KR20080109360A - Composition comprising the extract of crude drug complex for stimulating bone growth - Google Patents
Composition comprising the extract of crude drug complex for stimulating bone growth Download PDFInfo
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- KR20080109360A KR20080109360A KR1020070057566A KR20070057566A KR20080109360A KR 20080109360 A KR20080109360 A KR 20080109360A KR 1020070057566 A KR1020070057566 A KR 1020070057566A KR 20070057566 A KR20070057566 A KR 20070057566A KR 20080109360 A KR20080109360 A KR 20080109360A
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- extract
- growth
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- pharmaceutical composition
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Abstract
Description
도 1은 흰쥐에 테드라사이클린(tetracycline) 주사 후, 침착된 후지경골 골단부 성장판에 침착되어 발생하는 발광을 형광현미경으로 촬영한 사진이다: Figure 1 is a photograph taken by fluorescence microscopy of luminescence resulting from deposition on the deposited tibial epiphyseal growth plate after tetracycline injection in rats:
A: 식염수 투여군; A: saline administration group;
B: 성장호르몬(20 ㎍/㎏) 투여군; 및 B: growth hormone (20 µg / kg) administration group; And
C: 생약복합재 추출물(HT030, 500 ㎎/㎏) 투여군. C: group administered with the herbal extract extract (HT030, 500 mg / kg).
도 2는 흰쥐에 테트라사이클린 주사한 뒤 48 시간 후, 성장판과 발광선과의 간격을 측정한 그래프이다: Figure 2 is a graph measuring the distance between the growth plate and the luminescence line 48 hours after tetracycline injection in rats:
*: P< 0.05. * : P <0.05.
도 3은 흰쥐에서의 성장률을 나타낸 그래프이다:3 is a graph showing growth rate in rats:
*: P< 0.05. * : P <0.05.
본 발명은 생약복합재 추출물을 유효성분으로 함유하는 골길이 성장 촉진용 약학적 조성물에 관한 것으로, 보다 상세하게는 속단 및 두충으로 구성된 생약복합재 추출물을 유효성분으로 함유하는 골길이 성장 촉진용 약학적 조성물에 관한 것이다.The present invention relates to a pharmaceutical composition for promoting bone length growth containing herbal extracts as an active ingredient, and more particularly, to a pharmaceutical composition for promoting bone growth containing herbal extracts composed of fast-acting and tofu as active ingredients. It is about.
성장이란 신장의 증가를 말하며, 영양과 성장호르몬 등에 의하여 촉진된다. 특히 성장호르몬을 분비하는 뇌를 포함한 신경계는 유년기에 현저하게 생장하고, 그 후는 성장이 완만해진다. 따라서, 사람의 성장은 대부분 사춘기까지의 시기에 대부분 일어나며, 이 시기에 적절한 영양섭취가 이루어지지 않으면 성장이 제대로 이루어지지 않게 된다. 이에 영양의 균형화를 이루기 위하여 많은 성장 촉진용 건강보조식품이 출시되고 있으나, 단순히 성장을 위하여 도움이 되는 여러 가지 성분들의 조합에만 그침으로써 아직도 그 효과가 만족할 만한 수준에 도달하지 못하였다.Growth refers to the increase in height, and is promoted by nutrition and growth hormone. In particular, the nervous system, including the brain that secretes growth hormone, grows remarkably in childhood, and then grows slowly. Therefore, most of human growth occurs until the age of puberty, and if proper nutrition is not achieved at this time, the growth will not be done properly. In order to achieve nutritional balance, many growth-promoting health supplements have been released, but only the combination of various ingredients helpful for growth has not yet reached a satisfactory level.
장골의 길이성장은 신체의 신장과 골격을 결정지으며 특별한 기작에 의해 조절되어 진다. 특히 장골의 근위부성장판(epiphyseal growth plate)의 성장이 골의 길이 성장과정에 가장 중요한 척도가 된다. 성장판은 연골세포(chondrocyte)를 세포증식이 일어나기 전인 휴지부(resting zone), 증식시키는 증식부(proliferation zone), 연골세포의 성숙과 비대작용을 하는 성숙부(maturation zone) 및 비대 부(hypertrophic zone)로 나누어지고, 이들의 상호작용으로 장골의 길이성장이 이루어진다(Loveridge, N, J. Anim. Sci. 77, 190-196, 1999).The growth of the long bones determines the height and skeleton of the body and is controlled by specific mechanisms. In particular, the growth of the epiphyseal growth plate of the iliac bone is the most important measure in the bone growth process. The growth plate is a resting zone before chondrocytes proliferate, a proliferation zone that proliferates, a maturation zone and hypertrophic zone where maturation and hypertrophy of chondrocytes occur. And their interactions lead to long bone growth (Loveridge, N, J. Anim. Sci. 77, 190-196, 1999).
성장에 필요한 성장호르몬은 오래 전부터 왜소증(矮小症) 환자들의 치료목적으로 사용되어 왔고, 1985년 후반기에 이르러 유전자 재조합 방식의 성장호르몬이 상품화되기 시작하여 대량 생산 및 공급이 가능해지고 타질환의 위험성도 없어짐에 따라 최근에는 유전자 재조합 방식의 성장호르몬이 성장호르몬 결핍 질환의 치료제로 사용되고 있으며, 생체내의 엔케팔린(enkephalin)을 토대로 성장호르몬 분비활성을 갖는 6개의 아미노산으로 구성된 새로운 성장호르몬 분비 촉진제인 GHRP-6 (Growth hormone releasing peptide-6, His-D-Trp-Ala-Trp-D-Phe-Lys-NH2)가 개발되어(Bowers CY. et al., Endocrinology, 114, 1537-45, 1984), 비록 적은 흡수율이지만 경구 투여시에도 흡수가 되는 것으로 보고 되었다(Noriko I. et al ., Life Science, 47, 29-36, 1990). 이후에 계속적인 연구로 다른 펩티드성 성장호르몬 분비 촉진제인 GHRP-1 (Ala-His-D-β-Nal-Ala-Trp-D-Phe-Lys-NH2)과 GHRP-2 (D-Ala-D-β-Nal- Ala-Trp-D-Phe-Lys-NH2)라는 6개의 변화된 펩티드로 구성된 성장호르몬 분비 촉진제가 개발되어 보고 되었다. 그러나 이들은 생체내의 활성은 뛰어나지만 경구 투여시 그 흡수율이 2 내지 3 %에 머무르는 등 경구 투여에는 개선의 여지가 많은 것으로 보고 되었다.Growth hormone required for growth has been used for the treatment of dwarfism patients for a long time.In late 1985, the recombinant growth hormone was commercialized, and mass production and supply became possible, and the risk of other diseases Recently, genetically modified growth hormone has been used as a treatment for growth hormone deficiency disease, and GHRP-6, a new growth hormone secretagogue consisting of 6 amino acids with growth hormone secretion activity based on enkephalin in vivo (Growth hormone releasing peptide-6, His-D-Trp-Ala-Trp-D-Phe-Lys-NH2) has been developed (Bowers CY. Et al., Endocrinology , 114, 1537-45, 1984), although Absorption rate, but has been reported to be absorbed upon oral administration (Noriko I. et al ., Life Science , 47, 29-36, 1990). Subsequent research has led to other peptide growth hormone secretion promoters, GHRP-1 (Ala-His-D-β-Nal-Ala-Trp-D-Phe-Lys-NH2) and GHRP-2 (D-Ala-D A growth hormone secretagogue consisting of six modified peptides, -β-Nal-Ala-Trp-D-Phe-Lys-NH2), has been developed and reported. However, they have been reported to have a lot of room for improvement in oral administration, although the activity in vivo is excellent but the absorption rate stays at 2-3% upon oral administration.
