CN103083650B - Composition with bone mineral density addition function, and preparation method as well as application of composition - Google Patents
Composition with bone mineral density addition function, and preparation method as well as application of composition Download PDFInfo
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Abstract
The invention relates to a composition with a bone mineral density addition function. The composition is prepared from the following raw materials in parts by weight of: 10-30 parts of D-glucosamine hydrochloride, 8-15 parts of chondroitin sulfate, 2-8 parts of collagen, 1-7 parts of a rhizoma drynariae extract, 1-7 parts of a horny goat weed extract, and 10-30 parts of milk calcium, and 10<-7> to 10<-5> parts of vitamin D3, wherein the mass content of calcium in the milk calcium is greater than or equal to 25%; the mass content of mucopolysaccharide in the collagen is greater than or equal to 25%; the horny goat weed extract contains not less than 10% by mass of icariin; and the rhizoma drynariae extract is an extract obtained from rhizoma drynariae dry rootstock through alcohol extraction. The composition has a reasonable formula design; the experiments prove that the composition has the bone mineral density addition function which is better than calcium carbonate. In addition, the composition with the bone mineral density addition function is simple in formula and low in cost, and the materials are easily available.
Description
Technical field
The present invention relates to a kind of composition and method of making the same and the purposes with increase bone substance density improving function.
Background technology
Find according to China's the 4th nutritional survey, due to the change of dietary source, dietary habit and structure, China resident calcium intake still Shortcomings.Osteoporosis is a kind of due to reducing with bone amount of causing of many reasons and osseous tissue microstructure degenerative change a kind of general metabolism osteopathia that is feature, and wherein calcium deficiency is one of chief reason.Simultaneously osteoarthritis is person in middle and old age's common disease of a kind of arthralgia of causing due to Articular cartilage degeneration and joint function disturbance.These have become global public health problem.Increase bone density, effectively treatment osteoporosis and osteoarthritis and become the problem of people's extensive concern.The functional food that research and development can increase bone density will be with a wide range of applications.
Publication number is that the Chinese invention patent application of CN 101559218A discloses a kind of compositions with increase bone substance density improving function, by weight, the active component making said composition is: calcium carbonate 5-15 part, glucosamine hydrochloride 4-12 part, chondroitin sulfate 2-6 part, phosphopeptide caseinate 3-7 part, soybean isoflavone 2-6 part.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of new compositions with increase bone substance density improving function.
The present invention also will provide the preparation method and purposes with the new compositions increasing bone substance density improving function simultaneously.
For solving above technical problem, a kind of technical scheme that the present invention takes is as follows:
Have the compositions increasing bone substance density improving function, it is made up of the raw material of following weight portion: D-Glucosamine Hydrochloride 10 ~ 30 parts, chondroitin sulfate 8 ~ 15 parts, collagen protein 2 ~ 8 parts, Rhizoma Drynariae extract 1 ~ 7 part, Herba Epimedii extract 1 ~ 7 part, milk calcium 10 ~ 30 parts, vitamin D
310
-7~ 10
-4part, the icariin of 10% is more than or equal in wherein said Herba Epimedii extract containing mass fraction.
Preferably, described compositions is made up of the raw material of following weight portion: D-Glucosamine Hydrochloride 15 ~ 25 parts, chondroitin sulfate 10 ~ 13 parts, collagen protein 3 ~ 5 parts, Rhizoma Drynariae extract 2 ~ 4 parts, Herba Epimedii extract 2 ~ 4 parts, milk calcium 15 ~ 25 parts, vitamin D
310
-4~ 10
-7part.
Further preferably, in described compositions, the weight proportion of D-Glucosamine Hydrochloride, chondroitin sulfate, collagen protein, Rhizoma Drynariae extract, Herba Epimedii extract, milk calcium is followed successively by: 6.6 ~ 6.7:4:1.3 ~ 1.4:1:1:6.6 ~ 6.7.
Preferably, in described milk calcium, the mass content of calcium is more than or equal to 25%; In collagen protein, the mass content of mucopolysaccharide is more than or equal to 25%.
Preferably, in compositions, vitamin D
3quality be 0.0001% ~ 0.001% of milk calcium quality.
The compositions that what the present invention was above-mentioned has increases bone substance density improving function can conventionally be prepared.According to a concrete aspect, the preparation method of compositions is: take whole described raw material in proportion, fully mix, and has the compositions increasing bone substance density improving function described in being.
The invention still further relates to a kind of preparation with increase bone substance density improving function, the effective ingredient of said preparation at least comprises above-mentioned compositions.
