KR100679290B1 - A composition comprising an extract of ???­??­201 crude drug complex as an effective ingredient treating or preventing obesity - Google Patents

Abstract

The present invention relates to a composition for the prevention and treatment of obesity containing HwalGiDan (defined as HGD) -SJ-201 herbal compound, that is, upper leaf, Baikyeongryeong, Baekchul, Uiin, red soybeans, throat, chacha extract as an active ingredient. In detail, the composition of the present invention can be used for the purpose of preventing and treating obesity through the increase of high-density lipoprotein cholesterol (HDL-C) in the blood, a decrease in lipid-related index in the body and inhibition of weight gain.

Obesity, high density lipoprotein cholesterol, upper lobe, HGD-SJ-201 herbal combination, pharmaceutical composition

Description

A composition comprising an extract of HBDDX201 crude drug complex as an effective ingredient treating or preventing obesity

1 is a diagram showing the effect of HGD-SJ-201 on the weight change of male Zucker rats fed a high fat diet, the group fed normal feed (●), the group fed high fat feed (▼), 3% Figure showing the weight change of group (■) fed high fat diet containing HGD-SJ-201,

Figure 2 is a diagram showing the effect of HGD-SJ-201 on the weight change of high-fat diet fed female Zucker rats, the group fed normal feed (●), the group fed high fat feed (▼), 3% Figure showing the weight change of group (■) fed high fat diet containing HGD-SJ-201,

3 is a diagram showing the effect of HGD-SJ-201 on liver malondialdehyde (MDA) levels in Zucker rats fed a high fat diet, a group fed a normal feed (white), a group fed a high fat feed (black) Color), high-fat diet fed with 3% HGD-SJ-201 (gray), showing that HGD-SJ-201 reduces hepatic lipid peroxides, especially in males.

The present invention relates to a pharmaceutical composition for the prevention and treatment of obesity through the increase in high-density lipoprotein cholesterol (HDL-C) and weight gain inhibition in the blood.

The high standard of economic growth and incomes have improved the general living standards of the people, and the diet has also changed, reducing the consumption of grains and vegetables, while increasing the intake of fats, meat, and processed foods. Most of the nutrients, except for vitamin A and vitamin A, were consumed without deficiency (Shin HH, The development of functional food and research trends, 30 (1) , pp2-13, 1977). These changes in diet have also changed the pattern of disease, resulting in fewer malnutrition, but chronic degenerative diseases resulting from overnutrition or malnutrition such as obesity, coronary artery disease, diabetes, and cancer continue to increase, resulting in 96 years of death. According to the statistics, deaths due to circulatory diseases including hypertensive disease, cerebrovascular disease, ischemic heart disease, arteriosclerosis, etc., ranked 1st with 24.6% of all deaths and 2nd with cancer with 21.7% (Annual report). on the cause of death statistics, National Statistical Office, Republic of Korea, 1996).

Obesity is a condition in which excess fat accumulates in parallel with an increase in calorie intake in the balance of nutrition, and not only is it overweight, but also risk factors for chronic degenerative diseases such as diabetes, fatty liver, high blood pressure, hyperlipidemia, cardiovascular disease, and cancer. It is an important object of interest. Clinical and body mass index (BMI) which is most commonly used as panjeongbeop of obesity in the mechanics field: According to (Body Mass Index BMI) and the mortality rate is minimum when the BMI of 22 kg / m ² il for both men and women, 27 kg / m ² at greater than The risk of death is increased. If the body fat is 25% of body weight for men and 30% or more of body weight for women, and clinically, if the body mass index (BMI) is 30.1 or more, it is defined as obesity if the current body weight exceeds 20%. do. The risk of hypertension in obese adults aged 20-45 is 5-6 times higher than in normal adults, 2.9 times higher for diabetes and 1.5 times higher for hyperlipidemia. Pediatric obese children are more likely to become obese in adulthood, and many obese children often have psychological problems and are known to have many clinical symptoms such as depression, diabetes, fatty liver, hypertension, and hyperlipidemia. . In addition, obesity is a rapidly growing global problem in both developed and developing countries, and according to a recent report by the World Health Organization (WHO), about 250 million adults are obese and at least 500 million adults Be overweight (Bray GA, Handbook in Health Care, Newtown, PA, 1998). In Korea, as in developed countries, the prevalence of obesity is increasing due to lack of exercise due to westernization of vegetation (The Asia-Pacific Perspective: Redefining obesity and its treatment.WHO Western Pacific Region.Korean ed, p1-10, 2000). In animal experiments, the causes of obesity can be divided into spontaneous naturally occuring, genetic factors (mutations of one or more specific genes), dietary causes, neuroendocrine causes, etc. 95% of obesity belongs to simple obesity (Hill JO, An overview of the etiology of obesity. In: Eating disorders and obesity, The Guilford Press , pp 460-466, 2002). Simple obesity is caused by overeating and lack of exercise, and symptomatic obesity is caused by problems such as endocrine, hypothalamus, heredity, frontal lobe, and metabolism. Obesity has been a cause of involvement or exacerbation of various diseases such as hypertension, arteriosclerosis, fatty liver and diabetes. Therefore, it is better to prevent obesity in advance, and in case of obesity, it is very important for the prevention and health of various diseases to control body metabolism smoothly by reducing body fat. As the severity of obesity increases, many researches and developments have been made on substances and products for the prevention and treatment of obesity, but the use of anti-obesity drugs in the treatment of obesity is important, but Side effects are becoming a problem. It is well known that many products used to treat drugs have shown side effects and even social severity. Dexfenfluramine and fenfluramine are serotonin reuptake inhibitors that have been approved by the US Food and Drug Administration (FDA), but the heart valve abnormalities were discovered and the product was recovered from the market in October 1997. Fluoxectin has been reported for side effects such as allergic rash, nausea and insomnia, and side effects such as insomnia, headache, nausea and thirst also occur in diethylpropion, phentermine and madindol. It is observed. In addition, there are reports of side effects on the cardiovascular system of sibutramine and gastrointestinal fever side effects of Xenical (orlistat), a prescription drug for obesity drugs, which has recently been explosive (Fujioka K et al., Diabetes) . Obes. Metab. , 2 (3) , pp175-187, 2000; Leung WYS et al., Clinical Therapeutics , 25 (1) , pp58-80, 2003; McMahon FG et al., Arch.Int . Med. , 160 (14) , pp 2185-2191, 2000). Therefore, the development of a new functional material without side effects for the improvement and prevention of obesity is required.

Mori folium is a dried leaf of mulberry and cousal myofifolium. The taste is sensitive and its properties are limited. The leaves contain rutin, quercetin, moracetin, beta-sitosterol, campesterol, lupeol, myinositol 0.18%, Inosterone and the like. It is known to have effects such as hydration (relieves heat of blood and reduces moisture), nominal wind (reduces wind and clears eyes), and instructs the horse (taken from powder to eliminate cold sweat). In addition, it has been recorded that oriental medicines such as herbal herb have effects on small thirst along with baekbaekpi and silkworm cocoons (Information and Shin, Min-kyo; Doha medicinal herb), Younglimsa, pp545-546, 1998.

In addition, Poria cocos WOLF is a fungal nucleus that parasitic around the roots after 5 to 6 years of resection of pine trees. The main ingredient is carbohydrate, water, crude fiber, mineral and trace protein. Recently, many studies have been conducted on anticancer effects. It is reported that triterpene phase in Bokryeong has anti-soil, anti-inflammatory effects, and the fungal nucleus contains beta-pachyman, which takes up 93% of the dry weight. Pachymic acid, tumulosic acid, 3beta-hydroxylanosta-7,9, 24-triene-2 of triterpenoid compounds It contains acid (24-triene-2-acid), as well as plant solids, chitin, sterols, lecithin, adenine, histidine, choline, lipase, Proteinase and the like. Bokryeong acts on the digestive system such as diuretic, antimicrobial and gastric acid, and decreases blood sugar levels (Information, Shin Min-kyo, Doha medicinal metabolism, Yeonglimsa, pp40-43, 1998).

Whitetail ( Atractylodes macrocephala ) is the root of large flower indica and cognate myofibril. It acts as a diuretic, sweating against the water metabolism in the digestive tract and subcutaneous tissue, and is effective in pain, gastroenteritis, and edema. It contains 1.4% essential oils and its main ingredients are attractylone and attractyrol, which contain vitamin A. Bobi (익), Ik (益胃), humidity (燥濕), high-marked (固 表 止汗), has the effect of Antae. Nasopharyngeal medicine, loss of appetite, boredom erosion, scarredness, hari, lowering, edema, edema, jaundice, arthritis, each, Cures urinary tract, Hyun-un, Dohan, Jahan, Taegi-anxiety, Limb Sujong-jong (4) Metabolism, Younglimsa, p1026, 1998).

Ui-in (薏苡仁, Coicis semen ) is a dried perennial herb seed of Yulmu. The taste is sweet and slightly cold, and acts on parenteral and menopause. Carbohydrates, proteins, fats, calcium, iron, ash, vitamins B1, B2, nicotinic acid, and evenly contained, the acetone extract contains tumor suppressing ingredients. Anti-cancer, anti-inflammatory, cholesterol-lowering, sedative and analgesic effects have been found. It should be used with caution in pregnant women (Jin Ji-sup and Shin Min-kyo; Ilbo Hyangje (Drug Medicine) Dictionary, Younglimsa, p212, 1998).

Red bean (Phase 小豆, Phaseolus angularis ) is a seed of vine or red beans. The taste is sweet and sour and the property is flat. It contains about 50% carbohydrates such as starch and about 20% protein. It is good for those who have aging obesity, sweating at night, and chronic variability (Information and Shin Min-kyo;

The keg (木 通, Akebia quinata Decaisne ) is the diameter of woody vines and eight leaf vines. The taste is bitter and the temper is light. In addition to 11 kinds of akeboside, it contains betulin and myoinositol. It also contains 0.254% potassium. Stem contains stigmasterol and beta-sitosterol. Allow the body to loosen and allow the small intestine to open and pass through. Decoction of stem has diuretic and cardiac effects (Jung, Ji-Seop and Shin, Min-Kyo; Dohae Hyangje (Medicinal Herbal Medicine), Yeonglimsa, pp520-521, 1998).

