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KR920002161B1 - Method for preparing dietary fiber derived from diabetes treatment and herbal medicine - Google Patents

Method for preparing dietary fiber derived from diabetes treatment and herbal medicine Download PDF

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KR920002161B1
KR920002161B1 KR1019880004814A KR880004814A KR920002161B1 KR 920002161 B1 KR920002161 B1 KR 920002161B1 KR 1019880004814 A KR1019880004814 A KR 1019880004814A KR 880004814 A KR880004814 A KR 880004814A KR 920002161 B1 KR920002161 B1 KR 920002161B1
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dietary fiber
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박대규
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조선무약 합자회사
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract

내용 없음.No content.

Description

당뇨병 치료제 및 생약 유래 식이성 섬유의 제조방법Method for preparing dietary fiber derived from diabetes treatment and herbal medicine

제1도는 본 발명의 방법에 따라 제조한 식이성 섬유(CSP)를 12주간 경구투여했을 때 환자의 혈당치 변화를 공복시 및 식후 2시간후 측정한 수치의 변화도표이다.FIG. 1 is a change chart of the measured values of blood glucose levels of patients on fasting and 2 hours after eating orally administered dietary fiber (CSP) prepared according to the method of the present invention for 12 weeks.

본 발명은 항당뇨병약(혈당강하제)에 관한 것으로, 상세하게는 생약 63종으로부터 유래된 식이성 섬유의 제조방법 및 이를 함유한 항당뇨병약의 제조방법에 관한 것이다.The present invention relates to an anti-diabetic drug (hypoglycemic agent), and more particularly, to a method for producing dietary fiber derived from 63 herbal drugs and a method for producing an anti-diabetic drug containing the same.

종래부터 생약중 백합과에 속하는 지모(Anemarrhea asphodeloides Bunge)의 수성액기스는 경구투여에 의하여 혈당강하작용을 갖는다는 것이 알려져 있고(일본임상, 제25권, 2841면, 1967 및 일본공고특허 평1-25724참조), 물론 수종의 합성 경구 혈당강하제 및 인슐린(insulin)이 그동안 사용되어 왔으나, 이들 합성 경구 약제는 작용이 강하여 이상 저혈당이나 유산아시도시스를 야기하는등 부작용이 있을 뿐만 아니라 효과면에서 소아형 당뇨병에는 무효하다는 문제가 있으며, 인슐린은 유효성면에서는 최고이나 주사에 의한 투여가 불편하며 저혈당이나 알러지등의 부작용을 수반하므로 의사에 의한 신중한 관리하 투여가 바람직하였다.It has been known that aqueous extracts of Anemarrhea asphodeloides Bunge belonging to the family Liliaceae have a hypoglycemic action by oral administration (Japanese clinical trial, vol. 25, p. 2841, 1967 and Japanese Patent Publication No. 1--1). Of course, several synthetic oral hypoglycemic agents and insulin have been used for some time, but these synthetic oral medications have strong side effects such as abnormal hypoglycemia or lactic acidosis. There is a problem in that it is invalid, insulin is best in terms of efficacy, but the administration by injection is inconvenient and accompanied by side effects such as hypoglycemia or allergy, it was preferable to administer under careful management by a doctor.

이와 같은 제제 투여상의 단점 및 부작용이 있는 약제밖에 없는 상황에서도 매년 당뇨벙 환자는 증가하고 있어, 지금까지의 제제보다는 부작용이 적고 투여방법이 손쉬운 항당뇨병약의 출현이 요구되어 왔고, 이와 같은 사정을 감안하여 본 발명자는 우수한 항당뇨병약의 개발을 연구하던중 본 발명의 신규한 항당뇨병약을 개발하기에 이르른 것이다.Even in the situation where there are only drugs with disadvantages and side effects of the administration of such preparations, the number of patients with diabetes increases every year, and the emergence of anti-diabetic medicines with fewer side effects and easier administration methods has been required. In view of the above, the present inventors came to develop a novel antidiabetic medicine of the present invention while studying the development of an excellent antidiabetic medicine.

