CN116726141B - Composition for preventing and relieving osteoarthropathy and application thereof - Google Patents
Composition for preventing and relieving osteoarthropathy and application thereof Download PDFInfo
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- CN116726141B CN116726141B CN202310992980.7A CN202310992980A CN116726141B CN 116726141 B CN116726141 B CN 116726141B CN 202310992980 A CN202310992980 A CN 202310992980A CN 116726141 B CN116726141 B CN 116726141B
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Abstract
The invention belongs to the technical field of medical preparations, and particularly relates to a composition for preventing and relieving osteoarthropathy and application thereof. The composition for preventing and relieving osteoarthropathy is prepared from the following raw materials in parts by weight: 0.5-2 parts of vitamin C, 25-37 parts of glucosamine derivative, 0.3-0.6 part of manganese gluconate, 15-30 parts of dimethyl sulfone, 1-1.2 parts of boron-containing compound, 4.4-10 parts of chondroitin sulfate, 4-8 parts of lemon flavone, 4.4-8 parts of bone collagen peptide powder, 0.5-5 parts of boswellia serrata extract, 1-3 parts of turmeric extract and 0.04-0.15 part of sodium hyaluronate. The invention has better effect on preventing and relieving osteoarthropathy and has no side effect.
Description
Technical Field
The invention belongs to the technical field of medical preparations, and particularly relates to a composition for preventing and relieving osteoarthropathy and application thereof.
Background
Osteoarthropathy, also known as degenerative osteoarthropathy or osteoarthritis, is a disorder of bone pain, stiff feel, limited movement, etc. caused by destruction of articular cartilage, and is a clinically common disease, especially in middle-aged and elderly people, with high incidence, and common diseases are caused at the knee joint, spine, marrow joint and interphalangeal joint parts with heavy loads. The traditional treatment method of osteoarthropathy is to take anti-inflammatory analgesic after onset, and common medicines include acetaminophen, non-steroidal anti-inflammatory drugs (simply called anti-inflammatory drugs) and opium drugs. Although the medicine can relieve the symptoms of pain to a certain extent, the symptoms and root causes are treated, the side effects are strong, and the damage to the liver, the kidney and the digestive tract can be caused after long-term administration.
Chinese patent CN 1531932a discloses a process formulation of a composite chondroitin sulfate bone-strengthening tablet, which comprises (wt%): 30-50 parts of chondroitin sulfate, 40-60 parts of glucosamine hydrochloride, 2-3 parts of soybean isoflavone and the balance of auxiliary materials. The formula mainly utilizes the mixture of glucosamine hydrochloride and chondroitin sulfate to catalyze the synthesis of collagen and proteoglycan, thereby repairing cartilage and treating arthritis; and soybean isoflavone is added to affect bone metabolism and promote bone formation. The formulation is relatively single in composition and lacks components that have an effect of reducing inflammation.
Chinese patent CN 109106944a discloses a composition for preventing and treating osteoarthritis and its application, the composition contains non-denatured type II collagen and cartilage collagen peptide, and the weight ratio of the non-denatured type II collagen to the cartilage collagen peptide is most preferably 1:1.5-6, the composition further contains one or more of licorice extract, houttuynia cordata extract, turmeric and vitamin C. The composition of the patent prevents the degeneration of joints by supplementing the main components of the cartilage tissue of the joints, and focuses on prevention and treatment directions.
Chinese patent CN 101878029a discloses a pharmaceutical composition for the treatment and/or prevention of osteoarthropathy, which composition comprises: possibly sufficient amounts of a pharmaceutical carrier or diluent, a glycosaminoglycan, an alpha 2 adrenergic receptor activating compound, an anti-inflammatory agent, and stem cells. This patent exploits anxiolytic, analgesic, sedative and anaesthesia-free effects of ligands for the alpha 2 adrenergic receptor (especially agonists), while supplementing glycosaminoglycans and hyaluronic acid, both of which combine to confer compressibility and elasticity to cartilage. The composition mainly comprises organic synthetic medicines, and has certain side effects.
Disclosure of Invention
The invention aims to provide a composition for preventing and relieving osteoarthropathy, which has the effects of preventing osteoarthropathy and relieving pain; the invention also provides the use of the composition for preventing and alleviating osteoarthropathy.
