KR100830746B1 - Phamaceutical composition comprising SEPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, ACHYRANTHIS BIDENTATAE RADIX AND CIBOTIUM BAROMETZ L as main ingredients and pharmaceutical preparations containing them - Google Patents

Abstract

   The present invention is the SEAPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, Ussel (ACHYRANTHIS BIDENTATAE RADIX) and Gobi (Biopharmaceutical; Gucchi CIBOTII RHIZOMA: (Goldi ball) .))) Or one or more components selected from extracts extracted with water, lower alcohols, ethyl acetate, aromatic hydrocarbons, chlorinated hydrocarbons, and selected as a main ingredient, and include malt (HORDEI FRUCTUS GERMINIATUS), Angelica ( ANGELICAE GIGANTIS RADIX, REHMANNIAE RADIX PREPARAT, CINNAMOMI CORTEX, CARTHAMI FRUCTUS, GLYCYRRHIZAE RADIX, GLYCYRRHIZAE RADIX) Selected from SALVIAE MILTIORRHIZAE RADIX, Sansa (CRATAEGII FRUCTUS), Hyunsam (SCROPHU LARIAE RADIX), Motherwort (LEONURI HERBA), New Song (MASSAMEDICATA FERMENTATA), Soybean (SOJAE SEMEN), Red Bean (PHASEOLI SEMEN) Water, low The composition is composed of X extracted with a solvent selected from alcohol and ethyl acetate. The composition has an excellent effect on the prevention and treatment of osteoporosis, rheumatoid arthritis and disc symptoms.

   Occult bone, tofu, hyssop, agar, gupan, fern, osteoporosis, rheumatism, arthritis, disc

Description

   Pharmaceutical composition containing main ingredient, Ohjeolgol, Wooseol, Tofu, Ogapi, Gobi and Sphere, and pharmaceutical preparation containing it as a main ingredient L as main ingredients and pharmaceutical preparations containing them}

   Figure 1 shows a method for recovering the dry weight of the pharmaceutical composition according to the extraction process of the effective drug.

   Figure 2 shows the anti-inflammatory effect when inducing edema through the water extract as an effective drug.

   3A and 3B show the morphological changes of the synovial membrane cells and the RAW 264.7 cell line through the water extract as an effective drug using a polarizing microscope (X 200).

   Figure 4 is a graph showing the inhibition of COX-II production in the transcription step by stimulating LPS to Raw264.7 cell line through the water extract as an effective drug.

   Figure 5 shows the effect on the cell cycle through the effective drug water extract.

   FIG. 6 shows that the compound identified as the active ingredient of the pharmaceutical composition induces the inhibitory effect of COX-II of intramucosal synovial cells, and the cells are labeled with a secondary antibody, FITC, and then shaded with foil. After standing for some time, it was observed under a fluorescence microscope.

   Figure 7 shows the osteoporosis prevention and treatment effect from ovarian extraction rats through the water extract as an effective drug (x200, phase contrast microscope).

   Figure 8 shows the improvement of the disk is almost lost after treatment in patients with the disk eluted through the water extract as an effective drug through CT imaging.

   Figure 9 is a bar graph showing the statistical treatment for the treatment improvement effect after treatment in patients with bone disease.

Figure 10 shows the improvement of the disk is almost lost after treatment in patients with the disk eluted through MRI imaging.

   The present invention is the SEAPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, Ussel (ACHYRANTHIS BIDENTATAE RADIX) and Gobi (Retrofit: CIBOTII RHIZOMA: GUMMO BAROM (ETBOTIUM). It relates to a pharmaceutical composition containing the main component) and a pharmaceutical formulation thereof.

    At present, the cases of complaints with various bone diseases in Korea are known to increase every year. However, chemotherapy and surgery, which are used for the treatment of bone diseases, have not yet achieved perfect results. These bone diseases are progressing from chronic to degenerative due to aging and the medical burdens as well as the pain accompanying them are required to develop new materials that can be utilized in the clinical field as a whole.

   Rheumatoid arthritis and degenerative arthritis, known as adult disease and senile disease, are known to be refractory diseases, and these diseases are known to be caused by the activation of synovial cells of the joints and their aging and autoimmune factors. Rheumatoid and degenerative arthritis can be cured by developing drugs that kill or inhibit arthritis cells or inhibit or inhibit the expression of cyclooxygenase II (COX-II), an enzyme produced by these cells.