한편, 속단은 산토끼꽃과(川續斷科, dipsacaceae)에 속하는 다년생 초본인 천속단(Dipsacus asper Wall)의 뿌리로, 주된 성분은 숙신산(succinic acid), 베토니신(betonicine), 샨쯔히사이드 메틸 에스테르(shanzhiside methyl ester), 아케비아 사포닌 D(akebia saponin D) 및 daucosterol(도코스테롤)등이 있으며, 전통한의학에서는 보간신(補肝腎), 강근골(强筋骨), 익근골(益筋骨) 및 치요신(治腰腎)의 효능으로 몸이 허해서 발생하는 뼈와 근육이 약해지는 증상을 몸을 보(補)하여 강하게 해주는 약재로 사용되어 왔다. 이에 속단의 성장호르몬 분비촉진 활성을 갖는 글리코알칼로이드인 아스퍼로사포닌 H1의 유도체를 분리, 정제하는 방법에 대한 특허(제 10-0436219호)가 등록되어 있으며, 문헌으로는 치은섬유아세포의 세포주기조절에 미치는 영향(유석주 외, 대한치주학회지:35(1), 87, 2005), 마우스 두개골 세포의 분화에 미치는 영향(김동진 외, 대한치주학회지:34(4), 791, 2004), 흰쥐의 골다공증에 미치는 영향(안덕균 외, 본초분과학회지:9(1), 181, 1994) 조골세포의 분화에 미치는 영향(Chun-Hsu Yao, J Biomed Master Res Part B:Appl Biomaster 75B:277-88, 2005) 등에 대해 보고된 바 있다. 따라서, 속단의 성장에 미치는 영향은 조골세포의 분화를 촉진함으로써 골성장에 효과가 있는 것으로 추측되며, 성장판의 길이성장에 미치는 효과에 대해서는 연구된 바 없다.On the other hand, the genus is the root of the perennial herbaceous Dipsacus asper Wall belonging to the genus dipsacaceae, the main constituents are succinic acid, betonisin, and shantsuhiside methyl. Shanzhiside methyl ester, akebia saponin D, and daucosterol. In traditional Chinese medicine, interpolation, coccyx, pterygium and Chiyosin (治 腰 腎) has been used as a medicine to strengthen and strengthen the body's symptoms of weakening of bones and muscles caused by the body. Patent No. 10-0436219 discloses a method for isolating and purifying a derivative of Asperosaponin H1, a glycoalkaloid having a rapid growth hormone secretion activity. Effect on Regulation (Yuk-Soo Joo et al., Journal of Korean Periodontology: 35 (1), 87, 2005), Effects on Differentiation of Mouse Skull Cells (Dong-Jin Kim et al., 34 (4), 791, 2004), Rats Effect on Osteoporosis (Duk-kyun Ahn, et al., 9 (1), 181, 1994) Effect on Osteoblast Differentiation (Chun-Hsu Yao, J Biomed Master Res Part B: Appl Biomaster 75B: 277-88, 2005 ), And so on. Therefore, the effect on the growth of fasting is thought to have an effect on bone growth by promoting the differentiation of osteoblasts, has not been studied for the effect on the growth of the length of the growth plate.
두충은 두충나무과(Eucommiaceae)에 속한 낙엽교목인 두충(Eucommia ulmoides Oliver)의 나무껍질을 건조한 것으로 봄부터 여름 사이에 코르크층을 깍아버리고 나무껍질을 벗겨 햇볕에 말려 사용한다. 한방에서는 신농본초경 상품에 처음으로 기재되었고, 본초강목에서는 간과 신을 보하고 근골을 강하게 하며 태를 안정되게 하는데 쓰여 왔다고 한다(Whang, W. K. et al ., Kor . J. Pharmcogn , 27(10), 65-74, 1996). 또한 혈압을 낮추고 요통을 멈추게 하여 익모초 등과 함께 고혈압 치료에 대한 처방에 배합되어 사용되었으며 강장, 강정, 진통약으로 널리 사용되어 왔다. It is a dried bark of Eucommia ulmoides Oliver, a deciduous tree belonging to the Eucommiaceae family. It is used to dry the bark of the cork between the spring and summer, peel off the bark and dry it in the sun. In oriental medicine, it was first described in the new agricultural products, and in the herbal wood, it has been used to protect the liver, gods, strengthen the musculature, and stabilize the womb (Whang, WK et. al ., Kor . J. Pharmcogn , 27 (10), 65-74, 1996). In addition, it lowers blood pressure and stops back pain and is used in combination with motherwort for the treatment of hypertension and has been widely used as a tonic, gangjeong, and analgesic drug.
최근 두충의 약리학적 연구로는 항노화작용, 항피로작용, glucosidase inhibitor작용, 심장수축력 억제 작용, 혈관확장 작용, 항당뇨 작용, 진통 및 신경통, 단백질 합성 및 지질대사 촉진작용 등이 있다(Li Y. et al ., Biol . pharm . Bull, 22(6),582-585,1999). 또한 두충의 수피와 잎에서 각각 골흡수 및 골무기질의 손실방지, 골신생에 유의한 효과가 있어 골다공증 유발억제 응용이 가능하다고 보고된바 있다(Oh, H. S, et al ., J. of Herbology , 10(1), 59-68, 1995). Recent pharmacological studies of worms include anti-aging, anti-fatigue, glucosidase inhibitors, cardiac contractility, vasodilation, antidiabetic, analgesic and neuralgia, protein synthesis and lipid metabolism (Li Y et al ., Biol . pharm . Bull, 22 (6), 582-585, 1999). In addition, it has been reported that the application of osteoporosis-induced suppression has significant effects on bone resorption and prevention of loss of bone minerals and bone angiogenesis in the bark and leaves of the larvae (Oh, H. S, et al ., J. of Herbology , 10 (1), 59-68, 1995).
