CN104001157A - Compound preparation for preventing and treating osteoporosis and preparation method thereof - Google Patents
Compound preparation for preventing and treating osteoporosis and preparation method thereof Download PDFInfo
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- CN104001157A CN104001157A CN201410226893.1A CN201410226893A CN104001157A CN 104001157 A CN104001157 A CN 104001157A CN 201410226893 A CN201410226893 A CN 201410226893A CN 104001157 A CN104001157 A CN 104001157A
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- radix achyranthis
- achyranthis bidentatae
- herba epimedii
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Abstract
The invention provides a compound preparation for preventing and treating the osteoporosis and a preparation method thereof. The compound preparation consists of herba epimedii, radix achyranthis bidentatae, calcium citrate, casein phosphopeptides and magnesium stearate. The preparation method comprises the following steps: preparing powder by extracting the materials of the herba epimedii and the radix achyranthis bidentatae, sieving the calcium citrate, the casein phosphopeptides and the magnesium stearate, blending, mixing, granulating, metering, filling into capsules and packaging. The compound preparation and the preparation method provided by the invention have the advantages that elaborate prescription is adopted on the basis of the traditional theory of traditional Chinese medicine and the modern pharmacological research, the herba epimedii and the radix achyranthis bidentatae have the effects of nourishing liver and kidney and strengthening the muscles and bones; and by combination of the casein phosphopeptides and the calcium citrate, the absorption and utilization of calcium can be better enhanced, the calcium content in bones can be improved and the density of the bones can be increased, so that the two effects of increasing the density of the bones and preventing and treating the osteoporosis are achieved. A product prepared by the compound preparation not only is safe in administration and has obvious preventing and treating effects and health-care effect, but also is low in industrial production cost and has a good prospect for market development and application.
Description
Technical field
The invention belongs to medicine and field of health care food, be specifically related to compound preparation of a kind of Prevention and Treatment of Osteoporosis and preparation method thereof.
Background technology
Bone density is that bone mineral density (bone mineral density, BMD) is an important symbol of bone mass, reflects osteoporotic degree, the important evidence of prediction osteoporotic fracture.
People's bone density is to will be with the growth at age year by year because bone loss declines after peaking about 30 years old, and the speed of women's bone loss after climacteric starts is faster than elderly men.It is reported, men and women no matter, after 60 years old, 20%～30% during the general peaking of bone loss amount, maximum reaches 40%.Osteoporosis has become one of global public health problem, day by day gets more and more people's extensive concerning.At present, the total number of persons that osteoporosis is suffered from the whole world surpasses 200,000,000 people, and with regard to the U.S., within 45 years old, above women suffers from osteoporosis person every year just up to 1500-2000 ten thousand people, causes fracture person to have 130-150 ten thousand examples.China's patients with osteoporosis approximately has 8,400 ten thousand at present, accounts for 6.6% of total population.Sickness rate because of the concurrent fracture of osteoporosis is about 9.6% every year, and has the trend increasing year by year.According to World Health Organization's statistics, in current osteoporotic sickness rate Yi world commonly encountered diseases, frequently-occurring disease, leap to the 7th.Worldwide, Prevention and Treatment of Osteoporosis prevention fracture and treatment hypertension prevention apoplexy, treatment hyperlipidemia, prevention myocardial infarction are put into status of equal importance.
Osteoporosis, as modern civilization diseases, has become one of global important public hygiene problem.Its reason is that Decrease of Bone Mineral Density and osseous tissue micro structure are destroyed, thus the systemic disease that causes skeleton fragility to increase and fracture easily occurs.Osteoporosis can not have any symptom in early days, and the research of this respect in recent years has many, has mainly proposed to make a definite diagnosis by doing bone density inspection.By measuring bone density, can understanding, whether there is bone amount to reduce and osteoporosis.From bone amount, reducing to osteoporosis is a quantitative change process in various degree, strengthens the sickness rate that bone density can effectively reduce osteoporosis.
