KR100980819B1 - The composition comprising complex herbal extract as an active ingredient and the preparation method thereof - Google Patents

Abstract

The present invention relates to a composition and a method for producing the same containing a compound herbal extract as an active ingredient, and more specifically, Taeksa, rhubarb, health, licorice, broiler (cinnamon), peony, bark skin, sea tiger, ghost, half and horse riding Since the composition comprising the complex herbal extract as an active ingredient exhibits an anti-obesity effect by reducing the body mass index (BMI) of an obese or overweight subject, the composition is a pharmaceutical composition or health functional food for the prevention and treatment of obesity-related diseases. It can be usefully used.

Taxa, rhubarb, health, licorice, broiler (cinnamon), peony, peony, shiho, spirit, half, horse riding, obesity

Description

The composition comprising complex herbal extract as an active ingredient and the preparation method

The present invention relates to a pharmaceutical composition or health functional food for the prevention and treatment of obesity-related diseases containing a complex herbal extract as an active ingredient.

[1] Kang Jin-kyung, Concept of lifestyle-related diseases, Journal of Korean Medical Association, March. pp188-190 (2004)

Manson et al., New England J. Med., 333, pp 677-685, 1995.

Document 3: Kopleman P.G., Nature, 404, pp 635-643, 2000

Document 4 Must et al., JAMA, 282, pp 1523-1529, 1999

[Document 5] The 9th Amendment to Korea Pharmacopoeia, Korea Food and Drug Administration Notification No. 2007-89, 2007.12.28

Modern man has lived a rich and convenient life with the development of industry. As a result, high levels of medicine have led to an increase in life expectancy, but on the other hand, a new disease called lifestyle-related disease has emerged. Lifestyle disease is a disease that has been renamed since 2003, which we commonly know as hypertension, allergy, obesity, diabetes, cirrhosis, heart disease, and cancer. The concept of lifestyle diseases was introduced because these diseases can be treated by improving eating habits, lifestyle, and environmental factors (Kang, Jin Kyung, Concept of lifestyle diseases, Korean Medical Association, March, pp. 188-19). 190, 2004).

Obesity is known to cause adult diseases such as diabetes mellitus, high blood pressure, arteriosclerosis, hyperlipidemia, cardiovascular disease, fatty liver and various metabolic disorders, as well as constipation caused by pressure on the abdomen by fat tissue caused by obesity In many cases, it causes indigestion, gastrointestinal disorders, and the World Health Organization (WHO) has warned that obesity is a disease that needs treatment.

Obesity refers to a phenomenon in which excess calories are accumulated in the form of fat in the body by ingesting excessive calories compared to calories consumed. Obesity is thought to be caused by a variety of causes, including genetic influences, environmental effects from westernized diets, and psychological effects from stress, but the exact cause and mechanisms have not been clearly established. . However, because obesity is not only a problem of obesity itself, it can also act as a cause of diseases such as cardiovascular disease and diabetes (Manson et al., New England J. Med., 333, pp677-685, 1995; Kopleman PG, Nature, 404, pp635-643, 2000; Must et al., JAMA, 282, pp1523-1529, 1999). There is much interest in the treatment of obesity worldwide.

Obesity treatments include exercise therapy to increase the use of calories, diet and drug therapy to reduce the absorption of calories. However, for busy modern people, exercise therapy and diet alone cannot expect proper effects, so it is appropriate to combine safe drug therapy.

Among the most known obesity treatments to date, Xenical ™ (Roche Pharmaceuticals, Switzerland), Reductil ™ (Abbott, USA), Exolise ™ (Atopama, France), etc. Along with the side effects such as heart disease, respiratory disease, nervous system diseases, the efficacy is low, the development of a more effective obesity treatment situation is required.

Therefore, recently, in order to overcome the side effects of such chemical synthetic drugs, extensive research has been conducted on natural drug drugs with high human stability and few side effects even after long-term use.

Alismatis Rhizoma is a plantain Alisma As a tuber of orientale Juzepzuk (Texaceae Alismataceae), which removes the roots and bark, it is a triterpenoid alisol A, B, alisol A monoacetate, alisol B monoacetate (alisol B monoacetate), epialisol A and small amounts of alkaloids, and many other amino acids including essential oils (furfural), resins, acetylcholine, lecithin, asparagine and large amounts Sugars, phytosterols, phytosterols, oils (palmitin, stearin, oleine), many starches (23%) and proteins (7%). Root stems are preventive against diuresis, lowering blood pressure and liver damage in animal experiments. have.

Rhubarb (Rhubarb, Rhei Radix et Rhizoma) is Rheum palmatum Linne), Tangut rhubarb ( Rheum tanguticum Maximowicz ex Balf.) or medicinal rhubarb ( Rheum As the root and root stem of the officinale Baillon, Polygonaceae, the skin was removed, Sennoside A, B, C, D, E, F, Emodin, Chrysophanol, Rhein ), Aloe-emodin, Glucogallin, Raponticin, Rhatanin I, II, Lindleyin, Procyanidin b-13-O-gallate ( It contains ingredients such as Procyanidin b-13-O-gallate, and it has lower dead action to clean the intestines and promote metabolism. Frequently and after heavy, add alcohol and take it month after month. In addition, it has an effect of lowering anger, causing headache, redness of eyes, sore throat, swelling and soreness of the gums, swelling in the mouth and tongue, rashes, constipation, and constipation caused by blood fever. It is effective for accompanied by constipation due to heat poisoning, constipation, and rapid effect on appendicitis.