본 발명은 전통 한약서에 수재되어 소갈, 구건, 수척등에 광범위하게 사용되는 인삼산, 자음영양탕, 생백피탕, 문둥음자, 황기탕, 황연지황탕, 죽엽석고탕, 탕격산, 운림윤신환, 천지원 등 처방을 응용하여 전통약물로 사용되는 갈근 등 63종의 생약, 즉 갈근, 향부자, 상백피, 맥문동, 천문동, 황련, 치자, 황금, 박하, 죽엽, 활석, 석고, 대황, 황백, 반하, 백삼, 감초, 육계, 괄루인, 진피, 지모, 한수석, 산사, 신곡, 지실, 당귀, 백작약, 숙지황, 백출, 황기, 백복령, 연자육, 산약, 육종용, 오미자, 망초, 지골피, 연교, 후박, 우슬, 자단향, 사상자, 비해, 구기자, 복분자, 맥아, 산수유, 목단피, 육두구, 소백피, 익지인, 목통, 백자인, 석곡, 천궁, 행인, 목과, 청피, 금은화, 황정, 토사자, 석창포, 용안육으로부터 혈당 강하작용을 나타내는 식이성 섬유(C.S.P라 명명함)를 제조하는 방법 및 이를 함유한 항당뇨병약을 제공하고자 하는 것이다. 보다 구체적으로는, 본 발명에 있어서 식이성 섬유(CSP)는 생약재료 및 조성으로서, 갈근 0.935-1.265%, 향부자 0.935-1.265%, 상백피 0.935-1.265%, 맥문동 0.935-1.265%, 천문동 0.935-1.265%, 황련 0.935-1.265%, 치자 0.935-1.265%, 황금 0.935-1.265%, 박하 0.935-1.265%, 죽엽 0.935-1.265%, 활석 1.87-2.53%, 석고 1.87-2.53%, 대황 4.25-5.75%, 황백 0.935-1.265%, 반하 0.935-1.265%, 백삼 0.935-1.265%, 감초 0.935-1.265%, 육계 0.935-1.265%, 괄루인 4.25-5.75%, 진피 0.935-1.265%, 지모 0.935-1.265%, 한수석 0.935-1.265%, 산사 0.935-1.265%, 신곡 0.935-1.265%, 지실 0.935-1.265%, 당귀 4.25-5.75%, 백작약 4.25-5.75%, 숙지황 1.87-2.53%, 백출 0.935-1.265%, 황기 0.935-1.265%, 백복령 0.935-1.265%, 연자육 0.935-1.265%, 산약 2.635-3.565%, 육종용 0.935-1.265%, 오미자 0.935-1.265%, 망초 0.935-1.265%, 지골피 0.935-1.265%, 연교 0.935-1.265%, 후박 0.935-1.265%, 우슬 0.935-1.265%, 자단향 2.635-3.565%, 사상자 0.935-1.265%, 비해 0.935-1.265%, 구기자 0.935-1.265%, 복분자 0.935-1.265%, 맥아 0.935-1.265%, 산수유 0.935-1.265%, 목단피 0.935-1.265%, 육두구 0.935-1.265%, 소백피 0.935-1.265%, 익지인 0.935-1.265%, 목통 0.935-1.265%, 백자인 0.935-1.265%, 석곡 0.935-1.265%, 천궁 4.25-5.75%, 행인 0.935-1.265%, 목과 0.935-1.265%, 청피 0.935-1.265%, 금은화 0.935-1.265%, 황정 4.25-5.75%, 토사자 0.935-1.265%, 석창포 0.935-1.265%, 용안육 0.935-1.265%의 구성비에 해당하는 생약을 조절 또는 세절로 하여 에탄올 또는 에텔과 같은 유기용매로 추출하여 그 잔사를 원심분리하여 건조한 다음 가루로 만든 것이다.The present invention is widely used in traditional Chinese medicine, Sosam, Gueun, Tang, etc., widely used for Sogal, Gueun Nutrition, Saengbaekpitang, Mundongumja, Hwanggitang, Hwangyeonjihwangtang, bamboo leaf stone tang, Tanggeoksan, Unlimyunshinhwan, Cheonjiwon, etc. 63 kinds of herbal medicines such as brown root, which is used as a traditional medicine by applying the prescription, such as brown root, hyangbuja, baekbaek-dong, mackmun-dong, astronomical dong, yellow lotus, gardenia, golden, peppermint, bamboo leaf, talc, gypsum, rhubarb, yellow white, halved, white ginseng, licorice , Broiler, Glutinous, Dermis, Jimo, Hansuseok, Sansa, Singok, Jisil, Angelica, Count, Baekryok, Sugiji, Baekchul, Astragalus, Baekbokryeong, Yeonjak, Sanctuary, Breeding, Schisandra chinensis, Forage, Gigolpi, Yeongwa, Hakja, Wooseol, Rosewood incense, Casualties, comparison, Goji, bokbunja, malt, cornus, neck, skin, nutmeg, small white skin, ripe, neck, white porcelain, Seokgok, Cheongung, pedestrians, neck and skin, cheongpi, gilding, royal, earthenware, Seokpo, Yongan Dietary fiber (named CSP) It is to provide a method and an antidiabetic drug containing the same. More specifically, in the present invention, dietary fiber (CSP) is a herbaceous ingredient and composition, which is 0.935-1.265% brown root, 0.935-1.265% hyangbuja, 0.935-1.265% sangbaekpi, 0.935-1.265%, cheonmundong 0.935-1.265 %, Yellow flower 0.935-1.265%, gardenia 0.935-1.265%, golden 0.935-1.265%, mint 0.935-1.265%, bamboo leaf 0.935-1.265%, talc 1.87-2.53%, gypsum 1.87-2.53%, rhubarb 4.25-5.75%, Yellow white 0.935-1.265%, half 0.935-1.265%, white ginseng 0.935-1.265%, licorice 0.935-1.265%, broiler 0.935-1.265%, kalugin 4.25-5.75%, dermis 0.935-1.265%, jimo 0.935-1.265%, Hanseok 0.935-1.265%, Sansa 0.935-1.265%, New Song 0.935-1.265%, Fruits 0.935-1.265%, Angelica 4.25-5.75%, Earl of 4.25-5.75%, Sukji-hwang 1.87-2.53%, Baekchul 0.935-1.265%, Astragalus 0.935- 1.265%, Baekbokryeong 0.935-1.265%, Yeonjak 0.935-1.265%, Poisonous 2.635-3.565%, Breeding 0.935-1.265%, Schisandra chinensis 0.935-1.265%, Forget-me-not 0.935-1.265%, Phalanx 0.935-1.265%, Yeongyo 0.935-1.265% , Thickening 0.935-1.265%, right side 0.935-1.265%, rosewood 2.635-3.565%, Box 0.935-1.265%, compared with 0.935-1.265%, wolfberry 0.935-1.265%, Bokbunja 0.935-1.265%, malt 0.935-1.265%, Cornus 0.935-1.265%, Bark skin 0.935-1.265%, Nutmeg 0.935-1.265%, Sobaekpi 0.935-1.265%, ripe 0.935-1.265%, neck 0.935-1.265%, white porcelain 0.935-1.265%, Seokgok 0.935-1.265%, Cheongung 4.25-5.75%, pedestrian 0.935-1.265%, throat and 0.935-1.265%, cheongju 0.935 -1.265%, gold and silver coins 0.935-1.265%, yellow gold 4.25-5.75%, earthenware 0.935-1.265%, Seokchangpo 0.935-1.265%, dragon meat 0.935-1.265% Extracted with an organic solvent, the residue was centrifuged, dried and pulverized.

