CN104206949A - Composition for improving osteoporosis and increasing bone mineral density, preparation method of same and application of the same in preparation of health-caring product - Google Patents
Composition for improving osteoporosis and increasing bone mineral density, preparation method of same and application of the same in preparation of health-caring product Download PDFInfo
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- CN104206949A CN104206949A CN201410377674.3A CN201410377674A CN104206949A CN 104206949 A CN104206949 A CN 104206949A CN 201410377674 A CN201410377674 A CN 201410377674A CN 104206949 A CN104206949 A CN 104206949A
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- chondroitin sulfate
- collagen
- vitamin
- glucosamine
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- 230000035897 transcription Effects 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
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Abstract
A composition for improving osteoporosis and increasing bone mineral density, a preparation method of the same and an application of the same in preparation of a health-caring product. The composition comprises an active ingredient and auxiliary materials and is characterized in that the active ingredient includes following components, by weight, 65-85 parts of a raw medicine in an extract of epimedium, 5-15 parts of glucosamine, 5-15 parts of chondroitin sulfate, 1.5-3.5 parts of collagen and a proper amount of vitamin D3; and the auxiliary materials include following components, by weight, 1.5-4.5 parts of an excipient and 0.2-1.5 parts of a lubricant. The composition is designed especially for middle-aged and elderly people and is strong in targeted performance. In the invention, the composition is prepared through integration of Chinese and western medicines, not only is traditional Chinese medicine guide theory inherited but also modern medicinal treatment methods are referenced. An experimental result proves that epimedium in the formula can increases the bone mineral density and the chondroitin sulfate, the glucosamine, the collagen and the vitamin D3 have an effect of improving the osteoporosis. The composition has excellent effects of increasing the bone mineral density and promoting absorption of calcium.
Description
Technical field
The present invention relates to a kind of health-care products and, be specifically related to a kind ofly to improve osteoporosis, increase the composition, its preparation method of bone density and in the application of preparing on health products.
Background technology
Osteoporosis (OP) is that a kind of concealment occurs and the disease developing, and has become the bone health problem of worldwide concern.Along with the process of social senilization, the osteoporosis incidence of disease is continuous ascendant trend, directly threatens the elderly's Health and Living quality.Therefore improve osteoporotic prevention and treatment and seem most important.WHO adds up and shows, current global sufferers of osteoporosis face exceedes 200,000,000 people, and the U.S., West Europe and Japan reach more than 7,500 ten thousand, and China reaches 9,000 ten thousand.Its incidence of disease has leapt to the 7th of the various common diseases in the world.Osteoporosis (OP) has obviously become global, the ever-increasing bone health problem that the whole world is faced jointly.
According to statistics, at present, in the 50 years old above crowd in the whole world, the osteoporosis of female incidence of disease is 1/3, and the male sex is 1/5, respectively higher than the incidence of disease of breast cancer and prostate cancer.And osteoporotic fracture is estimated in Future 30 Years, the over half of all fracture cases will be accounted for.It has been generally acknowledged that, in west, every 4 women or every 8 male sex just have 1 to suffer from this disease.In the U.S., the low bone amount patient that existing 1,000 ten thousand sufferers of osteoporosis face and 1,800 ten thousand may develop into osteoporosis.According to estimation, be subject to osteoporotic puzzlement the U.S., Europe and nearly 7,500 ten thousand people of Japan, comprise 1/3 postmenopausal women and most the elderly, and the male patient of some.Only, at US and European, annual nearly 2,500,000 because osteoporosis causes fracture, only approximately annual 23000000000 dollars of this medical expenses.
China's osteoporosis disease prevention and cure situation is severe equally, osteoporosis more than 60 years old in crowd the incidence of disease be 56%, wherein women's incidence of disease is up to 60%-70%.The danger of women's generation osteoporotic fracture reaches 40%.The treatment of osteoporosis and osteoporotic fracture and nurse costlyly, causes heavy family, burden on society.China has at least 9,000 ten thousand people to suffer from osteoporosis; 2.1 hundred million people's bone amounts are below the normal, and have osteoporotic risk.At present, China more than 50 years old in crowd osteoporosis total prevalence rate be 15.7%, along with the prolongation of population life, this ratio progressively increase.The person in middle and old age fracture of China 70-80% causes because of osteoporosis, and poor prognosis and expend huge feature, and it brings very large psychology and life stress to patient and family, causes serious financial burden to society.Greatly reduce middle-aged and old life qualities, shorten its life cycle.
According to osteoporotic cause of disease situation, treat osteoporotic bone resorption inhibitor, bone formulation stimulant, bone mineralising promoter and other kinds totally four large classes that are broadly divided into, taking bone resorption inhibitor as primary treatment medicine.Bone resorption inhibitor being by reducing the production (as estrogen) of osteoclast or reducing osteoclast activity (as diphosphonate) and suppress the absorption of bone, prevents that bone amount from too much losing.Can use bone resorption inhibitor treatment to the serious osteoporosis patient of quick bone loss.After the risk problem exposure of HRT, at present taking bisphosphonates as dominant force.But the long-term use of these medicines all has obvious side effect, as bisphosphonates, side effect comprises oesophageal irritation, hypocalcemia, kidney irritation or very rare mandible necrosis, and clinical data shows that Diphosphonate treatment also can cause atrial fibrillation.
