CN102949710B - Pharmaceutical composition or healthcare product for increasing bone mineral density and preparation method of pharmaceutical composition or healthcare product - Google Patents
Pharmaceutical composition or healthcare product for increasing bone mineral density and preparation method of pharmaceutical composition or healthcare product Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition or healthcare product with the effect of increasing bone mineral density. The pharmaceutical composition comprises the following ingredients in parts by weight: 210-390 parts of calcium carbonate, 110-150 parts of D-glucosamine hydrochloride, 110-150 parts of chondroitin sulfate, 100-135 parts of magnesium carbonate, 60-70 parts of collagen, 165-290 parts of microcrystalline cellulose, 35-65 parts of sodium carboxymethyl starch, 20-40 parts of povidone K30 and 1-6 parts of magnesium stearate. After adding preparations to form the required auxiliary materials or carriers, any clinically acceptable proper pharmaceutical preparation or healthcare product can be prepared according to the conventional preparation method in the field. The pharmacological test results show that the pharmaceutical composition or healthcare product is capable of effectively increasing the bone mineral density, does not cause toxic and side effects to the animals, and is safe to take.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition or health product, relate in particular to a kind of pharmaceutical composition or health product that increase bone density effect that have, the invention still further relates to the preparation method of this pharmaceutical composition or health product, belong to field of health care food.
Background technology
Osteoporosis is a kind of low with bone amount, and bone micro-structure damages, and causes bone fragility to increase, and easily fracture occurring is the general osteopathia of feature.It is with the disease of skeletal system that bone strength declines, risk of bone fracture increases to feature that the state-run commune hospital of the calendar year 2001 U.S. proposes osteoporosis, two main aspects of bone strength reaction skeleton, i.e. bone density and burst quality.Along with the continuous aging of world population, Decrease of Bone Mineral Density crowd quantity increases, and osteoporosis incidence rate raises, and becomes global hygienic issues.The osteoporosis that Decrease of Bone Mineral Density causes has had a strong impact on the healthy and quality of the life of middle-aged and elderly people, and presents incidence rate and rise year by year, and the trend that the age reduces occurs.Incidence of osteoporosis and hazardness are large, and except bringing to individual serious health and menticide, consequent huge medicine and expenses of surgical treatment, also brought heavy economy and burden on society.Therefore how effectively to increase bone density, prevention of osteoporosis disease has become the problem of people's extensive concern.
Bone density is the bone mineral content of unit volume, and calcium and phosphorus are the main components of bone mineral, and it is more that they deposit in skeleton, and bone density is larger, and skeleton is just more solid.Bone is constantly carrying out bone reconstruction in life, and old bone is absorbed, and new bone constantly forms.Formation from the Childhood to one's mid-30s bone is greater than bone resorption, and bone amount continues to increase, and at 30～40 years old, densification and the hardness of bone reached maximum, after skeleton reaches peak value degree, with age growth bone-loss, caused Decrease of Bone Mineral Density.Decrease of Bone Mineral Density can not cause any symptom in early days, often easily by people, is ignored, once Decrease of Bone Mineral Density, below marginal value, will cause osteoporosis, occurs that skeleton pain, fracture, height become the performance such as short.Decrease of Bone Mineral Density person is exactly osteoporotic potential crowd.
Along with the continuous aging of world population, osteoporosis has become global hygienic issues, according to World Health Organization (WHO) to neck of femur density judgement, white people women in the time of 75 years old, will have 30% diagnosable be osteoporosis.At present existing 1,000 ten thousand sufferers of osteoporosis face and 1,800 ten thousand of the U.S. may develop into osteoporotic low bone amount patient.In China, situation also allows of no optimist, and China is the maximum country of aging population absolute quantity in the world at present, and osteoporosis occurs to increase progressively with the age, and 60 years old above crowd 22.6%, surpasses 80 years old crowd's incidence rate and reach 50%.From above statistical data, the health that is threatening middle-aged and elderly people that osteoporosis is serious.
