KR100876867B1 - Composition for treating or preventing osteoporosis, osteodystrophy, or fracture comprising a Batryticatus bombyx extract - Google Patents

Abstract

The present invention provides a composition for the prevention or treatment of osteoporosis, osteogenic disorders, or fractures comprising baekpja extract as an active ingredient.

Baekjap extract is useful for the prevention and / or treatment of osteoporosis or bone formation disorders by increasing the volume and thickness of trabecular bone and effectively lowering the concentrations of osteocalcin and Alkaline Phosphatase (ALP). In addition, the composition containing the baekpjaeng extract according to the present invention is useful for the prevention and / or treatment of fractures, as well as for the treatment of osteoporosis and / or osteogenic disorders, and also helps the bone growth of growing children. Furthermore, the composition of the present invention can reduce side effects to a minimum even when taken for a long time.

Sleep, Osteoporosis, Osteoporosis, Fracture

Description

Composition for treating or preventing osteoporosis, osteodystrophy, or fracture comprising a Batryticatus bombyx extract}

1 shows the change in uterine weight in each test animal group (**; p <0.01).

Fig. 2 shows changes in uterine tissue in each test animal group (magnifications of x25 and x100, respectively).

3A and 3B show the results of measuring the volume ratio (FIG. 3A) and the thickness (FIG. 3B) of the trabecular bone in each test animal group (*; p <0.05, **; p <0.01, ** *; p <0.001)

Figure 4 shows the results of measuring the 2D image of the small bone bone by Micro-CT in each test animal group.

Figure 5 shows the results of measuring the ALP content in the serum in each test animal group (*; p <0.05, **; p <0.01)

Figure 6 shows the results of measuring the osteocalcin content in the serum in each test animal group (*; p <0.05, **; p <0.01)

The present invention relates to a composition for the prevention or treatment of osteoporosis, osteogenic disorders, or fractures comprising baekpja extract as an active ingredient.

Osteoporosis is a skeletal disease that increases the risk of fractures and bone fragility due to low bone mass and destruction of the bone matrix (as defined by the World Health Organization in 1999). Clinical criteria are as follows.

1.normal: BMD≥-1 S.D. from the peak Bone Density.

2. osteopenia: -1 S.D.> BMD ≥ -2.5 S.D.

3. Osteoporosis: BMD≤ -2.5 S.D.

4. Severe osteoporosis: BMD≤ -2.5 S.D. And fracture

In addition, in 2006, the National Institutes of Health (NIH) referred to osteoporosis as "bone strength," which is because the risk of fracture does not decrease despite the increase in bone density. The emphasis is on change. Bone strength is determined by bone mineral density and bone quality, and bone quality is determined by bone microstructure, macrostructure, bone replacement rate, degree of mineralization, and the like. Therefore, osteoporosis is an increase in the risk of fracture due to weakened bone strength, and the occurrence site is defined as a skeletal disease in which the hip joint is best broken.

Osteoporosis is classified into osteoporosis due to primary osteoporosis, type 1. postmenopausal osteoporosis, type 2 senile osteoporosis, and secondary osteoporosis. Type 1 osteoporosis is caused by estrogen deficiency after menopause, resulting in increased calcium in the blood, decreased secretion of parathyroid hormone, and decreased absorption of calcium in the intestine, resulting in osteoporosis. Type 2 osteoporosis is caused by aging. Decreased response of vitamin D to 1α-hydroxylase by parathyroid hormone in the kidneys reduces the concentration of the active type 1,25 (OH) 2-Vitamin D3, which leads to lower intestinal calcium absorption. It is the main cause. Secondary osteoporosis is caused by hyperthyroidism, parathyroidism, and adrenal cortex hyperactivity. Other risk factors include lack of exercise, caffeine, alcohol, tobacco, age, Caucasian race, low weight, smoking, excessive drinking, long-term calcium intake, lack of estrogen, ovarian ablation, genetic effects and lifestyle problems.

