CN102000110A - Composition used for preventing or treating bone and joint diseases and preparation method thereof - Google Patents
Composition used for preventing or treating bone and joint diseases and preparation method thereof Download PDFInfo
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Abstract
The invention provides a composition used for preventing or treating bone and joint diseases. The composition contains D-glucosamine, a calcium compound and soy isoflavone, wherein the weight ratio of the D-glucosamine to the calcium compound to the soy isoflavone is (1.0-5.0): (1.5-5.5): (0.2-1.5). The invention provides a preparation method of the composition. The pharmacological research result shows that the composition has remarkable efficacy of calcium supplement and estrogen-like effect, can effectively inhibit osteoclast functions and prevent and treat osteoporosis, has the function of producing proteoglycan through stimulating chondrocytes, improves the repairing capability of the chondrocytes, and effectively prevents and treats the bone and joint diseases.
Description
Technical field
The present invention relates to a kind of composition and method of making the same that is used to prevent or treat Disease of bone and joint, particularly relate to a kind of health composition that is used for prevention of osteoporosis disease and osseous arthritis and preparation method thereof and be used for the treatment of osteoporosis and the pharmaceutical composition of osseous arthritis and preparation method thereof.
Background technology
Disease of bone and joint comprises osteoporosis and osseous arthritis.
Osteoporosis be with the bone amount reduce, 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 fracture.
The factor that causes bone loss is very complicated, and Recent study is thought and endocrine factors such as gonadal hormone (estrogen and testosterone) secretion minimizing, caused bone resorption to increase; The calcium-regulating hormone dyssecretosis causes bone metabolism disturbance; And malnutrition causes protein, calcium, phosphorus, vitamin and trace element Deficiency of Intake; Factors such as outdoor activity minimizing and vitamin D receptor (VDR) genovariation are closely related.
Osteoporosis (osteoporosis) is " a porous bone " according to English literal translation, has explained the change that bone form after the osteoporosis takes place visually.Along with the acceleration of aged tendency of population process, the generation ratio of osteoporosis in the crowd constantly raises.According to the preliminary statistics, minimizing of China's bone amount and patients with osteoporosis are up to 8000～9,000 ten thousand people.At present, have 200,000,000 women to suffer from osteoporosis all over the world approximately, among the women wherein over fifty, per two people just have a people to get this disease.In the U.S., 8,000,000 women and 2,000,000 male's patients with osteoporosis are arranged approximately, and 1,800 ten thousand people's bone densities are on the low side, and the annual fracture that causes because of osteoporosis reaches 1,500 ten thousand examples, wherein the osteoporotic hip fracture has 300,000 examples approximately, and only this medical expense every year of 1 is up to 900,000,000 dollars.In Canada, there are 1,400 ten thousand people to suffer from osteoporosis, be used for about 1,300,000,000 Canadian dollars of medical expense of diagnosis and treatment osteoporosis fracture every year.Australia is used for the treatment of about 1,000,000,000 Australian Dollars of medical expense that osteoporosis causes fracture every year, and 60% suffers from osteoporosis among the Australian women more than 60 years old.According to Sydney University, Australia skeleton and joint institute professor Fei Lisang Brooker statistics, there is 1,700,000 human hips fracture in the whole world every year approximately, 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.Synonym commonly used 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 that it has often been said, prolapse of lumbar intervertebral disc, Chondromalacia of patella, hyperosteogeny, hyperosteogeny (bony spur) etc. are the performance of osteoarthritis.Discovering in recent years; though the osteoarthritis pain is in the joint; its basic reason but is the degeneration and the Secondary cases caused by hyperosteogeny of articular cartilage (joint neonychium); because articular cartilage degenerates, attenuation, wearing and tearing, cause the skeleton direct friction of joint and the bone injury sexually transmitted disease (STD) change of secondary.The iconography of osteoarthritis shows that the edge, joint has hyperosteogeny to form, and the joint space narrows down, the epiphysis distortion, and uneven or hyperosteogeny appears in articular surface.In addition, constitutional arthropathies such as rheumatic and rheumatoid arthritis, ankylosing spondylitis, gout, femur head necrosis also can involve articular cartilage, so also can the secondary osseous arthritis.
