KR100456981B1 - Composition for preventing or treating osteoporosis comprising plant extracts and method of preparing the same - Google Patents

Abstract

The present invention is to prevent osteoporosis by a mixed extract of Anemarrhena Rhizoma (Liliaceae) and Leonurus sibiricus L. (益母草), etc. A therapeutic composition exhibiting a therapeutic effect and a method for producing the same. The present invention improves the bone formation of osteoporosis patients and has an effect on the pain caused by osteoporosis to alleviate the pain. The present invention exhibits anti-inflammatory and analgesic effects with fewer side effects as herbal extracts, and thus can be administered and administered long-term. It also has specificity to peripheral tissues without causing dependence and resistance.

Description

COMPOSITION FOR PREVENTING OR TREATING OSTEOPOROSIS COMPRISING PLANT EXTRACTS AND METHOD OF PREPARING THE SAME}

The invention narigwa (Liliaceae) of Arne Mare dressage or Li (Anemarrhena Rhizoma;知母) and Leo Lee kusu press Russ fertilization (Leonurus sibiricus L .;益母草), such as mixed extract and vitamin D ₃ of the Lamiaceae (vitamine D ₃ The present invention relates to a drug for the prevention and treatment of osteoporosis by reinforcement.

Anemarena lizoma used in the present invention is a perennial plant that is native to China and cultivated in the central region of Korea, the Korean name is Jimo. His representative is Anemarthena asphodelorides BUNGE, whose roots are anti-inflammatory, antipyretic and branch office in the Pharmacopoeia (KP, JP). It is used for diuresis, low back pain and pruning. In the present invention, the root diameter of hair is dried and used. This medicinal plant contains not only 6% of asphonin, but also steroid saponogens, flavonoids, tannins, and the like such as salsasaponin and malogenogen (Markogenin; 2-hydroxy sarsasapogenin). Geumbo was used for osteopathy fever in synonymous gabo and herbaceous trees, and when interpreting the term osteopathy fever, osteoporosis was developed in the middle of the bone, resulting in chronic pain. It means to appeal.

Another medicinal plant of the present invention, Leonulus sibiricus plant of the family Lamiaceae is a biennial herb up to about 1 m in height, the first year sprouted heart-shaped root leaves and the stem grows in the following year, Gils, fields, Grows in meadows and foothills. It is called motherwort because it is a herb that is good for women's health. The main ingredients are alkaloids Leonurin, Leonurinine, Leonurindine, Starhydrin, and bitter substances include phytosterin, essential oils, saponins, 0.5% oil, odorous substances, resins, rutin and organic acids. . It also contains coumarins and flavonoid glycosides (routines).

Outpost water and alcohol extracts have a calming effect on the central nervous system, slowing the heart rate, contracting the heart, and lowering blood pressure. Leonurin is one of the ingredients that makes the cardiac contraction strong and excites and suppresses the end of the vagus nerve. Therefore, lower blood pressure and diuretic action, that is, there is a cardiac diuretic action. The starhydrin ingredient is also an alkaloid that increases the contractility and tension of the animal's uterus. It is used for postpartum bleeding and excessive menstruation due to uterine contraction and hemostatic action. Good postpartum medication. Motherwort has been traditionally used for gynecological diseases and shows physiological control. Other examples include eczema and itching.

The following describes osteoporosis.

Bone is a calcified connective tissue associated with muscles. The surface is a thick, hard calcified tissue that acts as a strut to balance the body and protects the organs. The inside of the bone is bone marrow tissue that is the center of calcium metabolism. Bone is composed of organic substances such as collagen, osteocalcin, and osteonectin, and inorganic substances such as calcium, phosphorus, and fluorine, and water. In vivo, bone formation and bone resorption are always occurring. Bone formation is promoted by a small amount of parathyroid hormone, androgen, estrogen, fluorine, phosphorus, and the like, and bone resorption is promoted by physical decompression, weightlessness, large amounts of parathyroid hormone, and corticosteroids. Therefore, the balance between them is important for bone metabolism.

Osteoporosis is the most common metabolic bone disease in which bone formation is reduced due to decreased bone formation and increased bone resorption, resulting in a decrease in bone matrix.

Due to the reduction of bone matrix, bone strength is weakened, so fracture is easily generated, and thus there are many clinical difficulties. In particular, even a light impact may cause compression fracture of the spine and fracture of the femoral neck and electronic part.

