CN104489699A - Composition for increasing bone mineral density and preparation method of composition - Google Patents
Composition for increasing bone mineral density and preparation method of composition Download PDFInfo
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- CN104489699A CN104489699A CN201410709357.7A CN201410709357A CN104489699A CN 104489699 A CN104489699 A CN 104489699A CN 201410709357 A CN201410709357 A CN 201410709357A CN 104489699 A CN104489699 A CN 104489699A
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a composition for increasing bone mineral density and a preparation method of the composition. Chinese dwarf cherry, a Chinese herbal medicine extract refined by a modern extraction technology and other raw materials with the function of increasing the bone mineral density are scientifically compounded, are scientifically combined in an omnibearing manner, and work together, so as to achieve the effects of effectively promoting absorption of calcium from a plurality of aspects, restoring and rebuilding cartilago articularis, creating synovial fluid, and promoting collagen synthesis in the cartilago articularis, preventing cartilage from further degenerating, indirectly reducing osteoclast action, inhibiting re-absorption of bones, increasing bone calcium content and improving the mechanical property of the bone, so that the product has a good effect of increasing the bone mineral density. The integrating property and the biological stability of the composition can be further improved by a microwave drying technology in the preparation method. Due to the oxidation resistance of a grape pip extract in the raw materials, high adsorption and embedding effects of modified dietary fiber, and antifungal properties of the Chinese herbal medicine extract, the efficient, safe, nutrient and stable composition with the function of increasing the bone mineral density is finally prepared.
Description
Technical field
The present invention relates to composition, be specifically related to a kind of composition and method of making the same increasing bone density.
Background technology
In recent years, osteoporosis has become a kind of disease of worldwide serious threat human health, and day by day causes the attention of people.At present, the whole world has sufferers of osteoporosis face more than 200,000,000, and its incidence of disease has leapt to the 7th of the various common disease in the world.It has been generally acknowledged that, in west, in every 4 women or every 8 male sex, just have 1 to suffer from this disease.In the U.S., existing 1,000 ten thousand patients with osteoporosis and 1,800 ten thousand people may develop into the Low BMD patient of osteoporosis.Japan suffers from osteoporotic the elderly and has 900 ~ 1,000 ten thousand, accounts for 9% of Japanese total population.According to estimates, in the U.S., Europe and Japan, nearly 7,500 ten thousand people get involved, and wherein the overwhelming majority is postmenopausal women and most the elderly.China has progressively formed aged type society, and be the country that elderly population are maximum in the world, will step into old peak period to the middle of this century, within more than 60 years old, old man accounts for 27% of total population, reaches more than 400,000,000 people.OP can cause pain, fracture, deformity, forfeiture independent living ability even dead, not only drastically influence the Health and Living quality of elderly population, and expends a large amount of manpower of state's family and home and financial resources, become socioeconomic significant burden.Along with life expectancy extends and population structure change, osteoporosis will become more serious public health problem.WHO specifies that annual June 24 was osteoporosis day, and China has also been classified as the emphasis problem that country " 95 " tackles key problems.
Osteoporosis (osteoporosis, OP) refers to that in unit volume, bone amount reduces, so that the fine structure of bone changes, thus the class bone metabolic disease causing the increase of bone fragility even to be fractured.OP a kind ofly relates to everyone and with the chronic disease of continuous regression in people's a lot of year, has become the large disease threatening human health.OP can cause pain, fracture, deformity, forfeiture independent living ability even dead, not only drastically influence the Health and Living quality of elderly population, and expends a large amount of manpower of state's family and home and financial resources, become socioeconomic significant burden.
The OP cause of disease is illustrated so far not yet completely, and current medical circle thinks that hormone regulating and controlling, trophic factor, physical factor, immunity function and inherent cause are the reasons that OP occurs.Normal Bone m etabolism balance depends on the bon e formation caused by Gegenbaur's cell and these two processes of the bone information caused by osteoclast are in relative balance state.If due to the effect of above-mentioned factor, this poised state is destroyed, occurs that bone information is greater than bon e formation, the loss of bone amount, bone structure just can be caused to change and the not congruent pathological change of bone matrix mineralising, thus cause osteoporosis.Therefore, osteoclast and osteoblastic differentiation are all the key links determining whether OP occurs with being formed.
The treatment of OP is a great problem of puzzlement medical circle always, there is no specific drug at present, have HRT (HRT), SERM (SERM), Bisphosphonates etc. to the Main Means of this disease for the treatment of in the world now.HRT is considered to prevent and treat the effective means of PMO always, but result of study display, and prolonged application HRT has to be increased patient's cardiovascular system and to unify the risk that genital system occurs.Other anti-OP medicines, comprise promoting bone growing and suppress the medicine of bone information, prolonged application all has obvious side effect, easily causes complication, or cuts because of uncertain therapeutic efficacy, and dosage is difficult to the shortcomings such as grasp, and range of application is narrow.The loss of calcium causes osteoporotic main cause, and therefore, traditional method adopts the method prevention and therapy osteoporosis of replenishing the calcium, but there are some researches show, replenishes the calcium merely and can not improve osteoporosis symptoms.
Clinical practice proves, many there is filling liver kidney, the natural drug of strengthening the bones and muscles then can prevent and treat the clinical symptoms similar with OP effectively, safely, natural plants chemical substance-phytoestrogen is often rich in its effect preventing and treating OP with it relevant, as the SERM that the isoflavones in soybean is natural, it is similar to Raloxifene to bone tissue effect, can prevent and treat the bone loss of menopausal women or ovariectomized rat.There is the chemical composition mainly compound such as lignin, flavonoids, diphenylethylene of phytoestrogen sample effect.The bark of eucommia is the natural strong bone good medicine being rich in number of chemical material, and the bone disease of the clinical symptoms that its control is similar with OP has the history in over thousands of year.According to the literature, chemical composition mainly lignin, iridoids and the flavone compound of the bark of eucommia, lignin and iridoids are its characteristic chemical constituents, its index composition rosin element diglucoside has short propagation and differentiation to osteoblast, find that its mechanism of action is after deliberation: lignin composition and endogenous estrogen are structurally comparatively similar, it has estrogen-like action, thus promoting bone growing and suppression bone information.Domestic and international the experimental results shows, the bark of eucommia has good preventive and therapeutic effect to osteoporosis.Research shows that the root of kudzu vine, barrenwort also have bibliographical information to regulate hormonal readiness, there is the effect increasing bone density, chondroitin sulfate, bone collagen also can improve osteoporosis symptoms, improve function of joint, owing to there is antagonism or synergy after multi-medicament combination, also other toxic and side effects may be had.