Health (乾薑, Ginger, Zingiberis Rhizoma) is ginger ( Zingiber dried roots of officinale Roscoe, Ginger and Zingiberaceae. Starch occupies 40 ~ 60% of total, small amount of water vapor volatility, essential oils, spicy ingredients, resin protein, fiber, pentosan, starch and minerals. Ingredients such as Zingerone, Gingerol, Shogaol and the like, Citral, Linalool and the like are included. It promotes secretion of gastric juice and activates the peristalsis of the intestinal tract, which helps digestion and calms vomiting.It also has blood vessel movement center, respiratory center and cardiac excitability to increase blood pressure and promote blood circulation, anti-inflammatory action and It has an analgesic effect and exhibits a certain bactericidal effect on influenza bacteria, cholera bacteria, and ameliorating bacteria.

Licorice, Licorice, Glycyrrhizae Radix et Rhizoma, Glycyrrhiza uralensis Fischer, Glycyrrhiza glabra Linne) or Glycyrrhiza glycyrrhizin (6-10%), flavonoids and iso, glycyrrhizic / glycyrrhizic acid, saponin as intact or bark removed as intula or root stem of inflata Batal. , Coumarin, essential oils, starch, phytostrol, tannins and enzymes, beturic acid, oleanolic acid, liquiritigenin, isoliquiritigenin, liqueurin ( liquiritin), lituraside (licuraside), rhamnoliquiritin (rhamnoliquiritin), etc., and is effective in antimicrobial, anti-inflammatory, anti-allergic, antiviral, immune function enhancement. In addition, it can be used to treat injuries, gastric ulcers, drug intoxication, and plant poisoning. do. It also has expectoration, constipation, cramping, bile stimulation, antipyretic, antitussive, muscle relaxant, hepatoprotective and anticancer activity.

The broiler (Cinnamomi Cortex) is the broiler ( Cinnamomum) cassia Presl., the stem bark of Camphoraceae Lauraceae), as it is or with a slightly removed bark, contains 1 ~ 2% of volatile essential oils, 75 ~ 90% of cinnamic aldehyde, and other mucus , Tannin, etc. are contained, and essential oils include phellandrene, eugenol, and methyleugenol. Since it suppresses the central nerve, it has a sedative, analgesic, and antipyretic effect, promotes blood flow in the heart and coronary arteries, anti-radioactivity and white blood cell count, and inhibits skin fungi.

Pee (Peoniae Radix) is Paeonia As roots of lactiflora Pallas or other related plant species (Peaceaceae, Paeoniaceae), the monotelpenes (Albiflorin), Paeoniflorin, Oxypaeoniflorin, Benzolpaonniflorin ( Benzoylpaeoniflorin), benzoic acid (Benzoic acid) and tannins, such as tetragalloylglucose, pentagalloylglucose (Pentagalloylglucose) and hexagalloylglucose (Hexagalloylglucose). It works to soften the liver and stop pain, and the lack of blood causes complex yellowing, menstrual abdominal pain, cold sweating, convulsions in the hands and feet, headaches, epilepsy, various cramps, asthma, kidney stones, Very good for hemorrhoids.

Moutan Cortex ( Paeonia) suffruticosa Andrews, Peony and Paeoniaceae), which contains Paenol-glucoside, Paeonol-rhamnoglucoside, and the decomposition of glycosides during storage Preferred crystals are precipitated. It acts on the heart, liver, and kidneys to help with menstrual irregularities, cramps, bruises, hemorrhages, nosebleeds, and spots. In particular, this drug stops bleeding but does not clump and keeps blood flowing. . It also has sedation and hypnosis, analgesic action, lowering blood pressure, inhibiting leg swelling, and antibacterial action.

Shiple, Bupleuri Radix, Bupleurum falcatum Linne) or its varieties (mountain and Umbelliferae), containing saikosaponin a, c, d, e, alpha-spinasterol, stigmasterol, l-anomalin, etc. It is used to adjust the function of the liver, fever, detoxification, analgesic, tonic, is used for digestive diseases, respiratory diseases, circulatory diseases, etc. .

Jeoryeong (猪, Chuling, Polyporus) is jeoryeong (猪, Polyporus umbellatus Fries, fungus of Polygonaceae and Polyporaceae, Ergosterol, 2-Hydroxytetracosanic acid, Gluctar, Biotin, Sterol, ergosta It contains -4,6,8 (14), 22-tetraen-3-one, bithion, etc., and it is effective in diuresis, swelling and clearing, antitumor, antibacterial, complement and macrophage. There is activity.