Relevant expert reminds, and osteoporosis can be prevented, and takes measures ahead of time to increase bone density, and prevention of osteoporosis runs off, osteoporosis is not occurred or occur slighter, will be conducive to greatly the healthy of middle-aged and elderly people.
The medicine of osteoporosis has multiplely clinically, and its main mechanism is also different.Or take inhibition bone resorption as master or take promoting bone growing as main, also there is the medicine of some multiple action mechanism.The user of clinical application mostly is suffers from osteoporosis, and using dosage and the course for the treatment of need determine by patient's situation.
Domestic existing several are treated osteoporotic Chinese patent medicine, and majority has relief of symptoms, alleviates the curative effect of osteodynia.Chinese medicine still lacks about improving the large-scale clinical research of bone density, reduction risk of bone fracture, and long-term efficacy and safety need further research.
The health food up to now, with " increase bone substance density improving function " is divided into two classes substantially.One class is calcic, the health food that reaches increase bone density object by direct supplement calcium; Another kind of is that calcic or not take is not replenished the calcium as object, thereby but promotes the absorption of calcium to reach the health food that increases bone density this purpose by adjusting endocrine.This two class has to be increased the health food of bone substance density improving function and on market, has obtained good repercussion and also occupied certain share simultaneously.
With respect to day by day huge adaptation population's quantity, the health food market with increase bone substance density improving function is also saturated far away.Lack and a kind ofly in supplementary calcium, magnesium mineral matter, promote its absorption and the deposition in skeleton, also protect the health of cartilage and bone matrix simultaneously, play from many aspects the pharmaceutical composition or the health product that increase bone density effect.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition or health product that increase bone density effect that have.
Another object of the present invention is to provide the preparation method of this pharmaceutical composition or health product.
The present invention seeks to be achieved through the following technical solutions.
The object of the invention is to provide a kind of pharmaceutical composition or health product that increase bone density effect that have, and this pharmaceutical composition is mainly comprised of each component of following weight portion: calcium carbonate 210-390 part, D-Glucosamine Hydrochloride 110-150 part, chondroitin sulfate 110-150 part, magnesium carbonate 100-135 part, collagen protein 60-70 part, microcrystalline Cellulose 165-290 part, carboxymethyl starch sodium 35-65 part, PVP K30 are 20-40 part, magnesium stearate 1-6 part.
In order to reach better therapeutic effect, preferably, the mass parts of each component is: calcium carbonate 260-320 part, D-Glucosamine Hydrochloride 125-135 part, chondroitin sulfate 125-135 part, magnesium carbonate 80-115 part, collagen protein 50-60 part, microcrystalline Cellulose 205-240 part, carboxymethyl starch sodium 45-55 part, PVP K30 are 27-33 part, magnesium stearate 2-4 part.
Preferred, the mass parts of each component is: 288 parts of calcium carbonate, 130 parts of D-Glucosamine Hydrochlorides, 130 parts of chondroitin sulfate, 95 parts of magnesium carbonate, 55 parts of collagen protein, 220 parts of microcrystalline Cellulose, 49 parts of carboxymethyl starch sodium, PVP K30 are 3 parts of 30 parts, magnesium stearate.
Normal bone tissues is a kind of hard connective tissue consisting of cell and substrate, and cell mainly contains 3 kinds of osteoblast, osteocyte and osteoclasts.Osteoblast is the important cells of bone formation, skeleton development and growth, is responsible for synthetic, secretion and the mineralising of bone matrix; Osteoclast is the effector lymphocyte of bone resorption; Bone matrix is exactly the intercellular substance of bone, bone collagen fiber and mineral, consists of, and the two combination makes bone become hard and has certain elasticity.Calcium is the important composition composition of bone mineral, and collagen is the important substance that forms bone matrix.Along with the factors such as the age constantly increases, endocrine alteration cause osteoclast activity, surpass osteoblast, in bone matrix, bone ore deposit composition and collagen etc. run off gradually, finally make Decrease of Bone Mineral Density.
