CN101401833B - Composition for preventing and/or treating osteoporosis - Google Patents

Composition for preventing and/or treating osteoporosis Download PDF

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Publication number
CN101401833B
CN101401833B CN2008102166665A CN200810216666A CN101401833B CN 101401833 B CN101401833 B CN 101401833B CN 2008102166665 A CN2008102166665 A CN 2008102166665A CN 200810216666 A CN200810216666 A CN 200810216666A CN 101401833 B CN101401833 B CN 101401833B
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calcium
rat
dosage
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bone
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CN101401833A (en
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郭琥泉
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SHENZHEN KIND CARE MEDICINE CO Ltd
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SHENZHEN KIND CARE MEDICINE CO Ltd
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Abstract

The invention relates to a composition for preventing and/or treating osteoprosis, which comprises yak bone powder, active calcium, vitamin D3, D-Glucosamine Hydrochloride, isoflavones and an epimedium extract. The composition can prevent and/or treat the osteoprosis, has not toxic and side effects, does not induce other pathological changes or diseases.

Description

A kind of compositions that prevents and/or treats osteoporosis
Technical field
The present invention relates to a kind of compositions, relate in particular to a kind of compositions that prevents and/or treats osteoporosis with health purpose.
Background technology
Osteoporosis is meant that unit volume internal skeleton amount reduces, and osseous tissue is microstructural unusual, causes bone fragility to increase and fracture easily takes place being the general skeletal diseases of feature.A kind of common metabolic osteopathy during osteoporosis causes the factor of osteoporosis a lot, and important one is long-term calcareous Deficiency of Intake, along with the increase at age, the bone-loss aggravation, and health also weakens calcareous absorbability, cause negative calcium balance, osteoporosis occurs.In addition, lack exercise, climacteric women, putting treatment, lack the generation that calcium-regulating hormone, edible oxalic acid, food that phytic acid content is high also can quicken osteoporosis to a certain extent in the body.
For middle-aged and elderly people, especially to be skeleton decalcification phenomenon relevant with factor such as endocrine environment change for the calcium absorption obstacle that occurs of postmenopausal women, if replenish the calcium simply, can only do harm rather than good, the old people replenishes the calcium and not only can not improve osteoporosis, can increase the fracture incidence rate of old people's hip joint on the contrary exponentially, because too much replenishing the calcium can make the skeleton regeneration speed slow down, the skeleton flintiness lowers and the fragility increase, and too much replenishing the calcium also can be brought out atherosclerosis, digestion and urinary system calculus formation, senile dementia etc.
The osteoporotic medicine of clinical treatment mainly contains estrogen, calcitonin, calcium preparation, activated vitamin D, fluoride, bis phosphoric acid salt etc., but these chemicalses or exist the restriction in the application or take for a long time after can produce dependency, and the toxic and side effects of bringing out other pathological changes is arranged.
The inventor is to the reason of osteoporosis, pathomechanism and molecular biologically carried out deep research, but thinks by the bone density improving protect against osteoporosis.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of bone density improving, can prevent and/or treat osteoporosis, has no side effect, and can not bring out the compositions of other pathological changes or disease.
In order to address the above problem, the invention provides the compositions that a kind prevents and/or treats osteoporosis, it comprises: yak bone meal, activated calcium, vitamin D3, D-glucosamine hydrochlorate, soybean isoflavone, Herba Epimedii extract.
Above-mentioned composition further includes the physiology and goes up acceptable auxiliary, for example magnesium stearate.
Described compositions comprises the component of following weight proportion: yak bone meal 20~60, activated calcium 8~25, vitamin D3 0.1~0.2, D-glucosamine hydrochlorate 10~20, soybean isoflavone 10~20, Herba Epimedii extract 10~25, magnesium stearate 0.5~2.
Above-mentioned composition comprises the component of following weight proportion: yak bone meal 40, activated calcium 13, vitamin D3 0.13, D-glucosamine hydrochlorate 17.5, soybean isoflavone 16, Herba Epimedii extract 12, magnesium stearate 0.8.
Above-mentioned composition can be made any preparation on the pharmaceutics, preferred tablet, pill, capsule etc., more preferably capsule.Capsule does not need bonding force and pressure in the preparation, so disperse soon good absorbing in gastrointestinal tract; Can improve the stability of raw material, can not influenced by extraneous factor to damp and hot unsettled vitamins, capsule can be covered the abnormal smells from the patient of raw material itself, is convenient to take, and it is accurate, easy to use to have dosage, characteristics such as sealingly secure.
