WO2004030681A1

WO2004030681A1 - Pharmaceutical composition comprising bando deep ocean water or the concentrate thereof for the prevention and treatment of diabetes mellitus

Info

Publication number: WO2004030681A1
Application number: PCT/KR2003/002015
Authority: WO
Inventors: Ja Lim; G-Rewo Lim
Original assignee: Ja Lim; G-Rewo Lim
Priority date: 2002-10-01
Filing date: 2003-09-30
Publication date: 2004-04-15
Also published as: AU2003265106A1

Abstract

A pharmaceutical composition and health care food comprising Bando Deep Ocean Water', as used herein, means deep ocean like water drawn up from the underground at the depth ranging from 700 to 1000 m near Korean seashore region, contain not only inorganic component such as Na, Ca, Mg and K but also metal ion such as Se and Zn and have potent glucose-lowering activity which can be useful for the prevention and treatment of diabetes mellitus.

Description

PHARMACEUTICAL COMPOSITION COMPRISING BANDO DEEP OCEAN WATER OR THE CONCENTRATE THEREOF FOR THE PREVENTION AND TREATMENT OF DIABETES MELLITUS.

BACKGROUND OF THE INVENTION Technical Field

The present invention relates to a pharmaceutical composition containing Bando Deep Ocean Water or the concentrate thereof for the prevention and treatment of diabetes mellitus having blood glucose lowering activity.

Background Art

Diabetes mellitus is a mammalian condition in which the amount of blood glucose plasma is abnormally high.

Diabetes mellitus is known to exist in two forms of the disease. One of those is known as Type II, non-insulin dependent diabetes (NIDDM) or adult-onset, and another is juvenile diabetes or Type I, of which pancreas often continues to secrete normal amounts of insulin. However, this insulin is ineffective in preventing the symptoms of diabetes which include cardiovascular risk factors such as hyperglycemia, impaired carbohydrate mechanism, particularly glucose metabolism, glycosuria, decreased insulin sensitivity, centralized obesity hypertriglyceridemia, low HDL levels, elevated blood pressure and various cardiovascular effects. Many of these cardiovascular risk factors are known to precede the onset of diabetes by as much as a decade. These symptoms, if left untreated, often lead to severe complications, including premature atherosclerosis, retinopathy, nephropathy, and neuropathy. Insulin resistance is believed to be a precursor to overt NIDDM and strategies directed toward ameliorating insulin resistance may provide unique benefits to patients with NIDDM.

Current drugs used for managing Type II diabetes and its precursor syndromes, such as insulin resistance, fall within five classes of compounds: the biguanides, thiazolidinediones, the sulfonylureas, benzoic acid derivatives and alpha-glucosidase inhibitors. The biguanides, such as metformin, are believed to prevent excessive hepatic gluconeogenesis. The thiazolidinediones are believed to act by increasing the rate of peripheral glucose disposal. The sulfonylureas, such as tolbutamide and glyburide, the benzoic acid derivatives, such as repaglinide, and the alpha-glucosidase inhibitors, such as acarbose, lower plasma glucose primarily by stimulating insulin secretion.

Above sulfonylureas have disadvantages that these drugs cannot be administered to IDDM patient, NIDDM patient having decreased insulin secretion, and fecund female being worried about anomalous childbirth, abortion and stillbirth. Additionally, most of the sulfonylureas should be administered carefully to patient illed with liver dysfunction and kidney dysfunction because of sulfonylurea metabolism.

The pathway of biguanides such as metformin has not been verified clearly but the biguanides cannot increase the insulin secretion of pancreas. The biguanides show lower glucose-decreasing effect than the sulfonylureas but they have low occurrence of hypoglycemia. And the biguanides treatment may happen nausea, vomiting, diarrhea, eruption etc. in early stage and causes lactic acidosis of fatal side effect, so those are used only as experimental agents in U.S.A.

The sulfonylureas or the biguanides have above described disadvantages and side effects; therefore it is required to develop a new hypoglycemic drug having fewer side effects and greater safeties for effective treatment than those of current drugs.

Deep ocean water is located at below 200m from sea surface where does not occur photosynthesis and therefore, has lot of characteristics such as abundant inorganic mineral such as Zn, Se, Mn other than essential minerals i.e., Mg, Ca, K, Na, which can endow human or animal body with immune enhancing activity; high purity without contamination with various external polluting factors, for example, air, chemicals, pathogenic bacteria and so on; maturing activity by dint of abundant enzymes; physical stability; and radical scavenging activity etc (Japanese Patent No. 1995-34728).