The product that increases at present bone density class is a large class in health food, and this type of health food was subject to consumer's welcome very much in recent years, and market sale potentiality are larger.Country allows to use the raw material that increases bone density class in health products, and its functional component has Chinese herbal medicine class, chondroitin sulfates, Glucosamine class, collagen class, vitamins etc., with medicine-food two-purpose and to can be used for health food Chinese medicine class in the majority.Existing product still most methods that adopt tradition to replenish the calcium carries out osteoporotic prevention or treatment, as Caltrate D, calcium tablet, new Gaizhonggai board high calcium tablet etc. everyday.Part health products have adopted kinds of traditional Chinese medicines combination, as benefit and Changtai sheet, sealwort medlar capsule etc.
Each prior art is above all to only limit to replenish the calcium merely or carry out body conditioning.
Prior art only limits to replenish the calcium merely or carry out body conditioning.And product prescription of the present invention adopts Chinese and Western combination, both passed on traditional Chinese medicine guiding theory, use for reference again modern medicine methods for the treatment of, in its side, barrenwort confirms can increase bone density, chondroitin sulfate and Glucosamine, collagen and vitamin D through experimental study
3all there is the osteoporotic effect of improvement.By above reasonably science compatibility, reach various active composition and jointly play a role, be more conducive to improve use crowd's quality of life.Product of the present invention confirms increasing bone density, promoting to have good effect aspect calcium absorption through animal function test.
Summary of the invention
The object of this invention is to provide a kind of composition, its preparation method that improves osteoporosis, increases bone density, and in the application of preparing on health products.The present invention, for prevention, improvement, the treatment of middle-aged and old osteoporosis diseases, reaches the health-care efficacy that increases middle-aged and old bone densities.The present invention adopts Chinese and Western combination, has both passed on traditional Chinese medicine guiding theory, has used for reference again modern medicine methods for the treatment of, and in its side, barrenwort confirms can increase bone density, chondroitin sulfate and Glucosamine, collagen and vitamin D through experimental study
3all there is the osteoporotic effect of improvement.Meanwhile, the present invention creatively screens and has determined this preparation method of composition that contributes to improve osteoporosis, increases bone density.Make the effect of product clearer and more definite, stability is better, more meets market demands.
Technical solution of the present invention is, a kind of composition that improves osteoporosis, increases bone density, comprise active component and auxiliary material, it is characterized in that, described active component and weight ratio thereof are: crude drug 65-85, the Glucosamine 5-15 of Shorthorned Epimedium P.E, chondroitin sulfate 5-15, collagen 1.5-3.5, vitamin D
3in right amount; Auxiliary material is: excipient 1.5-4.5, lubricant 0.2-1.5.
The weight ratio of each component of further optimizing is: crude drug 70-80, the Glucosamine 8-12 of Shorthorned Epimedium P.E, chondroitin sulfate 8-12, collagen 2-3, vitamin D
3excipient 2-4, lubricant 0.5-1 in right amount.
25-45, Glucosamine 15-35, chondroitin sulfate 15-35, collagen 5-7, neo dohyfral D3 are appropriate, excipient 5-9, lubricant 1-3.[U1]
If do not adopt the crude drug of barrenwort, but directly adopt the extract of barrenwort, the weight ratio of described each component is: Shorthorned Epimedium P.E 30-40, Glucosamine 20-30, sodium chondroitin sulfate 20-30, collagen 5.5-6.5, vitamin D
3excipient 6-8, lubricant 1.5-2.5 in right amount.
The optimum weight ratio that the application recommends is one of following two kinds of formulas (one adopts the crude drug of barrenwort, and another is the extract that directly adopts barrenwort):
A. the crude drug 74 of Shorthorned Epimedium P.E, Glucosamine 10, chondroitin sulfate 10, collagen 2.5, vitamin D
30.00004, excipient 3, lubricant 0.7;
B. Shorthorned Epimedium P.E 36, Glucosamine 24, chondroitin sulfate 24, collagen 6, vitamin D
30.0001, excipient 7, lubricant 2.
Glucosamine described in above scheme refers to the sulfate of Glucosamine or the mixture of hydrochloride or phosphate or several salt;
Described chondroitin sulfate is sodium chondroitin sulfate or sylvite or other salt.
Described excipient is one or more the combination in dextrin, starch, microcrystalline cellulose, sucrose, lactose, sweet mellow wine;
Described lubricant is one or both the combination in dolomol, superfine silica gel powder, talcum powder;
Preparation of composition that this improves osteoporosis, increase bone density generally adopts oral agents, and formulation is: capsule, tablet, oral liquid, pill, granule, suck agent or electuary.
