양제근 추출물을 유효성분으로 함유하는 항암제 부작용에 의한 질환의 예방, 개선 또는 치료용 조성물

The present invention refers to amount number near (RumecisRadix) Anticancer activity to extract number pharmaceutical compositions for preventing or treating disease such as side effects are disclosed.

The number by said number near extract including method to process the amount can be a tank, not limited to:

1) Extracting applied amount number near the extraction solvent;

2) Step 1) extract of filtering step; and

3) Step 2) filtering extract cream and dried to extract step number tank.

Said step 1) extracted from the solvent can be water, C₁ - C₄ Of lower alcohols preferably does not bromic acid or a mixture of these.

In said manufacturing method, extraction of the filtration amount number near extract, an extract, immersion extraction, such as reflux cooling extraction and ultrasonic extraction, publicly known conventional method can be using all the sugar industry. Said extraction solvent is dried amount added is preferably 1 - 20 times number near volume of extraction, adding more preferably 3 - 10 times are disclosed. Extraction temperature 20 provided °C 50 preferably does not limited. In addition, extraction time is preferably 10 - 100 times, preferably 24 - 96 function of, most preferably does not limited time 72. In said method, step 3) the decompression of enrichment is using vacuum cream or vacuum rotary Eq preferably does not limited. In addition, drying reduced pressure drying, vacuum drying, boiling drying, preferably spray-dried or lyophilized does not limited.

Said arm is lung cancer, breast cancer, liver cancer, stomach cancer, colon cancer, colon cancer, skin cancer, bladder cancer, prostate cancer, ovarian cancer, cervical cancer, thyroid cancer, renal cancer, fiber sarcoma, melanoma and blood cancer cancer but without transferring any preferably selected from, but not limited to and, cancer diagnosis if the number does not relayed.

Antitumor antibiotic anticancer number is said number (antitumor antibiotics), phase billion number number (topoisomerase inhibitor), or taxane (taxane) based anticancer number is preferably does not limited clinical, pharmaceutical, therapeutic lifestyle available all anticancer number without using a tool.

Antitumor antibiotics (actinomycin D) D misfortune mote roh e said number is clarithromycin, erythromycin sulfate (bleomycin sulfate), capsaicin (daunomycin) multi right roh e, multi right deer rain shoes (daunorubicin), doxorubicin (doxorubicin), epitaxial (epirubicin) doxorubicin, doxorubicin (idarubicin) it is a child, american toe (mitomycin) erythromycin, erythromycin american toe (mitomycin-a C) selected from the group consisting - C mitt and erythromycin (mitramycin) but preferably more than one, not limited.

Said phase billion number number is irinotecan (irinotecan), camp camptothecin (camptothecin), norbornene biot new (novobiocin), epitaxial doxorubicin (epirubicin), leucine (dactinomycin) [tak mote roh e, cancerous company clean (amsacrine), daunomycin (etoposide) selected from the group consisting reel [ni gun hour [tu etoposide (teniposide) and preferably more than one which, is not limited.

Paclitaxel (paclitaxel) or docetaxel (docetaxel) [thak mountain system said anticancer number is preferably either or both will respect, of the present invention preferred embodiment tax [thak it will count and the most preferably disclosed.

Said anticancer number hematopoietic toxicity side effects disease, anemia and neutrophil 19 preferably selected from more than one but not the limited.

The total amount of the present invention relative to the weight of the present invention the compositions can be number near extract 0. 1 - 99. 9% By weight and as an active ingredient, about number dermatologically acceptable carrier, excipient or dilution number can be a number.

Various oral or parenteral composition of the present invention be a type number. If filling normally used under anger number number number, a specific number, number coupled, wet number, number disintegrating, dilution number or excipients such as surfactants using tank number number number with each other. Positive number number number is solid for oral administration, ring number, acid number, number granules, such as included in a capsule number, one or more compounds of at least one excipient such solid number number number for example, starch, calcium carbonate, sucrose (sucrose) or lactose (lactose), gelatin tank pressure is lowered number with each other. In addition, simple number excipients in addition to the magnesium salt of stearic acid, talc such as lubricating number are also are used. For oral administration include liquid suspension number number number, number content, oil number, which number syrup like a simple dilution number corresponding commonly used in water, in addition to the paraffin droplet number various excipients, for example wet number, sweetener number, direction number, number and the like can be preserved. For parental administration number number is a sterile aqueous solution, non-aqueous for number, number suspension, oil number, freeze-dried number number, number left multiple myelomas are included. For number include propylene glycol (propylene glycol) and number for non-aqueous suspension, polyethylene glycol, vegetable oil such as olive oil, such as the [ley which comes the [thu and ethyl ester is used as the injectable can be. As above [theyp brush left number for number (witepsol), mark with goal, twin (tween) 61, carcass five fingers, that it soaked, can be preparing gelatin is used as the alkali.

