CN107233563A - Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, preparation, using and preparation method thereof - Google Patents
Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, preparation, using and preparation method thereof Download PDFInfo
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- CN107233563A CN107233563A CN201710557511.7A CN201710557511A CN107233563A CN 107233563 A CN107233563 A CN 107233563A CN 201710557511 A CN201710557511 A CN 201710557511A CN 107233563 A CN107233563 A CN 107233563A
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Classifications
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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Abstract
The present invention disclose a kind of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, preparation, using and preparation method thereof, in parts by weight, the Tibetan medicinal composition raw material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, 10~20 parts of Rhizoma Drynariae extract, 5~15 parts of Shorthorned Epimedium P.E, 1~10 part of calcium agent, 1~10 part of D Glucosamine sulfate potassium chlorides, 1~10 part of chondroitin sulfate, 1~10 part of CPP, 1~10 part of vitamin D;The pre- preventing bone rarefaction remarkable result of Tibetan medicinal composition and its preparation, has no toxic side effect to human body.
Description
Technical field
The present invention relates to field of pharmacology, and in particular to a kind of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus,
Preparation, using and preparation method thereof.
Background technology
Osteoporosis be in, the elderly's common disease, frequently-occurring disease, have a strong impact on the Health and Living quality of such crowd,
Osteoporosis and its caused fracture occupy the 7th in current common disease, in seriously threaten, the health of the elderly,
Make the public health problem in the whole world.Osteoporosis is reduced with bone amount, including bone mineral and matrix equal proportion
Reduce, bone tissue microstructure is degenerated and is characterized, show as trabecular bone structure destruction, attenuate and be broken, and then cause the crisp of bone
Property increase, biomechanics of bone intensity decline, load endurance reduction, it is prone to capillary fracture or a kind of systemic bone of complete fracture
Bone disease.
It is many at present using replenishing the calcium, sex hormone, calcitonin, diphosphonate and fluoride etc. be used for clinical treatment, though have certain
Curative effect, but side effect is big.Simple replenishing the calcium is only capable of delaying but can not prevent the loss of bone amount.
The content of the invention
In view of this, this application provides a kind of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, preparation, application
And preparation method thereof;The pre- preventing bone rarefaction remarkable result of Tibetan medicinal composition and its preparation, has no toxic side effect to human body.
To solve above technical problem, the technical scheme that the present invention is provided is a kind of pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition, in parts by weight, the Tibetan medicinal composition raw material include:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone,
10~20 parts of Rhizoma Drynariae extract, 5~15 parts of Shorthorned Epimedium P.E, 1~10 part of calcium agent, D- Glucosamine sulfate potassium chlorides 1~
10 parts, 1~10 part of chondroitin sulfate, 1~10 part of CPP, 1~10 part of vitamin D.
It is preferred that, in parts by weight, the Tibetan medicinal composition raw material includes:25~40 parts of highland barley monascus, Yak Bone 15~
25 parts, 12~18 parts of Rhizoma Drynariae extract, 7~13 parts of Shorthorned Epimedium P.E, 2~8 parts of calcium agent, D- Glucosamine sulfate potassium chlorides
2~8 parts, 2~8 parts of chondroitin sulfate, 2~8 parts of CPP, 2~8 parts of vitamin D.
It is preferred that, in parts by weight, the Tibetan medicinal composition raw material includes:30 parts of highland barley monascus, 20 parts of Yak Bone, bone are broken
Mend 15 parts of extract, 10 parts of Shorthorned Epimedium P.E, 5 parts of calcium agent, 5 parts of D- Glucosamine sulfate potassium chlorides, 5 parts of chondroitin sulfate,
5 parts of CPP, 5 parts of vitamin D.
It is preferred that, the calcium agent is calcium carbonate, calcium citrate, calcium phosphate.
It is preferred that, the calcium agent calcium carbonate.
Present invention also offers a kind of Tibetan medicinal composition preparation of pre- preventing bone rarefaction containing highland barley monascus, the Tibetan medicine combination
Thing preparation is made up of above-mentioned Tibetan medicinal composition and pharmaceutically acceptable auxiliary material.
It is preferred that, the preparation formulation is solution, syrup, granule, capsule, powder, pill, tablet, lyophilized
Pulvis, patch, gel, film, vina or extract.