이에, 본 발명자들은 성장 촉진에 이용되는 성장호르몬의 고비용, 저흡수율 및 부작용 등의 문제점을 해결하고자, 천연물을 대상으로 검색하던 중 속단 및 두충을 함유하는 복합생약 추출물이 피하 주사한 성장호르몬보다 성장에 우수한 효과가 있음을 밝힘으로써 본 발명을 완성하였다. Thus, the present inventors, in order to solve the problems such as high cost, low absorption rate and side effects of the growth hormone used to promote growth, the complex herbal extracts containing fast-acting and worms during the search for natural products grow than the growth hormone injected subcutaneously The present invention has been completed by revealing that there is an excellent effect.
본 발명의 목적은 속단 및 두충으로 구성된 혼합물의 추출물을 유효성분으로 함유하는 골길이 성장 촉진용 약학적 조성물을 제공하는 것이다.It is an object of the present invention to provide a pharmaceutical composition for promoting bone length growth, which contains an extract of a mixture consisting of fasting and soybeans as an active ingredient.
상기 목적을 달성하기 위하여, 본 발명은 속단 및 두충으로 구성된 생약복합재 추출물을 유효성분으로 함유하는 골길이 성장 촉진용 약학적 조성물을 제공한다.In order to achieve the above object, the present invention provides a pharmaceutical composition for promoting bone length growth, containing the extract of the herbal medicine complex consisting of fast and soybean as an active ingredient.
또한, 본 발명은 상기의 조성물을 유효성분으로 함유하는 골길이 성장 촉진용 건강보조식품을 제공한다.In addition, the present invention provides a health supplement for promoting bone length growth containing the composition as an active ingredient.
이하, 본 발명에 대하여 상세히 설명한다.EMBODIMENT OF THE INVENTION Hereinafter, this invention is demonstrated in detail.
본 발명은 속단 및 두충으로 구성된 생약복합재 추출물을 유효성분으로 함유하는 골길이 성장 촉진용 약학적 조성물을 제공한다.The present invention provides a pharmaceutical composition for promoting bone length growth, which contains a herbal extract consisting of a fast and a worm as an active ingredient.
생약복합재 추출물은 속단 및 두충을 건조하여 마쇄한 후, 건조된 시료의 중량의 약 1 내지 20배, 바람직하게는 약 5 내지 15 배 분량의 물, 에탄올, 메탄올 등과 같은 C1 내지 C4의 저급 알코올 또는 약 1:0.1 내지 1:10, 바람직하게는 1:0.2 내지 1:5의 혼합비(v/v)를 갖는 이들의 혼합용매로, 실온에서 약 1 내지 24시간, 바람직하게는 5 내지 15 시간 동안, 가장 바람직하게는 6 시간 동안 추출하는 것이다. 추출 방법으로는 열수 추출, 냉침 추출, 환류냉각 추출 또는 초음파 추출 등이 바람직하며, 더욱 바람직하게는 환류가열 추출한 후 감압 농축함으로써 본 발명의 가용 추출물인 조추출물을 수득할 수 있었다. 이렇게 하여 수득한 속단 및 황기의 생약복합재 추출물을 "HT030"이라 명명하였다.The extract of the herbal compound is ground and dried by grinding soybean and tofu, and then about 1 to 20 times the weight of the dried sample, preferably about 5 to 15 times the amount of C 1 to C 4 , such as water, ethanol, methanol, etc. Alcohols or mixed solvents thereof having a mixing ratio (v / v) of about 1: 0.1 to 1:10, preferably 1: 0.2 to 1: 5, at room temperature for about 1 to 24 hours, preferably 5 to 15 For time, most preferably for 6 hours. The extraction method is preferably hot water extraction, cold extraction, reflux cooling extraction or ultrasonic extraction, and more preferably, the crude extract which is the soluble extract of the present invention can be obtained by heating under reflux heating and concentrating under reduced pressure. The herbal extracts of the fast-dry and Astragalus obtained in this way were named "HT030".
본 발명의 복합 생약 추출물의 조성비는 속단 1 ~ 5 중량부, 두충 1 ~ 3 중량부인 것이 바람직하며, 속단 1 ~ 3 중량부, 두충 1 ~ 2중량부인 것이 더욱 바람직하며, 속단 2 중량부, 두충 1 중량부인 것이 가장 바람직하다. The compositional ratio of the complex herbal extract of the present invention is preferably 1 to 5 parts by weight, 1 to 3 parts by weight of soybean, more preferably 1 to 3 parts by weight, 1 to 2 parts by weight of soybean, 2 parts by weight, soybean Most preferably, it is 1 weight part.
생약복합재 추출물의 성장의 측정을 위하여, 흰쥐를 음성 대조군, 실험군 및 양성 대조군의 3개의 군으로 나누어 매일 2회씩 4일 동안 음성 대조군에게는 식염수를, 실험군에게는 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1 참조) 또는 단일 약재의 추출물(비교예 1, 비교예 2 및 표 2 참조)을 각각 경구 투여하였고, 양성 대조군에게는 성장호르몬을 피하 주사하였다. 성장은 성장판에 테트라사이클린(tetracycline)이 침착된 후 성장한 경골부의 길이로 알 수 있으며, 이는 테트라사이클린의 침착으로 발색된 발광선과 성장판과의 간격을 측정함으로써 알 수 있다. 이를 위하여, 3일째에는 흰쥐에 테트라사이클린을 복강 주사하였고 그 후, 48 시간 경과한 5일째에는 흰쥐들을 에테르로 마취하여 희생하였다.In order to measure the growth of the herbal compound extract, the rats were divided into three groups, a negative control group, an experimental group, and a positive control group, twice daily for four days, for 4 days, and for the negative control group, the saline solution for the experimental group (HT030, Examples 1 to 5). And a single herbal extract (Comparative Example 1, Comparative Example 2 and Table 2) were orally administered, respectively, and a positive control group was injected subcutaneously with growth hormone. Growth can be seen by the length of the tibial portion grown after the tetracycline (tetracycline) is deposited on the growth plate, it can be seen by measuring the distance between the growth plate and the light emitting color developed by the deposition of tetracycline. To this end, rats were intraperitoneally injected with tetracycline on day 3 and then rats were sacrificed with ether anesthesia on day 5 after 48 hours.