Oral or parenteral composition of the present invention can be administered, either intraperitoneally or external skin upon parenteral administration, rectal, intravenous, muscle, subcutaneous, intrauterine epidural or cerebrovascular in selecting scan mode is preferably, most preferably a skin preparation for external use other.

The present invention according to the compositions have a number a therapeutically effective amount is administered. In the present invention, "a therapeutically effective amount about number" rational possibility [hyey/ risk ratio applicable to medical treatment in an amount sufficient to treat conditions and means, effective capacity level type of patient disease, severity, drug, drug sensitivity, administration time, routes and discharge ratio, a treatment period, simultaneous use the sealed elements and other medical fields can be determined according to well-known element. Composition of the present invention individual treatment on number administration can be with administration of other therapeutic or number, number on treatment of the existing method can be also be sequential or are administered simultaneously, can be single or multiple administration. Said components can be obtained in an amount of at least excellently considers both the maximum effect the amount administered important, this can be determined by one skilled for hereinafter.

Body weight of patients doses of the present invention composition, age, sex, health condition, dietary, administration time, administration method, excretion rate range along with a variety of severe diseases and which generates, based on the amount of daily dose amount number near extract 0. 01 Provided 2,000 mg/kg and, preferably and 30 provided 500 mg/kg, and more preferably 50 provided 300 mg/kg, 1 - 6 can be administered once per day. Of the present invention composition alone or in combination with surgery, radiation therapy, hormone therapy, using chemotherapeutic and biological reaction control number method and can be used in combination with.

In addition, the present invention refers to extract number amount number near the anticancer activity to disease by health food for preventing or ameliorating side effects are disclosed. Said extraction of the solvent can be water amount number near extract, C₁ - C₄ Of lower alcohols preferably does not bromic acid or a mixture of these. Antitumor antibiotic anticancer number is said number, including but not limited to clinical anticancer number number number or [thak mountain system phase billion, pharmaceutical, therapeutic lifestyle available all anticancer number without using a tool. Said disease by administration of the anticancer number hematopoietic toxicity, anemia and selected from the group consisting neutrophil 19 characterized in that least one.

Health food composition of the present invention is to use with other food or food ingredients either adding amount number near extract can be, according to the conventional method can be suitably. Said type of health food is simplified and a smooth free number. Performance examples of food amount number near said meat, sausage, bread, chocolate, candy, , confectionery, pizza, if, other noodles, gum type, ice cream acid number a dairy product, various sprocket, beverage, difference, drinkable number, alcoholic drinks and vitamin composite number and the like, health food comprising both in conventional meaning. Health beverage of the present invention composition including lower number or natural carbohydrate is like conventional beverage flavor can be additional active ingredient. The above-described natural carbohydrate glucose, oligosaccharides such as mono pathogenic agent, liver, such as shoe cross and d company kara id, and dextrin, cyclodextrin such as polysaccharide, xylitol, sorbitol, such as processes for the preparation of party alcohol among others. As sweetener number TAU denaturing detergent, such as Stevia extract or natural sweetener number, saccharin, oh [su group [lu with burning, can be use such as synthetic sweetener number. The ratio of said natural carbohydrate of the present invention composition per 100g generally about 0. 01 - 0. 04G, preferably about 0. 02 - 0. 03G are disclosed.

In addition to the active ingredient of the present invention various nutritional number said health foods, vitamin, electrolyte, flavor number, colored number, [pheyk the [thu it buys and salts thereof, alginic acid and salts thereof, organic acid, protective colloidal thickening number, pH control number, stabilizing number, antiseptic number, glycerin, alcohol, number or the like can be further used in carbonated drink containing the suspension of calcium hydroxide. In addition to number of cells can be further contain fruit juice or vegetable beverages for numerical control machine. These components can be used independently or mixing. The triazines of the present invention composition ratio of added 100 parts by weight of large number but not significant, 0. 01 - 2 Parts by weight of generally is selected from the range are disclosed.

