CN108685943A - A kind of tablet and preparation method thereof increasing bone density - Google Patents
A kind of tablet and preparation method thereof increasing bone density Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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- A61K31/12—Ketones
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- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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Abstract
The invention discloses a kind of tablets and preparation method thereof increasing bone density, the present invention is with aminoglucose hydrochloride, chondroitin sulfate, calcium carbonate, farnoquinone, vitamine D3 is primary raw material, with microcrystalline cellulose, magnesium stearate, coating powder is auxiliary material, prepare a kind of pharmaceutical composition increasing bone density, tablet prepared by the present invention is suppressed using intelligent production equipment by mixing, dissolubility is more preferable, meet GB10343-2008 standards, be conducive to human body quickly to absorb, absorptivity higher, it is effectively increased user of service's skeleton density, reduce middle-aged and the old's fracture probability, slow down bone aging speed.
Description
Technical field
The invention belongs to pharmaceutical preparation fields, relate generally to a kind of tablet and preparation method thereof increasing bone density.
Background technology
Bone density full name is bone mineral density, is an important indicator of bone strength, with a gram/cubic centimeter table
Show, is an absolute value.In Clinical practice bone density value due to the absolute value of different bone mineral density detectors difference, usually make
Judge whether bone density is normal with T values, T values are a relative values, and normal reference value is between -1 and+1.When T values less than-
It is abnormal when 2.5.Bone density is an important symbol of bone mass, reflects osteoporosis degree, predicts fracture risk
Important evidence.The drug of the increase bone density of prior art production is mainly phosphoric acid salt, and it is close that phosphoric acid salt treats osteoporosis
Year over be developed, phosphate can promoting bone growing, inhibit the destruction of osteocyte, can be with prolonged application.And n-3 how unsaturateds
Aliphatic acid, n-3 aliphatic acid influence the bone metabolism of the mankind, are risen and are adjusted to osteoblast and osteoclast by different mechanism of action
Effect strengthens n-3 aliphatic acid and is conducive to improve bone density.Existing medicament is weaker for the increase effect of bone density, needs to grow
Phase takes medicine, and clinical therapeutic efficacy is poor, and production cost is higher.
Invention content
The present invention is to solve to treat that the bone density lower pharmaceutical treatment period is longer, and effect is poor asks in the prior art
Topic provides a kind of tablet and preparation method thereof increasing bone density.
To solve the above problems, technical scheme is as follows:
A kind of tablet increasing bone density, includes the bulk pharmaceutical chemicals of following weight,
Aminoglucose hydrochloride:25-30 parts;
Chondroitin sulfate:15-20 parts;
Calcium carbonate:20-30 parts;
Farnoquinone:0.3-0.9 parts;
Vitamine D3:0.03-0.09 parts;
Microcrystalline cellulose:25-30 parts;
Magnesium stearate:0.7-1.2 parts;
Coating powder:1-4 parts.
Preferably, a kind of tablet increasing bone density, includes the bulk pharmaceutical chemicals of following weight,
Aminoglucose hydrochloride:26.67 parts;
Chondroitin sulfate:16 parts;
Calcium carbonate:25 parts;
Farnoquinone:0.67 part;
Vitamine D3:0.07 part;
Microcrystalline cellulose:27.96 parts;
Magnesium stearate:0.97 part;
Coating powder:2.67 part.