Dimethyl sulfone (MSM) is a kind of organic sulfur compound, is the necessary goods and materials of human collagen albumen synthesis.Dimethyl sulfone can ease pain.It can stop the propagation of pain nerve signal, also can improve collagen and connect, repair injured tissue.Zoopery proves, dimethyl sulfone can contain kneed deterioration really, also can increase the effect of cortisol, instead of quantity.Cortisol is the natural anti-inflammatory hormone in human body.Dimethyl sulfone can also be suppressed to fibrocellular generation, and fibroblast is then the principal element causing edema.Finally, dimethyl sulfone can also combine with the liquid in swollen tissue, thus detumescence.In human body and zoopery, dimethyl sulfone be used alone or with other nutritious supplementary pharmaceuticals, particularly tie up with bone element (sulfated glucosamine) together with use, therapeutic action can be had to arthritis.One is published in the Control release of the randomized double-blind on " clinical drug research " (Clinical Drug Investigation) and mentions, the dimethyl sulfone of the bone dimension element of 500 milligrams being added 500 milligrams can palliate the agonizing sufferings and swelling better, recover the mobility in joint, and resume speed sooner, more comprehensively.
Chinese patent CN 102218089B discloses a kind of Chinese medicine preparation, particularly there is the Chinese medicine preparation increasing bone density, improve osteoporosis and arthralgia function, this Chinese medicine preparation contains Shorthorned Epimedium P.E, Salvia root P.E, D-Glucosamine Hydrochloride, biological calcium carbonate (oyster calcium), Hydrolyzed Collagen, chondroitin sulfate isoreactivity composition, and wherein D-ammonia glucosamine salt hydrochlorate significantly can promote that Shorthorned Epimedium P.E and Salvia root P.E are to the effect of osteoblastic proliferation, differentiation.Said preparation bases oneself upon traditional Chinese medicine theory and studies in conjunction with modern medicine, by tonifying the liver and kidney, strengthening kidney and tonifying bone, promoting blood circulation and removing obstruction in channels and direct biology replenish the calcium and ossein, make kidney qi abundance, bone foster to some extent, improve ostalgia and arthralgia, improve climacteric quality of life, thus play the effect increasing bone density, improve osteoporosis and arthralgia.Chinese patent CN 101559218B discloses a kind of composition and method of making the same with increase bone substance density improving function.Active component contained by it is calcium carbonate, aminoglucose hydrochloride, chondroitin sulfate, CPP, isoflavones; The present invention is by above-mentioned raw materials rationally scientifically assembly, is made into oral formulations, said preparation taking convenience, the experiment proved that to have increase bone substance density improving function.Chinese patent CN 103798595A discloses a kind of health food increasing bone density, it comprises the raw material of following weight portion: the bark of eucommia 3-10, the root of kudzu vine 4-10, barrenwort 3-10, vitamine D3 0.000002-0.00001, chondroitin sulfate 0.3-1.5, calcium carbonate 0.3-1.5, collagen 0.2-1; Described health food also comprises auxiliary material, and auxiliary material weight is 6-10 of health food gross weight.This health food can increase bone density, and for osteoporosis and improve Bones and joints function, its effect is than being used alone the much effective of the bark of eucommia, the root of kudzu vine, barrenwort, chondroitin sulfate or bone collagen.Chinese patent CN 101248882B mono-kind has the nutraceutical promoting bone and bony articulation health, by calcium carbonate 11.11 ~ 22.22%, CPP 1.48 ~ 2.96%, aminoglucose hydrochloride 11.11 ~ 16.67%, collagen 6.66 ~ 11.11%, microcrystalline cellulose 12 ~ 56.6%, dolomol 0.24 ~ 0.57%, chondroitin sulfate 3.33 ~ 11.11%, dimethyl sulfone 2.22 ~ 7.77%, magnesium lactate 6 ~ 12%, Semen Vitis viniferae extract 0.56 ~ 1.33%, vitaminB10 .01 ~ 0.02%, vitamin B2 0.01 ~ 0.02%, vitamin C 0.67 ~ 2.22% forms, have and prevent, delaying osteoporosis, prevent arthritis, repair joint diaphragm, improve joint mobility, promote regenerating bone or cartilage, analgesia, anti-oxidation, prevent the generation of oxygen radical, delay effect of body aging.
The product curative effect of above-mentioned disclosed increase bone density is also very undesirable, there is following defect: the Chinese herbal medicine extract Chinese herbal medicine formula 1) used is simple, synergy is not comprehensive; 2) Chinese herbal medicine extract uses conventional methods preparation, and effective component extraction rate is low, causes wastage of material, and cost raises, and foodsafety is low; 3) the calcium source disclosed in product is mainly based on the inorganic calciums such as calcium carbonate or organic calcium, it all adopts the method extracting and developing of chemistry or synthesis to prepare, there is certain food security hidden danger, the application of calcium carbonate can have side effects to the patient of easy gasteremphraxis, calcium source single property; 4) stability problem of product is not well solved.
China's calcium fruits contains the nutriments such as abundant sugar, protein, mineral element, vitamin, amino acid, especially the content of calcium and iron is very high, in fresh fruit, calcium content can reach 60mg/100g, iron content 1.5mg/100g (apple is respectively 9mg/100g and 0.24mg/100g).Containing 17 seed amino acids in fruit, total amount reaches 338.3-451.7mg/100g, and wherein children growth essential amino acids content is up to 102.7-126.6mg/100g, especially lysine, valine, leucine and isoleucine content are very high, because of but the health fruit of children and old man.Containing total reducing sugar 5.20% in calcium fruits, reduced sugar 3.38%, organic acid 1.31%, has Vc6.17 milligram/100 gram.The kind benevolence of calcium fruit has the function of detumescence, diuresis, defaecation, and be a kind of well medicinal material, medical industry also can be processed.The cauline leaf of calcium fruit can feed ox, can utilize the feature that its biomass is large, drives the development of animal husbandry.
By natural food material---Chinese calcium fruit is applied to the product increasing bone density, not only can be that product provides that abundant foodsafety is high, calcium content is high, calcium utilization and the high natural plant calcium source of absorptivity and other nutriment, but also the development of the industries such as animal husbandry can be driven, realize sustainable development, at present, yet there are no the report Chinese calcium fruit being applied to increase bone density product.
Summary of the invention
Technical problem solved by the invention is the defect overcoming existing increase bone density product, by natural plant calcium source---Chinese calcium fruit and the modern multiple extractive technique of employing and refining Chinese herbal medicine extract and other to have the raw material science increasing bone substance density improving function composite, prepare the composition of a kind of safety, nutrition, efficient, stable increase bone density.