The composition for preventing and relieving osteoarthropathy is prepared from the following raw materials in parts by weight:
vitamin C0.5-2 parts
Glucosamine derivative 25-37 parts
0.3 to 0.6 part of manganese gluconate
Dimethyl sulfone 15-30 parts
1 to 1.2 parts of boron-containing compound
Chondroitin sulfate 4.4-10 parts
Lemon flavone 4-8 parts
4.4-8 parts of collagen peptide powder
0.5-5 parts of boswellia serrata extract
1-3 parts of turmeric extract
0.04-0.15 part of sodium hyaluronate.
The glucosamine derivative is D-glucosamine potassium sulfate or D-glucosamine hydrochloride.
The boron-containing compound is one or more of boron citrate, boron glycinate or boron L-aspartate.
The application of the composition for preventing and relieving osteoarthropathy is that the composition for preventing and relieving osteoarthropathy is prepared into a preparation by a carrier and/or an excipient.
The preparation is one of a tablet, a pill, a capsule, a granule or a medicinal granule.
The composition for preventing and relieving osteoarthropathy is preferably prepared from the composition for preventing and relieving osteoarthropathy, auxiliary materials, a lubricant, a disintegrating agent and a glidant through the steps of mixing, granulating, tabletting, and coating or not coating.
The application of the composition for preventing and relieving osteoarthropathy comprises the following steps:
(1) Uniformly mixing the glucosamine derivative, the lemon flavone, the boswellia serrata extract, the auxiliary materials and the turmeric extract to obtain mixed powder A;
(2) Wet mixing the mixed powder A with pure water, and granulating to obtain wet granules;
(3) Drying the wet granules and finishing the granules to obtain dry granules;
(4) Vitamin C, manganese gluconate, a boron-containing compound and sodium hyaluronate are uniformly premixed to obtain mixed powder B;
(5) Uniformly mixing chondroitin sulfate and bone collagen peptide powder to obtain mixed powder C;
(6) Uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the disintegrating agent, the lubricant and the glidant to obtain total mixed powder;
(7) Tabletting the total mixed powder to obtain tablets.
The auxiliary materials are one or more of calcium hydrophosphate, microcrystalline cellulose or sorbitol.
The auxiliary material is preferably calcium hydrophosphate.
The lubricant is stearic acid or magnesium stearate.
The lubricant is preferably stearic acid.
The disintegrating agent is one or more of croscarmellose sodium, sodium carboxymethyl starch or crospovidone.
The glidant is one or more of silicon dioxide, micro silica gel or talcum powder.
The specification of the tablet is 0.3-1.5 g/tablet.
The D-glucosamine potassium sulfate salt can be used for repairing joint diseases and protecting joints. The D-glucosamine hydrochloride can promote synthesis of cartilage cell proteoglycan, improve joint synovial fluid viscosity, and improve joint cartilage metabolism. Chondroitin sulfate is a compound rich in aminopolysaccharides, and can effectively keep cartilage moisture, lubricate joints, remove inflammatory substances in joint cavities, repair joint cartilage and relieve joint pain, swelling and stiffness. The combined use of D-glucosamine potassium sulfate/D-glucosamine hydrochloride and chondroitin sulfate promotes the synthesis of type II collagen and polysaccharide in human articular chondrocytes, maintains the stability of the chondrocyte extracellular matrix, reduces the death of the chondrocytes, and maintains the balance of anabolism and catabolism of the chondrocyte extracellular matrix. Boron and manganese play an indispensable auxiliary role in the above process, and if the lack causes the synthesis disorder of chondroitin, osteoblast activity is limited. Therefore, the D-glucosamine potassium sulfate/D-glucosamine hydrochloride, the chondroitin sulfate, the boron-containing compound and the manganese gluconate are synergistic, and the purposes of maintaining bone density, promoting cartilage synthesis and repairing articular cartilage can be achieved.
50% of constituent materials of articular cartilage are proteins containing sulfur elements such as collagen, and supplementing collagen plays an important role in the human body, while sulfur is an element essential for collagen synthesis. Dimethyl sulfone is a main source of sulfur element in human body, is an essential substance for synthesizing collagen protein in human body, has the functions of relieving pain and diminishing inflammation, and particularly has the function of relieving joint or other pains. Vitamin C deficiency will cause a disturbance of collagen synthesis. Collagen synthesis can be divided into two stages, namely intracellular procollagen synthesis and extracellular collagen fiber formation, and the effect of vitamin C on collagen synthesis is mainly reflected in the pre-alpha-peptide chain formation process of the procollagen synthesis stage. In this process, proline and lysine are catalyzed by related enzymes in the endoplasmic reticulum to form hydroxypropionamide and hydroxylysamide residues, and oxygen, vitamin C, etc. are required for activating such enzymes. Therefore, the compatibility of the dimethyl sulfone and the vitamin C promotes the synthesis of collagen, and additionally supplements the collagen, so that collagen molecules are ensured to be highly orderly arranged into a collagen fiber net frame structure, and the collagen fiber net frame structure has highly water-absorbing proteoglycan embedded therein, so that cartilage has unique elasticity, low friction and high compression resistance, and plays a role in preventing osteoarthropathy.
