CN101559218A - Composition with function of increasing bone density - Google Patents
Composition with function of increasing bone density Download PDFInfo
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- CN101559218A CN101559218A CNA200910078091XA CN200910078091A CN101559218A CN 101559218 A CN101559218 A CN 101559218A CN A200910078091X A CNA200910078091X A CN A200910078091XA CN 200910078091 A CN200910078091 A CN 200910078091A CN 101559218 A CN101559218 A CN 101559218A
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- CN
- China
- Prior art keywords
- calcium carbonate
- chondroitin sulfate
- compositions
- glucosamine hydrochloride
- composition
- Prior art date
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- Granted
Links
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- 230000037182 bone density Effects 0.000 title claims abstract description 24
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 69
- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims abstract description 39
- 229920001287 Chondroitin sulfate Polymers 0.000 claims abstract description 39
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- CBOJBBMQJBVCMW-BTVCFUMJSA-N (2r,3r,4s,5r)-2-amino-3,4,5,6-tetrahydroxyhexanal;hydrochloride Chemical compound Cl.O=C[C@H](N)[C@@H](O)[C@H](O)[C@H](O)CO CBOJBBMQJBVCMW-BTVCFUMJSA-N 0.000 claims abstract description 31
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Abstract
The invention relates to a composition with a function of increasing bone density and a preparation method thereof. Active components comprised by the composition are calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, casein phosphopeptide, and soy isoflavone. The composition is prepared by reasonably and scientifically matching and combining the raw materials, and is prepared into oral preparations which are convenient to take. Experiments prove that the composition has the function of increasing the bone density.
Description
Technical field
The present invention relates to a kind of composition and method of making the same, belong to the health food technology field with bone density improving function.
Background technology
Osteoporosis is a kind of skeletal diseases of general, is characterized in osteopenia, and the fine structure of osseous tissue is destroyed, and the fragility of bone is increased, and the danger of fracture increases.It can make except that head the skeleton at any position fracture.Because the aging of world population is even osteoporosis and osteopenia also are common metabolic osteopathy in developed country.Medical circle will have been prevented and treated osteoporosis, the prevention fracture is placed on position of equal importance with treatment hyperlipidemia, prevention myocardial infarction, treatment hypertension prevention apoplexy.According to incompletely statistics, the senile osteoporosis disease sickness rate of China more than 60 years old is about 59.89%, bone density improving, effectively treats the important topic that osteoporosis has become people's extensive concern.
Osteoporosis be one worldwide, more and more cause the health problem that people pay attention to.About 200,000,000 people in the whole world suffer from osteoporosis at present, and its sickness rate has leapt to commonly encountered diseases, frequently-occurring disease the 7th.Current research shows that in fact the osteoporosis in that China is considered to the peculiar disease of old people always just exists in the Childhood.Up to now, still do not have a kind of safe and effective method to make the skeleton after loosening recover normal bone amount and structure fully, therefore improve the understanding of people, understand its pathogenic factors, strengthen early prevention and seem particularly important osteoporosis danger.
Prevent or reduce the generation of primary disease, people take certain intervening measure just to seem very necessary except strengthening self health consciousness, making great efforts to form the good living habit.Health food has certain health care, and safe, can take for a long time, can satisfy the demand of people's daily health caring again, therefore, the exploitation bone density improving health food be with a wide range of applications.This product also can significantly reduce the risk factor that current sickness rate height, morbidity crowd are wide, have a strong impact on the osteoporosis disease of human health and quality of life in bone density improving, can strengthen the meaning and the value of osteoporosis early prevention greatly.
Summary of the invention
Based on above-mentioned situation, the object of the present invention is to provide a kind of compositions with bone density improving function; Another purpose provides the preparation method of above-mentioned composition; Also be to provide the application of above-mentioned composition in preparation prevention or minimizing osteoporosis product.