In addition, the present invention refers to extract auxiliary number amount number near to the anticancer activity to are disclosed. Said auxiliary number is the hematopoietic toxicity induced by the administration anticancer anticancer number, one or more side effects selected from anemia and neutrophil 19 characterized number number billion cancer are disclosed.

In addition to said auxiliary number near extract not only a positive number indicating a function same or similar anticancer active principle 1 containing at least one can be. Said clinical administration is oral or parenteral administration of anticancer auxiliary number when material which, when parenteral administration intraperitoneally scanning, scanning in colorectal cancer, hypodermic injection, intravenous injection, intramuscular injection, intrauterine epidural scanning, in the above described shortcomings in such as administration by injection or a thorax can be, can be used in form of a general pharmaceuticals number number.

Said anticancer auxiliary number is alone, or surgical, radiation therapy, hormone therapy, using chemotherapeutic and biological reaction control number method and can be used in combination with. Said anticancer auxiliary number daily dosage is about 0. 0001 Provided 100 mg/kg and, preferably 0. Which 001 provided 10 mg/kg, preferably administered 1 day - times the body weight of patients into many times but, age, sex, health condition, dietary, administration time, administration method, excretion rates and disease severity range according to the variety of disclosed.

The chamber of the present invention various parenteral administration anticancer auxiliary number can be administered clinical number number type, there is a guaranteed number number number under anger normally used, a specific number, number coupled, wet number, number disintegrating, dilution number number number or excipients such as surfactants using tank number with each other. For parenteral administration includes sterile aqueous solution number number, number for non-aqueous, suspension number, oil number, number or number lyophilized left without using a tool. They are suspended and include propylene glycol (Propylene glycol) number for non-aqueous for number, polyethylene glycol, vegetable oil such as olive oil, such as the [ley which comes the [thu and ethyl ester is used as the injectable can be. As above [theyp brush left number for number (witepsol), mark with goal, twin (tween) 61, carcass five fingers, that it soaked, can be characteristically preparing number is used as the alkali.

Hereinafter, the present invention broadcast receiver using more detailed in the embodiment. In the embodiment of the present invention is more specifically describe the present invention only these for the number one is a person with skill in the art that these range by not notified to the reduced in the art are disclosed.

In the embodiment 1. Amount number near Extract number bath

The active ingredient of the present invention high pressure liquid coolant amount number near extract number, China acid (number per light purchase in the mitochondria), produced in domestic acid (hub for purchase in the maul d new story) petitioned cities, province sanch'ong produced in domestic acid (hub for purchase in the maul d new story), cholla nam do posong produced in domestic acid (hub for purchase in the maul d new story) was formed. Said respective amount purchased by adults who number near 100g, 2 l rounded cap placed in with water is mixed. With reflux extraction device in a constant-temperature water cooling pipe connected to the heating (water bath) 1 2 times by acidifying, extracted from the total 2 times. Extract the paper filter paper (Whatman No. 2) And a vacuum pump (Vacuum pump, GAST) was degassed using filtering. Rotation concentrator (Rotary evaporator, EYELA) for dispensing a liquid conduit of decompressing the concentrated extract, after freezing and drying the concentrated extract, the extract obtained a positive number near homogenizing. A sealed plastic container for low temperature reservoir 4 °C until the experiment was for archiving.

In the embodiment 2. Docetaxel Identifying hematopoietic toxicity

Clinically used for current in order to identify the toxic effect of anticancer number in docetaxel (Docetaxel) of hematopoietic, docetaxel concentration according to mouse bone marrow cells an influence on growth and differentiation of hematopoietic stem ExVivo The ferroelectric layer has been confirmed.

