PH12019000141A1 - Use of adlay extract in lowering body weight with high fat diet - Google Patents

Abstract

The present invention provides use of an adlay extract composition in the manufacture of a medicament of lowering triglycerides, wherein the adlay extract composition comprises a carbon dioxide supercritical fluid extract of adlay bran.

Description

Lam., Coix exaltata Jacq., or Coix lacryma L.

The adlay extract composition according to the invention comprises a carbon dioxide supercritical fluid extract of adlay bran.

The carbon dioxide supercritical fluid extract of adlay bran according to the present disclosure refers to an extract obtained by extracting adlay bran with carbon dioxide supercritical fluid. The supercritical fluid refers to a homogenous fluid state finally obtained when the properties of gas and liquid get similar at a temperature higher than the critical temperature and a pressure higher than the critical pressure. Similar to gas, the supercritical fluid has compressibility, and similar to fluid, has the fluidity, and can be used for extraction; moreover, a commercial supercritical fluid extraction equipment is available, for example, NATEX, SEPAREX, UHDE and TAIWAN

SUPERCRITICAL TECHNOLOGY Co., Ltd. provide commercial supercritical fluid extraction equipments, of which the specifications are generally indicated by the capacity of the extraction tank, such as 500 g to 2000 kg for selection, so that a suitable supercritical fluid extraction equipment can be selected according to requirements. in one preferred embodiment of the disclosure, the carbon dioxide supercritical fluid extract of adlay bran is extracted with carbon dioxide supercritical fluid in the existence of a co-solvent. Preferably, the co-solvent is about 1 wt % to about 10 wt % C1 to C7 alcohol. In one embodiment of the disclosure, the carbon dioxide supercritical fluid extract of adlay bran is manufactured by co-extracting adlay bran with about 1 wt % to about 10 wt %

C1 to C7 alcohol and carbon dioxide supercritical fluid.

The term "C1 to C7 alcohol" as used herein refers to linear or branched, substituted or unsubstituted, mono- or poly- functional, and saturated or unsaturated alcohol; preferably unsubstituted, mono-functional and saturated alcohol. In another aspect, the C1 to C7 alcohol is preferably a C1 to C4 alcohol. In one preferred embodiment of the discloure, the C1 to C7 alcohol is methanol, ethanol, n-propanol, isopropanol, n-butanol, iso-butanol, sec-butanol, tert-butanol, 1-pentanol, 2-pentanol, 3-pentanol, 2-methyl-1-butanol, 2-methyl- 2-butanol, 3-methyl-2-butanol, 3-methyi-1-butanol, 2,2-dimethyl-1-propanol, 1- hexanol, 2,4-hexadiene-1-ol, 2-methyl-cyclopentanol, cyclohexanol, 1-heptanol, 2-heptanol, or cycloheptyl alcohol. More preferably, the C1 to C7 alcohol is methanol or ethanol; most preferably, the C1 to C7 alcohol is ethanol. The C1 to C7 alcohol can be used solely or in combinations.

The C1 to C7 alcohol as used herein is preferably an alcohol solution with a concentration of from about 49% (v/v) to about 99.9% (v/v), more preferably from about 75% (v/v) to about 99.9% (v/v); still more preferably from about 90% (v/v) to about 98.0% (v/v).

In one preferred embodiment of the disclosure, the carbon dioxide supercritical fluid extract of adlay bran is extracted at a pressure of from about 150 bar to about 600 bar; more preferably from about 200 bar to about 580 bar; still more preferably from about 350 bar to about 550 bar.

The temperature of extraction is preferably from about 30°C to about 80°C; more preferably from about 40°C to about 70°C; still more preferably from about 50°C to about 60°C.

In one preferred embodiment of the disclosure, the carbon dioxide supercritical fluid extract of adlay bran is extracted with a flux of carbon dioxide supercritical fluid of from about 20 kg/h to about 50 kg/h; more preferably from about 30 kg/h to about 45 kg/h; still more preferably from about 38 kg/h to about 40 kg/h.