The present invention is achieved by the following technical solutions:
A kind of compositions with bone density improving function, his contained active component is calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, soybean isoflavone, by weight, the active component of making said composition is: calcium carbonate 5-15 part, glucosamine hydrochloride 4-12 part, chondroitin sulfate 2-6 part, phosphopeptide caseinate 3-7 part, soybean isoflavone 2-6 part; Preferably, by weight, calcium carbonate 8-12 part, glucosamine hydrochloride 6-10 part, chondroitin sulfate 3-5 part, phosphopeptide caseinate 4-6 part, soybean isoflavone 3-5 part; Particularly preferably be, by weight, the active component of making said composition is: calcium carbonate 9-11 part, glucosamine hydrochloride 7-9 part, chondroitin sulfate 3.5-4.5 part, phosphopeptide caseinate 4.5-5.5 part, soybean isoflavone 3.5-4.5 part; Best of breed is 10 parts of calcium carbonate, 8 parts of glucosamine hydrochloride, 4 parts of chondroitin sulfate, 5 parts of phosphopeptide caseinates, 4 parts of soybean isoflavone.
Preparation of the present invention is an oral formulations; Comprise: hard capsule, soft capsule, granule, tablet, milk slice, sour milk tablet, colostrum sheet, chewable tablet, honeyed pill, concentrated honeyed pill, water-honeyed pill, condensed water honeyed pill, oral liquid, packed medicinal tea, decoction medicinal tea, beverage, powder, saccharide, medicated wine, preserve.
Described preparation also comprises adjuvant except that active component.
The preparation technology of described preparation comprises: gets calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, soybean isoflavone, sieves, add acceptable accessories, and mixing, prepared becomes required oral formulations routinely.
The preparation method of described tablet is: get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, soybean isoflavone, cross 80 mesh sieves respectively, add filler, mix, add wetting agent, granulate, dry, granulate adds lubricant, mixes, tabletting, coating, packing gets tablet.
The present composition has the function of bone density improving, is used for the application at preparation prevention or minimizing osteoporosis or relevant disease product.
Active component of the present invention all is commercially available or is prepared from according to the character of each active component.
Osteoporosis is impaired with the osseous tissue microstructure, and bone ore deposit composition and bone matrix equal proportion ground constantly reduce, the sclerotin attenuation, and bone trabecula quantity reduces, the disease of a kind of whole body dysostosis that increase of bone fragility and risk of fractures degree raise.It is many-sided producing osteoporotic reason, comprising heredity, life style, nutriture, disease and medicine etc.
This product is in the osteoporotic generation reason of analysis-by-synthesis, osteoporosis symptom, osteoporosis crowd's situation, and be foundation with modern pharmacology research, form improve bone density or help the effect of calcium absorption of the equal tool of each active component in conjunction with the functional characteristics prescription of chemistry that is mainly used in osteoporotic conditions at present and natural product.
Growth promoter and the metabolism of calcium to keeping human body; Keep, adjust the normal excitement of N﹠M; The division of cell; The activation of enzyme; Solidifying of blood; Endocrine activity and people's thinking activities or the like physiological function is significant.
In forming active component of the present invention, Maalox Antacid in and can generate the solubility calcium ion during gastric acid and blood calcium is risen by intestinal absorption.Because of its calcium content height, have no side effect, be to use the calcium complement agent of the most extensive, that calcium content is the highest, effective, price is low the best.
Glucosamine is a kind of natural amino monosaccharide, is present in human body particularly in the articular cartilage, is the base substance of synthesizing amino polysaccharide, also is the constituent of proteoglycan in the articular cartilage.It can act on articular cartilage specifically, recovers the normal metabolic function of chondrocyte, stimulates the proteoglycan that chondrocyte produces normal polymer structure, safeguards the morphosis of cartilage matrix; Suppress the generation of super oxyradical, collagenase and the phospholipase A2 of damage cartilage matrix II Collagen Type VI; Suppress the synthetic of prostaglandin, various harmful substances such as protection 17-hydroxy-11-dehydrocorticosterone are to the destruction of chondrocyte, thereby delay the pathological process and the progression of disease of bone articular degeneration, improve joint motion, alleviating pain.The total trend of glucosamine drug study shows that glucosamine can improve the symptom of osteoarthritis; promote the metabolic activity of articular cartilage to strengthen; the anabolism of collagen, ammonia polyose of candy and other structural protein increases, and the protection and the reparation of articular cartilage had crucial meaning.