The pathogenesis of osteoarthritis is studied to show that cytokines: interleukin (IL), tumor necrosis factor (tumor necrosis factor-. Alpha., TNF-. Alpha.), transforming growth factor (transforming growth factor, TGF), nitric Oxide (NO), leukotriene, etc. are considered to be closely related to the production of osteoarthritis.
Interleukin 6 (IL-6) inhibits the synthesis of cartilage glycoprotein, promotes the degradation of fibroblasts and matrix micro-molecules, and aggravates cartilage damage. Local high levels of IL-6 in the joint may be associated with its effects on chondrocyte proliferation, responsiveness to cartilage damage, and enhancement of arthritic responses. The Curcuma rhizome extract is dried rhizome extract of Curcuma longa L of Zingiberaceae, and contains curcumin as main ingredient. Curcumin can inhibit chondrocyte from releasing metalloproteinase-13 (MMP-13) and interleukin 6 (IL-6), reduce inflammatory reaction, and can also directly inhibit the expression of various cytokines such as IL-6, and has good stability and low cytotoxicity.
NO is widely involved in the metabolic activity of cells, and when being used as a free radical, has the effects of cytotoxicity and information transmission, and the abnormal increase of the content of articular cartilage and synovial fluid can cause serious arthropathy, and the NO can also generate biological effects with other inflammatory factors (such as IL-1, TNF-alpha and the like) to promote the destruction of the articular cartilage, and the negative biological effects are mutually overlapped and accelerate the pathological changes of joints. Lemon flavone is extract of lemon of Citrus of Rutaceae. The lemon flavone has obvious antioxidation effect, eliminates human free radicals, and is helpful for reducing the damage of the free radicals to human bodies.
The main ingredient of the Boswellia serrata extract is boswellic acid, which can inhibit synthesis of leukotriene in human body and inhibit activity of enzyme related to inflammatory reaction and hyaluronidase (an enzyme capable of hydrolyzing hyaluronic acid). Leukotrienes are the products of the antigen-stimulated response of inflammatory cells, such as eosinophils, mast cells, basophils, or macrophages, to various biological signals, including sensitized tissues. Leukotrienes induce inflammatory reactions such as joint swelling and pain, bone destruction and the like by inhibiting neutrophil apoptosis and inducing directional migration, causing joint pain and allergy, regulating and controlling immune cell differentiation, cytokine expression and other mechanisms.
The turmeric extract, lemon flavone and the boswellia serrata extract are eaten simultaneously, can synthesize cartilage, delay cartilage degradation and remove inflammatory reactants respectively, supplement each other, diminish inflammation and relieve pain, and has low side effect.
Curcumin contains hydroxyl, ether bond and ketone group, boswellic acid contains hydroxyl and carboxyl, lemon flavone contains ketone group, three form three-dimensional network structure through hydrogen bond, and the ketone group of curcumin and the ketone group of lemon flavone are mutually attracted, and the hydroxyl of curcumin and the hydroxyl of frankincense are mutually attracted, and the hydroxyl of curcumin and the carboxyl of frankincense are mutually attracted, so that three-dimensional network structure is more stable. In addition, curcumin is long-chain structure, boswellic acid is long-chain structure too, and both molecular chains twine each other, and lemon flavone is short-chain structure, and after the three mixes, lemon flavone free is between curcumin and boswellic acid molecular chain for three-dimensional network structure is further stable more, and the ability of synergetically clearing away free radical improves greatly.
The long-term administration of dimethyl sulfone can cause adverse reaction to digestive tract, such as nausea, emesis, acid regurgitation, abdominal pain, diarrhea, etc., while lemon flavone can slow down gastrointestinal peristalsis and relieve gastrointestinal discomfort. The dimethyl sulfone and the lemon flavone are taken simultaneously, so that adverse reactions caused by taking the dimethyl sulfone alone are greatly relieved, and the medicinal effects of the dimethyl sulfone and the lemon flavone are not influenced.