In order to achieve the above object, the present invention is by the following technical solutions:
Increase a composition for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 15-30 part, Chinese herbal medicine extract 12-30 part, calcium carbonate 10-28 part, calcium berry extract 15-25 part, chondroitin sulfate 5-10 part, milk calcium 2-10 part, CCP 2.5-8 part, magnesium lactate 3-6 part, dimethyl sulfone 2-4 part, grape seed extract 1.5-4 part, zinc lactate 0.15-0.3 part;
Preferably, the composition of described increase bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 20-25 part, Chinese herbal medicine extract 15-25 part, calcium carbonate 13-22 part, calcium berry extract 18-23 part, chondroitin sulfate 7-9 part, milk calcium 5-8 part, CCP 4-6 part, magnesium lactate 4-5.5 part, dimethyl sulfone 2.5-3.5 part, grape seed extract 2-3.5 part, zinc lactate 0.18-0.25 part;
More preferably, the composition of described increase bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 23 parts, Chinese herbal medicine extract 20 parts, 19 parts, calcium carbonate, calcium berry extract 20 parts, chondroitin sulfate 8 parts, milk calcium 7 parts, CCP 5 parts, magnesium lactate 4.8 parts, dimethyl sulfone 3 parts, grape seed extract 2.8 parts, zinc lactate 0.21 part;
Further, the composition of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 5-20 part, D-mannital 5-20 part, modified dietary fiber 5-20 part, hydroxypropyl methylcellulose 0.5-1.5 part, citric acid 0.5-1.5 part, dolomol 0.3-1 part;
Preferably, the composition of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 10-18 part, D-mannital 8-15 part, modified dietary fiber 15-18 part, hydroxypropyl methylcellulose 0.8-1.2 part, citric acid 0.8-1.2 part, dolomol 0.5-0.8 part;
More preferably, the composition of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 14 parts, D-mannital 11 parts, modified dietary fiber 17 parts, hydroxypropyl methylcellulose 1 part, citric acid 1 part, dolomol 0.6 part.
Further, described Chinese herbal medicine extract with the bark of eucommia, the root of kudzu vine, the red sage root, barrenwort, the rhizome of davallia, matrimony vine, when being classified as raw material ultrasonic cleaning, preparing through low temperature enzymolysis, water extraction alcohol extracting and the ultrasonic extraction of microwave radiation technology;
Preferably, the preparation method of described Chinese herbal medicine extract comprises the steps: to count by weight, takes bark of eucommia 13-27 part, root of kudzu vine 10-20 part, red sage root 8-15 part, barrenwort 5-12 part, rhizome of davallia 5-12 part, matrimony vine 3-8 part, Radix Angelicae Sinensis 3-5 part, put in the supersonic wave cleaning machine filling 0.1-0.3% sodium bicarbonate solution in 200W, 30KHz cleans 10-15min, drain, said herbal medicine being crushed to particle diameter is less than 2 millimeters, put Homogeneous phase mixing in container and add the water of 3-6 times of weight, obtain mixed material, control temperature 70 DEG C-90 DEG C keeps 2-4h, then 40-50 DEG C is cooled to, be 3.5-4.5 by lactic acid adjust ph, at power 150-300W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 60-80s, carry out compartment irradiation: irradiation 10s, interval 10s, irradiation like this 10 times, simultaneously at power 200-300W, ultrasonic assistant extraction is carried out under frequency 30-40KHz condition, then the mixing enzyme preparation adding mixed material gross weight 3-7% carries out enzymolysis, be 5.5-6.8 by lactic acid adjust ph, enzymolysis 2-4h, finally add the mixture of mixed material 0.5-3 times of w ethanol and propyl alcohol, the mass ratio of ethanol and propyl alcohol mixing is 1:1-3, control temperature to 60 DEG C-78 DEG C of maintenance 3-4h, filter, obtain the first filtrate, add the water of filter residue 1-3 times of weight, control temperature 85 DEG C-95 DEG C keeps 1-3h, is then cooled to 25-35 DEG C, filters, obtains the second filtrate, first filtrate and the second filtrate are merged according to mass ratio 2-4:1-3, filter vacuum concentrates postlyophilization, pulverizes and obtains Chinese herbal medicine extract,
Described mixed enzyme is dextranase, zytase, pentosanase, pectase 2-4:2-4:1-3:1-2 Homogeneous phase mixing in mass ratio.
Further, described calcium berry extract is that employing ultrasonic cleaning, the ultrasonic extraction of microwave radiation technology, high-pressure pulse electric extract and prepare through spontaneous fermentation with Chinese calcium fruit fresh fruit for raw material;
Preferably, the preparation method of described calcium berry extract comprises the steps: Chinese calcium fruit fresh fruit to put in the supersonic wave cleaning machine filling 0.8-1.2% sodium bicarbonate solution in 200W, 30KHz cleans 10-15min, drain, pulverize immediately after-18--22 DEG C of freezing 1-2h, freezing thickness of feed layer 3-5cm, grinding particle size 0.5-3mm, then add and pulverize material quality 0.5-2 water doubly, be 3.0-3.5 by lactic acid adjust ph, at power 200-300W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 100-120s, carry out compartment irradiation: irradiation 10s, interval 10s, control temperature 20-35 DEG C, irradiation like this 10 times, simultaneously at power 200-300W, ultrasonic assistant extraction is carried out under frequency 30-40KHz condition, insulation 1-3h, then, Microwave Extraction is carried out under power 200-400W, frequency 2000Hz condition, wherein, each microwave irradiation total time 120-135s, carry out compartment irradiation: irradiation 15s, interval 10s, control temperature 40-50 DEG C, irradiation like this 10 times, simultaneously at power 300-500W, carry out ultrasonic assistant extraction under frequency 40-50KHz condition, last Temperature fall to room temperature, in electric-field intensity 15-25kV/cm, burst length 300-500 μ s, carries out high-pressure pulse electric (PEF) and extracts 15-20min under pulse frequency 200-300Hz condition, abundant stirring extract, sealing, spontaneous fermentation 4-10d, filtering fermentation liquor obtains the first filtrate, add the water rinse of filter residue 2 times, filter to obtain the second filtrate, by the first filtrate and the second filtrate 1:2-5 Homogeneous phase mixing in mass ratio, namely mixed liquor ultrafiltration concentration, freeze drying, 30 DEG C of low-temperature grinding obtain calcium berry extract to granularity 0.1-0.3mm.
Further, described modified dietary fiber is that the Soluble Fiber cellulose content obtained through physics, chemistry or biological method process by dietary fiber is high, biologically active is strong has cellulose that is important, positive role to beneficial bacteria of intestinal tract group, compared with full diet fiber, its biological action is more powerful: 1) Soluble Fiber cellulose content is high, more easily utilized by probio, improve probio in the growth of enteron aisle and fertility, increase kind and the quantity of probio flora, reduce large intestine pH value, improve intestine microenvironment; 2) powerful adsorption capacity, through modified, cellulosic specific area increases, and network is enriched, and absorption affinity strengthens, and the organic molecule ability of chelating, absorption cholesterol and bile acids is stronger, suppress human body to their absorption; 3) ion-exchange capacity strengthens, and to metallic element, particularly heavy metal element adsorption effect is stronger; 3) the stronger and impact of acid and alkali, alkali, salt of retentiveness, dilatancy, thickening property;
Preferably, described modified dietary fiber is obtained through biology enzyme enzymolysis by one or more in inulin, apple fiber, common oats fibre, Semen Tritici aestivi fiber, rice bran, wheat bran;
More preferably, the preparation method of described modified dietary fiber comprises the following steps: by inulin, apple fiber, common oats fibre, Semen Tritici aestivi fiber, rice bran, wheat bran 8-10:4-7:3-5:2-4:1-3:1-2 Homogeneous phase mixing in mass ratio, add its quality 3-7 water doubly, room temperature 200-300W, 35-40KHz condition ultrasonic extraction 10-15min, simultaneously in electric-field intensity 20-40kV/cm, burst length 400-500 μ s, carries out high-pressure pulse electric extraction under pulse frequency 200-300Hz condition; Be 4.5-6.5 by lactic acid adjust ph, add the biology enzyme of mixture quality 0.1-0.3%, in 45-55 DEG C of enzymolysis 20-48min; Enzymolysis liquid reduced pressure concentration, freeze drying, low-temperature grinding to granularity are that namely 0.1-0.3mm obtains modified dietary fiber;
Described biology enzyme is zytase, cellulase, laccase, pectase, tannase, amylase and protease 6-10:4-8:3-5:2-4:1-3:1-3:0.3-0.5 Homogeneous phase mixing in mass ratio.