Above-described " in right amount " refers to vitamin D
3conventional amount used.For example: when the crude drug weight ratio of Shorthorned Epimedium P.E is 65-85, vitamin D
3weight ratio be 0.0001-0.00004.
Lubricant is one or both the combination in dolomol, superfine silica gel powder, talcum powder;
Raw material prescription of the present invention can be for any formulation.Preparation of the present invention, preferably oral formulations: capsule, tablet, oral liquid, pill, granule, suck agent, electuary etc., preferably capsule.
The technical scheme that [U2] completes second invention task of the application is, more than improves osteoporosis, increases the preparation method of the health-care products of bone density, it is characterized in that, step is as follows:
(1). choose raw material according to following weight ratio:
Crude drug 65-85, the Glucosamine 5-15 of Shorthorned Epimedium P.E, chondroitin sulfate 5-15, collagen 1.5-3.5, vitamin D
3in right amount; Auxiliary material is: excipient 1.5-4.5, lubricant 0.2-1.5.
(2). barrenwort extracts: epimedium herb is doubly measured to water boiling and extraction 2-4 time with 10-30, and each 1-3 hour, merges extract, be evaporated to relative density 1.0-1.5(40-60 DEG C) medicinal extract, dry (50-90 DEG C), pulverized 60-100 mesh sieve, obtain barrenwort dry extract fine powder, for subsequent use;
(3). pulverize: barrenwort dry extract was pulverized 60-100 mesh sieve, for subsequent use; Aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 60-100 mesh sieve, for subsequent use; Collagen, vitamin D
3, dextrin, talcum powder be placed in turnover barrel and deposit respectively;
(4). mix: get barrenwort dry extract, aminoglucose hydrochloride, sodium chondroitin sulfate, collagen that (3) step crushes, mix to obtain A; Dextrin and talcum powder mix, then with equivalent incremental method and vitamin D
3mix to obtain B; A, B are mixed, cross 30-60 mesh sieve;
(5). granulate: mixed supplementary material is added to granulator, add appropriate 60-80% edible alcohol to make softwood, 30-60 mesh sieve is granulated;
(6). dry, whole grain: will make wet granular is 40-70 DEG C at baking temperature, be dried to pellet moisture and be controlled at 3-8%, then cross the whole grain of 30-60 mesh sieve, obtain whole good particle;
(7). capsule charge, polishing, bottling: grain packing is become to capsule (the heavy 0.4-0.5g of Capsules content), and operation room humidity is controlled at and is no more than 50%.Capsule after filling is put in polishing machine and carried out polishing, and bottling, sealing, to obtain final product.
In prioritization scheme, step concrete operations are (3): after pulverizing: barrenwort dry extract was pulverized 80 mesh sieves, for subsequent use; Aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 80 mesh sieves, for subsequent use; Collagen, vitamin D
3, dextrin, talcum powder be placed in turnover barrel and deposit respectively, the outer batching of labeing feeds intake after the second people checks;
Step dry, whole grain (6): be to make moisture be controlled at 4-6% in 50-60 DEG C of dry processing above-mentioned wet granular; Dried particle is crossed to the whole grain of 40 mesh sieves, for subsequent use.
The scheme that completes the 3rd invention task of the application is: the described composition that improves osteoporosis, increase bone density improves osteoporosis in preparation, increases the application in bone density health products.
Traditional Chinese medical theory thinks that suffering from a deficiency of the kidney is osteoporotic basic reason, kidney essense abundance, medullization is raw active, bone is fully nourished and firm strong, otherwise kidney essense is lost few, bone loses and moistens fosterly, causes osteoporosis, therefore kidney-nourishing tcm drug has all been obtained gratifying achievement in the clinical treatment of osteoporosis and infrastest.Barrenwort is tradition and classical tonifying kidney and strengthening yang Chinese medicine, and the extraction that adopts modern advanced to carry out active principle separates, and reaches effect of warming and invigorating kidney Yang, strengthening the muscles and bones, and bibliographical information has remarkable effect for the yang deficiency syndrome of primary osteoporosis.Sodium chondroitin sulfate is the acid mucopolysaccharide that extracts preparation from animal tissue, is often used as and improves arthropathic complementary goods, to improving Senile degenerative arthritis, rheumatic arthritis has good effect.Main application approach is normal as the medicine for the treatment of joint disease and Glucosamine is used in conjunction with, and has pain relieving, promotes effect of regenerating bone or cartilage.Glucosamine is the most important monose that forms poly glucosamine and proteoglycan in articular cartilage matrix, can block the pathologic process of Osteoarthritis, prevents PD, improves joint motion, alleviating pain, and without significantly side effect.Collagen can maintain the automatic generting machanism of human body self cartilaginous tissue, and Saving cortilage avoids wearing and tearing and damages, and also can prevent the osteoarthritis that caused by a variety of causes, and this external enwergy is fixing calcareous, avoids calcium loss, causes Decrease of Bone Mineral Density.Vitamin D
3be not only the carrier that calcium is absorbed by body, and calcium is only at activated vitamin D
3under effect, could be utilized by bone, reach the effect of carrying high bone mass and improve biomechanical properties in bones performance, thereby reduce the fracture incidence due to osteoporosis.