즉, 생약을 에탄올로 환류 추출하고 원심분리하여 얻은 잔사에, 염화칼슘액과 α-아미라제를 가하고 가온한 후 pH를 3.8-4.8로 조절한 후 여기에 글루코아미라제를 가한 후 원심분리하고, 알카리 및 산처리한 후 정제수를 가하여 원심분리한 잔사를 건조하고 세말화함을 특징으로 하는 생약 유래 식이성 섬유의 제조방법과 이와같이 제조된 식이성 섬유를 항당뇨병약으로 사용가능하도록 제제화하는 방법을 특징으로 한다.In other words, the crude drug was extracted with reflux with ethanol and centrifuged to remove the residue. After adding calcium chloride solution and α-amylase and warming, the pH was adjusted to 3.8-4.8, after which glucoamylase was added and centrifuged. And a method of producing a herbal medicine-derived dietary fiber, characterized in that the residue is centrifuged by drying with purified water and then subjected to purified water, and a method of formulating the dietary fiber so prepared for use as an anti-diabetic drug. do.

본 발명에 따라 제조된 생약 유래 식이성 섬유질은 후기하는 실험을 통하여 제1도에서 보는 바와 같이 고혈당 억제효과가 있으며 임상시험에서도 현저한 효능이 있음이 증명되었다.The herbal fiber-derived dietary fiber prepared according to the present invention has a hyperglycemic inhibitory effect as shown in FIG.

본 발명에서 제시한 식이성 섬유질은 이스트우드(Eastwood)와 미첼(mitchell)이 주장한 구조상의 고분자인 폴리사카라이드(polysaccharide), 셀룰로오즈(cellulose), 헤미셀룰로오스(hemicellulose) 및 리그닌(Lignin)등으로 구성되며, 이것들을 복용할 경우 젠키스(Jenkis), 시마(Shima) 강(岡)등이 주장한 부피효과로 만복감을 주어 식사요법 준수를 용이하게 하며, 영양물 특히 당질의 흡수를 지연시켜 과혈당의 출현을 방지시키는 생약 유래 식이성 섬유질이다.The dietary fiber proposed in the present invention is composed of polysaccharides, cellulose, hemicellulose and lignin, which are structural polymers claimed by Eastwood and Mitchell. When taken, the volume effect claimed by Jenkis, Shima, etc. gives a feeling of fullness, making it easy to observe meal therapy, and delaying the absorption of nutrients, especially sugars, thus preventing the appearance of hyperglycemia. It is a herbal fiber derived dietary fiber.

이하, 본 발명의 실시예를 기재한다.Hereinafter, the Example of this invention is described.