Pinelliae Tuber is Pinellia ternata Breitenbach, a tuber of Chronicles and Araceae, completely removes the bark, beta-Sitosterol, Campesterol, Apigenin-6-C-beta-D-galactopyranoside (Apigenin) -6-C-beta-D-galactopyranoside, Choline, Dacosterol, Pinellia lectin, Pinellia polysaccaride PT-F-2-1 , Pinellin (Pinellin), etc., as a toxic component has an expectorant, antitussive action and drug decoction stops vomiting, and is effective in preventing silicosis.

Riding (升麻, Cimicifugae Rhizoma) riding (Cimicifuga heracleifolia Komarov), Candlestick Horseriding ( Cimicifuga simplex Wormskjord), Snow Horseriding ( Cimicifuga dahurica Maximowicz) or Stork Horse ( Cimicifuga) As root stem of foetida Linne, Ranunculaceae, beta-carotene, cimicifugenin, pomononetin, gallic acid, plant sterol, salicylic acid, tannic acid, tannin, calcium, chromium, iron, magnesium, manganese, phosphorus Contains potassium, selenium, silicon, zinc, vitamins B ₁ , B ₂ , B ₃ , and C. Natural phytoestrogens (Phyto-Estrogens) have the effect of significantly reducing various disorders and discomforts during menopause. Lowers blood pressure and cholesterol, prevents mucus production, prevents cardiovascular and blood circulation disorders, and helps with delivery and childbirth. It is also effective for menstrual cramps with menopausal symptoms and back pain. It is used for snake bites and arthritis.

The inventors of the present invention are convenient to take, compound absorption including talc, rhubarb, health, licorice, broiler, peony, bark skin, shiho, nymph, halves and horse riding that can be quickly absorbed in the body to maximize the efficacy and therapeutic effect The present invention was completed by confirming the anti-obesity effect of the preparation method of the extract and the composition containing these active ingredients.

In order to achieve the above object, the present invention is to prevent and treat obesity-related diseases containing complex herbal extracts including taxa, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, ghost, half and horse riding as an active ingredient Provide a pharmaceutical composition.

In addition, the present invention provides a dietary supplement for the prevention and improvement of obesity-related diseases, including complex herbal extracts including taxa, rhubarb, health, licorice, broiler, peony, bark skin, shiho, ghost, half and horse riding as an active ingredient to provide.

Such obesity-related diseases include obesity, diabetes, hypertension, arteriosclerosis, hyperlipidemia, cardiovascular disease or fatty liver, preferably obesity.

Complex herbal extracts defined herein is a mixed weight ratio (%) of talc, rhubarb, health, licorice, broiler, peony, bark skin, shiho, ghost, halves and horse riding 1-10: 1-5: 1-5: 1 ~ 5: 1-5: 1-5: 1-5: 1-10: 1-10: 1-5: 1-5, preferably 1-4: 1-2: 1-2: 1: 2: 1 ~ 2: 1 ~ 2: 1 ~ 2: 1 ~ 4: 1 ~ 4: 1 ~ 2: 1 ~ 2

The complex herbal extract as defined herein includes a solvent selected from water, including purified water, a lower alcohol having 1 to 6 carbon atoms or a mixed solvent thereof, preferably water, ethanol or a mixed solvent thereof.

The combined herbal extract as defined herein includes the preparation in the form of a liquid, suspension, tablet, capsule or injection, preferably a liquid.

In addition, the present invention provides a method for producing a complex herbal extract including taxa, rhubarb, health, licorice, broiler, peony, bark skin, shiho, ghost, half and horse riding.

The manufacturing method defined herein is a method for extracting the essential oil and non-essential components separately or a method for extracting the whole including the essential oil components, a method for extracting the essential oil components and extracting the non-essential components, preferably essential oil components and non-essential components And extracting them separately.

Hereinafter, the present invention will be described in detail.

Complex herbal extract of the present invention can be prepared as one embodiment as follows. Weight mix ratio of taxa, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, ghost, halves and horseback riding 1-10: 1-5: 1-5: 1-5: 1-5: 1-5: 1 5: 1 to 10: 1 to 10: 1 to 5: 1 to 5 parts by weight , preferably 1 to 4: 1 to 2: 1 to 2: 1 to 2: 1 to 2: 1 to 2: 1 2: 1 to 4: 1 to 4: 1 to 2: 1 to 2 parts by weight after mixing or cutting to powder; A solvent selected from 5 to 10 times, preferably 8 times (w / v%), weakly basic aqueous solution of water, lower alcohols having 1 to 6 carbon atoms or a mixed solvent thereof, preferably water, Reflux extraction, supercritical extraction, soxhlet extraction for 1 hour to 7 hours, preferably 3 hours to 6 hours at 10 ° C. to 120 ° C. with ethanol or a mixed solvent thereof, more preferably water or 30 to 100% ethanol. A second step of extracting by hot water extraction, cooling extraction or ultrasonic extraction, preferably by reflux extraction, supercritical extraction or soxhlet extraction; The compound herbal extract of the present invention can be obtained through a manufacturing method comprising a third step of concentrating this under reduced pressure.