   The present inventors have conducted a long study on herbal medicines that can be used for rheumatoid arthritis, degenerative arthritis, and disc diseases of the waist and neck. As a result, SEAPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, WUSSEL (ACHYRANTHIS BIDENTATAE RADIX) and Gobi (Biopharmaceuticals; Gucchi CIBOTII RHIZOMA: GUMMO BAUCCIZ (TIMOBOOZICI). Powder or or water-extracted X, which contains one or more ingredients selected as main ingredients, including malt (HORDEI FRUCTUS GERMINIATUS), ANGELICAE GIGANTIS RADIX, REHMANNIAE RADIX PREPARAT, broiler (CINNAMOMI CORTEX), safflower (CARTHAMI FRUCTUS), Licorice (GLYCYRRHIZAE RADIX), Wolfberry (LYCII FRUCTUS), Sokji (DIPSACI RADIX), Green-horn (CERVI CORNU), Dansam (SALVIAE MILTIORRHIZAE RADIX), Sansa (CRATAEGII FRUCTEMO) Extracted with at least one supplementary drug selected from LEONURI HERBA, MASSAMEDICATA FERMENTATA, SOJAE SEMEN, PHASEOLI SEMEN or its water extracts for arthritis and inflammation in molecular biological experiments and animal experiments The present invention found a surprising fact that the inhibition was complete.

As a result of active research on bone disease worldwide, as a result of the rapid increase in the bone marrow immunity, the pathogenesis of bone disease and the pathogenesis of arthritis have been revealed. Recently, several osteoporosis treatments have been developed and allenradates. , tamoxifen (tamoxifen), vitamin D ₃ (vitamin D _3), PTH (parathyroid hormone: PTH) and of sulfasalazine (sulfasalazine) were successful as the COX-II inhibitors are already commercialized in treating rheumatoid arthritis, wherein the anti-inflammatory agent (Becker K, Gromer S, Schirmer RH, Muller S. Thioredoxin reductase as a pathophysiological factor and drug target.Eur.J. Biochem., 2000 Oct 15; 267 (20): 6118-6125), thioredoxin reductase (a pathophysiological factor and drug target.Eur J. Biochem. 2000 Oct 15; 267 (20): 6118-6125 and the like are known and are in clinical or research and development, and as the treatment for osteoporosis, alendronate and raloxifen e), calcitonin (Moraghan TJ, Perez EA. Mayo Clin Proc. 2000 Aug; 75 (8): 821-9.), estradiol (Andersson TL, Stehle B, Davidsson B, Hoglund P. Maturitas. 2000 Jun 30; 35 (3): 245-52), genistein (Mazurek AP. Polkowski K.Acta Pol Pharm. 2000 Mar-Apr; 57 (2): 135-55., 1,25-dihydroxyvitamin D (3) (Am. J. Physiol. Endocrinol. Metab. 2000 Jul; 279 (1): E213-20), parathyroid hormone (Hunziker J, Wronski TJ, Miller SC. J. Dent. Res. 2000 Jun; 79 (6): 1431-8), alendronate (Kashyap AS, Kashyap S. Postgrad Med J. 2000 Jul; 76 (897): 417-8), estrogen receptor modulators, calcitonin, and bisphosphonates (Wimal-awansa SJ. J. Clin. Densitom. 2000 Summer; 3 (2): 187-201).