The present invention can be prepared by the following method for increasing the composition of bone density, comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 80-120 mesh sieve, then mix 10-25min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, the citric acid aqueous solution making 13-18% soluble in water, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 10-20 mesh sieve, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 50-60 DEG C dry 3-8min in microwave dryer, with the quick whole grain of 10-20 mesh sieve;
4) whole good particle and dolomol mixing 5-10min, mix and obtain composition.
The formulation of the present composition is oral formulations, can be capsule, tablet or granule, is preferably capsule.Described capsule has can cover raw material bitter taste, and it is clean and tidy, attractive in appearance, easily swallow.The bioavilability of capsule is high, and can improve drug stabilisation, product design is attractive in appearance, carries, taking convenience.
The present invention also provides the preparation method of above-mentioned composition, and it comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 80-120 mesh sieve, then mix 10-25min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, the aqueous solution making 13-18% soluble in water, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 10-20 mesh sieve, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 50-60 DEG C dry 3-8min in microwave dryer, with the quick whole grain of 10-20 mesh sieve;
4) whole good particle and dolomol mixing 5-10min, after mixing, make capsule, tablet or granule.
Preferably, the preparation method of composition of the present invention comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 100 mesh sieves, then mix 18min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 15% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 16 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 55 DEG C of dry 5min in microwave dryer, with the quick whole grain of 16 mesh sieve;
4) whole good particle and dolomol mixing 8min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Another object of the present invention is that the described composition for increasing bone density is preparing the application in food, health products or medicine.
Beneficial effect:
1. the present invention is according to traditional Chinese medicine health for increasing the composition of bone density, health care achievement in research that is theoretical and modern pharmacology develops, the bark of eucommia of nourishing disney and strengthening bone will be had, barrenwort, the root of kudzu vine promoting blood circulation and removing blood stasis, the strong bone of kidney tonifying, continue and hinder the pain relieving rhizome of davallia, stasis-dispelling and pain-killing, the red sage root of activating blood to promote menstruation, kidney tonifying nourishing the liver, antidotal matrimony vine, enrich blood, the Radix Angelicae Sinensis scientific compatibility of invigorating blood circulation also adopts modern advanced extractive technique to prepare the Chinese herbal medicine extract having and efficiently increase bone density, and with can suppress to destroy cartilage cell in order to avoid cartilage is decomposed or dissolves thus prevent the chondroitin sulfate of bone sclerosis, effectively can promote the absorption of calcium and can promote that bone is to the utilization of calcium, the aminoglucose hydrochloride of releasing osteoporosis symptom, CCP, analgesia pain relieving, contain kneed deterioration, recover the dimethyl sulfone of function of joint, combine the important trace element magnesium promoting calcium uptake, zinc, natural, safety, easy to digest, the calcium berry extract of easy absorption, effective elimination free radical, improve the grape seed extract of immunity, improve beneficial bacteria of intestinal tract group field planting, improve intestine microenvironment, promote the comprehensive science combinations such as the modified dietary fiber of absorption of nutrient ingredients, synergy, effectively promote the absorption of calcium from many aspects, repair and reconstruction articular cartilage, expedite the emergence of knuckle synovia, promote the synthesis of collagen in articular cartilage matrix, cartilage is stoped to be degenerated further, indirectly weaken osteoclast effect and suppress absorbing again of bone, increase calcium content of bone, improve bone biomechanical property, product is made to have the effect well increasing bone density.Finally prepare a kind of efficient, safety, nutrition, stable there is the composition increasing bone substance density improving function.
2. the modern advanced such as ultrasonic cleaning, biological enzymolysis, Microwave Extraction, ultrasonic extraction and high-pressure pulse electric extraction combine by Chinese herbal medicine extract, the calcium berry extract that prepared by the present invention, the drug effect not only increasing raw material availability, reduce composition cost, improve composition, the more important thing is the residues of pesticides, the heavy-metal residual that effectively eliminate plant material and killed remaining worm's ovum, improve the foodsafety of composition.
3. the modified dietary fiber prepared of the present invention is compared with full diet fiber, its biological action is more powerful: 1) Soluble Fiber cellulose content is high, more easily utilized by probio, improve probio in the growth of enteron aisle and fertility, increase kind and the quantity of probio flora, reduce large intestine pH value, improve intestine microenvironment; 2) powerful adsorption capacity, through modified, cellulosic specific area increases, and network is enriched, and absorption affinity strengthens, and the organic molecule ability of chelating, absorption cholesterol and bile acids is stronger, suppress human body to their absorption; 3) ion-exchange capacity strengthens, and to metallic element, particularly heavy metal element adsorption effect is stronger; 3) the stronger and impact of acid and alkali, alkali, salt of retentiveness, dilatancy, thickening property.
4. to have preparation method's technique of the composition increasing bone density effect simple in the present invention; be produced on a large scale; microwave drying technology wherein can further improve amalgamation and the biological stability of composition; add grape seed extract non-oxidizability in raw material, the powerful absorption of modified dietary fiber and bury function, composition that the antagonistic property of Chinese herbal medicine extract makes the present invention prepare are more stable, extend the shelf-life of composition.
Detailed description of the invention
The present invention is described below by specific embodiment.Unless stated otherwise, technological means used in the present invention is method known in those skilled in the art.In addition, embodiment is interpreted as illustrative, but not limits the scope of the invention, and the spirit and scope of the invention only limited by claims.To those skilled in the art, under the prerequisite not deviating from essence of the present invention and scope, the various change carry out the material component in these embodiments and consumption or change also belong to protection scope of the present invention.
