KR20130090935A - A composition comprising the extract of rosa rugosa for preventing and treating benign prostatic hyperplasia - Google Patents

Abstract

PURPOSE: A composition containing a Rosa rugosa extract for preventing and treating benign prostatic hyperplasia is provided to suppress type 2 5-alpha reductase in a benign prostate hyperplasia-induced rat and prostate cells, to have an excellent anti-inflammatory effect, and to be used as a material of pharmaceutical products and health foods. CONSTITUTION: A pharmaceutical composition for preventing and treating benign prostatic hyperplasia contains 0.001-50 wt% of a Rosa rugosa extract as an active ingredient. The extract is prepared from Rosa rugosa stems, flowers, roots, or plants using water, spirit, C1-C4 alcohols, or a mixture thereof. [Reference numerals] (AA,BB) Rosa rugosa(water); (CC,DD) Rosa rugosa(20% spirit); (EE,FF) Rosa rugosa (80% spirit)

Description

A composition comprising the extract of Rosa rugosa for preventing and treating benign prostatic hyperplasia}

The present invention relates to a composition for the prevention and treatment of hyperplasia of the prostate, which contains a glycolytic stem extract as an active ingredient.

[Reference 1] Assinder, SJ, Prostate. 68: 115-121 (2008)

Document 2 Tubaro A. et al. Drug Aging 20 (3): 185-195, 2003

Zhu YS et al. Steroid enzyme and Cancer 1155: 43-56, 2009

[Reference 4] One Information Interview, Dohae Hyangbo Ambassador, Younglimsa, p649-650, 1998

5 Ramos et al. Journal of Enthnopharmacology, 2003, 87, 241-246

Reference 6 Kikuzaki et al. phytochemistry, 1999, 52, 1307-1312

Document 7 Harborne J.B. Phytochemical methods: A guide to modern techniques of plant analysis, 3rd Ed., Pp 6-7, 1998

[Reference 8] Commentary on Korean Pharmacopoeia, Moon Sung-sa, Korea Pharmaceutical University Council, 5th Revision, p33-48, 1989

[9] Lee et al. J Ethnopharmacol. 118 (3): 412-7

10. Tatemichi S, J Urol. 2006 Sep; 176 (3): 1232-41

Document 11 Assinder SJ, Prostate. 2008, 68 (2): 115-21; Asada Y et al. Clin Endocrinol Metab. 2001, 86 (6): 2875-80

12. Konig et al. Prostate. 2004, 58 (2): 121-9

13 K Choi et al. Cancer Res. 2009 69 (2): 583-92

The present invention relates to a composition for the prevention and treatment of enlarged prostate, which contains a glycolytic extract as an active ingredient.

The present invention relates to a composition for the prevention and treatment of prostatic hypertrophy containing the extract of glycolysis, more specifically, the glycolytic 80% alcohol extract inhibits type 2 5-alpha reductase in prostate hypertrophy-induced white paper and prostate cells. The present invention relates to a new use of glycolytic stem extract, which can be usefully used as a material for medicines and health foods by showing excellent anti-inflammatory effect in inflammatory cells.

Prostatic hyperplasia is a male disease that occurs rapidly after 50 years of age in Korea, and the rate of increase of prostate hyperplasia in Korea has recently increased rapidly, exceeding 20% a year. This disease is caused by excessive proliferation of smooth and epithelial cells in the prostate transition zone and various urination disorders due to bladder obstruction. One mechanism of enlarged prostate is known to be related to the male hormone testosterone (T) and dihydrotestosterone (DHT).