흰쥐에서 테트라사이클린으로 침착되어 발색된 발광선과 성장판과의 간격을 형광현미경으로 촬영한 후(도 1 참조), 성장을 측정하였다. 그 결과, 복합생약제 추출물(HT030)은 골길이 성장에 영향을 주는 것으로 나타났다. HT030의 투여군( 실시예 1 내지 5 및 표 1 참조)의 골길이 성장은 음성 대조군 및 단일 약재의 추출물 투여군(비교예 1, 비교예 2 및 표 2 참조)의 골길이 성장에 비하여 통계적으로 높았다. *는 P< 0.05을 나타낸다. 또한 식염수를 투여한 음성 대조군의 성장을 100%로 하였을 경우, 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1) 투여군, 단일 약재의 추출물(비교예 1, 비교예 2 및 표 2) 투여군 및 양성 대조군의 성장률을 계산하여 보았다. 그 결과, 역시 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1) 투여군의 성장률은 음성 대조군, 단일 약재의 추출물 투여군 보다 유의성 있게 높았다.After capturing the interval between the emission line and the growth plate deposited with tetracycline in the rat by fluorescence microscopy (see FIG. 1), growth was measured. As a result, the complex herbal extract (HT030) was shown to affect the bone length growth. The bone length growth of the HT030 administration group (see Examples 1 to 5 and Table 1) was statistically higher than that of the negative control group and the extract administration group of the single medicinal herb (see Comparative Example 1, Comparative Example 2 and Table 2). * Represents P <0.05. In addition, when the growth rate of the negative control group administered with saline was 100%, the combination herbal extract (HT030, Examples 1 to 5 and Table 1) administration group, the extract of a single medicine (Comparative Example 1, Comparative Example 2 and Table 2) administration group And the growth rate of the positive control was calculated. As a result, the growth rate of the administration group of the composite herbal extracts (HT030, Examples 1 to 5 and Table 1) was significantly higher than the negative control group, the extract administration group of a single herb.
상기의 복합생약제 추출물(HT030)을 마우스에 경구 투여하여 독성 실험을 수행한 결과, 경구 투여 독성시험에 의한 50% 치사량(LD50)은 적어도 1,000 ㎎/㎏ 이상인 안전한 물질로 판단된다.As a result of oral administration of the compound herbal extract (HT030) to mice orally, a 50% lethal dose (LD 50 ) by oral toxicity test was determined to be a safe substance of at least 1,000 mg / kg or more.
생약복합재 추출물(HT030)은 안전한 물질이며, 우수한 골길이 성장의 효과를 나타내므로 골길이 성장 촉진용 약학적 조성물로서 제공될 수 있다. Herbal medicine composite extract (HT030) is a safe substance, because it shows the effect of excellent bone length growth can be provided as a pharmaceutical composition for promoting bone length growth.
본 발명의 골길이 성장 촉진용 약학적 조성물은 조성물 총 중량에 대하여 상기 생약복합재 추출물(HT030)을 0.1 내지 50 중량%로 포함하는 것이 바람직하나 이에 한정되는 것은 아니다. 본 발명의 생약복합재 추출물을 함유하는 조성물은 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다.The pharmaceutical composition for promoting bone length growth of the present invention preferably comprises 0.1 to 50% by weight of the herbal extract (HT030) based on the total weight of the composition, but is not limited thereto. The composition containing the herbal compound extract of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the preparation of the composition.
본 발명의 생약복합재 추출물의 약학적 투여 형태는 이들의 약학적 허용 가능한 염의 형태로도 사용될 수 있고, 또한 단독으로 또는 타 약학적 활성 화합물과 결합뿐만 아니라 적당한 집합으로 사용될 수 있다. The pharmaceutical dosage forms of the herbal complex extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, and may be used alone or in combination with other pharmaceutically active compounds as well as in a suitable collection.
본 발명의 조성물은 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에 어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. 목초액을 함유하는 조성물에 포함될 수 있는 담체, 부형제 및 희석제로는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 들 수 있다. 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다.The compositions of the present invention can be used in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like oral formulations, external preparations, suppositories and sterile injectable solutions. Carriers, excipients, and diluents that may be included in compositions containing wood vinegar include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate , Cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. When formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, and surfactants are usually used.
경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 생약복합재 추출액에 적어도 하나 이상의 부형제, 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로오스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스테아레이트, 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다.Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and the solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose, and the like in the herbal compound extract. (sucrose), lactose (lactose), gelatin, etc. are mixed and prepared. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. .
비경구 투여를 위한 제제에는 멸균된 수용액, 액제, 비수성용제, 현탁제, 유제, 동결건조 제제, 좌제, 주사제제가 포함된다. 비수성용제, 현탁제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기 제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다.Formulations for parenteral administration include sterile aqueous solutions, solutions, non-aqueous solutions, suspensions, emulsions, lyophilized preparations, suppositories, injections. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate and the like can be used. As a base of suppositories, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.
본 발명의 생약복합재 추출물의 바람직한 투여량은 환자의 상태 및 체중, 질병의 정도, 약물형태, 투여경로 및 기간에 따라 다르지만, 당업자에 의해 적절하게 선택될 수 있다. 그러나 바람직한 효과를 위해서, 본 발명의 생약복합재 추출물은 1일 0.0001 내지 1000 ㎎/㎏으로, 바람직하게는 0.001 내지 1000 ㎎/㎏으로 투여하는 것이 좋다. 투여는 하루에 한번 투여할 수도 있고, 수회 나누어 투여할 수도 있다. 상기 투여량은 어떠한 면으로든 본 발명의 범위를 한정하는 것은 아니다.Preferred dosages of the herbal extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration, and the duration, and may be appropriately selected by those skilled in the art. However, for the preferred effect, the herbal extract of the present invention is preferably administered at 0.0001 to 1000 mg / kg, preferably 0.001 to 1000 mg / kg per day. Administration may be administered once a day or may be divided several times. The dosage does not limit the scope of the invention in any aspect.
본 발명의 생약복합재 추출물은 쥐, 생쥐, 가축, 인간 등의 포유동물에 다양한 경로로 투여될 수 있다. 투여의 모든 방식은 예상될 수 있는데, 예를 들면, 경구, 직장 또는 정맥, 근육, 피하, 자궁내 경막 또는 뇌혈관내(intracerebroventricular) 주사에 의해 투여될 수 있다. The herbal complex extract of the present invention can be administered to various mammals such as mice, mice, livestock, humans. All modes of administration can be expected, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.
본 발명의 생약복합재 추출물은 독성 및 부작용은 거의 없으므로 장기간 복용 시에도 안심하고 사용할 수 있는 조성물이다.The herbal extract of the present invention is a composition that can be used with confidence even when taken for a long time because there is little toxicity and side effects.
또한 상기 본 발명의 조성물을 유효성분으로 함유하는 골길이 성장 촉진용 건강보조식품을 제공한다.In addition, it provides a dietary supplement for promoting bone length growth containing the composition of the present invention as an active ingredient.
생약복합재 추출물을 첨가할 수 있는 식품으로는, 예를 들어, 각종 식품류, 유제품, 음료, 껌, 차, 비타민 복합제, 건강보조 식품류 등이 있고, 분말, 과립, 정제, 캡슐 또는 음료인 형태로 사용할 수 있다.Foods to which the herbal compound extract can be added include, for example, various foods, dairy products, beverages, gums, teas, vitamin complexes, dietary supplements, etc., and are used in the form of powders, granules, tablets, capsules, or beverages. Can be.
