KR20200014566A - A composition for improving, preventing and treating of arthritis comprising Milk thistle and Achyranthes bidentata Blume - Google Patents

Abstract

The present invention relates to a composition for preventing and treating arthritis, which is possible to alleviate, prevent or treat diseases caused by arthritis by containing a mixture of Cirsium japonicum and Achyranthes aspera as an active component. In addition, since the composition has no toxicity, it is possible to be consumed in a form of food.

Description

Composition for improving, preventing and treating arthritis comprising milk thistle and Achyranthes bidentata Blume

The present invention relates to a composition for the improvement, prevention or treatment of arthritis, which contains a mixture consisting of thistle and wedge as an active ingredient.

Arthritis is a representative degenerative and intractable disease, with 12% of the world's population and 70% of people over 60 years old. 4 ~ 5% of Koreans are estimated to have degenerative arthritis and about 1% of patients with rheumatoid arthritis. It is estimated that 80% of older people have degenerative arthritis.

The degenerative arthritis is a disease in which local degenerative change occurs as the articular cartilage wears off, also called osteoarthritis or osteoarthritis. Osteoarthritis is a representative degenerative disease that is closely related to aging. About 10 to 15% of the entire population suffers from osteoarthritis. In particular, about 60 to 80% of the elderly aged 65 or older suffer from osteoarthritis.

The causes of degenerative arthritis are deeply related to aging and excessive weight, and the more and more severely in women as they age. Early symptoms include one or two joints with stiffness and pain, and prolonged prolongation of the cartilage, hardening of the subchondral bone, excess bone formation around the joint, and joint deformation.

Degenerative arthritis can be classified as primary (primary) or secondary (secondary). First, the primary cause of primary degenerative arthritis is unknown, but age, sex, genetic factors, and obesity are thought to be the cause. Primary (primary) degenerative arthritis is more common in women after middle age and more often in women. It is also related to family history. Obesity is about 2 times higher incidence than normal, and this is usually seen in weight bearing joints. Commonly involved joints include weight bearing and compression of the lumbar spine, hips, knees, and metatarsal joints of the moss of the foot. In particular, even within the joint, a certain area, for example, the inner joint of the knee joint is well invaded.

In females, the distal joints of the resin (finger joints away from the torso) and the first carpal metacarpal joints (the joints of the palm of the hand) are well invaded, and in men, hip involvement is common.

Second, secondary (secondary) degenerative arthritis can be caused by all trauma, disease and malformations that can damage joint cartilage. Congenital malformations include a lack of joint alignment, such as hip dysplasia or varus, and degenerative arthritis often occurs due to avascular necrosis, severe shock, or repeated minor trauma. In addition, many degenerative arthritis also appear in endocrine abnormalities such as acromegaly and diabetes, and metabolic diseases such as gout.

The cause of degenerative changes in articular cartilage has not yet been identified, but the absolute decrease in the number of chondrocytes and the imbalance of cartilage matrix synthesis and degradation in chondrocytes are known as one cause. Thus, until now, arthritis is not possible to cure the root, and the therapeutic agents developed so far are being treated in the direction of alleviating pain, suppressing inflammation, and preserving possible functions.

Treatment of degenerative arthritis that is currently used clinically includes drug therapy (analgesics, steroids, nonsteroidal anti-inflammatory drugs, etc.) or cartilage protection agents (hyaluronic acid, glucosamine, chondroitin, etc.) or surgical treatment (eg, joint surgery, Proximal tibia osteotomy, joint replacement, total knee arthroplasty, etc.). However, drug treatments only have the effect of non-specifically alleviating the pain or inflammatory response itself, and cartilage protection agents protect joints by only nourishing cartilage cells or mitigating shock.

It only plays a role. In addition, there is a side effect that can lead to osteoporosis, hypertension, diabetes, etc. due to loss of calcium when taking steroidal drugs for a long time.

Therefore, most of the drug treatment is used only for the purpose of reducing pain, and permanent arthroplasty is mainly used, but there are no drugs or surgical methods that provide a fundamental therapeutic effect.

