CN104095914A - Bone-peaceful capsule formula increasing bone mineral density and preparation method thereof - Google Patents
Bone-peaceful capsule formula increasing bone mineral density and preparation method thereof Download PDFInfo
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- CN104095914A CN104095914A CN201310115951.9A CN201310115951A CN104095914A CN 104095914 A CN104095914 A CN 104095914A CN 201310115951 A CN201310115951 A CN 201310115951A CN 104095914 A CN104095914 A CN 104095914A
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Abstract
The invention belongs to the technical field of traditional Chinese medicine and health food, and concretely relates to a bone-peaceful capsule formula increasing bone mineral density and a preparation method thereof. The bone-peaceful capsule preparation formula comprises fermented soybean, radix puerariae, radix achyranthis bidentatae, rhizoma drynariae and radix angelicae sinensis. The preparation method comprises: performing supercritical CO2 extraction on radix angelicae sinensis and fermented soybean, using ethanol with the concentration of 60-80% to perform heating refluxing extraction on radix puerariae, using ethanol with the concentration of 85-95% to perform heating refluxing extraction on radix achyranthis bidentatae and rhizoma drynariae, performing vacuum drying on the above extractives, crushing, mixing uniformly, spraying radix angelicae sinensis oil into the mixture, sieving by using a 16 mesh sieve, drying at 60 DEG C, filling a 0# capsule, polishing and bottling. The hard capsule preparation is capable of increasing the bone mineral density of osteoporosis crowds such as climacteric women and middle aged and elderly people, and has substantial efficacy on delaying pathology generation or alleviating symptoms. The product is pure traditional Chinese medicine health-care food which is clear in effective compositions, advanced in preparation technology, definite in efficacy, controllable in quality and high in safety.
Description
Technical field
The invention belongs to Chinese medicine and health food technology field, be specifically related to a kind of bone density that increases, pure compound Chinese medicinal preparation and the capsule preparation method thereof thereof of osteoporosis disease
Background technology
Along with the improvement of living condition and medical condition, people's life-span constantly extends, and global many countries enter aging society, and osteoporosis has become many countries, the frequently-occurring disease of developed country especially, commonly encountered diseases.A survey data of World Health Organization (WHO) (WHO) shows, in current 40 years old above crowd in the world, there is 20% ratio that degenerative bone pathological changes in various degree occurs, as the pain of skeleton, joint, muscles etc., swelling, acid is heavy, numb, tetanic and movable be obstructed etc.; Hyperosteogeny, cervical vertebra and lumbal vertebra, osteoporosis etc.Cause thus limb activity easily tired, also make the sickness rate of fracture significantly improve.
The census of population discovery of China to degenerative bone pathological changes, the sickness rate of this class disease has increase and the increasingly trend of rejuvenation year by year.This and modern work rhythm and job specification and environmental change are (as long-term seat office, long period of operation computer etc., lack enough physical work or physical training, and the radiation damage etc. of ion and ray due to air conditioner surroundings, mobile phone, TV and earth sphere depletion of the ozone layer) in close relations, should fully cause our attention and concern.According to incompletely statistics, the existing population in the whole nation reaches 13.7 hundred million, and within 60 years old, above old man reaches more than 1.87 hundred million.China's middle-aged and elderly people and postmenopausal women suffer from osteoporosis population estimate and reach more than 8,800 ten thousand, become the cardiovascular and cerebrovascular disease that continues, cancer, another the serious commonly encountered diseases after diabetes.
" putting prevention first and combining prevention with control " are the fundamental state policies of China's health service, and research and development have increase bone density, prevent the compound Chinese medicinal preparation of osteoporosis, are our urgent task and study hotspots.According to Ancient Times in China medical book " doctor's essence is through justice ", record: ", therefore the institute of bone person kidney is raw also, essence foot is bone marrow foot for kidney storing essence, the raw marrow of essence, marrow bone growth promoting, and marrow is in bone, and bone is strong for marrow foot ".The Traditional Chinese medical theory of ancient Chinese medicine doctor is thought, " liver governing tendons, kidney governing bones ", and caused by liver and kidney deficiency, causes injury of tendon and muscle bone to damage, and causes human bone mineral density to decline, and osteoporosis occurs.