It is preferred that, it is calculated in mass percent, Tibetan medicinal composition content range described in the preparation is 50%~90%.
It is preferred that, it is calculated in mass percent, Tibetan medicinal composition content range described in the preparation is 70%.
Present invention also offers application of the above-mentioned Tibetan medicinal composition in the health food of pre- preventing bone rarefaction.
Present invention also offers a kind of preparation method of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, including with
Lower step:In parts by weight, the composition material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, the rhizome of davallia are carried
Take 10~20 parts of thing, 5~15 parts of Shorthorned Epimedium P.E, 1~10 part of calcium agent, 1~10 part of D- Glucosamine sulfate potassium chlorides, sulfuric acid
1~10 part of chondroitin, 1~10 part of CPP, 1~10 part of vitamin D;After the raw material is crushed, solvent extraction,
Filtrate is collected, concentration is produced.
It is preferred that, the solvent is water or ethanol.
It is preferred that, the solvent is water or ethanol.
It is preferred that, the ethanol is 50~75vol% ethanol.
It is preferred that, the solvent extraction temperature is 75~100 DEG C.
It is preferred that, the solvent extraction time is 1~3h.
It is preferred that, the raw material is 1 with the solvent volume ratio:(5~10).
It is preferred that, the concentration is specially to be concentrated into density for 0.4~0.6g/mL.
Part described in technical solution of the present invention is in gram.
Natural statin substance content is high in highland barley monascus, and statin substance can promote bone cell proliferation, can increase bone close
Degree, the microstructure for repairing bone.
Rhizoma Drynariae extract can promote the osteogenic of mesenchymal stem cells MSCs to break up, moreover it is possible to promote the increasing of Gegenbaur's cell
Grow ripe with calcification, also have certain inhibitory action to osteoclastic bone resorption, can play improves the work of osteoporosis symptoms
With.
Shorthorned Epimedium P.E has the synthesis for promoting bone marrow cell DNA, promotes energy of the MSCs to osteoblast differentiation
Power.
Bone collagen is rich in Yak Bone marrow, deposition of the inanimate matters such as calcium, phosphorus on bone can be promoted, thus can be played
Repair the effect of gelatine basic stitch.
D- aminoglucose sulfates are a kind of derivatives of native amino monose, are synthetic proteins glycan in cartilage matrix
Necessary important component.Proteoglycans can make articular cartilage that there is absorption to impact by suppressing the tensile force of collagenous fibres
The function of power.Meanwhile, D- aminoglucose sulfates play direct antiinflammatory action, can relief from osteoarthritis pain symptom, change
Kind function of joint.
Chondroitin sulfate is the glutinous polysaccharose substance for being extracted from animal cartilage, in angiocardiopathy, preventing and treating of arthropathy etc.
Aspect has important effect, and chondroitin sulfate can provide pad effect, relax the impact and friction during action;It is used as delivery pipe
Road, chondroitin sulfate is that the important oxygen of cartilage conveying is supplied and nutrient, while carbon dioxide and waste are excluded.Other sulphur
Aching and limp ossein may also suppress the ferment of destruction cartilage, in case cartilage is decomposed or dissolved.
CPP is using bovine casein as raw material, by many with bioactivity made from biotechnology
Peptide, can effectively facilitate absorption and utilization of the human body to the divalent mineral nutrient such as calcium, iron, zinc.
Vitamin D is sterol analog derivative, can control and adjust the absorption of calcium with smoothly, adjust again in Bone m etabolism
Medicine body liquid should be, and osteoclast and osteoblast differentiation and propagation are all adjusted by vitamin D.
Calcium is the main component of bone, and the intake of calcium influences the nutritional status of bone.Calcium agent includes inorganic calcium and organic
Sour calcium, it is also one of method for replenishing the calcium to take calcium agent.
One of critical function of chondroitin is exactly, as conveyance conduit, important oxygen to be supplied and nutrient is delivered to joint,
IA waste is removed in help.Chondroitin sulfate is used cooperatively with D- aminoglucose sulfates, with analgesic, promotes cartilage
Effect of regeneration, can improve joint prob from basic.Pad effect is provided, the impact and friction during action is relaxed, can be by water
Divide suction proteoglycan intramolecular, make cartilage thickening, and increase IA synovia amount.
