CN103585174A - Composition for preventing or treating bone and joint disease and preparation method and application - Google Patents
Composition for preventing or treating bone and joint disease and preparation method and application Download PDFInfo
- Publication number
- CN103585174A CN103585174A CN201310485111.1A CN201310485111A CN103585174A CN 103585174 A CN103585174 A CN 103585174A CN 201310485111 A CN201310485111 A CN 201310485111A CN 103585174 A CN103585174 A CN 103585174A
- Authority
- CN
- China
- Prior art keywords
- glucosamine
- calcium
- soybean isoflavone
- capsule
- calcium carbonate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a composition for preventing or treating bone and joint diseases. The composition comprises D-glucosamine or salt of D-glucosamine, a calcium compound and soy isoflavone, wherein the weight ratio of the D-glucosamine or salt of the D-glucosamine to the calcium compound to the soy isoflavone is (2.5-5.0):(1.6-4):(0.2-1.0). The invention further provides a preparation method of the composition. Pharmacological study results show that the composition has a remarkable calcium supplement effect and an estrogen-like effect, and can effectively suppress osteoclast function so as to treat osteoporosis, and meanwhile the composition provided by the invention further has the capability to stimulate chondrocyte to generate and prompt repairing capability of chondrocyte, and bone and joint diseases can be effectively prevented and treated.
Description
The present invention is dividing an application of application number 200910092158.5;
The applying date of original application is: 2009.09.02;
The denomination of invention of original application is: a kind of for preventing or treat the composition and method of making the same of Disease of bone and joint
Technical field
The present invention relates to a kind ofly for preventing or treat the composition and method of making the same of Disease of bone and joint, particularly relate to a kind of health composition for prevention of osteoporosis disease and osseous arthritis and preparation method thereof and be used for the treatment of pharmaceutical composition of osteoporosis and osseous arthritis and preparation method thereof.
Background technology
Disease of bone and joint comprises osteoporosis and osseous arthritis.
Osteoporosis is to take that bone amount reduces, the microstructure degeneration of bone is feature, a kind of general skeletal diseases that causes the fragility of bone to increase and be easy to occur fracture.
The factor that causes bone loss is very complicated, and Recent study thinks that secretion reduces as gonadal hormone (estrogen and testosterone) with endocrine factors, causes bone resorption to increase; Calcium-regulating hormone dyssecretosis causes bone metabolism disturbance; And malnutrition causes protein, calcium, phosphorus, electrolytes and minerals Deficiency of Intake; The factors such as outdoor activity minimizing and vitamin D receptor (VDR) genovariation are closely related.
Osteoporosis (osteoporosis) is " bone of porous " according to English literal translation, has explained visually the change that bone form after osteoporosis occurs.Along with the acceleration of aged tendency of population process, the proportion of osteoporosis in crowd constantly raises.According to the preliminary statistics, the minimizing of China's bone amount and patients with osteoporosis are up to 8000～9,000 ten thousand people.At present, approximately have 200,000,000 women to suffer from osteoporosis all over the world, wherein, in women over fifty, every two people just have a people to obtain this disease.In the U.S., approximately have 8,000,000 women and 2,000,000 Male Osteoporosis patients, 1,800 ten thousand people's bone densities are on the low side, and the fracture causing because of osteoporosis every year reaches 1,500 ten thousand examples, wherein osteoporotic hip fracture approximately has 300,000 examples, and only this medical expense of 1 is every year up to 900,000,000 dollars.In Canada, there are 1,400 ten thousand people to suffer from osteoporosis, annual medical expense approximately 1,300,000,000 Canadian dollars for diagnosis and treatment osteoporosis fracture.Australia is used for the treatment of about 1,000,000,000 Australian Dollars of medical expense that osteoporosis causes fracture every year, and in 60 years old above Australian women, 60% suffers from osteoporosis.According to Sydney University, Australia skeleton and joint institute professor Fei Lisang Brooker statistics, the whole world approximately has 1,700,000 human hip fracture every year, and along with the aging of population, by 2025, the case of annual Hip Fracture will increase to 4,000,000.