T, a member of the male hormone, is converted to active DHT by 5-alpha reductase (5αRD) in the prostate, which is complexed with the androgen receptor (AR) and into the nucleus. The transfer proceeds. In this process, 5αRD, an enzyme involved in the conversion of active male hormone, exists in two types, type 5 and type 2. 5αRD type 1 is present in the liver and skin, although the distribution and activity of the prostate is not large, but 5αRD type 2 is mainly used. Prominent activity and distribution in the prostate gland. These enzymes are also distributed in the normal prostate gland, but in the case of enlarged prostate, it is overexpressed in the enlarged area. Therefore, the development of 5αRD inhibitors that inhibit 5αRD activity plays a major role in prostate drug treatment. Finasteride, which is developed as a prostate drug, inhibits 5αRD type2, inhibiting 70% in serum and 90% in prostate. May also serve to lower the affinity of type 1 (Assinder, SJ, Prostate. 68: 115-121 (2008); Tubaro A. et al. Drug Aging 20 (3): 185-195, 2003; Zhu YS et al. Steroid enzyme and Cancer 1155: 43-56, 2009).

Rosa rugosa used in the present invention belongs to the family Rosaceae and is distributed all over Korea inhabiting sandy beaches, and its components include citronellol, geraniol, and nerol. It is known to contain 2-5% essential oils and various phenolic compounds, such as eugenol, phenyl ethyl alcohol, etc. (Information Interviewer, Ilha Herbal Metabolism, Yeonglimsa, p649-650 , 1998).

To date, glycolytic extracts have been demonstrated antimicrobial and antioxidant effects (Ramos et al. Journal of Enthnopharmacology, 2003, 87, 241-246; Kikuzaki et al. Phytochemistry, 1999, 52, 1307-1312), 5RD inhibition No prostatic hypertrophy material used has been reported.

However, none of this document discloses or teaches the medical effects of glycolysis extracts on prostatic hyperplasia.

Glycogenated stem extract of the present invention is a type of 5-alpha-reductase 1 and 2 extracted from 12-week-old SD rat livers with high cytotoxicity and prostate hypertrophy in human prostate cancer cell lines. The present invention was confirmed by confirming the inhibitory effect of 5RD activity and PSA mRNA expression inhibition and COX-2, iNOS, IL-6, IL-1beta and other inhibitory effects in 5RD type 2 overexpressed prostate cell lines. Completed.

In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of enlarged prostate gland containing the corresponding extract as an active ingredient.

The glycolysis as defined herein includes stems, flowers, roots, outposts, etc., preferably stem regions.

The extract as defined herein includes extracts that are soluble in water, spirits, lower alcohols having 1 to 4 carbon atoms or mixed solvents thereof, preferably in water and alcohol mixed solvents.

Hereinafter, the present invention will be described in detail.

Water, spirits, etc., of about 1 to 100 times the weight of the sample, preferably about 2 to 20 times the weight of the sample after freeze-drying and crushing the stem material of the present invention, stems, flowers, roots, outposts, etc. Polar solvents selected from lower alcohols having 1 to 4 carbon atoms or mixed solvents thereof, preferably water and alcohol mixed solvents, more preferably 20 to 120 ° C., preferably in water and alcohol mixed solvents in a ratio of 1 to 1-10. Using an extraction method such as hot water extraction, cold extraction, reflux cooling extraction or ultrasonic extraction at 30 to 80 ℃ for about 1 to 72 hours, preferably 2 to 12 hours, preferably extracted by hot water extraction Filtration and concentration can yield the corresponding extracts of the present invention.

In addition, conventional fractionation processes can also be carried out (Harborne JB Phytochemical methods: A guide to modern techniques of plant analysis, 3rd Ed., Pp 6-7, 1998).

The corresponding stem extract of the present invention obtained by the above method is a 5-alpha (reductase) extracted from a 12-week-old SD rat liver with high cytotoxicity and prostate hypertrophy in human prostate cancer cell line. Inhibition of Type 1 and Type 2 Inhibition of 5RD activity and PSA mRNA expression in 5RD type 2 overexpressing prostate cell lines and reduction of inflammatory signals such as COX-2, iNOS, IL-6, IL-1beta As a result, it was confirmed that it is effective for the treatment and prevention of enlarged prostate.