Calcium can be divided into two kinds of mechanism of active transport and Passive intake in the absorption of small intestine.First, in duodenum and jejunum
Upper end (upper part of small intestine) absorbs calcium in saturable active transport mode, and this process need to be produced by vitamin D by its molecule
Thing --- calbindin (CaBP) is adjusted;Then it is main with undersaturated diffusion in ileum and distal small intestine (small intestine bottom)
Mode of movement Passive intake.With regard to small intestine generally speaking, the absorption area of bottom is much larger than top, and the uptake of small intestine bottom calcium is accounted for
The 75%~80% of gross absorption.Under normal physiological status, the region of small intestine middle and lower part Passive intake is influence calcium balance
Major part, it is only necessary to promote absorption of the distal small intestine to calcium.The calcium taken in food, in stomach and the acid condition of small intestine
Under, it can be in good dissolved state, but under the weakly alkaline environment of pH7 in the middle part of small intestine~8, calcium ion easily forms insoluble salt
Precipitation, hinders the diffusion transport of calcium, causes absorptivity to decline.CPP is due to the compatibility to divalent metal, energy
With calcium in this weakly alkaline environment formation soluble complexes of small intestine, the commutative combination of this moderate strength can effectively be prevented
Only the formation of calcium phosphate precipitation and increase the concentration of solubility calcium, and without prejudice to and intestinal mucosa are exchanged, so as to promote enteral calcium
Absorption.Simultaneously as CPP molecule carries the electric charge of high concentration, allow them to resist entering for enteral digestive ferment
One one-step hydrolysis, this property turns into the premise that it plays a role in enteron aisle.Therefore CPP, vitamin D are selected
The composition component provided with calcium agent as the present invention is administered simultaneously, it is possible to increase to the absorptivity of calcium, pre- preventing bone rarefaction.
Compared with prior art, its detailed description is as follows by the application:
Tibetan medicinal composition and its preparation of the pre- preventing bone rarefaction containing highland barley monascus that the present invention is provided, raw material include:
Highland barley monascus, Yak Bone, Rhizoma Drynariae extract, Shorthorned Epimedium P.E, calcium carbonate, D- Glucosamine sulfate potassium chlorides, sulfuric acid are soft
Ossein, CPP, vitamin D.Nine kinds of components play a part of pre- preventing bone rarefaction by multipath, highland barley monascus,
Rhizoma Drynariae extract, Shorthorned Epimedium P.E collective effect adjustable bone cell growth, propagation and differentiation, promote the increasing of Gegenbaur's cell
Grow, break up and calcification maturation, suppress osteoclastic bone resorption, bone density can be increased, the microstructure of bone is repaired, prevent sclerotin
It is loose;D- Glucosamine sulfate potassium chlorides and chondroitin sulfate improve joint prob for compounding, coordinate pre- preventing bone rarefaction;Carbonic acid
Calcium, CPP and vitamin D are the pre- preventing bone rarefactions in the form of replenishing the calcium and promote calcium uptake, and are matched somebody with somebody by component
Than pre- preventing bone rarefaction remarkable result.Meanwhile, human body is had no toxic side effect.
Embodiment
In order that those skilled in the art more fully understands technical scheme, with reference to specific embodiment pair
The present invention is described in further detail.
It is in parts by weight, described to hide the invention provides a kind of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus
Drug composition raw material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, 10~20 parts of Rhizoma Drynariae extract, barrenwort
5~15 parts of extract, 1~10 part of calcium agent, 1~10 part of D- Glucosamine sulfate potassium chlorides, 1~10 part of chondroitin sulfate, junket egg
White 1~10 part of phosphoeptide, 1~10 part of vitamin D.