Pharmaceutical composition of the present invention or health product based on medical science to the research of osteoporosis mechanism and Therapeutic Principle thereof; simultaneously according to pharmaceutical research achievement; having of filtering out not only supplements the mineral such as calcium, magnesium; promote its absorption and the deposition in skeleton simultaneously; also protect the health of cartilage and bone matrix, thereby effectively increase bone density, each component of the functions such as prevention of osteoporosis disease generation; according to theory of medicine prescription, according to certain weight proportion, be prepared from.
Calcium is the important composition composition of bone mineral, and calcium intake is not enough, and calcium content of bone reduces, and bone density can decline naturally.
Calcium is one of the abundantest inorganic elements of people's in-vivo content, accounts for 1.5%～2.0% of body weight for humans, and wherein 99% is present in skeleton and tooth.Skeleton is huge calcium storage vault of human body, and the precipitation of calcium in skeleton constantly carried out with dissolving, is remaining dynamic balance.In the meantime, human body need to supplement from the external world a large amount of calcium, with the form of bone calcium, is deposited in sclerotin, is particularly stored in bone trabecula, make bone constantly increase, increase thick, thicken, bone density increases, bone hardness increases.After skeleton reaches peak density, with age growth bone calcium, constantly lose, bone density reduces gradually.The calcium of q.s is taken in throughout one's life has positive impact to increasing bone density, and prevention of osteoporosis is had to certain effect.
Due to reasons such as food source, dietary habit and diet structures, the every day that China's different age people dietary calcium intake is generally recommended lower than Chinese Soclety of Nutrition nutrient allowance standard in meals.In low calcium diet crowd, due to long-term calcium Deficiency of Intake, bone calcium can not get supplementing, in order to maintain the balance of blood calcium, body will mobilize bone calcium to disengage, and keeps blood calcium concentration stable, this just causes the further minimizing of bone calcium, and bone density declines gradually, further develops to osteoporosis.
Calcium carbonate: the kind in calcium source is a lot, calcium carbonate calcium content is high, bioavailability better, have no side effect, be a kind of good calcium source.The effect of mending calcium carbonate and biological calcium is consistent, all can increase the bone density of disuse osteoporosis rat.
D-Glucosamine Hydrochloride: D-Glucosamine Hydrochloride is a kind of aminohexose extracting from natural chitin.Chitin is the unique positively charged natural degradable high molecular polymer of occurring in nature, has special biological activity.The important catabolite of chitin, except D-Glucosamine Hydrochloride, also comprises D-glucosamine sulfate and 2-Acetamido-2-deoxy-D-glucose.They dissociate in vivo completely, all with glucosamine form, are absorbed, once just be absorbed, have nothing to do with initial acid group, show identical activity in vivo.Modern pharmacological research shows, glucosamine has the physiological function that increases bone density.
Skeleton is combined and is formed with calcium salt by being reticular fiber protein collagen.Ossein has important function to the supplementing of calcium in skeleton, the intensity of skeleton and the maintenance of normal morphology.Glucosamine is a kind of natural amino monosaccharide, participate in structure tissue and cell membrane, it is the synthetic intermediate material of proteoglycan macromole, it can synthesize mucopolysaccharide, glycoprotein and Dan Baiduotang proteoglycan PG, Dan Baiduotang proteoglycan PG glue compound is attached on Collagen rack, jointly forms cartilage and bone matrix with collagen grid structure.
The enzyme that glucosamine can suppress to damage cartilage, as collagenase and phospholipase A 2, effectively prevents ossein decomposition, and protection osseous tissue is not destroyed.Exogenous glucosamine can stimulate chondrocyte synthetic proteins polysaccharide simultaneously, supplements the loss of cartilage matrix, and can prevent the release of the interior virulence factor of damaging cells, thereby promotes the repair and reconstruction of cartilage matrix.
Glucosamine has obvious inhibitory action to the too high bone conversion of rat, and can improve bone and build ability again, and Decrease of Bone Mineral Density and osteoporosis are had to obvious antagonism.D-glucosamine is the natural constituent of glycoprotein in human bone joint, there is anti-osteoarthritis effect, but also can suppress the activity of collagen hydrolytic enzyme, can impel union of fracture to promote the secretion of the factor-bone morphogenetic protein, mesenchymal cell is transformed to chondroblast and osteoblast, promote the formation of new bone, thereby there is the effect that increases bone density and osteoporosis.