The causes of osteoporosis are divided into primary and secondary. Primary osteoporosis is mainly osteoporosis in old age and postmenopausal osteoporosis. Secondary osteoporosis is hyperthyroidism, parathyroidism, adrenal cortex hyperactivity, pregnancy, and long-term fixation (e.g., Gypsum bandage fixation), malnutrition, drugs, tumors and other chronic complications.

Geriatric osteoporosis (including postmenopausal ones) is not known for its cause but has been recognized as involving a number of factors. Along with the deterioration of the balance of bone metabolism due to aging, a combination of various factors such as calcium deficiency, parathyroid hormone excess, calcitonine deficiency, active vitamin D deficiency, female hormone deficiency, and lack of exercise It is thought to be. Factors that strongly influence calcium metabolism include parathyroid hormone (PTH), calcitonin (CT), and 1,25- (OH) ₂ D ₃ . Parathyroid hormone, which is involved in the metabolism of calcium, and calcitonin secreted by C cells of the thyroid, act antagonistically. Calcitonin is a polypeptide of about 3500-4000 molecular weight that acts on bones to help calcium salts deposit on the bones. As a result, calcium and magnesium in the blood are reduced, and phosphate and hydroxyproline in the urine are also reduced. Parathyroid hormone (PTH) is also a polypeptide and has a molecular weight of 8447. Parathyroid hormones act on the bone to activate osteoclasts (Osteoclast) to increase bone resorption and increase the action of vitamin D ₃ in the small intestine mucosa. Therefore, calcium and magnesium in the blood increases, and hydroxyproline (Hydroxyproline) and phosphoric acid (PO ₄ ^3- ) in the urine increases. Estradiol, a steroid secreted by the ovary, activates osteoblasts in bone and prevents bone resorption.

After menopause in women, estrogen secretion decreases, resulting in a decrease in blood calcitonin, a decrease in 1,25- (OH) ₂ D ₃ synthesis in the kidneys, and an increase in parathyroid hormone secretion. As a result, the production of interleukin 6 (IL-6) and prostaglandin is increased to decrease calcium absorption in the small intestine, and osteoclasts are activated to increase bone resorption, thereby increasing the rate of bone loss, thereby increasing the incidence of osteoporosis. In general, when bone resorption becomes more active than bone formation, joint function is impaired, the spine gradually deforms, fine fractures occur in the spine and other parts, pain (especially back pain) increases, and mobility is reduced, Kidneys decrease

Until now, estrogen therapy, calcium therapy, and calcitonin therapy are mainly used for the treatment of osteoporosis, and recently, bisphosphonate-based drugs and simillar estrogen receptor modulator (SERM) drugs include raloxifene and droroxifene. In clinical trials.

Although estrogen therapy temporarily blocks bone resorption, the incidence of breast cancer is relatively increased, so prior investigation of breast cancer is necessary. Calcitonin therapy is safe and has an excellent analgesic effect, but its effect is insufficient for suppressing the increased bone resorption immediately after menopause, shows effect after about 5 years after menopause, and is expensive and has an economical disadvantage. Bisphosphonate formulations have a very low absorption rate and have an inhibitory effect on bone resorption but cause osteomalacia to increase the fracture rate.

To date, drugs have many side effects, mainly because they maintain bone density by inhibiting bone resorption. Therefore, it is ideal that new therapeutic agents not only inhibit bone loss but also have the function of restoring reduced bone mass.

The mixed extract of motherwort and gilt of the present invention seems to be able to treat and prevent osteoporosis by inhibiting bone resorption and increasing bone formation.

As seen above, the effects of osteoporosis and gynecological diseases have been reported for each plant, but the therapeutic and prophylactic effects of osteoporosis on the mixed extracts of the two plants have not been verified and the prescription has been reported. none. However, the present inventors confirmed that the mixed extract of the two plants showed an excellent effect on the division and activation of osteoblasts in cell experiments and found that the animal extracts have an excellent effect on osteoporosis. In addition, clinical cases confirmed that the mixed extract of the two plants has an excellent effect on osteoporosis. At the same time, the present invention was completed by verifying that there is no toxicity through animal experiments.

The mixed extract of Jimmy and motherwort used as an active ingredient in the present invention is obtained by the following method.

That is, to prepare a mixed extract of hair and motherwort, the mixture of hair and motherwort is extracted with water, filtered and the filtrate is saturated under high pressure to remove the coagulum precipitate formed by centrifugation to remove the organic solvent in the filtrate. The organic solvent soluble substance may be added to the mixture, and then the aqueous layer may be separated and freeze-dried to obtain a mixed extract in powder form or to be extracted with alcohol.