   Accordingly, the present invention is 10 to 200 parts by weight of the seopgolgol (SEPIAE OS), 50 to 500 parts by weight of the high ratio (CIBOOTII RHIZOMA: Geumboguchi (CIBOTIUM BAROMETZ (L.)), 50 to 500 parts by weight of the dew (ACHYRANTHIS BIDENTATAE RADIX) , 50 to 500 parts by weight of EUCOMMIAE CORTEX, 50 to 500 parts by weight of ACANTHOPANACIS CORTEX and 50 to 500 parts by weight of TESTUDINS PLASTRUM or its extract, if necessary, malt (HORDEI FRUCTUS GERMINIATUS) 10 to 200 parts by weight, 50 to 500 parts by weight (ANGELICAE GIGANTIS RADIX), 50 to 500 parts by weight of REHMANNIAE RADIX PREPARAT, 50 to 500 parts by weight windproof (LEDEBOURIELLAE RADIX), 50 to 500 parts by weight (CINNAMOMI CORTEX) Parts, Safflower (CARTHAMI FRUCTUS) 50 to 500 parts by weight, 10 to 200 parts by weight of SCOLOPENDRA, 10 to 200 parts by weight of LEDEBOURIELLAE RADIX, 10 to 200 parts by weight of licorice (GLYCYRRHIZAE RADIX), goji (LYCII FRUCTUS) 50 to 500 parts by weight, fast (DIPSACI RADIX) 1 00 to 500 parts by weight, CERVI CORNU 100 to 500 parts by weight, 20 to 200 parts by weight of Salvia Militiorrhiza RADIX, 10 to 200 parts by weight of Sansa (CRATAEGII FRUCTUS), 10 to 200 parts by weight of Hyunsam (SCROPHULARIAE RADIX) , 100 to 500 parts by weight of motherwort (LEONURI HERBA), 50 to 500 parts by weight of MASSA MEDICATA FERMENTATA, 50 to 500 parts by weight of SOJAE SEMEN, 10 to 200 parts by weight of red beans (PHASEOLI SEMEN) The supplements or supplements extracted with water extracts provide surprising results in inhibiting arthritis and inflammation in molecular biology experiments and animal experiments.

   That is, the object of the present invention, SEOPIAE OS, Stomach (EUCOMMIAE CORTEX), Ogapi (ACANTHOPANACIS CORTEX), Gupan (TESTUDINS PLASTRUM), Umbrella (ACHYRANTHIS BIDENTATAE RADIX) and Gobi (rescue: CIBOTII RHIZOMA: CIBOTIUM BAROMETZ (L.) Powder or water extracted X as the main ingredient, if necessary, malt (HORDEI FRUCTUS GERMINIATUS), REHMANNIAE RADIX PREPARAT, CINNAMOMI CORTEX, CARTHAMI FRUCTUS, Licorice (CARTHAMI FRUCTUS) RADIX, LYCII FRUCTUS, DIPSACI RADIX, CERVI CORNU, Dansam (SALVIAE MILTIORRHIZAE RADIX), SUNSA (CRROEGII FRUCTUS), SUNJAM (SCROPHULARIAE RADIX), MOTHERHERE (BAAUREDIA) FERMENTATA), SOJAE SEMEN, PHASEOLI SEMEN selected from the group consisting of one or more supplementary herbs or water thereof, which have excellent effects in the prevention and treatment of osteoporosis, rheumatoid arthritis, disc symptoms, and pharmaceutical preparations containing the same To To provide.

   Another object of the present invention is 10 to 200 parts by weight Oseogolgol (SEPIAE OS), CIBOTII RHIZOMA: 50 to 500 parts by weight of CIBOTIUM BAROMETZ (L.), 50 to 500 parts by weight of dew (ACHYRANTHIS BIDENTATAE RADIX), 50 to 500 parts by weight of EUCOMMIAE CORTEX, 50 to 500 parts by weight of ACANTHOPANACIS CORTEX, 50 to 500 parts by weight of TESTUDINS PLASTRUM or its extract, if necessary, malt (HORDEI FRUCTUS GERMINIATUS) 10 To 200 parts by weight, 50 to 500 parts by weight of REHMANNIAE RADIX PREPARAT, 50 to 500 parts by weight of CINNAMOMI CORTEX, 50 to 500 parts by weight of CARTHAMI FRUCTUS, 10 to 200 parts by weight of licorice (GLYCYRRHIZAE RADIX), LYCII FRUCTUS 50 to 500 parts by weight, DIPSACI RADIX 100 to 500 parts by weight, CERVI CORNU 100 to 500 parts by weight, SALVIAE MILTIORRHIZAE RADIX 20 to 200 parts by weight, Sansa (CRATAEGII FRUCTUS) 10 to 200 parts by weight, Hyunsam (SCROPHULARIAE RADIX) 1 0 to 200 parts by weight, 100 to 500 parts by weight of LEONURI HERBA, 50 to 500 parts by weight of MASSA MEDICATA FERMENTATA, 50 to 500 parts by weight of SOJAE SEMEN, 10 to 200 parts by weight of PHASEOLI SEMEN A pharmaceutical composition containing X as its main ingredient, wherein the pharmaceutical composition contains X as extracted from water or at least one auxiliary drug selected from and a pharmaceutically acceptable excipient, adjuvant, diluent, tonicity agent, preservative, bow To provide a pharmaceutical formulation having an excellent effect in the prevention and treatment of osteoporosis, rheumatoid arthritis and disc symptoms, formulated in the form of a pharmaceutically acceptable pharmaceutical formulation with a suspension and a dissolution aid.