Prepared by embodiment 1 raw material
1. the preparation of Chinese herbal medicine extract
The preparation method of described Chinese herbal medicine extract comprises the steps: to count by weight, takes the bark of eucommia 20 parts, the root of kudzu vine 15 parts, the red sage root 11 parts, barrenwort 10 parts, the rhizome of davallia 8 parts, matrimony vine 5 parts, Radix Angelicae Sinensis 4 parts, put in the supersonic wave cleaning machine filling 0.2% sodium bicarbonate solution in 200W, 30KHz cleans 12min, drain, said herbal medicine being crushed to particle diameter is less than 2 millimeters, put Homogeneous phase mixing in container and add the water of 5 times of weight, obtain mixed material, control temperature 80 DEG C keeps 3h, then 45 DEG C are cooled to, be 4 by lactic acid adjust ph, at power 200W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 70s, carry out compartment irradiation: irradiation 10s, interval 10s, irradiation like this 10 times, simultaneously at power 300W, ultrasonic assistant extraction is carried out under frequency 35KHz condition, then the mixing enzyme preparation adding mixed material gross weight 5% carries out enzymolysis, be 6.2 by lactic acid adjust ph, enzymolysis 3h, finally add the mixture of mixed material 2 times of w ethanol and propyl alcohol, the mass ratio of ethanol and propyl alcohol mixing is 1:2, control temperature to 70 DEG C keeps 4h, filters, obtains the first filtrate, add the water of filter residue 1-3 times of weight, control temperature 90 DEG C keeps 2h, is then cooled to 30 DEG C, filters, obtains the second filtrate, first filtrate and the second filtrate are merged according to mass ratio 3:2, filter vacuum concentrates postlyophilization, pulverizes and obtains Chinese herbal medicine extract,
Described mixed enzyme is dextranase, zytase, pentosanase, pectase 3:3:2:1.5 Homogeneous phase mixing in mass ratio.
2. the preparation of calcium berry extract
The preparation method of described calcium berry extract comprises the steps: Chinese calcium fruit fresh fruit to put in the supersonic wave cleaning machine filling 1% sodium bicarbonate solution in 200W, 30KHz cleans 12min, drain, pulverize immediately after-20 DEG C of freezing 1.5h, freezing thickness of feed layer 4cm, grinding particle size 1.5mm, then the water pulverizing material quality 1.5 times is added, be 3.2 by lactic acid adjust ph, at power 200W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 110s, carry out compartment irradiation: irradiation 10s, interval 10s, control temperature 28 DEG C, irradiation like this 10 times, simultaneously at power 300W, ultrasonic assistant extraction is carried out under frequency 35KHz condition, insulation 2h, then, Microwave Extraction is carried out under power 300W, frequency 2000Hz condition, wherein, each microwave irradiation total time 125s, carry out compartment irradiation: irradiation 15s, interval 10s, control temperature 45 DEG C, irradiation like this 10 times, simultaneously at power 400W, carry out ultrasonic assistant extraction under frequency 45KHz condition, last Temperature fall to room temperature, in electric-field intensity 20kV/cm, burst length 400 μ s, carries out high-pressure pulse electric (PEF) and extracts 18min under pulse frequency 250Hz condition, abundant stirring extract, sealing, spontaneous fermentation 7d, filtering fermentation liquor obtains the first filtrate, add the water rinse of filter residue 2 times, filter to obtain the second filtrate, by the first filtrate and the second filtrate 1:3 Homogeneous phase mixing in mass ratio, namely mixed liquor ultrafiltration concentration, freeze drying, 30 DEG C of low-temperature grinding obtain calcium berry extract to granularity 0.2mm.
3. the preparation of modified dietary fiber
The preparation method of described modified dietary fiber comprises the following steps: by inulin, apple fiber, common oats fibre, Semen Tritici aestivi fiber, rice bran, wheat bran 9:6:4:3:2:1.5 Homogeneous phase mixing in mass ratio, add the water of its quality 5 times, room temperature 300W, 40KHz condition ultrasonic extraction 12min, simultaneously in electric-field intensity 30kV/cm, burst length 500 μ s, carries out high-pressure pulse electric extraction under pulse frequency 300Hz condition; Be 4.5-6.5 by lactic acid adjust ph, add the biology enzyme of mixture quality 0.2%, in 50 DEG C of enzymolysis 35min; Enzymolysis liquid reduced pressure concentration, freeze drying, low-temperature grinding to granularity are that namely 0.2mm obtains modified dietary fiber;
Described biology enzyme is zytase, cellulase, laccase, pectase, tannase, amylase and protease 8:6:4:3:2:2:0.4 Homogeneous phase mixing in mass ratio.
The Chinese herbal medicine extract that following embodiment 2-8 uses, calcium berry extract, modified dietary fiber are embodiment 1 to be prepared, and other is commercial commodity.
Embodiment 2
Increase a capsule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 23 parts, Chinese herbal medicine extract 20 parts, 19 parts, calcium carbonate, calcium berry extract 20 parts, chondroitin sulfate 8 parts, milk calcium 7 parts, CCP 5 parts, magnesium lactate 4.8 parts, dimethyl sulfone 3 parts, grape seed extract 2.8 parts, zinc lactate 0.21 part;
The capsule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 14 parts, D-mannital 11 parts, modified dietary fiber 17 parts, hydroxypropyl methylcellulose 1 part, citric acid 1 part, dolomol 0.6 part.
Preparation method comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 100 mesh sieves, then mix 18min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 15% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 16 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 55 DEG C of dry 5min in microwave dryer, with the quick whole grain of 16 mesh sieve;
4) whole good particle and dolomol mixing 8min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Embodiment 3
Increase a capsule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 15 parts, Chinese herbal medicine extract 12 parts, 10 parts, calcium carbonate, calcium berry extract 15 parts, chondroitin sulfate 5 parts, milk calcium 2 parts, CCP 2.5 parts, magnesium lactate 3 parts, dimethyl sulfone 2 parts, grape seed extract 1.5 parts, zinc lactate 0.15 part;
The capsule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 5 parts, D-mannital 5 parts, modified dietary fiber 5 parts, hydroxypropyl methylcellulose 0.5 part, citric acid 0.5 part, dolomol 0.3 part;
Preparation method, comprises the following steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 80 mesh sieves, then mix 10min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 13% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 10 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, the dry 3min of temperature 50 C in microwave dryer, with the quick whole grain of 10 mesh sieve;
4) whole good particle and dolomol mixing 5min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Embodiment 4
Increase a capsule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 30 parts, Chinese herbal medicine extract 30 parts, 28 parts, calcium carbonate, calcium berry extract 25 parts, chondroitin sulfate 10 parts, milk calcium 10 parts, CCP 8 parts, magnesium lactate 6 parts, dimethyl sulfone 4 parts, grape seed extract 4 parts, zinc lactate 0.3 part;
The capsule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 20 parts, D-mannital 20 parts, modified dietary fiber 20 parts, hydroxypropyl methylcellulose 1.5 parts, citric acid 1.5 parts, dolomol 1 part;
Preparation method, comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 120 mesh sieves, then mix 25min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 18% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 20 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, the dry 8min of temperature 60 C in microwave dryer, with the quick whole grain of 20 mesh sieve;
4) whole good particle and dolomol mixing 10min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Embodiment 5
Increase a capsule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 20 parts, Chinese herbal medicine extract 15 parts, 13 parts, calcium carbonate, calcium berry extract 18 parts, chondroitin sulfate 7 parts, milk calcium 5 parts, CCP 4 parts, magnesium lactate 4 parts, dimethyl sulfone 2.5 parts, grape seed extract 2 parts, zinc lactate 0.18 part;
The capsule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 10 parts, D-mannital 8 parts, modified dietary fiber 15 parts, hydroxypropyl methylcellulose 0.8 part, citric acid 0.8 part, dolomol 0.5 part;
Preparation method, comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 120 mesh sieves, then mix 25min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 18% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 20 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, the dry 8min of temperature 60 C in microwave dryer, with the quick whole grain of 20 mesh sieve;
4) whole good particle and dolomol mixing 10min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Embodiment 6
Increase a capsule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 25 parts, Chinese herbal medicine extract 25 parts, 22 parts, calcium carbonate, calcium berry extract 23 parts, chondroitin sulfate 9 parts, milk calcium 8 parts, CCP 6 parts, magnesium lactate 5.5 parts, dimethyl sulfone 3.5 parts, grape seed extract 3.5 parts, zinc lactate 0.25 part;
The capsule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 18 parts, D-mannital 15 parts, modified dietary fiber 18 parts, hydroxypropyl methylcellulose 1.2 parts, citric acid 1.2 parts, dolomol 0.8 part;
Preparation method, comprises the following steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 80 mesh sieves, then mix 10min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 13% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 10 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, the dry 3min of temperature 50 C in microwave dryer, with the quick whole grain of 10 mesh sieve;
4) whole good particle and dolomol mixing 5min, after mixing, dress grain, selects capsule, polishing, makes capsule.