D-glucosamine has good effect to increasing bone density and cartilage metabolism; Chmice acute toxicity test, Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test, rat 30d feeding trial is studied the toxicity of D-Glucosamine Hydrochloride, and result does not show genetoxic and subacute toxicity action, has good safety.
Chondroitin sulfate: chondroitin sulfate (CS) is a kind of mucopolysaccharide being extensively present in humans and animals connective tissue; osseous tissue is had to defencive function; mainly be distributed in cartilage, bone, tendon, sarolemma and blood vessel wall, because thering is multiple biological activity, be used widely.Pharmacology and experimentation show, it has Saving cortilage cartilage, increases the function of bone density.At U.S. CS and aminoglucose, be added in food.
Chondroitin sulfate has higher ion polarity, and the deposition of this activity influence calcium ion for various cells in adjusting osseous tissue in sclerotin is significant; It also may be expressed and regenerating bone or cartilage by strengthening II collagen mRNA, promotes osteoblast hypertrophy and new bone formation, reaches the effect of the function that increases bone density.
Sulfated compound chrondroitin can improve bone mineral content and bone density, thereby reduce bone conversion ratio, rats with osteoporosis is improved to effect.CS can also Profilin hydrolytic enzyme and lysosomal enzyme, as Elastase, NAG glycosides enzyme etc. damage the generation of the enzyme of articular cartilage, protection cartilage.
U.S. CS and aminoglucose have been added in food, external listing to take the preparation that CS or CS and aminoglucose be main component a lot, CS and aminoglucose long-term taking, rate of side effects is very low, safety is good.
Magnesium carbonate: magnesium is to maintain one of necessary material orthobiosis in human body is also a requisite element in a lot of biochemical metabolism processes.According to the analysis of physiologist, generally become and in human body, roughly keep the magnesium content of 20～30 grams, wherein 70% with phosphate and carbonate form, participate in the composition of skeleton and tooth, the magnesium ion concentration in blood is containing 3.6 milligrams in hundred milliliters.
Due to the change of dietary structure, modern eats coarse grain less, and it is not enough causing the magnesium intake of most people.The factors such as job and life stress increase in addition, over loading mental work and bad life habits (excessive consumption of alcohol, coffee etc.) all can cause the loss of magnesium.Low magnesium can cause abnormal bone metabolism, and new osteogenesis speed slows down, and bone amount reduces.
Magnesium has the effect that promotes new osteogenesis and increase bone amount.The long-term abundance that obtains magnesium is supplied with, and can make cell tissue activation, and skeleton absorption mineral carries out just in cell activation, so it can make skeleton healthy and strong.The people of magnesium deficiency not, the incidence rate of fracture is lower, and magnesium deficiency person's fracture incidence rate obviously increases.After fracture occurs, as taken in time magnesium preparation, can make bore regenerating ability strengthen.
Take magnesium preparation or polyphagia containing the abundant food of magnesium, have the effect that delays the loss of old man's sclerotin.
Magnesium is to maintain one of necessary material of human normal function; can make cell tissue activation; magnesium human body also can in and the harm of organic acid to bone, simultaneously magnesium self is also the skeletogenous important minerals of structure, replenishes the calcium to take in appropriate magnesium simultaneously and can effectively increase bone density.
Collagen protein: collagen protein is maximum in human body, and the widest protein that distributes, is mainly distributed in the middle of connective tissue, is a kind of functional protein relevant with tissue and organ dysfunction.Skeleton is the complicated organism consisting of bone matrix and bone mineral, the above composition of bone matrix 90% is collagen, the main component of bone mineral is calcium hydroxy phosphate, first the formation of skeleton be that collagen fiber interweave mutually and form substrate net, then calcium, phosphorus are deposited in the space of collagen stroma net with the form of calcium hydroxy phosphate, form skeleton.Collagen protein is the adhesive of calcium hydroxy phosphate, and it and calcium hydroxy phosphate have formed the main body of skeleton jointly, to maintaining the complete of bone structure and bone biomechanical characteristic is extremely important.
