CN106727677A - A kind of preparation method of composite calcium carbonate/vitamine D3 piece - Google Patents
A kind of preparation method of composite calcium carbonate/vitamine D3 piece Download PDFInfo
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- CN106727677A CN106727677A CN201611204794.9A CN201611204794A CN106727677A CN 106727677 A CN106727677 A CN 106727677A CN 201611204794 A CN201611204794 A CN 201611204794A CN 106727677 A CN106727677 A CN 106727677A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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Abstract
The invention provides a kind of preparation method of composite calcium carbonate/vitamine D3 piece, the processing technology step of sweet orange powdered flavor addition when changing wet granulation, so as to reduce the fine powder amount in total mixed rear particle, change the mouthfeel of product, composite calcium carbonate/vitamine D3 piece obtained by the present invention has to be easy to prepare, user is easy to receive, and be easy to carry, storage, transport features, preparation technology is feasible, it is suitable for large-scale production, prepared composite calcium carbonate/vitamine D3 piece complete appearance is bright and clean, uniform color, and the piece has more preferable uniformity energy and dissolution rate higher, compare with existing production technology simultaneously, under equal yield, every service life of the drift of tablet press machine extends 6 months, reduce the production cost of enterprise.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of preparation side of composite calcium carbonate/vitamine D3 piece
Method.
Background technology
Calcium is content highest inorganic elements in human body, about 2% (1200~1400g or so) of percentage of liveweight, by first shape
Under the regulation of glandular hormone, calcitonin and vitamin D, body deposits calcium amount relative constancy, and 99% calcium is present in bone, tooth,
Bone is the support for constituting human body, is the basic repository of calcium in human body；Other 1% calcium is present in soft tissue, extracellular fluid
In blood, miscible calcium pool is referred to as, dynamic equilibrium is kept with bone calcium, to maintain the normal condition of all cells required.Calcium
Nerve, muscle stress, maintenances of nerve impulse conduction, cardiac rhythm, blood clotting, in the physiology course such as cell adhesion, performance
Extremely important physiological regulatory action.Therefore human body needs enough calcium, could maintain the balance and body bone of blood calcium
Growth, calcium deficiency then can produce various harm to health., because of stomach hypofunction, the Exposure to Sunlight that activity is reduced is or not the elderly
Foot causes the factors such as the vitamin d insufficiency of skin itself synthesis so that calcium intake is not enough.Primary osteoporosis is betided absolutely
Women after menstrual period, trace sth. to its source be female sex hormone synthesis reduce cause calcium absorbability decline and it is ill.Children, green grass or young crops are few
Year is in the fast phase for growing.This stage calcium deficiency is easily caused the generation of rickets, Organism immunoregulation function reduction, leads
Reason calcium deficiency and cause other related diseases.The stage of pregnant woman's pregnancy, because the insufficiency of intake of calcium agent can cause pregnant blood high
Pressure syndrome, serious infringement is brought to the physical and mental health of pregnant woman, and heavy burden is brought to society and family.Women breast-feeding their children bear
The heavy burden of nurture sons and daughters, it is the demand for being difficult to maintain body calcium that calcium amount of body requirement only leans on the supplement of meals during this.Certain
A little disease such as diseases such as hypoparathyroidism, osteoporosis, bone tumour, diabetes, give calcium preparation and aid in right amount
Treatment, the physical rehabilitation to patient is also of great advantage.
As the vitamine D3 of calcium agent conditioning agent, the absorptivity and availability of calcium can be improved.Mankind's calcium deficiency is suitable one
Divide and caused by lacking vitamin D.Human body skin under sunlight or ultraviolet light, through photochemical reaction composite part vitamin
D.But because the universal illumination of people is not enough.So as to cause vitamin D in whether teenager, young woman, or the elderly's body
All wretched insufficiency, can not meet the normal physiological function of people.
Under the conditions of the meals of current China resident, depend merely on food and be often difficult to meet human body to calcium and the need of vitamin D
Want, therefore people are necessary to take some calcium preparations and Vitamin D preparation.