[실시예 1]Example 1

상기 생약 갈근 11g, 향부자 11g, 상백피 11g, 맥문동 11g, 천문동 11g, 황련 11g, 치자 11g, 황금 11g, 박하 11g, 죽엽 11g, 활석 22g, 석고 22g, 대황 50g, 황백 11g, 반하 11g, 백삼 11g, 감초 11g, 육계 11g, 괄루인 50g, 진피 11g, 지모 11g, 한수석 11g, 산사 11g, 신곡 11g, 지실 11g, 당귀 50g, 백작약 50g, 숙지황 22g, 백출 11g, 황기 11g, 백복령 11g, 연자육 11g, 산약 31g, 육종용 11g, 오미자 11g, 망초 11g, 지골피 11g, 연교 11g, 후박 11g, 우슬 11g, 자단향 31g, 사상자 11g, 비해 11g, 구기자 11g, 복분자 11g, 맥아 11g, 산수유 11g, 목단피 11g, 육두구 11g, 소백피 11g, 익지인 11g, 목통 11g, 백자인 11g, 석곡 11g, 천궁 50g, 행인 11g, 목과 11g, 청피 11g, 금은화 11g, 황정 50g, 토사자 11g, 석창포 11g, 용안육 11g을 55℃에서 저온 건조하여 수분함량을 약 7% 이하로 한후 조절로 절단한 후 그중 1000g을 달아 여기에 85%의 에탄올 6리터를 가하고 수육상에서 환류냉각기를 설치하여 2시간 추출하고 원심분리하여 잔사를 3회 정제수로 세척한다.The herbal medicine roots 11g, Hyangbuja 11g, lettuce white 11g, Mcmundong 11g, astronomical 11g, yellow ginseng 11g, gardenia 11g, golden 11g, mint 11g, bamboo leaf 11g, talc 22g, gypsum 22g, rhubarb 50g, yellow white 11g, half g 11g, white ginseng 11g, Licorice 11g, broiler 11g, glutinous 50g, dermis 11g, gimo 11g, Hansuseok 11g, hawthorn 11g, new song 11g, fruit room 11g, Angelica 50g, Baekjak 50g, Sukjiwang 22g, Baekchul 11g, Astragalus 11g, Baekbokyeong 11g, Yeonjak 11g 31g, 11g for breeding, 11g for Schisandra chinensis, 11g forget-me-not, 11g, Golgolpig 11g, Yeongyo 11g, Thick 11g, Walnut 11g, Rosewood fragrance 31g, Casuall 11g, 11g, Wolfberry 11g, Bokbunja 11g, Malt 11g, Cornus 11g, Bark 11g, Nutmeg 11g, 11g bovine skin, 11g raw, 11g barrel, 11g white porcelain, 11g, Seokgok 11g, Cheongung 50g, almond 11g, neck and 11g, Cheongpi 11g, gold and silver 11g, yellow gold 50g, earthenware 11g, 11g Seokchangpo, 11g longan meat at 55 ℃ After adjusting the water content to about 7% or less, cut it with a control, and weigh 1000g of it, and add 85% of ethanol 6 Add liters, install reflux condenser on the water, extract for 2 hours, centrifuge and wash the residue with purified water three times.

여기에 3배량의 0.002M 염화칼슘(CaCl2) 액과 α-아미라제 20g을 가하여 90℃에서 40분간 가온하고 여기에 초산을 가하여 pH 4.5로 조절하고 글로코아미라제(glucoamylase) 40,000단위를 가하여 40℃에서 70시간 항온으로 유지한 다음 원심분리하고(3회이상 원심분리 반복) 다시 수산화나트륨(NaOH)로 pH 7로 조절하고 그 잔사에 3배량의 pH 8의 인산 완충용액을 가하여 35℃에서 6시간 항온으로 유지한 다음 원심분리(2회 이상 정제수를 가하여 반복)하여 그 잔사를 85℃에서 건조하여(수분함량 7% 이하) 세말(수율 77%)을 얻는다.To this, add 3 times of 0.002M calcium chloride (CaCl 2 ) solution and 20 g of α-amylase and warm it at 90 ° C. for 40 minutes, adjust acetic acid to pH 4.5 and add 40,000 units of glucoamylase to 40 After maintaining at constant temperature for 70 hours at 70 ℃ centrifugation (repeat 3 times or more), and again adjusted to pH 7 with sodium hydroxide (NaOH) and added 3 times the pH 8 phosphate buffer solution to the residue for 6 hours at 35 ℃ The solution is kept at a constant temperature and then centrifuged (repeated two times or more with purified water), and the residue is dried at 85 DEG C (water content of 7% or less) to obtain semal (yield 77%).