Preferably, said preparation is the conveniently oral formulations that is prepared from of technology.The concrete form of oral formulations can be such as capsule, granule, tablet, pill, oral liquid, beverage, powder, chewable tablet, electuary etc.
In view of the function of the increase bone density that the present composition has, can be applied to preparation increases in bone density product.
According to the present invention, all raw materials are all known, commercially available or prepare in accordance with known methods.
Owing to taking above technical scheme, the present invention compared with prior art tool has the following advantages:
Present composition recipe design is reasonable, the experiment proved that, its effect increasing bone density is good.In addition, present composition formula is simple, and raw material is easy to get, and cost is lower.
Accompanying drawing explanation
Fig. 1 shows rat after using tested material, and body weight is over time;
Fig. 2 show tested material on the impact of Rat Right femur Body Mass Index (
*represent p<=0.01);
Fig. 3 show tested material on the impact of Rat Right bone calcium content of femur (
*represent p<=0.05,
*represent p<=0.01);
Fig. 4 show tested material on the impact of femoral bmd (
*represent p<=0.05,
*represent p<=0.01).
Detailed description of the invention
In present composition raw material: the effect of D-Glucosamine Hydrochloride is mainly reflected in following four aspects: " leading to ", namely dredge the blood vessel of joint cyst wall; " clearly ", namely removes the impurity in articular cavity; " repair ", namely repair impaired articular cartilage; " benefit ", namely supplements the nutrient substance run off in joint.Chondroitin sulfate belongs to the one of mucopolysaccharide, has can promote Subchondral drilling, suppress new vessels, relax the curative effect such as pain, and with glucosamine with the use of, there is pain relieving, promote effect of regenerating bone or cartilage, fundamentally can improve joint prob.Collagen protein not only improves the toughness of skeleton, and also play the object of sticking calcium, articular cartilage is mainly made up of collagen protein.Rhizoma Drynariae extract refers to the extract that Rhizoma Drynariae dry rhizome obtains through alcohol extraction, and effect is the kidney invigorating bone strengthening, continuous wound of invigorating blood circulation.Recent studies have found that, Process of Total Flavonoids in Drynaria Fortunei Contained Serum has the external osteoblastic proliferation of promotion, differentiation, is suppressed to the effect of apoptosis of bone cells, namely has anti-osteoporosis activity.Also studies have found that and to share with Herba Epimedii that to treat osteoporosis effect better.Icariin is the extract of the dry stem and leaf of Herba Epimedii, it is phytoandrogen, cardiovascular and cerebrovascular vessel blood flow can be increased, promote hemopoietic function, improve immunologic function and bone metabolism, also there is kidney invigorating and YANG supporting, anti-ageing effect of waiting for a long time, also there is " Psoralen " effect simultaneously, good preventive and therapeutic effect is had to osteoporosis, antagonism is had to the osteoporosis caused by prolonged application adrenocortical hormone, can by affecting osteoblastic proliferation, differentiation and mineralising promoting bone growing, and reduce osteoclast number in vitro, weaken osteoclast absorption function.Milk calcium releases a kind of new calcium preparation recent years, absorbs fast and absorbance height is famous, so this research selection milk calcium is as calcium source with it.Vitamin D
3, have another name called nicotinic amine, cholecalciferol, can the calcification of growth promoting effects and skeleton, promote the absorption of calcium.
Below in conjunction with specific embodiment, the present invention will be further described in detail.In the raw material that following examples adopt, D-Glucosamine Hydrochloride (>=98%) is bought from the Zhejiang biochemical company limited of gold shell, chondroitin sulfate (derives from shark cartilage, >=90%) purchased from Ao Xing bio tech ltd, Zhejiang, Type Ⅱ collagen albumen (derives from chickling cartilage, mucopolysaccharide >=26%) purchased from the biochemical Co., Ltd of regent, Rhizoma Drynariae extract (alcohol extraction) and Herba Epimedii extract (>=10% icariin) are purchased from Shanxi Jiahe Plant Chemical Co., Ltd., milk calcium (calcium content >=25%), calcium carbonate (purity >=99%) and vitamin D
3purchased from upper Haicheng one raw-food material company limited.
Embodiment 1
This example provides a kind of and has the compositions increasing bone substance density improving function and the oral formulations containing said composition.With parts by weight, the composition of raw materials of compositions is as follows: D-Glucosamine Hydrochloride 20 parts, chondroitin sulfate 12 parts, collagen protein 4 parts, Rhizoma Drynariae extract 3 parts, Herba Epimedii extract 3 parts, milk calcium 20 parts, vitamin D
35*10
-5part.