Republic of Korea Patent Publication No. 10-2017-0143235 Republic of Korea Patent No. 0945960

An object of the present invention is to provide a pharmaceutical composition for the prevention or treatment of arthritis, containing a mixture consisting of thistle and wedge as an active ingredient.

In addition, another object of the present invention is to provide a food composition for the prevention or improvement of arthritis, containing a mixture consisting of thistle and wedge as an active ingredient.

Pharmaceutical compositions capable of preventing or treating arthritis of the present invention for achieving the above object may contain a mixture consisting of thistle and dew as an active ingredient.

The thistle and the dew may be mixed in a weight ratio of 1: 0.05 to 0.5.

The mixture of the thistle and the dew may be an extract extracted in a bath at 80 to 100 ℃.

The mixture of the thistle and the dew may be a dough kneaded by mixing the pulverized powder by mixing the respective substances with water.

The arthritis is osteoarthritis, osteoarthritis, rheumatoid arthrits, ankylosing spondylitis, reactive arthritis, psoriatic arthritis, systemic lupus erythematosus, polymyositis or polymyositis. It may be polymyalgia rhematica.

The thistle may be a mixed extract of a flower, a stem and a leaf of a thistle, and a root mixed in a weight ratio of 1: 0.5-3: 0.5-2.

The stem and leaf mixture may be mixed in a weight ratio of 1: 1-4 stem and leaf.

The thistle mixed extract may be a mixture of the extract of the extract of the bath in 80 to 100 ℃ by extracting the mixture of the flower of the thistle, the stem and the leaves in a bath at 80 to 100 ℃.

The milk thistle mixed extract may be added to the powder obtained by drying and grinding the remaining residue after extraction of the roots at 80 to 100 ℃.

In addition, the food composition that can improve or prevent the arthritis of the present invention for achieving the above-described other object may contain a mixture consisting of thistle and dew as an active ingredient.

The composition for improving, preventing or treating arthritis of the present invention can be effectively used for the prevention and treatment of arthritis diseases because it alleviates degenerative arthritis and rheumatoid arthritis, and can be ingested in the form of food because there is no toxicity.

The present invention relates to a composition for the improvement, prevention or treatment of arthritis, which contains a mixture consisting of thistle and wedge as an active ingredient.

Hereinafter, the present invention will be described in detail.

The composition for improving, preventing or treating arthritis of the present invention contains a mixture consisting of thistle and dew as an active ingredient.

Thistle

The milk thistle used in the present invention may be Silybum marianum (L.) Gaertn., Thorn thistle (Cirsium japonicum Fisch ex DC.var.spinossimum Kitam.) Or mixtures thereof, preferably white Thistle is to use alone.

The white thistle (Silybum marianum (L.) Gaertn.) Is a deep, shiny green plant with milky leafy veins, and is a long, thin plant that is divided into a wavy, spiny root-leaves at the edges. It is mainly found in embankment fences and abandoned lands. Useful parts of the plant are whole herbs, roots, leaves, seeds, and husks, and thistle seeds contain flavonoid compounds known as silymarin. Thistle seed extract contains 70-80% of silymarin.

Thistle according to the present invention is a mixed extract of a flower, a mixture of stems and leaves, and a root of thistle.

The flower of thistle is purple or red, and its length is 19-24 mm, and it is preferable to use only those having a length of 10 to 15 mm and not longer than that.

In addition, the thistle stem and leaves are used by mixing in a weight ratio of 1: 1-4, preferably 1: 2-3. When the content of the leaf on the basis of the stem is less than the lower limit, the bitter taste may be strong, and when the leaf is above the upper limit, it is not preferable for the effect on arthritis.

In addition, unlike the flowers, stems and leaves harvested twice a year, thistle roots are preferably dried every three years so that they are used after drying.

The flower of thistle, the mixture of stem and leaf, and the root are mixed in a weight ratio of 1: 0.5-3: 0.5-2, preferably in a weight ratio of 1: 1-2: 0.6-1. When the mixture of the stem and the leaf, and the root content of the flower is less than the lower limit, the effect on arthritis may not be excellent. When the upper limit is exceeded, the bitter taste may be strong and the effect on the arthritis may be lowered.