Therefore, there have been lots of reports on the development of deep ocean water due to above-described favorable advantages till now. For example, Japanese Patent Publication No. 2001-198575 discloses alkali reduction water reported to have treating activity of various gastrointestinal diseases such as intestinal abnormal fermentation, chronic diarrhea, indigestion, hyperchylia, etc, and strong acidic oxidization water reported to be used as a disinfectant of medical devices and food due its bactericidal activity. Japanese Patent Publication No. 2580428 discloses health beverage for the prevention of various present human disease such as diabetes, allergic disease, and cardiac infarction.

Japanese Patent Publication No. 1993-219921 and 1985-255729 disclose nutrient water comprising desalted deep ocean water and vitamins and health mineral water beverage respectively, all of which are incorporated herein by reference.

However, above described references relate to deep ocean water drawn up from the Fujiyama Bay in Japan and there have been no suggestion or disclosure on specific medical use and Deep Ocean like water drawn up from the seashore region.

Accordingly, present inventors endeavored to investigate specific pharmacological activity of deep ocean like water drawn up from the seashore region, designated as Bando

Deep Ocean Water (BDW) herein, found that it has potent the glucose in the blood plasma lowering activity by experimenting in vitro test and clinical test and finally have accomplished present invention.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide a pharmaceutical composition for the prevention and treatment of diabetes mellitus having the glucose in blood lowering activity, comprising Bando Deep Ocean Water and a pharmaceutically acceptable carrier.

Disclosure of the invention

In accordance with one aspect of the present invention, there is provided a pharmaceutical composition for the prevention and treatment of diabetes mellitus having the blood glucose lowering activity, comprising Bando Deep Ocean Water, hereinafter call as BDW, and a pharmaceutically acceptable carrier.

The term "Bando Deep Ocean Water", as used herein, means deep ocean like water drawn up from the underground at the depth ranging from 700 to 1000 m near Korean seashore region, preferably, East seashore region, more preferably, Kyonggi province region and comprise all the types such as natural form itself containing salt ingredient (BDW-1) and the concentrate thereof (BDW-2) and desalted form without salt ingredient (BDW-3) and the concentrate thereof (BDW-4), all of which are characterized in containing not only inorganic component such as Na, Ca, Mg and K but also metal ion such as Se and Zn.

Above described various forms of BDW may be prepared by the following procedures, which are merely exemplary and in no way limit the invention.

For example, BDW-1 drawn up from the underground at the depth ranging from 700 to 1000 m near Korean seashore region is subject to at least one desalting step selected from ion exchange column chromatography, the evaporative concentration process comprising natural evaporation process in the shadow, heat treatment and filtration process to remove resulting crude salt or electrolysis method resolving salt into ions through electrolyte apparatus to obtain BDW-3 and subsequent drying step adopting in conventional manner such as natural seasoning, hot wind drying, lyophilization and the like to obtain BDW-2 and BDW-4.

Specifically, in carrying out above described ion exchange, either a cation exchange resin or an anion exchange resin may be used. Examples of exchange resins that can be used for this purpose are: strong acidic cation exchange resins such as AG 50W-x8, Amberlite IR-120, and Dowex 50W-x8; weak acidic cation exchange resins such as Amberlite IRC-50, Bio-Rex 70, Duolite-436; weak basic cation exchange resins such as Amberlite IRA-67, and Dowex 3-x4A; strong basic cation exchange resins such as AG 2x8, Amberlite IRA-400, and Dowex 2-x8; modified cellulose cation exchange resins such as CM-Celluose and SE-Cellulose; and anion exchange resins such as DEAE Celluose; cationic sephadex-type resins such as G-25 and G-50 bead type cross-linked dextran resins; and modified bead-type ion exchange resins made from agarose such as Cepharose CL, Biogel A Cepharose resin, Fractogels and Toyopearl. The preferred resins are Toyopearl DEAE type exchange resins, and the more preferred are Toyoprearl DEAE- 650C type exchange resins. In carrying out above described electrolysis, electrolysis apparatus is not limited which can resolve water into ions, for example, two-part electrolytic cell type divided with diaphram. There are several types according to water supply methods preferably, once water supply to reservoir to be resolved for certain period, subsequent water supply to reservoir through tap water. In above described electrolysis, ferrite electrode, platinum plating titan electrode, titan platinum plasticized electrode and the like are preferable as an anode and stainless electrode, platinum plating titan electrode, titan platinum plasticized electrode and the like are preferable as a cathode.