Oral formulations is process for producing granula: take raw material in above-mentioned each component ratio, fully mix.Mixed powder is added appropriate dextrin, Icing Sugar, and mixing, drying and granulating, obtains granule.Specification: 8g/ bag, wherein composition levels is 6.2g/ bag.
Recommend instructions of taking and dose: every day 1 time, each 1 bag, one after each meal.
Embodiment 2
This example provides a kind of and has the compositions increasing bone substance density improving function and the oral formulations containing said composition.With parts by weight, the composition of raw materials of compositions is as follows: D-Glucosamine Hydrochloride 15 parts, chondroitin sulfate 11 parts, collagen protein 4 parts, Rhizoma Drynariae extract 3 parts, Herba Epimedii extract 3 parts, milk calcium 18 parts, vitamin D
35*10
-5part.
Oral formulations is tablet, and preparation method is: take raw material in above-mentioned each component ratio, fully mix.Mixed powder is added appropriate sodium carboxymethyl cellulose, mixing, add water-wet and granulate, dry, add appropriate magnesium stearate, tabletting, coating, obtain tablet.Specification: 800mg/ sheet, wherein composition levels is 775mg/ sheet.
Recommend instructions of taking and dose: every day 2 times, each 4.
Embodiment 3
This example provides a kind of and has the compositions increasing bone substance density improving function and the oral formulations containing said composition.With parts by weight, the composition of raw materials of compositions is as follows: D-Glucosamine Hydrochloride 10 parts, chondroitin sulfate 15 parts, collagen protein 6 parts, Rhizoma Drynariae extract 5 parts, Herba Epimedii extract 2 parts, milk calcium 15 parts, vitamin D
35*10
-5part.
Oral formulations is hard capsule, and preparation method is: take raw material in above-mentioned each component ratio, fully mix.Mixed powder is added appropriate sodium carboxymethyl cellulose, and mixing, add water moisturising preparations, loads No. 0 capsule, obtain capsule.Specification: 600mg/ grain, composition levels is 517mg/ grain.
Recommend instructions of taking and dose: every day 3 times, each 4
Embodiment 4
This example provides a kind of and has the compositions increasing bone substance density improving function and the oral formulations containing said composition.With parts by weight, the composition of raw materials of compositions is as follows: D-Glucosamine Hydrochloride 30 parts, chondroitin sulfate 10 parts, collagen protein 2 parts, Rhizoma Drynariae extract 6 parts, Herba Epimedii extract 5 parts, milk calcium 25 parts, vitamin D
35*10
-5part.
Oral formulations is oral liquid, and preparation method is: take raw material in above-mentioned each component ratio, fully mix.After mixed powder is added appropriate antiseptic and flavoring agent, stir evenly, filter, canned, sterilizing, obtains oral liquid.Specification: 10ml/ bottle, composition levels is 6.2g/ bottle.
Recommend instructions of taking and dose: every day 1 time, each 1 bottle, one after each meal.
the Efficacy experiments of the present composition
Bone density effect is increased for inquiring into mixture, middle and high dosage group is established in experiment, separately establish a low calcium matched group and a calcium carbonate control group, middle and high dosage group is with 504,1008 mg/kg. and the compositions of body weight (being equivalent to 5,10 times of human body recommended dose) dosage was to rat oral gavage 14 weeks, drink deionized water and low calcium feedstuff (calcium content 900 mg/kg) of ingesting, measure the indexs of correlation such as calcium in rats apparent absorptivity, body weight, femur weight, femur calcium content and bone density.Specific as follows.
1. materials and methods
1.1 material
1.1.1 laboratory animal and feedstuff SPF level SD male rat 45, body weight 60-75g, SPF level animal environment is raised.Low calcium feedstuff (formula: 46.57% corn starch, 14.00% casein, 12.50% dextrin, 10.00% sucrose, 5.00% fiber, 7.00% soybean oil, 1.00% vitamine supplement, 3.50% mineral additive, 0.18%L-cysteine and 0.25% choline), basic nutrition constituent content crude protein CP (%) 12.56, metabolizable energy ME (Mcal/kg) 3.51, crude fibre CF (%) 5.00, calcium (%) 0.09, total phosphorus (%) 0.30.Above purchased from Shanghai Slac Experimental Animal Co., Ltd..
1.1.2 tested material: according to the compositions of the formulated of embodiment 1, compositions and calcium carbonate contrast are all dissolved with the carboxymethyl cellulose of 0.5%.