The traditional Chinese medical science thinks that the kidney being the origin of congenital constitution, be the institute of essence Tibetan, and essence can be given birth to marrow, and bone marrow is the thing of bone growth promoting nourishing bone, and the Yuanyang of kidney residence the whole body, can the warm whole body, smoke damp diaphysis, and be the strong basic place of muscles and bones.Therefore deficiency of kidney-essence, the biochemical weary source of bone marrow, bone marrow is hollow, and skeleton loses supports; If decline of kidney-YANG, can not be warm, diaphysis loses in smoked pool, also can send out as primary disease.Blood stored in the liver, kidney storing essence, the traditional Chinese medical science has saying of " essence and blood sharing the same origin ", " The liver and the kidney have a common source ", and the vital essence in kidney is filled and is contained that to depend on moistening of blood foster.If losing bar, liver reaches, irritability stasis, and consumption impairment of YIN blood, deficiency of liver-blood, can cause deficiency of the kidney, bone marrow is lost and support, and limbs need not.Spleen is source of generating QI and blood, the spleen being the foundation of acquired constitution, and the kidney being the origin of congenital constitution, if spleen transporting not, spleen insufficiency of essence, do not support congenital the day after tomorrow, cause the weary source of kidney essense, and skeleton loses supports.Old people is because many internal organs are deficient, and kidney-jing deficiency is few, and kidney qi day declines, vital essence insufficiency of blood, and obstruction of collaterals by blood stasis, medullization source is not enough, and bone is become homeless foster, even just can there is the series of clinical manifestations such as back limbs pain, physical abnormality, difficulty in walking fracture.
Modern study shows, affects the many factors of bone density, is mainly subject to the impact of inherited genetic factors, endocrine factors and environmental factors.Inherited genetic factors comprises heredity, race, age and sex; Endocrine factors comprises gonadal hormone, system hormone and bone metabolism regulatory factor; Environmental factors comprises trophic factor, sports, health behavior, bad habit etc.
Medically also do not have at present safe and effective radical cure method, help loose skeleton to restore to the original state, therefore, correct understanding, early prevention seem particularly important.Up to the present, China ratifies altogether to increase bone density, improves 360 kinds of left and right of osteoporosis functional health care food, has mostly declared two or more health cares simultaneously, mainly concentrate on replenish the calcium, on enhancing immunity, slow down aging.
With regard to existing market product variety, the health food that increases bone density is divided into two classes substantially: a class is calcic, the health food that reaches increase bone density object by direct supplement calcium, formula mainly be take calcium as main, and coordinate interpolation vitamin D, major product to have the Lik-Sang board D-glucosamine calcium dimension D of nation sheet, os osseum star actor to tie up calcium tablet, the precious sheet of calcium etc.; Another kind of is that calcic or not take is not replenished the calcium as object, thereby but promote the absorption of calcium to reach the health food that increases bone density this purpose by adjusting endocrine, fill a prescription and raw materials usedly take soybean isoflavone as main, major product has QINGCHUN BAO board Margarita isoflavone capsule, eastern first board isoflavone tablet, the strong board soybean isoflavone calcium soft capsule of U.S. Australia etc.The product of Chinese prescription only has Ai Shili board Rieter relieving capsule, herbal natural wind board bone to add several products such as happy soft capsule, Bone Youth Leyuan Tablet.
Summary of the invention
The object of the present invention is to provide compound preparation of a kind of Prevention and Treatment of Osteoporosis and preparation method thereof, meticulous prescription on traditional theory of Chinese medical science and modern pharmacological research basis, Herba Epimedii and Radix Achyranthis Bidentatae have the effect of invigorating the liver and kidney, bone and muscle strengthening, phosphopeptide caseinate and calcium citrate share, can promote better calcium absorption utilization, improve calcium content of bone, increase bone density, thereby common performance increases the efficacy effect of bone density, Prevention and Treatment of Osteoporosis.The product that the present invention makes is not only taken safety, has significant control and health-care effect, and industrial production cost is low, has good market development application prospect.
