KR100846521B1 - Composition comprising an extract of herbal combination(oca-i) or the powder(oca-ii) thereof for preventing and treating diabetes mellitus - Google Patents

Abstract

A composition comprising the extract of herbal combination or the powder thereof is provided to prevent and treat diabetes mellitus by reducing blood sugar level without side effects in a synergism manner of the herbal combination. A pharmaceutical or health food composition for preventing and treating diabetes mellitus comprises the extract of herbal combination consisting of Opuntia ficus-indica (L.) Mill, Trichosanthes kirilowii Maxim., Paeonia suffruticosa Andrews, Dioscorea batatas Decaisne, Trigonella foenum-graecum L., Panax notoginseng (Burk.) F. H. Chen and Morus alba L. in a weight ratio of 45-80: 5-10: 3-10: 3-10: 3-10: 3-10: 3-5 or the powder thereof.

Description

Composition comprising an extract of herbal combination (OCA-Ⅰ) or the powder (OCA-Ⅱ) about for and and treating diabetes mellitus}

1 is a diagram showing the mean fasting glucose change with time of palm cactus stem powder,

Figure 2 is a diagram showing the mean fasting glucose change with time of the combined herbal extract (OCA-Ⅰ) and composite herbal powder (OCA-II),

3 is a diagram showing the glucose tolerance change with time of the palm cactus stem powder,

Figure 4 is a diagram showing the change in glucose tolerance with time of the combined herbal extract (OCA-I) and the combined herbal powder (OCA-II).

The present invention is a pharmaceutical composition for preventing and treating diabetes and a health functional food containing a complex herbal extract or powder thereof comprising palm cactus, cinnabar powder, bark skin, powder, fenugreek, samchimus root and upper leaf as an active ingredient having antidiabetic activity. It is about.

Diabetes mellitus is a disease affected by inherited factors such as obesity, diet, lack of exercise, and stress. It is defined as a metabolic disorder caused by the secretion of insulin from the pancreatic cells and a lack of action. It involves overproduction, breakdown of body fat and waste of protein and abnormally promotes glucagon secretion, causing metabolic disruption (Abrams, JJ, Ginsberg, H, et al., Metabolism of cholesterol and plasma trigyceride in nonketotic diabetes mellitus Diabetes , 31 , pp 903-910, 1982). Therefore, diabetes is a chronic metabolic disease that causes abnormal metabolic control functions in vivo, hyperglycemia, and excretion of glucose into urine, which causes complications such as the circulatory system if proper treatment and management are not carried out (Mandrup-Poulsen, T., British Medical Journal ., 316 , pp 1221-1225, 1998; Wilson, PWF et al., Am . J. Med., 80 , pp 3-9, 1986).

Diabetes is divided into two types, insulin-dependent (between IDDM or Type I diabetes) and insulin-independent (non-Insulin-Dependent Diabetes Mellitus; NIDDM or Type II diabetes). Type I diabetes mellitus is caused by a deficiency of insulin, a glucose-regulating hormone in the blood, and is often referred to as juvenile diabetes because it occurs mainly in young age groups of 10 to 20 years. Type 2 diabetes mellitus usually occurs after the forties and accounts for most of the diabetic patients in Korea. Unlike type I, it is called adult-type diabetes and the cause of the disease is not clear yet, but it is known to be caused by genetic factors and environmental factors. As a cause of type II diabetes, both pancreatic beta-cells with insulin secretion and target cells with defects in insulin action (insulin resistance) are observed.

  In particular, in diabetics, the incidence of cardiovascular diseases such as atherosclerosis, cerebral infarction, cerebral thrombosis, and myocardial infarction is higher, and the risk of death from coronary artery disease or cerebrovascular disease is higher. It is often caused by. This is known to be due to lipid peroxidation due to changes in lipid composition of biological membranes, including hyperglycemia or erythrocyte membranes and intracellular organelle membranes, due to changes in lipid metabolism accompanying diabetes.

The most important goal in the treatment of diabetes is to control blood glucose levels as close to normal as possible, and postprandial glycemic control, together with fasting blood glucose, is important for improving diabetes and preventing and treating complications (Jenkins, DJA Wolever et al., Starchy). foods and glycemic index, Diabetes Care , 11 , pp 149-159, 1988; Fuller, JH, Lancet , 1 , pp1373-1376, 1980; Hur, Kap-Bum, Korean Society of Nutrition, Abstract Paper, pp15-18, 1984; Jain, SK, J. Biol . Chem ., 264 , pp 21340-21345, 1989; Menendez, CM, Stoecker, BJ, The role of diet in improving glycemic control in Nutrition and Diabetes , pp 15-36, 1995).

However, modern medicine has not yet developed a method for treating diabetes, and it is known that controlling blood glucose to maintain blood sugar at a normal level is the best treatment. , Try three methods of diet (Bailey, CJ and C. Day., Diabetes Care ., 12, pp553-564., 1989; Koivisto, VA, Diabetes Care . 16 , pp 29-39, 1993). Since the dual drug therapy uses chemicals such as insulin and chemical oral hypoglycemic agents, the side effects of drug use and patient resistance are incessant problems. Therefore, the development of diabetes treatment using natural products is very important.