More than the reasonable compatibility of prescription, will effectively prevent middle-aged and old osteoporosises, improve its symptom.Perfect along with social security system, the increase of the income of residents, people are more and more ready to select stronger the having of some specific aims to improve osteoporosis, increase the health food of bone density effect.
The present invention with respect to the beneficial effect of prior art is:
1. Chinese and Western combination: prescription of the present invention adopts traditional Chinese medicine to reach the effect of nourishing disney and strengthening bone, compatibility natural products and nutriment simultaneously, play a role by mechanism separately, regulate function, jointly reach the effect that promotes bone cell growth, strengthens calcareous absorption.
2. prescription science: research shows that barrenwort has physiology and pharmacological action widely: (1) function of resisting osteoporosis: experiment showed, that barrenwort has the synthesis that promotes bone marrow cell DNA, illustrates that barrenwort has the osteoporotic effect of good control.(2) impact on function of immune system: kidney deficiency human T-cell quantity, pouring rate of rotation, antibody, antigen and reticuloendothelial system phagocytic hypofunction, and all can improve through kidney-reinforcing drug treatments such as barrenwort.(3) effect to cardiovascular system: the myocardial ischemia in rats that barrenwort decoction and extract cause pituitrin has certain protective role.Hypotensive effect, barrenwort decoction and water-ethanol leachate, to rabbit (2.5ml/kg), cat (2ml/kg) and the quiet note of rat (4ml/kg), are all hypotensive effect.Wherein with the most obvious to rabbit effect.(4) effect to hematological system: barrenwort decoction, polysaccharide and the general flavone effect comparison to Platelet, after the oral barrenwort decoction of Healthy People, red blood cell hematocrit obviously reduces, and erythrocyte electrophoretic time shortens, erythrocyte sedimentation rate is accelerated, thereby whole blood contrast viscosity is obviously reduced.
Chondroitin sulfate has: (1) promotes Gegenbaur's cell hyperplasia, induces new bone to form, accelerated bone healing; (2) suppress oedema, synovitis and articular cartilage damage, to anti-arthritis; (3) anti-oxidant, remove free radical and delaying senility; (4) adjust fat, lipopenicillinase, antithrombotic and antiatherosclerosis; Have not yet to see sodium chondroitin sulfate security bad reaction report, as medicine-food two-purpose natural origin product, its safety in utilization is better.
Glucosamine has: (1) stimulates cartilage cell to produce the glycoprotein with normal polymer structure, and inhibition can damage the enzyme of articular cartilage, prevents the infringement to cartilage cell; (2) antioxidation, suppresses the generation of the superoxide radical of damaging cells; (3) antiinflammatory action, the pain symptom of releasing arthritis, improves function of joint, stops the development of the osteoarthritis course of disease.Effectively agent and safe edible amount: with regard to the adverse drug reaction reporting quantities aspect comparison of patient in clinical research, Glucosamine is similar to placebo, is all safe.
Collagen has: (1) increases bone density: study and show, highly purified collagen can be treated the early stage osteoporosis causing due to calcium deficiency, and the collagen of molecular weight 4000-6000 can improve and suppress the decline of bone density effectively, maintains the function of bone.(2) keep moisture of skin: collagen is not medicine but food, not yet find the report of its toxic and side effect at present.Hydrolyzed Collagen, as a kind of food additives of having been permitted by countries in the world and medicine adding ingredient, not yet has any Reporting of harms at present.U.S. FDA is after having carried out the collagen product safety research of (comprising gelatin and Hydrolyzed Collagen), classified as in the catalogue (GRAS:Generally Recognized As Safe) of high safety grade, thereby collagen product has been endowed and the safe class of amino acid peer-level.
Vitamin D
3: there is (1) regulatory factor as bone matrix protein genetic transcription, regulate and control the synthetic of type i collagen and BGP; (2) promote osteoclast to generate, promote the bone resorption of osteoclast; (3) for the mineralising of bone provides suitable microcirculation; (4) prevent Gegenbaur's cell aging, aging Gegenbaur's cell is had to enhancing osteogenic action simultaneously.
3, quality control is tight: research data proves, contains the active ingredients such as polysaccharide, flavonoids, terpene in barrenwort, and wherein a large amount of polysaccharides, flavone compound are the key characters of barrenwort; Polysaccharide is that barrenwort promotes bone growth, strengthens immunity, antidotal important component, adopts sulfuric acid-phynol method quantitatively to control to polysaccharide.Adopt high performance liquid chromatography to carry out quality monitoring to chondroitin sulfate composition.