BDW-1, 2, 3 and 4 prepared by above preparation method contain abundant mineral ingredient.

Various experiments clearly show that BDW possess the blood glucose lowering activity.

Thus, the BDW of the present invention may be employed as a pharmaceutical agent for the prevention and treatment of diabetes mellitus by lowering blood glucose.

In accordance with another aspect of the present invention, there is also provided a use of BDW for manufacture of medicines employed for the prevention and treatment of diabetes mellitus by lowering blood glucose in human or mammals.

In accordance with another aspect of the present invention, there is also provided a method for the prevention and treatment of diabetes mellitus by lowering blood glucose in human or mammals, wherein the method comprises administering a therapeutically effective amount of BDW.

The pharmaceutical composition of the present invention comprises above BDW as 0.01 to 80 %, preferably 1 to 50 % by weight based on the total weight of the composition.

Hereinafter, the following formulation methods and excipients are merely exemplary and in no way limit the invention.

The inventive pharmaceutical formulation may be prepared in accordance with any of the conventional procedures. In preparing the formulation, the active ingredient is preferably admixed or diluted with a carrier, or enclosed within a carrier, which may be in the form of a capsule, sachet or other container. When the carrier serves as a diluent, it may be a solid, semi-solid or liquid material acting as a vehicle, excipient or medium for the active ingredient. Thus, the formulation may be in the form of a tablet, pill, powder, sachet, elixir, suspension, emulsion, solution, syrup, aerosol, soft and hard gelatin capsule, sterile injectable solution, sterile packaged powder and the like.

Examples of suitable carriers, excipients, or diluents are lactose, dextrose, sucrose, sorbitol, mannitol, starches, gum acacia, alginates, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoates, propylhydroxybenzoates, talc, magnesium stearate and mineral oil. The formulation may additionally include fillers, anti-agglutinating agents, lubricating agents, wetting agents, flavoring agents, emulsifϊers, preservatives and the like. The composition of the invention may be formulated so as to provide a quick, sustained or delayed release of the active ingredient after it is administrated to a patient, by employing any one of the procedures well known in the art.

The pharmaceutical formulation of the present invention can be administered via various routes including oral, transdermal, and subcutaneous, intravenous and intramuscular introduction. For treating a human patient, a typical daily dose of the above-mentioned compound may range from about 0.01 to 10 g kg body weight, preferably 1 to 5 g/kg body weight, and can be administered in a single dose or in divided doses. However, it should be understood that the amount of the active ingredient actually administered ought to be determined in light of various relevant factors including the condition to be treated, the chosen route of administration, the age, sex and body weight of the individual patient, and the severity of the patient's symptom; and, therefore, the above dose should not be intended to limit the scope of the invention in any way.

It is still another object of the present invention to provide a health care food or food additives comprising above BDW, together with a sitologically acceptable additive for the prevention and treatment of diabetes mellitus.

The above-mentioned BDW can be added to food or beverage for the prevention and alleviation of diabetes mellitus by lowering blood glucose. The amount of said BDW that may be added to food or beverage for the prevention and treatment of diabetes mellitus may generally range from about 0.1 to 15 w/w %, preferably 1 preferably 1 to 10 w/w % based on the total weight of food, and 1 to 30 g, preferably 3 to 10 g based on 100 ml of beverage.

The health care beverage composition of the present invention may contain other components, e.g., deodorants and natural carbohydrates as in conventional beverages. Examples of such natural carbohydrates are monosaccharides such as glucose and fructose; disaccharides such as maltose and sucrose; conventional sugars such as dextrin and cyclodextrin; and sugar alcohols such as xylitol, sorbitol and erythritol. As the deodorant, a natural deodorant such as taumatin, levaudioside A, and glycyrrhizin, or a synthetic deodorant such as saccharin and aspartam may be used. The amount of the above- described natural carbohydrate is generally in the range of about 1 to 20 g, preferably 5 to 12 g based on 100 ml of beverage.

Other components that may be added to the inventive food or beverage composition are various nutrients, vitamins, minerals, synthetic flavoring agents, coloring agents pectic acid and its salt, alginic acid and its salt, organic acids, protective colloidal adhesives, pH controlling agents, stabilizers, preservatives, glycerin, alcohol, carbonizing agents, fruit juices and vegetable juices.