Osseous arthritis (osteoarthritis) is a kind of chronic degenerative joint disease.Conventional synonym is a lot, as osteoarthritis, senile arthritis, degenerative osteoarthritis, proliferative arthritis, hypertrophiarthritis, chondromalacic arthrosis etc.Osseous arthritis can occur in the joint at each position of health, comprises knee joint, hip joint, joint of vertebral column (comprising cervical vertebra, lumbar vertebra), joints of hand (comprising wrist, palm or phalanx joint), joints of foot (comprising ankle joint, toe joint), shoulder joint, elbow joint etc.The cervical spondylosis it has often been said, prolapse of lumbar intervertebral disc, Chondromalacia of patella, hyperosteogeny, hyperosteogeny (bony spur) etc. are the performance of osteoarthritis.Research is in recent years found; although osteoarthritis pain is in joint; its basic reason is but degeneration and the Secondary cases caused by hyperosteogeny of articular cartilage (joint neonychium); because articular cartilage is degenerated, attenuation, wearing and tearing, cause the skeleton direct friction of joint and the bone injury sexually transmitted disease (STD) of secondary becomes.The iconography of osteoarthritis shows that edge, joint has hyperosteogeny to form, and joint space narrows down, epiphysis distortion, and there is uneven or hyperosteogeny in articular surface.In addition, the constitutional arthropathies such as rheumatic and rheumatoid arthritis, ankylosing spondylitis, gout, femur head necrosis also can involve articular cartilage, so also can secondary osseous arthritis.
Osseous arthritis is used in the crowds such as old people that more loading weight is larger, obesity, athlete common in joint, be the high and common disease of a kind of chronic progressive external joint disease, particularly old women of refractory relatively of sickness rate.In China, the sickness rate of joint disease is quite high, according to the Epidemiological study of Chinese combination of Chinese and Western medicine rheumatism Professional Committee, approximately has 27% people to exist joint in various degree ailing, and within 50 years old, above sickness rate reaches more than 60%.Current arthritic surpasses 100,000,000, and has the trend of rejuvenation, is having a strong impact on people's Health and Living quality.
Protect against osteoporosis has become one of current problem demanding prompt solution of China, actively development have the product of good prevention of osteoporosis disease effect be meet people growing for healthy demand.In recent years, one of problem of hot topic is by replenishing the calcium protect against osteoporosis both at home and abroad.
Calcium has multiple physiological action, as formed skeleton and the tooth of supporting health, safeguards normal activity neural and muscle, promotes the activity of some enzyme, participates in Blood Coagulation Process etc., particularly to upgrowth and development of children and important.Calcium deficiency can cause a series of clinical disease, as child's rickets, pigeon chest, and adult's osteomalacia, osteoporosis, legs and feet cramp etc.
Commercially available calcium preparation has more than 200 to plant at present, can be divided into more than ten and plant, as calcium carbonate, calcium oxide, calcium hydrogen phosphate, calcium phosphate, calcium chloride, calcium lactate, calcium gluconate etc. by its chemical composition.Bibliographical information, supplementary Maalox Antacid can make calcaneus bone amount increase, and improves human body skeleton density, prevents senile osteoporosis.Animal experiment proves, calcium carbonate and biological calcium have certain preventive effect to osteoporosis, and calcium carbonate is reasonable more economically.Calcium carbonate is typing English, U.S. pharmacopeia already, clinically always as calcium-supplementing preparation.Calcium oxide is strong basicity (pH > 12), must consume a large amount of gastric acid under one's belt, not only affects food digestion but also can produce stimulation to stomach; Calcium hydrogen phosphate and calcium phosphate belong to the inorganic salts of slightly solubility, need can be dissolved under the effect of gastric acid; Calcium chloride, because its solubization is good, was once replenished the calcium for emergency rating hemostasis, but because its side effect is eliminated more; The absorption that calcium lactate can increase lactate in body easily causes organism fatigue, therefore unsuitable long-term taking; Calcium gluconate is a kind of conventional calsium supplement, but diabetics should not be taken.
