving individuals.
이상의 결과로부터 본 발명품의 LD50 치는 본 시험에서 사용한 랫트에 최대 투여가능 용량인 60,000 mg/kg (임상용량의 약 900배) 이상으로 사료되며, 보다 고용량에서의 측정은 불가능하여, 안전한 약물로 평가할 수 있다. (표 17 참조)From the above results, the LD 50 value of the present invention is estimated to be 60,000 mg / kg (about 900 times the clinical dose), which is the maximum dose to rats used in this test. Can be. (See Table 17)
표 17 본 발명품을 경구투여한 비스터랫트의 생존율. Table 17 Survival rate of bister rats orally administered with the present invention.
본 발명에 따르면, 온신, 항피로, 강장, 강정작용을 갖는 2종의 동물성생약과 8종의 식물성생약으로 구성되어 온신, 항피로, 강정, 강장작용을 갖는 안정하고 안전성이 확보된 성기능 증진효과가 기대되는 건강기능식품을 얻을 수 있어, 본 발명은 산업적으로 매우 유용한 발명임이 틀림없다.According to the present invention, it is composed of two kinds of animal medicines with onxin, anti-fatigue, tonic, and jeongjeong action and 8 kinds of plant medicines, and has a stable and safe sexual function enhancement effect having onxin, anti-fatigue, jeongjeong, tonic action The functional foods expected to be obtained can be obtained, and the present invention must be an industrially useful invention.
Claims (4)
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20000031430A (en) * | 1998-11-06 | 2000-06-05 | 이정상 | Preparation of health food containing herb medicines |
KR20020090444A (en) * | 2001-05-25 | 2002-12-05 | 한국식품개발연구원 | The food to improve the sexual function of man |
KR20030075250A (en) * | 2002-03-18 | 2003-09-26 | 최성휴 | Natural Energy Pill Gold |
KR20040026277A (en) * | 2002-09-23 | 2004-03-31 | 김우영 | The health-supporting food being effective the sexual energy strength and its preparat ion method |
KR20040072510A (en) * | 2004-07-01 | 2004-08-18 | 김영근 | Health supplementary food using silkworm as main material |
KR20040108512A (en) * | 2003-06-17 | 2004-12-24 | 주식회사 닥터즈메디코아 | Extract of herbal mixture and composition for the impotence improvement comprising the same |
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Publication number | Priority date | Publication date | Assignee | Title |
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KR20000031430A (en) * | 1998-11-06 | 2000-06-05 | 이정상 | Preparation of health food containing herb medicines |
KR20020090444A (en) * | 2001-05-25 | 2002-12-05 | 한국식품개발연구원 | The food to improve the sexual function of man |
KR20030075250A (en) * | 2002-03-18 | 2003-09-26 | 최성휴 | Natural Energy Pill Gold |
KR20040026277A (en) * | 2002-09-23 | 2004-03-31 | 김우영 | The health-supporting food being effective the sexual energy strength and its preparat ion method |
KR20040108512A (en) * | 2003-06-17 | 2004-12-24 | 주식회사 닥터즈메디코아 | Extract of herbal mixture and composition for the impotence improvement comprising the same |
KR20040072510A (en) * | 2004-07-01 | 2004-08-18 | 김영근 | Health supplementary food using silkworm as main material |
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