According to the present invention, it is preferred that in parts by weight, the Tibetan medicinal composition raw material includes:25~40 parts of highland barley monascus,
15~25 parts of Yak Bone, 12~18 parts of Rhizoma Drynariae extract, 7~13 parts of Shorthorned Epimedium P.E, 2~8 parts of calcium agent, D- aminoglucoses
Sugared 2~8 parts of potassium sulfate salt, 2~8 parts of chondroitin sulfate, 2~8 parts of CPP, 2~8 parts of vitamin D.It is furthermore preferred that
In parts by weight, the Tibetan medicinal composition raw material includes:It is 30 parts of highland barley monascus, 20 parts of Yak Bone, 15 parts of Rhizoma Drynariae extract, excessive
10 parts of sheep leaves of pulse plants extract, 5 parts of calcium agent, 5 parts of D- Glucosamine sulfate potassium chlorides, 5 parts of chondroitin sulfate, 5 parts of CPP,
5 parts of vitamin D.It is preferred that, the calcium agent is calcium carbonate, calcium citrate, calcium phosphate.It is furthermore preferred that the calcium agent calcium carbonate.
Present invention also offers a kind of Tibetan medicinal composition preparation of pre- preventing bone rarefaction containing highland barley monascus, the Tibetan medicine combination
Thing preparation is made up of above-mentioned Tibetan medicinal composition and pharmaceutically acceptable auxiliary material.
According to the present invention, the preparation formulation be solution, syrup, granule, capsule, powder, pill, tablet,
Freeze dried powder, patch, gel, film, vina or extract.It is preferred that, it is calculated in mass percent, is hidden described in the preparation
Drug composition content range is 50%~90%.It is furthermore preferred that being calculated in mass percent, Tibetan medicinal composition described in the preparation
Content range is 70%.
Present invention also offers application of the above-mentioned Tibetan medicinal composition in the health food of pre- preventing bone rarefaction.
Present invention also offers a kind of preparation method of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, including with
Lower step:In parts by weight, the composition material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, the rhizome of davallia are carried
Take 10~20 parts of thing, 5~15 parts of Shorthorned Epimedium P.E, 1~10 part of calcium agent, 1~10 part of D- Glucosamine sulfate potassium chlorides, sulfuric acid
1~10 part of chondroitin, 1~10 part of CPP, 1~10 part of vitamin D;After the raw material is crushed, solvent extraction,
Filtrate is collected, concentration is produced.
According to the present invention, the solvent is water or ethanol.It is preferred that, the solvent is water or ethanol.It is furthermore preferred that described
Ethanol is 50~75vol% ethanol.It is preferred that, the solvent extraction temperature is 75~100 DEG C.It is preferred that, the solvent extraction
Time is 1~3h.The raw material is 1 with the solvent volume ratio:(5~10).It is 0.4 that the concentration, which is specially concentrated into density,
~0.6g/mL.
Part described in technical solution of the present invention is in gram.
Embodiment 1
The Tibetan medicinal composition of pre- preventing bone rarefaction containing highland barley monascus and preparation method thereof
Tibetan medicinal composition raw material includes:Highland barley monascus 30g, Yak Bone 20g, Rhizoma Drynariae extract 15g, Shorthorned Epimedium P.E
10g, calcium carbonate 5g, D- Glucosamine sulfate potassium chloride 5g, chondroitin sulfate 5g, CPP 5g, vitamin D 5g.
Preparation method:After above-mentioned raw materials are crushed, 90 DEG C, through solvent extraction 2.5h, are collected filtrate, take the filtrate to concentrate
It is 0.5g/mL to density, produces;The solvent is 75vol% ethanol;The raw material is 1 with the solvent volume ratio:8.
Embodiment 2
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 15g, Yak Bone 10g, Rhizoma Drynariae extract 10g, Shorthorned Epimedium P.E
5g, calcium carbonate 1g, D- Glucosamine sulfate potassium chloride 1g, chondroitin sulfate 1g, CPP 1g, vitamine D1 g.
Embodiment 3
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 25g, Yak Bone 15g, Rhizoma Drynariae extract 12g, Shorthorned Epimedium P.E
7g, calcium carbonate 2g, D- Glucosamine sulfate potassium chloride 2g, chondroitin sulfate 2g, CPP 2g, calciferol g.
Embodiment 4
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 40g, Yak Bone 25g, Rhizoma Drynariae extract 18g, Shorthorned Epimedium P.E
13g, calcium carbonate 8g, D- Glucosamine sulfate potassium chloride 8g, chondroitin sulfate 8g, CPP 8g, vitamin D 8g.