For achieving the above object, the present invention adopts following technical scheme:
The raw material of the compound preparation of Prevention and Treatment of Osteoporosis forms and mass fraction: a Herba Epimedii 24-26%, Radix Achyranthis Bidentatae 18-20%, calcium citrate 45-47%, phosphopeptide caseinate 7-9%, magnesium stearate 1-3%.
Preferably, raw material forms and mass fraction: Herba Epimedii 25%, Radix Achyranthis Bidentatae 19%, calcium citrate 46%, phosphopeptide caseinate 8%, magnesium stearate 2%.
Preparation method comprises the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under 60 ~ 80 ℃ of temperature, vacuum-0.04 ~-0.06MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in to capsule filling machine, by the specification of 450mg/ grain, fills; The capsule of having filled is carried out to polishing with buffing machine, remove the medicated powder that capsule shell adheres to, and reject underproof capsule; Capsule after polishing is loaded in the ethylene bottle that meets YBB00122002 < < oral stable medicinal polythene bottle with high density > > regulation to every bottled 60.
Formula for a product of the present invention forms the understanding of bone and modern pharmacology prescription according to the traditional Chinese medical science, and in side, Herba Epimedii is pungent, sweet, warm, returns liver, kidney channel, and useful vital essence, hard muscles and bones are mended waist knee joint, the effect of heart tonifying power; Radix Achyranthis Bidentatae is bitter, sour, property is flat, returns liver, kidney channel, has the effect of scattered silt blood, detumescence pain, invigorating the liver and kidney, bone and muscle strengthening; Two medicines share, and can mend altogether the deficient of " congenital ", play the effect of the kidney invigorating and essence nourishing, raw marrow bone strengthening.
Calcium is the abundantest inorganic elements of body burden, and in body, total amount surpasses 1000g, has the good reputation of human body " biological element ".Calcium in human body approximately 99% forms bone mineral, is distributed in skeleton and tooth, promotes its growth promoter, maintains its form and hardness; Approximately 1% is distributed in body fluid and soft tissue, although body fluid calcium content is few, is bringing into play important physiological function.
Phosphopeptide caseinate is to take bovine casein as raw material, through single enzyme or the hydrolysis of compound enzyme system, then the peptides of the phosphoric acid seryl-that contains cluster obtaining through separation and purification.The phosphopeptide caseinate of optimal dose can promote calcium absorption utilization better, improves calcium content of bone, increases bone density.
Just introduce efficacy effect and the modern pharmacological research effect of raw material below:
1, Herba Epimedii
Acrid in the mouth, sweet, warm in nature, return kidney, Liver Channel, Li Shizhen (1518-1593 A.D.) is recorded the effect with " beneficial vital essence, hard muscles and bones are mended waist knee joint, heart tonifying power " in < < Compendium of Materia Medica > >.Modern pharmacological research finds that Herba Epimedii is containing multiple flavones ingredient, as icariin, deoxidation methyl icariin, β-dehydrogenation methyl 3,5,7-trihydroxy-2-(4-methoxy-phenyl)-8-(3-methyl-but-2-enyl)-chromen-4-one, still containing volatile oil, lignanoid and alkaloid etc., there is adjusting body's immunity, promote osteogenesis, slow down aging, blood pressure lowering, increase coronary flow, antibacterial, antiviral, antiinflammatory action, blood fat reducing, blood sugar lowering, antitumor action etc.
[1].
Zhao Lina
[2]research Herba Epimedii and the osteoporotic Clinical efficacy comparison of hormone Replacement Therapy (HRT).Method is that 25 examples are measured and are diagnosed as osteoporotic postmenopausal women's double blind random and are divided into 2 groups through X-ray film and dual energy X-ray absorptiometry instrument, and test group 15 examples are given Herba Epimedii 200g/d decoction; It is oral that matched group 10 examples are given premarin 0.625mg, 1 time/d.After 3 ~ 6 months, judge curative effect.Result: test group remission effective percentage is 80%; Matched group remission effective percentage is that 90%, two group of effective percentage is relatively without significant difference (P > 0.05).Conclusion: Herba Epimedii has direct repression to osteoclast, can urge calcified bone and form increase, alleviates bone pain symptom, suitable with HRT osteoporosis effect.So adopting barrenwort for treating elderly woman osteoporosis is one of comparatively ideal method.