In addition, the pharmaceutical formulation of the present invention is already used as an agent (allendrate), tamoxifen (tamoxifen), vitamin B ₃ , parathyroid hormone (PTH), sulfasalazine (sulfasalazine), thioredoxin reductase (thioredoxin reductase), allendronate (alendronate), raloxifene, calcitonin (calcitonin), estradiol, estradiol, genistein, 1,25-dihydroxyvitamin D ₃ , alendronate, It may further contain one or more drugs selected from estrogen receptor modulators, biphosphonates, harpagide (the drug we have developed for use).

The herbal ingredients may be powdered, or each may be extracted alone to obtain an extract, and these extracts may be mixed, or the necessary herbal ingredients may be combined and extracted together.

Next, the present invention will be described in more detail with reference to Examples and Experimental Examples, which do not limit the scope of the present invention.

Example 1

   50g of Ojeolgol, 400g of Tofu, 500g of Ogapi, 450g of 100g of old plate, 450g of Gobi, and 500g of distilled water (or purified water) were mixed with distilled water (or purified water) in a volume of 2 to 5 times, and heated under reflux for 6 hours, followed by filtration to prepare filtrate. Concentrated to 200ml and then lyophilized to obtain a freeze-drying weight of about 300g (hereinafter CP water extract) (Fig. 1).

  Water extract obtained in the series of drying process as described above has osteoporosis, rheumatoid arthritis and anti-inflammatory activity effects as described below, respectively, water extract can be used as an active ingredient in the composition of the present invention.

Example 2

   Ogolgol 100g, Ogapi 250g, tofu 200g, hyssop 240g, old plate 140g, fern 500g, windproof 100g, malt 100g, Angelica 150g, wolfberry 120g and safflower 100g in the same manner as in Example 1 to obtain X.

Example 3

  Ojakgol 100g, Ogapi 200g, Tofu 200g, Umbrella 400g, Old plate 100g, Gobi 500g, Windproof 100g, Broiler 100g, Wolfberry 100g, Medicinal beans 100g and Safflower 100g in the same manner as in Example 1 to obtain X.                     

Example 4

   Ojeolgol 100g, Ogapi 200g, tofu 200g, hyssop 400g, old plate 100g, Gobi 500g, windproof 100g, broiler 100g, wolfberry 100g, medicinal soybeans 100g and safflower 100g is extracted with 70% ethanol and the solvent is removed to obtain an ethanol extract.

Example 5

   Ogigol 150g, Gugong 150g, Ogapi 150g, Tofu 200g, Root 300g, Gobi 400g, Windproof 50g, Angelica 50g, Malt 50g, Sookjihwang 50g, Broiler 100g, Safflower 100g, Licorice 50g, Sok 50g, Hyunsam 50g, Motherwort 50g, Red bean 50 g is extracted with water by the method of Example 1 to obtain X.

Example 6

  Ogigol 150g, Gugong 150g, Ogapi 150g, Tofu 200g, Root 300g, Gobi 400g, Windproof 50g, Angelica 50g, Malt 50g, Sookjihwang 50g, Broiler 100g, Safflower 100g, Licorice 50g, Sok 50g, Hyunsam 50g, Motherwort 50g, Red bean 50 g are powdered to obtain a powder.

Example 7

   Powder is obtained by pulverizing 50g of Ojeolgol, 400g of Tofu, 500g of Ogapi, 450g of 100g of old plate, and 500g of Gobi.

Experimental Example 1

 Edema Inhibitory Effect of Arthritis

   In order to observe the edema inhibitory effect of the pharmaceutical composition of the present invention in order to induce edema in 6 rats per experimental group in the body of 200g body weight ZYMOSAN-A (20 mg / ml / KG) 0.5ml and Freund's Adjuvant 0.5ml Was injected into the left foot ssam, and the progress of edema was observed for 70 days. Photographs were taken before and after the induction of edema, and CP extracts were prepared to 0.6mg / ml. 14 days of oral administration were used to investigate the chronic / acute suppression of edema. The observed results showed that the control group induced edema from day 4 and reached about 30 days to reach the highest peak, and took 45 days. , CP extract decreased from 7 days after edema was observed (Fig. 2).