[실시예 2-3]Example 2-3

실시예별로 조성과 처리방법을 달리한 결과 다음과 같이 CPS 건조분말을 제조할 수 있었다.As a result of changing the composition and treatment method for each embodiment was able to prepare a CPS dry powder as follows.

Figure kpo00001
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본 발명에 따라 얻은 식이성 섬유(CSP)말은 약제학적으로 허용되는 1종이상의 담체를 포함한 제제로 투여되며 그 조성은 화합물의 용해도, 화학적성질, 투여경로, 투여계획등에 따라 결정된다.The dietary fiber (CSP) end obtained in accordance with the present invention is administered in a formulation containing at least one pharmaceutically acceptable carrier, the composition of which depends on the solubility, chemical properties, route of administration, dosing schedule, etc. of the compound.

예를 들면, 본 C.S.P는 전분, 유당, 백당등 적당한 부형제, 안정화제, 감미제, pH 조정제, 현탁화제, 향료등을 1종이상 함유한 과립제, 정제, 캅셀제, 환제, 액제 또는 현탁액제등의 형태로 경구 투여한다. 본 C.S.P의 투여량과 투여방법은 환자의 상태에 따라서 결정된다. 치료량은 일반적으로 경구투여로 50-1500mg/kg/ 일이다.For example, the present CSP is in the form of granules, tablets, capsules, pills, liquids or suspensions containing one or more suitable excipients, stabilizers, sweeteners, pH adjusters, suspending agents, fragrances, such as starch, lactose, and sucrose. Administered orally. The dosage and method of administration of C.S.P is determined by the condition of the patient. The therapeutic amount is usually 50-1500 mg / kg / day by oral administration.

또한, 급성 독성 실험에서는, 숫놈 마우스(평균 체중 20g)을 사용하여 본 C.S.P의 5% 현탁수용액으로 5,000mg/kg씩 7마리에 경구 투여하였으나 사망한 예는 없었다. 따라서, 본 발명에 따른 제품의 급성독성은 무시할 정도임을 알 수 있다.In the acute toxicity experiment, male mice (average body weight 20 g) were orally administered to 7 mice at 5,000 mg / kg in 5% suspension of C.S.P. Thus, it can be seen that the acute toxicity of the product according to the invention is negligible.

이하, 본 발명의 제제예와 임상시험 결과를 기재한다.Hereinafter, the preparation examples and clinical trial results of the present invention will be described.

[제제예 1][Example 1]

과립제Granules

실시예 1에서 얻은 식이성 섬유(CSP)말 200g에 메칠셀룰로스 20g을 가하여 잘 혼합한 다음 로라 콤팩타에서 압축, 분쇄 사별하여 과립제를 만든다. 용량은 성인기준 1일 3회, 증상에 따라 1회 4.6-9.2g을 식후 복용한다.20 g of methyl cellulose was added to 200 g of the dietary fiber (CSP) powder obtained in Example 1, mixed well, and then compressed and ground in a Laura compactor to form granules. Dosage should be taken after meals 4.6-9.2g three times a day for adults and once a symptom.

[제제예 2][Example 2]

정제refine

실시예 1에서 얻은 식이성섬유(CSP)말 200g에 메칠셀룰로스 20g 및 스테아린산 마그네슘 5g을 가하여 잘 혼합한 것을 로라 콤팩타에 넣고 압축, 분쇄 사별하여 얻은 과립제를 직접 타정하여 760mg 정제를 만든다. 용량은 성인기준 1일 3회, 증상에 따라 1회 6-12정을 식후 복용한다.200 g of dietary fiber (CSP) obtained in Example 1 was added 20 g of methyl cellulose and 5 g of magnesium stearate, which were mixed well into a Laura compactor. The granules obtained by compression and crushing were directly compressed to make 760 mg tablets. The dose should be taken 6-12 tablets three times a day for adults and once a symptom.

[제제예 3][Example 3]

캅셀제Capsule

실시예 1에서 얻은 식이성섬유(CSP)말 200g에 칼슘카르복시메칠셀룰로오스(칼슘 씨엠씨) 10g을 가하여 잘 혼합한 것을 로라 콤팩타에서 압축, 분쇄하여 20메쉬 채로 사별한 분말형의 과립을 경질캅셀에 500mg씩 충진하여 경질 캅셀을 제조한다. 용량은 성인기준 1일 3회, 증상에 따라 1회 9-18캅셀을 식후 복용한다.10 g of calcium carboxymethyl cellulose (calcium CMC) was added to 200 g of the dietary fiber (CSP) powder obtained in Example 1, and the powdery granules, which were compressed and pulverized in a Laura compactor, separated into 20 meshes, were placed into hard capsules. Filling 500mg each to prepare a hard capsule. Dosage should be taken 9-18 capsules 3 times a day for adults and once depending on symptoms.