In ripple
[3]for inquiring into the impact of Icariin on Human Osteoblastic Cells in Vitro, adopt gradation enzyme digestion to be in vitro human osteoblast cell and cultivate, obtain the osteoblast that character is stable, purity is high; With mtt assay, do the research of icariin to osteoblastic proliferation.The icariin that found that variable concentrations all has facilitation to osteoblastic growing multiplication, with 10ngml
-1during concentration, it acts on (P < 0.05) the most by force; It is 100ngml that biochemical method is measured icariin concentration
-1and 10ngml
-1osteoblast secreting alkaline phosphorus phytase (AKP) is had to facilitation.When showing that icariin promotes osteoblastic proliferation, strengthened osteoblast osteogenic activity.
Qu Ping etc.
[4]inquire into the function of resisting osteoporosis of Herba Epimedii total flavones.Method: gavage gives retinoic acid 14d, causes rats with osteoporosis.With Herba Epimedii total flavones successive administration 28d, detect the variation of serum calcium, serum paraoxonase, alkaline phosphatase enzyme level, and get femur and carry out calcium content of bone mensuration and femur histopathologic examination.Result: the Herba Epimedii total flavones of each dosage does not all make significant difference to serum calcium, serum paraoxonase, alkali phosphatase normal physiological level, but all can increase bone calcium content of femur, cortex thickness of bone and bone trabecula quantity.Conclusion: Herba Epimedii total flavones has obvious preventive and therapeutic action to osteoporosis.
Wang Yunlin etc.
[5]observe the impact of Herba Epimedii on castration male rat bone density and bone structure performance.Experimental result shows: after castration, male rat application Herba Epimedii can prevent bone loss and improve bone structure performance.
2, Radix Achyranthis Bidentatae
Bitter, sour, property is put down, and returns liver, kidney channel, has the effect of scattered silt blood, detumescence pain, invigorating the liver and kidney, bone and muscle strengthening, is mainly used in soreness of waist and knee joint, and muscles and bones is unable, amenorrhea lump in the abdomen, the disease of dizziness due to hyperactivity of liver-YANG.Modern pharmacology research shows, Radix Achyranthis Bidentatae has protecting the liver, falls enzyme, analgesia, antiinflammatory, enhancing immunity and anti-aging effects.Its chemical composition is mainly polysaccharide, olive acids triterpenoid saponin and plant ketosteroid etc.
Appoint softhearted etc.
[6]investigate Radix Achyranthis Bidentatae total saponins and retinoic acid is caused to the preventive and therapeutic effect of osteoporosis rat.Method: the continuous gavage retinoic acid of rat causes experimental osteoporosis model, Radix Achyranthis Bidentatae total saponins by 30,100,300mgkg
-1dosed administration, observes and respectively organizes activities in rats situation and body weight change, measures bone density and bone calcium, bone phosphorus content.Result shows that Radix Achyranthis Bidentatae total saponins can improve the ordinary circumstance of osteoporosis rat, can significantly increase its body weight and bone density, rising bone calcium, bone phosphorus content.Conclusion: Radix Achyranthis Bidentatae total saponins has the effect of obvious control retinoic acid induced osteoporosis.
Dong Qunwei
[7]therapeutical effect Deng discussion Radix Achyranthis Bidentatae ecdysterone to osteoporosis in ovariectomized rats.Result shows that high dose and middle dosage Radix Achyranthis Bidentatae ecdysterone can obviously improve bone density and every biomechanics and the bone morphometry index of ovariectomized rats, and low dosage processed group also has certain therapeutical effect.Conclusion: Radix Achyranthis Bidentatae ecdysterone has to osteoporosis in ovariectomized rats the purposes of control, and be dose dependent.