Embodiment 7
Increase a tablet for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 23 parts, Chinese herbal medicine extract 20 parts, 19 parts, calcium carbonate, calcium berry extract 20 parts, chondroitin sulfate 8 parts, milk calcium 7 parts, CCP 5 parts, magnesium lactate 4.8 parts, dimethyl sulfone 3 parts, grape seed extract 2.8 parts, zinc lactate 0.21 part;
The tablet of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 14 parts, D-mannital 11 parts, modified dietary fiber 17 parts, hydroxypropyl methylcellulose 1 part, citric acid 1 part, dolomol 0.6 part.
Preparation method comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 100 mesh sieves, then mix 18min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 15% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 16 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 55 DEG C of dry 5min in microwave dryer, with the quick whole grain of 16 mesh sieve;
4) whole good particle and dolomol mixing 8min, after mixing, namely compressing tablet, film coating obtain tablet.
Embodiment 8
Increase a granule for bone density, prepared by the raw material primarily of following parts by weight:
Aminoglucose hydrochloride 23 parts, Chinese herbal medicine extract 20 parts, 19 parts, calcium carbonate, calcium berry extract 20 parts, chondroitin sulfate 8 parts, milk calcium 7 parts, CCP 5 parts, magnesium lactate 4.8 parts, dimethyl sulfone 3 parts, grape seed extract 2.8 parts, zinc lactate 0.21 part;
The granule of described increase bone density, also comprises the auxiliary material of following parts by weight:
Maltodextrin 14 parts, D-mannital 11 parts, modified dietary fiber 17 parts, hydroxypropyl methylcellulose 1 part, citric acid 1 part, dolomol 0.6 part.
Preparation method comprises the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 100 mesh sieves, then mix 18min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 15% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 16 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 55 DEG C of dry 5min in microwave dryer, with the quick whole grain of 16 mesh sieve;
4) whole good particle packs, seals and obtain granule.
By following verification experimental verification the present invention, there is increase bone substance density improving function:
One, animal experiment
1. experiment purpose
Study the effect with the composition increase bone density increasing bone substance density improving function of the present invention
2. Experimental agents
What prepare by specific embodiment 2 has the composition (capsule) increasing bone substance density improving function.
3. animal used as test
SPF level rat, female, Chinese Medical Sciences University's Experimental Animal Center provides.
4. experimental technique and result
Choose healthy SD rat 140, be female entirely, body weight 200 ± 20g, first carries out modeling process.Rat is through the anesthesia of lumbar injection 50mg/kg yellow Jackets, and in ventrimeson apart from introitus 3 ~ 4cm place unhairing after abdomen position is fixing, sterilization, by the silk thread ligation of fallopian tubal under ovary, wipes out ovary, wipe out another side ovary with method.Rat is divided into groups at random, be respectively Normal group, model control group, specific embodiment 2 obtained there is the composition group capsule (low, in and high dose group), calcium berry extract group and the Chinese herbal medicine extract group that increase bone substance density improving function, described calcium berry extract group refers in this embodiment of the present invention 2 capsule prepared by other component removing calcium berry extract, the capsule that the Chinese herbal medicine extract that what described Chinese herbal medicine extract group referred to that Chinese herbal medicine extract in the embodiment of the present invention 2 adopts is traditional water extraction, prepared by alcohol extracting method is prepared with other component; Often organize 18 ~ 20 mouse.Respectively each group of rat is weighed, numbering, and carry out administration by the dosage in table 1.
Weekly according to the changes of weight adjustment dosage of rat.
After 6 months, measure the BMD value of the bone density of each group of rat, femur weight in wet base, wet density, dry density, measurement result is as shown in table 1:
Table 1 has to be increased the capsule of bone substance density improving function and affects result to ovariectomized female rats bone density BMD
Note: compare * P<0.05 with the model control group same period; * P<0.01; * * P<0.001.
From table 1 experimental result, the neck of femur of model control group rat and the bone density of femur distal end are starkly lower than Normal group, have significant difference (P<0.001), show osteoporosis model modeling success.The middle and high dosage group with the capsule increasing bone substance density improving function that specific embodiment 2 obtains all can increase the neck of femur of ovariectomized female rats and the BMD value of femur distal end significantly, the femoral neck BMD value with the middle and high dosage group of the composition increasing bone substance density improving function that wherein specific embodiment 2 is obtained, compared with same period model control group, has significant difference (P<0.01).The middle and high dosage component of neck of femur does not improve 16.94%, 17.2% than the bone density of model group; The middle and high dosage component of femur meta does not improve 9.51%, 8.15% than the bone density of model group; The middle and high dosage component of femur distal end does not improve 15.41%, 10% than the bone density of model group.The capsule group that what specific embodiment 2 was obtained have increases bone substance density improving function all than not adding calcium berry extract group, traditional water extraction alcohol extracting Chinese herbal medicine group effect is strong, also illustrate: calcium berry extract of the present invention, Chinese herbal medicine extract have all made contribution to composition, have certain advance simultaneously.
The capsule that product effect obtained by embodiment of the present invention 3-8 is prepared than embodiment 2 is slightly poor, but it is more close, to sum up, the bone density increase of middle and high dosage group to ovariectomized female rats that what prepared by the present invention have increases the composition of bone substance density improving function has good effect.