At this time, gimo and motherwort are used in a weight ratio of 1: 0.2-5, preferably 1: 1-2, based on the weight. In particular, in the present invention, it is preferable to mix the hair and motherwort in a weight ratio of 1: 1.

Hereinafter, the preparation method of each mixed extract according to the present invention will be described in more detail.

According to the extraction method of the present invention, in the first step, the mixed water extract is pulverized by mixing dried gilt and motherwort, and extracted or heated by heating with water such as constant or distilled water as an extraction solvent or saturated steam pressure (100 to 140 ° C.). Extraction). The amount of water used for extracting the mixture of motherwort and motherwort is used 10 to 45 times, preferably 5 to 10 times, particularly preferably 7 times that of the dry material.

Next, the extract is centrifuged in the second step to remove the precipitate, and the extract is boiled again under saturated steam pressure (100 to 140 ° C.) to coagulate the remaining protein, and then filtered and removed by centrifugation or the like.

In the third step, the separated filtrate is extracted with an organic solvent such as chloroform, hexane, dichloromethane, cyclohexane, preferably chloroform or hexane to remove impurities such as resin and fiber, and the aqueous layer is again subjected to talc or the like. Purified to obtain freeze-dried to obtain the desired mixed water extract.

As another method of the present invention, the alcohol extract using alcohol as the extraction solvent of the hair and motherwort mixture can also obtain the same effect as the water extract. The method is as follows.

Medicinal plants such as gilt and motherwort are ground and mixed in a ratio of 5: 1 to 1: 5 by weight. It is preferably mixed in a ratio of 2: 1 to 1: 2 and eluted with one or two alcohols, preferably 70-80% alcohol, with occasional stirring for 48-72 hours at room temperature. The eluate is decanted and re-extracted by adding the same concentration of alcohol to the residue by the above method. The eluate is decanted and mixed with the first eluate. Alcohol is recovered from the mixed solution, talc is added to the remaining eluate, followed by stirring, followed by centrifugation, followed by filtration of only the supernatant. The filtrate is powdered by removing alcohol.

The mixed extract (water extract or alcohol extract) of the hair and motherwort obtained by the methods as described above may be usefully used as a therapeutic composition for osteoporosis, which is useful as described above. The present inventors have confirmed that the mixed extract has anti-inflammatory and analgesic effects while having a therapeutic effect on osteoporosis, and the mixed extract of the present invention was confirmed to be a very safe drug through an acute toxicity test.

The mixed extracts of gilts and motherwort according to the present invention are formulated in a form of a pharmaceutical composition suitable for clinical use, either alone or in combination with a pharmaceutically acceptable carrier, by a conventional method in the pharmaceutical art. It may be preferably administered orally. In general, the compositions of the present invention may be formulated in the form of tablets, capsules, solutions, suspensions or syrups suitable for oral administration, and may also be prepared in the form of beverages.

The dosage of the mixed extract according to the present invention may vary depending on the severity of the disease, sex, age, weight, and the desired effect of the patient to be administered, but in general, when orally administered to an adult, per kg of body weight It may be administered at a dose of 5-50 mg, preferably 10 to 40 mg per day.

Example

The following describes the present invention more specifically by way of examples and experimental examples, but these are provided only to illustrate the present invention, and the present invention is not limited in any way by them.

Example 1 Preparation of Mixed Water Extract of Balsam and Motherwort

The dried gilt and motherwort were pulverized, mixed at a weight ratio of 5: 4, and 90 g of the aliquots were added thereto. Then, distilled water or a constant 3000 ml was added thereto, followed by 40 ° C in a pressure cooker at a temperature of 121 ° C. and a saturated steam pressure of 15 psi. After high pressure extraction for ˜ 60 minutes, the extract was aliquoted and the residue was removed.

The extract was centrifuged to remove the precipitate, and the aqueous solution was filtered and then evaporated and concentrated to a total volume of 1500 ml. The filtrate was again saturated in a high-pressure cooker at a temperature of 121 ° C. and 15 psi of saturated steam for 15 minutes to produce a precipitate containing coagulated protein, which was then centrifuged to remove the precipitate and filtered.

The filtrate was added to a separatory funnel, and 400 ml of chloroform was added to elute the resin and fiber, and the chloroform layer was separated and removed. After repeating this method twice, n-hexane 200ml was added to the aqueous layer again to elute remaining resins, fibers and n-hexane soluble materials.