Conventionally the generation of sclerotin is substantially constant during more than thirty people's age, but the loss of collagen protein starts aggravation; When people's age surpasses 50 years old, the half when content of collagen protein is only 30 years old in skeleton.A large amount of losses of collagen protein change skeleton micro structure, and the mineral such as calcium can not fine deposition and run off in a large number.
Collagen protein is the important component part of bone matrix, and sufficient collagen protein can maintain bone matrix normal morphology and micro structure, strengthens the toughness of bone, promotes the absorption of calcium and the precipitation in skeleton, keeps bone health.
Replenishing collagen has collagen in reinforcement and synthesizes, and promotes the mineral absorptions such as calcium, magnesium, increases bone strength, promotes bone growth, strengthens the effect of bone density.
Various crude drug required for the present invention, specification all meets national medical standard, can obtain from managing company or manufacturer's purchase of Related product.
The needed adjuvant of preparations shaping or the carrier that in pharmaceutical composition of the present invention or health product, add are microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, PVP K30.
The needed adjuvant of preparations shaping or the carrier that in pharmaceutical composition of the present invention or health product, add, quality all meets the regulation of bis-of < < Pharmacopoeia of People's Republic of China > > and the required standard of GB 16740, can obtain from managing pharmaceutic adjuvant company or manufacturer's purchase of Related product.
In pharmaceutical composition of the present invention or health product, add after the needed adjuvant of preparations shaping or carrier, according to this area or conventional formulation method, be prepared into any acceptable suitable drugs preparation or health product clinically, it can be for example oral formulations, wherein, described oral formulations includes but not limited to tablet, capsule, granule, powder, pill, oral liquid, syrup or drop pill etc., is preferably tablet.
Pharmacology test result shows, pharmaceutical composition of the present invention or health product can effectively increase bone density.Animal, without toxicity, side effect, is taken to safety.
The usage of pharmaceutical composition of the present invention or health product and consumption: press tablet and calculate, 3 times on the oral one, each 2, every content of dispersion 1.0g.
The specific embodiment
Further describe by the following examples the present invention, it should be understood that these embodiment, only for the object of illustration, never limit the scope of the invention.
Test material:
1, calcium carbonate: (purchased from Beijing Wei Er health food company limited, triumphant news Red Star edible chemical company limited produces by Guilin).
2, D-Glucosamine Hydrochloride: (purchased from ZHEJIANG AOXING BIOTECHNOLOGY CO., LTD).
3, chondroitin sulfate: (purchased from ZHEJIANG AOXING BIOTECHNOLOGY CO., LTD).
: 4, magnesium carbonate: (purchased from Beijing Wei Er health food company limited, being produced by Liaoning Aoda Pharmaceutical Co., Ltd).
5, collagen protein: (purchased from Beijing Hua Da Jierui Biotechnology Co).
Adjuvant: microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate: (purchased from Chengdu Tian Chengcheng pharmaceutic adjuvant company limited, being produced by Ahua Pharmaceutical Co., Ltd., Liaocheng, Shandong).
Adjuvant: PVP K30: (purchased from Boai Xinkaiyuan Pharmacy stock Co., Ltd).
The preparation of embodiment 1 powder
Take each component: calcium carbonate 210g, D-Glucosamine Hydrochloride 110g, chondroitin sulfate 110g, magnesium carbonate 100g, collagen protein 60g, microcrystalline Cellulose 165g, carboxymethyl starch sodium 35g, by above-mentioned each component mix homogeneously, add 20g PVP K30 and magnesium stearate 1g, mix, pack in bag, obtain; Every packed amount is 1g.
The preparation of embodiment 2 granules
Take each component: calcium carbonate 390g, D-Glucosamine Hydrochloride 150g, chondroitin sulfate 150g, magnesium carbonate 135g, collagen protein 70g, microcrystalline Cellulose 290g, carboxymethyl starch sodium 65g, PVP K30 are 40g, magnesium stearate 6g, by above-mentioned each component mix homogeneously, granulation, packing, obtains.