Complex herbal extract of the present invention can be prepared as another embodiment as follows. Weight mix ratio of taxa, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, ghost, halves and horseback riding 1-10: 1-5: 1-5: 1-5: 1-5: 1-5: 1 5: 1 to 10: 1 to 10: 1 to 5: 1 to 5 parts by weight , preferably 1 to 4: 1 to 2: 1 to 2: 1 to 2: 1 to 2: 1 to 2: 1 2: 1 to 4: 1 to 4: 1 to 2: 1 to 2 parts by weight after mixing or cutting to powder; A solvent selected from 5 to 10 times, preferably 8 times (w / v%) of water, a lower alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof, preferably water, ethanol or their Lower alkanes and ethers having 1 to 6 carbon atoms as mixed solvents, more preferably water or nonpolar solvents for 1 hour to 7 hours, preferably 3 hours to 6 hours at 10 ° C. to 120 ° C. with 30 to 100% ethanol. A second step of extracting by essential oil extraction, supercritical extraction, or Soxhlet extraction, preferably extracted with hexane or cyclohexane, to obtain only essential oil components; In the second step, the essential oil component is added to the limited residue in a solvent selected from water, a lower alcohol having 1 to 6 carbon atoms or a mixed solvent thereof, preferably water, ethanol or a mixed solvent thereof, more preferably water or 30 to 100%. Reflux extraction, supercritical extraction, soxhlet extraction, hydrothermal extraction, cooling extraction or ultrasonic extraction, preferably reflux extraction, ultrace for 1 hour to 7 hours, preferably 3 hours to 6 hours at 10 ℃ to 120 ℃ with ethanol Extracting by a critical extraction method or a soxhlet extraction method; A fourth step of obtaining an essential oil component other than an essential oil component which is concentrated under a reduced pressure under reduced pressure of the extract prepared in the above step; The compound herbal extract of the present invention can be obtained through the preparation method comprising the fifth step of combining this with the essential oil component of the second step.

The present invention provides a pharmaceutical composition for the prevention and treatment of obesity-related diseases containing the complex herbal extract obtained by the above method as an active ingredient.

The present invention also provides a health functional food for the prevention and improvement of obesity-related diseases containing the complex herbal extract obtained by the above method as an active ingredient.

The pharmaceutical composition for the prevention and treatment of obesity-related diseases containing the multi-drug extract of the present invention comprises 0.1 to 100% by weight of the multi-drug extract based on the total weight of the composition.

The pharmaceutical composition containing the complex herbal extract of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the preparation of pharmaceutical compositions.

Pharmaceutical compositions containing the complex herbal extract of the present invention may be in the form of powder, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral preparations, suppositories, and sterile injectable solutions, respectively, according to a conventional method. Can be formulated and used. Carriers, excipients and diluents which may be contained in the composition containing the compound include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium Silicates, 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 form preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, which form at least one excipient such as starch, calcium carbonate, sucrose, etc. 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, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. . 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.

The amount of the combined herbal extract of the present invention may vary depending on the age, sex, and weight of the patient, but may be administered once to several times daily from 0.1 to 100 mg / kg. The dosage may also be increased or decreased depending on the route of administration, the severity of the disease, sex, weight, age, and the like. Therefore, the above dosage does not limit the scope of the present invention in any aspect.

The pharmaceutical composition may be administered to various mammals such as mice, mice, livestock, humans, and the like. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.

The present invention provides a health functional food for the prevention and improvement of obesity-related diseases comprising the complex herbal extract as an active ingredient. Foods to which it may be added include various foods, powders, granules, tablets, capsules, syrups, beverages, gums, teas, vitamin complexes, and health functional foods.

It may also be added to foods or beverages for the purpose of preventing obesity-related diseases. At this time, the amount of the compound herbal extract in the food or beverage may be added in 0.01 to 50% by weight of the total food weight, the health functional beverage composition may be added in a ratio of 0.02 to 5 g, preferably 0.01 to 1 g based on 100 ml. have.

The health functional beverage composition of the present invention is not particularly limited to other ingredients except the compound herbal extract as an essential ingredient in the indicated ratios, and may contain various flavors or natural carbohydrates as additional ingredients, as in general beverages. Can be. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And sugars such as conventional sugars such as polysaccharides such as dextrin, cyclodextrin and the like and xylitol, sorbitol, erythritol. As flavoring agents other than those mentioned above, natural flavoring agents (tautin, stevia extract) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of said natural carbohydrates is generally about 1-20 g, preferably about 3-15 g per 100 ml of the composition of the present invention.

In addition to the above, the complex herbal extract of the present invention is a variety of nutrients, vitamins, minerals (electrolytes), synthetic 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 colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the complex herbal extract of the present invention may contain a flesh for preparing natural fruit juice and vegetable beverage. These components can be used independently or in combination. The proportion of such additives is not so critical, but is usually selected in the range of 0 to about 50 parts by weight per 100 parts by weight of the complex herbal extract of the present invention.