4, evident in efficacy, with strong points: product of the present invention aims at the elderly and designs, with strong points, can effectively improve middle-aged and old osteoporosises, reach the health care that increases middle-aged and old bone densities.Prove through animal functional trial, product of the present invention can contribute to increase bone density, has further confirmed product effect.Because containing Herba Epimedii in this product prescription, children's growth is had to impact, the crowd that is not suitable for is children.
The animal functional trial that product of the present invention is carried out is as follows:
1, test specimen: embodiment 3 samples, capsule 's content is brown to brown granular agent and powder, puts normal temperature, lucifuge, the preservation of dry place.Given the test agent human body RD is 1.72g/ people/day.Positive control is Jiangu capsule for strengthening bone, purchased from Beijing Bao Tainingtang Bioisystech Co., Ltd.
2, experimental animal: 60 of SPF level female Wistar rats, body weight is 65-80g.Letting animals feed room temperature is controlled at 22-25 DEG C, and relative humidity is 50%-70%, in whole experimentation, and rat light application time every day 12h, drink deionized water, taking low calcium forage feed (calcium content is as 1.5g/kg).
3, test apparatus: micrometer, electronic balance, DPX-L dual energy X-ray absorptiometry instrument, Atomic Absorption Spectrometer
4, experimental animal grouping: healthy rat is divided into 6 groups at random, i.e. low calcium control group, positive controls, test specimen group (basic, normal, high dosage), 10 of every treated animals.
5, dosage designs and gives mode: test specimen human body RD is 1.72g/ people/day (with human body 60kg batheroom scale), establish respectively basic, normal, high three the dosage groups of test specimen with 5 times of this dosage, 10 times, 20 times, dosage is made as respectively 0.14g/kgbw/d, 0.29g/kgbw/d, 0.57g/kgbw/d.Positive controls dosage is made as 0.45 g/kgbw/d.
Test specimen is prepared by deionized water, and basic, normal, high dosage group compound concentration is respectively 14mg/ml, 29mg/ml, 57mg/ml, and positive control drug is formulated as concentration 45mg/ml by deionized water.Per os gives the tested material 10ml/ kgbw of mouse corresponding dosage, and low calcium control group gavage gives deionized water 1ml/100g body weight.Each group is administration every day 1 time above.
6, test method: respectively organize rat all with low calcium forage feed, freely drink water, weigh weekly height, body weight, experiment periods is 12 weeks.Off-test, puts to death animal, separates bilateral femur, gets wherein bilateral femur and, in 105 DEG C of baking boxs, bakes to constant weight and weigh femur dry weight.Adopt dual energy X-ray absorptiometry instrument to scan left bone thigh, represent this femur density with the bone density mean value of whole fl.Adopt the calcium content of bone of the right femur of atomic absorption spectroscopy determination.
7, result of the test is as follows:
The each treated animal of duration of test is ingested, drinking-water, stool and urine are normal, and growth and development situation and general performance are good, does not observe obviously abnormal and poisoning manifestations.
7.1, the impact on rat growthing development index (height, body weight, femur dry weight)
Height, the equal not statistically significant of body weight difference (P > 0.05) before each group test.The height difference not statistically significant (P > 0.05) of each group after test; The body weight value added of positive controls, test specimen high dose group is all higher than low calcium control group, difference has statistical significance (P < 0.05), difference not statistically significant between positive controls and test specimen high dose group (P > 0.05).
The weight value added of test specimen high dose group fl is apparently higher than low calcium control group, and difference has conspicuousness statistical significance (P < 0.01).In test specimen, the weight value added of dosage group, positive controls rat fl is higher than low calcium control group, and difference has statistical significance (P < 0.05).Test specimen low dose group and low calcium control group comparing difference no statistical significance (P > 0.05).
Above result shows that test specimen has the function of enhancing development.
7.2, the impact on rat bone density
In test specimen, dosage group, high dose group, positive controls fl density are higher than low calcium control group, and difference has statistical significance (P < 0.05).Test specimen low dose group and low calcium control group comparing difference no statistical significance (P > 0.05).
7.3, the impact on rat bone calcium content
The calcium content of bone of test specimen high dose group Rat Right femur obviously increases, and difference has statistical significance (P < 0.01) compared with low calcium control group, shows that this is positive; In test specimen, dosage group, positive controls are compared with low calcium control group, and difference also has statistical significance (P < 0.05); Test specimen low dose group and low calcium control group comparing difference no statistical significance (P > 0.05).
Judge according to the result of the increase bone density test of " health food inspection and assessment technique specification ", product of the present invention has the function that contributes to increase bone density, and is better than positive control drug on calcium content of bone and femur dry weight Index Influence.
Detailed description of the invention
Below by embodiment, the present invention is described in further details, these embodiment are only used for illustrating the present invention, do not limit the scope of the invention.
Embodiment 1:
[U3] Shorthorned Epimedium P.E 36, aminoglucose hydrochloride 24, sodium chondroitin sulfate 24, collagen 6, vitamin D
3in right amount; Auxiliary material is: dextrin 7, talcum powder 2.