 The mixed extract of the present invention is an extract extracted in bath for 20 to 30 hours, preferably 24 to 28 hours at 80 to 100 ℃. If the boiling water extraction temperature and time is less than the lower limit, the active ingredient may not be extracted. If the boiling water extraction temperature and time is greater than the upper limit, the burnt taste may be strong and the nutrients may be destroyed. In addition, when extraction is performed by other methods such as organic solvent extraction in addition to water bath extraction using water, the effect on arthritis is insignificant and bitter taste may occur strongly.

Specifically, the mixed extract is a mixture of flowers, a mixture of stems and leaves in a water bath extract, and extract the roots in a separate bath and mix later. Unlike the present invention, when the mixture is extracted by boiling water by mixing both the mixture of the flower, the stem and the leaves, and the roots, the bitterness is strong, and the effect on arthritis may be lowered.

Specifically, the method for producing thistle includes (A) mixing the flower of the thistle, a mixture of the stem and the leaf, and extracting the water at 80 to 100 ° C. to obtain an extract; (B) extracting the root of thistle at 80-100 ° C. to obtain an extract; And (C) lyophilizing the extracts obtained in the steps (A) and (B), respectively, and powdering and mixing the extracts. In addition, after the step (C), (D) drying and grinding the remaining residue extracted in the step (B); And (E) mixing 100 parts by weight of the powder mixed in the step (C) and 0.1 to 3 parts by weight of the powder of the step (D).

Unlike the steps (A) and (B), when the mixture is extracted with a mixture of flowers, stems and leaves, and roots, the bath is extracted, the bitterness is strong and the effect on arthritis may be lowered; Yield may be lowered when each of the flowers, the mixture of the stem and the leaves, and the roots are extracted in each bath.

When the root residue powder prepared in step (D) is added, the effect on the disease may be significantly improved as compared with the case where the root residue powder is not added.

Dew

The dew is used to remove the blood and boil if you use raw, if you boil the liver and gods to strengthen the muscles, skeleton. It is used for menstrual irregularities and postpartum abdominal pain by removing the blood, and it treats the rash in the mouth and tongue caused by the vulgaris. Pharmacological action, uterine excitement, cholesterol lowering action, diuretic action, hypoglycemic action, liver function improvement and the like have been reported.

This thistle and the dew is mixed in a weight ratio of 1: 0.05 to 0.5, preferably in a weight ratio of 1: 0.1 to 0.3.

When the amount of dew is less than the lower limit on the basis of thistle, the effect of improving, preventing or treating arthritis may be lower than that of using each substance alone. If the upper limit is exceeded, the amount of dew drops may be improved, prevented or treated. The effect may be lowered.

When the thistle and the dew is used alone, it shows 1.5 to 20 times lower efficacy than when using thistle and the dew together.

The form of the composition of the present invention may be prepared in the form of granules, pills, powder, juice, tea bags and the like.

For example, in the case of producing granules or pill, the milk thistle mixed extract is mixed with lyophilized powder and pulverized dew powder to prepare a dough, and the dough is formed into granules or pill using the prepared dough. .

As another example, in the case of producing granules, powders, pills and juices, the milk thistle and the dew powder are mixed in the ratio of the present invention, the extract extracted in a bath at 80 to 100 ° C. is filtered and then lyophilized to powder and then the powder obtained It can be molded to obtain granules or rings.

As another example, in the case of granules, powders, pears and blues, the thistles and dews may be mixed in the ratio of the present invention, and the extract extracted from the water bath for 20-30 hours at 80-100 ° C. and the thistles and dews in the ratio of the present invention. After mixing and pulverizing the powder in a weight ratio of 4-5: 1, the mixture may be extracted by boiling water at 60 to 70 ℃ for 40 to 55 hours and concentrated to obtain blue. In addition, the concentrated concentrate may be dried to obtain a powder. The concentrate may be dried to form a granule or a ring, and then dried again to obtain a complete granule or ring.

With this method, raw material powders are used, which eliminates the use of materials such as excipients and can yield higher amounts of active ingredients.

