COMPOSITION FOR PREVENTING, ALLEVIATING OR TREATING DISEASE CAUSED BY SIDE EFFECT OF ANTICANCER AGENT COMPRISING CISTANCHIS HERBA EXTRACT AS EFFECTIVE COMPONENT

The present invention refers to extract for breeding containing pharmaceutical compositions for preventing or treating disease such as cancer number side effects are disclosed.

the extract for breeding including method to process the number by the tank can be a, does not limited to:

1) extracting breeding for use in extraction solvent applied;

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, breeding extract for extraction of the filtration, heat extraction, immersion extraction, extraction and ultrasonic extraction using publicly known conventional method such as reflux cooling all contrast can be. 1 to 20 times the volume of said extraction solvent includes a dry breeding for extraction is preferably added, more preferably 3 - 10 addition times are disclosed. Extraction temperature is preferably 20 to 50 °C does not limited. In addition, extraction time is preferably 10 to 100 times, preferably 24 to 96 function of, most preferably does not limited time 72. In said method, step 3) the decompression of enrichment is limited using vacuum decompression thickener or vacuum rotary Eq preferably does not. 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 drug 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) and preferably more than one, is 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.

[Thak mountain system the drug is paclitaxel (paclitaxel) or one or both of said tax will respect to the process of (docetaxel) preferably, the most preferred of the present invention preferred embodiment [thak it will count and tax.

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

0 extract of the present invention relative to the weight of the present invention for the total the compositions can be cross-pollination. 1 to 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 or administration of other therapeutic number number on with administration of treatment on number of the existing method can be sequential or concurrent administration also can be, 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 extract for therapeutics in the daily dose 0. 01 and to 2,000 mg/kg, preferably between 30 and 500 mg/kg, more preferably 50 to 300 mg/kg and, by administering a single day can be 1 to 6. 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 for bondable number sarcoma cancer disease by health food for preventing or ameliorating side effects are disclosed. Said extraction of the solvent can be water extract for breeding, C₁ - C₄ Of lower alcohols preferably does not bromic acid or a mixture of these. Antitumor antibiotic anticancer number is said number, number number or [thak mountain system not limited clinical drug 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.

As therapeutics in the health food of the present invention is to extract for use with either adding other food or food ingredients can be, according to the conventional method can be suitably. Said type of health food is simplified and a smooth free number. Adding said extract for breeding food products include 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 to 0. 04g, preferably about 0. 02 to 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 to 2 parts by weight of generally is selected from the range are disclosed.

In addition, the present invention refers to extract for bondable to auxiliary number sarcoma cancer 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 the extract for breeding said auxiliary 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 to 100 mg/kg and, preferably 0. 001 to 10 mg/kg and, preferably administered 1 day dividing but many times to times the body weight of patients, 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 or excipients such as surfactants using tank number number number with each other. 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. Non-aqueous for number, number (Propylene glycol) for suspension include propylene glycol, 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. Number of crude extract for breeding

Active ingredient of the present invention extract for breeding number for a high pressure liquid coolant, for the actual light ([...], a compensation) was purchase from about number per breeding. Said 100g for adults who purchased breeding, 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 to a breeding for homogenizing a [...] obtained. 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, InVivo The ferroelectric layer has been confirmed.

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

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 even low concentrations of hematopoietic toxicity appearing as a starting point, in particular, appears to be very severe in making sure that the capable of 50 nm or more hematopoietic toxicity.

2) anticancer number is scanned mouse abdominal cavity Hematopoietic toxicity Effect confirmation (InVivo)

C57BL 6 [thak it will count of 50, 100 and 150 mg/kg mouse abdominal cavity scanning his tax. After after 7 and 3, mouse bone marrow cells are separated from the coefficient and greater, survival rates were measured.

As a result, when an injection of 50, 100 and 150 mg/kg [thak it will count as shown in the variation of tax also 2, 3 and 7 after after, significantly improved by reducing the number of isolated bone marrow cells, In Vivo In an animal model represents hematopoietic toxicity has been confirmed.

In the embodiment 3. Docetaxel For breeding for bone marrow toxicity induced by Heat Extract identifying restore effect bone marrow toxicity

In bone marrow cells is induced by breeding for tax [...] extract is formed by hematopoietic stem cells in order to identify whether, for breeding [thak it will count with a combination processing in alleviating effect myelodysplastic tax extract therefrom.

Specifically, greater after the separation of the bone marrow cells from mouse, mouse derived from recombinant stem cell factor, rm IL provided 3, recombinant human derived hematopoietic toxicity of bone marrow cells in a medium including maul curl [thu GF M3434 rh IL provided 6 and causing acidification of tax was 15 nm [thak it will count. Then, high pressure liquid coolant in a number 25, 50 and 100 micro g/Ml germplasm each extract for adding said in the embodiment 1, while inducing during growth of culturing hematopoietic stem 7. After 7, grown hematopoietic stem to obtain, the growth of CFU analysis of hematopoietic stem has been confirmed. Voice controls include, instead 0 extract for breeding. PBS containing 5% DMSO (vehicle) and conducting said method identical to the handled as the solvent.

As a result, as shown in the 3 and 4 may also extract for breeding by statistically significant reduction in colony from docetaxel induced hematopoietic stem has been confirmed by recover from (3 and also 4 also).

In the embodiment 4. For breeding Heat Extract Docetaxel Bone marrow derived bone marrow billion billion in animal model number number Employed for mitigating Confirmation

Extract the bone marrow hematopoietic safening effect induced in an animal model for breeding billion number in order to identify whether, mouse abdominal cavity after scanning to derive myelodysplastic billion tax [thak it will count number, extract for breeding by change therefrom.

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

As a result, as shown in the 5 also, docetaxel administration is reduced and regulated from the group consisting (Bone Marrow mononuclear cells) have significantly bone marrow cells, administration of bone marrow from the group consisting of resilient billion number is extract for breeding has been confirmed.

Said each administration group of mouse femur histological analysis of result of the docetaxel alone administration group in hematopoietic cells [...] fidelity (hypocellularity) errors due to abnormal cell structures intramedullary phenomena and (arrow tint) is found but, in administering a combination of group (also 6) characterized in that it has reduced phenomenon extract for breeding, thymic tissue (Thymus) pathological analysis results by administration of shrinkage and functional methods for breeding loss also docetaxel is recovered by the administration of a combination the inhibin (also 7).

Then, said controls, process of tax administration group, and a group of tax [thak it will count with 250 mg/kg 125 mg/kg extract for germplasm tax [thak it will count with the administration of a combination after measuring the body weight of mouse daily change extract for germplasm combined administration group, and the third 6 mouse by 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, table 1 as to disclosure, docetaxel in Thymus (thymus) reduces the weight of the spleen (spleen) and rapid processing group whereas, docetaxel and 125, 250 mg/kg in normal controls similar administration of the extract for germplasm group maintain levels of weight have substantially spleen, kind of the weight of the Thymus also docetaxel processing are also capable of confirming the degree insignificantly.

In said table 1, spleen and thymic index was determined from the formula.

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

On the other hand, mouse spleen (spleen) mRNA from the adipose tissue to obtain the hematopoietic cytokine expression changes involved in the therefrom. Process of tax (hematopoiesis) is effected by administering hematopoietic action, in particular myeloid progenitor cells (myeloid progenitor cell) involved in expression of IL provided 3 significantly reduced when the depth proliferation of cell differentiation, when tax [thak it will count with the administration of a combination extract for breeding, to restore the expression of reduced IL provided 3 (8 also) has been confirmed.