(the authorized announcement date of Chinese invention patent 201210417847.0 that applicant applies in applying date 2012.10.26
2013.09.18), the B of Authorization Notice No. CN 102908359 disclose a kind of system of children with composite calcium carbonate/vitamine D3 piece
The patent of invention of Preparation Method, the composite calcium carbonate that the patent is obtained/vitamine D3 piece is suitable for children, the elderly and uses, right
For the composite calcium carbonate required for adult/vitamine D3 piece, then disclosed formulation content and the process of production
The direct products vitamin d3 levels uniformity of acquisition and the dissolution rate of calcium are poor, involved children with composite calcium carbonate/
Vitamine D3 piece is adapted to the people of children, old man and dysphagia, is particularly well-suited to children.The preparation method has main steps that,
By Paris white and vitamine D3 mixing, pelletize, dry, sieving, always mixing, packing, but the sweet orange added in calcium carbonate D3 particles
Powdered flavor Main Function is to increase mouthfeel as flavouring.In the current technology of medicine, recipe quantity is added during wet granulation
50% sweet orange powdered flavor is together pelletized with other supplementary materials, is left 50% amount and is added when total mixed, because added when total mixed
Essence amount is more, cause it is total mixed after fine powder is more in particle, products taste is poor, and due in total mixed rear particle fine powder it is more, from
And often occur tablet when causing compressing tablet and take off lid or sliver phenomenon, so need to increase tablet press machine pressure, and tablet press machine is long-term
In high-pressure state, there is certain damage to tablet press machine, shorten the service life of tablet press machine and drift.
The content of the invention
According to above-mentioned elaboration, it is an object of the invention to provide a kind of preparation method of composite calcium carbonate/vitamine D3 piece,
There is provided the dissolution rate of the vitamin d3 levels uniformity and calcium calcium preparation high and in good taste, to meet people when replenishing the calcium simultaneously
The demand of vitamin D 3.
The technical scheme that the present invention is provided：A kind of composite calcium carbonate/vitamine D3 piece, is by the raw material system of following weight portion
Into：
1000~1600 parts of calcium carbonate, 0.0015~0.001 part of vitamine D3,500~600 parts of mannitol, PVP
10~20 parts of K30,1~15 part of aspartame, 100~240 parts of sweet orange powdered flavor, 10~20 parts of magnesium stearate, purified water
200~250 parts, appropriate amount of ethanol.
Specifically, being made from the following raw materials in parts by weight：Calcium carbonate 12.5kg, vitamine D3 55mg, mannitol
4.312kg, PVP K30 0.1159kg, aspartame 18g, sweet orange powdered flavor 1.08kg, magnesium stearate 90g, purified water
1.8152kg, ethanol 0.1509kg.
Specifically, being made from the following raw materials in parts by weight：Calcium carbonate 1450.0kg, vitamine D3 0.00638kg, sweet dew
Alcohol 500.19kg, PVP K30 13.44kg, aspartame 2.088kg, sweet orange powdered flavor 125.28kg, magnesium stearate
10.44kg, purified water 210.56kg, ethanol 17.5kg.
The preparation method of composite calcium carbonate/vitamine D3 piece is：In accordance with the following steps,
Step one, weighs calcium carbonate, mannitol, Icing Sugar, part polyethylene pyrrolidones, the 90% of recipe quantity of recipe quantity
Essence, be allowed to well mixed；
Step 2, is dissolved in the polyvinylpyrrolidone of remainder 30% appropriate ethanol and obtains the first solution；
Step 3, weighs the PVP K30 aqueous solution of PVP K30 and appropriate the purified water configuration 6% of recipe quantity；
Step 4, the vitamine D3 for taking recipe quantity adds appropriate 95% absolute ethyl alcohol dissolving is obtained the second solution,
The second solution is added in the fine powder of step one, is mixed, added the PVP K30 aqueous solution, the first solution and be made appropriate humidity
Softwood；
Step 5, softwood is pressed through the screen cloth of 14 mesh, is made particle；
Step 6, after wet granular is made, in 70 DEG C of dryings, takes out after drying, and carries out whole grain；
Step 7, the magnesium stearate of addition recipe quantity and the 10% of recipe quantity sweet orange powdered flavor are always mixed, total mixed
Compressing tablet afterwards；
Step 8, screening, product inspection, packaging.
According to foregoing preparation method, wherein：Part polyethylene pyrrolidones is about polyethylene and coughs up alkane in the step one
The 2/3 of ketone total amount.