In one preferred embodiment of the disclosure, the extraction time for the carbon dioxide supercritical fluid extract of adlay bran is from about 30 minutes to about 100 minutes; more preferably form about 40 minutes to about 60 minutes. in one embodiment of the disclosure, the ratio (w/w) of the carbon dioxide supercritical fluid to adlay bran in the carbon dioxide supercritical fluid extract of adlay bran is preferably about 5:1 to about 30:1; more preferably about 10:1 to about 20:1.

In one preferred embodiment of the disclosure, prior to extraction, the adlay bran is cut or blended into the small pieces or powder. In one another embodiment of the disclosure, prior to extraction, the adlay bran is dried. The manner of cutting, blending and/or drying is well-known to artisans skilled in this field.

Preferably, the extraction further comprises obtaining a liquid fraction from the extract, and a solid fraction is removed. The manner of removing the solid fraction to obtain the liquid fraction is well-known to artisans skilled in this field. :

Preferably, the extraction further comprises a condensing step. The manner of condensing is well-known to artisans skilled in this field, such as by a reduced-pressure condenser.

In one preferred embodiment of the disclosure, the extraction can be repeated, and the extract is collected by merging.

In one preferred embodiment of the disclosure, the adlay extract composition further comprises an antioxidant. According to the disclosure, the antioxidant includes but is not limited to vitamin E. in one preferred embodiment of the invention, the extract of adiay bran is subjected to a gas chromatography - flame ionization detector assay. The condition is listed below: i. gas chromatography: Thermo, Tract GC Ulture/ITQ 900) i. detector: flame ionization detector, FID) ii. column: RT®-2560 (Biscyanopropy! polisiloxane); inner membrane thickness: 0.2 um; inner diameter: 0.25 mm x 100 m (Restek) iv. column temperature: initial temperature: 100°C, 4min rate of temperature rise (1): 3 °C/min, final temperature: 210°C, 10 min rate of temperature rise (2): 2 °C/min, final temperature: 216°C, 5 min rate of temperature rise (3): 2 °C/min, final temperature: 218°C, 3 min rate of temperature rise (4): 2 °C/min, final temperature: 220°C, 5 min rate of temperature rise (5): 2 °C/min, final temperature: 240°C, 5 min v. detector temperature: 250°C vi. injector temperature: 225°C vii. mobile phase gas helium flow rate: 1 mL/min

Vii. sample injection volume: 1 ul

The spectrogram of the carbon dioxide supercritical fluid extract of adlay bran according to the disclosure with the gas chromatography - flame ionization detector is shown in FIG. 1.

The composition according to the invention is preferably a pharmaceutical composition or food composition

The pharmaceutical composition according to the invention is preferably administered topically or systemically by any method known in the art, including, but not limited to, intramuscular, intradermal, intravenous, subcutaneous, intraperitoneal, intranasal, oral, mucosal or external routes.

The appropriate route, formulation and administration schedule can be : determined by those skilled in the art. In the present invention, the pharmaceutical composition can be formulated in various ways, according to the corresponding route of administration, such as a liquid solution, a suspension, an emulsion, a syrup, a tablet, a pil, a capsule, a sustained release formulation, a powder, a granule, an ampoule, an injection, an infusion, a kit, an ointment, a lotion, a liniment, a cream or a combination thereof. If necessary, it may be sterilized or mixed with any pharmaceutically acceptable carrier or excipient, many of which are known to one of ordinary skill in the art.

The extract of adlay bran can be added to a conventional food composition (i.e. the edible food or drink or precursors thereof) in the manufacturing process of the food composition. Almost all food compositions can be supplemented with the extract of adlay bran of the invention. The food compositions that can be supplemented with the extract of adlay bran of the invention include, but are not limited to, candies, baked goods, ice creams, dairy products, sweet and flavor snacks, snack bars, meal replacement products, fast foods, soups, pastas, noodles, canned foods, frozen foods, dried foods, refrigerated foods, oils and fats, baby foods, or soft foods painted on breads, or mixtures thereof.

