CN107625786A - A kind of calcium carbonate vitamin D3Composition and its anhydrous swallow particle - Google Patents
A kind of calcium carbonate vitamin D3Composition and its anhydrous swallow particle Download PDFInfo
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- CN107625786A CN107625786A CN201610565002.4A CN201610565002A CN107625786A CN 107625786 A CN107625786 A CN 107625786A CN 201610565002 A CN201610565002 A CN 201610565002A CN 107625786 A CN107625786 A CN 107625786A
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- calcium carbonate
- vitamine
- anhydrous
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Abstract
The present invention relates to a kind of calcium carbonate vitamin D3Composition and its anhydrous swallow granule.Belong to field of pharmaceutical preparations.The Calcichew D3 composition of the present invention, and the inclusion composition or Calcichew D3 is anhydrous made of the composition swallows in particle, vitamine D3 is fed intake with vitamine D3 carrier format.Compared with the prior art, the present invention not only realizes that the granule rapid anhydrous can be swallowed in the oral cavity, good mouthfeel, improves the compliance of user, and solve vitamin D3The problem of content lack of homogeneity in the formulation and stability difference, particularly, compared with existing Calcichew D3 preparation, in unit formulation, while the present invention improves calcium carbonate content, loading amount is less than conventional dosage forms loading amount on the contrary.
Description
Technical field
The present invention provides a kind of calcium carbonate vitamin D3Composition and its anhydrous swallow granule.Belong to pharmaceutical preparation neck
Domain.
Background technology
Maalox Antacid, existing calcium carbonate tablet, carbonic acid Biocal, calcium carbonate granule, common process is calcium carbonate granule
Filling rod bag or tabletting after additional disintegrant and flavouring.It is simple to take calcium carbonate, absorb poor, vitamin D3Calcium can be aided in inhale
Receive, therefore the market of Calcichew D3 compound preparation is more wide.
Vitamine D3 is not soluble in water, and unstable, to light, thermo-responsive.To improve the solubility in oral compound preparation,
Improve vitamine D3 dissolubility and stability using B- cyclodextrin inclusion compounds, be made vitamine D3-B- cyclodextrin inclusion compounds again with
Solid pharmaceutical preparation is made in other calcic medicines, to reach the purpose (Zhang Xuenong etc., the uniform experiment design that improve dissolubility and stability
Application in compound calcium carbonate effervescent prescription screening, mathematics medicine and pharmacology magazine, 2000,13 (2):116)
CN00132317.2 discloses dispersed calcium carbonate-xylitol solid and chewing compound calcium carbonate tablet, wherein compound carbon
Sour Biocal is that (vitamine D3-B- rings are pasted by dispersed calcium carbonate-xylitol solid, zinc gluconate, vitamine D3
Essence), sugarless defatted milk powder, made of starch and talcum powder.
CN201310192774.4 disclose it is a kind of containing calcium effervescence tablet and its production and use, wherein by calcium carbonate and dimension
Raw plain D (preferably vitamine D3) is mixed to get mixture according to quality etc. point mode equal proportion, to ensure vitamin D each
Uniform content in piece.
CN201510743536.7 discloses a kind of composition and its preparation with calcium supplementing effect, including 30-40
The newborn mineral salt of part, 10-20 part sour milk powders, 10-15 part galactooligosaccharides, 3-5 parts kudzu-vine root powder and the dimension life of 0.001-0.005 parts
Plain D3.
, there are some defects in prior art Calcichew D3 compound preparation, such as vitamine D3 is degradable, in preparation
Loading amount is inaccurate.
The content of the invention
The defects of to overcome prior art, the present invention provide a kind of Calcichew D3 composition.The technology of the present invention side
Case is as follows：
The present invention provides a kind of Calcichew D3 composition, including calcium carbonate, vitamine D3 and pharmaceutically acceptable
Auxiliary material, it is characterised in that institute is made with vitamine D3 carrier format and calcium carbonate and pharmaceutically acceptable auxiliary material in vitamine D3
The composition stated.