The preparation of embodiment 3 tablets
Take each component: calcium carbonate 288g, D-Glucosamine Hydrochloride 130g, chondroitin sulfate 130g, magnesium carbonate 95g, collagen protein 55g, microcrystalline Cellulose 220g, carboxymethyl starch sodium 49g, PVP K30 are 30g, magnesium stearate 3g, mix, tabletting, packing, obtains.Every heavy 1g.
Test example 3 pharmaceutical composition of the present invention or health product increase the pharmacology test of bone density.
1. materials and methods
The tablet that 1.1 tested materials: embodiment 3 is prepared, is white powder after pulverizing, 1.0g/ sheet.
1.2 laboratory animals and environment
50 of the SPF level male SD rats of body weight 60g-80g, by east, Changsha Kaifu District, wound experimental animal science service portion provides, and laboratory animal production licence number is SCXK (Hunan) 2009-0012.Laboratory animal occupancy permit number is No. 2010-0010, SYXK (Hunan).
Experimental situation is barrier environment.22 ℃-24 ℃ of experimental session experimental situation temperature, humidity 50%-56%.
1.3 dosage group selections and tested material give mode
Low calcium feed formula (gram %); Casein 10.0, analysis for soybean powder 15.0, wheat flour 54.0, Oleum Arachidis hypogaeae semen 4.0, cellulose 2.0, AIN-76 salt-mixture 2.6, AIN-76 mixed vitamin 1.0, choline chloride 0.2, DL-methionine 0.2, starch 11.0, adds CaCO
3make feed calcium content reach 150mg/100g, as low calcium feedstuff (feedstuff is purchased from Beijing green permanent spring nutritional health food technological development company limited).
The prepared tablet calcium content of embodiment 3 is 11.1%.The oral recommended dose of human body is 6.0g every day, with everyone 60kg body weight, calculates, and amounting to dosage is 0.1g/kg.bw.If 5,10,30 times of the oral recommended amounts amount of tested material human body as low (0.50g/kg.bw), in (1.00g/kg.bw), high (3.00g/kg.bw) three dosage groups, calcium carbonate control group gives the calcium carbonate (calcium content that is equivalent to tested material high dose) of 0.83g/kg.bw dosage.
During sample preparation, basic, normal, high dosage is got respectively tested material 5.00g, 10.00g, 30.00g adds 1% carboxymethyl cellulose to 100ml, calcium carbonate control group is got 8.33g calcium carbonate (calcium content is 40%) and is added 1% carboxymethyl cellulose to 100ml, give respectively animal subject gavage, every day gavage once, gavage volume is 1.0ml/100g.bw, and low calcium matched group gives isopyknic 1% carboxymethyl cellulose.
From on-test, each treated animal all single cage is raised, the low calcium feedstuff of feed, and gavage gives the test solution that is subject to separately, drinks deionized water.3 totally months.
1.4 key instrument
SD-1000C bone mineral measuring instrument (Beijing Geology Research Inst., Ministry of Nuclear Industry's centre).
1.5 experimental technique
1.5.1 animal growth index
Weigh in weekly and height.
1.5.2 metabolism
Give this product after 4 weeks, rat is put in rustless steel metabolic cage and carries out three days metabolisms, collect 72 hours excrement, urine, with EDTA titration measuring calcium content.
1.5.3 femoral bmd is measured
When experiment finishes, sacrificed by decapitation rat, peels off right femur, in 105 ℃ of baking boxs, bakes to constant weight, is cooled to after room temperature, measures the bone density (BMD) of femur length, femur midpoint and distal end.
1.5.4 the mensuration of calcium content of bone
Weigh after the gross weight of femur, through high-temperature baking, femur is made to bone ash, after the HCl dissolving with 6mol/L, with EDTA titration measuring calcium content of bone.
1.6 experimental data statistics
Adopt SPSS (11.0) software to carry out variance analysis, result represents with mean+SD
1.7 results are judged
The calcium content of bone or the bone density that give tested material group are significantly higher than low calcium matched group, and compare and there is no significant difference with same dose calcium carbonate control group, and the absorbance of calcium is not less than calcium carbonate control group, can judge that this tested material has the effect that increases bone density.