Meanwhile, Opuntia ficus - indica var. saboten Makino is a tropical plant belonging to the Cactaceae family. It is a naturalized plant that grows on Jeju Island in Korea and is known as 'baeknyeoncho', and it grows around the coast of Wolyeong-ri, Hannyeong-eup, Bukjeju-gun. The fruit blossoms in April and May every year, and the fruit grows as the flowers grow, and the fruit ripens in purple in November and December. The fruit is close to 10cm in length and the fruit and stem are used for food. If you eat it on an empty stomach, it is effective in treating constipation, diuretic effect, activating intestinal movement and increasing appetite, and stem is effective in treating skin disease, rheumatism and burn. Known (Ibanez-Camacho, R. and R. Roman-Romos, Arch . Invest . Med . 10, pp223-230, 1979; Kang Soon Medical Center, Chinese Medicine Dictionary, p2731, 1985). In oriental medicine, the roots and stems of cactus are used as medicinal products, and they are also used for the treatment of dysentery, hemorrhoids, seawater, sore throat, lung use, useful intestines, and burns. In addition, it has been reported that it is effective in antipyretic, soothing, anti-inflammatory, detoxification, and diabetes control (Kangso New Medical School, Chinese Medicine Dictionary, p2731, 1985).

In addition to monosaccharides and polysaccharides (mucosa), palm cactus has been reported as a flavonoid-based component such as isorhamnetin, quercetin and kaempferol, and two kinds of dihydroflavonols have recently been reported. ) component of (+) - trans - dihydro quercetin ((+) - trans -dihydroquercetin) are reported. In addition, Anhlinin, Indicazanthin, Isobetaun, Betain, Saponin and the like are known (Park et al., Arch . Pharm . Res ., 21 , pp30-34, 1998; Ghanah et al., The effect of mescaline and some of it´s analongs on cholinergic neuromuscular transmission, Neuropharmacology., 32 , pp169-174, 1993).

Trichosantes kirilowii Maxim is a vine perennial herb belonging to the family of fruits, and its roots are called cheonhwabun, which have the effects of vibrancy, jigger, fortification, drainage, and swelling, and treat dry, sour and jaundice caused by fever. Bae, Ji-Hwan, Medicinal Plants in Korea, Kyohaksa, p349, 2001). Also known as a fly, its roots include many horses, Stigmasterol, β-sitosterol, saponin (approximately 1%), and trichosantin, a basic protein (pH, 9.4). , Constituents and use of herbs, January calligraphy, p584, 1991). In addition, it has been reported that the anti-diabetic effect in STZ-induced diabetic rats using a fly (Lim, SJ and SS Choi., Korean J. Nutr ., 30 , pp25-31, 1997).

Paeonia suffruticosa Andrews) is a larch tree belonging to the peony family, aka the roots of peony peony, which has the efficacy of fever, sheep blood, bloody blood, and herring. (Bae Gi-hwan, Korean medicinal plant, Kyohaksa, p170, 2001). Peonyol and its glycosides are the major pharmacological agents of peony roots, which are found only in the roots of peonies and not in the stems and peonies. Pheonol also has central inhibitory effects, such as sedation, fever, soreness and myrrhosis, as well as anti-inflammatory or bloody effects (attention, ingredients and use of herbs, January calligraphy, p. 247, 1991).

Mountain ox ( Dioscorea batatas Decaisne) is a plant belonging to the family Doscoreaceae and is known as a vine yam or a tuber of horses. It is harvested and dried between winter solstice after autumn fall, and its outer surface is white or yellowish brown. The interior is hard with powdered or painted keratin. The ingredients contain starches, mucus, proteins, fats, arginine and choline, and diastases. It is known to nourish, dry, tonic, boreum, gangjeong, digestion, branch and expectorant action to treat diarrhea, copper, anorexia, seawater, sogal, oil well, lobster, and urinary tract (Bae Gi-hwan, Korean medicinal plants, Kyohaksa, p551, 2001). In addition, Yumiji Hwangtang, which has the effect of consonant bosin, has the effect of scavenging boiled boil. It is used for a wounded road.

Fenugreek ( Trigonella foenum-graecum L) is a plant belonging to the legume, which uses dried dried seedlings, which causes pain in the lower back and knee with Shinyang Hur , and urinary pain caused by cold, stomach cramps, acidosis, and bladder paralysis. It is used for not being able to lie (Hu Chang-Gul, North Korea's Dong Bogam, Creative Culture, p124, 2000). Fenugreek seeds and leaves are been reported to decrease blood glucose in diabetic rats (Yadav, et al., Effects of sodium-orthovanadate and Trigonella foenum-graecum seeds on hepatic and renal lipogenic enzymes and lipid profile during alloxan diabetes. J. Biosci, 29, pp81-91, 2004; ..... Annida, B. and PSM Princ, Supplementation of fenugreek leaves lower lipid profile in streptozotocin-induced diabetic rats J. Med Food, 7, pp153-156, 2004).