Sun Fenyong etc.
[8]proliferation and the molecular mechanism thereof of research Radix Achyranthis Bidentatae to osteoblast strain HFOBI.19.Result shows that Radix Achyranthis Bidentatae Contained Serum and Radix Achyranthis Bidentatae ecdysterone all can promote osteoblastic propagation, and the rise that causes protein kinase A to regulate base β to express.Conclusion: preliminary judgement Radix Achyranthis Bidentatae has the effect that promotes human osteoblast cell's propagation in vitro, and its Main Function composition is ecdysterone, and is likely that the signal transduction path mediating by cAMP carries out.
Gao Changkun
[9]inquire into the preventive and therapeutic effect of Radix Achyranthis Bidentatae to the osteoporosis rat due to retinoic acid.Result shows that the spontaneous activity number of rat, bone density increase, and in blood Ca, blood P, bone Ca, bone P and bone, HP content increases, ALP activity decreased in blood.Conclusion: Radix Achyranthis Bidentatae decocting liquid can significantly increase the mobility of retinoic acid induced osteoporosis rat, the loss of the rat bone mineral nitrogen that prevention retinoic acid causes, increases content organic in its bone, improves bone density.
3, calcium citrate
At < < nutrient prime replenisher, declare and evaluate in regulation (trying) > >, calcium citrate is the wherein a kind of raw material as calcium complement agent.Calcium is the main component of skeleton, is maintaining nervimuscular irritability, promotes nerve ending secretion acetylcholine, improve permeability of cell membrane, increase blood capillary compactness, antiallergic, promotes the aspects such as tooth, skeleton calcification and formation to play an important role.It is necessary to normal Skeleton development that enough calcium is taken in, and calcium intake can not reduce the peak bone mass bone loss that also increase comes with old-age group completely.。Epidemiologic data prompting simultaneously, replenishes the calcium and can reduce the generation of Hip Fracture.The special chemical composition of calcium citrate and the absorption of good promotion human body to calcium, can supplement calcium effectively, prevents that osteoporosis from occurring, and corrects negative calcium balance.
Remaining tinkling of pieces of jades
[10]deng research, promote medicine calcium preparation and the impact of vitamin D on bone density (BMD) of bone mineralising.Result demonstration, after 6 months, treatment group is treated front bone density on average increases by 1.9%, has significant (P < 0.05) with the front relatively difference for the treatment of.And matched group is treated front bone density minimizing 0.3%, treatment front and back are without significant difference.Two groups relatively treat before and after bone density be changed significantly (P < 0.05).In therapeutic process, have no obvious untoward reaction.
Guo Chunying
[11]deng discussion, supplement calcium and the impact of vitamin D on bone loss and bone conversion.Conclusion be old people's a slice every day calcium carbonate and vitamin D complexing agent to preventing bone loss, improve the nutritional status of vitamin D, promoting bone growing and suppress bone resorption and have certain effect.
Ye Huichu
[12]deng discussion trace element zinc, the impact on rats in growing period bone density, sclerotin thickness of calcium and vitamin D deficiency.Result demonstration, the shortage of zinc, vitamin D, calcium or deficiency can cause Decrease of Bone Mineral Density, the attenuation of sclerotin thickness, serum bone alkaline phosphatase to raise.
4, phosphopeptide caseinate
Phosphopeptide caseinate (Casein Phosphopeptides, CPP) is to take bovine casein as raw material, through single enzyme or the hydrolysis of compound enzyme system, then the peptides of the phosphoric acid seryl-that contains cluster obtaining through separation and purification.Phosphopeptide caseinate is with the negative charge of high concentration, in neutrality or weakly alkaline environment can and Ca
2+in conjunction with generating soluble complexes, suppress precipitation and form.Experiment in vitro shows that phosphopeptide caseinate can keep the dissolubility of calcium in small intestinal, thereby promotes the Passive intake of calcium.