In addition, the glycolysis extract is a drug that has been used for a long time or edible herbal extracts of the present invention extracted therefrom also have no problems such as toxicity and side effects.

The pharmaceutical composition for preventing and treating prostatic hyperplasia containing the extract of the present invention comprises the extract in an amount of 0.1 to 50% by weight based on the total weight of the composition.

The pharmaceutical compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions.

Pharmaceutical dosage forms of the extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, or may be used alone or in combination with other pharmaceutically active compounds, as well as in any suitable collection.

The pharmaceutical composition containing the extract according to the present invention can be administered orally in the form of powders, granules, tablets, capsules, oral preparations such as suspensions, emulsions, syrups and aerosols, external preparations, suppositories and sterilized injection solutions And can be used as formulations. Examples of carriers, excipients and diluents that can be included in the composition containing the extract include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate , Cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrant, or a surfactant is usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and the solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose in the extract. Or lactose, gelatin, etc. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Witepsol, macrogol, Tween 61, cacao paper, laurin, glycerogelatin and the like may be used as a base for suppositories.

Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 0.0001 to 100 mg / kg, preferably 0.001 to 100 mg / kg per day. The administration may be carried out once a day or divided into several times. The dose is not intended to limit the scope of the invention in any way.

The extract of the present invention can be administered to mammals such as rats, mice, livestock, humans and the like in various routes. All modes of administration may be expected, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intra-uterine or intracerebroventricular injection.

The definitions of the excipients, binders, disintegrants, lubricants, copulation agents, flavoring agents, etc. of the present invention are those described in the literature known in the art and include those having the same or similar functions. , Korean College of Pharmacy, 5th Edition, p33-48, 1989).

In addition, the present invention provides a health functional food for preventing and improving prostate hyperplasia containing the corresponding extract as an active ingredient.

&Quot; Health functional food "as defined herein means food prepared and processed using raw materials or ingredients having functionality useful to the human body in accordance with Law No. 6727 on Health Functional Foods." Functional " Structure and function of the nutrient to control or physiological effects, such as to obtain a beneficial effect for health is intended to eat.

The dietary supplement for preventing the enlargement of the prostate gland of the present invention comprises the extract in an amount of 0.01 to 95%, preferably 1 to 80% by weight, based on the total weight of the composition.

In addition, it is possible to manufacture and process as a dietary supplement in the form of tablets, capsules, powders, granules, liquids, pills for the purpose of preventing prostate hyperplasia.

The present invention provides a dietary supplement containing the glycolysis extract as an active ingredient exhibiting an improvement and prevention effect of enlarged prostate. Examples of foods to which the extract can be added include various foods, beverages, gums, tea, vitamin complexes, and health functional foods.

It may also be added to foods or beverages for the purpose of preventing and improving prostatic hyperplasia. At this time, the amount of the extract in the food or beverage may be added to 0.01 to 15% by weight of the total food weight, the health beverage composition may be added in a ratio of 0.02 to 5g, preferably 0.3 to 1g based on 100ml.

The health functional beverage composition of the present invention has no particular limitation on the other ingredients other than the above-mentioned extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. Natural flavors (tau martin, stevia extracts (e.g., rebaudioside A, glycyrrhizin, etc.) and synthetic flavors (saccharin, aspartame, etc.) can be advantageously used as flavors other than those described above The ratio of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention.

In addition to the above, the extract of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the samples of the present invention may contain flesh for the production of natural fruit juices and fruit juice beverages and vegetable beverages. These components may be used independently or in combination. The proportion of such additives is not so critical but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the sample of the present invention.

As described above, 5-alpha-reductase 1 extracted from the stem cell extract of the present invention, 12-week-old SD rats, which have high cytotoxicity and prostate hypertrophy in human prostate cancer cell lines. Inhibitory activity against type 2 and type 2 Inhibition of 5RD activity and PSA mRNA expression in 5RD type 2 overexpressed prostate cell lines, and reduction of inflammatory signals such as COX-2, iNOS, IL-6, IL-1beta It can be usefully used as a pharmaceutical composition and health functional food for the treatment and prevention of enlarged prostate.