[제제예 4 ][Example 4]

환제Pill

실시예 1에서 얻은 식이성섬유(CSP)말 200g에 옥수수 전분 5g, 물 60ml를 가하여 상법에 따라 제환한 다음 70℃ 건조실에서 건조하여 환제를 만든다. 1환의 중량은 90mg으로 한다. 용량은 성인기준 1일 3회, 증상에 따라 1회 4.6-9.2g을 식후 복용한다.To 200 g of dietary fiber (CSP) horse obtained in Example 1, 5 g of corn starch and 60 ml of water were added and refilled according to a conventional method, followed by drying in a 70 ° C. drying chamber to form pills. The weight of one ring is 90 mg. Dosage should be taken after meals 4.6-9.2g three times a day for adults and once a symptom.

[제제예 5][Example 5]

액제Liquid

실시예 1에서 얻은 식이성섬유(CSP)말 200g에 카르복시메칠셀룰로오스(씨엠씨) 65g 및 감미료, 향료를 적당량 가하고 물을 넣어 3,260ml되게 한다음 교반기에서 잘 교반하여 현탁화된 액제를 만든다. 용량은 성인기준 1일 3회, 1회 75ml씩을 식후 복용한다.To 200 g of the dietary fiber (CSP) powder obtained in Example 1, 65 g of carboxymethyl cellulose (CMC), sweetener, and fragrance are added in an appropriate amount to make 3,260 ml of water, followed by stirring well in a stirrer to prepare a suspended solution. Dosage should be taken after meals 75ml 3 times a day for adults.

[제제예 6][Example 6]

현탁액제Suspension

실시예 1에서 얻은 식이성섬유(CSP)말 200g에 카르복시메칠셀룰로오스(씨엠씨) 65g 및 감미료, 향료를 적당량 가하고 물을 넣어 860ml되게 한다음 교반기에서 잘 교반하여 현탁액제를 만든다. 용량은 성인기준 1일 3회, 증상에 따라 1회 20-40ml씩을 식후 복용한다.To 200 g of the dietary fiber (CSP) powder obtained in Example 1, 65 g of carboxymethyl cellulose (CMC), sweetener, and fragrance are added in an appropriate amount, and water is added to make 860 ml, followed by stirring in a stirrer to make a suspension. Dosage should be taken 20-40ml three times a day for adults and once a day depending on symptoms.

[임상시험][Clinical test]

당뇨병 환자 10명에 제제예 1에 따라 제조된 C.S.P 과립 4.6g을 1일 3회씩 12주간 투여하고, 공복시 및 식사 2시간 후에 채혈한 다음, 통상의 효소법에 준하여 Glucose 측정용 V-glucose(일본, 日本製藥) kit를 사용하여 투여 전후의 혈청중 glucose량을 측정한 결과를 하기 표 1에 기재하였다.Ten patients with diabetes were administered 4.6 g of CSP granules prepared according to Formulation Example 1 three times a day for 12 weeks, and blood samples were taken on an empty stomach and 2 hours after a meal, and then V-glucose for measuring Glucose (Japan, The results of measuring the amount of glucose in serum before and after administration using the kit were described in Table 1 below.

[표 1]TABLE 1

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정상적인 혈당수치 기준이 공복시는 100mg/dl 이하이고, 식후 2시간후에는 120mg/dl 이하임을 감안하여 볼 때, 본 발명품은 상기 표 1에서 볼 수 있는 바와 같이 8주를 투여하면 거의 모든 환자에서 혈당치가 정상에 가까울 정도로 저하됨을 알 수 있고, 12주를 투여한 결과 정상의 혈당치를 유지하고 있음을 알 수 있어, 본 발명의 항당뇨병 약제는 매우 우수한 약제임이 증명되었다.Given that the normal blood glucose level is 100 mg / dl or less on an empty stomach and 120 mg / dl or less 2 hours after a meal, the present invention provides blood glucose levels in almost all patients when 8 weeks are administered as shown in Table 1 above. It can be seen that the lowering to the close to normal, and 12 weeks of administration showed that it maintains the normal blood sugar level, the antidiabetic drug of the present invention proved to be a very good drug.

참고로, 상기 표 1에서 평균수치를 그라프로 도시하여 나타낸 것이 제1도로서 제1도에 의하면 투여 8주후부터는 매우 정상적인 혈당치로 유지되고 있음을 쉽게 확인할 수 있다.For reference, it is easy to confirm that the average value in the graph shown in Table 1 is shown in FIG. 1 as FIG. 1 and maintained in a very normal blood glucose level after 8 weeks of administration.

따라서, 본 발명은 산업적으로 매우 유용한 발명임을 알 수 있다.Therefore, it can be seen that the present invention is an industrially very useful invention.