Three Roots ( Panax notoginseng (Burk.) FH Chen) belongs to the family Arboraceae, and is effective for self-tension, germ, hemostasis, small type and orthodoxy, and is used for the treatment of hemostasis, postpartum hemorrhage, carbuncle, spear and bruise (Seoul National University) , Institute of Oriental Medicine, Journal of Academic Affairs, p218, 2003). Also known as Samchil, Geumbulhwan, Ginsengsamchil, Samsamchil, Jeonsamchil or Sanchil, they are grown or grown in southern China (Yunnan, Guangxi, Sichuan). Root contains 3-8% saponin. The main ingredients are Ginsenoside, Rb ₁ , Rg ₁ And Rg ₂ . Roots have bloody and cardiac effects, which increase blood flow in the coronary arteries, reduce oxygen consumption in the myocardium, and reduce the amount of lipids and cholesterol in the blood (Painting, Herbal Use and Herbal Medicine, Jangwolseo, p426, 1991). Further, thirty-seven muscle has been shown that the blood glucose lowering effect and GTT effect in db / db mice and ob / ob mice (Xie et al., Effects of American ginseng berry extract on blood glucse levels in ob / ob mice. Am J. Clin . Med ., 30 , pp 187-194, 2004).

Morus alba L.) is a deciduous arboreous tree of Moraceae and grows about 3 ~ 7m. Methanol-soluble fraction of the mesenchymal layer inhibits glycosidase activity in the small intestine in normal mice, thereby reducing blood sugar when starch, maltose and sucrose are loaded. It was found that the inhibitory activity of the synergy was excellent (Lee, JS, MH Choi and SH Chung. Blood glucose-lowering effects of Mori Folium. Yakhak Hoeji., 39, pp367-372, 1995 ), hypoglycemic effect of mulberry and silkworm (Kim, JM and Y. Kazuhito. , Effects of alkaline ionized water on spontaneously diabetic GK-rats fed sucrose. Korean J. Lab. Anim. Sci ., 13, pp187-190, 1997). It has also been reported to confirm the hypoglycemic effect of mulberry leaves in alloxan-induced diabetic rats, and to reduce human blood sugar by making mulberry leaf ice cream (Kim Hyun-bok, Lee Wan-ju, Kim Sun-yeo, Lee Yong-gi, Yang-yeol, Lee Kang-no, Latent injury A Study on the Development of New Functional Substances Using Substances: A Study on the Preparation of Functional Foods Using Mulberry Leaves, Test and Research Report , Provincial Insect Research Institute, Rural Development Administration, pp317-322, 1997).

On the other hand, it has been found that a complex extract having an anti-diabetic and improving effect as an active ingredient extract obtained by varying the formulation of each of the above herbal medicines with one or two or more raw materials. For example, Korean Patent Laid-Open Publication No. 2005-0121874 discloses a composition for preventing or treating diabetes, including a dry extract from leaves of baeknyeoncho (stem-like leaves of baeknyeoncho, except thorns, roots and fruits of baeknyeoncho), Korea Korean Patent Laid-Open Publication No. 2006-0035921 discloses an antidiabetic food composition comprising herbal extracts such as cheonhwa flour and velvet skin, and pear extracts. Disclosed is a pharmaceutical composition for treating diabetes, including a herbal medicine. However, no disclosure or instruction has been made on the effects of diabetes prevention and treatment on complex herbal extracts consisting of palm cactus, nectarine, bark skin, powder, upper lobes, fenugreek and tricepsis, or powders thereof.

The inventors thus cactus ( Opuntia ficus - indica (L.) Mill) and weight change, dietary efficiency, fasting blood glucose and glucose load caused by diabetic induction of rats with natural powders, bark skin, powder, fenugreek, samchimus and upper lobes known to have functional effects such as hypoglycemia By testing the degree, the present invention was completed by confirming that the use of the compound herbal extract (OCA-I) or the compound herbal powder (OCA-II) of the present invention is superior to the antidiabetic effect rather than the use of the herbal medicine alone. It was.

An object of the present invention is palm cactus ( Opuntia ficus - indica (L.) Mill ), to provide a pharmaceutical composition and health functional food for the prevention and treatment of diabetes containing a complex herbal extract consisting of cheonhwa flour, bark skin, mountain medicine, fenugreek, samchimus and upper leaf as an active ingredient. .

In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of diabetes mellitus containing a complex herbal extract consisting of palm cactus, cheonhwabun, neck peel, powder, fenugreek, samchimus and upper lobe as an active ingredient. .

 Hereinafter, the method for obtaining a complex herbal extract or a complex herbal powder of the present invention will be described in detail.

The complex herbal extract of the present invention or the powder thereof may be washed and peeled and shredded, respectively, of the herbal drugs, at about 10 to 40 ° C., preferably at about 18 to 30 ° C. for about 1 to 20 days, preferably about 5 days to After 15 days of natural drying and powdering, about 1 to 10 times the weight of the powder sample, preferably about 4 to 7 times the amount of water, lower alcohols having 1 to 4 carbon atoms such as ethanol, methanol, or a mixed solvent thereof , Preferably, water, ethanol or methanol is added to the extraction method, such as hot water extraction, high pressure hot water extraction, reflux cooling extraction, ultrasonic extraction, preferably high pressure hot water extraction method for about 1 to 10 hours, preferably 2 to 5 from about 50 to 150 ℃ for a time, preferably a compound of the invention in the production was extracted by a maximum pressure of about 1 to 3kgf / cm ^2, preferably with shaking at about 1.3 to 1.7kgf / cm ² was filtered at about 80 to 130 ℃ To obtain an extract, it is possible to dry the residue extracted was concentrated under reduced pressure it back to the rotating vacuum concentrator with a vacuum freeze drier to obtain a dry powder of crude drug complex of the present invention by grinding in mills.