1 is a diagram showing the coverage of prostate cell lines of the corresponding stem water, 20% alcohol, 80% alcohol extract, (A) is a view showing the results in LNCaP, (B) PC3 cells,
Figure 2 is a graph showing the inhibitory effect of 5-alpha-reductase of glycolysis stem water, 20% alcohol, 80% alcohol extract in the liver of prostatic hypertrophy-induced white paper,
Figure 3 is a graph showing the inhibitory effect of glycolytic stem water, 20% alcohol, 80% alcohol extract for 5-alpha-reductase type2 in prostate cell lines,
Figure 4 is a diagram showing the effect of PSA mRNA expression of glycolysis 80% alcohol extract in prostate cell line,
5 is a view showing the inhibitory effect of glycolysis 80% alcohol extract.

Hereinafter, the present invention will be described in detail by the following Examples, Reference Examples and Experimental Examples.

However, the following Examples, Reference Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following Examples, Reference Examples and Experimental Examples.

Example 1.Preparation of Ginkgo Stem Extract

Preparation of the extract for confirming the inhibitory activity of 5RD type 1 and 2 of the glycolysis stem extract was carried out in the following manner.

1-1. Preparation of glycolytic 80% alcohol extract RR80S )

30kg of the stems of Danghwahwa (Gyeongil Pharmaceutical Co., Ltd.) were dried, and 60L of purified water and 240L of purified water were added to an extract / concentrator (1ton, Myeongil ENG), and extracted at 75 ° C. for 4 hours, and filtered using a filter network. After concentrating to 25 Brix at 45 ° C. and 750 mmHg using a concentrator (1ton, Myung Il E & C), 100 L of purified water was added and concentrated twice to 25 Brix to give 1,710 g of the corresponding 80% alcohol extract. Experimental Example It was used as a sample (hereinafter referred to as RR80S).

1-2. Preparation of glycolytic 20% alcohol extract RR20S )

30 kg of stems of Danghwahwa (Gyeongil Pharmaceutical Co., Ltd.) were dried and 240 L of purified water and 60 L of purified water were added to an extractor / concentrator (1ton, Myung Il ENG Co., Ltd.), and extracted at 95 ° C. for 4 hours, and filtered using a filter network. After concentrating to 25 Brix at 45 ° C. and 750 mmHg using a concentrator (1ton, Myung Il E & C), 100L of purified water was added and concentrated twice to 25 Brix to obtain 1,810 g of the corresponding 20% alcohol extract. Experimental Example It was used as a sample (hereinafter referred to as RR20S).

1-3. Preparation of glycolysis extract RRW )

30 kg of stems of Danghwahwa (Jangheung, Gyeongil Pharmacy, Jeollanam-do) were dried, and 300L of purified water was added to an extraction / concentrator (1ton, Myeongil ENG), extracted at 100 ° C. for 4 hours, and filtered using a filtering network. After concentrating to 25 Brix at 45 ° C. and 750 mmHg using a concentrator (1ton, Myeongil E & C), 100L of purified water was added thereto and concentrated twice to 25 Brix to obtain 2,060 g of the corresponding water extract. A sample was used (hereinafter referred to as RRW).

Experimental Example 1: Cytotoxicity Test of Glycerium Stem Extract

In order to confirm the cytotoxicity of the sample samples in human prostate cancer cell lines, the experiments were performed by applying the method disclosed in the literature (Lee et al. J Ethnopharmacol. 118 (3): 412-7).