Brief Description of the Drawings

The above and other objects and features of the present invention will become apparent from the following description of the invention, when taken in conjunction with the accompanying drawings, which respectively show:

Fig. la and lb show effect of Bando Deep Ocean Water in OGTT (Oral Glucose Tolerance Test): Fig. la shows effect of oral administration of Bando Deep Ocean Water on blood glucose level; Fig. lb shows effect of oral administration of Bando Deep Ocean Water on AUC (Area Under the Curve).

Fig. 2a and 2b show effect of Bando Deep Ocean Water in multiple low dose streptozotocin induced diabetic ICR mice: Fig. 2a shows effect of the oral administration of Bando Deep Ocean Water on blood glucose level; Fig. 2b shows effect of oral administration of Bando Deep Ocean Water on AUC (Area Under the Curve).

Best Mode for Carrying Out the Invention

The following Examples, Experimental Examples and Formulation Examples are intended to further illustrate the present invention without limiting its scope.

Example 1 : Preparation method of BDW-1 and 2

20 kg of Bando Deep Ocean Water was drawn up from the underground at the depth at 800 m located at Dukwoo-ri, Paltan-myeon, Hwasung-si, Kyonggi Province, South Korea and designated as BDW-1 herein. 2 kg of BDW-1 was used as test sample and remaining 18 kg of BDW-1 was lyophilized with freeze dryer (SamwonNangyul SFDSM24L model, Korea) to obtain 150 mg of concentrated powder designated as BDW- 2, which was used as test sample.

Example 2: Preparation method of BDW- 3

20 kg of BDW-1 was poured into water supply reservoir divided with cathode and anode parts of two-part reservoir type electrolysis apparatus and electrolysis was performed by flowing 0.1 to 3.0A of direct current for 60 min to obtain 8 kg of desalted BDW solution designated as BDW-3, which was used as test sample.

Example 3: Preparation method of BDW- 4 (1)

20 kg of BDW-1 was poured into water supply reservoir divided with cathode and anode parts of two-part reservoir type electrolysis apparatus and electrolysis was performed by flowing 0.1 to 3.0A of direct current for 60 mines to obtain 8 kg of desalted BDW solution designated as BDW-3. And then the solution was heated at the temperature ranging 80 to 120 ^°C for 24 hrs and dried at room temperature to obtain 200 mg of desalted BDW powder designated as BDW-4, which was used as test sample.

Example 4: Preparation method of BDW- 4 (2)

20 kg of BDW-1 was poured into 160 ml of Toyo pearl® DEAE-650C ion exchange resin (4.0x 30cm, Tosoh Co. Japan) equilibrated with desalted distilled water and eluted successively with 0, 0.1, 0.2, 0.3 and 3M NaCl solutions with a eluting velocity of 2 m£/hr. The eluted solutions were dialyzed using a dialysis membrane (Sigma co. USA) having 32 mm of mean width and 100 mMeet volume of benzoylated dialysis tubing running with desalted water three times for 4 hrs. The filtrate was lyophilized with freeze dryer (SamwonNangyul SFDSM24L model, Korea) to obtain 150 mg of concentrated powder designated as BDW-4, which was used as test sample.

Example 5: Characterization and component analysis of BDW

Comparison with the characters of BDW and Japanese Deep Ocean Water

Table 1 shows distinct characteristics of BDW comparing with conventional Deep Ocean Water obtained in Japan and disclosed in Korean Patent Publication No 2002-

4598.

As can be seen in Table 1 , BDW has fundamentally different characteristic from conventional Japanese Deep Ocean Water in the aspect of Existing depth, mean temperature, degree of hardness and Mean pH.

Table 1. Characteristic of BDW and Japanese Deep Ocean Water

Elementary Analysis of BDW-1

To determine the consisting component of BDW-1 and Deep Ocean Water (Japan), the elementary analysis of BDW-1 and Deep Ocean Water (Japan) was performed at KTRICI (Korea Testing and Research Institute for Chemical Industry) located at Seoul in Korea by conventional analysis method disclosed in APHA (revised Ed, 1998) and the result thus obtained is shown in Table 2.

Table 2. Result of Elemental analysis

As can be seen in Table 2, the amount of several minerals such as Fe, Mn, Zn etc in BDW-1 was much more abundant ranging 10 to 10000 fold than those of Deep Ocean Water (Japan) and particularly, The amount of Ca ion in BDW-1 was more abundant than that of Mg differing with Deep Ocean Water (Japan), which shows the consisting ingredients in BDW-1 are fundamentally different with those of Deep Ocean Water (Japan).