According to the results shown in Examples, the body weights of the normal diet group, the high fat diet group, the high fat diet with emulsifier group, and the high fat diet experimental groups treated with the adlay extract a composition groups for 8 weeks were evaluated. At beginning, the body weight of the high fat diet group (HFD) was significantly higher than that of the normal diet group and that of the high fat diet with the adlay extract composition groups. As the number of feeding weeks increased, the body weight gain in the HFD group and the high fat diet with emulsifier group was more significant than that of the high fat diet with the adlay extract composition groups. When the trial was carried out until the eighth week, it was found that the high fat diet with the adlay extract composition groups had a significant decrease in body weight compared with the high fat diet group with a dose- effect relationship, indicating that the adlay extract composition according to the disclosure is effective in lowering body weight with high fat diet.

The following examples are given for the purpose of illustration only and are not intended to limit the scope of the present invention.

Adlay extract composition

Drugs and reagents: Adlay seeds (C. lachrymajobi L., Taichung

Shuenyu no 4, TCS4) are purchased from the farmers in Taichung County,

Taiwan.

The shell and the seed coat of adlay were removed by using a mill, and 3 kg of adlay bran was fed into a stainless steel extraction inner tank, and then the inner tank was placed into an extraction tank of supercritical extraction equipment. The extraction was proceeded with a co-solvent of 2 kg/hr of 95% ethanol and carbon dioxide supercritical fluid.

The extraction conditions were: extraction pressure: 500 bar; extraction temperature: 55°C; frequency: 35 Hz; carbon dioxide flux: 40 to 42 kg/h; co- solvent: 5 wt% ethanol. The pressure raising time was set to 30 minutes; the extraction time is 50 minutes. When the pressure reached 200 bar, adding ethanol until the extraction was complete and then turning off the ethanol.

After extraction, 840 g of extract was obtained. Subsequently, 840 g of the extract was concentrated with a reduced-pressure condenser to remove water and alcohol. After concentration, 750 g of extract was obtained, and the concentration was four times. 0.45 g of vitamin E was added into the extract of adlay bran and filled into capsules. Each capsule contains 499.7 mg of the extract of adlay bran and 0.3 mg of vitamin E.

CE

Adlay extract composition for lowering body weight with high fat diet

Experimental animal: About 6-week-old male Syrian hamsters were purchased from the National Animal Experimental Center.

Animal feeding

Feeding conditions: According to the method for assessing blood lipids (2007) as amended by the Food and Drug Administration of the Ministry of

Health and Welfare. The hamsters were housed in a breeding room in the animal center, and each hamster was housed in a large feeding cage. The environment was set at 12 hours for light and dark, 50% humidity and 22 + 2 °C constant temperature.

Animal groupings and test articles feeding

Animal groupings were first temporarily numbered, and the animals are weighed and grouped by random number. After 1 week of adaptation, 72 hamsters were divided into 7 groups; one for normal diet group (basic feed), one for high fat diet group (HFD; 0.2% for cholesterol), one for high fat diet with emulsifier group (HFD+Em); and four for high fat diet with four different doses of the test article groups (HFD+0.5xJBMCL), (HFD+1xJBMCL), (HFD+5xJBMCL), and (HFD+10xJBMCL). Each group of 10 male hamsters were given with basic or high fat feed and drinking water.

Individual identification: Ear number (ear hole method).

Identification of the test group: Each group was provided with a label card indicating the cage number, strain, sex, age, date of entry, test period, test number, test name and animal number.

Test articles feeding method: Feeding with a gavage.

Basic feed: (1) Name: Laboratory Rodent Diet 5001 (2) Label: LabDiet®, USA (3) Source: PMI®Nutrition International, USA (4) Feeding method: free intake

(5) Basic feed contained 28.5% protein, 13.5% fat, and 58.0% sugar, with the calorie of 3.36 kcal/g. (6) High fat feed: The preparation and composition of the high fat feed were carried out according to the method proposed by Huang et al. (2015). 10% (w/w) lard and 0.2% (w/w) cholesterol (Sigma-Aldrich, St.

Louis, MO, USA) was added to 89.8% (w/w) of the basic feed; containing 21.88% protein, 33.59% fat and 44.53% sugar; with the calorie is 3.93 kcal/gram

Drinking water (1) Type: The drinking water used in this test is a reverse osmosis water treated by reverse osmosis pure water machine and charged into a high temperature and high pressure sterilized plastic bottle. (2) Water supply method: ag libitum

Dose conversion between experimental animal and human body: The recommended daily intake dose of the adlay extraction composition capsules was 500 mg. According to the method of conversion between human and laboratory animals announced by the US Food and Drug Administration in 2005, when using hamsters as experimental animals, 60 kg of adults were taken as a basis, and 7.4 times the recommended daily intake dose per kilogram of human body weight was converted as one time dose of the experimental animal. Therefore, the experimental groups are divided into 4 groups (0.5x: 30.84 mg, 1x: 61.67 mg, 5x: 308.35 mg, and 10x: 616.67 mg/kg body weight).