The safe capsule of bone of the present invention development, causes the pathogeny of osteoporosis according to Traditional Chinese Medicine, the preferred Semen Sojae Preparatum of " the liver and the kidney tonifying, bone and muscle strengthening " from many Chinese medicine, Radix Puerariae, Radix Achyranthis Bidentatae, Rhizoma Drynariae, the flavour of a drug such as Radix Angelicae Sinensis form compound recipe, be prepared into hard capsule preparation, multicomponent, many target spots, the multichannel advantage of performance compound Chinese medicinal preparation, produce the raw marrow of Psoralen, increase osteoblast, suppress osteoclast, increase the effect of calcium absorption, reach the object that increases bone density.
Summary of the invention
The safe capsule of bone of the present invention is to provide a kind of can increase bone density, safe capsule of pure compound Chinese medicinal preparation bone of Prevention and Treatment of Osteoporosis and preparation method thereof.For above-mentioned degenerative bone pathological changes crowd's sub-health state and the novel healthy food developing.It has the effect of bone and muscle strengthening and anti-organism fatigue, control applicable to climacteric women and mid-aged population frequently-occurring disease osteoporosis, health care and the prevention of the crowd's who also can be used for tackling modern work rhythm, job specification and must long-term static work occupation disease (various degenerative bone pathological changes), for delaying the generation of pathological changes or the alleviation of symptom has remarkable efficacy.
The safe capsule preparations of bone provided by the invention, its formula comprises that the various medical material proportionings such as Semen Sojae Preparatum, Radix Puerariae, Radix Achyranthis Bidentatae, Rhizoma Drynariae, Radix Angelicae Sinensis are by weight: Semen Sojae Preparatum 2500g～3500g, Radix Puerariae 1800g～2200g, Radix Achyranthis Bidentatae 950g～1050g, Radix Angelicae Sinensis 900g～1100g, Rhizoma Drynariae, 900g～1100g.
The preparation method of the safe capsule of bone of the present invention, the steps include:
(1) extraction of Chinese crude drug:
A, Radix Angelicae Sinensis, use supercritical CO
2device extraction quintessence oil, extraction conditions is: 45～55 ℃ of extraction temperature, extracting pressure 25～35Mpa, extraction time 1～2.5 hour, collects quintessence oil, and residue gives over to next step and extracts use.
B, Semen Sojae Preparatum, use supercritical CO
2device extraction quintessence oil, extraction conditions is: 40～55 ℃ of extraction temperature, extracting pressure 20～30Mpa, extraction time 1.5～2.5 hours, collects oils and fats, and residue gives over to next step and extracts use.。
C, Radix Puerariae, be that 60～80% alcohol heating reflux extract 1～3 time by concentration, each 1～2.5 hour, and decompression and solvent recovery, drying under reduced pressure, is ground into fine powder.
D, Radix Achyranthis Bidentatae, Rhizoma Drynariae concentration are that 85～95% alcohol heating reflux extract 1～3 time, each 1～3 hour, and decompression and solvent recovery, drying under reduced pressure, is ground into fine powder.
(2) preparation of capsule: by extract fine powder mix homogeneously such as Radix Puerariae, Radix Achyranthis Bidentatae, Rhizoma Drynariae, Semen Sojae Preparatums, Radix Angelicae Sinensis wet goods is sprayed in mixture, stir, 16 mesh sieves are granulated, and 60 ℃ of oven dry, fill No. 0 capsule, polishing, bottling, packing.