As another example, in the case of making a tea bag, a powder obtained by lyophilizing the extract of the thistle and the dew is roasted at 80 to 120 ° C. is packed in a tea bag.

The mixture of thistles and dews of the present invention has the meaning of broadly including mixed powders of thistles and dews, such as mixed powders of thistles and dews, which are formulated for administration to animals of a mixture of thistles and dews. . Although experiments have been carried out with mixtures of thistles and dews in the present invention, it will be appreciated by those skilled in the art that the desired effects can be achieved in the form of a mixture of thistles and dews.

On the other hand, the term 'containing as an active ingredient' in the present specification means containing an amount sufficient to achieve the efficacy or activity of thistle and dew. In one example, the thistle and the dew are used at a concentration of 10 to 1500 μg / ml, preferably 100 to 1000 μg / ml. Milk thistle and dew is natural as there is no adverse effect on the human body, even if excessive administration, the upper limit of the amount of milk thistle and dew included in the composition of the present invention can be carried out by those skilled in the art within the appropriate range.

The pharmaceutical composition of the present invention may be prepared using a pharmaceutically suitable and physiologically acceptable adjuvant in addition to the active ingredient, and the adjuvant may include excipients, disintegrants, sweeteners, binders, coatings, swelling agents, lubricants, Lubricants, flavors and the like can be used.

The pharmaceutical composition may be preferably formulated into a pharmaceutical composition comprising one or more pharmaceutically acceptable carriers in addition to the active ingredient described above for administration.

Formulation forms of the pharmaceutical composition may be granules, powders, tablets, coated tablets, capsules, suppositories, solutions, syrups, juices, suspensions, emulsions, drops or injectable solutions. For example, for formulation in the form of tablets or capsules, the active ingredient may be combined with an oral, nontoxic, pharmaceutically acceptable inert carrier such as ethanol, glycerol, water and the like. In addition, if desired or necessary, suitable binders, lubricants, disintegrants and coloring agents may also be included in the mixture. Suitable binders include, but are not limited to, natural and synthetic gums such as starch, gelatin, glucose or beta-lactose, corn sweeteners, acacia, trackercance or sodium oleate, sodium stearate, magnesium stearate, sodium Benzoate, sodium acetate, sodium chloride and the like. Disintegrants include, but are not limited to, starch, methyl cellulose, agar, bentonite, xanthan gum, and the like.

Acceptable pharmaceutical carriers in compositions formulated in liquid solutions are sterile and biocompatible, which include saline, sterile water, Ringer's solution, buffered saline, albumin injectable solutions, dextrose solution, maltodextrin solution, glycerol, ethanol and One or more of these components may be mixed and used, and other conventional additives such as antioxidants, buffers and bacteriostatic agents may be added as necessary. Diluents, dispersants, surfactants, binders and lubricants may also be added in addition to formulate into injectable formulations, pills, capsules, granules or tablets such as aqueous solutions, suspensions, emulsions and the like.

Furthermore, the method disclosed in Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA can be formulated according to each disease or component according to the appropriate method in the art.

The pharmaceutical composition of the present invention may be administered orally or parenterally, and in the case of parenteral administration, it may be administered by intravenous injection, subcutaneous injection, intramuscular injection, intraperitoneal injection, transdermal administration, or the like, and preferably, oral administration. .

Suitable dosages of the pharmaceutical compositions of the invention vary depending on factors such as the formulation method, mode of administration, age, weight, sex, morbidity, condition of food, time of administration, route of administration, rate of excretion and response to reaction, Usually an experienced physician can easily determine and prescribe a dosage effective for the desired treatment or prophylaxis. According to a preferred embodiment of the present invention, the daily dose of the pharmaceutical composition of the present invention is 0.001-10 g / kg.

The pharmaceutical compositions of the present invention may be prepared in unit dosage form by formulating with a pharmaceutically acceptable carrier and / or excipient according to methods which can be easily carried out by those skilled in the art. Or it may be prepared by incorporation into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension or emulsion in an oil or aqueous medium, or may be in the form of extracts, powders, granules, tablets or capsules, and may further include a dispersant or stabilizer.