The present invention relates to a composition containing the extract of the compound herbal as an active ingredient, and a method for producing the same, and in particular, a compound containing a taxa, rhubarb, health, licorice, broiler, peony, peony, shiho, herb, half and horseback Since the composition containing the extract as an active ingredient exhibits an anti-obesity effect by reducing the body mass index (BMI) of obese or overweight subjects, the composition is useful as a pharmaceutical composition or health functional food for the prevention and treatment of obesity-related diseases. Can be.

Hereinafter, the present invention will be described in detail by Examples and Experimental Examples. However, the following Examples and Experimental Examples are merely illustrative of the present invention, but the content of the present invention is not limited thereto.

Example  1. Preparation of dry powder

Taxi 286g, rhubarb 143g, health 143g, licorice 143g, broiler 143g, peony 143g, bark skin 143g, sea hoe 286g, age 286g, half 143g and horseback riding 143g (Japanese national fragrance, imported), or cut and powdered "HPJ").

Example  2. Combined Herbal Medicine Hydrothermal  Preparation of Extract

2-1. Reflux Extraction Method

50.0 g of HPJ obtained in Example 1 was poured into 400 ml of water, followed by swelling sufficiently, followed by reflux extraction in an extractor for 3-6 hours (x3), and the extract obtained by filtration was concentrated under reduced pressure until 60-70 Brix. To obtain a compound herbal hydrothermal extract 11.45 g (22.9%, hereinafter referred to as 'HPJ-H1').

2-2. Essential oil extraction

The medicine containing the essential oil component of 500.0 g of HPJ obtained in Example 1 was placed in an essential oil extraction device (Gyeongseo machine, COSMOS 660, Korea), and then swelled sufficiently with 5000 ml of water, and then refluxed in the extractor for 3-6 hours. Extract (x3) the essential oil in the refinery quantifier, remove the essential oil quantifier, add 5000 ml of water to the remaining residue in the extractor, extract it under reflux in the extractor for 3-6 hours, and filter the resulting extract at low temperature Concentrated and combined with the essential oil components first to obtain 113.5 g (22.7%, hereinafter referred to as 'HPJ-H2') of 60-70 Brix complex herbal hot water extract.

2-3. Supercritical extraction

50.0 g of HPJ obtained in Example 1 was extracted with essential oil using a supercritical extractor (JASCO, Japan) at 3 ml / min of carbon dioxide and ethanol, and 400 ml of water was added to the HPJ residue to swell for a sufficient time. Next, the mixture was refluxed in an extractor for 3-6 hours (x3), and the extract obtained by filtration was concentrated under reduced pressure until 60-70 Brix, and combined with the essential oil component taken first, 11.25 g (22.5%) Named 'HPJ-H3').

2-4. Soxhlet Extraction Method 1

The HPJ 50.0 g obtained in Example 1 was added to 400 ml of water using a Soxhlet apparatus (Daeshin Science, AP1240, Korea), swelled sufficiently, and then extracted under reflux in an extractor for 3-6 hours. (x3), the extract obtained by filtration was concentrated under reduced pressure at 60-70 Brix to obtain 11.50 g (23.0%, hereinafter referred to as 'HPJ-H4') of the compound herbal hot water extract.

2-5. Soxhlet Extraction Method 2

The medicine containing the essential oil component of the HPJ 50.0 g obtained in Example 1 was added to a Soxhlet apparatus (Soxhlet apparatus) and then swelled enough to put 200 ml of water, Soxhlet apparatus (Soxhlet apparatus) for 3-6 hours The mixture was extracted at reflux (x3), cooled to room temperature, filtered, and concentrated under reduced pressure (until 25% of the extract was extracted). The extracted concentrate was extracted three times with 100 ml of hexane, which is a nonpolar solvent, and concentrated. The filtrate and the residue were put in an extractor, and the remaining medicinal herbs and 400 ml of water were swelled sufficiently, followed by reflux extraction in a Soxhlet apparatus for 3-6 hours (x3), and the extract was filtered under reduced pressure. Concentrated and combined with the essential oil components first obtained 11.45 g (22.9%, hereinafter referred to as 'HPJ-H5') of 60-70 Brix complex herbal hot water extract.

Example  3. Preparation of the compound herbal 30% ethanol extract

3-1. Reflux Extraction Method 1

50.0 g of HPJ obtained in Example 1 was added to 400 ml of a 30% saturated ethanol mixed solution, followed by sufficient swelling, followed by reflux extraction in an extractor for 3-6 hours (x3), and the extract obtained by filtration was 60-70 Brix The mixture was concentrated under reduced pressure at low temperature until it was obtained 9.55 g of a compound herbal 30% ethanol extract (19.1%, hereinafter referred to as 'HPJ-E1').