Feature of the present invention: the natural biological flavonoid result of study in Semen Sojae Preparatum, Radix Puerariae of take is basis, in conjunction with our achievement in research to Chinese medicine Semen Sojae Preparatum for many years, therefrom obtain and the isoflavone that daidzein, puerarin etc. are representative is take in enrichment, defining it is the functional component that improves osteoporosis and increase bone density; In this formula for a product, principal agent is Semen Sojae Preparatum, the technique preparation by fermentation of these flavour of a drug, and the content that wherein amount of contained sequestered biological flavone is generally extracted from Semen sojae atricolor wants high, and easily for body absorbs; Application supercritical fluid extraction (SFE) new technique improves preparation technology, and at utmost enrichment and reservation effect component, remove the impurity such as heavy metal, pesticide residues and organic solvent residual; It is objective, reasonable, stable and controllable for quality that quality standard detects index; Functional component is clear and definite, and health-care effect is definite, safety non-toxic.
The safe capsule of compound bone of the present invention has the bone density that strengthens postmenopausal women and middle-aged and elderly people, prevents the effect of osteoporosis.
The specific embodiment
According to amounts of components of the present invention, select following 3 groups of prescriptions:
Prescription 1: Semen Sojae Preparatum 2500g, Radix Puerariae 1800g, Radix Achyranthis Bidentatae 950g, Radix Angelicae Sinensis 900g, Rhizoma Drynariae 900g.
Prescription 2: Semen Sojae Preparatum 3000g, Radix Puerariae 2000g, Radix Achyranthis Bidentatae 1000g, Radix Angelicae Sinensis 1000g, Rhizoma Drynariae 1000g.
Prescription 3: Semen Sojae Preparatum 3500g, Radix Puerariae 2200g, Radix Achyranthis Bidentatae 1050g, Radix Angelicae Sinensis 1100g, Rhizoma Drynariae 1100g.
Be prepared into as stated above 3 kinds of compound preparations.The quality index of the safe capsule of compound bone that after testing prepared by the present invention is as follows: (one) functional component index
(2) physical and chemical index
(3) microbiological indicator
(4) mensuration of total biological flavone: the preparation of reference substance solution, precision takes daidzein reference substance 10mg, puts in 50ml measuring bottle, add methanol 40ml, put slight fever in water-bath and make to dissolve, let cool, add methanol to scale, shake up, obtain (every 1ml is containing daidzein 200 μ g).
The preparation of need testing solution: get the content of 20 of this product, porphyrize, mixes, precision takes in right amount (content that is approximately equivalent to this product 5 capsules), puts in apparatus,Soxhlet's, and 100ml adds diethyl ether, reflux, to extracting liquid colourless, lets cool, and discards ether solution, add methanol 90ml, reflux is to extracting liquid colourless, in dislocation 100ml measuring bottle again, with a small amount of washing container of methanol, washing liquid is incorporated in measuring bottle, adds methanol to scale, shakes up.Precision measures 1.0ml, puts in 25ml measuring bottle, adds methanol to scale, shakes up, and obtains.
Assay method: the accurate reference substance solution 0.5ml that draws, need testing solution 5.0ml, is placed in respectively 25ml measuring bottle, each is diluted to scale with methanol, shakes up, according to spectrophotography (2010 editions appendix of Chinese Pharmacopoeia), at 248nm wavelength place, measure trap, calculate, obtain.
(5) mensuration of total saponins: the preparation of reference substance solution, take 105 ℃ of about 10mg of oleanolic acid reference substance that are dried to constant weight, accurately weighed, put in 50ml measuring bottle, add the about 40ml of methanol, put slight fever in water-bath and make to dissolve, let cool, add methanol to scale, shake up, obtain (in every 1ml, containing oleanolic acid 200 μ g).
