CN104001157B - Compound preparation of a kind of protect against osteoporosis and preparation method thereof - Google Patents
Compound preparation of a kind of protect against osteoporosis and preparation method thereof Download PDFInfo
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- CN104001157B CN104001157B CN201410226893.1A CN201410226893A CN104001157B CN 104001157 B CN104001157 B CN 104001157B CN 201410226893 A CN201410226893 A CN 201410226893A CN 104001157 B CN104001157 B CN 104001157B
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Abstract
The invention provides compound preparation of a kind of protect against osteoporosis and preparation method thereof, be made up of Herba Epimedii, Radix Achyranthis Bidentatae, calcium citrate, phosphopeptide caseinate, magnesium stearate.Extract powder process, calcium citrate, phosphopeptide caseinate, Magnesium Stearate through Herba Epimedii, Radix Achyranthis Bidentatae raw material, allotment mixing granulation, metering filled capsules, it is obtained to pack these steps.The present invention is meticulous prescription in traditional theory of Chinese medical science and modern pharmacological research basis, Herba Epimedii and Radix Achyranthis Bidentatae have effect of invigorating the liver and kidney, bone and muscle strengthening, phosphopeptide caseinate and calcium citrate share, can promote that calcium absorption utilizes better, improve calcium content of bone, increase bone density, thus the common efficacy effect playing increase bone density, protect against osteoporosis.The product that the present invention obtains not only takes safety, have significant control and health-care effect, and industrial production cost is low, has good market development application prospect.
Description
Technical field
The invention belongs to medicine and field of health care food, be specifically related to compound preparation of a kind of protect against osteoporosis and preparation method thereof.
Background technology
Bone density and bone mineral density (bonemineraldensity, BMD) are important symbols of bone mass, reflect osteoporotic degree, the important evidence of prediction osteoporotic fracture.
The bone density of people will decline because of bone loss year by year with the growth at age after about 30 years old to peaking, and the speed of women's bone loss after climacteric starts is faster than elderly men.It is reported, no matter men and women, after 60 years old, during the general peaking of bone loss amount 20% ~ 30%, 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 of osteoporosis is suffered from more than 200,000,000 people in the whole world, and with regard to the U.S., the women of more than 45 years old suffers from osteoporosis person every year just up to 1500-2000 ten thousand people, causes fracture person to have 130-150 ten thousand example.Current China patients with osteoporosis about has 8,400 ten thousand, accounts for 6.6% of total population.The sickness rate of the annual concurrent fracture because of osteoporosis is about 9.6%, and has the trend increased year by year.According to World Health Organization's statistics, current osteoporotic sickness rate leaps to the 7th in world's commonly encountered diseases, frequently-occurring disease.Worldwide, protect against 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 bone density reduces and osseous tissue micro structure is destroyed, thus causes skeletal fragility to increase and the systemic disease of fracture easily occurs.Osteoporosis can not have any symptom in early days, and the research of this respect in recent years has many, mainly proposes by doing bone density inspection to make a definite diagnosis.By measuring bone density, can understand and whether have bone amount to reduce and osteoporosis.Reducing to osteoporosis from bone amount 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, and be the institute of essence Tibetan, and essence can give birth to marrow, 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, smokes damp diaphysis, is the strong basic place of muscles and bones.Therefore deficiency of kidney-essence, the then 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 " essence and blood sharing the same origin ", the saying of " The liver and the kidney have a common source ", the vital essence in kidney is filled and contained that to depend on moistening of blood foster.Reach if liver loses bar, irritability stasis, consumption impairment of YIN blood, deficiency of liver-blood, then can cause deficiency of the kidney, and bone marrow is lost and supports, 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 not transporting, spleen insufficiency of essence, the day after tomorrow does not support congenital, then cause the weary source of kidney essense, and skeleton loses supports.Old people due to multi viscera deficient, kidney-jing deficiency is few, and kidney qi day declines, vital essence insufficiency of blood, obstruction of collaterals by blood stasis, and 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, mainly by 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 hormones and bone metabolism regulatory factor; Environmental factors comprises trophic factor, sports, health behavior, bad habit etc.
Medically also do not have safe and effective radical cure method at present, help loose skeleton to restore to the original state, therefore, correct understanding, early prevention seem particularly important.Up to the present, China ratifies to increase bone density, improve osteoporosis functional health care food about 360 kinds altogether, has mostly declared two or more health cares simultaneously, has mainly concentrated on and replenish the calcium, on enhancing immunity, slow down aging.