Experimental Example 1. Effect of Bando Deep Ocean Water in OGTT (Oral Glucose Tolerance Test)

To investigate the anti-diabetic activity of Bando Deep Ocean Water was measured effect of it in OGTT. ICR mice (6 weeks), which basal condition with fasting for 12 hours was orally administrated 1000 mg/kg, distilled water to control group and 1000 mg/kg, BDW-2 from Example 1 to sample group before 30 min of administration of glucose. After 30 min later, both control group and sample group were orally administrated 1.5 g/kg of glucose. Blood was collected on 0 min, 30 min, 60 min, 90 min, 120 min from vena supraorbitalis. The dose of glucose in plasma blood was measured by method of hinder.

At the result of that, the test sample group, which administrated 1000 mg/kg BDW- 2 from Example 1, represented 44.5 % of anti-diabetes effect when it compared with control group (See Fig. la and lb). Experimental Example 2. Effect of Bando Deep Ocean Water in multiple low dose streptozotocin-induced diabetic ICR mice

To investigate effect on diabetes of Bando Deep Ocean Water, experiment was carried with using MLD (Multiple low dose) streptozotocin-induced diabetic ICR mice, as followings.

At first, ICR mice (6 weeks) were administrated 40 mg/kg of streptozotocin (STZ) in abdominal cavity at punctual time daily for 5 days. At the same time, BDW-2 from Example 1 was orally administrated with the dose of 500 mg/kg. After 6 days later, the administration of STZ was stopped, and BDW-2 was only orally administrated with 500 mg/kg daily. After fasting 6 hours on every 5 days, ICR mice was measured plasma glucose and body weight. From the 16 days later, the administration of BDW-2 was stopped, and the change of blood glucose was investigated.

As a basis result of experimental example 1, the effect on diabetes of Bando Deep Ocean Water was examined by using MLD streptozotocin-induced diabetic ICR mice.

As a result of that, the control group and sample group did not show significantly differences for initial 5 days. On the 10 days after 6 days, the control group was induced diabetes by rising blood pressure to 21.3 mmoX/l. However, the blood glucose was 9.1 mmoX/l, and did not rise in the sample group. Namely, the rising of blood glucose was inhibited excellently. The blood glucose of the sample group was getting low narrowly to 15 day. After stopping administration, the blood glucose of the sample group was getting low continuously (See Fig. 2a).

In the body weight, the control group and the sample group did not show significantly differences. On the 19 days after stopping administration, the body weight of the sample group was lower than the control group (See Fig. 2b).

Clinical Example 1 :

A 55 years old Korean man lived at L.A. in USA, was a diabetes patient, and the index of blood glucose was 120 mg/dl, which is a little higher than normal (the normal is 78 mg/dl and 96 mg/dl, the 110 mg/dl before breakfast is usually normal). 100 mi of

BDW-3 had been prescribed twice a day orally for two months from Jan. 5, 2003 to Feb. 5,

2003 and the index of blood glucose reduced to 90 mg/dl.

Clinical Example 2: A 64 years old Korean female lived at Bugok-dong, Sangrok-ku, Ansan city,

Kyonggi-do in Korea, was a diabetes patient from 10 years ago, and the index of glucose in blood was 190 mg/dl before breakfast. He was of sufficient concern as over 260 mg/dl in 2 hrs later after eating. 1 g of BDW-4 had been prescribed twice a day orally for two months from Jan. 5 to Mar. 5 2003, and the index of blood glucose reduced to 90 mg/dl and 135 mg/dl.

Clinical Example 3:

A 70 years old Korean man lived at Sungpo-dong, Sangrok-ku, Ansan city, Kyonggi-do in Korea, was a diabetes patient from 6 years ago, and the index of glucose in blood was 170 mg/dl before breakfast, and 230 and 260 mg/dl after eating. So, he took a treatment in hospital regularly. 100 ml of BDW-1 had been prescribed twice a day orally for two months from Jan. 5 to Mar, 5 2003, and the index of blood glucose reduced to 80 mg/dl before eating and 140 mg/dl after eating.

The BDW of the present invention can be used in preparing a pharmaceutically effective powder, tablet, capsule, injection or liquid composition according to any one of the known conventional methods, as exemplified below.