The present invention also provides a food composition for improving, preventing or treating arthritis, which contains thistle and dew as an active ingredient.

The food composition according to the present invention may be formulated in the same manner as the pharmaceutical composition, used as a functional food, or added to various foods. Foods to which the composition of the present invention can be added include, for example, beverages, alcoholic beverages, confectionery, diet bars, dairy products, meat, chocolates, pizzas, ramen noodles, other noodles, gums, ice creams, vitamin complexes, and health supplements. Etc.

The food composition of the present invention may include not only thistles and dews as an active ingredient, but also components commonly added in preparing foods, and include, for example, proteins, carbohydrates, fats, nutrients, seasonings, and flavoring agents. . Examples of the above carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose, oligosaccharides and the like; And sugars such as conventional sugars such as polysaccharides such as dextrin, cyclodextrin and the like and xylitol, sorbitol, erythritol. As the flavoring agent, natural flavoring agents (tauumatin, stevia extract (for example rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used. For example, when the food composition of the present invention is prepared with a drink and a beverage, citric acid, liquid fructose, sugar, glucose, acetic acid, malic acid, fruit juice, and various plant extracts may be further included in addition to the thistle and dew drop of the present invention. .

The present invention provides a health functional food comprising a food composition for improving, preventing or treating arthritis, which comprises the thistle and dew as an active ingredient. Health functional food is a food prepared by adding milk thistle and dew to food materials such as beverages, teas, spices, gums, confectionery, encapsulated, powdered, suspensions, etc. This means, unlike general medicines, there is no side effect that can occur when taking a long-term use of foods as a raw material. The health functional food of the present invention thus obtained is very useful because it can be consumed on a daily basis. The amount of thistle and dew drop added in such a dietary supplement cannot be defined uniformly depending on the type of dietary supplement, but it may be added within a range that does not impair the original taste of the diet. 0.01 to 50% by weight, preferably 0.1 to 20% by weight. In addition, in the case of a health functional food in the form of pills, granules, tablets or capsules, it is usually added in the range of 0.1 to 100% by weight, preferably 0.5 to 80% by weight. In one embodiment, the dietary supplement of the present invention may be in the form of pills, tablets, capsules or beverages.

The present invention also provides the use of thistles and dew drops for the manufacture of a medicament or food for the improvement, prevention or treatment of arthritis. As described above, thistle and dew may be used for the purpose of improving, preventing or treating arthritis.

The present invention also provides a method for improving, preventing or treating arthritis comprising administering to a mammal an effective amount of thistle and dew.

As used herein, the term "mammal" refers to a mammal that is the subject of treatment, observation or experimentation, preferably human.

As used herein, the term “effective amount” means the amount of an active ingredient or pharmaceutical composition that induces a biological or medical response in a tissue system, animal or human, as thought by a researcher, veterinarian, doctor or other clinician, Amounts that induce alleviation of the symptoms of the disease or disorder. It will be apparent to those skilled in the art that the effective amount and frequency of administration for the active ingredients of the present invention will vary depending on the desired effect. Therefore, the optimum dosage to be administered can be readily determined by one skilled in the art and includes the type of disease, the severity of the disease, the amount of active ingredients and other ingredients contained in the composition, the type of formulation, and the age, weight, general health of the patient. It may be adjusted according to various factors, including the condition, sex and diet, time of administration, route of administration and rate of composition, duration of treatment, and drugs used simultaneously. In the prophylactic, therapeutic or ameliorating method of the present invention, in the case of an adult, it is preferable to administer thistle and hyssop at a dose of 0.001 g / kg to 10 g / kg when administered once to several times a day.

Compositions comprising thistle and wedge as active ingredients in the methods of treatment of the invention may be administered in a conventional manner via oral, rectal, intravenous, intraarterial, intraperitoneal, intramuscular, intrasternal, transdermal, topical, intraocular or intradermal routes. It can be administered.

Hereinafter, preferred examples are provided to help understanding of the present invention, but the following examples are merely for exemplifying the present invention, and various changes and modifications within the scope and spirit of the present invention are apparent to those skilled in the art. It is natural that such variations and modifications fall within the scope of the appended claims.