The preparation of need testing solution: the content of getting 20 of this product, porphyrize, mixes, and precision takes in right amount (content that is approximately equivalent to 5 of this product), put in apparatus,Soxhlet's, the 100ml that adds diethyl ether, reflux, to extracting liquid colourless, lets cool, discard ether solution, add methanol 90ml, reflux to extracting solution is negative to adding the inspection of acetic anhydride-concentrated sulphuric acid test solution again, filters, filtrate is put water-bath and is concentrated into dry, residue adds a small amount of dissolve with methanol, in dislocation 25ml measuring bottle, with a small amount of washing container of methanol, washing liquid is incorporated in measuring bottle, add methanol to scale, shake up, obtain.
Assay method: precision measures reference substance solution and each 0.5ml of sample solution, be placed in respectively in the water-bath of 10ml measuring bottle and volatilize methanol, let cool, each precision adds 5% vanillin anhydrous alcohol solution 0.5ml and 77% sulfuric acid solution 5.0ml, mix, two measuring bottles are put into 70 ℃ of water-baths simultaneously and heat 10 minutes, shake up, insert immediately in ice-water bath and place 15 minutes, according to spectrophotography (2010 editions appendix of Chinese Pharmacopoeia), at 538nm wavelength place, measure trap, calculate, obtain.
(6) other indexs: measure by Chinese Pharmacopoeia (2010 editions) and GB requirement regulation respectively.
The safe capsule of bone of the present invention increases the conclusion of bone substance density improving function test: get respectively the safe capsule 's content 133.3mg/kg.Bw/d of bone, 266.7mg/kg.Bw/d and 533.3mg/kg.Bw/d (be equivalent to human body recommended intake 5,10,20 times) the dosage Osteoporotic Model animal of feeding, result shows, when 533.3mg/kg.Bw/d (be equivalent to human body recommended dose 20 times) dosage, there is the effect of the animal pattern of increasing bone density.
The acute toxicity test conclusion of the safe capsule of bone of the present invention: the test of chmice acute Oral toxicity, male and female white mice per os MTD value is this sample of 15000mg/kg/b.wt and belongs to nontoxic level.
30 days feeding trial conclusions of the safe capsule of bone of the present invention: this product content with 2200,4400,6600mg/kg/b.wt/d (be equivalent to people's recommended dose 40,80,120 times), feed rat 30 days, result: the actual intake of high dose male and female rat is equivalent to 132 times and 127 times of recommended dose, does not all detect obvious illeffects to the every tested index of rat.The NOAEL value of feeding for 30 days of this sample is 6600mg/kg/d.
Claims (6)
1. formula of the safe capsule of the Chinese medicine preparation bone that increases bone density and preparation method thereof, it is characterized in that formula comprises: Semen Sojae Preparatum, Radix Puerariae, Radix Achyranthis Bidentatae, Rhizoma Drynariae, Radix Angelicae Sinensis, each component is by weight: Semen Sojae Preparatum 2500～3500g, Radix Puerariae 1800～2200g, Radix Achyranthis Bidentatae 950～1050g, Rhizoma Drynariae 900～1100g, Radix Angelicae Sinensis 900～1100g.
2. the safe capsule of the bone of increase bone density according to claim 1, is characterized in that various medical material proportionings are by weight: Semen Sojae Preparatum 2500g, Radix Puerariae 1800g, Radix Achyranthis Bidentatae 950g, Rhizoma Drynariae 900g, Radix Angelicae Sinensis 900g.
3. the safe capsule of the bone of increase bone density according to claim 1, is characterized in that various medical material proportionings are by weight: Semen Sojae Preparatum 3000g, Radix Puerariae 2000g, Radix Achyranthis Bidentatae 1000g, Rhizoma Drynariae 1000g, Radix Angelicae Sinensis 1000g.
4. the safe capsule of the bone of increase bone density according to claim 1, is characterized in that various medical material proportionings are by weight: Semen Sojae Preparatum 3500g, Radix Puerariae 2200g, Radix Achyranthis Bidentatae 1050g, Rhizoma Drynariae 1100g, Radix Angelicae Sinensis 1100g.