Chondroitin sulfate (CS) sodium salt and D-glucamine and D-galactose therapeutic alliance arthritis, but mitigation symptoms, its mechanism can be removed Na+ in a large amount of absorption synovial membranes for CS, promotes bone matrix hyperplasia, and destructive cartilage is recovered normally.But the CS of natural PHOSPHATIDYL ETHANOLAMINE derivatization avoids damage in natural joint cartilage surface protective tissue, and synthetic PECS is used in damaged part, simulates natural CSPG effect, can suppress the formation of pannus, the protection cartilaginous tissue.Chondroitin sulfate can be used for treatment early stage or moderate arthritis and non-evident effect; Illustrate that CS can promote osteoblastic hypertrophy, promote new bone formation, the process of accelerated bone healing.Oral CS can alleviate OA pain and improvement knee function, reduces the joint and corrodes progress.CS is a naturally occurring composition in the connective tissue, can be used for lubricated and support joint by bound water molecule, makes joint motion freely.
Phosphopeptide caseinate (CPP) derives from the peptide chain that is rich in phosphoserine in the casein, has affinity with the calcium iron ion, form soluble complexes, in whole small intestinal environment, keep dissolved state, the crystalline formation of insoluble phosphate be can delay and stop significantly, thereby the calcium of small intestinal, the absorption of ferrum increased.
Soybean isoflavone (Isoflovone) is the class secondary metabolite that Semen sojae atricolor forms in growth course, is a kind of in the biological flavone, and the estrogen of its structure and human secretory is quite similar, so be otherwise known as " phytoestrogen ".Soybean isoflavone can combine with estrogen receptor, shows two kinds of important biologic activity: estrogen activity and estrogen antagonist activity.For the low person of estrogen level, soybean isoflavone shows as weak estrogen action, combine with the estrogen receptor in the osteoblast, strengthen osteoblastic activity, promote generation, secretion and the bone mineralization process of bone matrix, but the generation of prevention of osteoporosis disease alleviates some simultaneously and estrogen level reduces diseases associated.
In sum, it is abundant that active component of the present invention all has the theoretical foundation that improves bone density or help calcium absorption, and each active component compatibility is used, and can improve the absorption of human body to calcium, bone density improving.Studies show that through pharmacological toxicology this compositions is safe and reliable in addition, the effect that improves bone density is arranged, with strong points, effective.Simultaneously, the present invention fills a prescription rationally, and meets State Food and Drug Administration's healthy food material use regulation.
Below example illustrates beneficial effect of the present invention by experiment:
Experimental example:
1, main material
Animal: cleaning level Wistar female rats, body weight 249-299g.Provide by Military Medical Science Institute's Experimental Animal Center.
Feedstuff: referring to " bone density improving functional experiment method " preparation in the Ministry of Public Health " health food check and assessment technique standard " (version in 2003).
The present composition (recommended amounts: 3.2g/ people. day (53.3mg/kgBW)).
2, method and result
At first, after middle hypogastric region unhairing is carried out partly sterilised with iodine tincture and ethanol, do 1cm left and right sides otch along the stomach wall median line rat is implemented the castration operation, extract bilateral ovaries through the anesthesia of rats by intraperitoneal injection 50mg/kgBW pentobarbital sodium solution; It is the same but do not extract bilateral ovaries that other gets the operation of one group of rat, makes Sham-operated control group.