Example 1.Bangtang Extract

Milk thistle

1 part by weight of thistle flower, 1 part by weight of a mixture of stems and leaves (stem: leaf = 1: 2 weight ratio), and 45 parts by weight of water, followed by extraction with a water bath at 95 ° C. for 24 hours to obtain an A extract, thistle root 0.6 Weight parts and 45 parts by weight of water extraction at room temperature for 24 hours at 95 ℃ to obtain a B extract and then lyophilized to prepare A powder and B powder, respectively, to prepare a mixed extract powder.

Bantang Extract

After mixing 100 parts by weight of thistle milk, 20 parts by weight of dew and 880 parts by weight of water, the mixture was spun with hot water at 90 ° C. for 24 hours, and then mixed with a compressed liquid obtained by compressing the heated liquid with a suspended solid for 5 minutes at 100 ° C. And then filtered to obtain a bath extract.

Example 2. Extract of Tangtang + Powder-> Extract of Tangtang

It was carried out in the same manner as in Example 1, and mixed with 100 parts by weight of thistle, 20 parts by weight of dew and 880 parts by weight of water, followed by agitation at 90 ° C. for 24 hours; 100 parts by weight of the milk thistle and 20 parts by weight of thistle powder were mixed and pulverized. The mixture was mixed at a weight ratio of 4: 1.

Example 3. Addition of thistle root roots

In the same manner as in Example 1, when preparing the thistle powder, the milk thistle roots were extracted with water, the remaining residues were dried and pulverized to obtain C powder (root residue powder), and then A powder, B powder and C powder were prepared. Thistle mixed powder (0.3 parts by weight of C powder with respect to 100 parts by weight of A powder + B powder) to prepare a thistle mixed extract powder and then using this to obtain a bath extract.

Example 4 Kneading

In the same manner as in Example 1, instead of preparing a bath extract, 100 parts by weight of the milk thistle and 20 parts by weight of thistle were mixed and pulverized.

Comparative Example 1. Thistle omitted

In the same manner as in Example 1, but thistle was omitted, using only the dew to obtain a bath extract.

Comparative Example 2. Oval

The same procedure as in Example 1 was carried out, but the extract of the bath was obtained using only thistle and omitting dew.

<Test Example>

Test Example 1. Measurement of Cell Viability

10 ul of HUVECs (human vascular endothelial cells, American Type Culture Collection (Manassas, VA, USA)) were used to induce neovascularization, and the powders of Examples and Comparative Examples were treated in a concentration-dependent manner. Apoptosis trends were determined by WST-1 assay.

division Of No treatment 100 / 250 / 500 / 750 / 1000 / Example 1 98.3 98.1 98.0 97.9 98.0 97.6 Example 2 99.1 98.8 98.5 98.4 98.5 98.1 Example 3 98.0 98.2 98.1 98.0 98.2 97.9 Example 4 98.1 98.1 98.1 97.5 97.5 97.0 Comparative Example 1 98.2 98.0 98.0 97.4 97.7 97.4 Comparative Example 2 98.2 98.0 97.7 97.5 97.6 97.3

As shown in Table 1, the extract prepared according to Examples 1 to 4 and the extract prepared according to Comparative Examples 1 to 2 of the present invention was confirmed that the cytotoxicity is low because the cell viability is excellent.

Test Example 2 Inhibitory Effect of Degenerative Arthritis

Wistar family mice were randomly divided into 7 groups of 10 animals. The test substance was administered for 6 weeks after the separation, and then degenerative arthritis was induced at the 7th week. Specifically, 3 mg / joint of MIA (mono iodoacetate) was injected once at a volume of 200 μg / ml in the joint cavity. Thereafter, the test substance is administered up to 8 parking days, followed by fasting on the day before necropsy, body weight is measured on the day of necropsy, and the joint tissue is fixed in 10% neutral buffered formalin solution and histopathological examination is performed. Histopathological examination was performed to read the efficacy on the effect on arthritis based on the index described in the following [Table 2] and [Table 3]. The arthritis index was calculated by dividing into four items in the pathologies of the osteoarthritis-induced femur and tibia, and compared with the positive control group. The relative evaluation was performed based on the following criteria and the results are shown in [Table 4].