Plantago asiaticae Semen is a seed of plantain or cognate green plant. The taste is sweet and the nature is cold. A mucilage made of polysaccharide plantasan is contained as a main component. In addition, phenylpropyl glycosides include plantainoside AF and iridoid glycosides, essential oils and flavonoids. It acts as a diuretic effect, Jinhae expectoration, etc. (Information and Shin Min-kyo; Dohae medicinal herb medicine dictionary, Yeonglimsa, p1005, 1998).

       Indeed, in the above-mentioned documents and research reports, the therapeutic effects of the herbal combinations on weight loss and obesity have not been reported at all.

Accordingly, the present inventors have found that the extract of HGD-SJ-201 herbal combinations including extracts of the upper lobe, baekbokyeong and baekchul, uiyiin, red soybeans, neck, and cha-jeon, increases blood HDL-C and decreases lipid index in the body The present invention was completed by confirming that there is an effect of preventing weight loss and obesity and preventing weight gain through simultaneous weight increase.

        An object of the present invention is to provide a pharmaceutical composition containing as an active ingredient HGD-SJ-201 herbal medicine extract having a weight loss and obesity prevention and treatment effect.

In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of obesity, including the herbal compound extract as an active ingredient and a pharmaceutically acceptable carrier, excipient or diluent.

Herbal combinations of the present invention as defined herein are Mori Folium , White Poria cocos , Atractylodes macrocephala , Eui-in ( Coicis semen ), Red Soybean (赤小豆) , Phaseolus angularis ), wood barrel ( Akebia quinata Decaisne ) and chacha ( Plango asiaticae Semen) (hereinafter referred to as HGD-SJ-201 herbal combination), preferably the composition ratio Upper lobe: Baekbokryeong: Baekchul: Righteous person: Red bean: Neck: Carcass (1-5: 0.1-0.5: 1-1.5: 1-1.5: 0.5-1: 0.5-1.5: 0.5-1) More preferably, it is mix | blended in the weight ratio (w / w) of 3: 0.5: 1.5: 1.5: 1: 1.1.5: 1.

The HGD-SJ-201 herbal complex extract includes an extract available in a solvent selected from water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof, and an extract treated with foam.

The extract is characterized in that it is included in the form of a pulverized product, extract or powder extract thereof. At this time, the composition according to the present invention includes a mixed extract comprising a single extract of each herbal medicine, or a complex extract prepared by extracting together a plant comprising two or more of each herbal medicine, the foaming treatment in the art It can be prepared using a well-known foaming method, for example, by extracting the treated extract through a process of immersing the herbal medicines in alcohol, salt and vinegar (3: 1: 1) mixed solution having a predetermined ratio Obtainable.

Hereinafter, the present invention will be described in detail.

The extract according to the present invention may be a crude extract prepared by applying a solvent extraction method using a conventional water extract, alcohol, etc. as a solvent, and may also be a fraction extract purified using column chromatography. Extraction method according to the present invention can be applied to all extraction methods known to those of ordinary skill in the art, for example, extraction with water, alcohol or mixed solvent, extraction method with bath or room temperature, etc. Including but not limited to.

In a preferred embodiment of the present invention, dried herbal medicines may be washed to remove foreign substances, etc. present on the surface of the material, and then dried in a dryer, mixed in an appropriate blending ratio, and ground to obtain the herbal powders.

In addition, 2 to 20 times, preferably 3 to 10 times the volume / weight of distilled water, lower alcohols having 1 to 4 carbon atoms or a mixed solvent thereof, preferably distilled water, methanol or 70% alcohol of the powdered complex herbal medicines. Alone or a mixed solvent thereof is added and cooled at a temperature of 0 ° C to room temperature, preferably 4 to 6 ° C for 12 hours to 48 hours, preferably 20 to 24 hours, or 80 to 110 ° C, preferably 1 to 24 hours, preferably 2 to 5 hours at an extraction temperature of 90 ℃ or more by extracting 2 to 5 times with water of 20 to 50 times the total amount of extraction by a hydrothermal extraction method without pressure to the complex herbal extracts available in polar solvents Extracts can be obtained, and the inventors have referred to the extracts produced by the above method as a disintegrant.

In addition, it is possible to obtain an extract treated with the foaming agent obtained by the manufacturing process by a foaming method well known in the art. For example, 10% natural salt of 3 to 10 times of the drying agent obtained from the manufacturing process The solution was dissolved for 30 to 52 hours by addition of the dissolved brine aqueous solution, and then dried. Then, the solution was deposited for 48 to 96 hours by addition of 3 to 10 times aqueous vinegar solution and 15% aqueous solution. Compound herbal extract produced by the method of manufacturing a pharmaceutical composition for preventing or treating obesity can be obtained by extracting the powder by a process similar to the extraction of the above and the above-mentioned saliva with 3 to 10 times water, methanol or 70% alcohol. The inventors called the extract produced by this method.

The present invention provides a pharmaceutical composition for the prevention and treatment of obesity, comprising a medicament extract treated with a medicinal agent or an emollient obtained by the above-described method and comprising a pharmaceutically acceptable carrier, excipient or diluent.

The herbal extracts have been used as food for a long time, and the enzyme activity of alanine aminotransferase (ALT) and aspartic acid aminotransferase (AST), which are indicators of liver toxicity, was normal in the HGD-SJ-201 administration group. As it belongs to the extract of the present invention extracted from it also does not have problems such as toxicity and side effects.

In addition, the composition obtained by the above method can be used for the purpose of inhibiting weight gain, preventing and treating obesity by increasing high density lipoprotein cholesterol (HDL-C) in the blood and decreasing lipid-related index in the body.

Pharmaceutical dosage forms of the extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, or may be used alone or in combination with other pharmaceutically active compounds, as well as in a suitable collection.

Pharmaceutical compositions comprising extracts according to the invention, in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral preparations, suppositories and sterile injectable solutions, respectively, according to conventional methods. Can be formulated and used. Carriers, excipients and diluents that may be included in the composition comprising the extract 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. Solid preparations for oral administration include tablets, pills, powders, granules, capsules and the like, and such solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose in the extract. Or lactose, gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups. In addition to commonly used simple diluents such as water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories. 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 the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.

Preferred dosages of the 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 desired effect, the extract of the present invention is preferably administered at 0.0001 to 100 mg / kg, preferably 0.001 to 100 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.

The extract 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 or intracerebroventricular injection.

Complex herbal extract of the present invention is a drug that can be used safely in long-term administration for the purpose of prevention because there is little toxicity and side effects.

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

However, the following Examples, Reference Examples, and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following Experimental Examples.

Example 1 Preparation and Preparation of Samples

1-1. Preparation of upper leaf (sweetener)

It was purchased at Daegu Yangnyeong Market and used as an experimental material for sweeteners.

1-2. Preparation of HGD-SJ-201 complex herbal medicine (cloning agent)

300 g, 50 g, 150 g, 150 g of Sangyeop (Daegu Yangnyeong Market), Baekbokryeong, Baekchul, Euiin, Jeoksodu (Gyeongdong Market), Kegong and Chae (Daegu Yangnyeong Market) purchased from Daegu Yangnyeong Market and Gyeongdong Market, respectively. , 100 g, 150 g, 100 g each was mixed to prepare a total of 1 kg.

1-3. Preparation of HGD-SJ-201 complex herbal medicine (cloning agent)

500 g, 100 g, 100 g, 100 g, 100 g of pure domestic leaf, Baekbokryeong, Baekchul, Euiin, Red Soybean, Kowl, and tea tea purchased from Daegu Yangnyeong Market and Gyeongdong Market were prepared for the toxicity test. , 50 g, 50 g each was mixed to prepare a total of 1 kg.

1-4. Preparation of HGD-SJ-201 Compound Herbal Formulation

3 kg of the dry matter preparation prepared in Example 1-2 was made with Gyeongjong Co., Ltd. of 15% alcohol concentration; Salt water and brewing vinegar (Ottogi, 160 Pyeongchon-dong, Buan-gu, Anyang-si, Gyeonggi-do), melted with 225-1, Sirae-dong, Gyeongju-si, Korea, 10% Cheonil Salt (422-7, Sinui-myeon, Sinan-myeon, Sinan-gun, Jeonnam) The mixture was deposited for 72 hours, dried for 48 hours in the shade, and then salted and drunk again for 48 hours using a ratio of 2: 1, and then dried in the shade for more than 72 hours to prepare a composite herbal preparation.

Example 2. Preparation of Water Extract of Samples

1 kg of each dry sample prepared in Example 1 was added to 50 L of distilled water and cooled. The extract was filtered, and the filtrate was concentrated under reduced pressure using an evaporator to a volume of 1 L and freeze-dried to obtain 15.5 g, 13.6 g, and 12.9 g of each powder extract.

Example 3 Administration and Statistical Treatment of Obesity-induced and HGD-SJ-201 Herbal Combination Extracts in Experimental Animals

3-1. Preparation of Laboratory Animals

A 5-week-old male Zucker FA / -rat, a genetic experimental animal model in which obesity is derived from adipocytes and is a genetic experimental animal model in which obesity is induced by leptin, a peptide hormone that has a strong feeding inhibitory and energy-stimulating activity. (n = 33), female Zucker FA /-rat (n = 33), and Japanese SLC were purchased through a central laboratory animal in Seoul and purified for 1 week, followed by three experimental groups: normal control group, positive control group, and test substance supply. For each group, 22 animals were placed in each experimental group for 8 weeks. The experimental diet supplied powdered animal feed (Samtaco Bio Korea Co., Ltd., Osan-si, Gyeonggi-do), temperature 23 ± 2 ℃, humidity 50 ± 10%, ventilation frequency 10-12 / hr, light intensity cycle 12 hours and roughness 200 Lux was fed and fed enough to intake water and feed freely.