Most of the drugs used for the treatment of osteoporosis are estrogen-based drugs, and in addition to the prevention and treatment of osteoporosis, they have been spotlighted because they improve vaginal dryness, hot flashes, sexual intercourse and urination difficulties in postmenopausal women. found (AV Place, Pouers M, PE Darley et al:.. A comparative study of double-bline estraderm premarin and in the amelioration of postmenopausal symptoms J Am Obstet Gynecol 1985; 152, 1992.). Subsequently, the need for hormone replacement therapy has emerged, resulting in bisphosphonate preparations and selective estrogen receptor modulator (SERM) preparations that inhibit bone resorption. ) Risedronate Zoledronate Ibandronate. Drugs currently approved by the US FDA include bisphosphonates Raloxifen and Risedronate Alendronate for the prevention and treatment of osteoporosis, and calcitonin and parathyroid hormone (PTH) 34), Teriparatide) and estrogen for prevention purposes. In recent years, as phytoestrogens, drugs containing Isoflanone compounds such as Daidzein, Genistein, Formononetin, and Biochanin A have been in the spotlight. have.

Osteodystrophy, also called osteotrophy, is a disease of bone caused by chronic renal failure. It is caused by congenital abnormal kidney function and dies when dialysis is not performed when the kidney is weak. This bone disease is called Renal Osteodystrophy. Bone diseases related to osteotrophy include osteomalacia and osteotease fibrosa.

Meanwhile, BATRYTICATUS BOMBYX is a medicinal herb listed in the Korean Pharmacopoeia of the Herbal Medicines Standards, and before the death of silkworm insects, Bombyx mori L., Beauveria bassiana (Bals. Vuill) It is said to dry stiff worms with leukemia due to infection. Tinnitus is called nap (천), cheonchung (天 蟲), sleepworm (蠶蟲), Baekgangjam (白 蠶), the nature of the flat (flat), the taste of Hamsin (무), non-toxic, soy sauce And on the lungs (herbology, 505-506, 1994).

Korean Patent Registration Nos. 487,112, 487,113, and Republic of Korea Patent Publication No. 10-2004-0012396 by the present inventors (4E, 6E, 2S, 3R) -2-N-Aikosanoyl -4,6-tetradecaspingenin, (4E, 6E, 2S, 3R) -2-N-docosanoyl-4,6-tetradecaspingadiine, and (4E, 2S, 3R) -2- It has been disclosed that N-octadecanoyl-4-tetradecaspingenin and the like promote brain nerve growth.

In addition, Korean Patent Registration No. 583,030 discloses a pharmaceutical composition for suppressing appetite and weight gain, including Baekjaeng extract as an active ingredient, and Korean Patent Registration No. 35,279 discloses Baekjajam extract 5α-Reductase (5α-Reductase) By inhibiting the activity of acne, hair loss, seborrheic dermatitis, dandruff or sebum-related diseases. In addition, Korean Patent Registration No. 535,875 discloses a skin whitening cosmetic composition containing baekpumja extract, etc., and Korean Patent Publication No. 10-2003-0086187 discloses an anti-aging cosmetics containing baekpumja extract, etc. The composition has been disclosed.

On the other hand, Korean Patent Registration No. 424,422 discloses a dietary supplement based on safflower seed, which is widely known for its efficacy in relation to bones such as fractures and osteoporosis, and has disclosed that it may include baekpjam to produce a tonic effect. . However, the patent only says that the addition of white slumber in safflower seed-containing dietary supplements is for the tonic effect.

Thus, no examples have been reported of using languid or cataract extracts in connection with the prevention or treatment of osteoporosis, osteogenic disorders, fractures.

The inventors of the present inventors have found that while performing a study on a nap extract, surprisingly, the nap extract has an excellent therapeutic effect on osteoporosis, bone formation disorders, and fractures.

Accordingly, an object of the present invention is to provide a composition for the prevention or treatment of osteoporosis, bone formation disorders, or fractures containing the baekpja extract.

According to one aspect of the present invention, there is provided a composition for the prevention or treatment of osteoporosis, bone formation disorders, or fractures comprising baekpja sleep extract as an active ingredient.

As used herein, the term "osteoporosis" includes all types of clinical classification according to bone mineral density (BMD) measurement, that is, osteoopenia, osteoporosis, and severe osteoporosis. In addition, primary osteoporosis includes type 1 postmenopausal osteoporosis, type 2 senile osteoporosis, and secondary osteoporosis.

In addition, the term "osteodystrophy" or "osteotrophic disease" includes Renal Osteodystrophy, and includes osteomalacia, osteotis fibrosa, and the like.