The aqueous layer was recovered, warmed to 60-80 ° C., and stirred with 500 g of talc, followed by filtration under reduced pressure, the talc was removed, the filtrate was gradually filtered again, and the filtrate was lyophilized to powder.

By the above method, 15 g of the total extract was obtained in a yield of about 17% (based on dry weight) in the mixed extract of gilt and motherwort.

Example 2: Preparation of Alcohol Extracts of Balck and Motherwort Mixtures

The dried gilt and motherwort were pulverized and mixed in a ratio of 1: 1, and 1.2 liter of 80% ethanol was added and eluted for 48 to 72 hours with occasional stirring at room temperature. The eluate was decanted and decanted, and 80% ethanol was added again to the remaining residue, and the same method was repeated to redissolve.

Ethanol was recovered from the reflux condenser by combining the re-eluate with the first eluate, followed by stirring with talc to the remaining eluate, followed by centrifugation to remove the precipitate, and the remaining supernatant was filtered.

Hexane and chloroform are added to the filtrate to remove resin, protein and fiber, and the remaining liquid is lyophilized to powder. At this time a brown powder was obtained in a yield of 20%.

Example 3: Composition of a Mixed Extract of Balm and Motherwort

The following specifically shows an example of the formulation of a mixed extract of hair and motherwort according to the present invention.

Formulation 1: Tablet

250 mg of the freeze-dried powdered mixed extract of the present invention prepared in Example 1, 260 mg of lactose for excipient direct hitting and 35 mg of avicel (microcrystalline cellulose), 15 mg of sodium starch glyconate as a disintegration aid, L for direct hitting as a binder 80 mg of -HPC (Low-hydroxyprophylce llulose) was mixed and mixed in a U-type mixer for 20 minutes. After completion of the mixing, 10 mg of the suspending agent magnesium stearate was further added and mixed for 3 minutes. After quantitative and hygroscopic tests, tableting and film coating were carried out to prepare tablets containing 250 mg of mixed extract per tablet.

Formulation 2: Syrup

An appropriate amount of sucrose was dissolved in a predetermined amount of water, and 80 mg of paraoxymethylbenzoate and 16 mg of paraoxypropylbenzoate were added thereto as a preservative, and then the lyophilized powdery mixed extract of the present invention prepared in Example 1 was used. 4.5 g was added and maintained at 60 ° C., completely dissolved, cooled, and 150 ml of distilled water was added to prepare a syrup.

Formulation 3: Capsule

300 mg of the lyophilized powdered mixed extract of the present invention prepared in Example 1 was mixed with 200 mg of lactose as a carrier to fill a hard gelatin capsule to prepare a capsule.

Formulation 4: Beverage Composition

After dissolving 500 mg of the lyophilized powdered mixed extract of the present invention prepared in Example 1 in an appropriate amount of water, vitamin C as an auxiliary ingredient, citric acid, sodium citrate, and high fructose as an auxiliary agent were added, and an appropriate amount was used as a preservative. After adding sodium benzoate, water was added to make the whole amount 100 ml to prepare a beverage composition.

Experimental Example 1: Effect of the mixed extract of the present invention on osteoporosis (animal experiment)

Nine-week-old SD rats were purified for one week and at 10 weeks of age, the ovaries were removed and the extracts were orally administered for three weeks from the next day. The positive control group was administered subcutaneously (s.c) for the same period. Sham-operation was performed as a comparative normal group and the ovary was not extracted.

After the last dose of the extract, the next day calcium gluconate was injected intraperitoneally with 50 mg / kg, and after 30 minutes, the animals were anesthetized and blood was collected to determine the calcium and calcitonin levels in the serum. The amount of calcium in serum was measured using absorbance and calcitonin was measured using antibody.

As a result, as shown in Table 1, the blood calcium concentration was significantly lowered in the ovarian-extracted rats as compared to the positive control, while in the mice treated with esterone, the blood calcium concentration was maintained as in the normal rats. Rats that received oral administration of 50 mg / kg or 100 mg / kg of mixed extracts maintained the same calcium concentrations as normal mice. The amount of calcitonin in the blood was similar.

Table 1. Changes of calcium and calcitonin in blood by oral administration of the mixed extract of the present invention

Serum calcium (mg / dl) Serum Calcitonin (pg / ml) Positive control 16.50 ± 0.73 2030 ± 149 Ovarian Extraction 13.45 ± 0.37 1740 ± 135 Ovarian Extraction-Esterone 16.96 ± 1.17 2133 ± 142 Ovary extraction-Inventive mixed extract (50 mg / kg) 17.78 ± 0.45 2120 ± 130 Ovary extraction-Inventive mixed extract (100 mg / kg) 18.22 ± 0.76 2252 ± 118

As a result of analysis of bone tissue, the ovary extracted rats showed a significant decrease in the weight and strength of the bones, but in the rats orally administered the mixed extract of the present invention, the ester and the normal rats were used in the weight and strength of the bones. No significant difference was observed with.