Sprague-Dawley-based male rats of 4 weeks of age were purchased from Samta Cobio Korea (Osan, Gyeonggi-do), and after 7 days of purification, healthy animals were selected and used for the experiment. Body weight was 200 ± 3 g at the start of administration. Solid feed for test animals in normal group under conditions of temperature 23 ± 2 ℃, relative humidity 50 ± 5%, ventilation frequency 10-15 times / hr, contrast period 12 hours (Samta Bio Bio, Osan Co., Ltd.) And filtered purified water was bred freely.

3-2. Inducing Obesity in Laboratory Animals

In the Zucker FA /-rats, the test substance-feeding group received 3% HGD-SJ-201 for 8 weeks by mixing high-fat powdered feed (1% cholesterol, 3% corn oil) with normal powdered feed, and the control and positive control groups, respectively. General feed and high fat diet (1% cholesterol, 3% corn oil) were supplied. After 8 weeks, the animals were necropsied and blood was collected.The liver tissue was liver perfused with pre-cooled 0.9% sodium chloride solution, the liver was extracted, the liver blood was removed with physiological saline, and then frozen in liquid nitrogen to lipid Peroxidation was measured, and the collected blood samples were analyzed for hematological and blood biochemical effects. Body weights of the test animals were measured once a week and clinical symptoms were observed.

The Sprague-Dawley rat diet was supplied in the same composition as in Table 1 for the normal group and the positive control group, and the test substance was fed to the high-fat diet 1,3,5. It was prepared and supplied at a concentration of%. For eight weeks, high-fat feed was given to the free feed group (control group), high-fat feed group, high-fat feed group + HGD-SJ-201 (group: 1, 3, 5%).

Seventy five-week-old Sprague-Dawley rats were grouped into seven groups of 10 rats for toxicity testing, followed by 0.5, 1 or 2 g / kg / BW The dose of was prepared on the day of administration and administered orally, the control group was administered orally once a day, 4 weeks only distilled water as a solvent.

Configuration Normal fat feed High Fat Feed Casein 200 200 Corn Starch (Maize Starch) 521 321 Sugar (Sucrose) 100 100 Corn oil (Maize oil) 100 100 Lard - 200 Cellulose 30 30 DL-methionine 2 2 mineral mix 35 35 vitamin mix 10 10 choline bitartarte 2 2 gross energy content (kcal / g) 4.25 5.20

  * AIN mineral mix containing (g / kg): calcium phosphate dibasic 500, sodium chloride 74, potassium citrate 220, potassium sulfate 52, magnesium oxide 24, manganous carbonate 3.5, ferric citrate 6, zinc carbonate 1.6, cupric carbonate 0.3, potassium iodate 0.01, sodium selenate 0.01, chromium potassium sulfate 0.55

  * AIN vitamin mix containing (g / kg): thiamin HCl 0.6, rivoflavin 0.6, pyridoxine HCl 0.7, niacin 3, calcium pantothenate 1.6, folic acid 0.2, biotin 0.02, vitamin B12 (0.1% trituration in manitol) 1, dry vitamin A palmitate (500,000 U / g) 0.8, dry vitamin E acetate (500 U / g) 10, vitamin D, trituration (400,000 U / g) 0.25, manadione sodium bisulfate complex 0.15

3-3. Statistical analysis

All results are expressed as mean ± standard deviation, and a homogeneous test (Levene's test) is performed to compare the homogeneity of the variances for each test result.If the variances are homogeneous, one-way analysis of vatiance , ANOVA), the Bonferroni test and Schiff test were performed to find the experimental group with significant differences from the control group. As a result of the homogeneous test (Levene's test), if the variance is heterogeneous, perform the appropriate data transformation and again perform the homogeneous test (Levene's test) on the deformation data. On the other hand, if the variances are not homogeneous, a non-parametric ANOVA test was performed and if the results were significant, a t-test method was selected and a statistical analysis was performed at p <0.05. .

Experimental Example 1. Improvement effect of the extract of the present invention in obesity-induced Zucker FA /-rat

1-1. Weight and organ weight changes

As shown in FIG. 1, the weight of the positive control group was increased by 161% in the male Zucker FA /-rat for 8 weeks and 153% in the HGD-SJ-201. As shown in FIG. 2, the weight gain rates of 139% and 143% were shown in the normal control group and the positive control group in the female Zucker FA / -rat, respectively, and 140% in the HGD-SJ-201 group.

In both male and female, weight gain was suppressed, but there was no significant difference. This is similar to the results of some weight loss reported previously in the human body (Kim SY et al., J. Korean Soc. Food Sci. Nutr. , 27 , pp1217-1222, 1998; Kim or et al., Soon -chunhyang J. Nat. Sci. , 5 , pp 167-171, 1999). The liver weights of the normal control group were 3.14 ± 0.183 g and 3.53 ± 0.145 g in the male rats, and the liver weights of the positive control group and the HGD-SJ-201 group were 3.54 ± 0.183 g and 3.53 ± 0.203 g, respectively. Increased to ( p <0.01). The liver weight of the positive control group was 3.28 ± 0.301 g in the female rats and 3.09 ± 0.142 in the HGD-SJ-201 group (see Table 2). This was consistent with reports of increased liver weight with high fat intake (Wursch P et al., J. Nutr. , 109 (4) , pp167-171, 1999; Park OJ et al., Kor. J. Nutr. , 27 (8) , pp785-794, 1994).

gender treatment Liver Left kidney Right kidney Epididymal adipose tissue Male Normal feed 3.14 ± 0.15 0.35 ± 0.03 0.34 ± 0.03 0.86 ± 0.16 High Fat Feed 3.54 ± 0.18 0.34 ± 0.03 0.34 ± 0.02 0.87 ± 0.13 High Fat Feed + HGD-SJ-201 3.53 ± 0.20 0.37 ± 0.05 0.34 ± 0.03 1.03 ± 0.36 Female Normal feed 2.87 ± 0.09 0.35 ± 0.04 0.36 ± 0.05 High Fat Feed 3.28 ± 0.30 0.36 ± 0.05 0.34 ± 0.05 High Fat Feed + HGD-SJ-201 3.09 ± 0.14 0.34 ± 0.02 0.35 ± 0.02

1-2. Blood and Serum Biochemical Results

Blood glucose and albumin obtained from Zucker FA / -rats fasted for 18 hours on the day of autopsy were collected by whole blood from the abdominal aorta under ether anesthesia, allowed to stand at room temperature for 30 minutes, and then centrifuged at 1,500 rpm for 10 minutes. , Total cholesterol (TC), triglycerides (TG), creatinine, glutamic acid oxaloacetic transaminase (GOT), high density lipoprotein cholesterol (HDL-C), total protein (TP), glutamate pyrubin Biochemical automated analyzer Hitachi- with acid aminotransferase (GPT), low density lipoprotein cholesterol (LDL-C), blood urea nitrogen (BUN), alkaline phosphatase (ALP), and lactate dehydrogenase It was measured using 747 (Hitachi medical, Japan). In male rats, HGD-SJ-201 group showed significant decrease in GOT and LDH levels ( p <0.01), high density lipoprotein cholesterol was increased, TP was increased and LDH was decreased compared to normal control group. Difference ( p <0.01) was shown (see Table 3). In female rats, the HGD-SJ-201 group showed a significant ( p <0.05) increase in high-density lipoprotein cholesterol levels (see Table 4). The HGD-SJ group in the HGD-SJ-201 group of Experimental Example 1-1 showed a decrease in liver weight with respect to the positive control group and the high density lipoprotein cholesterol in the serum of the male and female HGD-SJ-201 group. -201 can prevent obesity by increasing the ratio of high density lipoprotein cholesterol to total cholesterol.

Treatment Normal diet High-fat diet High-fat diet + HGD-SJ-201 Cholesterol (mg / dl) 76.1 ± 23.2 82.4 ± 26.52 92.8 ± 27.5 LDL (mg / dl) 13.1 ± 4.3 16.9 ± 5.3 17.4 ± 6.9 HDL (mg / dl) 26.9 ± 10.3 24.8 ± 9.3 32.1 ± 6.7 Triglycerides (mg / dl) 116.8 ± 61.1 104.0 ± 35.9 127.9 ± 46.3 ALT (IU / l) 61.5 ± 15.1 81.27 ± 16.224 * 68.1 ± 13.5 AST (IU / l) 181.6 ± 33.58 196.6 ± 26.3 165.6 ± 16.3 # ALP (mg / dl) 155.4 ± 64.5 140.9 ± 33.6 199.0 ± 59.1 LDH (IU / l) 5,899.0 ± 1238.0 5,956.4 ± 1167.1 4,339.1 ± 456.4 * # Total proteins (g / dl) 5.53 ± 0.41 6.00 ± 0.33 * 6.02 ± 0.18 * Albumin (g / dl) 4.23 ± 0.30 4.35 ± 0.23 4.36 ± 0.22 Glucose (mg / dl) 121.8 ± 30.3 126.4 ± 23.9 130.6 ± 18.4 BUN (mg / dl) 18.4 ± 8.8 18.5 ± 1.9 20.0 ± 1.8 Creatinine (mg / dl) 0.48 ± 0.09 0.62 ± 0.18 0.49 ± 0.10 * Significantly different from normal diet ( p <0.05) # Significantly different frim high-fat diet ( p <0.05)