The preparation method for increasing the tablet of bone density, includes the following steps,
Step 1 weighs:Each supplementary material is weighed by formula ratio, it is spare;
Step 2, mixing:The vitamine D3 of formula ratio, farnoquinone equal increments are mixed, mixed powder 1 is obtained;It will mixing
Powder 1 is uniformly mixed with the chondroitin sulfate of 50% formula ratio by equal increments method, obtains mixed powder 2, by mixed powder 2 and residual sulfuric acid
Chondroitin, calcium carbonate, aminoglucose hydrochloride, magnesium stearate, which are set, mixes 30min in mixing machine, be uniformly mixed, obtain and always mix
Powder;
Step 3, granulation, dry, whole grain:Mixed powder is transferred to trough type mixing machine, 70% ethyl alcohol softwood is added, with 20
Mesh sieve granulation, obtains wet granular, wet granular is dried, 20 mesh sieves of gained dry particl, dry particl answers uniform drying, nothing
Other impurity foreign matters;
Step 4, it is total mixed:Dry particl is added to the magnesium stearate of formula ratio, is uniformly mixed, incorporation time is 10 minutes;
Step 5, tabletting:By hybrid particles tabletting machine, trimmer weight is 0.73g/ pieces;
Step 6, coating:The coating powder (stomach dissolved film coating pre-mix dose) for taking formula ratio, is configured to 50% ethyl alcohol
10% coating solution preheats coating pan, controls 70 DEG C or so of inlet air temperature, and 45 DEG C or so of leaving air temp sieves qualified label
Fine powder is removed, is placed in coating pan, adjustment makes even spraying in the piece wicking surface of rotation, observes Gain weight at any time, until piece increases weight
About 3% stops, cooling after continuing drying with hot wind, takes out.
Preferably, tablets separated made from step 6 is packed into bottle, 60 pieces/bottle case by labeling, product inspection, detection
After qualification, storage preserves.
Preferably, the chondroitin sulfate described in step 1 and calcium carbonate material rate are 16/25.
Preferably, the wet granular drying temperature described in step 3 is within 50 DEG C, and moisture controls within 5%.
Preferably, the hot wind described in step 6, which continues drying process, to be completed in 10-15 minutes.
Compared with the existing technology, advantages of the present invention is as follows,
The present invention is main former with aminoglucose hydrochloride, chondroitin sulfate, calcium carbonate, farnoquinone, vitamine D3
Material prepares a kind of pharmaceutical composition increasing bone density, aminoglucose using microcrystalline cellulose, magnesium stearate, coating powder as auxiliary material
Sugared hydrochloride is a kind of white crystals, and odorlessness, slightly sweet taste are soluble easily in water, are slightly soluble in methanol, organic molten insoluble in ethyl alcohol etc.
Agent, it has important physiological function to human body, participates in the removing toxic substances of liver kidney, anti-inflammatory liver protecting and kidney invigorating effect is played, to treating rheumatic
It is by natural chitin extraction that arthritis, which has good curative effect, aminoglucose hydrochloride, is a kind of marine organisms system
Agent can promote the synthesis of human body mucopolysaccharide, improve the viscosity of knuckle synovia, can improve the metabolism of articular cartilage, Glucosamine
Hydrochloride is that medical field is considered as the substance that can treat bone and joint diseases at all only so far, and Glucosamine should be with sulphur
Aching and limp ossein is used cooperatively, and the effect of having analgesic, promote regenerating bone or cartilage, can improve joint prob from basic;
The present invention is only with based on aminoglucose hydrochloride, chondroitin sulfate, calcium carbonate, farnoquinone, vitamine D3
Raw material is wanted, using microcrystalline cellulose, magnesium stearate, coating powder as auxiliary material, uses trough type mixing machine to carry out drug in process of production
Raw material mixes, and drug ingedient mixes more uniform, drug effect higher;
The method that the present invention prepares the pharmaceutical composition for increasing bone density, using the farnoquinone of set amount, farnoquinone
Osteoporosis can be effectively treated and prevented, farnoquinone can be used for generating bone protein, then generate sclerotin jointly with calcium, increase
Add bone density, prevent from fracturing, in user of service's therapeutic process, there is higher absorbability, bone density enhancing effect is more
Obviously.
Specific implementation mode
With reference to specific embodiment, the present invention is further illustrated, but the invention is not limited in these to implement
Example.