1)In anticancer number of mouse bone marrow cells Hematopoietic toxicity Effect confirmation (Ex Vivo)

Mouse bone marrow cells are separated from was greater (femur). Then, added recombinant stem cells derived from tax [thak it will count, this grip factor (recombinant murine stem cell factor, rm stem cell factor), rm IL provided 3, human derived recombinant IL provided 6 rh erythropoietin (rh Erythropoietin) including a maul curl [thu GF M3434 (recombinant human IL provided 6, rh IL provided 6) and said medium by culturing bone marrow cells (methocult GF M3434) 7 - 10 days induced the growth of hematopoietic stem. Obtaining hematopoietic stem grown, colony forming unit analysis (Colony Formin Unit assay, CFU assay) by performing an influence on growth and differentiation of hematopoietic stem anticancer number is observed.

As a result, the disclosure also 1 as 15 nm [thak it will count as a result of processing of tax, mouse marrow bone marrow cells have been induced toxicity, the method of the present invention extract amount number near by, docetaxel (colony) reduced by the number of statistically significant hematopoietic stem colony group easily recover from, as well as cell, to such an extent as to confirm a negative cells were recovered.

In addition, emissive compound or a by a portion of a deck amount number to distinguish hematopoietic safening effects but, by installment amount according to the number of hematopoietic safening effect as the crushed without difference by 2 also near disclosure is 24.4 is crucial in both domestic China acid and acid, cholla nam do posong produced in relatively low concentrations 50 micro g/Ml is even domestic acid amount number near is crucial appeared.

Number near of hematopoietic safening effect on target amount by a portion (leaf and stem) divided into candelilla wax (root), for each, each concentration (50, 100 and 200 micro g/Ml) derived by the method number near extract amount to such an extent that the anticancer number hematopoietic stem colony reduction billion number has been confirmed. As a result, the disclosure also 3 number near the amount as the number of passes is hematopoietic safening effect has been identified both candelilla wax, candelilla wax rather than a target hematopoietic safening effect as signal peptides.

In the embodiment 3. Amount number nearHeat Extract Docetaxel Bone marrow derived bone marrow billion billion in animal model number number Employed for mitigating Confirmation

Bone marrow hematopoietic safening effect is induced in an animal model number near extract amount billion number in order to identify whether, mouse abdominal cavity after scanning to derive myelodysplastic billion tax [thak it will count number, by change amount number near extract therefrom.

Specifically, C57BL/6 mouse characterized but group 4, group 1 as the controls (control), and a population including 2% polysorbate 80 5% with ethanol saline are processed, group 2 is 30 mg/kg intraperitoneally 3 times [thak it will count of tax administration of docetaxel army and processing, the amount of extract from group 3 [thak it will count two days before tax administration number 1 1 125 mg/kg steel times for administration to a number near, docetaxel administration even during times 3 1 1 125 mg/kg docetaxel administration number number number near extract amount amount of light into electricity and administration of steel and near extract, said group 3 to group 4 is the same method, for administration to a human by administering a single extract from tax amount of 250 mg/kg [thak it will count two days before 1 1 and number near, 3 1 1 times the amount of 250 mg/kg docetaxel administration even during administration of 250 mg/kg docetaxel and amount of number number number near extract administration of group near extract steel among others.

Then, said controls, docetaxel administration group, the amount of tax [thak it will count with 125 mg/kg (amount number near -125) and tax amount of 250 mg/kg [thak it will count with the administration of a combination number near extract group number near extract daily change the body weight of a mouse combined administration group (number near -250 amount) after measuring, and mouse to the lowest 6 anatomical, a spleen (spleen) intra-bone marrow cell variations and hematopoietic action plays an important role and the weight of the Thymus (thymus) were measured.

As a result as shown in the table 1, in the case of mouse administering tax [thak it will count, involved in the spleen (spleen) Thymus (thymus) engine and a plurality of in-vivo hematopoietic abnormality of organs (organ index) results in a reduction in a sliding appears open due to reduced weight of index, [thak it will count with the administration of a combination engine in tax amount number near extract has been confirmed that a reduction in parts by weight of a group index.

Engine=weight (mg)/weight (g) of an individual (organ index, mg/g) of index

In addition, said group 1 - 4 (controls, docetaxel group, docetaxel + + docetaxel number near -250 amount number near -125 and amount) (Bone marrow mononuclear cells) cells harvested from bone marrow cells (femur) greater counting result, docetaxel alone administration group in a sliding valves are rapid decreasing number of bone marrow cells, in a statistically significant amount of administration of the group number near extract has been confirmed that the recover the patterned bone marrow cells (4 also).