Treatment Normal diet High-fat diet High-fat diet + HGD-SJ-201 Cholesterol (mg / dl) 67.6 ± 17.0 82.1 ± 15.8 84.6 ± 6.2 * LDL (mg / dl) 5.64 ± 1.57 10.9 ± 2.8 * 9.36 ± 1.03 * HDL (mg / dl) 27.6 ± 5.0 25.9 ± 4.8 * 35.0 ± 2.9 # Triglycerides (mg / dl) 125.3 ± 65.2 203.9 ± 88.1 * 137.9 ± 66.8 # ALT (IU / l) 59.5 ± 16.1 53.9 ± 9.0 45.3 ± 11.6 * AST (IU / l) 134.3 ± 32.3 144.1 ± 16.1 146.2 ± 15.6 ALP (mg / dl) 100.3 ± 48.2 95.5 ± 45.1 116.6 ± 41.2 LDH (IU / l) 2,400.6 ± 863.3 3,264.6 ± 492.9 * 3,290.9 ± 573.4 * Total proteins (g / dl) 6.48 ± 0.9 6.43 ± 0.61 6.68 ± 0.20 Albumin (g / dl) 5.14 ± 0.70 5.05 ± 0.63 5.25 ± 0.15 Glucose (mg / dl) 123.3 ± 39.8 137.2 ± 60.1 135.7 ± 11.3 BUN (mg / dl) 24.1 ± 4.3 19.7 ± 1.9 * 18.2 ± 3.2 * Creatinine (mg / dl) 0.44 ± 0.05 0.54 ± 0.13 * 0.64 ± 0.12 * * Significantly different from normal diet ( p <0.05) # Significantly different frim high-fat diet ( p <0.05)

1-3. Measurement of Lipid Peroxidation in Tissues

Measurement of lipid peroxidation in tissues to investigate the lipid peroxidation inhibitory effect of HGD-SJ-201 was performed using 1,1,3,3-tetraethoxypropane (1,1,3,3-tetraethoxypropane), a malondialdehyde (MDA) analog. (1,3,3-tetraethoxypropane, TEP) was measured by the thiobarbituic acid (TBA) method. After the extraction, the nitrogen-free liver tissue was sectioned and 9x phosphate buffered solution (PBS) cooled with ice was added and homogenized with a homogenizer while cooling with ice at the same time. To 1 ml of homogenized solution, add 1 ml of 8.1% sodium dodecyl sulfate solution, 2 ml of 20% acetic acid solution, vortex, add 1 ml of 0.8% TBA solution, react for 60 minutes at 95 ° C, and then cool the supernatant. The absorbance was measured at 532 nm using a spectrophotometer.

Intrahepatic lipid analysis of male rats showed 1.74 ± 0.083 mmol in the normal control group and 2.43 ± 0.174 mmol in the positive control group ( p <0.01). In addition, HGD-SJ-201 group was found to be 2.01 ± 0.350 mmol compared to the positive control group ( p <0.05). In female rats, hepatic lipid of normal control group was 1.72 ± 0.160 mmol, positive control group was 2.41 ± 0.131 mmol ( p <0.01), and HGD-SJ-201 group was 2.31 ± 0.265 mmol. Decreased compared to the control.

As shown in FIG. 3, the positive control group fed the high fat diet was significantly increased in both male and male compared to the normal control group, and the male HGD-SJ-201 group was significantly decreased in comparison with the positive control group. -SJ-201 group also showed a tendency to decrease compared to the positive control group. As a result, it can be seen that HGD-SJ-201 prevents the liver damage caused by the high fat diet to some extent, and the liver damage prevention of HGD-SJ-201 is the GOT of the male HGD-SJ-201 group serum of Experimental Example 2. This is also shown by the significant decrease in the and LDH levels.

Experimental Example 2. Improvement effect of the extract of the present invention treated with sisal (salt: salt: vinegar; 3: 1: 1) in obese induction SD rats

2-1. Dose determination experiment

Significant inhibitory effects began to appear at 5% of the single agent compared to the positive control group at 2 weeks after the administration of the sample. ( P <0.05). At the 5th and 6th weeks, all prescriptions from 1% to 5% showed a significant inhibitory effect. Especially from the 5th week, there was a significant difference in the positive control group and the positive control group. In other words, the test group increased significantly by 90% in the positive control group ( p <0.05), whereas in the test group, 112% and 1% of the sweetener and 5% of the test substance treated in the 5th week, respectively, compared to the positive control group. 120% showed inhibitory effect, and at week 6, 1% of the drug was started to show a significant inhibitory effect, and 5% of the sieve-treated test substance had a 124% of inhibitory effect ( p <0.05-0.001). Seemed. The overall effect on body weight was in the order of sweetener> cloning agent> foaming sample and in the order of 1%>3%> 5% in terms of dose, but the difference in effect at 3% and 5% concentration 3% was determined as the most effective dose in consideration of the dose (see Table 5).

Com. Day Group 0 One 2 3 4 5 6 HGD-SJ- 201 -WE NC 199.8 ± 2.5 237.1 ± 9.8 295.6 ± 10.4 340.1 ± 19.4 379.3 ± 27.3 403.5 ± 28.6 432.3 ± 36.8 PC 196.2 ± 2.3 246.6 ± 13.9 304.5 ± 13.4 367.4 ± 25.3 405.2 ± 32.6 447.3 ± 30.7 † 478.4 ± 43.8 † One% 199.6 ± 2.7 245.7 ± 6.8 299.3 ± 8.9 337.3 ± 18.5 367.5 ± 19.7 396.1 ± 28.9 * 422.2 ± 39.8 195.3 ± 2.5 239.5 ± 12.3 288.3 ± 7.7 341.2 ± 23.6 369.2 ± 21.5 384.3 ± 23.8 ** 418.0 ± 32.7 * 196.3 ± 1.9 234.6 ± 11.7 295.8 ± 17.2 334.6 ± 21.7 372.3 ± 19.4 378.4 ± 43.2 ** 405.3 ± 34.8 ** 3% 197.4 ± 1.4 241.9 ± 12.5 288.4 ± 18.2 334.5 ± 22.6 * 368.2 ± 16.8 385.8 ± 34.8 ** 414.9 ± 39.1 ** 200.4 ± 2.0 248.3 ± 11.3 279.3 ± 14.6 315.4 ± 19.2 * 359.1 ± 19.0 * 378.1 ± 32.8 ** 402.4 ± 40.5 ‡ * 198.7 ± 1.8 241.5 ± 13.4 283.5 ± 16.9 312.3 ± 18.4 * 346.0 ± 17.3 * 372.1 ± 43.2 ** 395.1 ± 38.6 ** 5% 200.1 ± 2.9 236.9 ± 15.6 274.2 ± 7.1 * 314.2 ± 15.6 * 354.2 ± 20.6 * 370.6 ± 31.8 ** 388.8 ± 40.8 ** 198.3 ± 2.5 240.3 ± 13.4 284.3 ± 10.3 311.4 ± 19.0 * 349.3 ± 25.3 * 375.6 ± 34.7 ** 397.3 ± 27.7 ** 195.2 ± 1.7 244.4 ± 14.2 274.2 ± 11.6 321.6 ± 22.6 * 356.2 ± 17.5 * 370.3 ± 30.6 ** 384.9 ± 36.7 **

2-2. Blood biochemical test

Blood biochemical tests were performed on animals fasted 20 to 24 hours prior to autopsy under ether anesthesia, and the blood obtained from pre-bleeding blood from the abdominal vein was placed in a serum separation centrifuge tube (SST tube, BD vacuutainer, USA) for 30 minutes at room temperature. After standing and coagulating, centrifugation at 3,000 rpm for 15 minutes was used to measure serum biochemical test using a biochemical automated analyzer Hitachi-747 (Hitachi medical, Japan). The experiment was carried out. The results are shown in Table 6 (effect on liver function metabolic index) and Table 7 (effect on improving lipid metabolism in blood).

Com. Day Group T. protein (g / dl) Albumin (g / dl) SGOT (IU / L) SGPT (IU / L) ALP (mg / dl) HGD- SJ-201 -WE NC 6.6 ± 0.5 3.4 ± 0.3 124.2 ± 21.0 38.2 ± 6.7 113.4 ± 19.3 PC 5.7 ± 0.4 2.9 ± 0.2 156.7 ± 20.4 † 48.4 ± 7.5 126.2 ± 20.3 One% 5.9 ± 0.3 2.9 ± 0.3 134.6 ± 23.7 43.6 ± 6.9 88.5 ± 18.4 6.1 ± 0.5 3.3 ± 0.3 126.4 ± 21.3 * 42.6 ± 6.3 98.3 ± 19.3 6.2 ± 0.6 3.4 ± 0.4 115.6 ± 26.1 * 39.5 ± 7.5 101.3 ± 21.5 3% 6.3 ± 0.5 3.4 ± 0.3 112.7 ± 16.7 * 38.5 ± 4.7 112.4 ± 28.5 6.4 ± 0.5 3.6 ± 0.3 109.3 ± 18.4 * 37.4 ± 3.9 103.4 ± 17.4 6.5 ± 0.6 3.4 ± 0.3 125.4 ± 19.2 * 36.5 ± 5.4 112.4 ± 15.9 5% 6.2 ± 0.4 3,3 ± 0.2 118.6 ± 22.8 * 34.5 ± 6.2 119.4 ± 14.3 6.4 ± 0.5 3.5 ± 0.3 117.5 ± 21.6 * 38.5 ± 8.4 123.3 ± 17.3 6.5 ± 0.6 3.4 ± 0.3 126.1 ± 23.9 * 40.3 ± 5.5 116.4 ± 18.7

As shown in Table 6, the total protein, albumin and ALP did not show a significant effect in all test substance-treated groups including the normal control group and the positive control group, while the liver function index SGOT was weak in the positive control group compared to the normal control group. There was an increase of 79% ( p <0.05), and the test group showed a significant decrease ( p <0.05) compared to the positive control group in the 3% and 5% all groups.