Osseous arthritis uses among the crowds such as the bigger old people of more loading weight, obesity, athlete common in the joint, be sickness rate height and the common disease that compares a kind of chronic progressive external joint disease, particularly old women of refractory.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, has 27% people to have in various degree joint slight illness approximately, and the sickness rate more than 50 years old reaches more than 60%.Present arthritic surpasses 100,000,000, and the trend of rejuvenation is arranged, and 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, and actively developing the product with good prevention of osteoporosis disease effect is to meet the growing demand for health of people.In recent years, one of popular topic is by replenishing the calcium protect against osteoporosis both at home and abroad.
Calcium has multiple physiological action, as constituting 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, adult osteomalacia, osteoporosis, legs and feet cramp etc.
Kind surplus at present commercially available calcium preparation has 200, can be divided into ten by its chemical constituent surplus kind, as calcium carbonate, calcium oxide, calcium hydrogen phosphate, calcium phosphate, calcium chloride, calcium lactate, calcium gluconate etc.Bibliographical information, additional Maalox Antacid can make the calcaneus bone amount increase, and improve the human body skeleton density, prevent senile osteoporosis.Animal experiment proves that calcium carbonate and biological calcium all 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 influences food digestion but also can produce stimulation to stomach; Calcium hydrogen phosphate and calcium phosphate belong to the inorganic salts of slightly solubility, and needing can be dissolved under the effect of gastric acid; Calcium chloride once had been used for injecting under the emergency rating and was replenishing the calcium because its molten aqueous is good, but owing to its side effect is eliminated more; The absorption that calcium lactate can increase lactate in the body causes organism fatigue easily, therefore should not take for a long time; Calcium gluconate is a kind of calsium supplement commonly used, but diabetics should not be taken.
Isoflavone is a kind of in the flavone compound, mainly is present in the leguminous plant, and soybean isoflavone is the secondary metabolite that forms in the soybeans they grow.Owing to be from plant extract, with estrogen analog structure is arranged, therefore be called phytoestrogen, the performance estrogen-like effects.The action intensity of soybean isoflavone than 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 was too high, isoflavone occupied acceptor site in " competition " mode, the weak estrogen effect of performance, thereby show as the effect that reduces body inner estrogen level on the whole.Immunology research and zoopery have confirmed that soybean isoflavone has the effect of tangible prevention of osteoporosis, particularly for the women after the menolipsis because ovarian function decline decrease in estrogen, the osteoporosis that the osteoclast activity increase causes, additional soybean isoflavone has more unique effect.Soybean isoflavone not only combines with estrogen receptor on the osteoclast, reduces its activity, and stops the secretion of osteoclastic acid in addition, and bone-loss is reduced.In addition soybean isoflavone can also enhancing body to the utilization of 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 the 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 the infringement of 17-hydroxy-11-dehydrocorticosterone and some nonsteroidal antiinflammatory drug, reduce the release of the endotoxin factor of damaging cells chondrocyte.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 that has gone on the market has glucosamine sulfate and glucosamine hydrochloride, from one of molecular structure is the salt acid group, another is a sulfate radical, and the two does not show tangible curative effect difference clinically, just analyzes the two difference to some extent from the safety of taking for a long time.The chloride ion that glucosamine hydrochloride decomposes generation in vivo not only produces stimulation to gastrointestinal tract, and Liver and kidney is also caused damage easily, and the sulfate ion that the glucosamine sulfate decomposition produces is the synthetic participant of albumen in the human body, so there is not this side effect.Glucosamine sulfate can be under the mediation of sulfate radical, be interconnected to constitute poly-polysaccharide such as chondroitin sulfate, keratan sulfate, hyaluronic acid, then by the proteic proteoglycan aggregate that connects to form of central authorities, and constitute cartilage matrix with materials such as collagen fiber, participate in cartilage metabolism, therefore can think that glucosamine sulfate is a physiologically substance the most basic in the cartilage metabolism.