Isoflavone is a kind of in flavone compound, is mainly present in leguminous plant, and soybean isoflavone is the secondary metabolite forming in soybeans they grow.Owing to being from plant extract, there is analog structure with estrogen, be therefore called phytoestrogen, performance estrogen-like effects.The action intensity of soybean isoflavone compared with estrogen a little less than and relax, thereby performance suppresses and collaborative two-ways regulation effect in vivo: when human body inner estrogen level is on the low side, isoflavone occupies estrogen receptor, and the weak estrogen effect of performance, shows the effect that improves estrogen level; When human body inner estrogen level is too high, isoflavone occupies acceptor site in " competition " mode, the weak estrogen effect of performance, thereby show as on the whole the effect that reduces body inner estrogen level.Immunology research and zoopery have confirmed that soybean isoflavone has the effect of obvious prevention of osteoporosis, particularly for the women after menolipsis due to the ovarian function decrease in estrogen that fails, the osteoporosis that osteoclast activity increase causes, supplementary soybean isoflavone has more unique effect.The soybean isoflavone not only estrogen receptor in osteoclast is combined, and reduces its activity, and stops in addition the secretion of osteoclastic acid, and bone-loss is reduced.In addition soybean isoflavone can also the utilization of enhancing body to calcium, thereby strengthened the effect of calcium-supplementing preparation.
Glucosamine is a kind of natural amino monosaccharide, it is the precursor substance of proteoglycan in synthetic articular cartilage substrate, can stimulate chondrocyte to produce the proteoglycan of normal polymer structure, proteoglycan can suppress some enzyme that can damage articular cartilage (as collagenase and phospholipase A2), suppress the generation of the superoxide radical of damaging cells, prevent 17-hydroxy-11-dehydrocorticosterone and the infringement of some nonsteroidal antiinflammatory drug to chondrocyte, reduce the release of the endotoxin factor of damaging cells.By above-mentioned effect, promote the repair and reconstruction of cartilage matrix, alleviate the pain symptom of osteoarthritis, improve function of joint, stop the development of the osteoarthritis course of disease.
The glucosamine having gone on the market has glucosamine sulfate and glucosamine hydrochloride, from one of molecular structure, it is salt acid group, another is sulfate radical, and the two does not show obvious Different therapeutical effect clinically, just from the safety of long-term taking, analyzes the two difference to some extent.The chloride ion that glucosamine hydrochloride decomposes generation in vivo not only produces and stimulates gastrointestinal tract, and Liver and kidney is also easily caused damage, and the sulfate ion that glucosamine sulfate decomposition produces is the synthetic participant of albumen in human body, therefore without this side effect.Glucosamine sulfate can be under the mediation of sulfate radical, be interconnected to constitute the poly-polysaccharide such as chondroitin sulfate, keratan sulfate, hyaluronic acid, then by the proteoglycan aggregate that connects to form of central albumen, and form cartilage matrix together with the materials such as collagen fiber, participate in cartilage metabolism, therefore can think that glucosamine sulfate is physiologically substance the most basic in cartilage metabolism.
Summary of the invention
For Disease of bone and joint (comprising osteoporosis and osteoarthritis) demand of high incidence in crowd, on the one hand, the invention provides a kind of compositions, it can prevent or treat osteoporosis effectively, increases bone density.On the other hand, osteoarthritis can also be prevented or treat to compositions provided by the invention effectively.Also on the one hand, the invention provides the preparation method of said composition.
More specifically, the invention provides a kind of health composition for prevention of osteoporosis disease and osteoarthritis and preparation method thereof, the present invention also provides a kind of pharmaceutical composition that is used for the treatment of osteoporosis and osteoarthritis and preparation method thereof.
According to an aspect of the present invention, the invention provides a kind of health composition or pharmaceutical composition, it comprises D-glucosamine or its salt, calcium containing compound and soybean isoflavone, and the weight ratio of described D-glucosamine or its salt, calcium containing compound and soybean isoflavone is followed successively by: (1.0～5.0): (1.5～5.5): (0.2～1.5).Further, the weight ratio of described compositions can be followed successively by: (1.5～4.5): (2.0～5.0): (0.3～1.0).From functional effect experimental data and cost accounting, consider, further, described composition weight ratio is followed successively by: (3.0～4.0): (3.5～4.0): (0.4～0.8).That is, within the scope of this weight ratio, can obtain more satisfied curative effect, spend rational medical expense.
Described D-glucosamine salt is the salt of D-glucosamine and mineral acid or organic acid composition.D-glucosamine described in the present invention can form D-Glucosamine Hydrochloride with salt acid group salify, also can be with other acid group as the form existence of the salifies such as sulfate radical, phosphate radical, lactate, glucose acid group, citrate.If those skilled in the art replace the salt acid group in prescription of the present invention with other acid group, will be understood that it does not exceed scope of the present invention.When described D-glucosamine is present in this compositions with salt form, can improve the dissolubility of D-glucosamine.