Statistical analysis: All data are expressed as mean + standard deviation (SD). The SPSS statistical software package version 20 was used for Analysis of Variance (ANOVA), and Duncan's Multiple Range Tests were used to test the significant difference between the different groups. It was considered statistically significant when P < 0.05.

Results

Effect of high fat diet (HFD) induced hamster body weight

According to the results shown in Table 1, the body weights of the normal diet group, the high fat diet group, the high fat diet with emulsifier group,

Co ————————————————————— and the four high fat diet experimental groups treated with four different doses (0.5x: 30.84 mg, 1x: 61.67 mg, 5x: 308.35 mg, and 10x: 616.67 mg/kg body weight) of the test article groups for 8 weeks were evaluated. At beginning, the body weight of the high fat diet group (HFD) was significantly higher than that of the normal diet group and that of the high fat diet with four doses of the adlay extract composition capsules groups (P<0.05). As the number of feeding weeks increased, the body weight gain of the hamsters in the HFD group and the high fat diet with emulsifier group was more significant than that of the high fat diet with four doses of the adlay extract composition capsules groups. When the trial was carried out until the eighth week, it was found that the high fat diet with four doses of the adlay extract composition capsules "JBMCL" groups had a significant decrease in body weight compared with the high fat diet group with statistically significant differences and a dose-effect relationship, indicating that the test article "adlay extract composition capsule" is effective in slowing the increase in body weight of experimental animals.

Table 1

Normal diet {| HFD

Week| (body weight, { (body weight, emulsifier

SE ee

EO Ul Cl nl aul ll Wiad [POT FTE IO AOA [ROS [18 20751 [152675

FOR [00 TT 7 FS A F303 4010 54145721 1. Normal diet; HFD: high fat diet; HFD + emulsifier (Em); HFD + 0.5 x JBMCL (30.84 mg/day/kg bw); HFD + 1 x JBMCL (61.67 mg/day/kg bw); HFD + 5 x

JBMCL (308.35 mg/day/kg bw) and HFD + 10 x JBMCL (616.67 mg/day/kg bw). 2. Data are expressed as mean (Mean) + standard deviation (S.D.), (n = 10/group). Statistical analysis was performed using Duncan's multiple range tests. P < 0.05 indicates that the values were significantly different (letters a, b,

— c, d, and e indicate the numbers arranged in descending order, and the group with the same letter symbol represents no significant difference).

Effect of adlay extract composition capsule on daily average feed intake of hamsters fed with high fat diet (HFD)

The daily average feed intakes of the normal diet group, the high fat diet group, the high fat diet with emulsifier group, and the four high fat diet experimental groups treated with four different doses (0.5x: 30.84 mg, 1x: 61.67 mg, 5x: 308.35 mg, and 10x: 616.67 mg/kg body weight) of the test article groups for 8 weeks were evaluated. According to the results shown in

Table 2, it can be seen that the average daily feed intake of each group increases normally with the increase of feeding time, and the average daily feed intake of each group of hamsters from the first week to the eighth week has no significant difference, indicating that all groups had normal eating.

Table 2:

Week Ne ia) Emulsifier 2 poco oe [oe © [1200082 1I180:052 [12 004067 [11 8021.05" [1200:082 [12002105 12 10:1.10" po [12104166 [12302231 1240.3 27° 1200-298 1200231 |12.30:2.00" [1240.07 1. Normal diet; HFD: high fat diet; HFD + emulsifier (Em); HFD + 0.5 x JBMCL (30.84 mg/day/kg bw); HFD + 1 x JBMCL (61.67 mg/day/kg bw); HFD + § x

JBMCL (308.35 mg/day/kg bw) and HFD + 10 x JBMCL (616.67 mg/day/kg bw). 2. Data are expressed as mean (Mean) t standard deviation (S.D.), (n = 10/group). Statistical analysis was performed using Duncan's multiple range tests. P < 0.05 indicates that the values were significantly different (letters a, b, c, d, and e indicate the numbers arranged in descending order, and the group with the same letter symbol represents no significant difference).