Arthritis Index for Evaluation of Efficacy of Arthritis in Pathology rescue cell
Transition and Radiation Areas 0: normal 0: normal 1: surface slightly irregular 1: slightly excess cell 2: surface irregularity 2: cell excess 3: deeply irregular surface 3: excessively heavy cells 4: gap in the transition area 4: weak cloning 5: clearance in the radiation region 5: cloning 6: crevice in travertine zone 6: severe cloning 7: loss of transition area 7: little cell shortage 8: radiation area loss 8: lack of cells 9: loss of calcification area 9: deeply lacking cells 10: complete dismantling 10: cell death

Arthritis Index for Evaluation of Efficacy of Arthritis in Pathology Cell contact area Pannus formation 0: normal 0: none 1: cell swelling 1: slightly 2: cell death 2: normal 3: cover

division Excipient Example 1 Example 2 Example 3 Example 4 Comparative Example 1 Comparative Example 2 rescue 2.00 1.00 0.50 0.60 1.40 1.70 1.90 Chondrocyte Tangent area 1.80 0.60 0.20 0.30 1.20 1.50 1.70 Transition and radiation area 7.30 3.10 2.10 2.40 4.20 5.90 6.50 Pannus Formation 0.80 0.60 0.20 0.40 0.60 0.70 0.80 Total score 11.90 5.30 3.00 3.70 7.40 9.80 10.90

As shown in Table 4 above, the control group (excipient) that induced only arthritis without treatment of the substance showed noticeable damage in the joint and the overall structure of the joint. On the other hand, the group administered with the extracts of Examples 1 to 4 was found to have an improvement effect in the contact area of the chondrocytes, and the group administered with the extracts of Comparative Examples 1 and 2 compared to the group of Examples 1-3. It was confirmed that the improvement effect was low in the contact area.

Therefore, the visible improvement effect on arthritis was confirmed in the group administered with the extracts of Examples 1 to 4, it was confirmed that Examples 2 and 3 show the best arthritis improvement effect among Examples 1 to 4.

Experimental Example 3. Rheumatoid Arthritis Inhibitory Effect

To investigate rheumatoid arthritis anti-inflammatory effects on the extracts prepared in Examples and Comparative Examples, the extracts prepared in Examples and Comparative Examples were administered to DBA / 1J mice (6 weeks old, 25 g, male, central experimental animals) for 16 weeks. It was. Arthritis was induced by dissolving collagen type 2 (Sigma, USA) in 0.1 M acetic acid at a concentration of 2 mg / ml and emulsifying it in Freund's incomplete adjuvant (Sigma, USA). Subsequently, the mice were subcutaneously injected into the right foot. Seven days after the first injection, the same amount was further inoculated in the tail portion and the control group was inoculated with the same amount of saline. Individuals forming periarticular redness, edema and swelling were visually selected on day 21 after the last inoculation. During the administration of the extract, 200 ㎍ of the extract was dissolved in 1 ml of 0.9% physiological saline, filtered through a membrane filter (pore size 0.2 μm, Whatman), and then orally administered once a day for 16 weeks.

division Control Example 1 Example 2 Example 3 Example 4 Comparative Example 1 Comparative Example 2 Rheumatic Factors
(u / ml) 22 20 19 15 27 29 24

As shown in Table 5, the extracts prepared according to Examples 1 to 4 of the present invention shows a low value compared to the group using the extracts prepared according to Comparative Examples 1 and 2 confirmed that the rheumatoid arthritis inhibitory effect It was.

Hereinafter, the preparation examples of the composition containing the powder of the present invention will be described, but the present invention is not intended to limit the present invention, but merely to explain in detail.

Formulation Example 1 Preparation of Powder

500 mg of the mixed extract powder obtained in Example 1

Lactose 100 mg

Talc 10 mg

The above ingredients are mixed and filled in an airtight cloth to prepare a powder.

Formulation Example 2 Preparation of Tablet

300 mg of the mixed extract powder obtained in Example 1

Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.