Claims (3)

갈근, 향부자, 상백피, 맥문동, 천문동, 황련, 치자, 황금, 박하, 죽엽, 활석, 석고, 대황, 황백, 반하, 백삼, 감초, 육계, 괄루인, 진피, 지모, 한수석, 산사, 신곡, 지실, 당귀, 백작약, 숙지황, 백출, 황기, 백복령, 연자육, 산약, 육종용, 오미자, 망초, 지골피, 연교, 후박, 우슬, 자단향, 사상자, 비해, 구기자, 복분자, 맥아, 산수유, 목단피, 육두구, 소백피, 익지인, 목통, 백자인, 석곡, 천궁, 행인, 목과, 청피, 금은화, 황정, 토사자, 석창포, 용안육 생약을 에탄올로 환류추출하고 원심분리하여 얻은 잔사에, 염화칼슘액과 α-아미라제를 가하고 가온한 후 pH를 3.8-4.8로 조절한 후 여기에 글루코아미라제를 가한 후 원심분리하고 잔사를 건조하고 세말함을 특징으로 하는 생약 유래 식이성 섬유의 제조방법.Brown root, hyangbuja, baekbaekpi, makmundong, astronomical dong, yellow lotus, gardenia, golden, peppermint, bamboo leaf, talc, gypsum, rhubarb, yellow baek, half, white ginseng, licorice, broiler, gwalyeoin, dermis, jimo, hansuseok, sansa, new song, jisil , Angelica, Earl of Peony, Sukjihwang, Baekchul, Astragalus, Baekbokryeong, Yeonjuk, Poisonous medicine, Breeding, Schisandra chinensis, Forget-me-not, Peel, Peel, Yeonjak, Habakja, Rosewood incense, Casualties, Compared to wolfberry, Bokbunja, Malt, Cornus, Barley skin, Nutmeg, Sobaek Blood, ripe, neck, white porcelain, Seokgok, Cheongung, passersby, throat, green skin, silver coin, yellow flower, earth and sand, Seokchangpo, longan meat herbal reflux extract and centrifuged the calcium chloride solution and α-amylase Method of producing a herbal medicine-derived dietary fiber, characterized in that after adding and warming to adjust the pH to 3.8-4.8, and then add glucoamylase, centrifugation, drying the residue and washing. 제1항에 있어서, 각 생약의 조성비율을 갈근 0.935-1.265%, 향부자 0.935-1.265%, 상백피 0.935-1.265%, 맥문동 0.935-1.265%, 천문동 0.935-1.265%, 황련 0.935-1.265%, 치자 0.935-1.265%, 황금 0.935-1.265%, 박하 0.935-1.265%, 죽엽 0.935-1.265%, 활석 1.87-2.53%, 석고 1.87-2.53%, 대황 4.25-5.75%, 황백 0.953-1.265%, 반하 0.935-1.265%, 백삼 0.935-1.265%, 감초 0.935-1.265%, 육계 0.935-1.265%, 괄루인 4.25-5.75%, 진피 0.935-1.265%, 지모 0.935-1.265%, 한수석 0.935-1.265%, 산사 0.935-1.265%, 신곡 0.935-1.265%, 신곡 0.935-1.265%, 지실 0.935-1.265%, 당귀 4.25-5.75%, 백작약 4.25-5.75%, 숙지황 1.87-2.53%, 백출 0.935-1.265%, 황기 0.935-1.265%, 백복령 0.935-1.265%, 연자육 0.935-1.265%, 산약 2.635-3.565%, 육종용 0.935-1.265%, 오미자 0.935-1.265%, 망초 0.935-1.265%, 지골피 0.935-1.265%, 연교 0.935-1.265%, 후박 0.935-1.265%, 우슬 0.935-1.265%, 자단향 2.635-3.565%, 사상자 0.935-1.265%, 비해 0.935-1.265%, 구기자 0.935-1.265%, 복분자 0.935-1.265%, 맥아 0.935-1.265%, 산수유 0.935-1.265%, 목단피 0.935-1.265%, 육두구 0.935-1.265%, 소백피 0.935-1.265%, 익지인 0.935-1.265%, 목통 0.935-1.265%, 백자인 0.935-1.265%, 석곡 0.935-1.265%, 천궁 4.25-5.75%, 행인 0.935-1.265%, 목과 0.935-1.265%, 청피 0.935-1.265%, 금은화 0.935-1.265%, 황정 4.25-5.75%, 토사자 0.935-1.265%, 석창포 0.935-1.265%, 용안육 0.935-1.265%로 하여 추출함을 특징으로 하는 제조방법.According to claim 1, wherein the composition ratio of each herbal medicine is 0.935-1.265%, Hyangbuja 0.935-1.265%, Sangbaekpi 0.935-1.265%, Mcmun-dong 0.935-1.265%, Cheonmun-dong 0.935-1.265%, Hwangnyeon 0.935-1.265%, Gardenia 0.935 -1.265%, gold 0.935-1.265%, mint 0.935-1.265%, bamboo leaf 0.935-1.265%, talc 1.87-2.53%, gypsum 1.87-2.53%, rhubarb 4.25-5.75%, yellow white 0.953-1.265%, halves 0.935-1.265 %, White Ginseng 0.935-1.265%, Licorice 0.935-1.265%, Broiler 0.935-1.265%, Gwalior 4.25-5.75%, Dermis 0.935-1.265%, Jim 0.935-1.265%, Hanseok 0.935-1.265%, Sansa 0.935-1.265% , New Song 0.935-1.265%, New Song 0.935-1.265%, Fruit 0.935-1.265%, Angelica 4.25-5.75%, Baekjak 4.25-5.75%, Sukji Hwang 1.87-2.53%, Baekchul 0.935-1.265%, Astragalus 0.935-1.265%, Baekbokyeong 0.935-1.265%, lotus root 0.935-1.265%, mountain medicinal 2.635-3.565%, breeding 0.935-1.265%, Schisandra chinensis 0.935-1.265%, forget-me-not 0.935-1.265%, phalanges hull 0.935-1.265%, edible 0.935-1.265%, thick pepper 0.935- 1.265%, right side 0.935-1.265%, rosewood 2.635-3.565%, casualties 0.935-1.265%, compared with 0.935-1 .265%, Wolfberry 0.935-1.265%, Bokbunja 0.935-1.265%, Malt 0.935-1.265%, Cornus 0.935-1.265%, Bark skin 0.935-1.265%, Nutmeg 0.935-1.265%, Soybean skin 0.935-1.265%, Ripe 0.935 -1.265%, keg 0.935-1.265%, white porcelain 0.935-1.265%, Seokgok 0.935-1.265%, Cheongung 4.25-5.75%, passercage 0.935-1.265%, neck and 0.935-1.265%, buffy 0.935-1.265%, gold silver 0.935-1.265 %, Hwangjeong 4.25-5.75%, earthenware 0.935-1.265%, Seokchangpo 0.935-1.265%, longan meat 0.935-1.265% extraction method. 제1항에 기재된 방법으로부터 얻은 식이성섬유 세말과 부형제, 안정화제, 감미제, pH 조정제, 현탁화제, 향료등의 약제학적으로 허용가능한 담체를 1종이상을 함유함을 특징으로 하는 당뇨병 치료제.A therapeutic agent for diabetes, comprising at least one pharmaceutically acceptable carrier such as dietary fiber semals, excipients, stabilizers, sweeteners, pH adjusters, suspending agents, and fragrances obtained from the method of claim 1.
KR1019880004814A 1988-04-27 1988-04-27 Method for preparing dietary fiber derived from diabetes treatment and herbal medicine Expired KR920002161B1 (en)