Table 2 have increase bone substance density improving function capsule on ovariectomized in rats wet density, dry density affect result
| Group | Femur volume (mL) | Femur dry weight (g) | Femur wet density (g/mL) | Femoral shaft density (g/mL) |
| Model control group | 0.54±0.02 | 0.5498±0.0524 | 1.51±0.07 | 1.07±0.05 |
| Normal group | 0.51±0.04** | 0.5217±0.0427 | 1.63±0.12* | 1.19±0.07*** |
| Composition (low) | 0.55±0.03 | 0.5386±0.0513 | 1.53±0.09* | 1.04±0.07 |
| Composition (in) | 0.54±0.03 | 0.5648±0.0412 | 1.58±0.09 | 1.16±0.06*** |
| Composition (height) | 0.53±0.04 | 0.5635±0.0522 | 1.55±0.12 | 1.14±0.05*** |
| Calcium berry extract | 0.53±0.02 | 0.5593±0.0263 | 1.54±0.12 | 1.13±0.04 |
| Chinese herbal medicine extract | 0.53±0.03 | 0.5476±0.0412 | 1.53±0.10 | 1.11±0.03 |
Note: compare * P<0.05 with the model control group same period; * P<0.01; * * P<0.001.
From table 2 experimental result, femur wet density and the dry density value of model control group rat all obviously reduce, and compared with same period Normal group, have significant difference (P<0.05, P<0.001); What specific embodiment 2 was obtained has femur wet density and the dry density that the middle and high dosage group of capsule increasing bone substance density improving function can increase ovariectomized female rats, the femoral shaft density value with the high dose group of the capsule increasing bone substance density improving function that wherein specific embodiment 2 is obtained is compared with same period model control group, there is significant difference (P<0.001, P<0.01); In sum, what specific embodiment 2 was obtained have the bone density increase of dosage to ovariectomized female rats in the capsule increasing bone substance density improving function has good effect.The capsule group that what specific embodiment 2 was obtained have increases bone substance density improving function all than not adding calcium berry extract group, traditional water extraction alcohol extracting Chinese herbal medicine group effect is strong, also illustrate: calcium berry extract of the present invention, Chinese herbal medicine extract have all made contribution to composition, have certain advance simultaneously.
The capsule that product effect obtained by embodiment of the present invention 3-8 is prepared than embodiment 2 is slightly poor, but it is more close, to sum up, the bone density increase of middle and high dosage group to ovariectomized female rats that what prepared by the present invention have increases the composition of bone substance density improving function has good effect.
Two, clinical testing
To specific embodiment 2 obtained there is the composition (capsule) increasing bone substance density improving function, choose and suffer from osteoporotic patient and verify, usage and dosage is: oral, 450mg/ grain, takes 30 days cycles by each 2, one day twice, result was as shown in table 3.
Table 3 has the composition of increase bone substance density improving function to osteoporosis symptoms patient clinical trial data
As can be seen from Table 3, there is bad reaction in none example of 15 routine sufferers of osteoporosis face, after 30 days, symptom all alleviates.Illustrate that the composition (capsule) with increase bone substance density improving function that specific embodiment 2 obtains is good to the result for the treatment of of osteoporosis symptoms.
The capsule that product effect obtained by embodiment of the present invention 3-8 is prepared than embodiment 2 is more close, to sum up, the composition (capsule) that what prepared by the present invention has increases bone substance density improving function has good result for the treatment of to the patient suffering from osteoporosis symptoms.
Claims (10)
1. one kind increases the composition of bone density, prepared by the raw material primarily of following parts by weight: aminoglucose hydrochloride 15-30 part, Chinese herbal medicine extract 12-30 part, calcium carbonate 10-28 part, calcium berry extract 15-25 part, chondroitin sulfate 5-10 part, milk calcium 2-10 part, CCP 2.5-8 part, magnesium lactate 3-6 part, dimethyl sulfone 2-4 part, grape seed extract 1.5-4 part, zinc lactate 0.15-0.3 part; Also comprise the auxiliary material of following parts by weight: maltodextrin 5-20 part, D-mannital 5-20 part, modified dietary fiber 5-20 part, hydroxypropyl methylcellulose 0.5-1.5 part, citric acid 0.5-1.5 part, dolomol 0.3-1 part;
Described Chinese herbal medicine extract with the bark of eucommia, the root of kudzu vine, the red sage root, barrenwort, the rhizome of davallia, matrimony vine, when being classified as raw material ultrasonic cleaning, preparing through low temperature enzymolysis, water extraction alcohol extracting and the ultrasonic extraction of microwave radiation technology;
Described calcium berry extract is that employing ultrasonic cleaning, the ultrasonic extraction of microwave radiation technology, high-pressure pulse electric extract and prepare through spontaneous fermentation with Chinese calcium fruit fresh fruit for raw material.
2. increase the composition of bone density as claimed in claim 1, it is characterized in that, prepared by the raw material primarily of following parts by weight: aminoglucose hydrochloride 20-25 part, Chinese herbal medicine extract 15-25 part, calcium carbonate 13-22 part, calcium berry extract 18-23 part, chondroitin sulfate 7-9 part, milk calcium 5-8 part, CCP 4-6 part, magnesium lactate 4-5.5 part, dimethyl sulfone 2.5-3.5 part, grape seed extract 2-3.5 part, zinc lactate 0.18-0.25 part; Also comprise the auxiliary material of following parts by weight: maltodextrin 10-18 part, D-mannital 8-15 part, modified dietary fiber 15-18 part, hydroxypropyl methylcellulose 0.8-1.2 part, citric acid 0.8-1.2 part, dolomol 0.5-0.8 part.
3. increase the composition of bone density as claimed in claim 1, it is characterized in that, the preparation method of described Chinese herbal medicine extract comprises the steps: to count by weight, take bark of eucommia 13-27 part, root of kudzu vine 10-20 part, red sage root 8-15 part, barrenwort 5-12 part, rhizome of davallia 5-12 part, matrimony vine 3-8 part, Radix Angelicae Sinensis 3-5 part, put in the supersonic wave cleaning machine filling 0.1-0.3% sodium bicarbonate solution in 200W, 30KHz cleans 10-15min, drain, said herbal medicine being crushed to particle diameter is less than 2 millimeters, put Homogeneous phase mixing in container and add the water of 3-6 times of weight, obtain mixed material, control temperature 70 DEG C-90 DEG C keeps 2-4h, then 40-50 DEG C is cooled to, be 3.5-4.5 by lactic acid adjust ph, at power 150-300W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 60-80s, carry out compartment irradiation: irradiation 10s, interval 10s, irradiation like this 10 times, simultaneously at power 200-300W, ultrasonic assistant extraction is carried out under frequency 30-40KHz condition, then the mixing enzyme preparation adding mixed material gross weight 3-7% carries out enzymolysis, be 5.5-6.8 by lactic acid adjust ph, enzymolysis 2-4h, finally add the mixture of mixed material 0.5-3 times of w ethanol and propyl alcohol, the mass ratio of ethanol and propyl alcohol mixing is 1:1-3, control temperature to 60 DEG C-78 DEG C of maintenance 3-4h, filter, obtain the first filtrate, add the water of filter residue 1-3 times of weight, control temperature 85 DEG C-95 DEG C keeps 1-3h, is then cooled to 25-35 DEG C, filters, obtains the second filtrate, first filtrate and the second filtrate are merged according to mass ratio 2-4:1-3, filter vacuum concentrates postlyophilization, pulverizes and obtains Chinese herbal medicine extract,
Described mixed enzyme is dextranase, zytase, pentosanase, pectase 2-4:2-4:1-3:1-2 Homogeneous phase mixing in mass ratio.