Formulation Example 3 Preparation of Capsule

200 mg of the mixed extract powder obtained in Example 1

3 mg of crystalline cellulose

Lactose 14.8 mg

Magnesium Stearate 0.2 mg

According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.

Formulation Example 4 Preparation of Injection

600 mg of the mixed extract powder obtained in Example 1

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

Na ₂ HPO _4, 12H ₂ O 26 mg

According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule.

Formulation Example 5 Preparation of Liquid

4 g of the mixed extract powder obtained in Example 1

10 g of isomerized sugar

5 g of mannitol

Purified water

According to the conventional method of preparing a liquid solution, each component is added to the purified water to dissolve, the lemon flavor is added appropriately, the above components are mixed, and then purified water is added to adjust the total amount to 100 g. To prepare a liquid formulation.

Formulation Example 6 Preparation of Granules

1,000 mg of the mixed extract powder obtained in Example 1

Vitamin Mixture

70 μg of vitamin A acetate

Vitamin E 1.0 mg

Vitamin B1 0.13 mg

Vitamin B2 0.15 mg

Vitamin B6 0.5 mg

0.2 μg of vitamin B12

Vitamin C 10 mg

10 μg biotin

Nicotinamide 1.7 mg

50 μg folic acid

Calcium Pantothenate 0.5 mg

Mineral mixture

Ferrous Sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

15 mg potassium monophosphate

Dicalcium Phosphate 55 mg

Potassium Citrate 90 mg

Calcium Carbonate 100 mg

Magnesium chloride 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixtures is mixed with a component suitable for granules in a preferred embodiment, the composition ratio may be arbitrarily modified, and the above components are mixed according to a conventional granulation method, and then granulated. It can be prepared and used in the manufacture of health functional food composition according to a conventional method.

Formulation Example 7 Preparation of Functional Beverage

 1,000 mg of the mixed extract powder obtained in Example 1

Citric Acid 1,000 mg

100 g oligosaccharides

Plum concentrate 2 g

1 g of taurine

Add 900 mL of purified water

After mixing the above components according to the conventional healthy beverage production method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed sterilized and then refrigerated Used to prepare functional beverage compositions of the invention.

Although the composition ratio is mixed with a relatively suitable component for a preferred beverage in a preferred embodiment, the compounding ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, and usage.

Claims (8)

A pharmaceutical composition for the prevention or treatment of arthritis, characterized in that it contains a mixture consisting of thistle and wedge as an active ingredient. The method of claim 1, wherein the mixture of thistle and the dew is a pharmaceutical composition for the prevention or treatment of arthritis, characterized in that the extract extracted by boiling water at 80 to 100 ℃ by mixing thistle and the dew in a weight ratio of 1: 0.05 to 0.5. The method of claim 1, wherein the arthritis is osteoarthritis, rheumatoid arthrits, ankylosing spondylitis, reactive arthritis, psoriatic arthritis, systemic lupus erythematosus, multiple Pharmaceutical composition for the prevention or treatment of arthritis, characterized in that the myositis (polymyositis) or polymyalgia rhematica. The method for preventing or treating arthritis of claim 1, wherein the thistle is a mixed extract of a flower, a stem and a leaf, and a root of a milk thistle mixed at a weight ratio of 1: 0.5-3: 0.5-2. Composition. The pharmaceutical composition for preventing or treating arthritis according to claim 4, wherein the mixture of the stem and the leaf is mixed at a weight ratio of 1: 1-4. The method of claim 4, wherein the mixed extract is a mixture of the thistle flower, the mixture of the stem and leaves and extract the extract of the bath at 80 to 100 ℃, and the extract of the extract of the bath at 80 to 100 ℃ separately characterized in that the mixture Pharmaceutical composition for the prevention or treatment of arthritis. The pharmaceutical composition for preventing or treating arthritis according to claim 6, wherein a powder obtained by drying and pulverizing the residue remaining after extracting the roots at 80 to 100 ° C. in a mixed extract is added to the mixed extract. Food composition for the improvement or prevention of arthritis, characterized in that it contains a mixture consisting of thistle and wedge as an active ingredient.