According to foregoing preparation method, wherein：The polyvinylpyrrolidone of remainder is about poly- second in the step 2
The 1/3 of alkene pyrrolidone total amount.
Composite calcium carbonate/vitamine D3 piece obtained by the present invention has to be easy to prepare, and user is easy to receive, and is easy to
Carry, storage, transport features, preparation technology is feasible, be suitable for large-scale production, prepared composite calcium carbonate/vitamine D3
Piece complete appearance is bright and clean, uniform color, and the piece have the more preferable uniformity can and dissolution rate higher, while with existing life
Production. art compares, and under equal yield, every service life of the drift of tablet press machine extends 6 months, reduces the life of enterprise
Produce cost.
Specific embodiment
Technical scheme is clearly and completely described below, it is clear that described embodiment is only this
A part of embodiment is invented, rather than whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art exist
The every other embodiment obtained under the premise of creative work is not made, the scope of protection of the invention is belonged to.
The present invention discloses following examples, and the composition of composite calcium carbonate provided by the present invention/vitamine D3 piece is as follows：
| Supplementary material title | 10000 tablet recipe consumptions | 1160000 tablet recipe consumptions |
| Calcium carbonate | 12.5kg | 1450.0kg |
| Vitamine D3 | 55mg | 0.00638kg |
| Mannitol | 4.312kg | 500.19kg |
| Aspartame | 18g | 2.088kg |
| Sweet orange powdered flavor | 1.08kg | 125.28kg |
| Magnesium stearate | 90g | 10.44kg |
| PVP K30 | 0.1159kg | 13.44kg |
| Purified water | 1.8152kg | 210.56kg |
| Ethanol | 0.1509kg | 17.5kg |
Specific preparation flow is as follows：
1. oxide spinel calcium, mannitol, Icing Sugar, polyvinylpyrrolidone A, 90% essence of recipe quantity is taken to crush respectively
It is standby 80~120 mesh sieves to be crossed into fine powder；
2. the above-mentioned oxide spinel calcium for crushing, mannitol, Icing Sugar, part polyethylene pyrrolidones, essence is taken fully to mix
Close uniform；
3. it is dissolved in 30% appropriate ethanol with the polyvinylpyrrolidone of remainder and obtains the first solution；
4. the PVP K30 aqueous solution of PVP K30 and appropriate the purified water configuration 6% of recipe quantity is weighed；
5. the vitamine D3 for taking recipe quantity adds the appropriate absolute ethyl alcohol dissolving is obtained the second solution；
6. the second solution is added in the fine powder that step 2 is obtained, is mixed, add the PVP K30 aqueous solution, the first solution
It is made the softwood of appropriate humidity；
7. pelletized after 70 DEG C of dried process with 14~20 eye mesh screens；
8. with 12~18 eye mesh screen whole grains；
9. add the magnesium stearate of recipe quantity and 10% sweet orange powdered flavor of recipe quantity always to be mixed, it is total it is mixed after press
Piece；
10. qualified through checking, bag is packaged into, obtain final product.
After changing technique, it mainly has influence, 2016 5 to the mixture homogeneity and plain piece quality of total mixed rear particle
Month, it is embodiment with 1,160,000 consumptions, 3 batches of experiments have been carried out according to the technique after change while having carried out process certification, in work
During skill checking, mainly the quality to plain piece after the mixture homogeneity and compressing tablet of total mixed rear particle has carried out checking investigation.
First, total mixed rear particle mixture homogeneity checking
Verification method：Add additional auxiliary material according to technological requirement, setting speed is 4 revs/min, mix 50 minutes, every batch
Detection calcium content, vitamin d3 levels and moisture always are sampled in mixed tank, the RSD of each sample point detected value is calculated.
Sampling method：It is to be mixed finish after sample at 2 points from total mixed tank upper, middle and lower three level sampling, upper strata, middle level samples at 1 point,
Lower floor samples at 2 points.
Acceptable standard：Calcium content is 0.264g/g~0.286g/g, RSD≤2.0%；Vitamin d3 levels 2.56ug/g
~3.33ug/g, RSD≤5.0%；Moisture≤2.0%, RSD≤5.0%.