With regard to existing market product variety, the health food increasing bone density is divided into two classes substantially: a class is calcic, is reached the health food increasing bone density object by direct supplement calcium, formula is mainly based on calcium, and coordinating interpolation vitamin D, major product has nation Lik-Sang board D-glucosamine calcium dimension D sheet, os osseum star actor ties up calcium tablet, the precious sheet of calcium etc.; Another kind of is not calcic or not for the purpose of replenishing the calcium, but promote the absorption of calcium by adjustment endocrine thus reach the health food increasing bone density this purpose, formula is raw materials used based on soybean isoflavone, and major product has QINGCHUN BAO board Margarita isoflavone capsule, eastern first board isoflavone tablet, Australia of U.S. is good for board soybean isoflavone calcium soft capsule etc.The product of Chinese prescription only has Ai Shili board Rieter relieving capsule, herbal natural wind board bone adds 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 protect against osteoporosis and preparation method thereof, meticulous prescription in traditional theory of Chinese medical science and modern pharmacological research basis, Herba Epimedii and Radix Achyranthis Bidentatae have effect of invigorating the liver and kidney, bone and muscle strengthening, phosphopeptide caseinate and calcium citrate share, can promote that calcium absorption utilizes better, improve calcium content of bone, increase bone density, thus the common efficacy effect playing increase bone density, protect against osteoporosis.The product that the present invention obtains not only takes safety, have 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 composition of the compound preparation of protect against osteoporosis 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 composition 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
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 60 ~ 80 DEG C, vacuum-0.04 ~-0.06MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in capsule filling machine, fills by the specification of 450mg/ grain; The capsule buffing machine of having filled is carried out polishing, removes the medicated powder of capsule shell attachment, and reject underproof capsule; Capsule after polishing is loaded on and meets in ethylene bottle that YBB00122002 " oral stable medicinal polythene bottle with high density " specifies, often 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, useful vital essence, hard muscles and bones, mends waist knee joint, effect of heart tonifying power; Radix Achyranthis Bidentatae is bitter, sour, property is put down, and returns liver, kidney channel, has effect of scattered silt blood, detumescence pain, invigorating the liver and kidney, bone and muscle strengthening; Two medicines share, and can mend the deficient of " congenital " altogether, play 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 is more than 1000g, has the good reputation of human body " biological element ".Calcium in human body about 99% formation bone mineral, is distributed in skeleton and tooth, promotes its growth promoter, maintains its form and hardness; About 1% is distributed in body fluid and soft tissue, although body fluid calcium content is few, plays important physiological function.
Phosphopeptide caseinate take bovine casein as raw material, through single enzyme or multiply anchor-pile hydrolysis, then the peptides of the phosphoric acid seryl-containing cluster obtained through separation and purification.The phosphopeptide caseinate of optimal dose can promote that calcium absorption utilizes 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.) records the effect with " beneficial vital essence, hard muscles and bones mend waist knee joint, heart tonifying power " in Compendium of Material 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 conditioner body immunity function, 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 hormone Replacement Therapy (HRT) osteoporotic Clinical efficacy comparison.Method 25 examples is diagnosed as osteoporotic postmenopausal women's double blind random through X-ray film and Dual-energy X-rays absorptionmetry mensuration be divided into 2 groups, and test group 15 example gives Herba Epimedii 200g/d decoction; It is oral that matched group 10 example gives premarin 0.625mg, 1 time/d.Curative effect is judged after 3 ~ 6 months.Result: test group remission effective percentage is 80%; Matched group remission effective percentage is that 90%, two groups of effective percentage compare without significant difference (P > 0.05).Conclusion: Herba Epimedii has direct repression to osteoclast, can urge calcified bone and form increase, alleviate bone pain symptom, suitable with HRT osteoporosis effect.So, adopt barrenwort for treating elderly woman osteoporosis to be one of comparatively ideal method.