Summary of the invention
At Disease of bone and joint (comprising osteoporosis and osteoarthritis) demand of high incidence in the crowd, on the one hand, the invention provides a kind of compositions, it can effectively prevent or treat osteoporosis, bone density improving.On the other hand, compositions provided by the invention can also effectively prevent or treat osteoarthritis.Also on the one hand, the invention provides the preparation method of said composition.
More specifically, the invention provides a kind of health composition that is used 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).Consider that from functional effect experimental data and cost accounting further, described composition weight ratio is followed successively by: (3.0～4.0): (3.5～4.0): (0.4～0.8).That is, in this weight ratio scope, can obtain satisfied curative effect, spend rational medical expense.
The described D-glucosamine salt salt that to be D-glucosamine form with mineral acid or organic acid.D-glucosamine described in the present invention can form the D-glucosamine hydrochlorate with salt acid group salify, also can exist with salifiable forms such as other acid group such as sulfate radical, phosphate radical, lactate, glucose acid group, citrates.If those skilled in the art replace the salt acid group in the 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 among the present invention can select for use all for example, can be calcium carbonate, calcium oxide, calcium hydrogen phosphate, calcium phosphate, calcium chloride, calcium lactate, calcium gluconate, calcium citrate etc. by the picked-up of human body safety to reach the calcium source of effect of supplemented calcium.Our preferred calcium carbonate, this is because calcium carbonate calcium content height not only is dissolved in gastric acid, and good absorbance is arranged, and reasonable price, taking convenience.Thereby the calcium carbonate among the present invention replaces will be understood that also it does not exceed scope of the present invention with other calcium containing compound.
For example, in a better embodiment, the preparation finished product of 400mg comprises D-glucosamine hydrochlorate 175mg, calcium carbonate 195mg, soybean isoflavone 30mg; Perhaps restrain and contain glucosamine sulfate 1750 grams in the agent intermediate, calcium carbonate 1950 grams, soybean isoflavone 300 grams 4000.
According to a further aspect in the invention, the invention provides the preparation method of said composition, it comprises the steps:
Take by weighing raw material D-glucosamine, calcium containing compound, soybean isoflavone and necessary adjuvant in proportion,, make various oral formulations according to the technological requirement of made peroral dosage form.
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, or the like.For the consideration of galenic pharmacy, can also in compositions of the present invention, further add suitable adjuvant, for example diluent, fluidizer, binding agent, lubricant etc. selectively.
In a specific embodiment of the present invention, adopt the capsular technology of preparation of compositions of the present invention to comprise the steps:
1) gets the raw materials ready to take by weighing in advance and pulverize, cross raw material D-glucosamine hydrochlorate, calcium carbonate, soybean isoflavone and the necessary adjuvant of 100 mesh sieves, fully mixing for standby use by prescription.
2) filled capsules Autocapsulefillingmachine filled capsules is adjusted loading amount and is made it reach every 0.40g.
3) the capsule polishing is polished on the capsule buffing machine the good capsule of fill.
4) the bottling capsule is counted pack into polyolefin plastics bottle and sealing.
5) adorn a box and a vanning bottle external pasting label, packing into description is printed on the special capsule of date of manufacture, lot number and effect duration, and packing into successively is printed on the special corrugated paper extranal packing box of date of manufacture, lot number and effect duration again, to be checked.
6) the warehouse-in finished product is put dry shady and cool place and is preserved through putting in storage after the assay was approved, and temperature is below 30 ℃.