The main component of the sodium hyaluronate is hyaluronic acid, and the hyaluronic acid is a unique linear mucopolysaccharide, is the main component of a joint sliding cavity, can play a role in lubricating joints, can protect joint cartilage and increase the mobility of the joints.
The beneficial effects of the invention are as follows:
the invention has better effect on preventing and relieving osteoarthropathy and has no side effect.
Drawings
Fig. 1 is a graph of VAS pain scoring results.
Fig. 2 is a graph of WOMAC joint index scoring results.
Fig. 3 is a graph of the results of the thickness of the swelling of the feet of mice.
Fig. 4 is a graph of the results of murine arthritis scoring.
Detailed Description
The invention is further described below with reference to examples.
Example 1
The raw materials comprise the following components in parts by weight:
vitamin C:1 part of D-glucosamine potassium sulfate salt: 37 parts of manganese gluconate: 0.44 parts of dimethyl sulfone: 22 parts of boron citrate: 0.46 part of glycine boron: 0.3 part of L-boron aspartate: 0.42 part of chondroitin sulfate: 4.4 parts of lemon flavone: 5 parts of bone collagen peptide powder: 4.4 parts of boswellia serrata extract: 5 parts of turmeric extract: 3 parts of sodium hyaluronate: 0.04 part of calcium hydrophosphate: 14.04 parts of stearic acid: 1 part of croscarmellose sodium: 1 part of silicon dioxide: 0.5 part.
The preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, lemon flavone, boswellia serrata extract, calcium hydrophosphate and turmeric extract are mixed for 10 minutes in a mixer, and are uniformly mixed to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the crosslinked sodium carboxymethyl cellulose, the stearic acid and the silicon dioxide to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 360mg plus or minus 5 percent.
Example 2
The raw materials comprise the following components in parts by weight:
vitamin C:0.5 part of D-glucosamine hydrochloride: 25 parts of manganese gluconate: 0.6 part of dimethyl sulfone: 15 parts of boron citrate: 0.5 part of glycine boron: 0.2 part of L-boron aspartate: 0.5 part of chondroitin sulfate: 10 parts of lemon flavone: 4 parts of bone collagen peptide powder: 5 parts of boswellia serrata extract: 3 parts of turmeric extract: 2 parts of sodium hyaluronate: 0.15 parts of microcrystalline cellulose: 66.55 parts of magnesium stearate: 1 part of sodium carboxymethyl starch: 0.5 part of silicon dioxide: 0.5 part.
The preparation method comprises the following steps:
(1) D-glucosamine hydrochloride, lemon flavone, boswellia serrata extract, microcrystalline cellulose and turmeric extract are mixed for 10 minutes in a mixer, and the mixture is uniformly mixed to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the magnesium stearate, the silicon dioxide and the sodium carboxymethyl starch to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 500 mg+/-5%.
Example 3
The raw materials comprise the following components in parts by weight:
vitamin C:2 parts of D-glucosamine potassium sulfate salt: 30 parts of manganese gluconate: 0.3 parts of dimethyl sulfone: 30 parts of boron citrate: 0.3 part of glycine boron: 0.5 part of L-boron aspartate: 0.2 part of chondroitin sulfate: 8 parts of lemon flavone: 8 parts of bone collagen peptide powder: 8 parts of boswellia serrata extract: 0.5 parts of turmeric extract: 1 part of sodium hyaluronate: 0.1 part of sorbitol: 63.2 parts of magnesium stearate: 1.2 parts of sodium carboxymethyl starch: 1.5 parts of talcum powder: 0.2 parts.
The preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, lemon flavone, boswellia serrata extract, sorbitol and turmeric extract are mixed for 10 minutes in a mixer, and mixed uniformly to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the magnesium stearate, the talcum powder and the sodium carboxymethyl starch to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 540mg plus or minus 5 percent.
Comparative example 1
The raw materials comprise the following components in parts by weight:
vitamin C:1 part of D-glucosamine potassium sulfate salt: 37 parts of manganese gluconate: 0.44 parts of dimethyl sulfone: 22 parts of boron citrate: 0.46 part of glycine boron: 0.3 part of L-boron aspartate: 0.42 part of chondroitin sulfate: 4.4 parts of bone collagen peptide powder: 4.4 parts of boswellia serrata extract: 5 parts of turmeric extract: 3 parts of sodium hyaluronate: 0.04 part of calcium hydrophosphate: 19.04 parts of stearic acid: 1 part of croscarmellose sodium: 1 part of silicon dioxide: 0.5 part.
The preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, boswellia serrata extract, calcium hydrophosphate and turmeric extract are mixed for 10 minutes in a mixer, and are uniformly mixed to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the crosslinked sodium carboxymethyl cellulose, the stearic acid and the silicon dioxide to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 360mg plus or minus 5 percent.
Comparative example 2
The raw materials comprise the following components in parts by weight:
vitamin C:1 part of D-glucosamine potassium sulfate salt: 37 parts of manganese gluconate: 0.44 parts of dimethyl sulfone: 22 parts of boron citrate: 0.46 part of glycine boron: 0.3 part of L-boron aspartate: 0.42 part of chondroitin sulfate: 4.4 parts of lemon flavone: 5 parts of bone collagen peptide powder: 4.4 parts of turmeric extract: 3 parts of sodium hyaluronate: 0.04 part of calcium hydrophosphate: 19.04 parts of stearic acid: 1 part of croscarmellose sodium: 1 part of silicon dioxide: 0.5 part.
The preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, lemon flavone, calcium hydrophosphate and turmeric extract are mixed for 10 minutes in a mixer, and are uniformly mixed to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the crosslinked sodium carboxymethyl cellulose, the stearic acid and the silicon dioxide to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 360mg plus or minus 5 percent.
Comparative example 3
The raw materials comprise the following components in parts by weight:
vitamin C:1 part of D-glucosamine potassium sulfate salt: 37 parts of manganese gluconate: 0.44 parts of dimethyl sulfone: 22 parts of boron citrate: 0.46 part of glycine boron: 0.3 part of L-boron aspartate: 0.42 part of chondroitin sulfate: 4.4 parts of lemon flavone: 5 parts of bone collagen peptide powder: 4.4 parts of boswellia serrata extract: 5 parts of sodium hyaluronate: 0.04 part of calcium hydrophosphate: 17.04 parts of stearic acid: 1 part of croscarmellose sodium: 1 part of silicon dioxide: 0.5 part.
The preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, lemon flavone, boswellia serrata extract and calcium hydrophosphate are mixed for 10 minutes in a mixer, and are uniformly mixed to obtain mixed powder A.
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes. Discharging the materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules.
(3) And (3) placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles.
(4) Vitamin C, manganese gluconate (anhydrous), boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, and then mixed powder B is obtained.
(5) And uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free from caking, thus obtaining mixed powder C.
(6) And uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the crosslinked sodium carboxymethyl cellulose, the stearic acid and the silicon dioxide to obtain the total mixed powder.
(7) Tabletting by a rotary tablet press, wherein the loading amount is 360mg plus or minus 5 percent.
1. Effect verification
180 volunteers with age 50-65 years and knee joint disease were summoned, and divided into six groups of 30 persons each, each of which was taken with the products of examples 1-3 and comparative examples 1-3, 2 times per day, 3 tablets each time. The continuous administration was carried out for 9 weeks, using internationally recognized VAS pain scores [ from 0 ("no pain at all") to 10 ("maximum pain") ] and WOMAC osteoarthritis index as observations, scoring tests were carried out before administration, 3 weeks, 6 weeks, 9 weeks, respectively, and adverse reactions were recorded.
The verification results are shown in fig. 1 and 2. The results show that: the tablet prepared by the composition of the invention can be taken regularly and quantitatively, so that the purpose of preventing and relieving osteoarthropathy can be achieved in a relatively short time; and no adverse reactions occurred in the volunteers during the eating period and after the test. In comparison with example 1, comparative example 1 lacks lemon flavone, comparative example 2 lacks boswellia serrata extract, comparative example 3 lacks turmeric extract, and neither of comparative examples 1-3 is as effective as example 1.
2. Anti-inflammatory test in mice
Test materials: tablets of example 1, physiological saline, tablets of comparative example 1, tablets of comparative example 2, tablets of comparative example 3, ELISA kits, type II collagen, complete Freund's adjuvant.
Animals: 50 DBA/1 mice, male, 6-8 weeks old, and body weight 18-20g.
Construction of arthritis model: primary immunization: each mouse was injected intradermally with 100. Mu.l of an emulsion of type II collagen and complete Freund's adjuvant, and the first immunization was recorded as 1d. A second boost was performed in the same way at 21 d.
After the model preparation is completed, oral gastric lavage experiments are started: the 50 model mice were randomly divided into five groups, which were respectively designated as example 1 group, comparative example 2 group, comparative example 3 group and blank control group, and the tablets of example 1, comparative example 1 and comparative example 2 were respectively given, and the tablets of comparative example 3 were administered by gastric lavage at a dose of 30mg/kg, and the blank control group was administered with an equal amount of physiological saline. Each group of animals was continuously gavaged for 28 days, 1 time per day.