Equally, the calcium containing compound in the present invention can be selected and allly can by human-body safety, be absorbed to reach the calcium source of effect of supplemented calcium, for example, can be calcium carbonate, calcium oxide, calcium hydrogen phosphate, calcium phosphate, calcium chloride, calcium lactate, calcium gluconate, calcium citrate etc.Our preferred calcium carbonate, this is that not only calcium content is high because of calcium carbonate, is dissolved in gastric acid, and has good absorbance, and reasonable price, taking convenience.Thereby the calcium carbonate in the present invention replaces also will be understood that it does not exceed scope of the present invention with other calcium containing compound.
For example, in a preferred embodiments, the preparation finished product of 400mg comprises D-Glucosamine Hydrochloride 175mg, calcium carbonate 195mg, soybean isoflavone 30mg; Or in 4000 restraint agent intermediate, contain 1750 grams of glucosamine sulfate, 1950 grams of calcium carbonate, 300 grams of soybean isoflavone.
According to a further aspect in the invention, the invention provides the preparation method of said composition, it comprises the steps:
Take in proportion raw material D-glucosamine, calcium containing compound, soybean isoflavone and necessary adjuvant, according to the technological requirement of made peroral dosage form, make various oral formulations.
It will be appreciated by those skilled in the art that compositions of the present invention can make various suitable peroral dosage forms, for example, tablet, capsule, granule, oral liquid, etc.For the consideration of galenic pharmacy, can also in compositions of the present invention, further add selectively suitable adjuvant, such as diluent, fluidizer, binding agent, lubricant etc.
In a specific embodiment of the present invention, the technique that adopts compositions of the present invention to prepare capsule comprises the steps:
1) get the raw materials ready and take in advance and pulverize by formula, cross raw material D-Glucosamine Hydrochloride, calcium carbonate, soybean isoflavone and the necessary adjuvant of 100 mesh sieves, fully mixing for standby use.
2) filled capsules Autocapsulefillingmachine filled capsules, adjusts loading amount and makes it reach every 0.40g.
3) capsule polishing is carried out polishing to the good capsule of fill on capsule polisher.
4) bottling capsule counting packs polyolefin plastics bottle sealing into.
5) mounted box and vanning bottle external pasting label pack the special capsule that is printed on date of manufacture, lot number and effect duration into, then pack successively the special corrugated paper extranal packing box that is printed on date of manufacture, lot number and effect duration into together with description, to be checked.
6) warehouse-in finished product, through putting in storage after the assay was approved, is put dry shady and cool place and is preserved, and temperature is below 30 ℃.
Note: above-mentioned 1～4 operation should be carried out in the workshop of 100,000 grades of cleanliness factors, and should meet the requirement of GB17405-1998.
In addition, the present invention also provides the application of described compositions in the medicine of preparation prevention or treatment Disease of bone and joint.Described Disease of bone and joint comprises osteoporosis and osteoarthritis etc.
Compositions of the present invention, its feature is:
One side is for the feature of osteoporosis, for osteoblast provides suitable calcium source; Be aided with the soybean isoflavone with phytoestrogen effect, the activity that suppresses osteoclast reduces the loss of bone simultaneously.
On the other hand, for the cause of disease of osseous arthritis, in formula, add the precursor substance D-glucosamine of synthetic cartilage matrix protein polysaccharide, strengthened the repair ability of chondrocyte.
D-glucosamine, calcium and soybean isoflavone three synergism, play increase bone density jointly, repairs impaired articular cartilage, effectively prevents and treat generation and the development of osteoporosis and osseous arthritis.
Compositions of the present invention, its advantage is:
Preferably calcium carbonate is calcium source, and not only calcium content is high, is dissolved in gastric acid, and has good absorbance, its reasonable price, taking convenience.
The soybean isoflavone adding in formula has the non-steroid material of extensive threpsology's value, health care and therapeutics meaning, is referred to as phytoestrogen.In recent years, Epidemiological study, human body intervention study and the research of integral animal level all confirm: soybean isoflavone can not only be brought into play the plurality of health care functions of estrogen-like, and do not have estrogenic tumor promotion and the effect of feminizing.No matter therefore men and women, can prevent and treat osteoporosis with it, reduce Blood Cholesterol content, anti-cancer and anticancer.