In addition, the term "fracture" refers to a condition in which continuity of bone or cartilage is completely or incompletely lost or causes linear deformation. Fractures are repeated with pathological fractures caused by anatomical location, degree of fracture, direction of fracture surface, open window, number of fractures, stability, presence of fracture fragments, osteoporosis and tumor osteomyelitis, which are special fractures. It is classified as a fatigue fracture or the like generated by the addition, the term "fracture" includes all of these.

Baekjapsae extract increases the volume and thickness of trabecular bone in accordance with bone density, and effectively lowers the levels of osteocalcin and alkaline phosphatase, which are markers of bone formation, Useful for treatment. In addition, the composition containing the baekpjaeng extract according to the present invention is useful for the prevention and / or treatment of fractures, as well as for the treatment of osteoporosis and / or osteogenic disorders, and also helps the bone growth of growing children. Furthermore, the composition of the present invention can reduce side effects to a minimum even when taken for a long time.

Baekjaeng extract used in the composition of the present invention is known manufacturing methods, for example, Korean Patent Registration No. 487,112, 487,113, 583,030, Republic of Korea Patent Publication No. 10-2004-0012396, 10-2002- It can manufacture by the method disclosed by 0035279 etc. Preferably, the extract of Napa nap is obtained by extracting Napa nap using water, C ₁ -C ₄ alcohol, or a mixed solvent of water and C ₁ -C ₄ alcohol as an extraction solvent, and more preferably. As the extraction solvent, one obtained by extracting a white nap using water or ethanol can be used.

In the preparation of Baekjap extract, the extraction temperature is different depending on the extraction solvent used, but may be a temperature in the range of about 15 ~ 150 ℃. In addition, the amount of the extraction solvent used is about 1 to about 20 times, preferably about 500 to 2000 ml for 100 g Baek nap, more preferably about 1000 ml for 100 g Baek nap, extraction time For about 1 to 6 hours, may be performed once or a plurality of times, but is not limited thereto.

Extraction process for the preparation of Baekjap extract can be carried out according to the method of cold extraction, hot extraction, superfluid extraction, centrifugal extraction, ultrasonic extraction, reflux cooling extraction, etc. . In addition, after performing the extraction process, to obtain the baekjaam extract in a liquid form in which the impurities are removed by filtration in accordance with a conventional method, or by a conventional concentration method, for example, a concentration step by the shaum concentration, etc. and / or a conventional drying method, for example For example, by performing a drying process, such as drying under reduced pressure, freeze-drying, baekpja extract can be obtained in powder form.

The composition of the present invention can be formulated into a pharmaceutical composition comprising a pharmaceutically acceptable carrier in addition to the baekpja extract, powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like according to conventional methods Oral dosage forms, external preparations, suppositories, and sterile injectable solutions.

The pharmaceutically acceptable carrier is lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline Cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, mineral oil and the like. Also included are diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, surfactants, and the like. Oral solid preparations include tablets, pills, powders, granules, capsules and the like, which solid preparations include at least one excipient such as starch, calcium carbonate, sucrose or lactose. ), Gelatin, and the like, and may include a lubricant such as magnesium stearate, talc, and the like. Oral liquid preparations include suspensions, solvents, emulsions, syrups, and the like, and may include water, diluents such as liquid paraffin, wetting agents, sweeteners, fragrances, preservatives, and the like. Parenteral preparations include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories, and non-aqueous solvents and suspending agents include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and ethyl. Injectable esters such as oleate and the like. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.

The dosage of the nap extract contained in the pharmaceutical composition depends 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. For example, the baekjapyeon extract may be administered in a dose of 1 to 600 mg / kg, preferably 10 to 100 mg / kg per day, the administration may be administered once or several times a day. In addition, the pharmaceutical composition may include 0.001 to 50% by weight of baekpjam extract based on the total weight of the composition.

In addition, the extract of Baekgangjam was found in Chongjeong-san, Ojaksungi-san, Chupung Geodamhwan Sopungsan, Baekgang-zamsan, and Non-sunsilgi-san (秘傳 順) Cheonmahwan Taegeukhwan Metal Complex Samhaesan Gagammahaenggamseoktang Pediatric Rejuvenation Dankook Chrysanthemum Tea It is also possible to formulate it in the form of a pharmaceutical composition with the prescription of Oriental medicine such as Chosan Okhochupungsan Shootpungsan Daebok Lak Jung Jeongganhwan. have.

The composition of the present invention can be formulated into a food composition for the prevention or treatment of osteoporosis, bone formation disorders, or fractures, including the baekpja extract as an active ingredient.