Yu Bo
[3]for inquiring into the impact of Icariin on Human Osteoblastic Cells in Vitro, adopting gradation enzyme digestion to be in vitro human osteoblast cell and cultivating, obtaining the osteoblast that character is stablized, purity is high; The research of icariin to osteoblastic proliferation is done with mtt assay.Found that the icariin of variable concentrations all has facilitation, with 10ngml to osteoblastic growing multiplication
-1its effect the strongest (P < 0.05) during concentration; It is 100ngml that biochemical method measures icariin concentration
-1and 10ngml
-1facilitation is had to osteoblast secreting alkaline phosphorus phytase (AKP).While showing that icariin promotes osteoblastic proliferation, enhance 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 change of serum calcium, serum paraoxonase, alkaline phosphatase levels, 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 physiologic levels, 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, and have effect of scattered silt blood, detumescence pain, invigorating the liver and kidney, bone and muscle strengthening, be mainly used in soreness of waist and knee joint, 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 causes osteoporosis rat preventive and therapeutic effect to retinoic acid.Method: the continuous gavage retinoic acid of rat causes experimental osteoporosis model, Radix Achyranthis Bidentatae total saponins by 30,100,300mgkg
-1dosed administration, observes each group of activities in rats situation and body weight change, measures bone density and bone calcium, bone phosphorus content.Result display Radix Achyranthis Bidentatae total saponins can improve the ordinary circumstance of osteoporosis rat, can significantly increase its body weight and bone density, raise bone calcium, bone phosphorus content.Conclusion: Radix Achyranthis Bidentatae total saponins has significantly control retinoic acid induced osteoporosis effect.
Dong Qunwei
[7]deng discussion Radix Achyranthis Bidentatae ecdysterone to the therapeutical effect of osteoporosis in ovariectomized rats.Result display high dose and middle dosage Radix Achyranthis Bidentatae ecdysterone obviously can improve the bone density of ovariectomized rats and every biomechanics and Trabecular area index, and low dosage processed group also has certain therapeutical effect.Conclusion: Radix Achyranthis Bidentatae ecdysterone has osteoporosis in ovariectomized rats prevents and treats purposes, and in dose dependent.
Sun Fenyong etc.
[8]research Radix Achyranthis Bidentatae is to the proliferation of osteoblast strain HFOBI.19 and molecular mechanism thereof.Result display Radix Achyranthis Bidentatae Contained Serum and Radix Achyranthis Bidentatae ecdysterone all can promote osteoblastic propagation, and cause protein kinase A to regulate the rise of base β expression.Conclusion: preliminary judgement Radix Achyranthis Bidentatae has the effect promoting human osteoblast cell's propagation in vitro, and its Main Function composition is ecdysterone, and is likely that the signal transduction path mediated by cAMP is carried out.
Gao Changkun
[9]inquire into Radix Achyranthis Bidentatae to the preventive and therapeutic effect of the osteoporosis rat caused by retinoic acid.Spontaneous activity number, the bone density of result display rat increase, and in blood Ca, blood P, bone Ca, bone P and bone, HP content increases, and in blood, ALP activity reduces.Conclusion: Radix Achyranthis Bidentatae decocting liquid significantly can increase the mobility of retinoic acid induced osteoporosis rat, the loss of the rat bone mineral nitrogen stoping retinoic acid to cause, increases content organic in its bone, improves bone density.
3, calcium citrate
In " nutrient prime replenisher declare with evaluate specify (trying) ", calcium citrate is the wherein a kind of raw material as calcium complement agent.Calcium is the main component of skeleton, at the nervimuscular irritability of maintenance, promotes nerve ending secretion acetylcholine, improve permeability of cell membrane, increase blood capillary compactness, antiallergic, promote that the aspects such as tooth, skeleton calcification and formation play an important role.It is necessary that enough calcium is taken in normal Skeleton development, and calcium intake can not reduce peak bone mass completely and increase with aged and next bone loss.。Epidemiologic data prompting simultaneously, replenishes the calcium and can reduce the generation of Hip Fracture.The special chemical composition of calcium citrate and good promotion human body, to the absorption of calcium, effectively can supplement calcium, prevent osteoporosis from occurring, and correct negative calcium balance.
Remaining tinkling of pieces of jades
[10]promote that the medicine calcium preparation of bone mineralising and vitamin D are on the impact of bone density (BMD) Deng research.Result shows, and after 6 months, treatment group comparatively treats front bone density on average increases by 1.9%, compares difference have significant (P < 0.05) with before treatment.And matched group comparatively treats front bone density minimizing 0.3%, without significant difference before and after treatment.Before and after two groups of comparison therapy, bone density is changed significantly (P < 0.05).Obvious untoward reaction is had no in therapeutic process.
Guo Chunying
[11]deng the impact that the supplementary calcium of discussion and vitamin D are changed bone loss and bone.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 to have certain effect.