Experimental Example 2: Effect of the mixed extract of the present invention on osteoblasts

Cultivation of rat cranial cells (calvarial cells) in the control group was treated with physiological saline at a concentration of 1 ㎍ / ㎖, the comparison group, respectively, 1 ㎍ / ㎖ of the hair extract, 1 ㎍ / ㎖ of motherwort extract, the mixed extract of the present invention 1 Μg / ml is administered. After 48 hours, cell homogenate was sonicated, and alkaline phosphatase (ALP) activity was measured using the kit.

As a result, as shown in Table 2, the mixed extract of the present invention was observed to significantly promote differentiation of osteoblasts than each extract.

Table 2. Effect on the osteoblast differentiation of the mixed extract of the present invention

Alkaline phosphatase activity (U / μg protein) Control 0.11 ± 0.03 Hair extract 0.17 ± 0.04 Motherwort extract 0.09 ± 0.04 Mixed extract of the present invention 0.23 ± 0.07

Experimental Example 3: Effect of the mixed extract of the present invention on osteoporosis (clinical case)

After 10 years of menopause, the vertebral bone concentration was 0.332 g / cm ² (29% of normal people, osteoporosis) and the patient who could not walk for more than 10 minutes was orally administered 20 mg / kg of the mixed extract of the present invention twice a day for 12 weeks. As a result of the patient's bone density it has been observed to increase from 0.332g / cm ² to 0.476g / cm ² showed that the bone cell growth, up 13% clinically had to walk more than 30 minutes.

Experimental Example 4: Analgesic effect of the mixed extract of the present invention

In order to investigate the analgesic effect of the mixed extract of the present invention was investigated using the tail-flick method. Using the white paper, 30 minutes after the administration of physiological saline to the control group and the extract to the experimental group, the time required to escape the tail sideways after high-density beam at 2-5 cm of the tail of the white paper was measured (latency). Measure with threshold. Calculate percent inhibition using the equation below.

Percent inhibitory effect =

100 x [(latency) _{present invention-} (latency) _control ] / [10-(latency time) _control ]

As shown in Table 3, the mixed extract of the present invention showed an elevated analgesic effect compared to each extract.

Table 3. Analgesic Effects of the Mixed Extract of the Present Invention

Time in seconds Control 2.0 ± 0.2 Hair extract 3.4 ± 0.4 Motherwort extract 2.8 ± 0.4 Mixed extract of the present invention 7.8 ± 0.7

Experimental Example 5: Anti-inflammatory effect of the mixed extract of the present invention

The anti-inflammatory effect of the mixed extract of the present invention was investigated using the carrageenin paw-edema method. Using white paper, physiological saline was administered to the control group, extracts were administered to the experimental group, and the dose to the ankle was measured by a plethysmometer. Immediately inject 0.1 ml of saline solution of 1% carrageenin into the plantar skin, calculate the volume of foot edema by measuring the dose to the ankle with swelling after 1 hour, and then use the formula below to express the percent inhibition effect (% inhibition). )

Percent inhibitory effect =

100-(volume difference) _invention / (volume difference) _control x 100

As shown in Table 4, the mixed extract of the present invention showed an increased anti-inflammatory effect compared to each extract.

Table 4. Anti-inflammatory action of the mixed extract of the present invention

% Inhibition Control 2.1 ± 0.2 Hair extract 58.7 ± 10.4 Motherwort extract 53.9 ± 9.8 Mixed extract of the present invention 64.3 ± 8.7

Experimental Example 6: Acute toxicity test for the mixed extract of the present invention (single dose toxicity test)

36 normal ICR mice (males, 22 ± 1 g) were divided into 6 groups of A to F, 6 in 1 group, group A was administered with saline as a control group, and group B was administered per kg of body weight. Equivalently to administering 1 g of the mixed extract of gilt and motherwort of 1, 2.5 g in Group C, 5 g in Group D, 7.5 g in Group E and 10 g in Group F, respectively, and then 1 As a result of weekly observation, no abnormal animals were found even in the group administered with 10 g / kg. Therefore, LD ₅₀ value by oral administration of the mixed extract of the hairy motherwort and the motherwort of the present invention was found to be a very safe material to the body at 10 g / kg or more. In other words, it can be clearly seen that the mixed water extract of the mother and motherwort according to the present invention can be safely administered with little toxicity.