The D-glucosamine adding in formula is a kind of natural amino monosaccharide, derive from chitin and/or chitosan hydrolyzate product, can promote the repair and reconstruction of cartilage matrix, from etiology, control pathological process and the advancing of disease of osteoarthrosis, improve joint motion, alleviating pain.
Pharmaceutical research result shows, compositions of the present invention has the effect of replenishing the calcium significantly, has estrogen-like effects, has the ability that cartilaginous tissue is repaired that strengthens.Can increase bone density, effectively prevention or treatment osteoporosis and osteoarthritis.
In order to understand better essence of the present invention, below by the description to embodiment of the present invention, describe in detail but do not limit the present invention.
The specific embodiment
The present invention's test material used, if no special instructions, is commercially available purchase product.
The preparation method that embodiment 1～4 is composition capsule of the present invention.Embodiment 5～8 is the preparation method of present composition tablet.Before preparation, raw material D-Glucosamine Hydrochloride, calcium carbonate, soybean isoflavone should be pulverized respectively, be crossed 100 mesh sieves.Formula is all in 10000 (sheets), and unit formulation effective ingredient 0.4g or 0.8g(all calculate with the total weight of D-Glucosamine Hydrochloride, calcium carbonate, soybean isoflavone).Embodiment 9 is the effect evaluation of strong precious grace capsule.
Embodiment 1
Take raw material D-Glucosamine Hydrochloride 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 120g, magnesium stearate 80g, PVP160g.Mix, check, loads every 0.436g of capsule (D-Glucosamine Hydrochloride, calcium carbonate and soybean isoflavone add up to 0.4 gram), polishing, packing, check.
Embodiment 2
Take raw material D-glucosamine sulfate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 140g, magnesium stearate 60g, PVP200g.Mix, check, loads every 0.436g of capsule (D-glucosamine sulfate, calcium carbonate and soybean isoflavone add up to 0.4 gram), polishing, packing, check.
Embodiment 3
Take raw material D-Glucosamine Hydrochloride 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 120g, magnesium stearate 40g, PVP240g.Mix, check, loads every 0.840g of capsule (D-Glucosamine Hydrochloride, calcium carbonate and soybean isoflavone add up to 0.8 gram), polishing, packing, check.
Embodiment 4
Take raw material D-glucosamine sulfate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 160g, magnesium stearate 80g, PVP160g.Mix, check, loads every 0.840g of capsule (D-glucosamine sulfate, calcium carbonate and soybean isoflavone add up to 0.8 gram), polishing, packing, check.
Embodiment 5
Take raw material D-Glucosamine Hydrochloride 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 120g, magnesium stearate 80g, PVP160g.Mix, granulate, check, every 0.436g of tabletting (wherein D-Glucosamine Hydrochloride, calcium carbonate and soybean isoflavone add up to 0.4 gram), coating, packing, check.
Embodiment 6
Take raw material D-glucosamine sulfate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 140g, magnesium stearate 60g, PVP200g.Mix, granulate, check, every 0.436g(of tabletting wherein D-glucosamine sulfate, calcium carbonate and soybean isoflavone adds up to 0.4 gram), coating, packing, check.
Embodiment 7
Take raw material D-Glucosamine Hydrochloride 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 120g, magnesium stearate 40g, PVP240g.Mix, granulate, check, every 0.84g(of tabletting wherein D-Glucosamine Hydrochloride, calcium carbonate and soybean isoflavone adds up to 0.8 gram), coating, packing, check.
Embodiment 8
Take raw material D-glucosamine sulfate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 160g, magnesium stearate 80g, PVP160g.Mix, granulate, check, every 0.84g(of tabletting wherein D-glucosamine sulfate, calcium carbonate and soybean isoflavone adds up to 0.8g), coating, packing, check.
Embodiment 9 effect evaluations
1, the male ablactation of laboratory animal wistar rat is 60, and body weight 70-80 gram, purchased from Institute of Experimental Animals, Chinese Academy of Medical Sciences's breeding field.