Embodiment 5
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 45g, Yak Bone 30g, Rhizoma Drynariae extract 20g, Shorthorned Epimedium P.E
15g, calcium carbonate 10g, D- Glucosamine sulfate potassium chloride 10g, chondroitin sulfate 10g, CPP 10g, vitamin
D10g。
Embodiment 6
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 30g, Yak Bone 20g, Rhizoma Drynariae extract 15g, Shorthorned Epimedium P.E
10g, calcium citrate 5g, D- Glucosamine sulfate potassium chloride 5g, chondroitin sulfate 5g, CPP 5g, vitamin D 5g.
Embodiment 7
The present embodiment and the difference of embodiment 1 are:
Tibetan medicinal composition raw material includes:Highland barley monascus 30g, Yak Bone 20g, Rhizoma Drynariae extract 15g, Shorthorned Epimedium P.E
10g, calcium phosphate 5g, D- Glucosamine sulfate potassium chloride 5g, chondroitin sulfate 5g, CPP 5g, vitamin D 5g.
Embodiment 8
The present embodiment and the difference of embodiment 1 are:
Preparation method:After raw material described in embodiment is crushed, through 75 DEG C of solvent extraction 1h, filtrate is collected, the filtrate is taken
Density is concentrated into for 0.6g/mL, is produced;The solvent is water;The raw material is 1 with the solvent volume ratio:5.
Embodiment 9
The present embodiment and the difference of embodiment 1 are:
Preparation method:After raw material described in embodiment is crushed, through 100 DEG C of solvent extraction 3h, filtrate is collected, the filtrate is taken
Density is concentrated into for 0.4g/mL, is produced;The solvent is 50vol% ethanol;The raw material is 1 with the solvent volume ratio:
10。
Embodiment 10
Tibetan medicinal composition solution of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition solution of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition solution
It is 50% to state Tibetan medicinal composition content.
Embodiment 11
Tibetan medicinal composition syrup of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition syrup of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition syrup
It is 52% to state Tibetan medicinal composition content.
Embodiment 12
Tibetan medicinal composition granule of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition granule of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition granule
It is 55% to state Tibetan medicinal composition content.
Embodiment 13
Tibetan medicinal composition capsule of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition capsule of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition capsule
It is 60% to state Tibetan medicinal composition content.
Embodiment 13
Tibetan medicinal composition powder of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition powder of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition powder
Drug composition content is 65%.
Embodiment 14
Tibetan medicinal composition pill of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition pill of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition pill
Drug composition content is 68%.
Embodiment 15
Tibetan medicinal composition tablet of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition tablet of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition tablet
Drug composition content is 70%.
Embodiment 15
Tibetan medicinal composition freeze dried powder of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition freeze dried powder of the osteoporosis containing highland barley monascus;It is calculated in mass percent, the Tibetan medicinal composition freeze dried powder
Described in Tibetan medicinal composition content be 72%.
Embodiment 16
Tibetan medicinal composition patch of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition patch of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition patch
Drug composition content is 75%.
Embodiment 17
Tibetan medicinal composition gel of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition gel of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition gel
It is 80% to state Tibetan medicinal composition content.
Embodiment 18
Tibetan medicinal composition film of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition film of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition film
Drug composition content is 82%.
Embodiment 19
Tibetan medicinal composition vina of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition vina of the osteoporosis containing highland barley monascus;It is calculated in mass percent, is hidden described in the Tibetan medicinal composition vina
Drug composition content is 85%.
Embodiment 20
Tibetan medicinal composition extract of the pre- preventing bone rarefaction containing highland barley monascus
Tibetan medicinal composition made from Example 1~9, adds customary adjuvant, mixes, conventionally, and prevention is made
Tibetan medicinal composition extract of the osteoporosis containing highland barley monascus;It is calculated in mass percent, institute in the Tibetan medicinal composition extract
It is 90% to state Tibetan medicinal composition content.
Embodiment 21
Physical and chemical index detection is carried out to Tibetan medicinal composition prepared by embodiment 1,1 is the results are shown in Table.
Table 1
Project | Index |
Lead (in terms of pb) mg/kg≤ | 1.5 |
Arsenic (in terms of As) mg/kg≤ | 1.0 |
Total mercury (in terms of Hg) mg/kg≤ | 0.3 |
Testing result shows, in Chinese medicine composition made from the preparation method provided by the present invention, reduces lead, total
The content of the heavy metals such as arsenic, total mercury, the content of lead is controlled within 1.5mg/kg, the content control of total arsenic 1.0mg/kg with
Interior, the content of total mercury is controlled within 0.3mg/kg, and human body is had no toxic side effect.