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FR2802100A1 (en) * 1999-12-10 2001-06-15 Top Pharm Lab ACTIVE AMYLASE
KR101407188B1 (en) * 2012-07-18 2014-06-13 영농조합법인 이도 A composition comprising an extract of fermented or non-fermented combined crude drugs for treating and preventing abnormal metabolic diseases
KR101534142B1 (en) * 2013-07-08 2015-07-07 대구한의대학교산학협력단 A composition comprising an extract of combined crude drugs for treating and preventing abnormal metabolic diseases
CN107789506A (en) * 2016-08-30 2018-03-13 王玉生 A kind of Chinese medicine composition for being used to treat diabetes
CN108143875A (en) * 2016-12-06 2018-06-12 北京中医药大学东方医院 A kind of Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof

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Publication number Priority date Publication date Assignee Title
KR100407651B1 (en) * 2000-12-11 2003-12-01 최동성 Novel use of functional Coptis chinensis Franch extract and process for preparation thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2802100A1 (en) * 1999-12-10 2001-06-15 Top Pharm Lab ACTIVE AMYLASE
WO2001041794A3 (en) * 1999-12-10 2002-09-12 Top Pharm Lab Activated amylase
KR101407188B1 (en) * 2012-07-18 2014-06-13 영농조합법인 이도 A composition comprising an extract of fermented or non-fermented combined crude drugs for treating and preventing abnormal metabolic diseases
KR101534142B1 (en) * 2013-07-08 2015-07-07 대구한의대학교산학협력단 A composition comprising an extract of combined crude drugs for treating and preventing abnormal metabolic diseases
CN107789506A (en) * 2016-08-30 2018-03-13 王玉生 A kind of Chinese medicine composition for being used to treat diabetes
CN108143875A (en) * 2016-12-06 2018-06-12 北京中医药大学东方医院 A kind of Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof
CN108143875B (en) * 2016-12-06 2020-09-11 北京中医药大学东方医院 Traditional Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof

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