또한, 성장 촉진의 효과를 목적으로 식품 또는 음료에 첨가될 수 있다. 이 때, 식품 또는 음료 중의 상기 추출물의 양은 전체 식품 중량의 0.01 내지 15 중량%로 가할 수 있으며, 건강 음료 조성물은 100 ㎖를 기준으로 0.02 내지 5 g, 바람직하게는 0.3 내지 1 g의 비율로 가할 수 있다. It may also be added to foods or beverages for the purpose of promoting growth. At this time, the amount of the extract in the food or beverage can be added in 0.01 to 15% by weight of the total food weight, the health beverage composition is added in a ratio of 0.02 to 5 g, preferably 0.3 to 1 g based on 100 ml Can be.
본 발명의 건강 기능성 음료 조성물은 지시된 비율로 필수 성분으로서 상기 생약복합재 추출물을 함유하는 외에는 다른 성분에는 특별한 제한이 없으며 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토스, 수크로오스 등; 및 폴리사카라이드, 예를 들어 덱스트린, 시클로덱스트린 등과 같은 통상적인 당, 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 상술한 것 이외의 향미제로서 천연 향미제(타우마틴, 스테비아 추출물(예를 들어 레바우디오시드 A, 글리시르히진등) 및 합성 향미제(사카린, 아스파르탐 등)를 유리하게 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ㎖당 일반적으로 약 1 내지 20 g, 바람직하게는 약 5 내지 12 g이다.The health functional beverage composition of the present invention is not particularly limited to other ingredients except the herbal compound extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. have. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those mentioned above, natural flavoring agents (tauumatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of said natural carbohydrates is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.
상기 외에 본 발명의 복합생약제 추출물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 중진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있다. 그밖에 본 발명의 생약복합재 추출물은 천연 과일 주스 및 과 일 주스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 그렇게 중요하진 않지만 본 발명의 추출물 100 중량부 당 0.1 내지 약 20 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, the complex herbal extract of the present invention may be used in various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors such as flavoring agents, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid And salts thereof, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the herbal extract of the present invention may contain the flesh for the production of natural fruit juice and fruit juice beverage and vegetable beverage. These components can be used independently or in combination. The proportion of such additives is not so critical but is generally selected in the range of 0.1 to about 20 parts by weight per 100 parts by weight of the extract of the present invention.
이하 본 발명을 실시예, 실험예 및 제제예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail by Examples, Experimental Examples and Formulation Examples.
단, 하기 실시예, 실험예 및 제제예는 본 발명을 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예, 실험예 및 제제예에 한정되는 것은 아니다.However, the following Examples, Experimental Examples, and Formulation Examples are merely illustrative of the present invention, and the content of the present invention is not limited to the following Examples, Experimental Examples, and Formulation Examples.
<실시예 1 내지 5> 생약복합재<Examples 1 to 5> herbal medicine composite material 추출물(HT030)의 제조Preparation of Extract (HT030)
경동시장(서울)에서 구입한 속단 및 두충 각각 400 g을 건조한 후 표 1과 같은 구성과 중량비가 되도록 중량을 측정하여 마쇄하였다. 시료의 중량의 10배에 해당하는 70% 에탄올(실시예 1 내지 4) 또는 증류수(실시예 5)를 첨가하여 6 시간 환류가열 추출한 후, 감압 여과하여 추출액과 잔사를 분리하였다. 이후 감압회전농축기를 사용하여 감압 농축하여 각각의 농축액을 얻었으며, 이를 이용하여 -70℃에서 동결한 후 동결건조기를 이용하여 분말을 얻어 각각 약재의 수율을 구하였으며(속단 33.36%, 두충 11.97%), 약재혼합 비율에 따라 얻은 동결건조분말을 혼합하여 최종 추출액(이하 "HT030"이라 명명함)을 하기 실험의 시료로 사용하였다.400 g each of fast-growing and tofu worms purchased from Gyeongdong Market (Seoul) was dried and then ground by measuring the weight of the composition and weight ratio as shown in Table 1. 70% ethanol (Examples 1 to 4) or distilled water (Example 5) corresponding to 10 times the weight of the sample was added thereto, followed by heating under reflux for 6 hours, followed by filtration under reduced pressure to separate the extract and the residue. Thereafter, each of the concentrates was obtained by concentrating under reduced pressure using a vacuum concentrator, which was then frozen at -70 ° C to obtain a powder using a lyophilizer to obtain the yield of each medicine (fast 33.36%, tofu 11.97%). ), The lyophilized powder obtained according to the mixing ratio of the medicine was used as a final extract (hereinafter referred to as "HT030") as a sample of the experiment.
<비교예 1 및 비교예 2> 단일 약재 추출물 제조<Comparative Example 1 and Comparative Example 2> Preparation of a single herbal extract
하기의 표 2와 같은 조성비로 이루어진 조성물을 실시예 1 내지 4와 같은 방법으로 추출하여 제조하였다. 본 발명의 성장 효과를 비교하기 위하여 양성 대조군으로는 성장호르몬을 이용하였고, 음성 대조군으로는 식염수를 이용하였다.The composition consisting of the composition ratio as shown in Table 2 below was prepared by extracting in the same manner as in Examples 1 to 4. In order to compare the growth effect of the present invention, growth hormone was used as a positive control, and saline was used as a negative control.
<실험예 1> 생약복합재 추출물(HT030)에 의한<Experimental Example 1> by the herbal extract extract (HT030) 성장의 측정Measure of growth
생약복합재 추출물(HT030)에 의한 성장의 측정을 위하여, 실험에 이용한 동물은 스프라규-다울리(Sprague-Dawley)계 수컷 흰쥐(3주령)로 샘타코(대한민국)로부터 구입하여 사용하였고, 실험절차는 미 국립보건원의 동물관리 지침에 의해서 수행되었다. 온도는 20 ± 2℃, 조명은 07:00~19:00시 사이 조건으로 통일하였으며, 음식과 물은 리비툼(libitum)을 통해 공급되었으며, 쥐의 무게는 매일 측정되었다.In order to measure the growth by the herbal extract (HT030), the animals used in the experiment were Sprague-Dawley male rats (3 weeks old) purchased from Samtako (Korea) and used. The procedure was performed in accordance with the National Institutes of Health animal care guidelines. Temperatures were unified under conditions of 20 ± 2 ° C and illumination between 07:00 and 19:00 hours, food and water were supplied through libitum, and rats were weighed daily.