The D-glucosamine hydrochlorate has another name called Portugal's amine sugar hydrochlorate, belongs to natural aminosaccharide, easily absorbs.Under the effect of D-glucosamine hydrochlorate, can improve intravital calcareous absorption.Glucosamine exists with the form of hydrochlorate; molecule is single; molecular weight is little; in extracellular matrix in the mode of disperse near chondrocyte, turn round synthesizing amino glucose polysaccharide in chondrocyte by the glucose transport carrier; the one-step synthesis Dan Baijutang of going forward side by side; the Dan Baijutang glue compound with elastomer of the common formation of collagen grid structure, plays a part bearing pressure, the gentle blow stress of conduction, protection cartilage structure and subchondral bone attached on the substrate collagen rack.Glucosamine also has faint antiphlogistic effects, but its mechanism is different with nonsteroidal anti-inflammatory drug, and glucosamine is by the proteoglycan that stimulates the chondrocyte generation to have normal polymer structure, stabilizing cell membrane, thus play antiinflammatory action.
Soybean isoflavone extracts from Semen sojae atricolor and obtains, and it has the class estrogen action, clinically reduces bone loss after the menopause with soybean isoflavone, and can avoid the side effect of hormone.
Herba Epimedii extract has class steroidal structure, is the architecture basics of function of resisting osteoporosis, and effects such as the osseous tissue protein synthesis of promotion and Oesteoblast growth are arranged, can increase the bone activation frequency, both suppress bone resorption, stimulate bone formation again, thereby keep the bone amount, its clinical having no side effect.
Os Bovis grunniens is that bovid yak (Bos grunniens) is rejected the muscle mesentery, removes the dry bone of bone marrow, it not only contains, and to enrich natural biological calcareous, also contain the synthetic indispensable element of sclerotin such as bone collagen, bone polypeptide and phosphorus, magnesium, zinc, copper, ferrum, this compound bio is calcareous more to help absorbing and bony remodeling of calcium.
Activated calcium is to utilize eggshell, and fishbone powder, Concha Ostreae etc. is the prepared calcareous material of raw material, and it contains abundant organic calcium, bioavailability height in vivo, the preferred Concha Ostreae of the embodiment of the invention through high-temperature calcination, hydrolysis purify and goods.
Vitamin D3 is a kind of calmodulin, by to small intestinal, three kinds of organ effects of kidney and bone, keep and regulate the level of plasma calcium phosphorus, promote of the absorption of mucous membrane of small intestine epithelial cell to calcium, also can promote the heavily absorption of kidney proximal tubule to calcium, then be that calcified deposits and dissolving discharge effect exist simultaneously to bone, and bone metabolism is had dual regulation.
Compositions of the present invention has no side effect, and greater than 20000mg/kg, it belongs to non-toxic type to said composition to rat oral LD50, and does not have mutation, teratogenesis, side effect such as carcinogenic.The human body recommended amounts is 1.92g/ days.
The present composition can increase the bone density of body, the calcium content in the raising bone, increases bone weight, promptly can promote the generation of bone and the increase of bone calcium; And its calcium digestibility is higher than inorganic calcium carbonate, is easy to be digested and assimilated by body.And test as can be known the present composition preventing and treating osteoporosis simultaneously, and can not cause other toxic and side effects, can not cause other pathological changes or secondary disease yet.
The specific embodiment
Embodiment 1
Material is bought the source:
Refining yak bone meal Beijing Jia Kang source development in science and technology company limited is bought
Jia Kang source development in science and technology company limited in vitamin D3 Beijing is bought
Jia Kang source development in science and technology company limited in D-glucosamine hydrochlorate Beijing is bought
Jia Kang source development in science and technology company limited in soybean isoflavone Beijing is bought
Jia Kang source development in science and technology company limited in magnesium stearate Beijing is bought
Herba Epimedii extract Sanjiang Biologica Engineering Co., Ltd., Xi-an City buys
Activated calcium Shijiazhuang grand big good fortune Bioceuticals Inc. buys
Get above-mentioned each material and cross 40 mesh sieves, will sieve then vitamin D3 and magnesium stearate are mixed in proportion, again with this mixture and Herba Epimedii extract by weight incremental method mix, it is always mixed that last and other raw materials are put into mixer.Mixed material is being filled on the capsule filling machine automatically, and every contains content 0.32g, and operating condition requires 18~25 ℃ of temperature, and relative humidity is below 60%.Sampling detects, and qualified back numbering is standby.Populated capsule is polished on buffing machine.