2, tested material
2.1 low calcium feed formulas (g/kg): casein 100, analysis for soybean powder 150, Semen Tritici aestivi flour 526, Oleum Arachidis hypogaeae semen 40, cellulose 25, starch 110, AIN-76 mixed vitamin 10, AIN-76 mixed inorganic 35, DL-methionine 2, choline chloride 2, in feedstuff, the content of vitamin D is 1000IU/kg.
2.2 strong precious grace: according to the formula of embodiment 3, do not add adjuvant, (every kg is containing D-Glucosamine Hydrochloride 0.4375g, calcium carbonate 0.4875g, soybean isoflavone 0.75g).Adult's recommended dose 0.8g/ day, calcic 156mg.
2.3 tested materials are good for the basic, normal, high dosage group of precious grace: on the basis of low calcium feedstuff, add strong precious grace be mixed with semisynthetic feed by 5 times, 15 times and 30 times of adult's per kilogram of body weight recommended dose every day.Strong precious grace adult recommended dose is 0.8g/ day, average weight 60Kg, and recommended dose is 0.013g/kgBW/d; Strong precious grace low dose group is 0.067g/kgBW/d; In strong precious grace, dosage group is 0.200g/kgBW/d; Strong precious grace high dose group is 0.400g/kgBW/d.With the rat per kilogram of body weight 100g that on average takes food, the synthetic diet of making is respectively 0.667g/kg, 2.00g/kg, 4.00g/kg containing strong precious grace.
3, experimental animal grouping and test method
Animal is raised after one week at clean level Animal House, is divided at random 6 groups, every group of 10 animals according to body weight.Wherein 3 groups is matched group, gives respectively low calcium feedstuff or adds and be equivalent to the contained calcium carbonate of middle and high dosage experiments group in low calcium feedstuff; 3 groups is test group, adds respectively the strong precious grace of 5 times, 15 times and 30 times recommended dose of adult on low calcium feedstuff basis.Every single cage of animal is fed, ad lib, and drink deionized water, weighs, and records food-intake.Be 12 weeks experimental period, refers to table 1.
Animal feeding is sacrificed by decapitation after 12 weeks, separates right side femur, measures femur length.At 105 ℃ of baking boxs, bake to constant weight, weigh bone weight.
With SD-1000 borne densitometers, measure the bone density of femur mid point and femur distal end.
Accurately take tested material sample, animal feed 0.300～1.000g, rat femur is baked to whole after constant weight and is adopted wet method digestion, uses atomic absorption spectroscopy determination calcium content.
The grouping of table 1 animal experiment and tested material increment
4, result:
The impact of 4.1 strong precious grace Capsule in Rats body weight
The impact (M ± SD) of the strong precious grace Capsule in Rats body weight of table 2
Table 2 has been listed the rat body weight of the 1st, the 4th, the 8th and the 12nd week.Before experiment, each body weight of organizing rat does not have significant difference (p>0.05); Feed after 4,8,12 weeks, each body weight of organizing rat is still without significant difference (p>0.05); The strong precious grace experimental group calcium carbonate control group comparison close with calcium preparation amount, the body weight of rat does not have significant difference (p>0.05) yet.
The impact of 4.2 strong precious grace Capsule in Rats femur length, weight and bone calcium amounts
Table 3 rat femur length, weight and bone calcium amount (M ± SD)
Note:
*with the comparison of low calcium matched group, p<0.05;
#compare p<0.05 with middle dosage calcium carbonate control group
As can be seen from Table 3, the rat femur weight of the strong precious grace experimental group of high dose calcium carbonate group and middle and high dosage is significantly higher than low calcium matched group (p<0.05), and strong the calcium carbonate control group comparison close with calcium preparation amount of precious grace experimental group, the femur length of rat and weight there was no significant difference (p>0.05).The femur calcium total amount of high dose calcium carbonate group and middle and high dosage experiments group rat and femur calcium content are all significantly higher than low calcium matched group (p<0.05); The femur calcium content of middle dosage experiments group rat is significantly higher than same dosage calcium carbonate control group (p<0.05); And the femur calcium content of high dose experimental group rat with dosage calcium carbonate control group comparing difference not significantly (p>0.05).