While embodiments of the present invention have been illustrated and described, various modifications and improvements can be made by persons skilled in the art. it is intended that the present invention is not limited to the particular forms as illustrated, and that all the modifications not departing from the spirit and scope of the present invention are within the scope as defined in the following claims.

USE OF ADLAY EXTRACT IN LOWERING BODY WEIGHT WITH HIGH FAT

DIET

BACKGROUND OF THE INVENTION

1. Field of the invention

The invention relates to an extract of adlay bran; more particularly, to use of an adlay extract in lowering body weight with high fat diet. 2, Description of the Related Art

Adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) seeds, also called

Job's tears, are a component of traditional Chinese medicine (TCM) and have long been used as an anti-inflammatory agent to treat warts, chapped the skin, rheumatism, and neuralgia (Li S.C. Pen-tsao kangmu (Systematic

Pharmacopoeia); China, 1596). A recent study showed that dehulled adlay (DA) modulated the microbiota in the intestinal tract of rats (Chiang, W.; Cheng,

C.; Chiang, M.; Chung, K. T. J. Agric. Food Chem. 2000, 48, 829-832.). Also, the anti-inflammatory and antioxidative effects of adlay were elucidated in vitro (Lee, M. Y.; Tsai, S. H.; Kuo, Y. H.; Chiang, W. Food Sci. Biotechnol. 2008, 17, 1265-1271; Kuo, C. C.; Shih, M. C.; Kuo, Y. H.; Chiang, W. J. Agnc. Food

Chem. 2001, 49, 1564-1570). Contents of various potent compounds in adliay seeds from different origins were quantified (Wu, T. T.; Charles, A. L.; Huang,

T. C. Food Chem. 2007, 104, 1509-1515). Several phenolic antioxidants were isolated from adlay seeds, and bioactive components in adlay seeds were found to be stable during processing (Hsu, H. Y.; Lin, B. F.; Lin, J. Y.; Kuo, C.

C.; Chiang, W. J. Agric. Food Chem. 2003, 51, 3763-3769). Lignans and phenolic compounds were isolated from adlay hull (AH) in an assay-guided isolation (Kuo, C. C.; Shih, M. C.; Kuo, Y. H.; Chiang, W. J. Agric. Food Chem. 2001, 49, 1564-1570). Flavanone and several phenolic acids were isolated from antiinflammatory fractions of adlay seeds (Huang, D. W.; Kuo, Y. H.; Lin,

F. Y., Lin, Y. L.; Chiang, W. J. Agric. Food Chem. 2009, 57, 2259-2266;

Huang, D. W; Chung, C. P.; Kuo, Y. H.; Lin, Y. L.; Chiang, W. J. Agric. Food

Chem. 2009, 57, 10651-10657; Chen, H. J.; Chung, C. P.; Chiang, W.; Lin, Y.

L. Food Chem. 2011, 126, 1741-1748). Phenolic alcohol in the adlay testa (AT) was reported to possess antiallergic activity (Chen, H. J.; Shih, C. K.; Hsu, H.

Y.; Chiang, W. J. Agric. Food Chem. 2010, 58, 2596-2601). In addition, DA and adlay bran (AB) were shown to retard carcinogenesis through an anti-

inflammatory pathway (Shih, C. K.; Chiang, W.; Kuo, M. L. Food Chem. Toxicol. 2004, 42, 1339-1347; Li, S. C.; Chen, C. M.; Lin, S. H.; Chiang, W.,; Shih, C. K.

J. Sci. Food Agric. 2011, 91, 547-552), and ferulic acid was regarded as the active component in a further investigation (Chung, C. P.; Hsu, H. Y.; Huang,

D. W.; Hsu, H. H.; Lin, J. T.; Shih, C. K.; Chiang, W. J. Agric. Food Chem. 2010, 58, 7616-7623).

Although there are many uses of adlay seeds reported, various applications of extract of adlay seeds remain to be developed.