Below the composition capsule that supplies test agent to provide for Shenzhen one moral hall of experiment prepares according to the method described above, and lot number is 20050512, gets content and tests, and content is the yellow-white powder, and its prescription sees Table 1,
Table 1 composite formula
Figure G2008102166665D00041
Every 0.32g.
1, toxicological evaluation experiment:
1.1 rat acute per os toxicity test
Laboratory animal: the SD rat is provided by Zhejiang Province's Experimental Animal Center, body weight 180-220g.
Dosage and medication: adopt the maximum tolerated dose method, establish dosage group of sample 20000mg/kg body weight, 20 rats, 2 per os are irritated stomaches in the male and female half and half, 24 hour.Take by weighing capsule 's content 20g adding distil water to 40ml, promptly be mixed with 0.5g/ml (can irritate the stomach Cmax), press the 20ml/kg body weight and irritate the stomach rat.Observation index: after the contamination, observe ordinary circumstance, poisoning symptom and the death state of rat, the observation period was limited to for two weeks, obtained half lethal dose LD 50, determine the acute toxicity classification, the results are shown in Table 2,
Table 2 rat acute per os toxicity test result
Figure G2008102166665D00042
By table 2 as seen, compositions is to female, the male per os LD of rat 50All greater than the 20000mg/kg body weight, according to acute toxicity grading criteria, its rat acute per os toxicity belongs to non-toxic type.
1.2 chmice acute per os toxicity test
Laboratory animal: the ICR mice is provided by Zhejiang Province's Experimental Animal Center, body weight 18-22g.
Dosage and medication: adopt the maximum tolerated dose method, establish dosage group of sample 20000mg/kg body weight, 20 rats, the secondary per os is irritated stomach in the male and female half and half, 24 hour.Take by weighing capsule 's content 20g adding distil water to 40ml, promptly be mixed with 0.5g/ml (can irritate the maximum agricultural university of stomach), press the 20ml/kg body weight and irritate the stomach rat.
Observation index: after the contamination, observe ordinary circumstance, poisoning symptom and the death state of mice, the observation period was limited to for two weeks, obtained half lethal dose, determined the acute toxicity classification, the results are shown in Table 3,
Table 3 chmice acute per os toxicity test result
By table 3 as seen, compositions is to female, the male per os LD of mice 50All greater than the 20000mg/kg body weight, according to acute toxicity grading criteria, its chmice acute per os toxicity belongs to non-toxic type.
1.3Ames test
Test strain: select histidine auxotroph Salmonella typhimurium TA97, TA97, TA100, TA102 for use, provided, after Biology identification is qualified, test by the inspection of Ministry of Public Health food.
Dosage and positive control: adopt flat board to mix method, non-metabolism activation system with four strain bacterial strains carries out prerun, bacterium or antibacterial phenomenon do not appear increasing in the result when dosage is the 5000ug/ ware, then five dosage groups of test and Selection 8,40,200,1000 and 5000ug/ ware take by weighing the 2.0g content, adding a small amount of sterile distilled water mixes well, add sterile distilled water again to 40ml, the aseptic 5000ug/ ware that is mixed with is as maximum dose level, do 5 times of dilutions respectively, be made into 1000,200,40, each dosage of 8ug/ ware.Establish blank group, solvent control group (distilled water) and positive controls (ICR-191, daunorubicin, NaN3, ametycin, 2-AF, 1 simultaneously, the 8-dihydroxyanthraquinone), it is parallel that every kind of each test concentrations of bacterial strain is established three wares, test under S9 and the not tame S9 condition of being in, retest once, on the direct count culture medium each bacterial strain return to become clump count, the results are shown in Table 4, table 5
Table 4Ames result of the test (for the first time)
Figure G2008102166665D00052
Figure G2008102166665D00061
Table 5Ames result of the test (for the second time)
Figure G2008102166665D00062
Figure G2008102166665D00071
By table 4, table 5 as can be known, the sample of various dose returns the twice that becomes clump count above blank group, solvent control group (distilled water) at the change bacterium colony number average that returns that adds S9 and do not add under the S9 condition, and each dosage is set up no tangible dose-response relationship, and the Salmonella reversion test result of compositions is negative.