(1) Foot swelling degree measurement and arthritis scoring
The thickness of the left hind paw on the same side of each group of mice was measured with vernier calipers on days 1, 7, 14, 21, 28 of gavage, respectively, and the results are shown in figure 3. Meanwhile, an arthritis score was made, and each paw was scored separately according to the extent of lesions of the remaining 3 uninjected limbs and whether or not the toes were inflamed, except for the right post-induction site:
0 point: no evidence of erythema and swelling;
1, the method comprises the following steps: erythema and mild swelling are localized to the midfoot or ankle;
2, the method comprises the following steps: erythema and mild swelling spread from the ankle joint to the midfoot;
3, the method comprises the following steps: erythema and mild swelling spread from ankle to joint;
4, the following steps: erythema and severe swelling include ankle, foot and toe.
The cumulative score was recorded as the arthritis index for each mouse at 0-4 points, and the results are shown in FIG. 4.
As can be seen from fig. 3 and 4, the anti-inflammatory effects of the example 1 group, the comparative example 2 group and the comparative example 3 group are all superior to those of the blank control group, and the anti-inflammatory effects of the example 1 group are superior to those of the comparative example 1 group, the comparative example 2 group and the comparative example 3 group. The tablet of example 1 has the effects of improving arthritis swelling, reducing arthritis score and delaying the progression of arthritis.
(2) Comparison of mouse serum TNF-alpha, IL-1 beta, IL-6 and IL-17 levels
On day 28 of gastric lavage, after measurement of the degree of sufficient swelling and arthritis scoring, levels of tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1 beta), interleukin-6 (IL-6) and interleukin-17 (IL-17) in serum of each group of mice were examined by ELISA, and the results are shown in Table 1.
As can be seen from Table 1, the levels of TNF-a, IL-1B, IL-6 and IL-17 in the serum of mice in the example 1 group, the comparative example 2 group and the comparative example 3 group were reduced as compared with the blank control group, and the example 1 group was superior to the comparative example 1 group, the comparative example 2 group and the comparative example 3 group, demonstrating that the composition of the present invention has a remarkable anti-inflammatory effect.
Claims (1)
1. The composition for preventing and relieving osteoarthropathy is characterized by comprising the following raw materials in parts by weight:
vitamin C:1 part of D-glucosamine potassium sulfate salt: 37 parts of manganese gluconate: 0.44 parts of dimethyl sulfone: 22 parts of boron citrate: 0.46 part of glycine boron: 0.3 part of L-boron aspartate: 0.42 part of chondroitin sulfate: 4.4 parts of lemon flavone: 5 parts of bone collagen peptide powder: 4.4 parts of boswellia serrata extract: 5 parts of turmeric extract: 3 parts of sodium hyaluronate: 0.04 part of calcium hydrophosphate: 14.04 parts of stearic acid: 1 part of croscarmellose sodium: 1 part of silicon dioxide: 0.5 parts;
the preparation method comprises the following steps:
(1) D-glucosamine potassium sulfate salt, lemon flavone, boswellia serrata extract, calcium hydrophosphate and turmeric extract are mixed for 10 minutes in a mixer, and mixed uniformly to obtain mixed powder A;
(2) Placing the mixed powder A into a wet mixer, adding pure water as an adhesive, and wet mixing for 2 minutes; discharging materials, and granulating all the materials in a swing granulator by a 16-mesh screen to obtain wet granules;
(3) Placing the prepared wet particles into a high-efficiency boiling dryer for drying, and granulating the dried materials by a swinging granulator to obtain dry particles;
(4) Vitamin C, anhydrous manganese gluconate, boron citrate, boron glycinate, L-aspartic acid boron and sodium hyaluronate are premixed uniformly until the colors are consistent and no agglomeration exists, so as to obtain mixed powder B;
(5) Uniformly mixing chondroitin sulfate and bone collagen peptide powder until the color is consistent and the powder is free of caking, so as to obtain mixed powder C;
(6) Uniformly mixing the dry particles, the mixed powder B, the mixed powder C, the dimethyl sulfone, the crosslinked sodium carboxymethyl cellulose, the stearic acid and the silicon dioxide to obtain total mixed powder;
(7) Tabletting by a rotary tablet press, wherein the loading amount is 360mg plus or minus 5 percent.
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