2 results
2.1 the impact of tested material on rat body weight
The impact of table 1 tested material on rat body weight
From table 1, the starting weight difference of respectively organizing rat before experiment does not have significance (P > 0.05); The end-body of each dosage experiments group rat weighs and has a net increase of the value added difference of comparing with calcium carbonate control group does not have significance (P > 0.05).
The impact of 2.2 tested materials on rat height
The impact of table 2 tested material on rat height
From table 2, the initial height of respectively organizing rat before experiment does not have significant difference (P > 0.05); Calcium carbonate control group, high dose group are tested last height and are significantly higher than low calcium matched group (P < 0.05).The last height value added difference of each group experiment does not have significance (P > 0.05); The lifelong length of high dose experimental group rat and have a net increase of the value added difference of comparing with calcium carbonate control group and there is no significance (P > 0.05).
The impact of 2.3 tested materials on rat femur length and bone density
The impact of table 3 tested material on rat femur length and bone density
From table 3, each organizes the femur length no significant difference (P > 0.05) of rat; Calcium carbonate control group, high dose group rat femur distal end bone density, femur center bone density are significantly higher than low calcium matched group (P < 0.05 or P < 0.01); Sample high dose group femur center bone density and femur distal end bone density are compared difference with calcium carbonate control group do not have significance (P > 0.05)
The impact of 2.4 tested materials on rat femur weight and calcium content
The impact of table 4 tested material on rat femur weight, calcium content of bone and TC
TC=femur weight (g) * calcium content (g/g)
From table 4, each organizes femur weight and the comparison of low calcium matched group of rat, no significant difference (P > 0.05); The femur calcium content of calcium carbonate control group, high dose group rat, TC are significantly higher than low calcium matched group (P < 0.05); The femur weight of high dose experimental group rat, femur calcium content and TC are compared with corresponding calcium carbonate control group does not have significant difference (P > 0.05).
2.5 tested materials are taken in the impact of calcium, excrement calcium and urine calcium on rat
Table 5 tested material is taken in the impact of calcium, excrement calcium and urine calcium on rat
From table 5, middle and high dosage group, calcium carbonate control group rat are taken in calcium, excrement calcium is significantly higher than low calcium matched group (P < 0.01), and the urine calcium content of middle and high dosage group, calcium carbonate control group rat is significantly higher than low calcium matched group (P < 0.05 or P < 0.01); The absorption calcium of high dose experimental group rat, excrement calcium and urine calcium content are compared difference with corresponding calcium carbonate control group do not have significance (P > 0.05).
The impact of 2.6 tested materials on rat apparent absorption rate and calcium Retention
The impact of table 6 tested material on calcium in rats metabolism
Apparent absorption rate (%)=(taking in calcium-excrement calcium)/absorption calcium * 100;
Calcium Retention (%)=(taking in calcium-excrement calcium-urine calcium)/absorption calcium * 100;
From table 6, the apparent absorption rate of middle and high dosage group, calcium carbonate control group calcium in rats and calcium Retention are significantly lower than low calcium matched group (P < 0.01), and the apparent absorption rate of high dose group calcium is compared with corresponding calcium carbonate control group with calcium Retention does not have significant difference (P > 0.05).
3. brief summary
With the tested material of 0.50g/kg.bw, 1.00g/kg.bw, 3.00g/kg.bw dosage, to rat oral gavage, the result after three months shows: 3.00g/kg.bw dosage group is tested last height and is significantly higher than low calcium matched group (P < 0.05); 3.00g/kg.bw dosage group rat femur center and distal end bone density, femur calcium content and TC are significantly higher than low calcium matched group (P < 0.05 or P < 0.01); 1.00g/kg.bw, 3.00g/kg.bw dosage group rat are taken in calcium, excrement calcium and urine calcium content and are significantly higher than low calcium matched group (P < 0.05 or P < 0.01); 1.00g/kg.bw, 3.00g/kg.bw dosage group calcium in rats apparent absorption rate and calcium Retention are significantly lower than low calcium matched group (P < 0.01).The above indices of 3.00g/kg.bw dosage group rat does not have significance (P > 0.05) with corresponding calcium carbonate control group comparing difference.