1.4 mouse marrow cell micro nuclear test
Laboratory animal: the ICR mice is provided by Zhejiang Province's Experimental Animal Center, body weight 25-30g
Dosage and medication: establish three dosage groups of sample 2500,5000 and 10000mg/kg body weight, prepare with distilled water.Other establishes negative control (distilled water) and positive controls (cyclophosphamide 60mg/kg body weight), every group of 10 mices, male and female half and half.Gave at interval sample in 24 hours for the second time, 2500,5000mg/kg body weight dosage component another name get product content thing 10,20g adding distil water to 40ml be made into 0.25,0.50g/ml, press 10ml/kg body weight filling stomach.Last takes out the bone marrow of sternum film-making to 6 hours execution mices behind the sample, formaldehyde fixed, and Giemasa dyeing, every 1000 of animal counting is had a liking for polychromatophil (PCE) during microscopy, and calculating micronucleus permillage (MN ‰) the results are shown in Table 6,
Table 6 mouse marrow cell micro nuclear test result
Group (mg/kg) number of animals (only) PCE (individual) MNPCE) MN (‰) PCE/RBC
Negative control (H2O) 5 5,000 7 1.4 ± 1.1 1.26 ± 0.31
Be subjected to 2,500 5 5,000 6 1.2 ± 0.8 1.11 ± 0.10
Female examination 5,000 5 5,000 7 1.4 ± 1.1 1.14 ± 0.14
Thing 10,000 5 5,000 6 1.2 ± 0.8 1.29 ± 0.23
Cyclophosphamide 60 5 5,000 151 30.2 ± 7.4# 1.24 ± 0.51
X 2 0.154
P 0.985
Negative control (H2O) 5 5,000 5 1.0 ± 1.2 1.29 ± 0.36
Be subjected to 2,500 5 5,000 7 1.4 ± 0.6 1.15 ± 0.18
Male examination 5,000 5 5,000 6 1.2 ± 0.8 1.11 ± 0.09
Thing 10,000 5 5,000 6 1.2 ± 0.8 1.27 ± 0.19
Cyclophosphamide 60 5 5,000 136 27.2 ± 12.2# 1.15 ± 0.33
X 2 0.334
P 0.954
Compare #P<0.01 with negative control group
As shown in Table 6, each dosage group dimension nuclear rate and negative control group, difference do not have significance (P〉0.05), so compositions mouse microkernel test result is negative.
1.5 mouse sperm deformity test
Laboratory animal: the ICR mice is provided by Zhejiang Province's Experimental Animal Center, body weight 30-35g
Dosage and medication: establish three dosage groups of sample 2500,5000 and 10000mg/kg body weight, prepare with distilled water.Other establishes negative control (distilled water) and positive controls (ametycin 2.0mg/kg body weight), every group of 7 male mices.2500,5000mg/kg body weight dosage component another name get content 10,20g adding distil water to 40ml be made into 0.25,0.50g/ml, press 10ml/kg body weight filling stomach.10000mg/kg body weight dosage group takes by weighing content 20g adding distil water and is made into 0.50g/ml to 40ml, presses the 20ml/kg body weight and irritates stomach, continuous 5 days, matched group is made same treatment, and to the 35th day of sample, mice was put to death in the cervical vertebra dislocation first, select 5 mices to get two side epididymises at random, put into the plate of containing an amount of normal saline, epididymis is shredded four layers of lens paper suction strainer with eye scissors, direct smear, natural drying, methanol is fixed, and dyes with 1% Yihong.And then check the sperm state under the high power lens, and every mice is checked 1000 of complete sperms, record distortion sperm type and number calculate rate of teratosperm (%), the results are shown in Table 7.
The result of table 7 mouse sperm deformity
Figure G2008102166665D00081
Compare #P<0.01 with negative control group
As shown in Table 7, each dosage group rate of teratosperm and negative control group relatively, difference is (P〉0.05) not significantly, so sperm malformation test is negative.
2, to the influence of rat physiological and biochemical index
Laboratory animal and testing conditions: experiment is provided by Chinese Academy of Sciences's Shanghai Experimental Animal Center with the SD rat, cleaning level, body weight 60-80g; The experimental animal room temperature is 20-23 ℃, relative humidity scope 50-70%.