Two human prostate cancer cell lines (LNCaP, PC3; ATCC, USA) were used to examine the cytotoxicity range. Two prostate cell lines, LNCaP and PC3, were seeded in 96 well-plates with cells / well and incubated at 37 ° C for 18 hours. After 24 hours of treatment at 50, 100 ㎍ / mL, MTT (3- (4, 5-dimethylthiazol-2-yl) -2, 5-diphenyltetrazolium bromide: 1mg / mL, Sigma aldrich, USA) After reacting at 37 ° C. for 2 hours, the formed forazane was confirmed by measuring absorbance at 570 nm and reference 630 nm.

As a result of the experiment, as shown in Figure 1, the glycolytic alcohol 80% extract was confirmed to show a high cytotoxicity cell viability up to 25 ㎍ / mL.

Experimental Example  2: 5-alpha- using liver of white paper Reductase ( RD ) Type 1 and Type 2 Low performance  Experiment

In order to confirm the inhibitory activity of 5-alpha-reductase type 1 and type 2 using white livers of the sample samples, experiments were performed as follows by applying the method disclosed in the literature (Tatemichi S, J Urol. 2006 Sep; 176 (3): 1236-41).

To confirm the inhibition of 5RD type1 and 2, livers of 12-week-old male SD rats (Samtaco, South Korea) were used. Three weeks of 7-week-old SD rats (Samtako, South Korea) were used to induce prostate hypertrophy, followed by estrogen (E8875, Sigma aldrich, USA) and testosterone propionate (F0675, Tokyo Chemical Industry, Japan) for 4 weeks, respectively. Organs were extracted by subcutaneous injection once a week at a concentration of / μl and 62.5 mg / μl to cause prostate enlargement and sacrifice. The extracted organs were homogenized with 10-fold phosphate buffer (phosphate buffer, pH 7.4) and centrifuged at 3,000 rpm to use as enzyme source. Three kinds of glycolysis extract was applied to the concentration of 25μg / mL from the results of Experimental Example 1 and ELISA assay (Bio Vendor, Bruno, Czzecho) was used to measure the inhibitory ability of 5RD. In this ELISA assay, T-to-DHT conversion was measured. A positive control was used at a concentration of 50 nM of Finesteride (T0028, TCI, Tokyo, Japan), an inhibitor of 5RD type 2, which is currently used.

As a result of the experiment, the inhibitory effect was confirmed in the corresponding compounds and 80% alcohol extract than the positive control. (See FIG. 2).

Experimental Example  3: 5 RD type2  5 of Glycerin Stem Extract in Overexpressed Prostate Cell Lines RD  activation Inhibition  Experiment

In order to confirm the inhibitory activity of the 5RD type2 overexpressing prostate cell lines of the Example samples against inhibitory activity of 5RD activity, the experiments were performed as described below (Assinder SJ, Prostate. 2008, 68 (2)): 115-21; Asada Y et al. Clin Endocrinol Metab. 2001, 86 (6): 2875-80).

In order to examine the inhibitory activity of 5RD type 2, which is known to be mainly related to prostatic hypertrophy, a cell line overexpressed SRD5A2 was used in the LNCaP cell line (CRL-1740, ATCC, USA), and the cell line produced was 10% (w / v). ) Was cultured in RPMI1640 medium (LM011-01, WelGENE, USA) containing fetal bovine serum. Charcoal stripped Fetal Calf Serum (F6765, Sigma, USA) was inoculated with 6 X 10 ⁵ cells / well in 6-well plates to examine the activity of 5RD type 2 in the prepared cell lines. ) Was treated with RPMI medium for 48 hours. During the period of charcoal-strip, each glycolysis extract was treated at a concentration of 25 μg / mL, and then the activity was measured using the same ELASA assay carried out in Experiment 2 by rolling the medium.

The results of the experiment are shown in Figure 3, 80% alcohol extract was found to have the highest inhibition.