The food composition may be used as a health functional food, and the term "health functional food" refers to a food manufactured and processed using raw materials or ingredients having functional properties useful for the human body according to the Health Functional Food Act No. 6727. As used herein, the term "functionality" means ingestion for the purpose of obtaining useful effects on health use such as nutrient control or physiological action on the structure and function of the human body.

The food composition may include a conventional food additive, and the suitability as the "food additive", unless otherwise specified, according to the General Regulations of the Food Additives Code and General Test Methods approved by the Food and Drug Administration, etc. Judging by the standards and standards.

Examples of the items listed in the "Food Additive Revolution" include, for example, chemical compounds such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamon acid, natural additives such as color pigments, licorice extracts, crystalline cellulose, high color pigments, guar gum, Mixed preparations, such as a sodium L- glutamate preparation, an addition of an alkali, a preservative preparation, and a tar pigment preparation, are mentioned.

The food composition of the present invention may comprise 0.01 to 95%, preferably 1 to 80% by weight of the baekpyong extract relative to the total weight of the composition for the purpose of preventing and / or improving osteoporosis, bone formation disorders, or fractures. Can be. It may also be prepared and processed in the form of tablets, capsules, powders, granules, liquids, pills, and the like, for the purpose of preventing and / or improving osteoporosis, bone formation disorders, or fractures.

Hereinafter, the present invention will be described in more detail through Examples and Test Examples. However, these Examples and Test Examples are for illustrating the present invention, and the scope of the present invention is not limited to these Examples and Test Examples.

Example  One. White sleep  Preparation of Extract

Put 100g of Baekgangjam (Korea, Gyeongdong Market) into 1L of distilled water, make it 500ml by diluting at 100 ℃ for 2 hours, filter the extract with filter paper, and concentrate it under reduced pressure using an evaporator. Removed and lyophilized for about 5 days using a lyophilizer to obtain 18 g of zinnia extract and cryopreserved.

Example  2. White sleep  Preparation of Extract

After adding 1 L of ethanol to 100 g of Baekjap, ultrasonic extraction was performed for 30 minutes and filtered to obtain a primary extract. Next, 1 L of ethanol was added to the white nap, and the ultrasonic extraction was repeated twice for 30 minutes to obtain a second extract, and then the first extract and the second extract were combined to form a mixed extract. The mixed extract was concentrated under reduced pressure and lyophilized to obtain 13.5 g of a dry white nap powder extracted in a yield of 13.5%.

Test Example . Ovarian Extraction Rat  Animal test

1. Ovary extraction and White sleep  Extract dosage

Sprague Dawley rats (Orient, South Korea) weighing about 150-180 g at 6 weeks of age. The animals were reared at 23 ± 1 ° C, 55 ± 5% relative humidity, and 12 hours of light and shade. Feed was used as a pellet diet (5L79, Orient, Korea).

Rats were assigned to the Sham group (Sham; Sham-operation Group), the control group (OVX; Ovariectomized-operation Group), and the baekryam extract administration group (BC; BATRYTICATUS BOMBYX Ovariectomized-operation Group) estrogen group (E2; 17β-estradiol Ovariectomized-operation Group). Divided into four groups (n = 6 each). Except for the Sham group, ovarian ablation was performed in the control group, the languid group, and the estrogen group.

Ovarian extraction was performed as follows: 1.5% isoprorane (Choong-Wae Pharma Co., Korea), 70% N ₂ O and 30% O ₂ gas using a gas anesthesia machine (SurgiVet, USA). After general anesthesia, the hairs of both abdominal abdomen were shaved, and the position was flat and 10% was disinfected with potadidine solution (Samil Pharm: Iodine, South Korea). Incision of the skin, abs, and peritoneum about 2 cm from the lower abdomen around the midline, exposing the ovary below one side of the abdomen, ligation of the fallopian tube with sterilized tweezers, and then excision of one ovary and again using silk thread The peritoneum, abs and skin were closed. On the other side, the ovaries were extracted in the same way.

The Sham group was a virtual surgical group, and the peritoneal incision was performed in the same way, and the ovaries were unsealed and used as normal groups.

After 29 weeks of ovary extraction, the Sham and control groups received 1 ml of corn oil orally, and the E2 group dissolved 17β-estradiol (Sigma, USA) in corn oil at 0.5 mg / kg. A dose was orally administered, and the group containing the guinea pig extract was dissolved in corn oil, and then administered orally at a dose of 100 mg / kg. The oral administration was performed for 3 weeks at a total of 8 weeks.