Embodiment 1:
A kind of preparation method for the tablet increasing bone density, includes the following steps:
Composition of raw materials:Aminoglucose hydrochloride:26.67 parts;Chondroitin sulfate:16 parts;Calcium carbonate:25 parts;Vitamin
K2:0.67 part;Vitamine D3:0.07 part;Microcrystalline cellulose:27.96 parts;Magnesium stearate:0.97 part;Coating powder:2.67 part.
Step 1 weighs:Each supplementary material is weighed by formula ratio, it is spare;
Step 2, mixing:The vitamine D3 of formula ratio, farnoquinone equal increments are mixed, mixed powder 1 is obtained;It will mixing
Powder 1 is uniformly mixed with the chondroitin sulfate of 50% formula ratio by equal increments method, obtains mixed powder 2, by mixed powder 2 and residual sulfuric acid
Chondroitin, calcium carbonate, aminoglucose hydrochloride, magnesium stearate, which are set, mixes 30min in mixing machine, be uniformly mixed, obtain and always mix
Powder;
Step 3, granulation, dry, whole grain:Mixed powder is transferred to trough type mixing machine, 70% ethyl alcohol softwood is added, with 20
Mesh sieve granulation, obtains wet granular, wet granular is dried, 20 mesh sieves of gained dry particl, dry particl answers uniform drying, nothing
Other impurity foreign matters;
Step 4, it is total mixed:Dry particl is added to the magnesium stearate of formula ratio, is uniformly mixed, incorporation time is 10 minutes;
Step 5, tabletting:By hybrid particles tabletting machine, trimmer weight is 0.73g/ pieces;
Step 6, coating:The coating powder (stomach dissolved film coating pre-mix dose) for taking formula ratio, is configured to 50% ethyl alcohol
10% coating solution preheats coating pan, controls 70 DEG C or so of inlet air temperature, and 45 DEG C or so of leaving air temp sieves qualified label
Fine powder is removed, is placed in coating pan, adjustment makes even spraying in the piece wicking surface of rotation, observes Gain weight at any time, until piece increases weight
About 3% stops, cooling after continuing drying with hot wind, takes out.
Embodiment 2:
In increasing the composition of raw materials of tablet of bone density, aminoglucose hydrochloride, chondroitin sulfate, calcium carbonate, dimension
Raw element K2, vitamine D3, microcrystalline cellulose, magnesium stearate, the presence of each ingredient of coating powder and composition range are that increase bone is close
It spends drug and realizes the indispensable condition of drug effect.It keeps 1 other conditions of embodiment constant, composition of raw materials is replaced with into following each group
Formula is prepared respectively increases bone density drug.
A group composition of raw materials:Aminoglucose hydrochloride:25 parts;Chondroitin sulfate:15 parts;Calcium carbonate:20 parts;Vitamin
K2:0.3 part;Vitamine D3:0.03 part;Microcrystalline cellulose:25 parts;Magnesium stearate:0.7 part;Coating powder:1 part;
B group composition of raw materials:Aminoglucose hydrochloride:25 parts;Chondroitin sulfate:20 parts;Calcium carbonate:20 parts;Vitamin
K2:0.3 part;Vitamine D3:0.03 part;Microcrystalline cellulose:25 parts;Magnesium stearate:0.7 part;Coating powder:1 part;
C group composition of raw materials:Aminoglucose hydrochloride:30 parts;Chondroitin sulfate:20 parts;Calcium carbonate:30 parts;Vitamin
K2:0.9 part;Vitamine D3:0.09 part;Microcrystalline cellulose:30 parts;Magnesium stearate:1.2 part;Coating powder:4 parts;
D group composition of raw materials:Aminoglucose hydrochloride:30 parts;Chondroitin sulfate:20 parts;Calcium carbonate:28 parts;Vitamin
K2:0.3 part;Vitamine D3:0.03 part;Microcrystalline cellulose:25 parts;Magnesium stearate:0.7 part;Coating powder:1 part;
E group composition of raw materials:Aminoglucose hydrochloride:30 parts;Chondroitin sulfate:20 parts;Calcium carbonate:28 parts;Vitamin
K2:0.3 part;Vitamine D3:0.03 part;
F group composition of raw materials:Aminoglucose hydrochloride:30 parts;Chondroitin sulfate:20 parts;Calcium carbonate:28 parts.