The postoperative animal is divided into high dose group (recommended amounts is 1599mg/kgBW for 30 times), middle dosage group (recommended amounts is 533mg/kgBW for 10 times) at random according to body weight, low dose group (recommended amounts is 267mg/kgBW for 5 times), oophorectomize+solvent (contrast of castration model) group, calcium carbonate positive controls; Other establishes the sham-operation negative control group; Every group of single cage of 10 animals raised.High, medium and low dosage group is irritated stomach by design dosage with the 1ml/100gBW per os and is given the present composition, sham-operation negative control and oophorectomize+solvent (contrast of castration model) group is irritated stomach with the equivalent deionized water, the calcium carbonate positive controls gives calcium carbonate, and dosage is that 408mg/kgBW is suitable with the high dose group calcium content.All laboratory animal is all drunk deionized water, weighs once 12 weeks of experimental period weekly.
Animal feeding sacrificed by decapitation after 12 weeks, separate the right side femur, 105 baking ovens dry to constant weight, the weighing bone is heavy, use the bone mineral measuring instrument, measure the bone density of rat femur mid point and femur distal end, adopt wet method digestion, with the Z-2000 of Hitachi atomic absorption spectroscopy determination femur calcium content, the results are shown in 1-2.
Table 1 present composition is to the influence of rat femur weight and calcium content of bone (X ± s)
* compare P＜0.05 with the castration model control group
By table 1 as seen, Sham-operated control group and castration model control group compare, and unit femur calcium content is apparently higher than the castration model control group, and difference has significance (P＜0.05), and the modeling success is described; Each dosage group and castration model control group compare, and the unit femur calcium content of high dose group and middle dosage group rat is significantly higher than castration model control group rat (P＜0.05).
Table 2 present composition is respectively organized relatively (X ± SD) of rat bone density and femur length
* compare P＜0.05 with the castration model control group
By table 2 as seen, each dosage group of the present composition and castration model control group compare, and rat femur distal end bone density value, rat femur mid point bone density value (except the low dosage) etc. all is higher than castration model control group (P＜0.05); Each dosage group of the femur length present composition and castration model control group comparing difference do not have significance, have only sham operated rats to be lower than castration model control group (P＜0.05).
Consolidated statement 1, table 2, experimental result show that the present composition has the effect of bone density improving function.
Concrete embodiment
Come further to set forth preparation of compositions method of the present invention by the following examples.
Embodiment 1:
Calcium carbonate 250g glucosamine hydrochloride 200g chondroitin sulfate 100g
Phosphopeptide caseinate 125g soybean isoflavone 100g magnesium stearate 4g dextrin 5g
30 POVIDONE K 30 BP/USP 3016g stomach dissolution type film coating material 40g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, cross 80 mesh sieves respectively, add dextrin, mix, add 30 POVIDONE K 30 BP/USP 3075% alcoholic solution and granulate, 16 mesh sieve granulate, granule is standby; Take by weighing magnesium stearate by recipe quantity, cross 80 mesh sieves, mix, tabletting (the heavy 0.8g of sheet) with above-mentioned granule; Get stomach dissolution type film coating powder, be mixed with 8% 70% alcoholic solution, plain sheet is dropped into coating in the coating machine, promptly get tablet.
Wherein stomach dissolution type film coating material package is drawn together hydroxypropyl emthylcellulose 31.6g, 2g polyethylene glycol 6000, Pulvis Talci 1.2g, the edible green S of titanium dioxide 1.2g, 4g.
Eating method and amount: every day 2 times, each 2.
Embodiment 2:
Calcium carbonate 375g glucosamine hydrochloride 300g chondroitin sulfate 50g
Phosphopeptide caseinate 175g soybean isoflavone 50g maltose alcohol 49g, sucralose 1g,
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, cross 80 mesh sieves respectively, mix, add maltose alcohol, sucralose, mixing, the 80-90% alcohol granulation, drying, packing promptly gets granule.
Embodiment 3:
Calcium carbonate 125g glucosamine hydrochloride 100g chondroitin sulfate 150g
Phosphopeptide caseinate 75g soybean isoflavone 150g pregelatinized Starch 130g
Micropowder silica gel 5g aspartame 15g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add the pregelatinized Starch of recipe quantity, aspartame, mixing adds micropowder silica gel, mixing, granulate, packing promptly gets granule.