After 36 weeks of ovarian extraction, 20% chloral hydrate (Fluka, South Korea) solution was intraperitoneally injected to anesthetize, blood was collected from the heart, left at room temperature for 30 minutes to coagulate, and then centrifuged at 3,000. Serum was separated by centrifugation at rpm for 15 minutes and used for testing.

In addition, after the rats of each group were killed, the uterus, the left femur and the tibia were removed, blood, body fluids and other tissues were removed from the filter paper, and weighed by an electronic balance. In particular, the uterus was fixed in 4% formalin (formalin) solution for 3 days to confirm histological changes, paraffin embedded and specimens were made and observed by staining with hematotoxin-eosin.

The contents of ALP (Alkaline Phosphatase) and osteocalcin (Osteocalin), which are bone markers, were measured from the serum.

2. Changes in uterine weight and tissues due to drug administration (histologic observation)

Uterus was extracted and fixed in 10% neutral formalin solution for 3 days, followed by a stepwise dehydration process ranging from 70 to 100% alcohol, followed by clear xylene and paraffin embedding. Paraffin-embedded uterine tissue was cut to 5 μm with microtomes, stained with hematoxyline & eosin (H & E), and observed under a fluorescence microscope. In each group, changes in uterine weight and tissue are shown in FIGS. 1 and 2, respectively.

As shown in Figure 1, the weight of the uterus was increased by 10 times and 4 times in the Sham group and the E2 administration group compared to the OVX group, respectively, but BC administration group was almost similar to the OVX group. Uterine atrophy occurs during ovarian extraction, indicating that ovarian extraction was successful. In addition, the effect of estrogen is to proliferate the endometrial lumen epithelium (LE) and the endometrial glands (GE). In the E2 group, the LE and GE sites are enlarged like the Sham group. There was no significant change in the endothelial cells of the BC administration group (see FIG. 2).

3. Micro - CT  By inspection Suzhou bone  Volume and Suzhou bone  Thickness measurement

The volume and thickness of trabecular bone related to the bone density of the left femur were confirmed by micro-CT examination at 16, 28, and 36 weeks. After ovarian extraction, the rats were sacrificed at 16 and 28 weeks without the use of micro-CT, and the micro-CT was extracted with the left thigh extracted at 36 weeks after ovarian extraction. Small bone volume and small bone thickness were measured.

Micro-CT system consists of micro-focus x-ray (L8121-01, Hamamatsu, Japan), rotating object holder, CMOS flat-panel x-ray detector (C7943CA-02, Hamamatsu, Japan) and data parallel processing system. It is. The x-ray and source distance are fixed at 433mm, the source and detector are fixed, and the object rotates between them to obtain projection data. The rat contained in the object holder was kept alive using 1.5% isoflurane (Choong-Wae Pharma Co., Korea), 70% N2O and 30% O ₂ gas using a gas anesthesia machine (SurgiVet, USA). Anesthetize with. It is a source of micro-focus x-ray of Micro-CT and has various focal spot sizes of 550 μm in size, and the pixel size of the flat-panel x-ray detector is 100 μm. The 23 μm pixel of this image, the martix size of the image is 512x512, and the subject holder rotates with an accuracy of 0.083 degrees. Micro-CT scans the entire field of view (FOV) on the left femoral neck and a partial FOV scan of the region of interest (ROI) to determine the correct ratios (Chun et. al 2004). The FOV region is reconstructed to determine the ratio and thickness of trabeculae. At this time, the data parallel processing system for image reconstruction was performed using a computer with dual CPUs (AthlonMP 2200+, AMD, USA) and 100 Mbps Ethernet. The fuzzy distance transform (FDT) algorithm was applied to calculate the volume fraction (BV / TV,%) and bone thickness (Tb.Th, μm) of the trabecula in the inside of the rectangle of the left femur of the 2D image. (In Kon Chun 1., et al., In vivo trabecular thickness measurement in cancellous bones: longitudinal rat imaging studies.Physiol.Meas. 27 (2006) 695-702)

As a result of measuring the volume ratio and thickness of the small femur neck of the left femur neck obtained by measuring as described above is shown in Figures 3a and 3b, the 2D image of the small bone of the neck of the left femur by Micro-CT is shown in Figure 4 same.