Prepare according to following step:
(1) shatter: Shorthorned Epimedium P.E, aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 60 mesh sieves, for subsequent use;
(2) mix: by Shorthorned Epimedium P.E, aminoglucose hydrochloride, sodium chondroitin sulfate, collagen, mix A; Dextrin and talcum powder mix, then with equivalent incremental method and vitamin D
3mix B; A, B are mixed, cross 40 mesh sieves;
(3) granulate: mixed supplementary material is added to granulator, and add appropriate 60% edible alcohol, granulate with 40 eye mesh screens, make wet granular;
(4) dry, whole grain: will make wet granular is 40-50 DEG C at baking temperature, drying time 2-3h condition under be dried to pellet moisture at 3-5%, then cross the whole grain of 40 mesh sieves, obtain whole good particle;
(5) grain packing is become to capsule (the heavy 0.4-0.5g of Capsules content).Operation room humidity is controlled at and is no more than 50%.Polishing, bottling, sealing, to obtain final product.
Embodiment 2:
The supplementary material weight ratio of getting is barrenwort 76, sodium chondroitin sulfate 8.5, Glucosamine Sulphate 8.5, collagen 2, vitamin D
3in right amount; Auxiliary material is dextrin 3.2, talcum powder 1.
(1) extract: epimedium herb is with 15 times of amount water boiling and extraction 2 times, each 1.5 hours, merge extract, be evaporated to relative density 1.2-1.3(50 DEG C) medicinal extract, vacuum drying (60-80 DEG C), obtains barrenwort dry extract;
(2) shatter: barrenwort dry extract, Glucosamine Sulphate, sodium chondroitin sulfate were pulverized 60 mesh sieves, for subsequent use;
(3) mix: by barrenwort dry extract, Glucosamine Sulphate, sodium chondroitin sulfate, collagen, mix A; Dextrin and talcum powder mix, then with equivalent incremental method and vitamin D
3mix B; A, B are mixed, cross 30 mesh sieves;
(4) granulate: mixed supplementary material is added to granulator, and add appropriate 60% edible alcohol, granulate with 40 eye mesh screens, make wet granular;
(5) dry, whole grain: will make wet granular is 45-55 DEG C at baking temperature, drying time 2-3h condition under be dried to pellet moisture at 4-8%, then cross the whole grain of 30 mesh sieves, obtain whole good particle;
(6) grain packing is become to capsule (the heavy 0.4-0.5g of Capsules content).Operation room humidity is controlled at and is no more than 50%.Polishing, bottling, sealing, to obtain final product.
Embodiment 3:
The supplementary material weight ratio of getting is barrenwort 74, sodium chondroitin sulfate 10, aminoglucose hydrochloride 10, collagen 2.5, vitamin D
3in right amount; Auxiliary material is dextrin 3, talcum powder 0.7.
Prepare according to following step:
(1) extract: epimedium herb is with 20 times of amount water boiling and extraction 3 times, each 2 hours, merge extract, be evaporated to relative density 1.2-1.3(50 DEG C) medicinal extract, vacuum drying (60-80 DEG C), obtains barrenwort dry extract;
(2) shatter: barrenwort dry extract, aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 80 mesh sieves, for subsequent use;
(3) mix: by barrenwort dry extract, aminoglucose hydrochloride, sodium chondroitin sulfate, collagen, mix A; Dextrin and talcum powder mix, then with equivalent incremental method and vitamin D
3mix B; A, B are mixed, cross 40 mesh sieves;
(4) granulate: mixed supplementary material is added to granulator, and add appropriate 70% edible alcohol, granulate with 40 eye mesh screens, make wet granular;
(5) dry, whole grain: will make wet granular is 50-60 DEG C at baking temperature, drying time 2-3h condition under be dried to pellet moisture at 4-6%, then cross the whole grain of 40 mesh sieves, obtain whole good particle;
(6) grain packing is become to capsule (the heavy 0.4-0.5g of Capsules content).Operation room humidity is controlled at and is no more than 50%.Bottling, sealing, to obtain final product.
Embodiment 4, with 1[U4] basic identical, but weight ratio is as follows: the crude drug 65 of Shorthorned Epimedium P.E, Glucosamine 5, chondroitin sulfate 5, collagen 1.5, neo dohyfral D3 are appropriate; Excipient 1.5, lubricant 0.2.
Embodiment 5, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 85 of Shorthorned Epimedium P.E, Glucosamine 15, chondroitin sulfate 15, collagen 3.5, neo dohyfral D3 are appropriate; Excipient 4.5, lubricant 1.5.
Embodiment 6, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 65 of Shorthorned Epimedium P.E, Glucosamine 15, chondroitin sulfate 5, collagen 3.5, neo dohyfral D3 are appropriate; Excipient 1.5, lubricant 1.5.
Embodiment 7, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 85 of Shorthorned Epimedium P.E, Glucosamine 5, chondroitin sulfate 15, collagen 1.5, neo dohyfral D3 are appropriate; Excipient 4.5, lubricant 0.2.