The present invention is a palm cactus obtained by the manufacturing process ( Opuntia ficus - indica ), Trichosantes kirilowii Maxim., Paeonia Suffruticosa Andrews, Dioscorea batatas Decaisne, fenugreek ( Trigonella) foenum - graecum L.), thirty-seven root (Panax notoginseng (Burk.) F.H. Provided is a pharmaceutical composition for the prevention and treatment of diabetes, comprising a complex herbal extract consisting of Chen) and upper leaf ( Morus alba L.) or powder thereof as an active ingredient.

In addition, the complex herbal extract of the present invention or powder thereof is palm cactus: cloth pollen: neck peel: powder: fenugreek: samchileun: upper lobe 10-89: 2-20: 2-15: 2-15: 2-15 : 2-15: 1-10 Mixed weight ratio (%), Preferably palm cactus: Cinnabar powder: Bark skin: Powder: Fenugreek: Samchileun: Upper lobe 45-80: 5-10: 3-10: 3-10: 3-10: 3-10: 3-5 is characterized in that the mixed weight ratio (%).

       The pharmaceutical composition for preventing and treating diabetes of the present invention comprises the extract or its powder in an amount of 0.1 to 50% by weight, based on the total weight of the composition.

The pharmaceutical composition comprising the extract of the present invention or a powder thereof may further include appropriate carriers, excipients and diluents commonly used in the preparation of pharmaceutical compositions.

Carriers, excipients and diluents which may be included in the extract of the present invention or powder thereof may include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, Calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

Compositions comprising extracts of the present invention or powders thereof are in the form of oral dosage forms, external preparations, suppositories, and sterile injectable solutions, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups and aerosols, respectively, according to conventional methods. Can be formulated and used.

     Specifically, when formulated, it may be prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, and the like. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and such solid preparations include at least one excipient such as starch, calcium carbonate, It can be prepared by mixing sucrose, lactose and gelatin. In addition to the simple excipients, lubricants such as magnesium stearate and talc may also be used. Liquid preparations for oral use include suspensions, solvents, emulsions and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances and preservatives, in addition to the commonly used simple diluents, water and liquid paraffin. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations and suppositories. As the non-aqueous solvent and suspending agent, vegetable oils such as propylene glycol, polyethylene glycol and olive oil, and injectable esters such as ethyl oleate may be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter and glycerogelatin can be used.

Preferred dosages of the extracts or powders thereof 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 desired effect, the extract of the present invention or powder thereof may be administered in 0.0001 to 100 mg / kg, preferably in an amount of 0.001 to 100 mg / kg divided once or several times daily. Extract or composite herbal powder of the present invention in the composition may be formulated in an amount of 0.0001 to 50% by weight based on the total weight of the total composition.

The pharmaceutical composition of the present invention can be administered to mammals such as mice, mice, livestock, humans, etc. by various routes. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural and Intracerebroventricular injections.

In another aspect, the present invention provides a dietary supplement for preventing and improving diabetes containing a complex herbal extract or a complex herbal powder consisting of palm cactus, nectarine, velvet skin, powder, fenugreek, samchimus and upper lobe as an active ingredient.

Extracts or powders thereof of the present invention can be used in a variety of drugs, food and beverages for the prevention and treatment of diabetes. Foods to which the extract of the present invention or powder thereof may be added include, for example, various foods, beverages, gums, teas, vitamin complexes and dietary supplements, and the like, powders, extracts, granules, tablets and capsules or beverages. Can be used in the form of phosphorus.

Extracts or powders thereof of the present invention are medicaments that can be used with confidence even for long-term use for the purpose of prevention because they have little toxicity and side effects.

The extract of the present invention or a powder thereof may be added to food or beverage for the purpose of preventing and treating diabetes. At this time, the amount of the extract or powder thereof in the food or beverage is generally added to the health food composition of the present invention 0.01 to 15% by weight of the total food weight, the health beverage composition is 0.02 to 30 g based on 100 ml Preferably, it can be added in the ratio of 0.3-10 g.

In addition to containing the extract or powder thereof as essential ingredients in the indicated ratio, the health beverage composition of the present invention has no particular limitation on the liquid component, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. Can be. Examples of the above-mentioned natural carbohydrates include monosaccharides such as disaccharides such as glucose and fructose, for example polysaccharides such as maltose and sucrose, and conventional sugars such as dextrin and cyclodextrin. Sugar alcohols such as xylitol, sorbitol and erythritol. As flavoring agents other than those described above, natural flavoring agents (tauumatin, stevia extract (e.g., Rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of natural carbohydrates is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.

In addition to the above, the extract of the present invention or powder thereof 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, chocolate), pectic acid and salts thereof, Alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages and the like. In addition, the extract of the present invention or a powder thereof may contain a flesh for preparing 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 from the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

Hereinafter, the present invention will be described in detail by Examples and Experimental Examples.

However, the following Examples and Experimental Examples are only illustrative of the present invention, and the content of the present invention is not limited to the following Examples and Experimental Examples.