Vitamine D3 carrier described above, is made up of vitamine D3 and auxiliary material, and the auxiliary material is selected from hydrogenated vegetable oil, bright
In glue, starch, sucrose, tocopherol it is one or two kinds of more than；Preferably, described vitamine D3 carrier is DSM vitamin
D3 carriers.
Composition described above, wherein, in unit formulation, the dosage of calcium carbonate is calculated by calcium, can be 250mg,
200mg, 500mg, preferably 500mg；The dosage of vitamine D3 carrier is calculated by vitamine D3, can is 3ug, 5ug, is preferably
5ug
As another object of the present invention, the medicament for including composition described above is also provided, or by group described above
Medicament made of compound, such as the oral solid formulation such as granule, tablet, capsule.
Preferably, the invention provides a kind of calcium carbonate vitamin D3It is anhydrous to swallow particle, including granules of main drug and flavoring
Agent, wherein described granules of main drug is made up of composition described above.
Composition described above or described calcium carbonate vitamin D3It is anhydrous to swallow particle, wherein it is described pharmaceutically
Acceptable auxiliary material, supplementary product kind and dosage, are not particularly limited, and can be that pharmaceutically conventional auxiliary material and suitable auxiliary material are used
Amount.Illustratively, described auxiliary material, sodium carboxymethylcellulose, hydroxypropyl methylcellulose etc. can be selected from selected from adhesive, is rectified
Taste agent is selected from sorbierite, maltodextrin etc., sweetener is selected from Aspartame, one or both of acesulfame potassium etc. with
On.
Calcium carbonate vitamin D described above3It is anhydrous to swallow particle, wherein described Calcichew D3 composition can
Described granules of main drug is obtained so that particle is made by pharmaceutically conventional granulating process；Preferably, it is made by wet granulation
Described granules of main drug, solvent for use can be water, ethanol etc. in wet granulation, and granular size can be 300-500um, preferably
The mesh sieve whole grain of particle 20 is made.
Calcium carbonate vitamin D described above3It is anhydrous to swallow particle, wherein described granules of main drug and the weight of flavouring
Than being not particularly limited, such as can be 3:1、2：1、1:1, preferably 3：1
Calcium carbonate vitamin D described above3It is anhydrous to swallow particle, wherein described flavouring be selected from acid (such as
Selected from citric acid, malic acid, tartaric acid etc.), auxiliary sweetener (being selected from sorbierite, maltodextrin, sucrose etc.), sweetener
It is more than one or both of (being selected from Aspartame, Sucralose etc.), flavor enhancement (being selected from orange taste agent etc.).
As the preferred embodiment of the present invention, calcium carbonate vitamin D described above3It is anhydrous to swallow particle, wherein singly
In the preparation of position, calcium carbonate is with Ca2+500mg is calculated as, vitamine D3 carrier is with vitamin D3It is calculated as 5ug.
Preferably, the calcium carbonate vitamin D that the present invention is described above3It is anhydrous to swallow particle, wherein vitamine D3 carrier
From the vitamine D3 carrier of DSM N. V.'s production.
It is highly preferred that the present invention provides, a kind of Calcichew D3 is anhydrous to swallow particle, in unit formulation, Ca2+
500mg, vitamin D35ug, its single dose composition are：
Preparation process is as follows：
1. wet granulation：Calcium carbonate, sorbierite, carboxymethyl cellulose sodium, Aspartame etc. are mixed in wet granulator,
Purpose mixes material, and 50% ethanol solution is added using spray pattern, material is formed shape of sand by granulation, ensures material
The mouldability of particle after drying.From the wet whole grain of 20 mesh sieves.
Wherein, before combination, calcium carbonate crosses 100 mesh sieves, sorbierite crushed 60 mesh sieves, to ensure that material is well mixed.
2. dry：Control material temperature:40-50 DEG C, the dry moisture of granulation end point control：1%-3%, the mesh of particle 20 is made
Sieve whole grain.