The result：It is total checking three batches of calcium carbonate D3 pieces of production to be checked according to default method and standard in proof scheme
Journey is sneaked out, is as a result shown：Process certification three batches adds material according to technological requirement, mixes 50 minutes, 4 revs/min of rotating speed.Mixing
According to process certification scheme sampling detection calcium content, vitamin d3 levels and moisture after end.Inspection result shows that calcium content is equal
Between 0.264g/g~0.286g/g, RSD≤2.0%；Vitamin d3 levels between 2.56ug/g~3.33ug/g, and
Content RSD≤5.0%；Measure moisture≤2.0%, RSD≤5.0%.Testing result such as table 1 below：
Particle calcium content, vitamin d3 levels, moisture mixture homogeneity after the process certification of table 1 is always mixed
After total mixed to it is total it is mixed after particle according to《Calcium carbonate D3 pieces intermediate products, product to be packaged test stone operational procedure》
Test, its quality meets《Calcium carbonate D3 pieces intermediate products, product to be packaged quality standard》.
2nd, compressing tablet and plain piece quality verification
Verification method：Compressing tablet, sampling detection are carried out by regulation parameter.
Sampling method：It is random every 15 minutes to take 10 survey gross weights of plain piece；Plain piece was taken at random every 1 hour every tablet press machine
20 detection proterties, outward appearance, friability, weight differentials；Every 1 hour inspection tablet press machine principal pressure.
Acceptable standard：
A. proterties：This product is white or off-white color piece.
B. outward appearance：Should complete bright and clean, uniform color.
C. friability：This product 10 is taken, is shone《Tablet friability inspection technique standard practice instructions》(SOP-QC-0032) examine
Look into, less loss weight must not cross 0.9%, and must not detect fracture, cracking and the piece crushed.
D. weight differential：Test sample 20 is taken, is pressed《Tablet weight variation inspection technique standard practice instructions》(SOP-QC-
0001) check, limit test of weight variation is ± the 4.0% of average piece weight, must not be more than 2 beyond limit test of weight variation, not
There must be 1 the 1 of overrun times.
E. material balance：98.5~100.0%, yield >=98.0%.
F. without obvious dust from flying in operating process, produced without fragment in plain piece circular flow.
The result：Checking three batches of calcium carbonate D3 piece pressures of production are checked according to default method and standard in proof scheme
Piece process, as a result shows：The parameter that tablet press machine is specified by technological procedure carries out compressing tablet, pinch roller principal pressure in left and right in tableting processes
It is all higher than 60KN；Random every 60 minutes to take 20 survey monolithic weights of plain piece, inspection record shows plain piece proterties, outward appearance, weight difference
Different, friability meets the requirements, and, 98.5~100.0%, yield is >=98.0% for material balance rate；Without bright in operating process
Aobvious dust from flying, tablet forming technique is feasible.
3rd, quality of the pharmaceutical preparations comparative study
Sample ID：Calcium carbonate D3 pieces
Production unit：Beijing Kangyuan Pharmaceutical Co., Ltd.
3.1 investigate project
This is removed to content specified in standard (calcium content, vitamin d3 levels), proterties, discriminating, uniformity of dosage units, crisp
Broken degree, microbial limit investigate outer, increased drug dissolution investigation, and emphasis proves that drug production process change does not cause medicine
Product dissolved corrosion changes.