1.2 method
After rat adaptability feeds 1 week, 4 groups are divided at random by body weight, be respectively low calcium matched group (n=12), middle dosage group (n=10), high dose group (n=11) and calcium carbonate control group (n=12), middle dosage group (5 times of human body recommended dose) and high dose group (10 times of human body recommended dose), 504mg/ kilogram is respectively to sample amount. body weight and 1008mg/ kilogram. body weight, Ca content is respectively 41.7mg/ kilogram. body weight, 83.4mg/ kilogram. body weight, calcium carbonate control group calcium content is suitable with high dose group, be 208.5mg/ kilogram to sample amount. body weight.Each experimental group is freely drunk deionized water and is given low calcium feedstuff (Ca content 900mg/ kilogram).Low calcium matched group gavage every day gives the carboxymethyl cellulose of 1 milliliter 0.5% by 100 grams of rat body weights, middle and high dosage group and calcium carbonate control group give 1 milliliter of corresponding tested material according to 100 grams of rat body weights respectively, gavage is to quadrat method, claim weekly a weight regulation accordingly to sample amount, fasting 12 hours before weighing.The rat of high dose group and calcium carbonate control group carries out calcium metabolism experiment in 3 days after low calcium feedstuff raises 3 weeks continuously, measures the apparent absorptivity of calcium, and measures height, the body weight of rat.Continue to feed to 13 weeks.Each group of rat height, body weight, femur weight, calcium content of bone and bone density is detected at the end of experiment.
1.3.1 calcium absorption experiment: record 3 days food-intakes, accumulative collection 72 hours feces, measures calcium content in feedstuff and feces.Micro-wave digestion is used, with inductivity coupled plasma mass spectrometry (ICP-MS) mensuration calcium content wherein after feedstuff and feces nitric acid dissolve.
Take in calcium (mg)=feed calcium content (mg/g) × feed consumption (g)+tested material calcium content (mg)
Excrement calcium (mg)=fecal calprotectin content (mg/g) × stool output (g)
Apparent absorptivity (%)=(taking in calcium-excrement calcium)/absorption calcium × 100% of calcium
1.3.2 calcium content of bone measures: get the right side femur of drying to constant weight (105 degree of baking ovens) and weigh, grind, with micro-wave digestion after nitric acid dissolve femur, with inductivity coupled plasma mass spectrometry (ICP-MS) mensuration calcium content wherein.
1.3.3 thighbone density measures: thighbone samples adopts single photon bone density machine (SD1000) to measure the bone density of mid point distal end and whole femur.
1.3 statistical disposition: statistics adopts SPSS10.0 statistical software to carry out statistical analysis, statistical method adopts t inspection, and origin8 maps.
1.4 results judge: result judges with reference to Ministry of Public Health " health food inspection and assessment technical specification " (version in 2003), the calcium content of bone or the bone density that give tested material group are significantly higher than low calcium matched group, and be not less than same dose calcium carbonate control group, the absorbance of calcium is not less than calcium carbonate control group, can judge that this tested material has the effect increasing bone density.
2, results and discussions
2.1 tested materials are on the impact of rat body weight and height
In experimentation, the body weight of each experimental group rat does not have significant difference (p>0.05), see Fig. 1.During animal feeding 4 weeks and test the height of last each experimental group rat and body weight does not have significant difference (p>0.05).
2.2 tested materials are on the impact of the metabolism of calcium in rats
After 3 weeks, the high dose group utilizing metabolic cage to induce low calcium feedstuff and calcium carbonate control group rat carry out calcium metabolism experiment.Record the food-intake of 3 days, the accumulative collection feces of 72 hours, after nitric acid dissolve micro-wave digestion, measure the calcium content in feedstuff and feces with inductivity coupled plasma mass spectrometry (ICP-MS), calculate the apparent absorptivity (%) taking in calcium (mg), excrement calcium (mg) and calcium according to the following formula:
Take in calcium (mg)=feed calcium content (mg/g) × feed consumption (g)+tested material calcium content (mg)
Excrement calcium (mg)=fecal calprotectin content (mg/g) × stool output (g)
Apparent absorptivity (%)=(taking in calcium-excrement calcium)/absorption calcium × 100% of calcium
Therefrom visible, the apparent absorptivity of calcium carbonate control group and high dose group calcium does not have significant difference (p>0.05).Result of calculation is see table 1.
Table 1 tested material is on the impact (x ± s) of calcium in rats metabolism
2.3 tested materials affect rat femur Body Mass Index
Rat Right femur Body Mass Index=right femur dry weight/body weight * 100%.See table 2 and Fig. 2, calcium carbonate control group, middle dosage group and high dose group Rat Right femur Body Mass Index are significantly higher than low calcium matched group, and calcium carbonate control group, middle dosage group and high dose group each experimental group Rat Right femur Body Mass Index do not have significant difference.Show that low calcium feedstuff causes the reduction of femur Body Mass Index.