Prompting this tested material under this experiment condition has the effect that increases rat bone density.
Claims (5)
1. one kind has pharmaceutical composition or the health product that increase bone density effect, it is characterized in that, the weight portion of each component is: 288 parts of calcium carbonate, 130 parts of D-Glucosamine Hydrochlorides, 130 parts of chondroitin sulfate, 95 parts of magnesium carbonate, 55 parts of collagen protein, 220 parts of microcrystalline Cellulose, 49 parts of carboxymethyl starch sodium, PVP K30 are 3 parts of 30 parts, magnesium stearate.
2. pharmaceutical composition claimed in claim 1 or health product, is characterized in that: add after the needed adjuvant of preparations shaping or carrier, according to this area conventional formulation method, be prepared into any acceptable suitable drugs preparation or health product clinically.
3. according to the pharmaceutical composition of claim 2 or health product, it is characterized in that: described pharmaceutical preparation is tablet, capsule, granule, powder, pill, oral liquid or syrup.
4. according to the pharmaceutical composition of claim 3 or health product, it is characterized in that: described pharmaceutical preparation is tablet.
5. pharmaceutical composition claimed in claim 1 or health product have and increase the medicine of bone density effect or the purposes of health product in preparation.
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| CN104543674A (en) * | 2015-01-04 | 2015-04-29 | 北京世纪合辉医药科技股份有限公司 | Health food for improving bone and joint health as well as preparation method thereof |
| CN105520135A (en) * | 2015-12-20 | 2016-04-27 | 雷西云 | Healthy food with function of treating osteoporosis |
| CN105770850A (en) * | 2016-04-25 | 2016-07-20 | 南京邦康生物技术有限公司 | Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product |
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| CN107583041A (en) * | 2017-09-14 | 2018-01-16 | 南通荣成医药化工有限公司 | A kind of osteoporosis calcium tablet |
| CN111135284A (en) * | 2019-12-11 | 2020-05-12 | 武汉跃莱健康产业有限公司 | Composition for improving bone mineral density and preparation method and application thereof |
| CN111012900B (en) * | 2019-12-27 | 2023-09-19 | 北大荒完达山乳业股份有限公司 | Composition with bone mineral density increasing function and preparation method and application thereof |
| CN114982956A (en) * | 2022-04-26 | 2022-09-02 | 广东长兴生物科技股份有限公司 | Glucosamine chondroitin calcium tablet and preparation method thereof |
| CN114832020B (en) * | 2022-05-30 | 2023-03-17 | 北京朗迪制药有限公司 | Pharmaceutical composition for preventing and treating child developmental disorder and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101248882A (en) * | 2008-03-28 | 2008-08-27 | 北京东方兴企食品工业技术有限公司 | Nutrition food product with promoting health of bones and bone arthrosis |
| CN102218089A (en) * | 2011-06-08 | 2011-10-19 | 华夏先葆(北京)中药研究院有限公司 | Chinese medicine preparation capable of increasing bone density and improving osteoporosis and arthralgia |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101904866A (en) * | 2010-09-07 | 2010-12-08 | 许阳 | Medicinal composition for treating osteoporosis and preparation method thereof |
| CN102178933B (en) * | 2011-04-20 | 2013-05-15 | 威海康博尔生物药业有限公司 | Preparation for preventing and treating osteoporosis and osteoarthrosis |
-
2012
- 2012-05-08 CN CN201210138467.3A patent/CN102949710B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101248882A (en) * | 2008-03-28 | 2008-08-27 | 北京东方兴企食品工业技术有限公司 | Nutrition food product with promoting health of bones and bone arthrosis |
| CN102218089A (en) * | 2011-06-08 | 2011-10-19 | 华夏先葆(北京)中药研究院有限公司 | Chinese medicine preparation capable of increasing bone density and improving osteoporosis and arthralgia |
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