Embodiment 22
Acute toxicity maximum resistance test
It is maximum that according to embodiments of the present invention 10~20 Tibetan medicinal composition preparations prepared carry out acute toxicity in animal body
Resistance test, the day maximal tolerance dose that mouse is administered is 420 times of adult's consumption per day, does not observe the present invention under this dosage
The toxic reaction of the preparation prepared.
Embodiment 23
Mouse model experiment
Modelling and administration
Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus that embodiment 1~9 is prepared, add water mixing respectively,
Tibetan medicinal composition solution of the pre- preventing bone rarefaction containing highland barley monascus is made;It is calculated in mass percent, the Tibetan medicinal composition is molten
Tibetan medicinal composition content described in liquor is 50%;Numbering A-I respectively.
Rat is randomly divided into 10 groups, every group 10.In addition to blank control group, other 9 groups of rats by intraperitoneal injection 50mg/kgBW
Nembutal sodium solution is anaesthetized, and middle lower abdomen unhairing is carried out after partly sterilised with the tincture of iodine and alcohol, and it is left to be 1cm along stomach wall median line
Right cut mouthful implements castration operation to rat, extracts bilateral ovaries.
After female rats excisions ovary March, decrease in estrogen, bone conversion accelerates, and bone information is more than bon e formation, bone weight
Build it is unbalance cause bone amount to reduce, trabecular bone structure change, bone biomechanical property be deteriorated, bone fragility increase and easily fracture,
Form obvious osteoporosis status.
Daily oral gavage gives each experimental group Tibetan medicinal composition, and blank control group, model group give distilled water, experiment week
12 weeks phases.
The experiment recorded according to embodiment carries out femur weight, the detection of femur total calcium content, the results are shown in Table 2.
The rat femur weight of table 2 and calcium content of bone
Compared with blank group, model group unit femur calcium content is significantly reduced, illustrate potential model modeling success;With blank
Group compares, and the present invention provides pre- Tibetan medicinal composition of the preventing bone rarefaction containing highland barley monascus as the unit femur calcium content of experimental group
Significantly rise.
Embodiment 24
Long-term clinical trials
First, subjects
1st, with reference to " Chinese's osteoporosis suggestion diagnostic criteria (the second original text) ", it is necessary to possess overall pain, more with waist
Back pain is obvious, and microtrauma can cause fracture, or scheuermann kyphosis deformity, or bone density (BMD) to reduce more than 2 standard deviations
Person.
2nd, inclusive criteria:1) there are typical OP clinical symptoms, meet OP diagnostic criteria;2) age is between 45-70 Sui
Person;3) voluntarily as study subject, informed consent form, and energy reception test pharmaceutical dosage form are signed, it is ensured that complete course for the treatment of person.
3rd, exclusion standard:
1) Secondary cases such as hyperparathyroidism, malacosteon, rheumatoid arthritis, Huppert's disease sclerotin dredges
Loose disease and other serious complication persons;
2) substantially bow-backed deformity, disabled and disability person is presented;
3) serious cardiovascular and cerebrovascular diseases, liver, kidney, lung and hemopoietic system primary disease person are suffered from;4. within the course for the treatment of observation period,
Due to a variety of causes, such as go out, residence migration can not obtain follow-up person on request;5. to this drug allergy person or to a variety of
Drug allergy person;
4) mental disease or patients with Alzheimer disease;
5) fail during testing by regulation medication or the person of dropping by the wayside.
Patient 50 is chosen according to above-mentioned standard, wherein man 25, female 25, average age 50 years old.
2nd, treatment method
1st, medicament and dosage:
Medicament:Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus that Example 1 is prepared, addition is conventional auxiliary
Material, is mixed, conventionally, and Tibetan medicinal composition tablet of the pre- preventing bone rarefaction containing highland barley monascus is made;With mass percent
Tibetan medicinal composition content is 50% in meter, Tibetan medicinal composition tablet;
Dosage:Twice a day, each one.It was a course for the treatment of with 30 days, is carried out continuously two courses for the treatment of.