Annotate: 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 characteristics are:
One side is at the characteristics of osteoporosis, for osteoblast provides suitable calcium source; Be aided with the soybean isoflavone with phytoestrogen effect simultaneously, the activity that suppresses osteoclast reduces the loss of bone.
On the other hand,, in prescription, added the precursor substance D-glucosamine of synthetic cartilage matrix protein polysaccharide, strengthened the repair ability of chondrocyte at the cause of disease of osseous arthritis.
D-glucosamine, calcium and soybean isoflavone three synergism play bone density improving jointly, repair impaired articular cartilage, effectively prevent and treat the generation and the development of osteoporosis and osseous arthritis.
Compositions of the present invention, its advantage is:
Preferred calcium carbonate is the calcium source, and not only the calcium content height is dissolved in gastric acid, and good absorbance is arranged, its reasonable price, taking convenience.
The soybean isoflavone that adds in the prescription 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 does not have the estrogenic short cancer effect and the effect of feminizing.No matter therefore the men and women can prevent and treat osteoporosis with it, reduce cholesterol level in the blood, anti-cancer and anticancer.
The D-glucosamine that adds in the prescription 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 the pathological process and the advancing of disease of etiology control osteoarthrosis, improve joint motion, alleviating pain.
Pharmaceutical research is the result show, 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 bone density improving, effectively prevent or treat osteoporosis and osteoarthritis.
In order to understand essence of the present invention better,, describe in detail but do not limit the present invention below by description to embodiment of the present invention.
The specific embodiment
The used test material of the present invention if no special instructions, is commercially available purchase product.
Embodiment 1～4 is the preparation method of composition capsule of the present invention.Embodiment 5～8 is the preparation method of present composition tablet.Raw material D-glucosamine hydrochlorate, calcium carbonate, soybean isoflavone pulverize separately should be crossed 100 mesh sieves before the preparation.Fill a prescription all in 10000 (sheets) unit formulation effective ingredient 0.4g or 0.8g (all calculating) with the total weight of D-glucosamine hydrochlorate, calcium carbonate, soybean isoflavone.Embodiment 9 is the strong capsular effect evaluation of precious grace.
Embodiment 1
Take by weighing raw material D-glucosamine hydrochlorate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 120g, magnesium stearate 80g, PVP 160g.Mix, check is loaded every 0.436g of capsule (D-glucosamine hydrochlorate, calcium carbonate and soybean isoflavone add up to 0.4 gram), polishing, packing, check.
Embodiment 2
Take by weighing raw material D-glucosamine sulfate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 140g, magnesium stearate 60g, PVP 200g.Mix, check is loaded 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 by weighing raw material D-glucosamine hydrochlorate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 120g, magnesium stearate 40g, PVP 240g.Mix, check is loaded every 0.840g of capsule (D-glucosamine hydrochlorate, calcium carbonate and soybean isoflavone add up to 0.8 gram), polishing, packing, check.
Embodiment 4
Take by weighing raw material D-glucosamine sulfate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 160g, magnesium stearate 80g, PVP 160g.Mix, check is loaded 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 by weighing raw material D-glucosamine hydrochlorate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 120g, magnesium stearate 80g, PVP 160g.Mix, granulate, check, every 0.436g of tabletting (wherein D-glucosamine hydrochlorate, calcium carbonate and soybean isoflavone add up to 0.4 gram), coating, packing, check.
Embodiment 6
Take by weighing raw material D-glucosamine sulfate 1750g, calcium carbonate 1950g, soybean isoflavone 300g, microcrystalline Cellulose 140g, magnesium stearate 60g, PVP 200g.Mix, granulate, check, every 0.436g of tabletting (wherein D-glucosamine sulfate, calcium carbonate and soybean isoflavone add up to 0.4 gram), coating, packing, check.
Embodiment 7
Take by weighing raw material D-glucosamine hydrochlorate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 120g, magnesium stearate 40g, PVP 240g.Mix, granulate, check, every 0.84g of tabletting (wherein D-glucosamine hydrochlorate, calcium carbonate and soybean isoflavone add up to 0.8 gram), coating, packing, check.