SUMMARY OF THE INVENTION

In the present disclosure, an adlay extract is surprisingly found to have effects in lowering body weight with high fat diet.

The present disclosure provides use of an adlay extract composition in the manufacture of a medicament of lowering body weight with high fat diet, wherein the adlay extract composition comprises a carbon dioxide supercritical fluid extract of adlay bran.

The present disclosure provides a pharmaceutical compositing for lowering body weight with high fat diet, which comprises an effective amount of an adlay extract composition and optionally a pharmaceutically acceptable carrier or excipient, wherein the adlay extract comprises a carbon dioxide supercritical fluid extract of adlay bran.

The present disclosure also provides a method for lowering body weight with high fat diet in a subject in need of such treatment, which comprises administering to said subject the pharmaceutical composition as mentioned above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the spectrogram of the carbon dioxide supercritical fluid extract of adlay bran according to the disclosure with the gas chromatography - flame ionization detector.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure provides use of an adlay extract composition in the manufacture of a medicament of lowering body weight with high fat diet,

wherein the adlay extract composition comprises a carbon dioxide supercritical fluid extract of adlay bran.

The present disclosure provides a pharmaceutical compositing for lowering body weight with high fat diet, which comprises an effective amount of an adlay extract composition and optionally a pharmaceutically acceptable carrier or excipient, wherein the adlay extract comprises a carbon dioxide supercritical fluid extract of adiay bran.

The present disclosure also provides a method for lowering body weight with high fat diet in a subject in need of such treatment, which comprises administering to said subject the pharmaceutical composition as mentioned above.

The present disclosure can be more readily understood by reference to the following detailed description of various embodiments of the invention, the examples, and the chemical drawings and tables with their relevant descriptions. It is to be understood that unless otherwise specifically indicated by the claims, the invention is not limited to specific preparation methods, carriers or formulations, or to particular modes of formulating the extract of the invention into products or compositions intended for topical, oral or parenteral administration, because as one of ordinary skill in the relevant arts is well aware, such things can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meaning:

Often, ranges are expressed herein as from "about" one particular value and/or to "about" another particular value. When such a range is expressed, an embodiment includes the range from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the word "about," it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to and independently of the other endpoint. As used herein the term "about" refers to 1 10%.

"Optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. For example, the phrase "optionally comprising an agent” means that the agent may or may not exist.

It must be noted that, as used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular.

The term "subject" as used herein denotes any animal, preferably a mammal, and more preferably a human. The examples of subjects include humans, non-human primates, rodents, guinea pigs, rabbits, sheep, pigs, goats, cows, horses, dogs and cats.

The term "effective amount" of an active ingredient as provided herein means a sufficient amount of the ingredient to provide the desired regulation of a desired function, such as gene expression, protein function, or the induction of a particular type of response. As will be pointed out below, the exact amount required will vary from subject to subject, depending on the disease state, physical conditions, age, sex, species and weight of the subject, the specific identity and formulation of the composition, etc. Dose regimens may be adjusted to induce the optimum therapeutic response. For example, several divided doses may be administered daily or the dose may be proportionally reduced as indicated by the exigencies of the therapeutic situation. Thus, it is not possible to specify an exact "effective amount."

However, an appropriate effective amount can be determined by one of ordinary skill in the art using only routine experimentation.

The term "treating" or "treatment" as used herein denotes reversing, alleviating, inhibiting the progress of, or improving the disorder, disease or condition to which such term applies, or one or more symptoms of such disorder, disease or condition.