Chen Yafei
[13]deng the impact of having studied phosphopeptide caseinate human calcium being absorbed.Result of the test shows, takes the experimental group urine calcium recruitment of casein containing protein phosphoeptide calcium tablet, and taking the not matched group urine calcium recruitment of casein containing protein phosphoeptide calcium tablet has obvious rising, and significant difference.This prompting phosphopeptide caseinate can improve the absorption of human gastrointestinal tract to calcium, and phosphopeptide caseinate can effectively promote the absorption of human body to calcium.
Phosphopeptide caseinate, because of the affinity to divalent metal, can form soluble complex with calcium in this weakly alkaline environment of small intestinal.This combination can effectively prevent the precipitation of insoluble calcium phosphate in neutrality arrives the small intestinal environment of meta-alkalescence, increases the concentration of solubility calcium, thereby promotes the absorption of enteral calcium.Animal experiment shows, phosphopeptide caseinate can improve the storage of calcium in bone and stay, and improves calcium content in bone, weakens osteoclast effect and suppresses absorbing again of bone.
[14]
Animal experiments show in a large number, and phosphopeptide caseinate can improve the storage of calcium in bone and stay, and can promote the utilization of skeleton to calcium, weaken osteoclast effect and suppress absorbing again of bone.Sato etc. point out, in the diet of mouse during casein containing protein phosphoeptide Acker casein, will increase in Thigh bone tissue radiation through the calcium content of labelling.The reports such as K.Ashida, the leghorn of the normal calcium daily ration of feeding, can improve bone mass and bone content of ashes after interpolation phosphopeptide caseinate.Separately have test to show, phosphopeptide caseinate can reduce the sickness rate of osteodysplasty, can alleviate the generation of osteopathia.
[15]
Remarkable advantage of the present invention is: formula for a product of the present invention be take traditional theory of Chinese medical science as basis, prescription forms meticulously, Herba Epimedii, Radix Achyranthis Bidentatae have the effect of invigorating the liver and kidney, bone and muscle strengthening, on the basis of the whole conditioning of Chinese herbal medicine, phosphopeptide caseinate and calcium citrate share, and can promote better calcium absorption utilization, improve calcium content of bone, increase bone density, thereby common performance increases the health care of bone density.This product is the combination of Traditional Chinese medical theory and modern medicine study, and it has compared with similar products its advantage and feature on formula.
Production technology process convenient operation of the present invention, can realize industrialization and produce continuously, and production cost is low.By product pilot experiment of the present invention is verified, result shows that whole production process is smooth, and production technology is reasonable, easy and simple to handle, and product yield is stable, and product indices all meets the regulation of company standard, and the production technology that proves product of the present invention is rational.Believe that, with the advantage of product uniqueness of the present invention, good quality, after putting on market, its market prospect is boundless.
List of references:
[1] Lin Jiahuan. Herba Epimedii Advance on Pharmacological Activities. Chinese Clinical medical research magazine, 2007,13 (12): 1748-1749.
[2] Zhao Lina. Herba Epimedii is prevented and treated osteoporosis Clinical evaluation. modern combination of Chinese and Western medicine magazine, 2003,12 (9): 922-923.
[3] Yu Bo etc. the effect of Icariin on Human Osteoblastic Cells in Vitro. traditional Chinese medical science bonesetting, 2006,18 (6): 17-18.
[4] Qu Ping etc. Theraputic Effect of Total Flavonoids of Herba Epimedii research. drug research, 2005,14(11): 25-26.
[5] Wang Yunlin, etc. the impact of Herba Epimedii on castrated rats bone density and bone structure performance. Chinese Tissue Engineering Study and clinical rehabilitation, 2008,12(50): 9893-9896.
[6] appoint softhearted, etc. Radix Achyranthis Bidentatae total saponins control experimental osteoporosis effect research. Anhui medicine, 2010,14(10): 1133-1135.