Table 2 tested material is on the impact of rat femur Body Mass Index
2.4 tested materials are on the impact of rat femur calcium content
We measure the content of rat bone calcium from 8 rats of random selecting every group.Right bone calcium content of femur (mg/g)=right bone calcium content of femur (mg)/right femur dry weight (g).See table 3 and Fig. 3, middle dosage group and high dose group rat bone calcium content pole are significantly higher than low calcium matched group (p<0.01), calcium carbonate group rat bone calcium content is significantly higher than low calcium matched group (p<0.05), high dose group calcium content of bone is significantly higher than calcium carbonate control group (p<0.05), and middle dosage group calcium content of bone and calcium carbonate control group do not have significant difference.
Table 3 tested material is on the impact of rat bone calcium content
2.5 tested materials are on the impact of rat femur bone density
Bone density (BMD)=bone mineral content (BMC)/bone wide (BW).See table 4 and Fig. 4, calcium carbonate control group, middle dosage group and high dose group rat fl distal end, mid point and whole femoral bmd pole are significantly higher than low calcium matched group (p<0.01), high dose group fl mid point bone density is significantly higher than calcium carbonate control group (p<0.05), and middle dosage group and calcium carbonate control group do not have significant difference, calcium carbonate control group, middle dosage group and high dose group rat fl distal end bone density and whole femoral bmd all do not have significant difference.
Table 4 tested material is to femoral bmd (g/cm
2) impact
3, conclusion
By feeding to SD rat, 14 weeks tested materials find: no matter accept dosage or high dose in compositions, the body weight of rat and height and calcium carbonate control group all do not have significant difference, and the apparent absorptivity of high dose group calcium and corresponding dosage calcium content calcium carbonate control group are also without there being significant difference.Middle dosage group and high dose group rat femur calcium content of bone and bone density comprise distal end, center-side and whole femur and are all significantly higher than low calcium matched group, and high dose group calcium content of bone and mid point bone density are significantly higher than calcium carbonate control group.Can judge that this tested material has the effect increasing bone density according to Ministry of Public Health " health food inspection and assessment technical specification " (version in 2003).
Above to invention has been detailed description; its object is to allow the personage being familiar with this art can understand content of the present invention and be implemented; can not limit the scope of the invention with this; the equivalence change that all spirit according to the present invention are done or modification, all should be encompassed in protection scope of the present invention.
Claims (5)
1. there is the compositions increasing bone substance density improving function, it is characterized in that: described compositions is made up of the raw material of following weight portion: D-Glucosamine Hydrochloride 10 ~ 30 parts, chondroitin sulfate 8 ~ 15 parts, collagen protein 2 ~ 8 parts, Rhizoma Drynariae extract 1 ~ 7 part, Herba Epimedii extract 1 ~ 7 part, milk calcium 10 ~ 30 parts, vitamin D
310
-7~ 10
-4part; In described compositions, the weight proportion of D-Glucosamine Hydrochloride, chondroitin sulfate, collagen protein, Rhizoma Drynariae extract, Herba Epimedii extract, milk calcium is followed successively by: 6.6 ~ 6.7:4:1.3 ~ 1.4:1:1:6.6 ~ 6.7, vitamin D
3quality be 0.0001% ~ 0.001% of milk calcium quality, be more than or equal to the icariin of 10% containing mass fraction in wherein said Herba Epimedii extract, in described milk calcium, the mass content of calcium is more than or equal to 25%, and in described collagen protein, the mass content of mucopolysaccharide is more than or equal to 25%.
2. there is a preparation method for the compositions increasing bone substance density improving function as claimed in claim 1, it is characterized in that: take whole described raw material in proportion, fully mix, there is described in being the compositions increasing bone substance density improving function.
3. there is the preparation increasing bone substance density improving function, it is characterized in that: the effective ingredient of said preparation comprises compositions according to claim 1.
4. preparation according to claim 3, is characterized in that: said preparation is the conveniently oral formulations that is prepared from of technology.
5. preparation according to claim 4, is characterized in that: described preparation for being selected from capsule, granule, tablet, pill, oral liquid, any one in powder and electuary.
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| CN110897152A (en) * | 2019-11-22 | 2020-03-24 | 安徽萨普丽生物医药有限公司 | Composition and capsule for increasing bone mineral density and preparation method thereof |
| CN114651980A (en) * | 2022-03-29 | 2022-06-24 | 马玉芝 | Composition and preparation for increasing bone mineral density of climacteric women and preparation method |
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