The dosage design: basic, normal, high three dosage groups and a matched group are established in experiment, the dosage of three dosage groups is respectively 0.8,1.6, the 3.2g/kg body weight, 25 times, 50 times and 100 times of (people's recommended amounts 1.92g/ days being equivalent to people's recommended amounts, each dosage is evenly admixed normal feedstuff respectively by body weight 10% conversion, give in the feedstuff mode, high dose group accounts for 3.2% of normal feedstuff.
Experimental technique: 80 of SD rats, divide 4 groups at random, male and female half and half, single cage is raised, ad lib, record body weight and food-intake, experiment periods end vein is got blood and is carried out hematological examination, and broken end is got blood and is carried out the blood biochemical analysis, dissecting the income internal organs observes, and get liver,kidney,spleen, stomach, intestinal, testis/ovary and carry out histopathologic examination's (paraffin section, H-E dyeing, spectroscopic analysis).
Interpretation of result: variance analysis
Table 8 compositions is to the influence of rat body weight (X ± SD)
Figure G2008102166665D00091
Table 9. compositions is to the influence of rat total foodstuff utilization rate and all food utilizations (X ± SD)
Figure G2008102166665D00101
By table 8,9 visible each dosage group rat body weight and matched group no significant difference (P〉0.05) relatively, to weight gain, food-intake, the total foodstuff utilization rate, there are no significant (P〉0.05) with the matched group comparing difference for all food utilizations.Illustrate that said composition can not influence the absorbing of materials such as appetite, food utilization and carbohydrate of rat.
Table 10. compositions is to the influence of HB, RBC, WBC (X ± SD)
Figure G2008102166665D00111
As shown in Table 10, the hemoglobin (HB) of each dosage group rat, red blood cell count(RBC) (RBC), numeration of leukocyte (WBC) and matched group relatively there are no significant difference (P〉0.05).Illustrate that body does not have untoward reaction to compositions.
Table 11. compositions is to leukocyte differential count lymph, monokaryon, granulocytic influence (X ± SD)
As shown in Table 11, each dosage group rat leukocyte classification lymph, monokaryon, granulocyte and matched group comparison there are no significant difference (P〉0.05).Therefore illustrate that compositions do not have other medicine side effect to body.
Table 12 compositions is to the influence of blood biochemistry of rats index (X ± SD)
Figure G2008102166665D00121
As shown in Table 12, each dosage group rat blood serum glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood urea nitrogen, creatinine, cholesterol, triglyceride and matched group comparing difference not significantly (P〉0.05).The proof compositions does not have influence to liver, kidney, can not cause burden to liver, kidney, yet can not be affected and cause other relevant diseases because of liver, renal function.
Table 13 compositions is to the influence of blood biochemistry of rats index (X ± SD)
Figure G2008102166665D00131
As shown in Table 13, numerical value is all in normal range, remove low, middle dosage group male rat total serum protein, globulin and zhoazu more all is significantly increased, difference all has significance (P<0.05), there are no significant for all the other dosage group rat blood serum blood glucose, total protein, albumin, globulin, white/ball ratio and matched group comparing difference (P〉0.05).Illustrate that taking in compositions can not cause other secondary diseases.
The influence of table 14 compositions and dirty body ratio heavy to Rats Organs and Tissues (X ± SD)
Figure G2008102166665D00132
As shown in Table 14, heavy and the contrast ratio significant difference (P<0.05) of each dosage group rat ovary, there are no significant (P〉0.05) but three dosage groups are respectively with the matched group comparing difference, all the other each dosage group Rats Organs and Tissues are heavy, liver,spleen,kidney, testis and dirty body ratio, liver/body, spleen/body, kidney/body, testis (ovary)/body and matched group compare, there are no significant for difference (P〉0.05).Illustrate that compositions grows internal organs, reproductive development has no adverse effects, and also can not cause the relevant disease of these internal organs.