[7] Dong Qunwei, etc. the therapeutical effect of Radix Achyranthis Bidentatae ecdysterone to osteoporosis in ovariectomized rats. ACAD J GCP, 2009,25(5): 512-515.
[8] Sun Fenyong, etc. Radix Achyranthis Bidentatae promotes effect and the mechanism research of osteoblastic proliferation. Chinese crude drug, and 2004,27(4): 264-266.
[9] Gao Changkun, the experimentation of Radix Achyranthis Bidentatae to retinoic acid Induced Osteoporosis of Rats preventive and therapeutic effect. basic unit's Chinese medicine magazine, 2001,15(2): 9-11.
[10] remaining tinkling of pieces of jades, etc. the impact on bone density of calcium preparation and vitamin D. vitamin and mineral special column, 2000,8(4): 266-267.
[11] Guo Chunying, the change of taking bone density and biochemical indicator after calcium vitaminize D etc. old people with osteoporosis. Chinese Clinical nutrition magazine, 2000,8(3): 205-207.
[12] Ye Huichu, etc. zinc, calcium and the vitamin D experimentation to rats in growing period bone mineral density. Children in China Health Care, 2007,15(3): 278-281.
[13] Chen Yafei, etc. phosphopeptide caseinate promotes the effect research that human calcium absorbs. Food Science, and 2002,23(4): 130-132.
[14] Tang Chunyan, Qi Desheng. the progress of phosphopeptide caseinate in the nutrition of animal calcium. Guangdong feedstuff, 2006,15(2): 30-31.
[15] Duan Junhong, etc. phosphopeptide caseinate (CPP) and calcium, ferrum nutrient research progress. feed industry, 2007,28(6): 37-40.
The specific embodiment
The raw material of the compound preparation of Prevention and Treatment of Osteoporosis forms and mass fraction: a Herba Epimedii 24-26%, Radix Achyranthis Bidentatae 18-20%, calcium citrate 45-47%, phosphopeptide caseinate 7-9%, magnesium stearate 1-3%.
Preparation method comprises the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under 60 ~ 80 ℃ of temperature, vacuum-0.04 ~-0.06MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in to capsule filling machine, by the specification of 450mg/ grain, fills; The capsule of having filled is carried out to polishing with buffing machine, remove the medicated powder that capsule shell adheres to, and reject underproof capsule; Capsule after polishing is loaded in the ethylene bottle that meets YBB00122002 < < oral stable medicinal polythene bottle with high density > > regulation to every bottled 60.
Embodiment 1
A kind of raw material of compound preparation of Prevention and Treatment of Osteoporosis forms and mass fraction: Herba Epimedii 25%, Radix Achyranthis Bidentatae 19%, calcium citrate 46%, phosphopeptide caseinate 8%, magnesium stearate 2%.
Preparation method comprises the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under temperature 60 C, vacuum-0.04MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in to capsule filling machine, by the specification of 450mg/ grain, fills; The capsule of having filled is carried out to polishing with buffing machine, remove the medicated powder that capsule shell adheres to, and reject underproof capsule; Capsule after polishing is loaded in the ethylene bottle that meets YBB00122002 < < oral stable medicinal polythene bottle with high density > > regulation to every bottled 60.
Embodiment 2
A kind of raw material of compound preparation of Prevention and Treatment of Osteoporosis forms and mass fraction: Herba Epimedii 24%, Radix Achyranthis Bidentatae 20%, calcium citrate 45%, phosphopeptide caseinate 9%, magnesium stearate 2%.
Preparation method comprises the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under 80 ℃ of temperature, vacuum-0.06MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in to capsule filling machine, by the specification of 450mg/ grain, fills; The capsule of having filled is carried out to polishing with buffing machine, remove the medicated powder that capsule shell adheres to, and reject underproof capsule; Capsule after polishing is loaded in the ethylene bottle that meets YBB00122002 < < oral stable medicinal polythene bottle with high density > > regulation to every bottled 60.