Embodiment 8
Take by weighing raw material D-glucosamine sulfate 3500g, calcium carbonate 3900g, soybean isoflavone 600g, microcrystalline Cellulose 160g, magnesium stearate 80g, PVP 160g.Mix, granulate, check, every 0.84g of tabletting (wherein D-glucosamine sulfate, calcium carbonate and soybean isoflavone add 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 is available from Institute of Experimental Animals, Chinese Academy of Medical Sciences's breeding field.
2, tried thing
2.1 low calcium feed formula (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, the content of vitamin D is 1000IU/kg in the feedstuff.
2.2 strong precious grace: according to the prescription of embodiment 3, do not add adjuvant, (every kg contains D-glucosamine hydrochlorate 0.4375g, calcium carbonate 0.4875g, soybean isoflavone 0.75g).Adult's recommended dose 0.8g/ day, calcic 156mg.
2.3 tried the strong basic, normal, high dosage group of precious grace of thing: on the basis of low calcium feedstuff, add doubly by 5 times, 15 times and 30 of adult's per kilogram of body weight recommended dose every day and to add strong precious grace and be mixed with semisynthetic feed.Strong precious grace adult recommended dose is 0.8g/ day, average weight 60Kg, and then recommended dose is 0.013g/kgBW/d; Strong precious grace low dose group is 0.067g/kgBW/d; The dosage group is 0.200g/kgBW/d in the strong precious grace; 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 then making contains strong precious grace and is respectively 0.667g/kg, 2.00g/kg, 4.00g/kg.
3, experimental animal grouping and test method
Animal is divided into 6 groups according to body weight, every group of 10 animals at random after cleaning level Animal House is raised a week.Wherein 3 groups is matched group, hangs down the calcium feedstuff respectively or add in low calcium feedstuff to be equivalent to the contained calcium carbonate of middle and high dosage experiments group; 3 groups is test group, adds the strong precious grace of 5 times, 15 times and 30 times recommended dose of adult respectively on low calcium feedstuff basis.Every single cage of animal is fed, ad lib, and the drink deionized water is weighed, the record food-intake.Be 12 weeks experimental period, sees table 1 for details.
Animal feeding sacrificed by decapitation after 12 weeks separates the right side femur, measures femur length.Roasting to constant weight at 105 ℃ of baking boxs, the weighing bone is heavy.
Measure the bone density of femur mid point and femur distal end with the SD-1000 borne densitometers.
Accurately take by weighing and tried matter sample, animal feed 0.300～1.000g, rat femur is roasting wholely to the constant weight to adopt wet method digestion, uses the atomic absorption spectroscopy determination calcium content.
Table 1 animal experiment divides into groups and is tried the thing increment
4, result:
4.1 strong precious grace capsule is to the influence of rat body weight
The strong precious grace capsule of table 2 is to the influence of rat body weight (M ± SD)
Table 2 has been listed the rat the the 1st, the 4th, the 8th and the body weight in the 12nd week.Before the experiment, each body weight of organizing rat does not have significant difference (p＞0.05); After feeding for 4,8,12 weeks, each organizes the body weight of rat does not still have significant difference (p＞0.05); The calcium carbonate control group that strong precious grace experimental group is close with the calcium preparation amount compares, and the body weight of rat does not have significant difference (p＞0.05) yet.
4.2 strong precious grace capsule is to the influence of rat femur length, weight and bone calcium amount
Table 3 rat femur length, weight and bone calcium amount (M ± SD)
Annotate: * and low calcium matched group compare, 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 the strong precious grace experimental group calcium carbonate control group close with the calcium preparation amount compares, femur length of rat and weight there was no significant difference (p＞0.05).Femur calcium total amount of high dose calcium carbonate group and middle and high dosage experiments group rat and femur calcium content all are significantly higher than low calcium matched group (p＜0.05); The femur calcium content of middle dosage experiments group rat is significantly higher than with 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).