3.2 assays
According to State Food and Drug Administration's standard YBH05962009 calcium carbonate D3 tablet qualities standard to the three of trial-production
The product for criticizing product and former technique productions carries out calcium content and vitamin d3 levels measure.Testing result shows：Calcium content exists
In the range of labelled amount (95.0%~105.0%) regulation, vitamin d3 levels are advised in labelled amount (90.0%~122.5%)
In fixed scope.Three batches of trial production products meet quality standard regulation with former technique productions product product.Assay
It is shown in Table 2：
The finished product content detection data of table 2
| Lot number | Calcium content | Vitamin d3 levels |
| 20160548 | 100.9% | 93.9% |
| 20160549 | 100.0% | 100.5% |
| 20160550 | 100.9% | 106.8% |
| 20150438 | 100.7% | 105.2% |
3.3 proterties
According to State Food and Drug Administration's standard YBH05962009 calcium carbonate D3 tablet qualities standard to the three of trial-production
The product for criticizing product and former technique productions carries out proterties inspection：Three batches of trial production products are class with former technique productions outturn sample
White tablets, meet drug standard regulation.Assay is shown in Table 3：
The finished product proterties inspection result of table 3
| Lot number | Proterties |
| 20160548 | It is off-white color piece |
| 20160549 | It is off-white color piece |
| 20160550 | It is off-white color piece |
| 20150438 | It is off-white color piece |
3.4 differentiate
According to State Food and Drug Administration's standard YBH05962009 calcium carbonate D3 tablet qualities standard to the three of trial-production
The product for criticizing product and former technique productions carries out discriminating item inspection.Inspection result shows：Differentiate 1, differentiate 2, differentiate that 3 meet
The drug standard specifies.Assay is shown in Table 4：
The finished product identification check result of table 4
3.5 check
3.5.1 uniformity of dosage units (vitamine D3)
According to State Food and Drug Administration's standard YBH05962009 calcium carbonate D3 tablet qualities standard to the three of trial-production
The product for criticizing product and former technique productions carries out uniformity of dosage units (vitamine D3) item inspection.Inspection result shows three batches of examination lifes
Produce product and meet regulation with former technique productions product, be shown in Table 5.
3.5.2 friability
According to State Food and Drug Administration's standard YBH05962009 calcium carbonate D3 tablet qualities standard to the three of trial-production
The product for criticizing product and former technique productions carries out friability item inspection.Inspection result shows three batches of trial production products with former technique
Production product meets regulation, is shown in Table 5.
The finished product content uniformity of table 5 and friability inspection result
3.5.3 microbial limit
This product is taken, is shone《Chinese Pharmacopoeia》(2010 editions) microbial decolorization (annex XI J) checks that three batches are produced as a trial
Product meets regulation with the microbial limit of former technique productions product.Assay is shown in Table 6：
The limit test of microbe data of table 6
3.5.4 dissolution rate
Because this product is chewable tablets, so carrying out dissolution test through the tablet and powder of chewing using the tablet simulation after broken.
Specific method is：Some tablets are pulverized, the particle between 14 mesh~60 mesh sieves is taken, 6 parts is precisely weighed again by piece, the traditional Chinese medicines according in
Allusion quotation annex X C《Dissolution method》Second method is checked, and as dissolution medium, rotating speed is per minute 100 to the hydrochloric acid with 0.1mol/L
Turn, operate in accordance with the law, during through 30 minutes, draw dissolution fluid in right amount, filtration, precision draws subsequent filtrate 25ml, according to " under assay
Determination of calcium content method " is determined, and calculates the stripping quantity of every.Inspection result shows：The change of this drug production process does not cause
Medicine dissolved corrosion changes.Inspection result is shown in Table 7：
The dissolution test data of table 7
| Lot number | Dissolution rate |
| 20160548 | 98% |
| 20160549 | 98% |
| 20160550 | 98% |
| 20150438 | 98% |
Conclusion：Result of study
Checked by existing quality standard using the three batches of samples of technique quantity-produced after change and meet regulation, and with
The product quality indifference of current technology production, the change of technique does not cause medicine dissolved corrosion to change.Technique after change
The need for my company's production finished product can be met.
4th, the testing data of preparation stability Comparison Study
Sample ID：Calcium carbonate D3 pieces
Production unit：Beijing Kangyuan Pharmaceutical Co., Ltd.
4.1 investigate condition
(1) accelerated test (40 DEG C ± 2 DEG C, RH75% ± 5%) 1,2,3 and 6 months, plastic bottle packaging.
(2) long term test (25 DEG C ± 2 DEG C, RH60% ± 10%) 3,6 months, plastic bottle packaging.
4.2 investigate project
Because the instructions of taking of calcium carbonate D3 pieces is removed to property specified in standard to be swallowed after chewing in the oral cavity
Outside shape, friability, calcium content and vitamin d3 levels are investigated, the investigation of dissolution rate is increased.