Rat pathological tissue check result: dissect and do not find obviously unusual (each treated animal is 20), mirror checks that down to find liver, liver tunicle complete, lobules of liver structure no abnormality seen, hepatic cords becomes radial arrangement, Kupffer is not seen hypertrophy in the sinus hepaticus, a small amount of rat central veins of hepatic lobules and the slight congestion of lobule central area hepatic sinusoid, but do not see hepatocyte atrophy, degeneration, do not see brown particle calmness (matched group: female rats 1 example, male rat 2 examples yet; High dose group: male rat 2 examples, female rats 1 example, totally 20 of this treated animals), a small amount of rat liver cell mild swelling, strip distribution (matched group buck 1 example, high dose group buck 1 example), the visible a small amount of lymphoid cell in a small amount of rat liver portal area soaks into (matched group buck 1 example, each 1 example of the female tom of high dose group).Kidney: cortex, the obvious mechanism of medullary substance thing difference, medullary ray is clear.Glomerule does not have congested or hemorrhage, and structure is no abnormal, and the renal pelvis mucosa is complete, abnormal changes such as no biochemistry.A small amount of rat kidney kidney proximal tubule epithelial cell mild swelling (each 1 example of the female tom of matched group, high dose group: buck 1 example, jenny 2 examples), Distal convoluted tubule and collecting tubule are not seen pathological change, matter vasodilation hyperemia (matched group buck 1 example between indivedual rat kidney cortex, high dose group jenny 1 example), the matter congestion of blood vessel between the local renal tubules,convoluted of indivedual rat kidney, a small amount of erythrocyte excessive (high dose group buck 1 example).Spleen: the spleen tunicle is complete, white pulp clear in structure, a small amount of slight dilatation and congestion of Rats Spleen snius lienis (each 1 example of the female tom of matched group).Harmonization of the stomach intestinal (small intestinal, duodenum): mucomembranous epithelial cell form no abnormality seen, lamina propria, tela submucosa, flesh layer and placenta percreta do not have cell infiltration, and gastric gland, enteraden all do not have pathological changes such as atrophy, hypertrophy, degeneration.Testis: not atrophy of convoluted seminiferous tubule, spermatogenic cells at different levels are arranged not disorderly, and a matter no abnormality seen changes.Ovary: visible growing follicles at different levels, a matter no abnormality seen.
3. to the influence of sclerotin
Laboratory animal: cleaning level SD rat, female, 60-75g is provided by Chinese Academy of Sciences's Shanghai Experimental Animal Center, and the receptacle temperature is 20-25 ℃, relative humidity 40-70%, feedstuff is provided by the two preferential companies of lion laboratory animal feed technology in Suzhou.
The dosage design: the sample calcium content is 17.1%, if basic, normal, high three dosage, promptly 0.16,0.32, the 0.96g/kg feedstuff, other establishes low calcium matched group (normal feedstuff) and calcium carbonate control group (identical with the high dose calcium level), calcic is respectively 1.50, the 3.52g/kg feedstuff.(could ask the technical staff from this basic, normal, high dosage, to release each component content scope of compositions? in addition, the prescription of the compositions that the prescription of which dosage group provides corresponding to previous table 1?)
Sample preparation: take in situation (about 8g/100gBW/ day) according to designing requirement of this test dose and animal feed, respectively sample 60g, 120g, 360g being mixed normal feedstuff mixes thoroughly to 30kg, make pellet, the feedstuff of basic, normal, high three kinds of different sample sizes, feed for respectively three treated animals.Low calcium matched group gives normal feedstuff.Get calcium content and be 40% calcium carbonate 152.2g and mix normal feedstuff and mix thoroughly to 30kg, make pellet the calcium carbonate control group feedstuff.The normal feedstuff prescription sees Table 15,
Table 15 normal feedstuff prescription
Normal feedstuff prescription (Ca 2+Meter is adjusted into the 150mg/100g feedstuff)
Figure G2008102166665D00151
1. use after the HIGH PRESSURE TREATMENT.2. salt-mixture: each component content: KH in every kg salt-mixture 2PO 4501.4g; NaCl74.0g; MgCO 3, 50.2g; Ferrous lactate 5.4g; Lactic acid 4.16g; MnCO 33.5g; CuSO 4.5H 2O0.605g; Na 2SeO 36.6mg; KI7.76mg; Cr 3Cl.6H 2O0.292g; Arrive 1kg with sucrose.3. mixed vitamin: each component content in every kg mixed vitamin: vitamin A 4000,000IU; Vitamin D3 100,000; VE500IU; VK5mg; Vitamin B1 600mg; Vitamin B2 600mg; Vitamin B6 700mg; Vitamin B12 1mg; Nicotinic acid 3g; Folic acid 200mg; Calcium pantothenate 1.6g; Biotin 20mg; Arrive 1kg with sucrose.
Give sample: free diet, experimental session rat drink deionized water.