The term "carrier" or "excipient" as used herein refers to any substance, not itself a therapeutic agent, used as a carrier and/or diluent and/or adjuvant, or vehicle for delivery of a therapeutic agent to a subject or added to a formulation to improve its handling or storage properties or to permit or facilitate formation of a dose unit of the composition into a discrete article such as a capsule or tablet suitable for oral administration. Suitable carriers or excipients are well known to persons of ordinary skill in the art of manufacturing pharmaceutical formulations or food products. Carriers or excipients can include, by way of illustration and not limitation, buffers, diluents, disintegrants, binding agents, adhesives, wetting agents, polymers, lubricants, glidants, substances added to mask or counteract a disagreeable taste or odor, flavors, dyes, fragrances, and substances added to improve appearance of the composition. Acceptable carriers or excipients include citrate buffer, phosphate buffer, acetate buffer, bicarbonate buffer, stearic acid, magnesium stearate, magnesium oxide, sodium and calcium salts of phosphoric and sulfuric acids, magnesium carbonate, talc, gelatin, acacia gum, sodium alginate, pectin, dextrin, mannitol, sorbitol, lactose, sucrose, starches, gelatin, cellulosic materials (such as cellulose esters of alkanoic acids and cellulose alkyl esters), low melting wax cocoa butter, amino acids, urea, alcohols, ascorbic acid, phospholipids, proteins (for example, serum albumin), ethylenediamine tetraacetic acid (EDTA), dimethyl sulfoxide (DMSO), sodium chloride or other salts, liposomes, mannitol, sorbitol, glycerol or powder, polymers (such as polyvinyl-pyrrolidone, polyvinyl alcohol, and polyethylene glycols), and other pharmaceutically acceptable materials. The carrier should not destroy the pharmacological activity of the therapeutic agent and should be non-toxic when administered in doses sufficient to deliver a therapeutic amount of the agent.

The composition according to the invention comprises an extract of adlay bran. The adlay bran according to the invention preferably is obtained from dehulled adlay seeds. The term "dehulled adlay seeds" as used herein refers to seeds of adlay without hulls, testas, coverings, shells, or pods. The manner of removing the hulls, coverings, shells or pods from the adlay seeds is well-known to artisans skilled in this field. In general, the dehulled adlay seeds comprises bran and endosperm, and the manner of obtaining the bran from the dehulled adlay seeds is well-known to artisans skilled in this field.

The adlay seeds referred to in this invention are not particularly limited.

Preferably, the adlay belongs to Gramineae family, Panicoideae sub-family, and Coix species, or Poales order, Poaceae family, and Coix species. More preferably, the adlay is Coix lachryma-jobi, Coix lachryma-jobi L., Coix lachryma-jobi L. var. ma-yuen Stapf, Coix agrestis Lour., Coix arundinacea

Claims (12)

CLAIMS WHAT IS CLAIMED IS:

1. Use of an adlay extract composition in the manufacture of a medicament of lowering body weight with high fat diet, wherein the adlay extract composition comprises a carbon dioxide supercritical fluid extract of adlay bran.

2. The use according to Claim 1, wherein the adlay is Coix lachryma-jobi L..

3. The use according to Claim 1, wherein the carbon dioxide supercritical fluid extract of adlay bran is manufactured by co-extracting adlay bran with about 1 wt % to about 10 wt % C1 to C7 alcohol and carbon dioxide supercritical fluid.

4 The use according to Claim 3, wherein the C1 to C7 alcohol is ethanol.

5. The use according to Claim 1, wherein the carbon dioxide supercritical fluid extract of adlay bran is extracted at a pressure of from about 150 bar to about 600 bar and a temperature of from about 30°C to about 80°C.

6. The use according to Claim 1, wherein the adlay extract composition comprises vitamin E.

7. A pharmaceutical compositing for lowering body weight with high fat diet, which comprises an effective amount of an adlay extract composition and optionally a pharmaceutically acceptable carrier or excipient, wherein the adlay extract comprises a carbon dioxide supercritical fluid extract of adlay bran.

8. The pharmaceutical composition according to Claim 7, wherein the adlay is Coix lachryma-jobi i...

9. The pharmaceutical extract composition according to Claim 7, wherein the carbon dioxide supercritical fluid extract of adlay bran is manufactured by co-extracting adlay bran with about 1 wt % to about 10 wt % C1 to C7 alcohol and carbon dioxide supercritical fluid he

. ' wt

10. The pharmaceutical extract ‘composition according to Claim 9, wherein the C1 to C7 alcohol is ethanol.

11. The pharmaceutical extract composition according to Claim 1, wherein the carbon dioxide supercritical fluid extract of adlay bran is extracted at a pressure of from about 150 bar to about 600 bar and a temperature of from about 30°C to about 80°C.

12. The pharmaceutical extract composition according to Claim 1, wherein the adlay extract composition comprises vitamin E.