Experimental Example 3: Toxicity test

Methods The acute toxicity tests on ICR mice (mean body weight 25+5 g) and Sprague-

Dawley rats (235+10 g) were performed using the BDW-2 and 4. Each group consisting of 3 mice or rats was administrated intraperitoneally with 20mg/kg, lOmg/kg and 1 mg/kg of test compounds or solvents (0.2 ml, i.p.) respectively and observed for 24 hrs.

Results

There were no treatment-related effects on mortality, clinical signs, body weight changes and gross findings in any group or either gender. These results suggested that the compounds prepared in the present invention were potent and safe.

Hereinafter, the formulating methods and kinds of recipients will be described, but the present invention is not limited to them. The representative preparation examples were described as follows.

Preparation of powder

BDW-2 500mg

Corn Starch lOOmg Lactose lOOmg

Talc lOmg

Powder preparation was prepared by mixing above components and filling sealed package.

Preparation of tablet

BDW-2 lOOmg

Corn Starch lOOmg

Lactose lOOmg

Magnesium Stearate 2mg Tablet preparation was prepared by mixing above components and entabletting.

Preparation of capsule

BDW-2 50mg

Lactose 50mg Magnesium Stearate lmg

Tablet preparation was prepared by mixing above components and filling gelatin capsule h bvy r c.nonnvvpennttiinonnflall g σeellaattiinn p nrreepnaarrflattiinonn m meetthhoodd

Preparation of injection BDW-2 lOOmg

Distilled water for injection optimum amount

PH controller optimum amount

Injection preparation was prepared by dissolving active component, controlling pH to about 7.5 and then filling all the components in 2ml ample and sterilizing by conventional inj ection preparation prepared.

The heath care food was exemplarily prepared by the following method.

[Preparation of health care food] A scorched dried meal mixture of brown rice, barley, glutinous rice and Job's tear was pulverized and sieved to obtain grain particles of 60 meshes or less. Also, a mixture of black bean, black sesame and wild sesame was steamed, dried, scorched, pulverized and sieved to obtain seed particles of 60 mesh or less.

The dried BDW-2 obtained in Example 1 was pulverized and sieved to obtain particles of 60 meshes or less, which were mixed with the grain particles and seed particles in the following proportions to prepare a granule type health food. Grains : brown rice 30w%, Job's tear 15w%, barley 20w%, Seeds : wild sesame 7w%, black bean 8w%, black sesame 7w%, Dried powder of BDW : 3w%, Shiitake mushroom 0.5w%, rehmania root 0.5w%

The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the present invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims

Industrial Applicability

The compounds according to the present invention are useful for the prevention and treatment of diabetes mellitus.

Claims

1. A pharmaceutical composition for the prevention and treatment of diabetes mellitus having blood glucose lowering activity comprising Bando Deep Ocean Water, designated as BDW, and a pharmaceutically acceptable carrier.

2. The pharmaceutical composition of claim 1 wherein BDW is selected from natural form itself containing salt ingredient (BDW-1) and the concentrate thereof (BDW- 2), desalted form without salt ingredient (BDW-3) and the concentrate thereof (BDW-4).

3. The pharmaceutical composition of claim 1 wherein BDW is drawn up from the underground at the depth ranging from 700 to 1000 m near Korean seashore region.

4. The pharmaceutical composition of claim 3 wherein BDW is drawn up from the underground at the depth ranging from 700 to 1000 m near East seashore region.

5. The pharmaceutical composition of claim 4 wherein BDW is drawn up from the underground at the depth ranging from 700 to 1000 m near Kyonggi province region.

6. The pharmaceutical composition of claim 1 wherein BDW is characterized in containing not only inorganic component such as Na, Ca, Mg and K but also metal ion such as Se and Zn.

7. The pharmaceutical composition of claim 1 of which type its selected from tablet, capsule, solution, suspension or syrup.

8. The pharmaceutical composition of claim 1 wherein the amount of said

BDW ranges from 0.01 to 50 % by weight based on the total weight of the composition.

9. A use of BDW as set forth in claim 1 for manufacture of medicines employed for the prevention and treatment of diabetes mellitus by lowering blood glucose in human or mammals.

10. A method of treating diabetes mellitus by lowering blood glucose in men or mammals, wherein the method comprises administering a therapeutically effective amount of BDW as set forth in claim 1.

11. A health care food comprising Bando Deep Ocean Water as set forth in claim 1, and a sitologically acceptable additive for the prevention and alleviation of diabetes mellitus.

12. The health care food of claim 11, wherein the food is of a powder, tablet, capsule, or beverage type.