Com. Day Group T. Cho (mg / dl) TG (mg / dl) HDL-C (mg / dl) LDL-C (mg / dl) PL (mg / dl) HGD- SJ- 201-WE NC 77.4 ± 5.7 70.3 ± 6.7 53.4 ± 4.8 11.7 ± 1.1 93.3 ± 17.3 PC 134.5 ± 26.3 ‡ 112.4 ± 15.3 ‡ 37.4 ± 3.7 † 58.9 ± 4.7 ‡ 122.7 ± 23.5 † One% 125.3 ± 17.5 ‡ 104.5 ± 10.1 † 39.6 ± 2.7 † 46.2 ± 6.9 ‡ 117.4 ± 16.6 122.7 ± 12.4 ‡ 99.4 ± 7.8 38.5 ± 3.8 † 43.5 ± 4.6 ‡ 125.6 ± 12.5 † 113.4 ± 10.5 † 98.4 ± 8.5 39.5 ± 2.1 † 44.5 ± 7.4 ‡ 115.6 ± 23.1 3% 115.5 ± 16.3 † 96.7 ± 6.8 41.4 ± 3.3 41.7 ± 6.8 ‡ 105.6 ± 14.6 * 105,4 ± 11.3 * 94.6 ± 6.9 40.6 ± 4.5 43.6 ± 7.5 ‡ 110.4 ± 18.5 95.3 ± 8.4 * 85.7 ± 7.9 * 45.3 ± 3.9 35.3 ± 2.1 † *  98.6 ± 16.3 ** 5% 101.4 ± 9.4 * 95.3 ± 9.5 43.6 ± 5.3 40.4 ± 3.6 ‡ 105.6 ± 11.4 99.5 ± 7.2 * 93.6 ± 9.5 44.1 ± 8.6 37.9 ± 5.5 † * 100.3 ± 10.4 * 89.3 ± 5.8 * 85.3 ± 7.4 * 49.3 ± 5.9 * 38.6 ± 4.8 † * 119.4 ± 16.4

As shown in Table 7, the effect of improving blood lipid metabolism was 174% in the total control group in the positive control group compared to the normal control group, and this increase was increased up to 3% of the single agent of the test substance. Was significantly increased up to 136-162%, while the decrease began to be significantly suppressed compared to the positive control from 3% of the releasing agent ( p <0.05-0.001). In the case of triglycerides, 1% of the control group and 1% of the test substance were significantly increased compared to the normal control group, and the decrease was significantly suppressed only in the 3% and 5% sieve treatment groups. High-density lipoprotein cholesterol (HDL-C) was suppressed in all treatment groups of the positive control group and 1% of the test substance compared to the normal control group, and the increase was significantly increased only in the 5% sieve treatment group. It was a phenomenon. Low-density lipoprotein cholesterol (LDL-C) was significantly increased in all test substance groups, including the positive control group, compared to the normal control group. It was suppressed in the treatment group. Phospholipids showed a significant increase of 131% in the positive control group and 134% in the drug-treated group, compared with the normal control group, and 134% in the control group, respectively. 80-86% of the drug groups showed significant inhibitory effects ( p <0.05-0.001).

2-3. Lipid content measurement

The total lipid content in liver tissue and feces was determined by Folch et al. (Folch J et al., J. Biol. Chem. , 226, pp 497-502, 1957), and cholesterol content was determined by Zlatkis and Zak et al. (Zlatkis A et al, Anal. Biochem., 29 , pp143-146, 1969), the triglyceride content was determined by Bigg et al. (Biggs HG et al., Clin. Chem., 21 , pp437-441, 1975). The content of bile acid in stool was determined by Tokunaga et al. (Tokunaga T et al., J. Nutr. Sci. Vitaminol. , 32 , pp111-121, 1986), followed by extracting the bile acid from the stool. Measured using. That is, a 1: 1 amount of acetone and ethanol were added to a predetermined amount of the side, and the mixture was stirred for 1 hour, and then, a predetermined amount of the sample was taken from the supernatant obtained by centrifugation twice at 3000 rpm for 20 minutes, and the solvent was evaporated with nitrogen gas. After dissolving with sodium and diethyl ether to extract the lower bile acid, it was measured using a bile acid analysis kit. The results are shown in Table 8 below.

Com.        Day Group T. Lipid (mg / dL) T.CHO (mg / dl) Bile Acid (mg / ㎗) liver side liver side liver side HGD-SJ-201-WE NC 143.6 ± 13.1 117.4 ± 13.2 14.7 ± 2.5 8.63 ± 2.6 29.3 ± 4.6 14.6 ± 3.5 PC 185.9 ± 26.7 155.3 ± 16.7 38.3 ± 6.3 18.72 ± 4.1 57.8 ± 6.3 34.7 ± 5.7 One% 173.1 ± 19.4 143.6 ± 12.6 30.2 ± 4.8 13.63 ± 3.6 46.3 ± 4.1 33.5 ± 6.3 173.9 ± 18.4 147.4 ± 20.3 29.6 ± 2.6 14.87 ± 1.9 45.8 ± 7.1 30.2 ± 2.9 167.4 ± 15.3 140.6 ± 19.2 31.4 ± 3.5 15.42 ± 4.5 49.1 ± 3.9 33.6 ± 3.4 3% 169.5 ± 18.3 133.6 ± 10.4 27.3 ± 2.4 12.44 ± 2.1 39.2 ± 3.6 28.3 ± 2.7 166.3 ± 17.8 131.3 ± 14.5 24.6 ± 4.7 10.81 ± 3.2 38.1 ± 2.5 25.2 ± 5.3 153.4 ± 11.2 120.5 ± 13.7 18.3 ± 6.1 9.34 ± 1.2 31.6 ± 2.3 17.3 ± 6.2 5% 160.3 ± 13.1 129.3 ± 10.8 20.6 ± 3.6 11.45 ± 2.4 32.6 ± 2.7 19.5 ± 4.7 158.5 ± 14.6 133.9 ± 19.4 19.7 ± 1.3 12.56 ± 2.9 30.3 ± 1.9 23.4 ± 7.5 150.7 ± 10.3 126.2 ± 11.3 17.9 ± 1.9 9.23 ± 0.7 30.9 ± 3.5 18.6 ± 3.2

The effects of lipids on liver and stool lipids in liver tissue were significantly increased in total lipids, total cholesterol and triglycerides in the positive control group (132, 260, 197%) compared to the normal control group. The test substance of each test item was continuously increased to 1%. On the other hand, inhibition showed significant inhibitory effects ( p <0.05-0.001) in 3% of the releasing agent, sieve treatment group and 5% of all test substance groups. On the other hand, the effect on the lipid content in feces showed a tendency similar to the lipid content in liver tissue.

2-4. Body fat, protein measurement and protein DNA content of brown adipose tissue

The sacrificed rats were abdominal, removed all contents of the gastrointestinal tract, dried until the content at 105 ℃, homogenized in a mixer and homogenized, and about 20 g of the body fat was measured by Soxhlet extraction method, body protein mass was measured. , Body protein mass was calculated by measuring nitrogen content by Kjeldahl method using degreasing sample and applying nitrogen coefficient 6.25. The body fat increase and body protein increase were calculated at the start of the experiment on the body fat and body protein mass based on the data obtained from the measurement of body fat mass and body protein mass at the sacrifice of 8 rats similar in weight to the test rats. This was then subtracted from the body fat mass and body protein mass at the end of the experiment.

The weight of the epithelial epididymal tissue and the retro-peritoneal tissue after renal resection were measured. The protein content of the interscapular brown adipose tissue (IBAT) was 0.3 in the sample. N sodium hydroxide was added and homogenized using a tissue homogenizer, and then obtained by dissolving at 45 ° C. for 1 hour, followed by Lowry method (Lowry OH et al., J. Biol. Chem. , 193 , pp265-275, 1951). The DNA content was determined by extracting DNA with 8% perchloric acid and then Burton's diphenylamine method improved by Giles and Myers. The results are shown in Table 9 below.

Com. Day Group Adipose tissue (g) Body fat (g) Body protein (mg) DNA Conc. ( ug ) HGD-SJ-201-WE NC 7.67 39.0 ± 6.4 68.7 ± 3.4 396.6 ± 34 PC 11.42 ‡ 55.3 ± 5.1 † 67.5 ± 3.3 427.3 ± 67 One% 9.84 † * 50.4 ± 6.5 † 66.2 ± 3.5 435.6 ± 44 9.13 † * 48.5 ± 5.7 65.7 ± 3.1 442.6 ± 35 8.42 ** 49.2 ± 5.9 66.3 ± 3.4 449.3 ± 49 3% 7.32 ** 45.7 ± 4.1 69.3 ± 3.0 456.8 ± 54 † 6.42 ** 41.6 ± 3.0 * 66.7 ± 2.9 462.7 ± 61 † 5.92 ** 40.5 ± 2.6 * 67.9 ± 2.5 469.1 ± 48 † 5% 7.54 ** 43.7 ± 3.6 64.8 ± 3.7 447.2 ± 53 † 6.29 ** 42.6 ± 4.0 65.1 ± 3.2 451.6 ± 48 † 5.73 ** 40.1 ± 1.9 * 65.3 ± 3.3 463.2 ± 65 †

Adipose tissue showed a significant increase of 148% in the positive control group compared to the normal control group, whereas 1,3,5% in the test substance group showed a significant inhibitory effect. In particular, 3% and 5% showed very strong inhibitory effect, and among them, the effect in the foam treatment group showed a significant inhibitory effect compared to other test groups ( p <0.05-0.001). In addition, the body fat was increased by 141% in the test substance group and the inhibitory effect was 3% in the abdominal and sieve groups and 5% of the sieve group ( p <0.05). . In the case of body protein, no significant change was observed in all test substance groups. On the other hand, the concentration of DNA was significantly increased ( p <0.05) in all test groups of 3% and 5% compared to the normal control group.

Experimental Example 3. Toxicity Test

Seventy-week-old Sprague-Dawley male rats were grouped into seven groups of ten animals each, followed by the preparation of lobe sweetener and abdominal agent at the dose of 0.5, 1 or 2 g / kg / bw, respectively. Oral administration, and the control group was administered only once or daily for 4 weeks distilled water as a solvent to conduct a toxicity test.