Embodiment 8, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 70 of Shorthorned Epimedium P.E, Glucosamine 8, chondroitin sulfate 8, collagen 2, neo dohyfral D3 are appropriate, excipient 2, lubricant 0.5.
Embodiment 9, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 80 of Shorthorned Epimedium P.E, Glucosamine 12, chondroitin sulfate 12, collagen 3, vitamin D
3excipient 4, lubricant 1 in right amount.
Embodiment 10, substantially the same manner as Example 1, but weight ratio is as follows: Shorthorned Epimedium P.E 25, Glucosamine 15, chondroitin sulfate 15, collagen 5, vitamin D
3excipient 5, lubricant 1 in right amount.
Embodiment 11, substantially the same manner as Example 1, but weight ratio is as follows: Shorthorned Epimedium P.E 45, Glucosamine 35, chondroitin sulfate 35, collagen 7, vitamin D
3excipient 9, lubricant 3 in right amount.
Embodiment 12, substantially the same manner as Example 1, but weight ratio is as follows: Shorthorned Epimedium P.E 30, Glucosamine 20, chondroitin sulfate 20, collagen 5.5, vitamin D
3excipient 6, lubricant 1.5 in right amount.
Embodiment 13, substantially the same manner as Example 1, but weight ratio is as follows: Shorthorned Epimedium P.E 40, Glucosamine 30, chondroitin sulfate 30, collagen 6.5, vitamin D
3excipient 8, lubricant 2.5 in right amount.
Embodiment 14, substantially the same manner as Example 1, but weight ratio is as follows: the crude drug 74 of Shorthorned Epimedium P.E, Glucosamine 10, chondroitin sulfate 10, collagen 2.5, vitamin D
30.00004, excipient 3, lubricant 0.7.
Embodiment 15, substantially the same manner as Example 1, but weight ratio is as follows: Shorthorned Epimedium P.E 36, Glucosamine 24, chondroitin sulfate 24, collagen 6, vitamin D
30.0001, excipient 7, lubricant 2.
Embodiment 16-embodiment 23, basic identical with above each embodiment, but described Glucosamine refers to the sulfate of Glucosamine or the mixture of hydrochloride or phosphate or several salt;
Described chondroitin sulfate is sodium chondroitin sulfate, sylvite or other salt;
Described excipient is respectively one or more the combination in dextrin, starch, microcrystalline cellulose, sucrose, lactose, sweet mellow wine;
Described lubricant is respectively one or both the combination in dolomol, superfine silica gel powder, talcum powder;
Preparation of composition that this improves osteoporosis, increase bone density is respectively: capsule, tablet, oral liquid, pill, granule, suck agent or electuary.
Claims (10)
1. a composition that improves osteoporosis, increases bone density, comprise active component and auxiliary material, it is characterized in that, described active component and weight ratio thereof are: crude drug 65-85, the Glucosamine 5-15 of Shorthorned Epimedium P.E, chondroitin sulfate 5-15, collagen 1.5-3.5, vitamin D
3in right amount; Each auxiliary material and weight ratio thereof are: excipient 1.5-4.5, lubricant 0.2-1.5.
2. the composition that improves osteoporosis, increases bone density according to claim 1, it is characterized in that, the weight ratio of described each component is: crude drug 70-80, the Glucosamine 8-12 of Shorthorned Epimedium P.E, chondroitin sulfate 8-12, collagen 2-3, vitamin D
3excipient 2-4, lubricant 0.5-1 in right amount.
3. the composition that improves osteoporosis, increases bone density according to claim 2, it is characterized in that, the weight ratio of described each component is: Shorthorned Epimedium P.E 25-45, Glucosamine 15-35, chondroitin sulfate 15-35, collagen 5-7, vitamin D
3excipient 5-9, lubricant 1-3 in right amount.
4. the composition that improves osteoporosis, increases bone density according to claim 3, it is characterized in that, the weight ratio of described each component is: Shorthorned Epimedium P.E 30-40, Glucosamine 20-30, chondroitin sulfate 20-30, collagen 5.5-6.5, vitamin D
3excipient 6-8, lubricant 1.5-2.5 in right amount.
5. the composition that improves osteoporosis, increases bone density according to claim 4, is characterized in that, the weight ratio of described each component is one of following two kinds of formulas:
A. the crude drug 74 of Shorthorned Epimedium P.E, Glucosamine 10, chondroitin sulfate 10, collagen 2.5, vitamin D
30.00004, excipient 3, lubricant 0.7;
B. Shorthorned Epimedium P.E 36, Glucosamine 24, chondroitin sulfate 24, collagen 6, vitamin D
30.0001, excipient 7, lubricant 2.