Ye Huichu
[12]deng discussion trace element zinc, calcium and vitamin D deficiency are on the impact of rats in growing period bone density, sclerotin thickness.Result shows, and the shortage of zinc, vitamin D, calcium or deficiency can cause bone density reduction, sclerotin lower thickness, serum bone alkaline phosphatase raise.
4, phosphopeptide caseinate
Phosphopeptide caseinate (CaseinPhosphopeptides, CPP) take bovine casein as raw material, through single enzyme or multiply anchor-pile hydrolysis, then the peptides of the phosphoric acid seryl-containing cluster obtained through separation and purification.Phosphopeptide caseinate with the negative charge of high concentration, in neutral or weakly alkaline environment can and Ca
2+in conjunction with generation soluble complexes, precipitation is suppressed to be formed.Experiment in vitro display phosphopeptide caseinate can keep the dissolubility of calcium in small intestinal, thus promotes the Passive intake of calcium.
Chen Yafei
[13]etc. the impact that have studied phosphopeptide caseinate and absorb human calcium.Result of the test shows, and takes the experimental group urine calcium recruitment of casein containing protein phosphoeptide calcium tablet, and the matched group urine calcium recruitment comparatively taking not 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 namely phosphopeptide caseinate effectively can promote that human body is to the absorption of 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 effectively can prevent the precipitation of insoluble calcium phosphate in the small intestine condition of neutrality to meta-alkalescence, increases the concentration of solubility calcium, thus 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]
A large amount of animal experiment shows, phosphopeptide caseinate can improve the storage of calcium in bone and stay, and can promote that skeleton is to the utilization of calcium, weakens osteoclast effect and suppresses 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 the calcium content radiated through labelling.The reports such as K.Ashida, the leghorn of normal calcium daily ration of feeding, can improve bone mass and ash content after adding 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 is based on traditional theory of Chinese medical science, meticulous prescription forms, Herba Epimedii, Radix Achyranthis Bidentatae have effect of invigorating the liver and kidney, bone and muscle strengthening, on the basis of Chinese herbal medicine entirety conditioning, phosphopeptide caseinate and calcium citrate share, and can promote that calcium absorption utilizes better, improve calcium content of bone, increase bone density, thus the common health care playing increase bone density.This product is the combination of Traditional Chinese medical theory and modern medicine study, and it has its advantage and feature compared with similar products on formula.
Production technology process convenient operation of the present invention, can realize industrialization continuous seepage, production cost is low.By verifying product pilot experiment of the present invention, result shows that whole production process is smooth, and production technology is reasonable, easy and simple to handle, and product yield is stablized, and product indices all meets the regulation of company standard, proves that the production technology of product of the present invention is rational.Believe that, with the advantage of product uniqueness of the present invention, excellent 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 prevents and treats 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. the traditional Chinese medical science bonesets, and 2006,18 (6): 17-18.
[4] Qu Ping etc. Theraputic Effect of Total Flavonoids of Herba Epimedii is studied. drug research, 2005,14(11): 25-26.
[5] Wang Yunlin, etc. the impact on castrated rats bone density and bone structure performance of. Herba Epimedii. 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 study. Anhui medicine, 2010,14(10): 1133-1135.
[7] Dong Qunwei, etc. Radix Achyranthis Bidentatae ecdysterone is to the therapeutical effect of osteoporosis in ovariectomized rats. ACAD J GCP, 2009,25(5): 512-515.
[8] Sun Fenyong, etc. Radix Achyranthis Bidentatae promotes effect and the study mechanism of osteoblastic proliferation. Chinese crude drug, 2004,27(4): 264-266.
[9] Gao Changkun, Radix Achyranthis Bidentatae is to the experimentation of retinoic acid Induced Osteoporosis of Rats preventive and therapeutic effect. basic unit's J Chinese, 2001,15(2): 9-11.
[10] remaining tinkling of pieces of jades, etc. calcium preparation and vitamin D are on the impact of bone density. vitamin and mineral special column, 2000,8(4): 266-267.
[11] Guo Chunying, takes the change of 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 vitamin D are to the experimentation of 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 study that human calcium absorbs. Food Science, 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, melt quality progress. feed industry, 2007,28(6): 37-40.