After administration of the test substance, mortality, clinical symptoms and changes in body weight, feed and drinking intake were observed, hematological and hematological examinations were performed, and autopsy was performed to observe major organ abnormalities. Histopathology An inspection was conducted. As a result, some of the rats treated with oral leaf extracts for 28 days resulted in some changes in hematological and hemobiochemical markers, but some body-protective effects were expected as the indicators related to liver function decreased. As a result, the extract of the present invention did not show a change in toxicity even in more than 2,000 mg / kg rats, the minimum lethal dose (LD ₅₀ ) was determined to be more than 500 mg / kg safe material.

Clinical Example 1. Clinical Trial

1-1. Dose determination experiment

People with body mass index above 23.0 (kg / m ² ) (50 years old or older; 2, 40-49 years old; 12, 30-39 years old; 10 people, 20-29 years old; 19 people, 19 years old or younger; 2 people) In order to determine the proper dose of HGD-SJ-201 herbal complex extract to be treated, 20 g, 40 g, 60 g and 80 g of SJ-101 herbal complex extract were fed for 1 month. Is shown in Table 10 below.

Volume Item (unit) Before implementation After implementation t value p -value M ± SD M ± SD 20 g Weight (kg) 66.14 ± 3.52 65.51 ± 2.90 1.27 0.2458 Muscle mass (kg) 41.81 ± 2.99 40.94 ± 1.81 1.24 0.2558 Body fat (kg) 21.83 ± 2.56 22.13 ± 3.03 -0.51 0.6287 % Of body fat 32.98 ± 3.30 33.69 ± 3.57 -0.79 0.4535 Retention index 25.24 ± 1.63 25.00 ± 1.51 1.23 0.2596 Mineral (kg) 2.51 ± 0.14 2.47 ± 0.08 1.25 0.2524 40 g Weight (kg) 72.30 ± 11.79 71.81 ± 11.14 1.32 0.2094 Muscle mass (kg) 45.94 ± 7.61 43.87 ± 6.01 2.33 0.0369 Body fat (kg) 23.64 ± 5.50 25.19 ± 6.23 -1.98 0.0692 % Of body fat 32.49 ± 4.44 34.74 ± 4.46 -2.19 0.0472 Retention index 27.49 ± 3.39 27.34 ± 3.18 0.98 0.3442 Mineral (kg) 2.76 ± 0.34 2.76 ± 0.29 -0.04 0.9695 60 g Weight (kg) 68.67 ± 4.80 68.31 ± 4.54 1.92 0.1036 Muscle mass (kg) 42.74 ± 4.54 38.94 ± 6.78 1.30 0.2400 Body fat (kg) 23.41 ± 2.71 24.21 ± 1.77 -0.71 0.5026 % Of body fat 34.16 ± 3.95 35.34 ± 2.48 -0.74 0.4885 Retention index 27.51 ± 1.40 27.36 ± 1.41 2.29 0.0616 Mineral (kg) 2.55 ± 0.21 2.58 ± 0.33 -0.36 0.7309 80 g Weight (kg) 76.14 ± 18.76 76.03 ± 18.17 0.25 0.8124 Muscle mass (kg) 47.92 ± 12.84 42.46 ± 13.31 1.68 0.1319 Body fat (kg) 25.46 ± 9.13 26.10 ± 7.21 -0.73 0.4847 % Of body fat 33.03 ± 7.87 34.38 ± 5.60 -1.00 0.3470 Retention index 28.98 ± 4.59 28.93 ± 4.34 0.24 0.8131 Mineral (kg) 2.79 ± 0.59 2.91 ± 0.78 -1.10 0.3017

In the group fed with 20 g of HGD-SJ-201 herbal complex extract, body weight and body mass index decreased, muscle mass and minerals decreased, and body fat mass and body fat percentage increased. In the groups fed 40 g, 60 g and 80 g HGD-SJ-201 herbal complex extracts, the body weight, body mass index and muscle mass were decreased and the mineral, body fat mass and body fat percentage were increased, but 80 g HGD-SJ-201 herbal complex extracts were supplied. Muscle loss was the highest in one group at 5.46 kg. Therefore, 40 g, 60 g of HGD-SJ-201 herbal complex extract was used in this experiment.

1-2. HGD-SJ-201 Herbal Compounds According to Feeding Period

The body measurements were measured the height, weight, waist circumference and hip circumference and the upper arm, scapula, abdomen, leg and side abdomen by calipers. Body mass index (Kg / m2) was calculated by height and weight. The Waist-Hip Ratio was calculated from the circumference and the hip circumference. Blood pressure was measured twice using a mercury sphygmomanometer in a steady state to use the average blood pressure. The body fat rate, body fat amount, body fat rate, protein amount, etc. were measured using In Body 3.0, and the results are shown in Table 11 below.

group division Start 1.5 months 3 months p-value M ± SD M ± SD M ± SD HGD SJ-201 40g Waist circumference (cm) 80.70 ± 8.57 77.50 ± 7.02 78.51 ± 7.11 NS Hip circumference (cm) 100.67 ± 9.49 102.40 ± 8.02 101.13 ± 7.67 NS Scapula (mm) 32.43 ± 6.47 33.33 ± 6.61 34.33 ± 6.77 NS Side abdomen (mm) 32.43 ± 6.90 32.33 ± 7.63 34.13 ± 8.42 NS Upper arm (mm) 33.03 ± 5.96a 34.63 ± 6.48a 40.67 ± 8.21b  p <0.05 Thigh (mm) 37.30 ± 5.89 38.68 ± 6.37 39.53 ± 7.93 NS Abdomen (mm) 36.37 ± 8.60 36.73 ± 8.24 38.67 ± 10.72 NS Systolic Blood Pressure (mmHg) 116.20 ± 14.08 120.06 ± 11.26 117.80 ± 13.46 NS Diastolic blood pressure (mmHg) 73.60 ± 14.47 76.13 ± 8.28 75.93 ± 7.33 NS Pulse (times) 77.33 ± 15.47 79.73 ± 14.61 76.40 ± 14.70 NS Weight (kg) 68.51 ± 10.52 67.54 ± 11.11 67.75 ± 12.27 NS Muscle mass (kg) 41.29 ± 7.39 40.49 ± 7.68 41.02 ± 7.69 NS Body fat (kg) 23.49 ± 6.38 23.36 ± 6.17 23.66 ± 7.22 NS % Of body fat 33.82 ± 4.25 34.15 ± 3.75 33.99 ± 4.73 NS Body mass index (kg / m2) 26.17 ± 3.12 25.75 ± 3.24 26.06 ± 3.51 NS W / H ratio 0.88 ± 0.05 0.88 ± 0.05 0.88 ± 0.05 NS Protein (kg) 10.42 ± 2.00 10.22 ± 2.13 10.35 ± 2.12 NS Mineral (kg) 2.72 ± 0.24 2.67 ± 0.24 2.70 ± 0.24 NS HGD SJ-20 1 60g Waist circumference (cm) 88.30 ± 10.14 86.77 ± 10.14 85.73 ± 10.41 NS Hip circumference (cm) 101.94 ± 5.77 102.55 ± 4.82 101.36 ± 5.12 NS Scapula (mm) 40.41 ± 8.54 40.64 ± 9.26 40.73 ± 9.37 NS Side abdomen (mm) 34.50 ± 5.58 33.77 ± 5.81 31.55 ± 5.75 NS Upper arm (mm) 33.82 ± 5.15 35.86 ± 6.12 36.45 ± 6.52 NS Thigh (mm) 33.05 ± 9.93 33.45 ± 9.55 34.23 ± 10.95 NS Abdomen (mm) 40.86 ± 5.55 39.27 ± 7.57 39.73 ± 7.37 NS Systolic Blood Pressure (mmHg) 124.09 ± 12.6 123.91 ± 12.84 127.55 ± 13.09 NS Diastolic blood pressure (mmHg) 81.45 ± 10.51 81.09 ± 10.55 85.19 ± 13.87 NS Pulse (times) 71.09 ± 9.06 71.36 ± 7.16 73.55 ± 10.82 NS Weight (kg) 71.77 ± 13.39 70.76 ± 13.48 70.61 ± 13.36 NS Muscle mass (kg) 40.85 ± 13.01 43.95 ± 10.46 44.05 ± 10.44 NS Body fat (kg) 24.99 ± 4.32 24.20 ± 4.37 23.95 ± 4.28 NS % Of body fat 35.05 ± 4.41 34.40 ± 4.58 34.14 ± 4.57 NS Body mass index (kg / m2) 27.86 ± 3.03 27.44 ± 3.04 27.36 ± 2.98 NS W / H ratio 0.92 ± 0.04 0.92 ± 0.05 0.91 ± 0.05 NS Protein (kg) 11.32 ± 3.00 11.73 ± 2.80 11.75 ± 2.80 NS Mineral (kg) 2.72 ± 0.53 2.60 ± 0.48 2.61 ± 0.48 NS