Comparative example  One. Palm cactus  Stem powder manufacturer

Opuntia palm tree cactus (Mt. Jeju Island) provided by Wolyeong-ri Cactus Village in Hallim-eup, Jeju-si, Jeju-do ficus -indica var. After washing and peeling 20 kg of saboten Makino stem (Jeju-do), it is chopped , and naturally dried at a temperature of 18 to 30 ° C. for about 5 to 15 days, followed by primary grinding with a disc mill and a cyclone mill. mill 2) to obtain 2 kg of palm cactus stem powder of the present invention.

Example  One. Palm cactus  stem, Natural flower , Medicine , Fenugreek , Three muscles  And Upper lobe  Preparation of Extracts or Powders

1-1. Palm cactus  stem, Natural flower , Medicine , Fenugreek , Three muscles  And Upper lobe  Preparation of Extract

Opuntia stems purchased from YAG JUN DONG BANG TRADING CO. (Los Angeles, CA) ficus - indica (L.) Mill, Mexican) 630 g, Trichosantes kirilowii Maxim. Made in China) 80g, Paeonia suffruticosa Andrews, Chinese 60g, Dioscorea batatas Decaisne, Chinese 60g, upper leaf Morus alba L. China) 50g, fenugreek (Trigonella foenum - graecum L. 60 g of China) and 60 g of Panax notoginseng (Burk. F.H. Chen, China) were washed and peeled, and then chopped. After adding about 5.5 times the weight of the powder sample, water was added to the herbal extractor extractor, shaken at 120 degrees Celsius for 3 hours at a maximum pressure of 1.5kgf / cm ² , followed by filtration to obtain the extract of the present invention. The concentrated residue was concentrated under reduced pressure at 60 ° C. with a vacuum rotary concentrator, and the extracted residue was dried with a vacuum freeze dryer and pulverized with a mill to obtain dried herbal powders of the present invention.

1-2. Palm cactus  stem, Natural flower , Medicine , Fenugreek , Three muscles  And Upper lobe  Manufacture of powder

The herbal powders of Example 1-1 were used to obtain the herbal powders of the present invention by the same method as in Comparative Example 1.

Example  2. Preparation of Complex Herbal Extract or Powder

2-1. Complex herbal extracts ( OCA Preparation of -I)

Palm cactus extract of each herbal extract obtained in Example 1-1: Cinnabar powder: Bark skin: Powder: Fenugreek: Samchil-Geun: Upper leaf in a mixed weight ratio (%) of 63: 8: 6: 6: 6: 6: 5 The mixed herbal extract of the present invention (hereinafter referred to as OCA-I) was prepared by mixing.

2-2. Complex herbal powder ( OCA -II) Preparation

Palm cactus which is each herbal powder obtained in Example 1-2: Cactus powder: Thymus skin: Powder: Fenugreek: Samchil root: Upper lobe in a mixed weight ratio (%) of 63: 8: 6: 6: 6: 6: 5 The mixed herbal powder (hereinafter referred to as OCA-II) of the present invention was prepared by mixing and used as a test sample.

Reference Example  1. Component Analysis

AOAC method (AOAC, Official methods of analysis., 15th, Association of Analytical Chemists, 1990) for the component analysis of the palm cactus stem powder of Comparative Example 1 and the composite herbal powder (OCA-II) of Example 2-2 The contents of water, crude ash, crude protein, crude fat and crude fiber were measured. Moisture is the Weende method, crude ash is the analytical method, crude protein is the Kjeldahl protein assay (Kjeltec system, ITecator), crude fat is the Soxhlet extraction method, crude fiber is the acid and alkali decomposition method (Fibertec system, ITecator) G) was quantified as shown in Table 1 below.

division ingredient  % (wet basis) % (DM basis) Palm Cactus Stem (Comparative Example 1) moisture 92.35 ± 0.13 Ash  1.58 ± 0.00 22.48 ± 0.03 protein  0.55 ± 0.00 7.85 ± 0.02 Fat  0.19 ± 0.01 2.73 ± 0.02 fiber 0.80 ± 0.03 11.44 ± 0.05 Soluble Nitrogen (NFE)  4.53 ± 0.01 55.50 ± 0.03 OCA-II (Example 2-2) moisture   9.17 ± 0.03 Ash 21.15 ± 0.10 23.73 ± 0.12 protein 6.70 ± 0.03 9.48 ± 0.04 Fat 1.83 ± 0.05 2.05 ± 0.07 fiber  6.98 ± 0.07 7.06 ± 0.08 Soluble Nitrogen (NFE) 54.17 ± 0.07 57.67 ± 0.07

Reference Example  2. Preparation for Experiment

2-1. Experimental Animal Placement and Experimental Diet

The experimental animals received 8 weeks-old male Sprague-Dawley Rats with an average body weight of 250 (± 10) g from Setaco Co., Ltd., and published 32 rats per experiment. After 7 days of adaptation, the control group (NC), diabetes-induced control group (DC), and diabetes-induced treatment group (DO-5, DO-10) fed palm cactus stem powder were randomly divided into 8 animals for 3 weeks. Breeding. Likewise, NC, control group (DC), combined herbal extract (OCA-1) and diabetic treatment group (OCA-2, OCA-5) fed the combined herbal powder were randomly divided into eight groups for 3 weeks. Breeding. The experiment was carried out for each material in total five times. At this time, all experimental animals were separated and bred one by one in the metal cage (Cage), the environment in the breeding room was maintained at a temperature of 20 ~ 25 ℃, relative humidity 60 ~ 70%, photoperiod 12 hours.