6. according to the composition that improves osteoporosis, increase bone density one of claim 1-5 Suo Shu, it is characterized in that:
Described Glucosamine refers to the sulfate of Glucosamine or the mixture of hydrochloride or phosphate or several salt;
Described chondroitin sulfate is sodium chondroitin sulfate or sylvite or other salt;
Described excipient is one or more the combination in dextrin, starch, microcrystalline cellulose, sucrose, lactose, sweet mellow wine;
Described lubricant is one or both the combination in dolomol, superfine silica gel powder, talcum powder;
Preparation of composition that this improves osteoporosis, increase bone density is: capsule, tablet, oral liquid, pill, granule, suck agent or electuary.
7. the preparation method who improves osteoporosis, increases the composition of bone density claimed in claim 1, is characterized in that, step is as follows:
(1). choosing raw material according to following weight ratio is: crude drug 65-85, the Glucosamine 5-15 of Shorthorned Epimedium P.E, chondroitin sulfate 5-15, collagen 1.5-3.5, vitamin D
3in right amount; Auxiliary material is: excipient 1.5-4.5, lubricant 0.2-1.5;
(2). barrenwort extracts: epimedium herb is doubly measured to water boiling and extraction 2-4 time with 10-30, and each 1-3 hour, merges extract, is evaporated to the medicinal extract of 40-60 DEG C of relative density 1.0-1.5, and 50-90 DEG C of vacuum drying, obtains barrenwort dry extract;
(3). pulverize: barrenwort dry extract was pulverized 60-100 mesh sieve, for subsequent use; Aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 60-100 mesh sieve, for subsequent use; Collagen, vitamin D
3, dextrin, talcum powder be placed in turnover barrel and deposit respectively;
(4). mix: get barrenwort dry extract, aminoglucose hydrochloride, sodium chondroitin sulfate, collagen that (3) step crushes, mix to obtain A; Dextrin and talcum powder mix, then with equivalent incremental method and vitamin D
3mix to obtain B; A, B are mixed, cross 30-60 mesh sieve;
(5). granulate: mixed supplementary material is added to granulator, add appropriate 60-80% edible alcohol to make softwood, 30-60 mesh sieve is granulated;
(6). dry, whole grain: will make wet granular is 40-70 DEG C at baking temperature, be dried to pellet moisture and be controlled at 3-8%, then cross the whole grain of 30-60 mesh sieve, obtain whole good particle;
(7). capsule charge, polishing, bottling: grain packing is become to capsule; The heavy 0.4-0.5g of Capsules content, operation room humidity is controlled at and is no more than 50%; Capsule after filling is put in polishing machine and carried out polishing, and bottling, sealing, to obtain final product.
8. the preparation method who improves osteoporosis, increases the composition of bone density according to claim 7, is characterized in that, step concrete operations are (3): after pulverizing: barrenwort dry extract was pulverized 80 mesh sieves, for subsequent use; Aminoglucose hydrochloride, sodium chondroitin sulfate were pulverized 80 mesh sieves, for subsequent use; Collagen, vitamin D
3, dextrin, talcum powder be placed in turnover barrel and deposit respectively, the outer batching of labeing feeds intake after the second people checks.
9. according to the preparation method of the composition that improves osteoporosis, increase bone density described in claim 7 or 8, it is characterized in that step dry, whole grain (6): be to make moisture be controlled at 4-6% in 50-60 DEG C of dry processing above-mentioned wet granular; Dried particle is crossed to the whole grain of 40 mesh sieves, for subsequent use.
10. the composition that improves osteoporosis, increase bone density claimed in claim 1 improves osteoporosis in preparation, increases the application in bone density health products.
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| CN105030879A (en) * | 2015-05-15 | 2015-11-11 | 江西师范大学 | Chitosan oligosaccharide bone-fortifying health-caring product and production method thereof |
| CN105232634A (en) * | 2015-10-12 | 2016-01-13 | 临沂草之美医药科技有限公司 | Application of pharmaceutical composition for preparing osteoporosis treating drug |
| CN105942501A (en) * | 2016-05-03 | 2016-09-21 | 宣城柏维力生物工程有限公司 | Tablets capable of increasing bone density and preparation method of tablets |
| CN106235311A (en) * | 2016-07-28 | 2016-12-21 | 广州赛莱拉干细胞科技股份有限公司 | A kind of compositions promoting skeletal system health and application thereof |
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| CN115804451A (en) * | 2022-11-25 | 2023-03-17 | 广州欣盛通健康管理科技有限公司 | Composition beneficial to increase of bone density and application of composition in food |
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| CN107495349A (en) * | 2017-09-29 | 2017-12-22 | 武汉华士特工业生物技术开发有限公司 | A kind of functional food composition of increase bone density containing maca and green plum and preparation method thereof |
| WO2021062888A1 (en) * | 2019-09-30 | 2021-04-08 | 青岛琛蓝医药科技发展有限公司 | Complex composition with function of promoting bone and joint health and application thereof |
| CN115804451A (en) * | 2022-11-25 | 2023-03-17 | 广州欣盛通健康管理科技有限公司 | Composition beneficial to increase of bone density and application of composition in food |
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