Embodiment 4:
Calcium carbonate 200g glucosamine hydrochloride 250g chondroitin sulfate 75g
Phosphopeptide caseinate 150g soybean isoflavone 125g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add mannitol, the aspartame of recipe quantity, mixing is granulated, drying, and tabletting gets chewable tablet.
Embodiment 5:
Calcium carbonate 300g glucosamine hydrochloride 150g chondroitin sulfate 125g
Phosphopeptide caseinate 100g soybean isoflavone 75g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add adjuvant, conventional method is made capsule.
Embodiment 6:
Calcium carbonate 225g glucosamine hydrochloride 175g chondroitin sulfate 112.5g
Phosphopeptide caseinate 112g soybean isoflavone 87.5g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add adjuvant, conventional method is made milk slice.
Embodiment 7:
Calcium carbonate 275g glucosamine hydrochloride 225g chondroitin sulfate 87.5g
Phosphopeptide caseinate 138g soybean isoflavone 112.5g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add adjuvant, conventional method is made pill.
Embodiment 7:
Calcium carbonate 210g glucosamine hydrochloride 180g chondroitin sulfate 87.5g
Phosphopeptide caseinate 137.5g soybean isoflavone 112.5g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add adjuvant, conventional method is made packed medicinal tea.
Embodiment 8:
Calcium carbonate 250g glucosamine hydrochloride 200g chondroitin sulfate 100g
Phosphopeptide caseinate 125g soybean isoflavone 100g
Get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, the soybean isoflavone of recipe quantity, pulverize, sieve, add adjuvant, conventional method is made oral liquid.
Claims (7)
1, a kind of compositions with bone density improving function, it is characterized in that, by weight, the active component of making said composition is: calcium carbonate 5-15 part, glucosamine hydrochloride 4-12 part, chondroitin sulfate 2-6 part, phosphopeptide caseinate 3-7 part, soybean isoflavone 2-6 part.
2, compositions according to claim 1, it is characterized in that, by weight, the active component of making said composition is: calcium carbonate 8-12 part, glucosamine hydrochloride 6-10 part, chondroitin sulfate 3-5 part, phosphopeptide caseinate 4-6 part, soybean isoflavone 3-5 part.
3, compositions according to claim 1 and 2, it is characterized in that, by weight, the active component of making said composition is: calcium carbonate 9-11 part, glucosamine hydrochloride 7-9 part, chondroitin sulfate 3.5-4.5 part, phosphopeptide caseinate 4.5-5.5 part, soybean isoflavone 3.5-4.5 part.
4, according to any described a kind of compositions among the claim 1-3, it is characterized in that described preparation is an oral formulations with bone density improving function; Comprise: hard capsule, soft capsule, granule, tablet, milk slice, sour milk tablet, colostrum sheet, chewable tablet, honeyed pill, concentrated honeyed pill, water-honeyed pill, condensed water honeyed pill, oral liquid, packed medicinal tea, decoction medicinal tea, beverage, powder, saccharide, medicated wine, preserve.
5, any described preparation of compositions method among the claim 1-3, it is characterized in that, described preparation technology comprises: get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, soybean isoflavone, sieve, add acceptable accessories, mixing, prepared becomes required oral formulations routinely.
6, preparation of compositions method according to claim 5 is characterized in that, described tablet is preparation like this: get calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, soybean isoflavone, cross 80 mesh sieves respectively, add filler, mix, add wetting agent, granulate drying, granulate adds lubricant, mixes, tabletting, coating, packing gets tablet.
According to any described compositions among the claim 1-3, it is characterized in that 7, described compositions is used for the application at preparation bone density improving product.
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Application publication date: 20091021 Assignee: Beijing Baode Runsheng Pharmaceutical Technology Development Co.,Ltd. Assignor: BEIJING INCREASE PHARMACEUTICAL TECHNOLOGY Co.,Ltd. Contract record no.: 2014110000034 Denomination of invention: Composition with bone mineral density addition function, and preparation method as well as application of composition Granted publication date: 20120530 License type: Exclusive License Record date: 20140620 |
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