ingredient Content (g / kg) Casein 200 Sucrose 500 Corn starch 150 Corn oil 50 Cellulose 50 AIN- mineral complexes (AIN-Mineral mix ¹⁾⁾ 35 AIN-vitamin complex (AIN-Vitamin mix ^{2 )} ) 10 DL-methionine 3 Choline bitartrate 2 ¹⁾ Composition of AIN-76 Mineral Complex (g / kg) ²⁾ Composition of AIN-76 Vitamin Complex (g / kg) ingredient content ingredient content Calcium phosphate (dibasic) 500.00 Thiamine-HCl 0.60 Sodium chloride 74.00 Riboflavin 0.60 Potassium citrate, monohydrate 220.78 Pyridoxine-HCl 0.70 Potassium sulfate 52.00 Niacin 3.00 Magnesium Oxide 24.00 Calcium pantothenate 1.60 Manganese carbonate 3.50 Folic acid 0.20 Ferric citrate 6.00 Biotin 0.02 Zinc carbonate 1.60 Vitamin B ₁₂ (Vitamin B ₁₂₎ 1.00 Cupric carbonate 0.30 Vitamin A palmitate 0.80 Potassium iodate 0.01 Vitamin E Acetate 10.00 Sodium selenite 0.01 Vitamin D ₃ (Vitamin D ₃ ) 0.25 Chromium potassium sulfate 0.55 Menadione Sodium Bisulfite 0.15 Sucrose, finely powdered 118.03 Sucrose, finely powdered 981.08

 Meanwhile, the basic dietary composition was prepared according to the specification standard of AIN-76 (American Institute Nutrition-76) as shown in Table 2 above. In each experiment, the normal group (NC) and the diabetes-induced control group (DC) freed the basic diet, and were treated with 5% palm cactus stem powder (DO-5) and 10% palm cactus stem powder (DO-10). The dietary diet was free-vegetated by adding cactus stem powder to 5% and 10% of the basic dietary feed powder, and the treatment group for diabetes induced 0.1% of combined herbal extract (OCA-1) and mixed herbal powder (OCA-2). To 2% and compound herbal powder (OCA-5) was added to 5% level was vegan.

2-2. Rat  Diabetes-induced treatment

The rats were fasted for 12 hours before the diet was fed for 7 days, and 50 mg / kg of STZ diabetes-induced substance dissolved in STZ (Streptozotocin) in 0.1M Citrate buffer (pH 4.5). Intraperitoneal injection. After 24 hours, the incidence of diabetes was measured with a urine glucose measurement strip (Strip, Yeongdong Pharm., Uriscan GP2). The following individuals were intraperitoneally injected three times and fasted 12 hours after the final induction of diabetes, and fasting blood glucose reached 300 mg / dl or more to make a diabetes-induced control group (DC). The normal group (NC), which did not induce diabetes, was intraperitoneally injected with the same amount of Saline up to the second and third stages in the same manner as the preparation of the diabetes-induced control group (DC).

2-3. Statistical processing

All the values measured in this experiment were expressed as mean ± standard deviation, and after analysis of variance (ANOVA), the significance of the difference between the mean values was analyzed using Statistical Analysis System (SAS). Duncan's multiple range test was performed at P <0.05.

Experimental Example  One. Rat  Weight change measurement

The composite herbal extract (OCA-I) and the combined herbal powder (OCA-II) obtained in Example 2 were added to the basic dietary feed powder of the diabetic rats to measure the weight change before and after the induction of diabetes. Body weight was measured using Kim's method (Kim, Mi-Jung, Effect of Amaranth Diet on Blood Glucose and Lipid Metabolism in Diabetic Rats, Korea Thesis, 20, 2001).

First, before feeding the experimental diet for each treatment section of Reference Example 2, the body weight is measured to one decimal place (0.1 g) using a 2-digit scale (0.01 g), and three times at 1 week intervals during the experimental diet intake period. Experimental results are shown in Table 3 below.

As a result, as shown in Table 3, the final average weight of OCA-I and OCA-II was lower than that of the normal group (NC) but higher than that of the diabetes-induced control group (DC). In particular, the OCA-II content was high. The higher the final mean weight, the lesser the weight loss caused by diabetes.

Therefore, the compound herbal extracts (OCA-Ⅰ) and compound herbal powders (OCA-II) are superior to the weight loss phenomenon than the palm cactus stem powder, the higher the content was confirmed that more effective in improving the low weight of diabetes.

division Treatment Body weight at start (g) Weight at end (g) Final weight (g) Comparative Example Palm Cactus Stem (Comparative Example 1) NC 273.33 ± 4.98 ^a 346.00 ± 5.13 ^a 72.67 ± 2.91 ^a DC 236.00 ± 2.25 ^b 204.35 ± 7.98 ^b -30.25 ± 9.35 ^b DO-5 231.25 ± 2.01 ^b 218.63 ± 2.73 ^b -12.63 ± 4.26 ^b DO-10 230.38 ± 2.81 ^b 216.00 ± 9.08 ^b -14.37 ± 9.44 ^b Example OCA-I (Example 2-1) NC 253.71 ± 4.25 ^{1) a} 304.14 ± 6.40 ^a 50.43 ± 4.42 ^a DC 235.29 ± 4.58 ^b 174.29 ± 13.95 ^c -61.00 ± 12.14 ^c OCA-1 244.24 ± 3.54 ^ab 231.37 ± 9.70 ^b -11.29 ± 9.57 ^b Example OCA-II (Example 2-2) NC 253.71 ± 4.25 ^{1) a} 304.14 ± 6.40 ^a 50.43 ± 4.42 ^a DC 235.29 ± 4.58 ^b 174.29 ± 13.95 ^c -61.00 ± 12.14 ^c OCA-2 242.14 ± 4.04 ^ab 221.86 ± 10.70 ^b -20.29 ± 9.53 ^b OCA-5 246.86 ± 4.80 ^ab 245.71 ± 14.43 ^b -1.14 ± 10.92 ^b