4.3 strong precious grace capsule is to the influence of rat bone density
Table 4 result is as can be seen: 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 all is 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 also is 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 with dosage calcium carbonate control group (p＜0.05); In dosage experiments group rat femur mid point bone density with relatively do not have significant difference (p＞0.05) with the dosage calcium carbonate control group.Under calcium preparation amount same case, experimental group and calcium carbonate control group compare, and rat femur distal end bone density does not have significant difference (p＞0.05).
Table 4 is respectively organized relatively (M ± SD) of rat bone density
Annotate: * and low calcium matched group be p＜0.05 relatively;
#Compare p＜0.05 with high dose calcium carbonate group
This experimental result shows that 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 compare, and 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 0.200g/kgBW the strong capsular experimental group rat of precious grace, its femur calcium content is significantly higher than with dosage calcium carbonate control group rat (p＜0.05); Give 0.400g/kgBW the strong capsular experimental group rat of precious grace, its femur mid point bone density is significantly higher than with dosage calcium carbonate control group rat (p＜0.05).
Therefore, strong precious grace capsule has the effect of bone density improving.
More than the description of better embodiment of the present invention is not limited the present invention, those skilled in the art can carry out multiple change or make various schemes according to the present invention, only otherwise break away from spirit of the present invention, all should belong to the scope of claims of the present invention.
Claims (12)
1. 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: 1.0～5.0: 1.5～5.5: 0.2～1.5.
2. the described compositions of 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: 1.5～4.5: 2.0～5.0: 0.3～1.0.
3. the described compositions of 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: 3.5～4.0: 0.4～0.8.
4. the described compositions of one of claim 1～3 is characterized in that, in the 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, the described D-glucosamine salt salt that to be D-glucosamine form with mineral acid or organic acid.
6. the described compositions of one of claim 1～5 is characterized in that, described calcium containing compound is a calcium carbonate.
7. the described compositions of one of claim 1～6 is characterized in that, described compositions is an oral formulations.
8. the described compositions of claim 7 is characterized in that, described oral formulations is tablet, capsule, granule or oral liquid.
9. the described preparation of compositions method of one of claim 1～8 may further comprise the steps:
Take by weighing D-glucosamine hydrochlorate, calcium carbonate, soybean isoflavone respectively, add adjuvant selectively, make oral formulations.
10. the described preparation of compositions method of claim 9 is characterized in that, described adjuvant is to be selected from one or more of diluent, binding agent, fluidizer and lubricant.
11. the application of the described compositions of one of claim 1～8 in the medicine of preparation treatment or prevention Disease of bone and joint.
12. the described application of claim 11 is characterized in that, described Disease of bone and joint is osteoporosis or osseous arthritis.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2015182960A (en) * | 2014-03-20 | 2015-10-22 | 国立大学法人弘前大学 | Bone density increasing agent, osteoclast activity inhibitor and bone remodeling improver |
| CN105559062A (en) * | 2015-12-20 | 2016-05-11 | 雷西云 | Health-care food with calcium supplementing function |
| CN111826343A (en) * | 2020-07-23 | 2020-10-27 | 北京中卫医正科技有限公司 | Cell culture solution for enhancing induced cartilage differentiation, method and application |
-
2009
- 2009-09-02 CN CN2009100921585A patent/CN102000110A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2015182960A (en) * | 2014-03-20 | 2015-10-22 | 国立大学法人弘前大学 | Bone density increasing agent, osteoclast activity inhibitor and bone remodeling improver |
| CN105559062A (en) * | 2015-12-20 | 2016-05-11 | 雷西云 | Health-care food with calcium supplementing function |
| CN111826343A (en) * | 2020-07-23 | 2020-10-27 | 北京中卫医正科技有限公司 | Cell culture solution for enhancing induced cartilage differentiation, method and application |
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