Embodiment 3:
In increasing the preparation method of tablet of bone density, mixed powder is transferred to trough type mixing machine by step 3, is added 70%
The step of ethyl alcohol softwood is sieved with 20 mesh and pelletized, obtains wet granular is particularly critical, is to ensure that the tablet drug effect for increasing bone density is made
One of steps necessary.Ensure that 1 other conditions of embodiment are constant, the processing mode for only changing the step three is:Mixed powder is turned
70% ethyl alcohol softwood is added in slot-in type mixing machine, is sieved and is pelletized with 20 mesh, obtained wet granular, wet granular is dried, and gained is dry
Particle answers uniform drying with 20 mesh sieves, dry particl, without other impurity foreign matters.
Embodiment 4:
In increasing the preparation method of tablet of bone density, step 6 controls 70 DEG C or so of inlet air temperature, leaving air temp 45
DEG C or so it is particularly important, keep 1 other conditions of embodiment it is constant, the processing mode for only changing the step six is:Take formula ratio
Coating powder (stomach dissolved film coating pre-mix dose) is configured to 10% coating solution with 50% ethyl alcohol, preheats coating pan, control air inlet
Qualified label is weeded out fine powder, is placed in coating pan by 100 DEG C or so of temperature, 45 DEG C or so of leaving air temp, and adjustment makes uniformly to spray
Mist observes Gain weight at any time in the piece wicking surface of rotation, until piece weightening about 3% stops, it is cooling after continuing drying with hot wind,
It takes out.
Embodiment 5:
It is also that successfully to prepare bone close the step of incorporation time in step 4 in increasing the preparation method of tablet of bone density
One of committed step of tablet of degree.
A groups:Keep 1 other conditions of embodiment constant, the processing mode for only changing the step four is:Dry particl addition is matched
The magnesium stearate just measured is uniformly mixed, and incorporation time is 20 minutes.
B groups:Keep 1 other conditions of embodiment constant, the processing mode for only changing the step four is:Dry particl addition is matched
The magnesium stearate just measured is uniformly mixed, and incorporation time is 30 minutes.
C groups:Keep 1 other conditions of embodiment constant, the processing mode for only changing the step four is:Dry particl addition is matched
The magnesium stearate just measured is uniformly mixed, and incorporation time is 5 minutes.
By medicament made from embodiment 1-5 for increasing bone density experiment
Using the small white mouse cultivated under the equal conditions of laboratory as experiment sample, 12 identical genders, quality phase are chosen
Difference is not more than 2% small white mouse, test experience specimen spinal position bone density initial value T1.
The increase bone density medicament in feeding embodiment 1-5 is distinguished under same culture conditions, experiment sample passes through seven days
Culture, experimenter detect small white mouse backbone position bone density numerical value T2, are obtained by following calculation again:
(T2-T1)/T1*100% obtains bone density changing value
Embodiment 1-5 experiment sample bone densities change table
According to the above results it is found that being compared by embodiment 1-5 bone density changing values, composition prepared by the present invention is added
Solution bone density value added highest, and experiment sample promotion effect is weaker in embodiment 2 and embodiment 5, is tested in embodiment 4
Sample bone density declines 30%, and bone density value substantially reduces, and the above results show that A groups and embodiment 3 are for reality in embodiment 2
It tests sample bone density value not promoted, bone density castering action highest of the embodiment 1 for experiment sample.
It should be noted that above-described embodiment is only presently preferred embodiments of the present invention, there is no for the purpose of limiting the invention
Protection domain, the equivalent replacement or replacement made on the basis of the above all belong to the scope of protection of the present invention.