The impact of 4.3 strong precious grace Capsule in Rats bone densities
Table 4 result can be found out: the rat femur mid point bone density of middle dosage calcium carbonate group, high dose calcium carbonate group and basic, normal, high strong precious grace experimental group is all significantly higher than low calcium matched group (p<0.05); The strong precious grace experimental group rat femur distal end bone density of middle and high dosage is also significantly higher than low calcium matched group (p<0.05).
The bone density of high dose experimental group rat femur mid point is significantly higher than same dosage calcium carbonate control group (p<0.05); Middle dosage experiments group rat femur mid point bone density with dosage calcium carbonate control group, relatively there is no significant difference (p>0.05).Under calcium preparation amount same case, experimental group and calcium carbonate control group comparison, rat femur distal end bone density does not have significant difference (p>0.05).
Table 4 is respectively organized rat bone density comparison (M ± SD)
Note:
*compare p<0.05 with low calcium matched group;
#compare p<0.05 with high dose calcium carbonate group
This experimental result shows, the strong precious grace capsule that gives 0.200g/kgBW and 0.400g/kgBW can make femur weight, femur calcium content and the femur density of rat be significantly higher than low calcium matched group (p<0.05).The strong precious grace capsule that gives 0.067g/kgBW, 0.200g/kgBW and 0.400g/kgBW all can make the bone density of rat femur mid point be significantly higher than low calcium matched group (p<0.05).
Under feed calcium content same case, strong precious grace capsule experimental group and calcium carbonate control group comparison, the bone density of the body weight of rat, femur length and weight, femur distal end does not all have significant difference (p>0.05).
Give the 0.200g/kgBW experimental group rat of strong precious grace capsule, its femur calcium content is significantly higher than same dosage calcium carbonate control group rat (p<0.05); Give the 0.400g/kgBW experimental group rat of strong precious grace capsule, its femur mid point bone density is significantly higher than same dosage calcium carbonate control group rat (p<0.05).
Therefore, strong precious grace capsule has the effect that increases bone density.
Above the description of preferred embodiments of the present invention is not limited to the present invention, those skilled in the art can carry out multiple change or make various schemes according to the present invention, only otherwise depart from spirit of the present invention, all should belong to the scope of claims of the present invention.
Claims (11)
1. a compositions that is used for the treatment of or prevents Disease of bone and joint, comprise D-glucosamine or its salt, calcium containing compound and soybean isoflavone, the weight ratio of described D-glucosamine or its salt, calcium containing compound and soybean isoflavone is followed successively by: 2.5～5.0:1.6～4.0:0.2～0.9.
2. compositions claimed in claim 1, is characterized in that, the weight ratio of described D-glucosamine or its salt, calcium containing compound and soybean isoflavone is followed successively by: 2.8～4.5:2.0～3.5:0.3～0.9.
3. compositions claimed in claim 1, is characterized in that, the weight ratio of described D-glucosamine or its salt, calcium containing compound and soybean isoflavone is followed successively by: 3.0～4.0:2.5～3.0:0.4～0.8.
4. the described compositions of one of claim 1～3, is characterized in that, in unit formulation, comprises D-glucosamine or its salt 175mg～350mg, calcium containing compound 195mg～390mg, soybean isoflavone 30mg～60mg.
5. the described compositions of one of claim 1～4, is characterized in that, described D-glucosamine or its salt are the salt of D-glucosamine and mineral acid or organic acid composition.
6. the described compositions of one of claim 1～4, is characterized in that, described calcium containing compound is calcium carbonate, is the precipitated calcium carbonate being transformed for calcium oxide that the ground calcium carbonate than deriving from stone is more conducive to absorb.
7. the described compositions of one of claim 1～4, is characterized in that, described soybean isoflavone extracts from Semen sojae atricolor, contains daiazi, glycitin, genistin, daidzein, Glycitein and genistein active component.
8. the described compositions of one of claim 1～4, is characterized in that, described compositions is oral formulations, comprises tablet, capsule, granule or oral liquid.
9. application rights requires a preparation method for one of 1～8 described compositions, comprises the following steps:
Take respectively raw material D-Glucosamine Hydrochloride, calcium carbonate, soybean isoflavone, add selectively one or more adjuvants of diluent, binding agent, fluidizer and lubricant, make oral formulations.