실험쥐들은 8마리씩 4개의 군으로 나누어, 음성 대조군에게는 식염수를, 실험군에게는 500 ㎎/㎏의 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1) 및 500 ㎎/㎏의 단일 약재의 추출물(비교예 1, 비교예 2 및 표 2)을 매일 2회씩 4일간 경구 투여하였고, 양성 대조군에는 성장호르몬을 20 ㎍/㎏ 농도로 피하 주사하였으며, 3일째에는 테트라사이클린(tetracycline; 20 ㎎/㎏)을 복강 주사하여 성장판에 침착되게 하였다. 테트라사이클린 주사로부터 48 시간이 경과한 5일째에는 흰쥐들을 에테르로 마취하여 희생하였다.The mice were divided into four groups of eight rats, saline solution for the negative control group, 500 mg / kg of the complex herbal extract (HT030, Examples 1 to 5 and Table 1) and 500 mg / kg of the single herbal extract ( Comparative Example 1, Comparative Example 2 and Table 2) were administered orally twice daily for 4 days, growth hormone was injected subcutaneously at a concentration of 20 μg / kg in the positive control group, and on the third day tetracycline (20 mg / kg) Was injected into the growth plate by intraperitoneal injection. On day 5 48 hours after tetracycline injection, rats were sacrificed by anesthesia with ether.
실험 5일째 희생한 흰쥐로부터 분리한 족경골은 4% 인산염-완충액 파라포름알데히드(phosphate-buffered paraformaldehyde)에 48 시간 고정시킨 후, 30% 수크로오스(sucrose)용액에 침지시켜 탈수하였다. 이 후 고정된 골조직을 동결한 후 크라요컷(cryocut)을 사용하여 족경골(tibia) 근위부(proximal part)의 시상절편(sagital section)을 매 40 ㎛씩 절편한 후 수집하여 조직 표본으로 사용하였다. 그 후 절편은 길이 성장분석을 위해 사용되었다. On the fifth day of the experiment, the tibia was isolated from the sacrificed rats, fixed in 4% phosphate-buffered paraformaldehyde for 48 hours, and then immersed in 30% sucrose solution. Thereafter, frozen bone tissue was frozen and cryocut was used to cut the sagittal sections of the tibia proximal part every 40 μm and collected and used as tissue samples. Sections were then used for length growth analysis.
성장의 측정을 위해 성장판과 테트라사이클린(tetracycline)으로 침착되어 발색한 발광선과의 간격을 형광현미경으로 측정하였고(Hansson et al., Calcified Tissue Research, 10(3), 238, 1972, 도 1), 각 절편마다의 평균값을 산출하였다. 모든 절차는 2명의 관찰자에 의해 맹검법으로 측정되었다. 결과는 평균 ± 표준편차로 표현되었으며, 모든 그룹간의 차이는 스튜던트-T 테스트(Student-T test) 검정법으로 하고 표준편차에서 유의한 차이가 있으나 검정이 적절치 않은 경우에는 크루스칼-왈리스 테스트(Kruskall-Wallis test) 검정법을 이용하였다. In order to measure the growth, the distance between the growth plate and the emission line developed by tetracycline was measured by fluorescence microscopy (Hansson et al., Calcified Tissue Research, 10 (3), 238, 1972, FIG. 1), The average value for each section was calculated. All procedures were blinded by two observers. The results were expressed as mean ± standard deviation, and the difference between all groups was the Student-T test test and there was a significant difference in the standard deviation, but the Kruskall-Wallis test was not appropriate. Wallis test) was used.
그 결과, 복합생약재 추출물의 투여(실시예 1 내지 5 및 표 1)는 음성 대조군 및 단일 약재의 추출물(비교예 1, 비교예 2 및 표 2) 투여군 보다 통계적으로 유의하게 성장을 가져왔다. 도 2는 표 3의 결과 중 음성 대조군, 양성 대조군, 비교예 1, 비교예 2 및 실시예 1의 성장을 나타낸 것이다. *는 P< 0.05를 나타낸다. As a result, the administration of the composite herbal extracts (Examples 1 to 5 and Table 1) resulted in a statistically significant growth than the negative control group and the extract of the single herbal extracts (Comparative Example 1, Comparative Example 2 and Table 2). Figure 2 shows the growth of the negative control group, the positive control group, Comparative Example 1, Comparative Example 2 and Example 1 of the results of Table 3. * Represents P <0.05.
또한 식염수를 투여한 음성 대조군의 성장을 100%로 하였을 경우, 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1) 투여군, 단일 약재의 추출물(비교예 1, 비교예 2 및 표 2) 투여군 및 양성 대조군의 성장률을 계산하여 보았다. 그 결과, 역시 복합생약제 추출물(HT030, 실시예 1 내지 5 및 표 1) 투여군의 성장률은 음성 대조군, 단일 약재의 추출물 투여군 보다 유의성 있게 높았다. 도 3은 표 3의 결과 중 음성 대조군, 양성 대조군, 비교예 1, 비교예 2 및 실시예 1의 성장률을 나타낸 것이다. * 는 P < 0.05를 나타낸다. In addition, when the growth rate of the negative control group administered with saline was 100%, the combination herbal extract (HT030, Examples 1 to 5 and Table 1) administration group, the extract of a single medicine (Comparative Example 1, Comparative Example 2 and Table 2) administration group And the growth rate of the positive control was calculated. As a result, the growth rate of the administration group of the composite herbal extracts (HT030, Examples 1 to 5 and Table 1) was significantly higher than the negative control group, the extract administration group of a single herb. Figure 3 shows the growth rate of the negative control, positive control, Comparative Example 1, Comparative Example 2 and Example 1 of the results of Table 3. * Represents P <0.05.
통계학적 검정 : student-T testStatistical test: student-T test
* : P < 0.05 * : P <0.05
1)계산식 = 100 + (실험군 길이성장 - 음성 대조군 길이성장)/음성 대조군 길이성장×100 1) Formula = 100 + (Experimental Length Growth-Negative Control Length Growth) / Negative Control Length Growth × 100
<실험예 2> 생약복합재Experimental Example 2 Medicinal Herb Composites 추출물(HT030)의 급성 독성실험Acute Toxicity Test of Extract (HT030)
생약복합재 추출물(HT030)에 대한 급성 독성을 알아보기 위하여, 하기와 같은 실험을 수행하였다.In order to determine the acute toxicity of the herbal extract (HT030), the following experiment was performed.
4주령의 특정 병원체 부재(SPF, specific pathogens free) ICR계 마우스를 암수 각각 3 마리씩 4개군(암수 각각 3마리/실험군)으로 나누어, 온도 22 ± 3℃, 습도 55 ± 10%, 조명 12L/12D 조건의 동물실 내에서 사육하였다. 마우스는 실험에 사용되기 전 1주일 정도 순화시켰다. 실험 동물용 사료(마우스 및 랫트용, Dyets, 미국) 및 음수를 멸균한 후 공급하였으며 자유 섭취시켰다.SPF (specific pathogens free) ICR mice divided into 4 groups (3 males and 3 females / experimental group) at 4 weeks of age, temperature 22 ± 3 ° C, humidity 55 ± 10%, illumination 12L / 12D It was bred in a condition animal room. Mice were allowed to acclimate for about a week before being used in the experiment. Feed for experimental animals (for mice and rats, Dyets, USA) and negative water were supplied after sterilization and free intake.