Claims (7)
1. a kind of tablet increasing bone density, which is characterized in that include the bulk pharmaceutical chemicals of following weight,
Aminoglucose hydrochloride:25-30 parts;
Chondroitin sulfate:15-20 parts;
Calcium carbonate:20-30 parts;
Farnoquinone:0.3-0.9 parts;
Vitamine D3:0.03-0.09 parts;
Microcrystalline cellulose:25-30 parts;
Magnesium stearate:0.7-1.2 parts;
Coating powder:1-4 parts.
2. a kind of tablet increasing bone density as described in claim 1, which is characterized in that include the original of following weight
Expect medicine,
Aminoglucose hydrochloride:26.67 parts;
Chondroitin sulfate:16 parts;
Calcium carbonate:25 parts;
Farnoquinone:0.67 part;
Vitamine D3:0.07 part;
Microcrystalline cellulose:27.96 parts;
Magnesium stearate:0.97 part;
Coating powder:2.67 part.
3. such as a kind of preparation method of the tablet of increase bone density of claim 1-2 any one of them, which is characterized in that including
Following steps,
Step 1 weighs:Each supplementary material is weighed by formula ratio, it is spare;
Step 2, mixing:The vitamine D3 of formula ratio, farnoquinone equal increments are mixed, mixed powder 1 is obtained;By mixed powder 1 with
The chondroitin sulfate of 50% formula ratio is uniformly mixed by equal increments method, mixed powder 2 is obtained, by mixed powder 2 and residual sulfuric acid cartilage
Element, calcium carbonate, aminoglucose hydrochloride, magnesium stearate, which are set, mixes 30min in mixing machine, be uniformly mixed, obtain total mixed powder;
Step 3, granulation, dry, whole grain:Mixed powder is transferred to trough type mixing machine, 70% ethyl alcohol softwood is added, is sieved with 20 mesh
Granulation, obtains wet granular, wet granular is dried, gained dry particl answers uniform drying with 20 mesh sieves, dry particl, without other
Impurity foreign matter;
Step 4, it is total mixed:Dry particl is added to the magnesium stearate of formula ratio, is uniformly mixed, incorporation time is 10 minutes;
Step 5, tabletting:By hybrid particles tabletting machine, trimmer weight is 0.73g/ pieces;
Step 6, coating:The coating powder (stomach dissolved film coating pre-mix dose) for taking formula ratio, 10% is configured to 50% ethyl alcohol
Coating solution preheats coating pan, controls 70 DEG C or so of inlet air temperature, and qualified label is weeded out fine powder by 45 DEG C or so of leaving air temp,
It is placed in coating pan, adjustment makes even spraying in the piece wicking surface of rotation, observes Gain weight at any time, until piece weightening about 3% stops
Only, cooling after continuing drying with hot wind, it takes out.
4. a kind of preparation method of tablet increasing bone density as claimed in claim 3, which is characterized in that step 6 to be made
Tablets separated be packed into bottle, 60 pieces/bottle case by labeling, and after product inspection, detection are qualified, storage preserves.
5. a kind of preparation method of tablet increasing bone density as claimed in claim 3, which is characterized in that described in step 1
Chondroitin sulfate is 16/25 with calcium carbonate material rate.
6. a kind of preparation method of tablet increasing bone density as claimed in claim 3, which is characterized in that described in step 3
Wet granular drying temperature is within 50 DEG C, and moisture controls within 5%.
7. a kind of preparation method of tablet increasing bone density as claimed in claim 3, which is characterized in that described in step 6
Hot wind, which continues drying process, to be completed in 10-15 minutes.
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| CN114259042A (en) * | 2020-09-16 | 2022-04-01 | 山东荆卫生物科技有限公司 | Health food for increasing bone density and preventing and treating osteoarthritis and preparation method and application thereof |
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