group division Start 1.5 months 3 months p-value M ± SD M ± SD M ± SD Pla- cebo Waist circumference (cm) 84.06 ± 7.85 80.00 ± 6.41 79.44 ± 7.49 NS Hip circumference (cm) 102.00 ± 7.25 99.63 ± 6.93 100.44 ± 6.48 NS Scapula (mm) 31.00 ± 9.01 31.31 ± 8.72 31.56 ± 8.20 NS Side abdomen (mm) 34.81 ± 8.03 34.00 ± 6.85 33.75 ± 8.03 NS Upper arm (mm) 30.56 ± 11.36 31.19 ± 12.13 33.25 ± 11.97 NS Thigh (mm) 34.31 ± 13.86 35.69 ± 15.74 33.31 ± 13.86 NS Abdomen (mm) 38.19 ± 5.99 39.00 ± 7.00 36.19 ± 7.41 NS Systolic Blood Pressure (mmHg) 123.50 ± 14.33 123.38 ± 16.27 124.63 ± 15.08 NS Diastolic blood pressure (mmHg) 77.13 ± 10.38 78.62 ± 11.56 85.12 ± 12.90 NS Pulse (times) 74.50 ± 14.08 75.00 ± 14.80 74.38 ± 14.55 NS Weight (kg) 69.50 ± 7.46 68.31 ± 7.31 68.70 ± 7.46 NS Muscle mass (kg) 44.61 ± 7.09 44.00 ± 6.85 44.28 ± 7.19 NS Body fat (kg) 22.29 ± 6.64 21.73 ± 6.39 21.83 ± 5.96 NS % Of body fat 31.97 ± 8.15 31.71 ± 8.04 31.76 ± 7.67 NS Body mass index (kg / m2) 26.36 ± 2.83 25.91 ± 2.65 25.96 ± 2.59 NS W / H ratio 0.89 ± 0.04 0.88 ± 0.04 0.88 ± 0.03 NS Protein (kg) 11.91 ± 1.91 11.79 ± 1.80 11.88 ± 1.89 NS Mineral (kg) 2.63 ± 0.33 2.61 ± 0.31 2.63 ± 0.32 NS  HCA (Garcinia Cambogia, Hydroxy- citric Acid) Waist circumference (cm) 82.41 ± 5.95 83.32 ± 5.79 84.32 ± 6.49 NS Hip circumference (cm) 100.95 ± 7.54 100.76 ± 7.68 100.86 ± 8.91 NS Scapula (mm) 35.82 ± 6.77 37.14 ± 9.52 40.36 ± 7.09 NS Side abdomen (mm) 35.91 ± 6.06 36.45 ± 7.25 41.09 ± 7.19 NS Upper arm (mm) 32.05 ± 6.15 33.64 ± 7.87 39.00 ± 7.52 NS Thigh (mm) 32.68 ± 8.62 31.30 ± 6.46 31.80 ± 7.27 NS Abdomen (mm) 40.32 ± 7.87 41.64 ± 9.21 43.64 ± 9.63 NS Systolic Blood Pressure (mmHg) 121.73 ± 9.53 121.00 ± 6.40 123.19 ± 17.62 NS Diastolic blood pressure (mmHg) 81.91 ± 10.17 81.27 ± 9.10 79.09 ± 13.52 NS Pulse (times) 72.64 ± 7.47 72.09 ± 8.48 71.09 ± 5.87 NS Weight (kg) 67.99 ± 9.55 67.41 ± 9.05 67.94 ± 10.2 NS Muscle mass (kg) 39.46 ± 5.22 40.66 ± 2.21 40.65 ± 2.40 NS Body fat (kg) 24.36 ± 7.78 24.24 ± 7.42 24.85 ± 8.33 NS % Of body fat 35.15 ± 5.28 35.39 ± 5.12 33.06 ± 11.96 NS Body mass index (kg / m2) 27.26 ± 3.97 27.01 ± 3.78 27.24 ± 4.13 NS W / H ratio 0.92 ± 0.07 0.92 ± 0.06 0.93 ± 0.07 NS Protein (kg) 10.53 ± 1.02 10.85 ± 0.60 10.85 ± 0.66 NS Mineral (kg) 2.57 ± 0.28 2.45 ± 0.10 2.45 ± 0.11 NS

The weight of the 40 g group of HGD-SJ-201 herbal extract extract was 68.51 kg at the start, 67.54 kg after 1.5 months, 67.75 kg after 3 months, and 0.76 kg decreased after 3 months and body mass index was 26.17 kg at the beginning. Slightly decreased from / m ² to 26.06 kg / m ² . In 60 g group of HGD-SJ-201 herbal extract extract, there was no significant difference in all items, but waist circumference, side abdomen, abdomen, hip circumference, body fat mass, body fat percentage, body mass index, waist / hip circumference ratio were decreased. After 3 months, it gradually decreased from 71.77 kg to 70.61 kg after 1.16 kg and increased muscle mass and body protein mass. In the Placebo group, waist circumference and flank decreased slightly after 1.5 months and 3 months, but hip circumference, body weight, muscle mass, body fat mass, body fat percentage, body mass index, waist / hip circumference ratio, protein, systolic blood pressure and minerals after 1.5 months. It decreased slightly and increased after three months. In the group taking HCA (Hydroxy-citric Acid), weight loss was very low at 0.05 kg per 3 months, body fat mass and waist / hip circumference increased, and body mass index decreased 0.02. It was very low compared to, and there was no significant time difference in all items. Anthropometric measurements of the groups at the end (after 3 months) showed significant differences between the groups only in the scapula and lateral abdomen ( p <0.05). Body weight and body mass index decreased slightly after 60 months of HGD-SJ-201 herbal extracts only 3 months after 1.5 months, and increased in other groups. Body fat percentage was 40 g of HGD-SJ-201 herbal extracts, HCA (Garcinia cambogia, Hydroxy-citric acid) and HGD-SJ-201 herbal extracts decreased in 60 g but increased in Placebo. Muscle mass increased slightly with the exception of HCA (Hydroxy-citric Acid), and 60 g of HGD-SJ-201 herbal extract extract was effective for weight loss while maintaining health.

1-3. HGD-SJ-201 Changes in Blood Components According to Herbal Supplements

After fasting for more than 12 hours, fasting antecubital vein blood was collected, followed by calcium (CA), inorganic phosphorus (IP), blood sugar (GLU), creatinine (CRE), urine nitrogen (BUN) and uric acid at Chungbuk National University Hospital. (UA), total cholesterol (CHO), total protein (TP), albumin (ALB), geotye (GOT), alkaline phosphatase (ALP), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein Cholesterol (LDL-C), Iron Concentration (FE), Free Fatty Acid (NE), Unbound Iron Concentration (UIBC), Phospholipid (PL), Total Iron Binding Concentration (TIBC), Lipase (LIP), Leukocytes, Red Blood Cells, Hemoglobin, Total Erythrocyte concentration, erythrocyte mean index, mean erythrocyte hemoglobin, mean erythrocyte hemoglobin concentration, platelets, and the like were examined, and the results are shown in Table 12 below.

group division Start 1.5 months 3 months p-value M ± SD M ± SD M ± SD HGD SJ-201 40g CA (mg / dl) 9.27 ± 2.14a 7.24 ± 0.87b 8.60 ± 2.01a p <0.01 IP (mg / dl) 3.10 ± 0.59 3.14 ± 0.44 3.40 ± 0.68 NS GLU (mg / dl) 82.53 ± 12.89a 74.93 ± 9.18b 70.13 ± 8.68b p <0.01 CRE (mg / dl) 0.67 ± 0.12 0.68 ± 0.10 0.71 ± 0.11 NS BUN (mg / ㎗) 11.55 ± 3.87 10.10 ± 3.44 12.25 ± 3.88 NS UA (mg / dl) 3.78 ± 1.15 3.97 ± 1.15 3.98 ± 0.75 NS CHO (mg / dl) 158.20 ± 33.41 148.60 ± 32.02 171.13 ± 44.49 NS TP (g / ㎗) 6.36 ± 1.12a 5.53 ± 0.67b 6.30 ± 1.18a p <0.05 ALB (g / ㎗) 4.09 ± 0.86 3.57 ± 0.45 3.92 ± 0.62 NS GOT (IU / L) 16.29 ± 10.25 13.95 ± 3.69 16.43 ± 4.62 NS GPT (IU / L) 18.32 ± 22.93 10.59 ± 3.79 14.85 ± 6.06 NS ALP (IU / L) 70.02 ± 30.47 100.00 ± 41.48 90.13 ± 47.48 NS TG (mg / dl) 75.73 ± 29.31 66.47 ± 31.89 81.47 ± 45.78 NS HDL (mg / dl) 46.12 ± 11.08 45.98 ± 9.93 54.66 ± 10.74 NS LDLC (mg / dl) 91.67 ± 20.54 77.32 ± 29.00 97.31 ± 30.18 NS FE 55.80 ± 35.35 44.80 ± 43.10 48.07 ± 36.69 NS NE 0.46 ± 0.28 0.36 ± 0.18 0.39 ± 0.22 NS UIBC -231.33 ± 67.76b -160.40 ± 71.79a -214.13 ± 55.96b p <0.05 PL 158.60 ± 25.23a 121.60 ± 38.72b 119.53 ± 29.95a p <0.01 TIBC (µg / cc) 287.13 ± 54.28a 205.20 ± 83.78b 262.20 ± 68.92a p <0.01 LIP 13.60 ± 5.19 10.00 ± 5.39 11.53 ± 3.94 NS HGD SJ-20 1 60g CA (mg / dl) 10.85 ± 1.27a 7.72 ± 0.89b 7.36 ± 1.13b p <0.001 IP (mg / dl) 3.35 ± 0.97 3.18 ± 0.53 3.09 ± 0.46 NS GLU (mg / dl) 94.91 ± 13.98 86.36 ± 19.78 83.91 ± 15.74 NS CRE (mg / dl) 0.71 ± 0.07 0.74 ± 0.11 0.72 ± 0.13 NS BUN (mg / ㎗) 12.09 ± 2.26 11.13 ± 2.67 10.54 ± 2.49 NS UA (mg / dl) 4.39 ± 0.93 4.44 ± 1.43 4.24 ± 1.65 NS CHO (mg / dl) 200.54 ± 43.26a 168.36 ± 33.21b 155.36 ± 31.82b p <0.05 TP (g / ㎗) 7.73 ± 0.75a 6.15 ± 0.72b 5.83 ± 1.01b p <0.001 ALB (g / ㎗) 4.95 ± 0.61a 3.95 ± 0.48b 3.75 ± 0.59b p <0.001 GOT (IU / L) 21.29 ± 8.82 23.36 ± 12.35 22.91 ± 12.77 NS GPT (IU / L) 30.41 ± 27.87 27.18 ± 28.67 26.36 ± 29.21 NS ALP (IU / L) 62.50 ± 18.75b 99.73 ± 27.43a 94.82 ± 30.12a p <0.01 TG (mg / dl) 123.82 ± 47.13 85.09 ± 20.62 72.73 ± 17.53 p <0.01 HDL (mg / dl) 52.57 ± 14.13 49.36 ± 13.19 45.55 ± 8.84 NS LDLC (mg / dl) 127.26 ± 25.92a 87.91 ± 35.02b 80.00 ± 33.21b p <0.01 FE 75.60 ± 27.05 68.20 ± 70.64 56.40 ± 37.74 NS NE 0.64 ± 0.23a 0.37 ± 0.16b 0.35 ± 0.08b p <0.05 UIBC -210.20 ± 78.73 -170.80 ± 51.57 -181.40 ± 75.48 NS PL 186.00 ± 62.78 142.00 ± 13.86 143.80 ± 10.61 p <0.05 TIBC (µg / cc) 285.80 ± 84.39 239.00 ± 41.21 237.80 ± 52.05 NS LIP 14.80 ± 5.89 15.00 ± 5.05 14.40 ± 4.45 NS