Experimental Example  4: 5 RD type2  Of 80% Glycolytic Stem Extracts in Overexpressed Prostate Cell Lines PSA  Impact on change experiment

In order to confirm the effect on the PSA changes in 5RD type2 overexpressing prostate cell lines of the above sample samples, experiments were performed as follows (Lee et al. J Ethnopharmacol. 2008, 118 (3): 412-7).

In the above experimental examples, changes in prostate specific antigen (PSA), a target of prostate cancer, were examined in prostate cell lines prepared with 80% alcohol extracts that showed excellent inhibition in 5RD type1 and 2. PSA is a proteolytic enzyme synthesized from epithelial cells of the prostate gland. It is a useful tumor marker used for the selection of prostate cancer. It is a factor that must be reviewed when screening prostatic hypertrophy materials using 5RD inhibition to ensure that there is no error in the diagnosis of prostate cancer. Lee et al. J Ethnopharmacol. 2008, 118 (3): 412-7).

Prostate cancer cells were cultured in 6 well plates in RPMI 1640 medium containing 10% (w / v) fetal bovine serum for 3 days, and LNCaP cell lines were replaced with RPMI 1640 medium containing 10% CS-FCS for 3 days, followed by 50 nM concentration. Synthetic androgen R1881 (R0908, Sigma, USA) was treated. After 6 hours, the total concentration of RNA was extracted by treating 80% alcohol extract with the corresponding stem at 25 μg / mL and 16 hours later, RT-PCR was performed under the conditions shown in Table 1 below. The target gene primers involved are:

PSA Forward primer 5'-GCCCACCCAGGAGCCAGCACT-3 ' SEQ ID NO: 1 Reverse primer 5'-GGCCCCCAGAATCACCCGAGCAG-3 ' SEQ ID NO: 2 GAPDH Forward primer 5'-CGCGGGGCTCTCCAGAACATCATCC-3 ' SEQ ID NO: 3 Reverse primer 5'-CTCCGACGCCTGCTTCACCACCTTCTT-3 ' SEQ ID NO: 4

In this example, the glycolytic 80% alcohol extract inhibited the mRNA expression of PSA at a concentration of 25 μg / mL (FIG. 4).

Experimental Example  5: Anti-inflammatory activity test of glycolytic stem extract

In order to confirm the effect on the anti-inflammatory factors of the sample samples, the experiment was performed by applying the method disclosed in the literature (Konig et al. Prostate. 2004, 58 (2): 121-9).

Since prostatic hypertrophy is often accompanied by prostatitis, it was confirmed by measuring the inflammatory activity of the glycolytic stem extract (Choi KC et al. Cancer Res. 2009 69 (2): 583-92).

Inflammatory cells were examined using Raw264.7 (TIB-71, ATCC, USA). Inflammatory cells were cultured in 6-well plates to 70% confluence and the corresponding extracts were treated at a concentration of 25 μg / mL each. After 18 hours, LPS (L2654, Sigma, USA, 0.1 μg / mL) was treated for 2 hours to induce inflammation and harvested cells by harvesting RNA and RT-PCR under the conditions shown in Table 2 below. Was implemented. Relevant target gene primers such as COX-2, iNOS, IL-6, IL-1beta are as follows:

COX-2 Forward primer 5'-GAGTAAGAGGCACTTGCATT -3 ' SEQ ID NO: 5 Reverse primer 5'-TGGAGGCGAAGTGGGTTTTA -3 ' SEQ ID NO: 6 iNOS Forward primer 5'-TCTTGGAGCGAGTTGTCCAT -3 ' SEQ ID NO: 7 Reverse primer 5'-GGGTCGTAATGTCCAGGAAGT -3 ' SEQ ID NO: 8 IL-6 Forward primer 5'-TCCATCCAGTTGCCTTCTTG -3 ' SEQ ID NO: 9 Reverse primer 5'-CCACGATTTCCCAGAGAACA -3 ' SEQ ID NO: 10 IL-1beta Forward primer 5'-GTTGACGGACCCCAAAAGAT -3 ' SEQ ID NO: 11 Reverse primer 5'-AAGGTCCACGGGAAAGACAC -3 ' SEQ ID NO: 12 GAPDH Forward primer 5'-GTGTTCCTACCCCCAATGTGT- 3 ' SEQ ID NO: 13 Reverse primer 5'-AGGAGACAACCTGGTCCTCAGT -3 ' SEQ ID NO: 14

RT-PCR was performed with the above primers, and the LPS-induced inflammatory signal was reduced to the same level as the untreated group except for IL-1bet with 80% of glycolytic alcohol (FIG. 5).