As can be seen in Figures 3a and 3b, when comparing the square area of the small femoral bone image of the left femur, compared with the Sham group at 28 weeks, the volume of the trabecular bone is 49.8%, BC group 43.6% E2 In the group, the decrease in bone thickness was decreased by 8.89% in the OVX group, 0.95% in the BC group, and 2.91% in the E2 group. At 28 weeks, the volume of trabecular bone (P <0.001) was significantly decreased in ovarian extraction group compared to normal group, indicating that osteoporosis was induced.

As a result of drug treatment for 29 weeks from ovarian extraction to 8 weeks after ovarian extraction, 36% of ovarian extraction, 8 weeks after drug administration, the OVX group had a 47% reduction in the area of the osseous bone compared with the Sham group. BC group 18.9% and E2 group 10%. Compared with the OVX group, the BC group increased by 55.5% (P <0.01) and the E2 group increased by 72.72% (P <0.001). In terms of bone thickness, the OVX group was 13.1% lower than the Sham group, the BC group was the same as the normal group, the E2 group was 3.9% higher, the BC group was 15.07% (P <0.05), and the E2 group was 19.56% (P). <0.01) significantly increased.

 As can be seen in the 2D image of the 36th week (see FIG. 4), the network of the OVX group of bone shochu is sticky, but the bone shochu of BC group is clearly connected to the network.

Therefore, the eight-week dole extract is increased about 56% of the small bone volume and 15% of the thickness of the small bone compared to the OVX group. Therefore, the white nap extract can be effectively used for the prevention and treatment of osteoporosis, bone formation disorders, and fractures.

4. Bone formation Marker  inspection

Osteocalcin is a non-collagen protein produced in osteoblasts and fused to the extracellular matrix of bone, where the newly generated osteocalcin is released into the blood. Since osteosynthesis is increased in osteoblasts due to increased bone resorption during ovarian resection, it is known as a bone formation index that indirectly reflects the activity of osteoblasts. In addition, ALP (Alkaline Phosphatase) is an enzyme that is produced during osteoblast formation of osteoblasts, some of which is secreted into the blood, which is also an indicator of bone formation. Increasing the deposition of local bone minerals and active formation of childhood bone formation increases, and also increases in hepatobiliary system diseases and bone diseases accompanied with bone formation. It is also reported that ALP is increased after ovarian resection.

Blood obtained by cardiac puncture of each group of animals was left for 30 minutes and centrifuged at 3,000 rpm for 15 minutes and stored at -80 ° C.

The serum osteocalcin concentration was measured using an EIA kit (Biomedical Technologies, Staughton, IN, USA), and ALP activity was measured using an ELISA kit (Asan Pharmaceutical, Seoul, Korea), and the results are shown in FIG. 5 (ALP). Content) and FIG. 6 (osteocalcin content).

5 and 6, ALP increased 69% in the OVX group, 11% in the BC group, and 3% in the E2 group compared to the Sham group. Compared with OVX group, BC group decreased by 36% and E2 group by 39%. Osteocalcin increased 39% in OVX, 3% in BC, and 1% in E2 compared to Sham. Compared with OVX group, BC group decreased 26% and E2 group decreased 28%.

Therefore, it can be seen that osteoporosis is treated in the Baekjap extract-administered group because the serum content of osteocalcin and ALP is significantly reduced compared to the OVX group.

Baekjapsae extract increases the volume and thickness of trabecular bone in accordance with bone density, and effectively lowers the levels of osteocalcin and alkaline phosphatase, which are markers of bone formation, Useful for treatment. In addition, the composition containing the baekpjaeng extract according to the present invention is useful for the prevention and / or treatment of fractures, as well as for the treatment of osteoporosis and / or osteogenic disorders, and also helps the bone growth of growing children. Furthermore, the composition of the present invention can reduce side effects to a minimum even when taken for a long time.

Claims (4)

A composition for the prevention or treatment of osteoporosis, bone dysplasia, or fracture comprising baekpjaeng extract as an active ingredient. The composition according to claim 1, wherein the baekjap extract is obtained by extracting with an extraction solvent selected from the group consisting of water, C ₁ -C ₄ alcohol, and a mixed solvent of water and C ₁ -C ₄ alcohol. The composition of claim 2, wherein the extractant is water or ethanol. delete

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