4. increase the composition of bone density as claimed in claim 1, it is characterized in that, the preparation method of described calcium berry extract comprises the steps: Chinese calcium fruit fresh fruit to put in the supersonic wave cleaning machine filling 0.8-1.2% sodium bicarbonate solution in 200W, 30KHz cleans 10-15min, drain, pulverize immediately after-18--22 DEG C of freezing 1-2h, freezing thickness of feed layer 3-5cm, grinding particle size 0.5-3mm, then add and pulverize material quality 0.5-2 water doubly, be 3.0-3.5 by lactic acid adjust ph, at power 200-300W, Microwave Extraction is carried out under frequency 2000Hz condition, wherein, each microwave irradiation total time 100-120s, carry out compartment irradiation: irradiation 10s, interval 10s, control temperature 20-35 DEG C, irradiation like this 10 times, simultaneously at power 200-300W, ultrasonic assistant extraction is carried out under frequency 30-40KHz condition, insulation 1-3h, then, Microwave Extraction is carried out under power 200-400W, frequency 2000Hz condition, wherein, each microwave irradiation total time 120-135s, carry out compartment irradiation: irradiation 15s, interval 10s, control temperature 40-50 DEG C, irradiation like this 10 times, simultaneously at power 300-500W, carry out ultrasonic assistant extraction under frequency 40-50KHz condition, last Temperature fall to room temperature, in electric-field intensity 15-25kV/cm, burst length 300-500 μ s, carries out high-pressure pulse electric and extracts 15-20min under pulse frequency 200-300Hz condition, abundant stirring extract, sealing, spontaneous fermentation 4-10d, filtering fermentation liquor obtains the first filtrate, add the water rinse of filter residue 2 times, filter to obtain the second filtrate, by the first filtrate and the second filtrate 1:2-5 Homogeneous phase mixing in mass ratio, namely mixed liquor ultrafiltration concentration, freeze drying, 30 DEG C of low-temperature grinding obtain calcium berry extract to granularity 0.1-0.3mm.
5. increase the composition of bone density as claimed in claim 1, it is characterized in that, the preparation method of described modified dietary fiber comprises the following steps: by inulin, apple fiber, common oats fibre, Semen Tritici aestivi fiber, rice bran, wheat bran 8-10:4-7:3-5:2-4:1-3:1-2 Homogeneous phase mixing in mass ratio, add its quality 3-7 water doubly, room temperature 200-300W, 35-40KHz condition ultrasonic extraction 10-15min, simultaneously in electric-field intensity 20-40kV/cm, burst length 400-500 μ s, carries out high-pressure pulse electric extraction under pulse frequency 200-300Hz condition; Be 4.5-6.5 by lactic acid adjust ph, add the biology enzyme of mixture quality 0.1-0.3%, in 45-55 DEG C of enzymolysis 20-48min; Enzymolysis liquid reduced pressure concentration, freeze drying, low-temperature grinding to granularity are that namely 0.1-0.3mm obtains modified dietary fiber;
Described biology enzyme is zytase, cellulase, laccase, pectase, tannase, amylase and protease 6-10:4-8:3-5:2-4:1-3:1-3:0.3-0.5 Homogeneous phase mixing in mass ratio.
6. increase the composition of bone density as claimed in claim 1, it is characterized in that, the formulation of described composition is oral formulations.
7. increase the composition of bone density as claimed in claim 6, it is characterized in that, described oral formulations is capsule, tablet or granule.
8. increase the preparation method of the composition of bone density as described in as arbitrary in claim 1-7, it is characterized in that, comprise the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 80-120 mesh sieve, then mix 10-25min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, the aqueous solution making 13-18% soluble in water, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 10-20 mesh sieve, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 50-60 DEG C dry 3-8min in microwave dryer, with the quick whole grain of 10-20 mesh sieve;
4) whole good particle and dolomol mixing 5-10min, after mixing, make capsule, tablet or granule.
9. increase the preparation method of the composition of bone density as claimed in claim 8, it is characterized in that, comprise the steps:
1) according to formula, get aminoglucose hydrochloride, Chinese herbal medicine extract, calcium carbonate, calcium berry extract, chondroitin sulfate, milk calcium, CCP, magnesium lactate, dimethyl sulfone, grape seed extract, zinc lactate respectively, pulverize, cross 100 mesh sieves, then mix 18min, obtain mixed powder;
2) by maltodextrin, D-mannital, modified dietary fiber, hydroxypropyl methylcellulose, citric acid, soluble in water make 15% the aqueous solution, as adhesive;
3) in described mixed powder, add described adhesive and make softwood, granulate with 16 mesh sieves, obtain wet granular, put in power 3000W, frequency 2000Hz, temperature 55 DEG C of dry 5min in microwave dryer, with the quick whole grain of 16 mesh sieve;
4) whole good particle and dolomol mixing 8min, after mixing, dress grain, selects capsule, polishing, makes capsule.
10. the composition increasing bone density as described in as arbitrary in claim 1-7 is preparing the application in food, health products or medicine.
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| CN104824677A (en) * | 2015-04-14 | 2015-08-12 | 贵阳德昌祥药业有限公司 | Bone density increase health food and preparation method thereof |
| CN105214072A (en) * | 2015-11-04 | 2016-01-06 | 华夏先葆(北京)中药研究院有限公司 | A kind of improve bone and arthralgia pharmaceutical composition and method for making and purposes |
| CN106421757A (en) * | 2016-09-09 | 2017-02-22 | 杨森健 | Composition for assisting in treating gout and increasing bone density and application of composition |
| WO2018107324A1 (en) * | 2016-12-12 | 2018-06-21 | 湘北威尔曼制药股份有限公司 | Calcium supplement composition for decreasing risk of hypercalcemia and use thereof |
| CN112472735A (en) * | 2020-12-08 | 2021-03-12 | 雷允上药业集团有限公司 | Composition for enhancing bone mineral density and preparation method and application thereof |
| EP3866823A4 (en) * | 2018-10-19 | 2022-11-09 | Fong, Sonny | Powdered botanical extract preparations and formulations thereof |
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