Experimental technique: birth 4 week ablactation rat is through one week of laundering period, and fasting 12 hours is weighed and random packet, and 10 every group, sub-cage rearing.Drink deionized water, each group according to dosage design gave for 12 weeks, write down each treated animal body weight and food-intake weekly, did the calcium absorption experiment the 3rd week, continued then to feed.Calcium absorption experiment: 4 weeks of ablactation rat sub-cage rearing around the birth, measure height, body weight weekly once, carry out calcium metabolism experiment in 3 days after testing for 3 weeks, write down 3 days food-intakes, collect 72 hours feces, calcium content in mensuration feedstuff and the feces.The feedstuff sample is crossed and was mixed 20 mesh sieves, and 80 ℃ of oven for drying of excrement sample are put in the exsiccator levigate after the cooling.Get the excrement sample and handle Determining Ca by Atomic Absorption Spectrometry content.
The calcium digestibility is calculated by following formula:
Take in calcium content (mg/g) * 3 day feed consumption in calcium (mg)=feedstuff
Calcium content (mg/g) * 3 day feces output in excrement calcium (mg)=feces
The apparent digestibility of calcium=(taking in calcium-excrement calcium)/absorption calcium * 100%
Femoral bmd is measured: dissect rat, peel off the left side femur, use QDR-4000 type borne densitometers and measure rat femur center and femur distal end bone density, then femur is dried to constant weight.
Calcium content of bone is measured: adopt atomic absorption method to measure, get rat one side femur and dry to constant weight in 105 ℃ of baking ovens, right title sample is handled, and measures with atomic absorption spectrophotometer.
Computing formula: calcium (mg/g)=(C * V)/(W * 1000)
C: the calcium concentration that obtains on the instrument (ug/ml)
W: key heavy (g)
V: sample constant volume (ml)
Statistical method: SPSS variance analysis
Table 16 compositions is to the influence of rat body weight
Figure G2008102166665D00161
By table 16 as seen, feed sample after 12 weeks, 0.32g/kg, 0.96g/kg sample sets rat body weight and weight increase are apparently higher than the normal feedstuff group; 0.96g/kg sample sets body weight and weight increase and calcium carbonate control group relatively do not have significant difference.
Table 17 compositions is to the influence of rat height
Figure G2008102166665D00171
By table 17 as seen, feed sample after 4 weeks, each organizes the rat height and the height increase does not all have significant difference.
The influence that table 18 compositions absorbs calcium in rats
Figure G2008102166665D00172
By table 18 as seen, same dose calcium is taken in level, and the apparent digestibility of 0.96g/kg sample sets calcium is significantly higher than calcium carbonate control group.
Table 19 compositions is to the influence of weight, bone calcium and the bone density of rat femur
Figure G2008102166665D00181
By table 19 as seen, 0.32g/kg sample sets femur weight, femur distal end bone density, calcium content of bone all are significantly higher than the normal feedstuff group; 0.96g/kg sample sets femur weight, femur distal end bone density, calcium content of bone all are significantly higher than the normal feedstuff group; 0.96g/kg sample sets femur weight, femur distal end bone density, calcium content of bone are compared there was no significant difference with calcium carbonate control group.

Claims (2)

1. compositions that prevents and/or treats osteoporosis is characterized in that described compositions made by the component of following weight proportion: yak bone meal 40, activated calcium 13, vitamin D3 0.13, D-glucosamine hydrochlorate 17.5, soybean isoflavone 16, Herba Epimedii extract 12, magnesium stearate 0.8.
2. the described compositions of claim 1 is characterized in that described compositions is made for capsule preparations.
CN2008102166665A 2008-09-27 2008-09-27 Composition for preventing and/or treating osteoporosis Expired - Fee Related CN101401833B (en)

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CN103110744B (en) * 2013-03-20 2014-10-15 吉林华康食元生物科技有限公司 Traditional Chinese medical health-care preparation for increasing bone density and preparation method thereof
CN103599176A (en) * 2013-11-07 2014-02-26 苏州冉新生物技术有限公司 Composition for enhancing bone density
CN104324319A (en) * 2014-09-26 2015-02-04 洛阳华以生物工程有限公司 Health-caring product promoting health of bone joint
CN107233563A (en) * 2017-07-10 2017-10-10 西藏月王藏药科技有限公司 Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, preparation, using and preparation method thereof
CN109170916A (en) * 2018-11-02 2019-01-11 丽睿客信息科技(北京)有限公司 One kind keeps fit and healthy food compositions and preparation method thereof
CN111631397A (en) * 2020-06-08 2020-09-08 夏新兴 Health-care composition capable of increasing bone mineral density and preparation method thereof

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