Experimental Example  2. Rat Negative water , Dietary Intake  And Dietary efficiency  Measure

In the same manner as in Experiment 1, the experiment was performed using the following methods to determine the amount of food, food intake and dietary efficiency before and after feeding the experimental diet for three weeks after diabetes-induced treatment. Negative numbers autonomic intake Kane and daily average 1 negative by measuring the interval consumption water was calculated as (ml / day) (goyoungcheol, Streptozotocin effect the upper lobe complex extracts of movement in diabetic rats on blood glucose and lipid metabolism, Myongji Ph.D. Thesis , 28 , 2003), the dietary intake was measured at an average daily intake (g / 3wk) measured at two-day intervals, and the Food Efficiency Ratio (FER) (g / g diet) 1 (Kim, Mi-Jung, Effect of Amaranth Diet on Blood Glucose and Lipid Metabolism in Diabetic Rats, Korea Thesis , 21 , 2001)

As a result, as shown in Table 4 below, the average daily drinking amount or average dietary intake (g / 3wk) of rats was significantly reduced in OCA diabetic induction group compared to the diabetic control group (DC). Showed. In addition, the average dietary efficiency (FER) (g / g diet) of rats was increased in the OCA diabetes-induced treatment compared to the diabetes-induced control (DC).

division Treatment Drinking water amount (ml / day) Dietary Intake (g / 3wk) Food efficiency (g / g diet) Comparative Example Palm Cactus Stem (Comparative Example 1) NC 26.42 ± 1.88 ^c 494.81 ± 9.40 ^c 14.70 ± 0.73 ^a DC 199.09 ± 8.93 ^a 757.97 ± 27.10 ^a -4.25 ± 1.34 ^b DO-5 183.98 ± 8.64 ^a 730.46 ± 26.30 ^ab -1.85 ± 0.62 ^b DO-10 144.44 ± 6.14 ^b 649.51 ± 23.79 ^b -2.36 ± 1.59 ^b Example OCA-I (Example 2-1) NC 25.78 ± 1.58 ^{1) c} 483.23 ± 17.87 ^b 10.37 ± 0.65 ^a DC 196.02 ± 3.42 ^a 725.34 ± 15.77 ^a -8.43 ± 1.70 ^c OCA-1 175.78 ± 5.16 ^b 707.80 ± 7.27 ^a -1.43 ± 1.11 ^b Example OCA-II (Example 2-2) NC 25.78 ± 1.58 ^{1) c} 483.23 ± 17.87 ^b 10.37 ± 0.65 ^a DC 196.02 ± 3.42 ^a 725.34 ± 15.77 ^a -8.43 ± 1.70 ^c OCA-2 180.71 ± 5.06 ^b 705.80 ± 15.25 ^a -2.87 ± 1.34 ^b OCA-5 169.71 ± 3.26 ^b 716.10 ± 22.64 ^a -0.22 ± 1.55 ^b

Therefore, the combined herbal extract (OCA-Ⅰ) and the combined herbal powder (OCA-II) lower the drinking and food intake and increase the dietary efficiency than the palm cactus stem powder, thereby suppressing the next, multi-food phenomenon. It was confirmed that the effect of increasing the low and low dietary efficiency, the higher the content is more effective in improving the symptoms of diabetes.

Experimental Example  3. Rat  Measurement of hypoglycemic effect after diabetes

In order to investigate the hypoglycemic effect of the combined herbal powder (OCA-II) obtained in Example 2-2 after the induction of diabetes, experiments were performed using the whole blood method as follows (Kim, Mi-Jung, Amaranth diet of diabetic-induced rats). Effects on Blood Glucose and Lipid Metabolism, Master's Thesis , Korea University , 24 , 2001).

Rats were prepared in the same manner as Experimental Example 1 and the normal group (NC) and diabetes-induced control group (DC) with the solution and STZ-diabetic substance. Experimental formulas for each treatment group of Reference Example 2 were fasted before and after the start of the intake period, and blood was collected from the rat tail vein in a fasted state after 12 hours of blood collection and measured three times at an interval of one week during the experiment period. At this time, the fasting blood glucose of the collected venous blood was measured with a blood glucose meter (MyCare GAM-2200, Green Cross) and used as an average value.

  As a result, as shown in Figures 1 and 2 below, the average fasting blood glucose was significantly reduced in the composite herbal extract and the diabetic induction treatment of the powder compared to the palm cactus stem powder, and the content was higher than in the diabetic control group (DC). More significantly decreased blood sugar.

Therefore, the compound herbal extract and its powder are superior to the hypoglycemic effect than the palm cactus stem powder, the higher the content was confirmed that the more effective in controlling the blood glucose of diabetes mellitus.