Dissolution test method：Some tablets are pulverized, the particle between 14 mesh~60 mesh sieves is taken, is precisely weighed again by piece
6 parts, according to Chinese Pharmacopoeia annex X C《Dissolution method》Second method check, the hydrochloric acid with 0.1mol/L as dissolution medium, rotating speed
It is 100 turns per minute, operates in accordance with the law, during through 30 minutes, draw dissolution fluid in right amount, filtration, precision draws subsequent filtrate 25ml, shines
" the lower determination of calcium content method of assay " is determined, and calculates the stripping quantity of every.
4.4 accelerated tests
Change quantity-produced three batches (20160548,20160549,20160550 batches) sample, accelerated condition after technique
The experiment of lower 6 months, the proterties of sample, friability, calcium content, vitamin d3 levels have no significant change, and meet quality mark
Accurate regulation.Dissolution rate is unchanged in acceleration probation, and compares with the sample (20150438 batches) of former technique productions, number
According to no marked difference, 8 are the results are shown in Table.
The accelerated test of table 8 investigates result
5th, long term test
With the three batches of samples of technique quantity-produced after change, by the long-term conditions experiment of lower 6 months, the property of sample
Shape, friability, calcium content, vitamin d3 levels have no significant change, and meet the regulation of quality standard.Dissolution rate is in probation
Interior unchanged and compare with the sample of former technique productions, both do not have difference at data.The results are shown in Table 9.
The long term test of table 9 investigates result
To sum up result of the test shows that the calcium carbonate D3 pieces of new technology production do not cause the change of the quality of the pharmaceutical preparations；Do not have yet
Causing preparation stability reduces, and illustrates that new technology can meet the quality requirement of my product, and medicine the term of validity term of validity not
Make an amendment.
The above, specific embodiment only of the invention, but protection scope of the present invention is not limited thereto, and it is any
Those familiar with the art the invention discloses technical scope in, change or replacement can be readily occurred in, should all contain
Cover within protection scope of the present invention.Therefore, protection scope of the present invention described should be defined by scope of the claims.
Claims (3)
1. the preparation method of a kind of composite calcium carbonate/vitamine D3 piece, it is characterised in that：In accordance with the following steps,
Step one, weigh the calcium carbonate of recipe quantity, mannitol, Icing Sugar, part polyethylene pyrrolidones, recipe quantity 90% perfume (or spice)
Essence, is allowed to well mixed；
Step 2, is dissolved in the polyvinylpyrrolidone of remainder 30% appropriate ethanol and obtains the first solution；
Step 3, weighs the PVP K30 aqueous solution of PVP K30 and appropriate the purified water configuration 6% of recipe quantity；
Step 4, the vitamine D3 for taking recipe quantity adds appropriate 95% absolute ethyl alcohol dissolving is obtained the second solution, in step
The second solution is added in one fine powder, is mixed, added the PVP K30 aqueous solution, the first solution and be made the softwood of appropriate humidity；
Step 5, softwood is pressed through the screen cloth of 14 mesh, is made particle；
Step 6, after wet granular is made, in 70 DEG C of dryings, takes out after drying, and carries out whole grain；
Step 7, the magnesium stearate of addition recipe quantity and the 10% of recipe quantity sweet orange powdered flavor are always mixed, and are pressed after always mixing
Piece；
Step 8, screening, product inspection, packaging.
2. the preparation method of a kind of composite calcium carbonate/vitamine D3 piece according to claim 1, it is characterised in that：It is described
Part polyethylene pyrrolidones is about the 2/3 of PVP total amount in step one.
3. the preparation method of a kind of composite calcium carbonate/vitamine D3 piece according to claim 1, it is characterised in that：It is described
The polyvinylpyrrolidone of remainder is about the 1/3 of polyvinylpyrrolidone total amount in step 2.
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| CN201611204794.9A CN106727677A (en) | 2016-12-23 | 2016-12-23 | A kind of preparation method of composite calcium carbonate/vitamine D3 piece |
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ID=58897848
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Address after: 102200 No. 3 Changliu Road, Liucun Town, Changping District, Beijing Applicant after: Beijing Zhendong Kang Yuan Pharmaceutical Co., Ltd. Address before: 102200 No. 3 Changliu Road, Liucun Town, Changping District, Beijing Applicant before: Beijing Kang Yuan pharmaceutical Co. Ltd |
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Application publication date: 20170531 |