3-2. Reflux Extraction Method 2

The medicine containing the essential oil component in 50.0 g of HPJ obtained in Example 1 was swelled sufficiently in 200 ml of 30% saturated ethanol mixed solution, followed by extraction under reflux in an extractor for 3-6 hours (x3), and then cooled and filtered. The extract was concentrated under reduced pressure (until 25% of the extract), and the extract was extracted three times with 100 ml of hexane, a non-polar solvent, and concentrated to take the essential oil components. The filtrate and residue were placed in an extractor and the remaining herbs were extracted. The mixture was poured into 400 ml of 30% saturated ethanol mixed solution, swelled sufficiently, extracted under reflux for 3-6 hours in the extractor (x3), concentrated under reduced pressure under reduced pressure, and combined with the essential oil components taken first. 11.45 g (22.9%, hereinafter referred to as 'HPJ-E2') of crude 30% ethanol extract was obtained.

Example  4. Preparation of Complex Herbal 70% Ethanol Extract

50.0 g of HPJ obtained in Example 1 was poured into 400 ml of a 70% saturated ethanol mixed solution, sufficiently swelled, refluxed in an extractor for 3-6 hours (x3), and the extract was filtered to obtain 60-70 Brix The mixture was concentrated under reduced pressure at low temperature until 12.05 g (24.1%, hereinafter referred to as 'HPJ-E3') of the crude herbal 70% ethanol extract was obtained.

Example  5. Preparation of Compound Herbal 100% Ethanol Extract

5-1. Reflux Extraction Method

50.0 g of HPJ obtained in Example 1 was poured into 400 ml of 100% ethanol and sufficiently swelled, followed by reflux extraction in an extractor for 3-6 hours (x3), followed by filtration until the extract was 60-70 Brix. Concentration under reduced pressure under reduced pressure yielded 9.60 g (19.2%, hereinafter referred to as 'HPJ-E4') compound 100% ethanol extract.

5-2. Supercritical extraction

50.0 g of HPJ obtained in Example 1 was taken with essential oil components using a supercritical extractor (JASCO, Japan) at 3 ml / min of carbon dioxide and ethanol, and 400 ml of 100% saturated ethanol mixed solution was added to the HPJ residue. After swelling for enough time, the mixture was refluxed in an extractor for 3-6 hours (x3), and the extract obtained by filtration was concentrated under reduced pressure until it reached 60-70 Brix, followed by 11.35 g (22.7%) of a compound herbal 100% ethanol extract. , Hereinafter referred to as 'HPJ-E5').

Example  6. Combined Herbal Medicine Weakly basic  Preparation of Extract

0.05 g of sodium bicarbonate (NaHCO ₃ ) was previously added to 400 ml of water, and 50.0 g of HPJ obtained in Example 1 was added thereto, followed by swelling for 12 to 24 hours, followed by extraction under reflux for 3-6 hours (x3). ), The extract obtained by filtration was concentrated under reduced pressure until it became 60-70 Brix to obtain 11.95 g of a compound herbal weakly basic extract (23.9%, hereinafter referred to as 'HPJ-WB').

It describes an example of the formulation of a composition comprising a complex herbal extract of the present invention, the present invention is not intended to limit it, but is intended to explain in detail only.

Formulation example  One. Liquid  Produce

HPJ-H1 459 mg

10 mg potassium sorbate

0.04 ml of polysorbate 80

Copulation

Flavoring Agent

Purified water

The above components are mixed to prepare a liquid according to a conventional liquid preparation method.

Formulation example  2. Suspension  Produce

HPJ-H1 459 mg

Hydroxyethyl Cellulose 30 mg

Agar 30 mg

1.6 g of D-sorbitol 70%

Flavoring Agent

Purified water

The above components are mixed to prepare a suspending agent according to a conventional suspending agent production method.

Formulation example  3. Preparation of Tablets

HPJ-H1 459 mg

Starch 100 mg

Magnesium stearate proper amount

Coating base amount

The above components are mixed and tablets are prepared according to a conventional tablet production method.

Formulation example  4. Preparation of Capsules

HPJ-H1 459 mg

Starch 100 mg

Talc 1 mg

Magnesium stearate proper amount

The above ingredients are mixed to produce a capsule according to a conventional method for producing a capsule.

Formulation example  5. Preparation of Injectables

HPJ-E1 459 mg

Mannitol 180 mg

_{Na 2 HPO 4 · 12H 2 O} 26 mg

Sterile distilled water for injection

Usually, it is prepared in the above-described content of ingredients per one vial (20 ml) according to the preparation method of the injection.

Formulation example  6. Manufacture of health food

HPJ-E3 1000 mg

Vitamin mixture proper amount

70 μg of Vitamin A Acetate

Vitamin E 1.0 mg

Vitamin B1 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

Nicotinamide 1.7 mg

50 μg folic acid

Calcium Pantothenate 0.5 mg

Mineral mixture

Ferrous Sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

15 mg potassium monophosphate

Dicalcium 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 a composition that is relatively suitable for the health functional food, the composition is mixed in a preferred embodiment, but the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health functional food manufacturing method. Then, the granules may be prepared and used for preparing the nutraceutical composition according to a conventional method.