Experimental Example  4. Rat Sugar tolerance  Measure

Glucose tolerance test (GTT) experiments were performed using Kim's method to measure the ability of glucose in the blood to enter cells (Kim, Mi-Jung, Amaranth diet and blood glucose levels in diabetic rats). Effect on Lipid Metabolism, Master's Thesis , Korea University , 25 , 2001).

Rats were divided into treatment groups as in Experimental Example 1 and fed the experimental diet as in Reference Example 2-1, and after 3 weeks, fasted 12 hours before blood collection to measure fasting blood glucose and measuring 50mg / kg glucose (Glucose). ), And blood was collected from the rat tail vein four times for two hours at 30 minute intervals. Fasting blood glucose of the collected venous blood was measured with a blood glucose meter (MyCare GAM-2200, Green Cross).

Experimental results, as shown in Figures 3 and 4 showed a rapid blood sugar reduction after administration of the complex herbal extract and its powder.

Therefore, the compound herbal extract and its powder have an excellent effect of glucose tolerance, and the higher the content, the more effective the effect of restoring glucose tolerance on diabetes.

Hereinafter, the preparation examples of the pharmaceutical composition and the health functional food comprising the composite herbal extract of the present invention and powder thereof, but the present invention is not intended to limit the present invention is to be described in detail only.

Formulation example  One. Powder  Produce

      20 mg of the complex herbal extract of Example 2-1 (OCA-I)

Lactose 100 mg

Talc 10 mg

The above ingredients are mixed and filled in an airtight cloth to prepare a powder.

Formulation example  2. Preparation of Tablets

      10 mg of the combined herbal powder of Example 2-2 (OCA-II)

      Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.

Formulation example  3. Manufacture of capsule

      Combined herbal powder (OCA-Ⅱ) 10 mg

3 mg of crystalline cellulose

Lactose 14.8 mg

Magnesium Stearate 0.2 mg

According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.

Formulation example  4. Preparation of Injectables

      Combined herbal extract (OCA-Ⅰ) 10 mg

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

Na ₂ HPO ₄ 12H ₂ O 26 mg

According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule (2 ml).

Formulation example  5. Liquid  Produce

OCA-Ⅱ 20 mg

10 g of isomerized sugar

5 g of mannitol

Purified water

According to the conventional method of preparing a liquid solution, each component is added and dissolved in purified water, lemon flavor is added to the mixture, and then the above ingredients are mixed, purified water is added to adjust the total amount to 100 ml, and then filled in a brown bottle. The solution is prepared by sterilization.

Formulation example  6. Manufacture of healthy food

OCA-Ⅱ 1000 mg

Vitamin Mixture

70 μg of Vitamin A Acetate

Vitamin E 1.0 mg

Vitamin B ₁ 0.13 mg

Vitamin B2 0.15 mg

Vitamin B6 0.5 mg

0.2 μg of vitamin B12

Vitamin C 10 mg

10 μg biotin

Nicotinic Acid 1.7 mg

Folate 50 ㎍

Calcium Pantothenate 0.5mg

Mineral mixture

Ferrous Sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

Potassium monophosphate 15 mg

Dibasic calcium phosphate 55 mg

Potassium Citrate 90 mg

Calcium Carbonate 100 mg

Magnesium chloride 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixtures is mixed with a component suitable for a health food in a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health food manufacturing method. The granules may be prepared and used for preparing the nutraceutical composition according to a conventional method.

Formulation example  7. Manufacture of health drinks

OCA-Ⅱ 1000 mg

Citric acid 1000 mg

100 g oligosaccharides

Plum concentrate 2 g

1 g of taurine

Add 900 ml of purified water

After mixing the above components in accordance with a 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 then refrigerated and stored in the present invention For the preparation of healthy beverage compositions.

Although the composition ratio is mixed with a component suitable for a favorite beverage in a preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, and usage.

As described above, the palm cactus of the present invention ( Opuntia ficus - indica (L.) Mill), cheonhwabun, mokdanpi, Yam, fenugreek, thirty-seven muscle and combined herbal extracts or a powder consisting of a reconstituted tobacco sheet is an excellent antidiabetic effect it can be used as a useful pharmaceutical compositions and dietary supplements to prevent and treat diabetes have.

Claims (6)

Stem of the Opuntia ficus-indica (L.) Mill, Trichosantes kirilowii Maxim., Paeonia suffruticosa Andrews, Dioscorea batatas Decaisne , Fenugreek ( Trigonella foenum-graecum L.) The mixed weight ratio (%) of root ( Panax notoginseng (Burk.) F.H. Chen) and upper leaf ( Morus alba L.) was 45-80: 5-10: 3-10: 3-10: 3-10: 3 -10: A pharmaceutical composition for preventing and treating diabetes, comprising the water extract of the complex herbal medicine consisting of 3-5 or a powder thereof as an active ingredient. delete delete delete The mixed weight ratio (%) of the stem, natural powder, bark skin, powder, fenugreek, samchiol and upper leaf of palm cactus is 45-80: 5-10: 3-10: 3-10: 3-10: 3-10: 3 Health functional food for the prevention and improvement of diabetes containing water extract of the complex herbal consisting of -5 or powder thereof as an active ingredient. delete

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