2nd, criterion of therapeutical effect:According to Zheng Xiao cornel new Chinese medicines guideline of clinical investigations (tentative) (s) Beijing:Chinese Medicine
Science Press, 2002;357-358. to formulate criterion of therapeutical effect.It is effective:Pain is wholly absent, and BMD, which is checked, shows bone density
Increase;Effectively:Pain is relieved, and BMD, which is checked, has no that bone density declines;It is invalid:Compared with before treatment, each side nothing changes
It is kind.
3rd, result of the test:50 patients all meet effective standard after treatment.
It the above is only the preferred embodiment of the present invention, it is noted that above-mentioned preferred embodiment is not construed as pair
The limitation of the present invention, protection scope of the present invention should be defined by claim limited range.For the art
For those of ordinary skill, without departing from the spirit and scope of the present invention, some improvements and modifications can also be made, these change
Enter and retouch and also should be regarded as protection scope of the present invention.
Claims (10)
1. a kind of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, it is characterised in that in parts by weight, the Tibetan medicine group
Compound raw material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, 10~20 parts of Rhizoma Drynariae extract, barrenwort are extracted
5~15 parts of thing, 1~10 part of calcium agent, 1~10 part of D- Glucosamine sulfate potassium chlorides, 1~10 part of chondroitin sulfate, casein phosphorus
Sour 1~10 part of peptide, 1~10 part of vitamin D.
2. Tibetan medicinal composition according to claim 1, it is characterised in that in parts by weight, the Tibetan medicinal composition raw material
Including:25~40 parts of highland barley monascus, 15~25 parts of Yak Bone, 12~18 parts of Rhizoma Drynariae extract, Shorthorned Epimedium P.E 7~13
Part, 2~8 parts of calcium agent, 2~8 parts of D- Glucosamine sulfate potassium chlorides, 2~8 parts of chondroitin sulfate, 2~8 parts of CPP,
2~8 parts of vitamin D.
3. Tibetan medicinal composition according to claim 1, it is characterised in that in parts by weight, the Tibetan medicinal composition raw material
Including:30 parts of highland barley monascus, 20 parts of Yak Bone, 15 parts of Rhizoma Drynariae extract, 10 parts of Shorthorned Epimedium P.E, 5 parts of calcium agent, D- amino
5 parts of glucosamine sulphate sylvite, 5 parts of chondroitin sulfate, 5 parts of CPP, 5 parts of vitamin D.
4. Tibetan medicinal composition according to claim 1, it is characterised in that the calcium agent is calcium carbonate, calcium citrate, phosphoric acid
Calcium.
5. a kind of Tibetan medicinal composition preparation of pre- preventing bone rarefaction containing highland barley monascus, it is characterised in that the Tibetan medicinal composition system
Agent is made up of any one of Claims 1 to 4 Tibetan medicinal composition and pharmaceutically acceptable auxiliary material.
6. Tibetan medicinal composition preparation according to claim 5, it is characterised in that the preparation formulation is solution, syrup
Agent, granule, capsule, powder, pill, tablet, liquid drugs injection, freeze dried powder, patch, gel, film, pill, vina
Or extract.
7. according to the Tibetan medicinal composition preparation described in claim 5, it is characterised in that be calculated in mass percent, institute in the preparation
It is 50%~90% to state Tibetan medicinal composition content range.
8. application of the Tibetan medicinal composition in the health food of pre- preventing bone rarefaction according to any one of Claims 1 to 4.
9. a kind of preparation method of Tibetan medicinal composition of the pre- preventing bone rarefaction containing highland barley monascus, it is characterised in that including following step
Suddenly:In parts by weight, the composition material includes:15~45 parts of highland barley monascus, 10~30 parts of Yak Bone, Rhizoma Drynariae extract
10~20 parts, 5~15 parts of Shorthorned Epimedium P.E, 1~10 part of calcium agent, 1~10 part of D- Glucosamine sulfate potassium chlorides, chondroitin sulfate
1~10 part of element, 1~10 part of CPP, 1~10 part of vitamin D;After the raw material is crushed, solvent extraction is collected
Filtrate, concentration, produces.
10. preparation method according to claim 9, it is characterised in that the solvent is water or ethanol.
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