Formulation example  7. Manufacture of health drinks

HPJ-E2 1000 mg

Citric acid 1000 mg

100 g oligosaccharides

Plum concentrate 2 g

1 g of taurine

900 ml of purified water whole

After mixing the above components according to the conventional healthy beverage production method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed sterilization and then refrigerated and stored Used to prepare the healthy beverage composition of the invention.

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

Experimental Example  One. Stability test

In order to test the stability of the products prepared in Formulation Examples 1 and 3, Notification of Food and Drug Administration No. 2007-14 (March 19, 2007) 2007-89, 2007. 12. 28) According to the microbial limit test method of the general test method was tested as follows.

Samples were collected at each test period by storing them at an accelerated condition of 75% relative humidity for 6 months at 40 ° C. Content test method was liquid chromatograph method equipped with an ultraviolet absorption photometer (measured wavelength 250 nm) using a solvent gradient method using a C18 column, glycyrrhizin acid in licorice, cinnamic acid in broiler meat, peony and total plaque in bark skin. A method of co-quantitating oniflorin was used.

As a result of the experiment, as shown in Table 1 and Table 2, there is little change in the content of cinnamic acid, glycyrizinic acid in licorice, total peonyflorin in peony and bark skin of the broiler of Formulation Example 1, stable in pH and microbial test items In addition, the content of cinnamic acid in the broilers of Formulation Example 3, glycyrrhizin acid in licorice, peony and bark skin is almost unchanged, stable in disintegration and microbial test items, and can be confirmed to be a very pharmaceutically stable formulation. there was.

Item / period (month) first 1 month later 2 months later 4 months later 6 months later Appearance fitness Fit Fit Fit Fit Confirm Fit Fit Fit Fit Fit content Broiler (Sinnamsan) 105.2% 104.9% 104.8% 104.3% 104.2% Peony / Peony (Peoniflorin) 103.3% 103.0% 102.9% 102.6% 102.4% Licorice (Glycylic Acid) 107.3% 107.6% 107.3% 107.1% 106.5% pH 4.21 4.20 4.20 4.19 4.18 importance 1.053 1.052 1.053 1.052 1.051 beauty
student
water Bacteria Not detected Not detected Not detected Not detected Not detected Fungus Not detected Not detected Not detected Not detected Not detected Specific bacteria (E. coli) Not detected Not detected Not detected Not detected Not detected

Item / period (month) first 1 month later 2 months later 4 months later 6 months later Appearance fitness Fit Fit Fit Fit Confirm Fit Fit Fit Fit Fit box
Amount Broiler (Sinnamsan) 106.3% 105.9% 105.6% 105.5% 105.1% Peony / Peel
(Phaeniflorin) 104.7% 104.2% 104.0% 103.7% 103.8% Licorice (Glycylic Acid) 102.6% 102.2% 102.1% 101.6% 101.5% Disintegrate 12 minute, 20 seconds 12 minute, 40 seconds 12 minute, 50 seconds 13 minute, 20 seconds 13 minute, 30 seconds beauty
student
water Bacteria Not detected Not detected Not detected Not detected Not detected Fungus Not detected Not detected Not detected Not detected Not detected Specific bacteria (E. coli) Not detected Not detected Not detected Not detected Not detected

Experimental Example 2. Comparative Dissolution Test

In order to measure the extraction efficiency test of the effective bioactive components of the HPJ (powder) obtained in Example 1 and the product prepared in Formulation Example 2, the following experiment was carried out according to the dissolution test method described in the Korean Pharmacopoeia.

HPJ (powder) and Formulation Example 2 were added in one dose each, using gastric eluent 500 ml for 10 minutes, 20 minutes, 30 minutes, under gastric acidic conditions (9 tablets disintegration test method, first solution, pH 1.2). The mixture was stirred for 60 minutes and 120 minutes, and the sample solution was taken at each time slot, and the effective bioactive component content was compared according to the stability test method of Experimental Example 1. Calculations were converted into percentages for each reference content of powder and extract.

As a result, as shown in Table 3, the content of cinnamic acid in broilers, glycyrrhizin acid in licorice, total peonyflorin in peony and bark skin is relatively higher than that of HPJ, and the extraction efficiency of the active ingredient in Formula 2 is 10 minutes. It was confirmed that it appeared very high.

Item / time 10 minutes 20 minutes 30 minutes 60 minutes 120 minutes HPJ Broiler (Sinnamsan) 47.2% 49.8% 52.1% 54.3% 56.4% Peony / Peel
(Phaeniflorin) 86.3% 86.8% 87.4% 88.2% 89.2% licorice
Glyceric acid 43.2% 44.8% 46.4% 47.9% 48.3% Formulation Example 2 Broiler (Sinnamsan) 82.5% 84.3% 85.2% 88.7% 92.1% Peony / Peel
(Phaeniflorin) 98.2% 98.5% 99.2% 99.8% 99.7% licorice
Glyceric acid 65.6% 65.7% 65.8% 66.2% 66.4%

Experimental Example 3. Clinical Trial

The following experiment was conducted for a simple clinical trial of obese and overweight subjects of the product prepared in Preparation Example 1.