Experimental Example  6. Acute Toxicity Experiment

Specific pathogen-free (SPF) SD rats at 6 weeks of age were used for acute toxicity tests. Two animals of each group were orally administered to the corresponding extract of the present invention at a dose of 100 mg / kg. After administration of the test substance, mortality, clinical symptoms, and changes in body weight were observed. Hematological and hematological examinations were performed. Necropsy was performed to visually observe abnormalities in organs and thoracic organs.

As a result of this experiment, there were no clinical symptoms or dead animals in all animals treated with the test substance, and no toxicity change was observed in weight change, blood test, blood biochemical test and autopsy findings. As a result, the extract of the present invention did not show a change in toxicity even in rats up to 100 mg / kg, respectively, and the minimum lethal dose (LD ₅₀ ) was determined to be a safe substance of 100 mg / kg or more.

Hereinafter, an example of the preparation of a pharmaceutical composition including the extract of the present invention will be described, but the present invention is not intended to limit the present invention, but is intended to be described in detail.

Formulation example  One. Sanje  Produce

RR80S Extract 20 mg

Lactose 100 mg

Talc 10 mg

The above components are mixed and filled in airtight bags to prepare powders.

Formulation example  2. Preparation of tablets

RR20S Extract 10 mg

Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components, tablets are prepared by tableting according to the usual preparation method of tablets.

Formulation example  3. Preparation of capsules

RRW Extract 10 mg

Crystalline cellulose 3 mg

Lactose 14.8 mg

Magnesium stearate 0.2 mg

The above components are mixed according to a conventional capsule preparation method and filled in gelatin capsules to prepare capsules.

Formulation example  4. Preparation of injections

RR80S Extract 10 mg

180 mg mannitol

Sterile sterilized water for injection 2974 mg

Na ₂ HPO ₄ 12H ₂ O 26 mg

(2 ml) per ampoule in accordance with the usual injection method.

Formulation example  5. Liquid  Produce

RR20S Extract 20 mg

10 g of isomerized sugar

5 g of mannitol

Purified water

According to the conventional method for preparing a liquid, each component is added and dissolved in purified water, lemon flavor is added, the above components are mixed, purified water is added, the whole is adjusted to 100 ml by adding purified water, and then filled in a brown bottle. The solution is prepared by sterilization.

Claims (8)

A pharmaceutical composition for the prevention and treatment of enlarged prostate, containing a glycolysis extract as an active ingredient. The pharmaceutical composition of claim 1, wherein the glycolysis is stem, flower, root or outpost. The pharmaceutical composition according to claim 1, wherein the extract is an extract available in a polar solvent selected from water, alcohol, lower alcohols having 1 to 4 carbon atoms, or a mixed solvent thereof. The pharmaceutical composition according to claim 1, wherein the extract is included in an amount of 0.001 to 50% by weight based on the total weight of the composition. Health functional foods for the prevention and improvement of prostatic hyperplasia containing a glycolysis extract as an active ingredient. 6. The dietary supplement of claim 5, wherein the dietary supplement is in the form of a tablet, capsule, powder, granule, liquid, or pill. Health supplement containing as an active ingredient a glycolytic extract showing the effect of preventing and improving prostate hyperplasia. 8. The method of claim 7,
The food is a dietary supplement, which is a food, drink, gum, tea, vitamin complex, or health functional food.

Images