Experimental Example 2

 Influence on Inhibition of Inflammation

In order to identify the active ingredient used as an active ingredient in the composition of the present invention, for the CP extract obtained according to the method of the present invention, cell morphological changes were identified from the raw 264.7 cell line, which is a synovial membrane cell and inflammation-related cells important for inflammation of the joint. In order to confirm the cell morphological changes by dispensing 10 ⁴ cells into 6 wells and incubating them at 37 ° C. in a 5% CO ₂ INCUBATOR, the cell morphological changes were shown to be suppressed rather than cell proliferation and induced cell death. Could be (Figures 3a, b).

Experimental Example 3

   Confirmation of COX-II Protein Expression by RT-PCR Analysis

In order to determine the effect of the CP extract obtained according to the method of the present invention on the inhibition of COX-2 expression, an indicator protein of rheumatoid arthritis, cells were washed twice with PBS as described above and then RNA RNA solution was added thereto. After separating the nucleic acid and protein in the cell and centrifuged for 15 minutes at 15,000 rpm, add supernatant and 200µl of isopropanol and mix and leave for 15 minutes in the refrigerator-20 ℃, centrifuged to separate the total RNA and RT After PCR, 1% agarose gel was found to induce expression in the control group and negative control group (lane 1, 2, 4), while CP extract and treatment group showed that the expression was suppressed (lane 3). , 5) (FIG. 4).

Experimental Example 4

In order to observe the effect on the cell cycle, macrophage cells, Raw 264.7 cell line, were mixed with 10 ³ cells in a 60 mm culture dish, cultured for one day, and washed with PBS to obtain 50 ng / ml of CP extract. Dispense into each dish and stimulate for 2 hours, remove the supernatant by adding CP extract final concentration to 25㎍ / ml, wash with PBS, treat trypsin, collect the cells, put them in 1.5ml eppendorf tube, and 2,000 rpm After removing the supernatant by centrifugation for 5 minutes at 1% by adding 100% EtOH. At this time, 5 μg / ml propidium iodide and RNAse were mixed and prepared, and the fixed cells were centrifuged to remove the supernatant and then washed once with PBS. At the same time, the dye is added to the immobilized DNA and warmed in a thermostat at 37 ℃. As a result, the stained cells were sealed in foil and stored at 4 ° C. and subjected to flow cytometry analysis. The analyzer was FACscan (Becton Dicknson, CA). As a result, the control group showed relatively high G0 / G1 level at the G0 / G1, S, and G2 / M levels, whereas the G0 / G1 level showed a quiescence in the CP extract administration group, which is consistent with inducing cell death as in Experiment 2 It can be seen that (Fig. 5).

Experimental Example 5

 Inhibition of COX-II Expression by Immunocytochemistry

In order to investigate whether the compound identified as the active ingredient of the pharmaceutical composition isolated according to the present invention induces the inhibitory effect of COX-II of intramucosal synovial membrane cells, the cells were cultured on a medium containing penicilin / streptomycin in 5% DMEM medium. 10 ⁴ cells were dispensed in a 6 well culture dish containing a round cover glass and incubated at 37 ° C for 24 hours. CP extract was added to 10 ㎍ / ml and the reaction was observed. After washing with PBS, the cells were fixed on the cells with metanol, and then washed with PBS. After washing with PBS, labeled with the primary antibody COX-II, it was left at 4 ° C. for about 1 hour and the secondary antibody phosphor (fluorescein isothiocyanate: FITC) was labeled and shaded with foil and left for about 1 hour and observed under a fluorescence microscope. COX-II was not expressed in the normal group, but the control group was strongly expressed. Doha whereas drug treated group was expressed relative to Al inhibited (FIG. 6).

Experimental Example 6

Osteoporosis Suppression in Ovarian Extracted Rats

   In order to observe the inhibitory effect on osteoporosis, the ovaries were removed from rats of 200g body weight, and the daily dose of CP extract was orally administered at 500 mg / ml. After 1cm cutting, demineralized and parrafin-embedded blocks were made and cut to 5㎛ in the microtome, and photographed after observation with a phase contrast microscope at 100 magnification by hematoxylin / eosin staining. Almost disappeared as little around the growth plate while CP extract administration group showed the same recovery or improvement effect as the normal group (Fig. 7).