상기 실시예에서 제조한 생약복합재 추출물(HT030)을 0.5% 트윈(tween) 80에 50 ㎎/㎖ 농도로 조제한 후, 마우스 체중 20 g 당 0.04 ㎖(100 ㎎/㎏), 0.2 ㎖(500 ㎎/㎏) 및 0.4 ㎖(1,000 ㎎/㎏)씩 경구 투여하였다. 시료는 단회 경구 투여하였으며, 투여 후 7일 동안 다음과 같이 부작용 또는 치사 여부를 관찰하였다. 즉, 투여 당일은 투여 후 1 시간, 4 시간, 8 시간, 12 시간 뒤에, 그리고 투여 익일부터 7 일째까지는 매일 오전, 오후 1 회 이상씩 일반 증상의 변화 및 사망 동물의 유무를 관찰하였다. 또한, 투여 7 일째에 동물을 치사시켜 해부한 후 육안으로 내부 장기를 검사하였다. 투여 당일부터 1일 간격으로 체중의 변화를 측정하여 생약복합재 추출물(HT030)에 의한 동물의 체중 감소 현상을 관찰하였다.After preparing the herbal compound extract (HT030) prepared in the above example at a concentration of 50 mg / ml in 0.5
실험 결과, 시료를 투여한 모든 마우스에서 특기할 만한 임상증상이 나타나지 않았고 폐사된 마우스도 없었으며, 또한 체중변화, 혈액검사, 혈액생화학 검사, 부검소견 등에서도 독성변화는 관찰되지 않았다.As a result, no significant clinical symptoms were observed in all the mice treated with the sample, no mice died, and no toxicity change was observed in weight change, blood test, blood biochemistry test, autopsy findings, etc.
그러므로 생약복합재 추출물(HT030)은 모든 마우스에서 1,000 ㎎/㎏까지 독성변화를 나타내지 않았으며, 경구투여 최소치사량(LD50)이 1,000 ㎎/㎏ 이상인 안전한 물질로 판단되었다.Therefore, the herbal extract (HT030) did not show any toxicity change up to 1,000 mg / kg in all mice, and it was judged as a safe substance with oral administration minimum dose (LD 50 ) of 1,000 mg / kg or more.
하기에 본 발명의 조성물을 위한 제제예를 예시한다.Examples of preparations for the compositions of the present invention are illustrated below.
<제제예 1> 약학적 제제의 제조Preparation Example 1 Preparation of Pharmaceutical Formulation
<1-1> 주사제제의 제조<1-1> Preparation of Injection
생약복합재 추출물(HT030) 10 ㎎Medicinal Herb Extract (HT030) 10 mg
소디움 메타비설파이트 3.0 ㎎Sodium Metabisulfite 3.0 mg
메틸파라벤 0.8 ㎎Methylparaben 0.8 mg
프로필파라벤 0.1 mgPropylparaben 0.1 mg
주사용 멸균증류수 적량Appropriate sterile distilled water for injection
상기의 성분을 혼합하고 통상의 방법으로 2 ㎖로 한 후, 2 ㎖ 용량의 앰플에 충전하고 멸균하여 주사제를 제조한다.The above ingredients are mixed and made into 2 ml by a conventional method, and then filled into 2 ml ampoules and sterilized to prepare an injection.
<1-2> 정제의 제조<1-2> Preparation of Tablet
생약복합재 추출물(HT030) 200 ㎎Medicinal Herb Extract (HT030) 200 mg
유당 100 ㎎
전분 100 ㎎
스테아린산 마그네슘 적량Magnesium stearate proper amount
상기의 성분을 혼합하고 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다.The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.
<1-3> 캡슐제의 제조<1-3> Preparation of Capsule
생약복합재 추출물(HT030) 10 ㎎Medicinal Herb Extract (HT030) 10 mg
유당 50 ㎎Lactose 50 mg
전분 50 ㎎Starch 50 mg
탈크 2 ㎎Talc 2 mg
스테아린산 마그네슘 2 ㎎2 mg magnesium stearate
상기의 성분을 혼합하고 통상의 캡슐제의 제조방법에 따라서 젤라틴 캡슐에 충전하여 캡슐제를 제조한다.Capsules are prepared by mixing the above ingredients and filling into gelatin capsules according to a conventional method for preparing capsules.
<1-4> 액제의 제조<1-4> Preparation of Liquid
생약복합재 추출물(HT030) 1000 ㎎Medicinal Herb Extract (HT030) 1000 mg
설탕 20 g20 g of sugar
이성화당 20 g20 g of isomerized sugar
레몬향 적량Lemon flavor
정제수를 가하여 전체 1000 ㎖로 맞추었다. 통상의 액제의 제조방법에 따라 상기의 성분을 혼합한 다음, 갈색병에 충전하고 멸균시켜 액제를 제조한다.Purified water was added to adjust the total volume to 1000 ml. According to the conventional method for preparing a liquid, the above components are mixed, and then filled into a brown bottle and sterilized to prepare a liquid.
<제제예 2> 식품의 제조Preparation Example 2 Preparation of Food
<2-1> 건강보조식품의 제조<2-1> Preparation of Health Supplements
생약복합재 추출물(HT030) 1000 ㎎Medicinal Herb Extract (HT030) 1000 mg
비타민 혼합물 적량Vitamin mixture proper amount
비타민 A 아세테이트 70 ㎍70 μg of Vitamin A Acetate
비타민 E 1.0 ㎎Vitamin E 1.0 mg
비타민 B1 0.13 ㎎Vitamin B1 0.13 mg
비타민 B2 0.15 ㎎Vitamin B2 0.15 mg
비타민 B6 0.5 ㎎Vitamin B6 0.5 mg
비타민 B12 0.2 ㎍0.2 μg of vitamin B12
비타민 C 10 ㎎Vitamin C 10 mg
비오틴 10 ㎍10 μg biotin
니코틴산아미드 1.7 ㎎Nicotinic Acid 1.7 mg
엽산 50 ㎍50 μg folic acid
판토텐산 칼슘 0.5 ㎎Calcium Pantothenate 0.5mg
무기질 혼합물 적량Mineral mixture
황산제1철 1.75 ㎎Ferrous Sulfate 1.75 mg
산화아연 0.82 ㎎Zinc Oxide 0.82 mg
탄산마그네슘 25.3 ㎎Magnesium carbonate 25.3 mg
제1인산칼륨 15 ㎎Potassium monophosphate 15 mg
제2인산칼슘 55 ㎎Dibasic calcium phosphate 55 mg
구연산칼륨 90 ㎎
탄산칼슘 100 ㎎
염화마그네슘 24.8 ㎎Magnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 건강보조식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 건강보조식품 제조방법에 따라 상기의 성분을 혼합한 다음, 통상의 방법에 따라 건강보조식품 조성물 제조(예, 영양캔디 등)에 사용할 수 있다.Although the composition ratio of the vitamin and mineral mixture is a composition suitable for a relatively healthy supplement in a preferred embodiment, the composition ratio may be arbitrarily modified, and the above components are mixed according to a conventional dietary supplement manufacturing method. Then, it can be used for preparing a dietary supplement composition (eg, nutrition candy, etc.) according to a conventional method.