Detailed description of the invention
The raw material composition of the compound preparation of protect against osteoporosis 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
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 60 ~ 80 DEG C, vacuum-0.04 ~-0.06MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in capsule filling machine, fills by the specification of 450mg/ grain; The capsule buffing machine of having filled is carried out polishing, removes the medicated powder of capsule shell attachment, and reject underproof capsule; Capsule after polishing is loaded on and meets in ethylene bottle that YBB00122002 " oral stable medicinal polythene bottle with high density " specifies, often bottled 60.
Embodiment 1
A kind of raw material composition of compound preparation of protect against osteoporosis 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
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 60 C, vacuum-0.04MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in capsule filling machine, fills by the specification of 450mg/ grain; The capsule buffing machine of having filled is carried out polishing, removes the medicated powder of capsule shell attachment, and reject underproof capsule; Capsule after polishing is loaded on and meets in ethylene bottle that YBB00122002 " oral stable medicinal polythene bottle with high density " specifies, often bottled 60.
Embodiment 2
A kind of raw material composition of compound preparation of protect against osteoporosis 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
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 80 DEG C, vacuum-0.06MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in capsule filling machine, fills by the specification of 450mg/ grain; The capsule buffing machine of having filled is carried out polishing, removes the medicated powder of capsule shell attachment, and reject underproof capsule; Capsule after polishing is loaded on and meets in ethylene bottle that YBB00122002 " oral stable medicinal polythene bottle with high density " specifies, often bottled 60.
Embodiment 3
A kind of raw material composition of compound preparation of protect against osteoporosis 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
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 70 C, vacuum-0.05MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage
Mixture is placed in capsule filling machine, fills by the specification of 450mg/ grain; The capsule buffing machine of having filled is carried out polishing, removes the medicated powder of capsule shell attachment, and reject underproof capsule; Capsule after polishing is loaded on and meets in ethylene bottle that YBB00122002 " oral stable medicinal polythene bottle with high density " specifies, often bottled 60.
Product of the present invention shows through acute oral toxicity test: be all greater than 20.0g/kgbw to the maximum tolerated dose of female, male Kunming mouse, belong to nontoxic level.Three genetic toxicity test results are feminine gender.Through 30 days feeding trials: product capsule 's content of the present invention mixes in feedstuff to SD rat feeding 30 days by the ratio with 1.69%, 3.38%, 6.75%, experimental session, animal growth is good, each dosage group body weight, weightening finish, food utilization, routine blood indexes, blood biochemistry index, organ weights and internal organs/body weight ratio compare with matched group, there was no significant difference (P>0.05).Gross anatomy and tissue pathology checking have no the abnormal change relevant with sample.Below all prove that the safety of this product is very high.
The foregoing is only preferred embodiment of the present invention, all equalizations done 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 protect against osteoporosis, is characterized in that: raw material composition 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 protect against osteoporosis according to claim 1, is characterized in that: raw material composition and mass fraction: Herba Epimedii 25%, Radix Achyranthis Bidentatae 19%, calcium citrate 46%, phosphopeptide caseinate 8%, magnesium stearate 2%.
3. prepare a method for the compound preparation of protect against osteoporosis as claimed in claim 1, it is characterized in that: comprise the following steps:
(1) Herba Epimedii, Radix Achyranthis Bidentatae raw material extract powder process
Through quality standard check select Herba Epimedii, Radix Achyranthis Bidentatae raw material after pre-treatment, by the 70wt.% alcoholic solution reflux, extract, 2 times of 10 times amount, each 1 hour, extracted twice liquid merged, and filtered; Under temperature 60 ~ 80 DEG C, vacuum-0.04 ~-0.06MPa condition, being concentrated into 60 DEG C of relative densities is the extractum of 1.20; Under temperature 60 C, vacuum-0.08MPa condition, be dried to water content less than 5%; Dry extract 80 mesh sieves are pulverized, obtains Herba Epimedii, Radix Achyranthis Bidentatae extract powder;
(2) calcium citrate, phosphopeptide caseinate, Magnesium Stearate
Calcium citrate, phosphopeptide caseinate, magnesium stearate mistake 80 mesh sieves respectively selected are checked through quality standard;
(3) mix
After Herba Epimedii, Radix Achyranthis Bidentatae extract powder and phosphopeptide caseinate are mixed 10 minutes, add calcium citrate and magnesium stearate, remix 20 minutes;
(4) capsule-filling, subpackage.
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| EP3937882A4 (en) * | 2019-03-13 | 2023-04-12 | The University of Melbourne | Compositions and methods for promoting mineralization |
| 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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