Experimental Example 7

Improvement of disk through CT imaging

   In order to investigate the clinical pharmacological effect on the series of activating effects according to the present invention, the CP extract obtained according to the method of the present invention is taken through an example in which a disc flows from a disc patient, and then a CT scan is performed after treatment. As a result, as shown in FIG. 8, the disk was almost lost. Therefore, the present results and pharmacological action and confirming the substantial therapeutic effect of patients with bone disease proved that the present CP extract has a beneficial treatment and prevention effect on bone disease (Fig. 8). In order to confirm the statistical significance, the results of randomized phone surveys were randomly analyzed after the CT scan and the psychological and activity of the patient. CP extract has proved to have beneficial therapeutic and prophylactic effects on bone disease (FIG. 9).

Experimental Example 8

Statistical processing on the improvement effect of disk

   In order to investigate the clinical pharmacological effects, CP extracts were taken from patients with discs flowing out of the disc patients, followed by CT scans after treatment. At the time of recording, there was a therapeutic effect such that there was no trace of disk rupture (FIG. 10).

   As confirmed from the above experimental results, the novel composition of the present invention has excellent pharmacological effect. Therefore, the composition of the present invention can be usefully used as a pharmaceutical composition. The pharmaceutical composition of the present invention may vary depending on the sex, age, degree of disease, etc. of the patient, but if the composition of the present invention is used without extracting the composition of the present invention with water or an organic solvent, 1.0 g to 50 g per day is used. If used in the form of X, 10mg to 1000mg per day can be administered once to several times per day.

Compounds of the present invention are already used as an agent for osteoporosis, arthritis and ruptured discs, allenrate, tamoxifen, vitamin B ₃ , parathyroid hormone (PTH), sulfasalazine (sulfasalazine) ), Thioredoxin reductase, alendronate, raloxifene, calcitonin, calcitonin, estradiol, genistein, 1,25-dihydroxyvitamin D ₃ , used in combination with drugs such as alendronate, estrogen receptor modulators, biphosphonates, harpagide It may be.

   By using the compound of the present invention and the above drug, it is possible to reduce the normal dose of the existing drug, thereby reducing the problems with the existing drugs.

The compounds of the present invention may be mixed with excipients, adjuvants, analgesics, isotonic agents, preservatives, and other pharmaceutically acceptable adjuvants, which are commonly used pharmaceutically, and formulated into pharmaceutically acceptable formulations for pharmaceutical purposes. Suitable formulations may be prepared. Such pharmaceutical preparations may be formulated into injections, solutions, tablets, capsules, powders, syrups and the like.

   Next, the present invention will be described in more detail as formulation examples.

Formulation Example 1

   Water extract 500mg of Example 1

   Appropriate sterile distilled water for injection

   pH adjuster

   500 mg of Example 1 was dissolved in distilled water for injection, adjusted to pH about 7.6 with a pH adjuster, and then the total amount was 2 ml, and then filled in a 2 ml ampoule and sterilized to prepare a medicinal needle injection.

Formulation Example 2                     

   500 mg of water extract powder of Example 2

   Appropriate sterile distilled water for injection

   pH adjuster

   500 mg of Example 1 was dissolved in sterile distilled water for injection, the pH was adjusted to about 7.2 with a pH adjuster, the whole was made to 2 ml, and then filled in an ampoule of 2 ml to prepare a medicinal needle injection.

Formulation Example 3

   500 mg of water extract powder of Example 1

   Lactose 100mg

   Starch 100mg

   Magnesium stearate proper amount

   The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.

Formulation Example 4

   500 mg of water extract powder of Example 1

   Lactose 100mg

   Starch 50mg

   Magnesium stearate proper amount

   The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.

Formulation Example 5                     

   500 mg of water extract powder of Example 1

   Lactose 100mg

   2 mg magnesium stearate

   After mixing the above components, the inside is filled with a polyethylene coated coated chloride and sealed to prepare a powder.

Formulation Example 6

   X 500mg of Example 1

   Lactose 50mg

   Starch 50mg

   Talc 2mg

   Magnesium stearate appropriate amount

   The capsules are prepared by mixing the above components and filling gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 6

    X powder 500 mg of Example 1

    Lactose 100mg

    Starch 93mg

    Tackle 2mg

   Magnesium stearate proper amount

   The capsules are prepared by mixing the above ingredients and filling gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 7

   X 5g of Example 1

   20 g of sugar

   20 g of isomerized sugar

   Lemon flavor

   Add 100 ml of purified water

   The above components are mixed according to a conventional method for preparing a liquid, and filled into 100 ml of brown bottle and sterilized to prepare a liquid.