group division Start 1.5 months 3 months p-value M ± SD M ± SD M ± SD Pla- cebo CA (mg / dl) 10.26 ± 1.64a 8.28 ± 1.48b 7.28 ± 0.99b p <0.01 IP (mg / dl) 2.84 ± 0.62 3.05 ± 0.46 2.98 ± 0.41 NS GLU (mg / dl) 85.38 ± 14.27a 78.75 ± 10.85ab 70.88 ± 8.54b p <0.05 CRE (mg / dl) 0.66 ± 0.10 0.75 ± 0.17 0.71 ± 0.18 NS BUN (mg / ㎗) 11.50 ± 3.16 10.38 ± 3.45 10.74 ± 3.46 NS UA (mg / dl) 4.66 ± 0.98 4.32 ± 1.08 4.04 ± 1.12 NS CHO (mg / dl) 172.75 ± 40.43 161.13 ± 31.64 145.38 ± 29.07 NS TP (g / ㎗) 7.16 ± 1.14a 6.49 ± 0.76ab 5.70 ± 1.04b p <0.05 ALB (g / ㎗) 4.65 ± 0.77a 4.16 ± 0.60ab 3.63 ± 0.66b p <0.05 GOT (IU / L) 17.30 ± 3.52 20.41 ± 11.63 18.63 ± 12.24 NS GPT (IU / L) 16.17 ± 8.37 15.89 ± 7.92 13.13 ± 6.60 NS ALP (IU / L) 70.25 ± 26.90b 110.38 ± 28.20a 107.13 ± 32.69a p <0.05 TG (mg / dl) 91.13 ± 19.96 79.33 ± 45.38 61.83 ± 34.12 NS HDL (mg / dl) 56.35 ± 8.41 59.06 ± 13.24 52.38 ± 15.65 NS LDLC (mg / dl) 97.04 ± 30.57 81.04 ± 26.71 76.63 ± 20.00 NS FE 83.00 ± 70.00 39.50 ± 18.63 52.50 ± 31.03 NS NE 0.48 ± 0.30 0.31 ± 0.13 0.41 ± 0.14 NS UIBC -194.50 ± 102.66 -183.00 ± 49.14 -210.25 ± 20.66 NS PL 164.25 ± 12.55 124.75 ± 23.13 151.75 ± 16.36 NS TIBC (µg / cc) 277.50 ± 44.25 222.50 ± 34.88 262.75 ± 29.69 NS LIP 13.00 ± 6.98 21.25 ± 8.85 12.00 ± 7.16 NS  HCA (Garcinia Cambogia, Hydroxy- citric Acid) CA (mg / dl) 11.06 ± 2.34a 7.53 ± 1.47b 7.07 ± 0.67b p <0.001 IP (mg / dl) 3.22 ± 0.32 3.23 ± 0.70 2.92 ± 0.46 NS GLU (mg / dl) 100.91 ± 28.52a 81.27 ± 10.38b 77.45 ± 11.52b p <0.05 CRE (mg / dl) 0.61 ± 0.19 0.57 ± 0.17 0.65 ± 0.09 NS BUN (mg / ㎗) 13.37 ± 2.61 12.23 ± 2.76 10.52 ± 2.97 NS UA (mg / dl) 4.82 ± 1.29 4.21 ± 1.19 3.82 ± 0.75 NS CHO (mg / dl) 189.09 ± 42.51 168.63 ± 36.66 150.36 ± 34.07 NS TP (g / ㎗) 7.44 ± 0.90a 5.88 ± 0.96b 5.56 ± 0.52b p <0.001 ALB (g / ㎗) 4.74 ± 0.66a 3.73 ± 0.56b 3.53 ± 0.33b p <0.001 GOT (IU / L) 19.92 ± 6.93 17.16 ± 10.21 19.27 ± 10.51 NS GPT (IU / L) 20.43 ± 12.42 15.54 ± 9.32 18.45 ± 15.47 NS ALP (IU / L) 62.55 ± 10.93b 90.82 ± 21.28a 90.73 ± 12.21a p <0.001 TG (mg / dl) 143.00 ± 111.74 112.73 ± 92.79 114.5564.41 NS HDL (mg / dl) 51.08 ± 8.13 47.18 ± 11.68 46.45 ± 9.95 NS LDLC (mg / dl) 112.39 ± 30.65a 96.55 ± 21.12ab 83.91 ± 24.53b p <0.05 FE 54.09 ± 46.81 31.64 ± 28.96 39.09 ± 30.59 NS NE 0.45 ± 0.22 0.42 ± 0.23 0.38 ± 0.17 NS UIBC -238.27 ± 75.88 -203.72 ± 74.68 -234.82 ± 69.11 NS PL 155.45 ± 44.74 139.09 ± 50.16 149.91 ± 30.11 NS TIBC (µg / cc) 292.36 ± 63.61 235.36 ± 66.79 273.91 ± 53.17 NS LIP 16.64 ± 5.75 14.82 ± 5.49 18.64 ± 11.03 NS

The blood CA of the group taking 40 g of HGD-SJ-201 multiple herbal extracts was lower from 9.27 mg / dL to 8.6 mg / dL after 3 months at the beginning and showed statistically significant difference at p <0.05 level. . Inorganic, creatinine and uric acid gradually increased and did not show significance. Glucose was significantly lower at p <0.05 level at 70.13 mg / dL after 3 months at 82.53 mg / dL initiation, and 40 g of HGD-SJ-201 multiple herbal extracts were effectively lowered. In low-density lipoprotein, total cholesterol, and triglycerides, it was markedly lowered after 1 and a half months in the normal category, and increased significantly after 3 months, taking 40 g 1 and a half hGD-SJ-201 complex herbal extracts for people with high cholesterol. This has been shown to be effective. When 60 g of HGD-SJ-201 complex herbal extracts were fed, calcium, blood sugar, urine nitrogen, total cholesterol, triglycerides, albumin, GOT, high density lipoprotein, and low density lipoprotein were gradually lowered. Was markedly lower, which was effective in lowering cholesterol and lipids, and statistically significant differences were found at p <0.05 and p <0.01 levels, respectively. In the placebo-fed group, blood glucose ( p <0.05), calcium ( p <0.01), triglycerides ( p <0.05) and albumin ( p <0.05) decreased significantly over time and alkaline phosphatase significantly increased. ( P <0.05), total cholesterol, uric acid, and low-density lipoprotein were gradually decreased but not significant. High density lipoproteins increased and decreased. In the HCA group, calcium, albumin and triglycerides were significantly decreased at p <0.001 level after 3 months, and blood glucose and low density lipoprotein level were significantly increased at p <0.05 level. Total cholesterol, uric acid, urine nitrogen, triglyceride, high-density lipoprotein and lipase gradually decreased, but there was no significant difference.

Based on the clinical results, HGD-SJ increases body protein, decreases body weight, body mass index, and body fat percentage, and significantly lowers lipid-related index in the body such as total cholesterol, low density lipoprotein, neutral lipid, blood sugar, and phospholipid. 60 g herbal extract extract was effective for weight loss.

Although the formulation example of the pharmaceutical composition containing the extract of HGD-SJ-201 herbal medicine of the present invention will be described, the present invention is not intended to limit the present invention but is intended to be described in detail only.

Formulation Example 1 Preparation of Powder

HGD-SJ-201 Herbal Combination Extract 20 mg

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 Tablet

HGD-SJ-201 Herbal Combination Extract 10 mg

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 Preparation of Capsule

HGD-SJ-201 Herbal Combination Extract 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 Injection

HGD-SJ-201 Herbal Combination Extract 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 Preparation of Liquid

HGD-SJ-201 Herbal Combination Extract 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 to the purified water to dissolve it, the lemon flavor is added appropriately, the above components are mixed, purified water is added, the whole is adjusted to 100 ml by the addition of purified water, and then filled in a brown bottle. The solution is prepared by sterilization.

The HGD-SJ-201 herbal extract extract of the present invention inhibits weight gain by increasing HDL-C in the blood and improving lipid metabolism in the body, and at the same time prevents and treats obesity through weight loss and, in particular, decomposition of abdominal fat. It can be used as a pharmaceutical composition.

Claims (5)

Mori Folium , White Poria cocos , Baekchul, Atractylodes macrocephala , Coicis semen , Phaseolus angularis , Wooden barrel, A pharmaceutical composition for preventing and treating obesity, comprising as an active ingredient an extract of a herbal combination comprising Akebia quinata Decaisne ) and a chaga (Plangogo asiaticae Semen) as an active ingredient.  According to claim 1, wherein the composition ratio of the herbal compound combination is upper leaf: baekbokyeong: baekchul: uiyiin: red small head: neck: tea tea (1-5: 0.1-0.5: 1-1.5: 1-1.5: 0.5-1: 0.5-1.5 : 0.5 ~ 1) weight ratio (w / w) pharmaceutical composition.  The pharmaceutical composition according to claim 2, wherein the composition ratio of the herbal compound combination is upper leaf: baekbokyeong: baekchul: uiyiin: red soybean: neck: tea tea (3: 0.5: 1.5: 1.5: 1: 1.5: 1) weight ratio (w / w) . The method of claim 1, wherein the extract is obtained through a process of immersing an extract or a herbal medicine available in a solvent selected from water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof in a salt, vinegar, and seed mixture solution. A pharmaceutical composition comprising a herbal extract. delete

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