In addition, autopsies and histopathological examinations were performed on the experimental animals used to measure the LD ₅₀ value in the following manner.

At the end of the test, all surviving animals were bled after ether anesthesia, and the organs were extracted and visually examined for all organ abnormalities. Autopsied organs were fixed in 10% neutral formalin solution for at least 10 days for pathological examination, and then dehydrated and embedded in a paraffin embedding apparatus (Fisher, Histomatic Tissue Processor, 166A), followed by a rotary microtome (AO Rotary Microtome). 5 μm sections were made and observed with hematoxylin and eosin staining.

The histologic findings of all animals in each group dissected under the microscope were as follows. The ideal findings of drug administration were not observed in the tissues in which the mixed water extracts of the hairs and motherwort were administered up to 10 g / kg of mouse body weight. In addition, no abnormal findings by drug administration were observed in the kidneys, and no abnormal findings by drug administration were observed in cardiomyocytes of the heart. Abnormalities due to drug administration were not observed in the other major organs, gastrointestinal tract, pancreas, lung, spleen, adrenal gland, brain, testes, ovaries and bone marrow.

Therefore, the mixed water extract of gilt and motherwort of the present invention had no side effects on the whole organs even when administered 10 g per 1 kg of body weight, the maximum dose that can be administered to the mouse, and also does not cause toxicity such as any organ damage. Appeared to be safe.

As described above, the present invention provides a composition for preventing or treating osteoporosis comprising a mixed extract of gilt and motherwort plants, the composition of the present invention is a herbal extract with fewer side effects, and can be administered and administered long-term. In addition, the composition of the present invention has anti-inflammatory and analgesic effects and is expected to have an immediate effect on the pain caused by osteoporosis and is expected to be a great help in the treatment of osteoporosis patients. In addition, the compositions of the present invention do not lead to dependencies and resistance. This effect is far superior to the effects of each extract of baldder and motherwort.

Claims (10)

A composition for preventing or treating osteoporosis, comprising a mixed extract of hair and motherwort with water or a mixed solvent of water and lower alcohol. The composition for preventing or treating osteoporosis according to claim 1, wherein the mixed extract is obtained by mixing the hair and motherwort with a weight ratio of 5: 1 to 1: 5. The composition for preventing or treating osteoporosis according to claim 1 or 2, further comprising a pharmaceutically acceptable carrier, excipient or diluent, and formulated in a pharmaceutical unit dosage form. a) mixing gimos and motherwort in a weight ratio of 5: 1 to 1: 5 by weight and extracting with water or a mixed solvent of water and a lower alcohol; b) filtering the extract of step a); c) saturating the filtrate of step b) under a high temperature and a high pressure of # 100 to 140 ° C. to form a precipitate of coagulated protein, followed by centrifugation to remove it; d) extracting the filtrate from which the precipitate of step c) is removed with an organic solvent and separating the aqueous layer to remove the useful material of the filtrate; And e) lyophilizing the separated aqueous layer of step d) Method for producing a composition for preventing or treating osteoporosis comprising a. The method of claim 4, wherein A pharmaceutically acceptable excipient is further added to the mixed water extract of lyophilized hair and motherwort of step e) to prepare a formulation selected from the group consisting of tablets, capsules, solutions, suspensions, syrups, and edible beverages. Steps to Method for producing a composition for preventing or treating osteoporosis further comprising. The method of claim 4, wherein Method for producing a composition for the prevention or treatment of osteoporosis, wherein the extraction solvent in the step a) is water, and is used in a weight ratio of 1: 10-45 based on the mixture of gilt and motherwort. The method of claim 4, wherein Method for producing a composition for preventing or treating osteoporosis using chloroform or hexane as the organic solvent of step d). The method of claim 4, wherein Method for producing a composition for preventing or treating osteoporosis, wherein the extraction solvent of step a) is an alcohol having 1 to 5 carbon atoms in a concentration of 70 to 80% by weight. Herbal medicine which is effective in preventing or treating osteoporosis, which contains a mixed extract of hair and motherwort with water or a mixed solvent of water and lower alcohol as an active ingredient. A health supplement that is effective in preventing or treating osteoporosis, which contains a mixed extract of hair and motherwort with water or a mixed solvent of water and a lower alcohol as an active ingredient.