5. the safe capsule of the bone of increase bone density according to claim 1, is characterized in that effect becomes as follows: total biological flavone >=2500mg/100g, total saponins >=1250mg/100g.
6. according to the preparation method of the safe capsule of the bone of the increase bone density one of claim 1～4 Suo Shu, it is characterized in that concrete steps are;
(1) Chinese medicine ingredients is extracted
A, Radix Angelicae Sinensis, use supercritical CO
2device extraction, extraction conditions is 45～55 ℃ of extraction temperature, extracting pressure 25～35Mpa, extraction time is 1.0～2.5 hours, obtains quintessence oil, after extraction, residue is continued to employ;
B, Semen Sojae Preparatum, use supercritical CO
2device extraction, extraction conditions is 40～55 ℃ of extraction temperature, extracting pressure 20～30Mpa, extraction time is 1.5～2.5 hours, obtains quintessence oil, after extraction, residue is continued to employ;
C, Radix Puerariae, Radix Angelicae Sinensis residue, Semen Sojae Preparatum residue concentration are that 60～80% alcohol heating reflux extract 1～3 time, each 1～2.5 hour, and decompression and solvent recovery, drying under reduced pressure, is ground into fine powder;
D, Radix Achyranthis Bidentatae, Rhizoma Drynariae concentration are that 85～95% alcohol heating reflux extract 1～3 time, each 1～3 hour, and decompression and solvent recovery, drying under reduced pressure, is ground into fine powder.
(2) capsule preparation
By extract fine powder mix homogeneously such as Semen Sojae Preparatum, Radix Puerariae, Radix Achyranthis Bidentatae, Rhizoma Drynariae, Radix Angelicae Sinensis, Radix Angelicae Sinensis wet goods is sprayed in mixture, stir, 16 mesh sieves are granulated, and 60 ℃～70 ℃ oven dry, fill No. 0 capsule, polishing, bottling, packing.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114522196A (en) * | 2022-01-21 | 2022-05-24 | 广州中医药大学第三附属医院(广州中医药大学第三临床医学院、广州中医药大学附属骨伤科医院、广东省中医骨伤研究院) | Compound traditional Chinese medicine for preventing and treating osteoporosis and preparation method thereof |
| CN116473236A (en) * | 2023-04-19 | 2023-07-25 | 安徽昊天生物科技有限公司 | Sports nutrition food for recovering after sports and preparation method thereof |
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| CN102579562A (en) * | 2012-02-27 | 2012-07-18 | 苏州爱斯欧蒂生物科技有限公司 | Health care product for preventing osteoporosis |
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Patent Citations (2)
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| CN101181487A (en) * | 2007-11-21 | 2008-05-21 | 胡公英 | Chinese medicine composition orally taken for curing osteosporosis |
| CN102579562A (en) * | 2012-02-27 | 2012-07-18 | 苏州爱斯欧蒂生物科技有限公司 | Health care product for preventing osteoporosis |
Non-Patent Citations (1)
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114522196A (en) * | 2022-01-21 | 2022-05-24 | 广州中医药大学第三附属医院(广州中医药大学第三临床医学院、广州中医药大学附属骨伤科医院、广东省中医骨伤研究院) | Compound traditional Chinese medicine for preventing and treating osteoporosis and preparation method thereof |
| CN114522196B (en) * | 2022-01-21 | 2022-08-26 | 广州中医药大学第三附属医院(广州中医药大学第三临床医学院、广州中医药大学附属骨伤科医院、广东省中医骨伤研究院) | Compound traditional Chinese medicine for preventing and treating osteoporosis and preparation method thereof |
| CN116473236A (en) * | 2023-04-19 | 2023-07-25 | 安徽昊天生物科技有限公司 | Sports nutrition food for recovering after sports and preparation method thereof |
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