Formulation Example 1 was administered to 20 subjects, 12 males, and 8 females three times a day, 30 ml once a day for 2-3 months. However, 15 years of age or younger was to lose 1/2. Obesity before and after the experiment was measured according to Equation 1 using the body mass index (BMI) as an index. If the body mass index (BMI) index is 25 or more, it was classified as obese, and if the body mass index (BMI) was 23 or more, it was classified as overweight.

Calculation formula for body mass index: body mass index (BMI) = [body weight (kg) / height (m) ² ]

As a result, as shown in Table 4 below, all of the subjects of the short-term clinical trial had individual differences, but the body mass index (BMI) value was confirmed to be reduced by about 1.05 ± 0.75 compared to before the experiment.

division Days taken gender age Height (cm) Body weight (kg / kg) Body weight (after / kg) BMI (previous) BMI (after) BMI car 01 3 months south 35 174 82.4 79.2 27.2 26.2 -1.0 02 3 months south 42 164 77.9 73.6 29.0 27.4 -1.6 03 2 months south 12 152 59.6 57.2 25.8 24.8 -1.0 04 3 months south 13 159 66.2 63.5 26.2 25.1 -1.1 05 2 months south 46 171 83.4 79.8 28.5 27.3 -1.2 06 2 months south 33 182 84.2 79.6 25.4 24.0 -1.4 07 3 months south 11 153 60.7 58.7 25.9 25.1 -0.8 08 3 months south 15 172 76.2 72.5 25.8 24.5 -1.3 09 3 months south 38 173 84.7 79.6 28.3 26.6 -1.7 10 2 months south 40 172 80.6 78.4 27.2 26.5 -0.7 11 3 months south 14 165 74.3 70.8 27.3 26.0 -1.3 12 3 months south 13 157 63.7 59.3 25.8 24.1 -1.7 13 3 months female 26 163 66.8 64.8 25.1 24.4 -0.7 14 2 months female 12 155 58.7 56.5 24.4 23.5 -0.9 15 3 months female 18 162 68.5 63.7 26.1 24.3 -1.8 16 2 months female 12 152 59.3 56.2 25.7 24.3 -1.3 17 2 months female 29 160 65.2 64.2 25.5 25.1 -0.4 18 2 months female 14 162 63.4 61.7 24.2 23.5 -0.6 19 3 months female 13 158 62.2 58.9 24.9 23.6 -1.3 20 3 months female 21 163 67.2 66.4 25.3 25.0 -0.3

Claims (9)

Weight mix ratio of taxa, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, ghost, halves and horseback riding 1-10: 1-5: 1-5: 1-5: 1-5: 1-5: 1 ~ 5: 1 ~ 10: 1 ~ 10: 1 ~ 5: A pharmaceutical composition for the prevention and treatment of obesity, containing as an active ingredient a complex herbal extract consisting of 1 to 5 parts by weight. delete delete The pharmaceutical composition according to claim 1, wherein the complex herbal extract is an extract available in a solvent selected from water including purified water, a lower alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof. The pharmaceutical composition according to claim 1, which is a liquid or suspension. Weight mix ratio of taxa, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, ghost, halves and horseback riding 1-10: 1-5: 1-5: 1-5: 1-5: 1-5: 1 ~ 5: 1 ~ 10: 1 ~ 10: 1 ~ 5: Health functional food for the prevention and improvement of obesity containing a compound herbal extract consisting of 1 to 5 parts by weight as an active ingredient. delete A first step of cutting, pulverizing and then mixing talc, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, honey, half and horseback; Reflux extraction, supercritical extraction, Soxhlet extraction, A second step of extracting by hot water extraction, cooling extraction or ultrasonic extraction; A method for producing the complex herbal extract of claim 1 comprising a third step of concentrating this under reduced pressure. A first step of cutting, pulverizing and then mixing talc, rhubarb, health, licorice, broiler, peony, bark skin, sea tiger, honey, half and horseback; Essential oil extraction method, supercritical extraction method for 1 hour to 7 hours at 10 ℃ to 120 ℃ with a solvent selected from water containing purified water 5 to 10 times the weight of the crude drug powder, lower alcohol having 1 to 6 carbon atoms or a mixed solvent thereof Or a second step of extracting by Soxhlet extraction to obtain only essential oil components as a nonpolar solvent; Reflux extraction method, supercritical extraction method, soxhlet extraction method, hot water extraction method, cooling extraction method for 1 hour to 7 hours with a solvent selected from water, a lower alcohol having 1 to 6 carbon atoms or a mixed solvent thereof to the residue except the essential oil component in the second step Or a third step of extracting by ultrasonic extraction; A fourth step of obtaining an essential oil component other than an essential oil component which is concentrated under a reduced pressure under reduced pressure of the extract prepared in the above step; A method for producing the complex herbal extract of claim 1 comprising the fifth step of combining this with the essential oil component of the second step.