Formulation Example 8

   Example 5 x 5 g

   20 g of sugar

   20 g of isomerized sugar

   Lemon flavor

   Add 100 ml of purified water

   The above components are mixed according to a conventional method for preparing a liquid, and filled into 100 ml of brown bottle and sterilized to prepare a liquid.

Formulation Example 9

   X 500mg of Example 1

   Alenate 10mg                     

   Appropriate sterile distilled water for injection

   pH adjuster

   X 500 mg of Example 1 was dissolved in distilled water for injection, adjusted to pH about 7.6 with a pH adjuster, and then the total amount was 2 ml, and then filled into 2 ml ampoules and sterilized to prepare an injection.

Formulation Example 10

   X 500mg of Example 1

   Tamoxifen 10mg

   Appropriate sterile distilled water for injection

   pH adjuster

   X 500 mg of Example 1 was dissolved in sterile distilled water for injection, adjusted to pH 7.2 with a pH adjuster, and the whole was made to 2 ml, and then filled in a 2 ml ampoule to prepare an injection.

Formulation Example 11

   X 500mg of Example 1

   20 mg sulfasalin

   Lactose 100mg

   Starch 100mg

   Magnesium stearate proper amount

   The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.                     

Formulation Example 12

   X 500mg of Example 1

   Alendronate 50mg

   Lactose 100mg

   Starch 50mg

   Magnesium stearate proper amount

   The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.

Formulation Example 13

   X 500mg of Example 1

   Lactose 50mg

   Starch 50mg

   Talc 2mg

   Magnesium stearate appropriate amount

   The capsules are prepared by mixing the above components and filling gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 14

   X 1000mg of Example 1

   Raloxifene 10mg

   Lactose 50mg                     

   Starch 50mg

   Talc 2mg

   Magnesium stearate appropriate amount

   The capsules are prepared by mixing the above components and filling gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 14

   X 100mg of Example 1

   Pamideronic disodium 20mg

    Lactose 100mg

    Starch 93mg

    Tackle 2mg

   Magnesium stearate proper amount

   The capsules are prepared by mixing the above components and filling gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 16

   X 1000mg of Example 1

   Pamideronide Disodium 1000mg

   20 g of sugar

   20 g of isomerized sugar

   Lemon flavor                     

   Add 100 ml of purified water

The above components are mixed according to a conventional method for preparing a liquid, and filled into 100 ml of brown bottle and sterilized to prepare a liquid.

   As described in detail above, SEAPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, Ussel (ACHYRANTHIS BIDENTATAE RADIX) and Gobi (Rescue: CIBOTII RHIZOMA: Gold Mogubazuki (L.) or powder or X as a main ingredient, and if necessary, malt (HORDEI FRUCTUS GERMINIATUS), REHMANNIAE RADIX PREPARAT, CINNAMOMI CORTEX, CARTHAMI FRUCTUS, Licorice (GLYCYRRHIZAE RADIX) Gojija (LYCII FRUCTUS), DIPSACI RADIX, green tree (CERVI CORNU), Dansam (SALVIAE MILTIORRHIZAE RADIX), Sansa (CRATAEGII FRUCTUS), Hyunsam (SCROPHULARIAE RADIX) Compositions containing X extracts extracted from SOJAE SEMEN, PHASEOLI SEMEN or one or more supplemental medicines or water thereof have excellent effects in the prevention and treatment of osteoporosis, rheumatoid arthritis and disc symptoms.

Claims (7)

  SEPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, Ussel A pharmaceutical composition for the prevention and treatment of osteoporosis, rheumatoid arthritis, and disc symptoms, comprising powdered or extracted extract with water as an active ingredient.   SEPIAE OS, EUCOMMIAE CORTEX, ACANTHOPANACIS CORTEX, TESTUDINS PLASTRUM, Ussel Contains extracts extracted with powder or water as main ingredients, HORDEI FRUCTUS GERMINIATUS, REHMANNIAE RADIX PREPARAT, CINNAMOMI CORTEX, CARTHAMI FRUCTUS, Licorice (GLYCYRRHIZAE RADIUS), Gugija DIPSACI RADIX, CERVI CORNU, Salvia (SALVIAE MILTIORRHIZAE RADIX), Sansa (CRATAEGII FRUCTUS), Hyunsam (SCROPHULARIAE RADIX), Motherwort (LEONURI HERBA), Shingok (MASSA MEDICATA DENSOJA) A pharmaceutical composition for the prevention and treatment of osteoporosis, rheumatoid arthritis, and disc symptoms, comprising X extracted with one or more supplementary herbs selected from PHASEOLI SEMEN or water thereof.   10-200 parts by weight of SEPIAE OS, 50-500 parts by weight of EUCOMMIAE CORTEX, 50-500 parts by weight of ACANTHOPANACIS CORTEX, 50-500 parts by weight of TESTUDINS PLASTRUM, ACHYRANTHIS BIDENTATAE RADIX ) 50 to 500 parts by weight and high ratio (removal: CIBOTII RHIZOMA: CIBOTIUM BAROMETZ (L.)) 50 to 500 parts by weight or its extract as a main ingredient, HORDEI FRUCTUS GERMINIATUS 10 to 200 parts by weight , 50-500 parts by weight of REHMANNIAE RADIX PREPARAT, 50-500 parts by weight of CINNAMOMI CORTEX, 50-500 parts by weight of CARTHAMI FRUCTUS, 10-200 parts by weight of GLYCYRRHIZAE RADIX, Goji (LYCII FRUCTUS) ) 50 to 500 parts by weight, DIPSACI RADIX 100 to 500 parts by weight, 100 to 500 parts by weight of CERVI CORNU, Salviae (SALVIAE MILTIORRHIZAE RADIX) 20 to 200 parts by weight, Sansa (CRATAEGII FRUCTUS) 10 to 200 parts by weight 10, 200 parts by weight, motherwort (LE) ONURI HERBA) 100 to 500 parts by weight, 50 to 500 parts by weight of MASSA MEDICATA FERMENTATA, 50 to 500 parts by weight of SOJAE SEMEN, 10 to 200 parts by weight of red beans (PHASEOLI SEMEN) or Pharmaceutical composition for the prevention and treatment of osteoporosis, rheumatoid arthritis, disc symptoms containing x extracted with water.   Osteoporosis, wherein the pharmaceutical composition of claim 1 or 2 is formulated in the form of a pharmaceutically acceptable pharmaceutical formulation together with a pharmaceutically conventionally acceptable excipient, adjuvant, diluent, isotonic agent, preservative, ointment, dissolution aid, Pharmaceutical preparations with excellent effects in the prevention and treatment of rheumatoid arthritis and disc symptoms. The method according to claim 4, which is already used as an allenrate, tamoxifen, vitamin B ₃ , parathyroid hormone (PTH), sulfasalazine, alendronate, and raloxifene ), Calcitonin, estradiol, genistein, 1,25-dihydroxyvitamin D ₃ , alendronate, biphosphonates, harpagide It further contains one or more drugs selected from and in the form of a pharmaceutically conventionally acceptable pharmaceutical preparation together with pharmaceutically conventionally acceptable excipients, adjuvants, diluents, isotonic agents, preservatives, suspending agents and solubilizing agents. Pharmaceutical formulations with excellent effects in the prevention and treatment of formulated osteoporosis, rheumatoid arthritis and disc symptoms.  Osteoporosis and rheumatoid arthritis, wherein the pharmaceutical composition of claim 3 is formulated in a pharmaceutically acceptable pharmaceutical formulation together with a pharmaceutically conventionally acceptable excipient, adjuvant, diluent, isotonic agent, preservative, ointment agent, and dissolution aid. And pharmaceutical preparations having an excellent effect on the prevention and treatment of disc symptoms. According to claim 6, Alendrate (tamoxifen), Vitamin B ₃ , Parathyroid hormone (PTH), Sulfasalazine, Alendronate, Raloxifene already used as a drug ), Calcitonin, estradiol, genistein, 1,25-dihydroxyvitamin D ₃ , alendronate, biphosphonates, harpagide It further contains one or more drugs selected from and in the form of a pharmaceutically conventionally acceptable pharmaceutical preparation together with pharmaceutically conventionally acceptable excipients, adjuvants, diluents, isotonic agents, preservatives, suspending agents and solubilizing agents. Pharmaceutical formulations with excellent effects in the prevention and treatment of formulated osteoporosis, rheumatoid arthritis and disc symptoms.

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