<2-2> 밀가루 식품의 제조<2-2> Preparation of Flour Food
생약복합재 추출물(HT030) 0.1 ~ 10.0 중량부를 밀가루에 첨가하고, 이 혼합물을 이용하여 통상의 방법으로 빵, 케이크, 쿠키, 크래커 및 면류를 제조하여 건강 증진용 식품을 제조하였다.Herb compound composite extract (HT030) 0.1 ~ 10.0 parts by weight was added to the flour, and using this mixture to prepare bread, cake, cookies, crackers and noodles in a conventional manner to prepare a food for health promotion.
<2-3> 스프 및 육즙(gravies)의 제조<2-3> Preparation of Soups and Gravys
생약복합재 추출물(HT030) 0.1 ~ 1.0 중량부를 스프 및 육즙에 첨가하여 통상의 방법으로 건강 증진용 육가공 제품, 면류의 수프 및 육즙을 제조하였다.Herbal medicine composite extract (HT030) 0.1 ~ 1.0 parts by weight was added to soup and gravy to prepare a health-promoting meat products, soup of noodles and gravy in a conventional manner.
<2-4> 그라운드 비프(ground beef)의 제조<2-4> Preparation of Ground Beef
생약복합재 추출물(HT030) 10 중량부를 그라운드 비프에 첨가하여 통상의 방법으로 건강 증진용 그라운드 비프를 제조하였다.10 parts by weight of the herbal compound extract (HT030) was added to the ground beef to prepare a ground beef for health promotion in a conventional manner.
<2-5> 유제품(dairy products)의 제조<2-5> Production of Dairy Products
생약복합재 추출물(HT030) 0.1 ~ 1.0 중량부를 우유에 첨가하고, 상기 우유를 이용하여 통상의 방법으로 버터 및 아이스크림과 같은 다양한 유제품을 제조하였다.Herb compound composite extract (HT030) 0.1 ~ 1.0 parts by weight was added to the milk, using the milk to prepare a variety of dairy products such as butter and ice cream in a conventional manner.
<2-6> 선식의 제조<2-6> Preparation of Wire
현미, 보리, 찹쌀, 율무를 공지의 방법으로 알파화시켜 건조시킨 것을 배전한 후 분쇄기로 입도 60 메쉬의 분말로 제조하였다.Brown rice, barley, glutinous rice, and yulmu were alphad by a known method, and then dried and roasted to prepare a powder having a particle size of 60 mesh.
검정콩, 검정깨, 들깨도 공지의 방법으로 쪄서 건조시킨 것을 배전한 후 분쇄기로 입도 60 메쉬의 분말로 제조하였다.Black beans, black sesame seeds, and perilla were also steamed and dried by a known method, and then ground to a powder having a particle size of 60 mesh.
생약복합재 추출물(HT030)을 진공 농축기에서 감압, 농축하고, 분무, 열풍건조기로 건조하여 얻은 건조물을 분쇄기로 입도 60 메쉬로 분쇄하여 건조분말을 얻었다.The herbal compound extract (HT030) was decompressed and concentrated in a vacuum concentrator, dried by spraying and drying with a hot air dryer, and ground to a particle size of 60 mesh using a grinder to obtain a dry powder.
상기에서 제조한 곡물류, 종실류 및 생약복합재 추출물(HT030)의 건조분말을 다음의 비율로 배합하여 통상의 방법으로 제조하였다.The dry powders of the grains, seeds and herbal extracts (HT030) prepared above were blended in the following ratio to prepare a conventional method.
곡물류(현미 30 중량부, 율무 15 중량부, 보리 20 중량부),Cereals (30 parts by weight brown rice, 15 parts by weight brittle, 20 parts by weight of barley),
종실류(들깨 7 중량부, 검정콩 8 중량부, 검정깨 7 중량부),Seeds (7 parts by weight perilla, 8 parts by weight black beans, 7 parts by weight black sesame seeds),
생약복합재 추출물(HT030)의 건조분말(1 중량부),Dry powder (1 part by weight) of the herbal extract extract (HT030),
영지(0.5 중량부),Ganoderma lucidum (0.5 parts by weight),
지황(0.5 중량부)Foxglove (0.5 part by weight)
<제제예 3> 음료의 제조Preparation Example 3 Preparation of Beverage
<3-1> 건강 음료의 제조<3-1> Preparation of Healthy Drinks
생약복합재 추출물(HT030) 1000 ㎎Medicinal Herb Extract (HT030) 1000 mg
구연산 1000 ㎎Citric acid 1000 mg
올리고당 100 g100 g oligosaccharides
매실농축액 2 gPlum concentrate 2 g
타우린 1 g1 g of taurine
정제수를 가하여 전체 900 ㎖Add 900 ml of purified water
통상의 건강음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1 시간동안 85℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2 ℓ용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 건강음료 조성물 제조에 사용한다. After mixing the above components according to the conventional healthy beverage production method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed sterilization and refrigerated and then Used to prepare the healthy beverage composition of the invention.
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 수요계층, 수요국가, 사용 용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다.Although the composition ratio is a composition suitable for a preferred beverage in a preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, use purpose.
<3-2> 야채쥬스의 제조<3-2> Preparation of Vegetable Juice
생약복합재 추출물(HT030) 0.5 g을 토마토 또는 당근 등의 야채의 쥬스 1,000 ㎖에 가하여 통상의 방법으로 건강 증진용 야채쥬스를 제조하였다.0.5 g of the herbal compound extract (HT030) was added to 1,000 ml of vegetable juice such as tomato or carrot to prepare a vegetable juice for health promotion in a conventional manner.
<3-3> 과일쥬스의 제조<3-3> Preparation of fruit juice
생약복합재 추출물(HT030) 0.1 g을 사과 또는 포도 등의 과일의 쥬스 1,000 ㎖에 가하여 통상의 방법으로 건강 증진용 과일쥬스를 제조하였다.0.1 g of the herbal extract extract (HT030) was added to 1,000 ml of fruit juices such as apples or grapes to prepare fruit juice for health promotion in a conventional manner.
상기와 같이, 본 발명의 속단 및 두충으로 구성된 생약복합재 추출물은 성장에 효과를 나타내므로, 골길이 성장 촉진용 약학적 조성물에 이용될 수 있을 뿐 아니라 건강보조식품으로도 이용 가능하다. As described above, the herbal extract of the present invention consisting of fast and soybean extract is effective in growth, not only can be used in the pharmaceutical composition for promoting bone growth, but also as a dietary supplement.
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