Embodiment 3
A kind of raw material of compound preparation of Prevention and Treatment of Osteoporosis forms and mass fraction: Herba Epimedii 26%, Radix Achyranthis Bidentatae 18%, calcium citrate 47%, phosphopeptide caseinate 7%, magnesium stearate 2%.
Preparation method comprises the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under temperature 70 C, vacuum-0.05MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in to capsule filling machine, by the specification of 450mg/ grain, fills; The capsule of having filled is carried out to polishing with buffing machine, remove the medicated powder that capsule shell adheres to, and reject underproof capsule; Capsule after polishing is loaded in the ethylene bottle that meets YBB00122002 < < oral stable medicinal polythene bottle with high density > > regulation to every bottled 60.
Product of the present invention shows through acute oral toxicity test: maximum tolerated dose female, male Kunming mouse is all greater than to 20.0g/kgbw, belongs to nontoxic level.Three genetic toxicity test results are all negative.Through 30 days feeding trials: the ratio with 1.69%, 3.38%, 6.75% mixes in feedstuff product capsule 's content of the present invention to SD rat feeding 30 days, experimental session, animal growth is good, each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, organ weights and internal organs/body weight ratio and matched group comparison, there was no significant difference (P>0.05).Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking.Below the safety that all proves this product is very high.
The foregoing is only preferred embodiment of the present invention, all equalizations of doing according to the present patent application the scope of the claims change and modify, and all should belong to covering scope of the present invention.
Claims (3)
1. a compound preparation for Prevention and Treatment of Osteoporosis, is characterized in that: raw material forms and mass fraction: Herba Epimedii 24-26%, Radix Achyranthis Bidentatae 18-20%, calcium citrate 45-47%, phosphopeptide caseinate 7-9%, magnesium stearate 1-3%.
2. the compound preparation of Prevention and Treatment of Osteoporosis according to claim 1, is characterized in that: raw material forms and mass fraction: Herba Epimedii 25%, Radix Achyranthis Bidentatae 19%, calcium citrate 46%, phosphopeptide caseinate 8%, magnesium stearate 2%.
3. a method of preparing the compound preparation of Prevention and Treatment of Osteoporosis as claimed in claim 1, is characterized in that: comprise the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
The Herba Epimedii of selecting through quality standard check, Radix Achyranthis Bidentatae raw material are after pre-treatment, and by the 70wt.% alcoholic solution reflux, extract, of 10 times of amounts 2 times, each 1 hour, extracted twice liquid merged, filtration; Under 60 ~ 80 ℃ of temperature, vacuum-0.04 ~-0.06MPa condition, be concentrated into the extractum that 60 ℃ of relative densities are 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content below 5%; Dry extract is pulverized with 80 mesh sieves, obtained Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, magnesium stearate are sieved
The calcium citrate of selecting through quality standard check, phosphopeptide caseinate, magnesium stearate are crossed respectively 80 mesh sieves;
(3) mix
Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate were mixed after 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage.
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| US20200197486A1 (en) * | 2017-03-14 | 2020-06-25 | The University Of Melbourne | Complexes for treating sensitivity |
| CN113766904A (en) * | 2019-03-13 | 2021-12-07 | 墨尔本大学 | Compositions and methods for promoting mineralization |
| CN115969961A (en) * | 2023-03-17 | 2023-04-18 | 北京朗迪制药有限公司 | Calcium, VD and protein peptide composition for improving bone mineral density and preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113766904A (en) * | 2019-03-13 | 2021-12-07 | 墨尔本大学 | Compositions and methods for promoting mineralization |
| CN115969961A (en) * | 2023-03-17 | 2023-04-18 | 北京朗迪制药有限公司 | Calcium, VD and protein peptide composition for improving bone mineral density and preparation method and application thereof |
| CN115969961B (en) * | 2023-03-17 | 2023-05-12 | 北京朗迪制药有限公司 | Calcium, VD and protein peptide composition for improving bone mineral density and preparation method and application thereof |
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