10. application rights requires the capsule method of preparing of one of 1～9 described compositions, comprising:
Material preparation step, takes in advance and pulverizes by formula, crosses raw material D-Glucosamine Hydrochloride, calcium carbonate, soybean isoflavone and the necessary adjuvant of 100 mesh sieves, fully mixing for standby use;
Filled capsules step, adopts Autocapsulefillingmachine filled capsules, adjusts loading amount and makes it reach formula requirement;
Capsule polishing step, the capsule good to fill carries out polishing on capsule polisher;
Subsequent step, comprise that capsule counting packs polyolefin plastics bottle sealing into, bottle external pasting label pack into together with description be printed on date of manufacture, lot number and effect duration special capsule, reinstall be printed on date of manufacture, lot number and effect duration special packing crates, sampling according to end product quality standard test warehousing after passing, put shady and cool dry place and deposit.
The application of one of 11. 1 kinds of claim 1～9 described compositions, can be applied to prevent Disease of bone and joint as health product, also can it is characterized in that as pharmaceutical applications in treatment Disease of bone and joint, described Disease of bone and joint is osteoporosis or osseous arthritis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310485111.1A CN103585174A (en) | 2009-09-02 | 2009-09-02 | Composition for preventing or treating bone and joint disease and preparation method and application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310485111.1A CN103585174A (en) | 2009-09-02 | 2009-09-02 | Composition for preventing or treating bone and joint disease and preparation method and application |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009100921585A Division CN102000110A (en) | 2009-09-02 | 2009-09-02 | Composition used for preventing or treating bone and joint diseases and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103585174A true CN103585174A (en) | 2014-02-19 |
Family
ID=50075628
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310485111.1A Pending CN103585174A (en) | 2009-09-02 | 2009-09-02 | Composition for preventing or treating bone and joint disease and preparation method and application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103585174A (en) |
-
2009
- 2009-09-02 CN CN201310485111.1A patent/CN103585174A/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101248882B (en) | Nutrition food product with promoting health of bones and bone arthrosis | |
| CN106135890A (en) | A kind of alimentation composition contributing to bony articulation health | |
| CN103736074B (en) | A kind of increase bone density health-caring capsule and preparation method thereof | |
| CN102318835A (en) | Composition for reducing bone loss and preparation method thereof | |
| CN103783532B (en) | A kind of composite protein powder of anti-sarcopenia decay and preparation method thereof | |
| CN102949710B (en) | Pharmaceutical composition or healthcare product for increasing bone mineral density and preparation method of pharmaceutical composition or healthcare product | |
| CN102552877A (en) | Health-care preparation for improving osteoporosis and increasing bone density and preparation method thereof | |
| CN102423487B (en) | Osteoarticular health-care composition and its application | |
| CN106072651B (en) | It is a kind of with increasing bone density, composition of anti-inflammatory and analgesic effect and preparation method thereof | |
| CN101711786B (en) | Preparation used for relieving osteoarthropathy and enhancing immunity | |
| CN101559218A (en) | Composition with function of increasing bone density | |
| CN103735572A (en) | Composition having bone mineral density increasing function, anti-inflammatory function and analgesia function, and preparation method of the composition | |
| CN104605226A (en) | Healthcare product with function of increasing bone mineral density | |
| CN104116022B (en) | For composite heal-care food improving climacteric syndrome and preparation method thereof | |
| CN106213492A (en) | A kind of lifter motion function also increases health-oriented products and the preparation method of bone density | |
| CN104824677A (en) | Bone density increase health food and preparation method thereof | |
| CN101716194A (en) | Multi-flavor chewable calcium tablets and production process thereof | |
| CN101279089B (en) | Donkey-hide gelatin calcium composition and preparing process thereof | |
| CN103349674B (en) | Tortoise shell rana japonica oil composition for increasing bone density and preventing osteoporosis | |
| CN102000110A (en) | Composition used for preventing or treating bone and joint diseases and preparation method thereof | |
| CN101268836B (en) | Nutrition high calcium medicinal granule and preparing technique | |
| CN102626463A (en) | Natural medicine compound for increasing bone mineral density and preventing and treating osteoporosis | |
| CN104001157B (en) | Compound preparation of a kind of protect against osteoporosis and preparation method thereof | |
| CN105770850A (en) | Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product | |
| CN109464651A (en) | A kind of amelioration of disease induced by metabolic disorder in cartilage healthy food and composite medicine |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20140219 |