It is 3. mixed eventually：Flavoring auxiliary material part is added, is mixed.Wherein, before flavoring auxiliary material part adds, sorbierite crosses 60 mesh
Sieve processing, citric acid crushed the processing of 60 mesh sieves.
It is 4. filling：Ensure product specification loading amount and the homogeneity of sample.If desired, appropriate glidant can also be added,
Such as superfine silica gel powder or talcum powder, carry out helping stream.
Active composition calcium carbonate and vitamin D of the present invention3It is anhydrous swallow particle, not only have in the oral cavity
Quickly swallowed beneficial to anhydrous, preparation good mouthfeel in whole process, improve the compliance of user, and solve traditional calcium carbonate
Preparation oral needs to chew, and specific crowd is taken and is inconvenient, and solves vitamin D3Content uniformity in the formulation
The problem of poor.Particularly, in unit formulation, while improving calcium carbonate content, loading amount is less than conventional dosage forms loading amount (this hair on the contrary
Bright Calcichew D3 is anhydrous to swallow granule, and unit formulation loading amount, which can control, is no more than 2g, and existing same type system
Agent loading amount is generally 3-4g), anhydrous granule loading amount of swallowing of the invention is small and be advantageous to mouthfeel, makes carrying and takes more square
Just, and from specific vitamin D3The form of carrier is added in preparation, can effectively ensure vitamin D3Stability and
Homogeneity is mixed, preparation technology is easy, production efficiency is high and formulation is taken easy to carry, is applicable that crowd is wide, and production cost is low.
Solves conventional dosage forms dysphagia, chewing is laborious, mouthfeel is bad.It is poor for the elderly and children's swallow and masticatory ability
Crowd contribute to its carry and take.
The present invention Calcichew D3 composition and its it is anhydrous swallow particle, thrown using vitamine D3 carrier
Material, especially with DSM vitamine D3 carrier, vitamine D3-B- cyclodextrin inclusion compounds are used relative to prior art
Or quality etc. divides the technology of mode mixed calcium carbonate and vitamine D3, the advantageous effect of acquirement is mainly manifested in：Vitamine D3
Carrier buying is convenient, or homemade preparation technology is simple, and the content of vitamine D3 is uniform, and sample stability is good, is easy to
Storage and transport.
Embodiment
Present invention is further explained and described with embodiment below, embodiment is provided and is understood not to this hair
Bright protection domain is construed as limiting.
Embodiment 1：
By 500 system of unit dosage, fed intake：
Preparation technology：
1. wet granulation：Calcium carbonate, sorbierite, carboxymethyl cellulose sodium, Aspartame etc. are mixed in wet granulator,
Purpose mixes material, and 50% ethanol solution is added using spray pattern, material is formed shape of sand by granulation, ensures material
The mouldability of particle after drying.From the wet whole grain of 20 mesh sieves.
Wherein, before combination, calcium carbonate crosses 100 mesh sieves, sorbierite crushed 60 mesh sieves, to ensure that material is well mixed.
2. dry：Control material temperature:40-50 DEG C, the dry moisture of granulation end point control：1%-3%, the mesh of particle 20 is made
Sieve whole grain.
It is 3. mixed eventually：Flavoring auxiliary material part is added, is mixed, is made that Calcichew D3 is anhydrous to swallow particle.Wherein,
Before flavoring auxiliary material part adds, sorbierite crosses the processing of 60 mesh sieves, citric acid crushed the processing of 60 mesh sieves.
It is 4. filling：Ensure product specification loading amount and the homogeneity of sample.If desired, appropriate glidant can also be added,
Such as superfine silica gel powder or talcum powder, carry out helping stream.
As a result：The anhydrous good mouthfeel for swallowing particle of obtained Calcichew D3, unit formulation loading amount in below 2g,
And vitamin D3Detection level is stable, and homogeneity is good.
Embodiment 2
Prescription：
By 400 system of unit dosage, fed intake：
Preparation technology：
Calcium carbonate, sorbierite, starch 1500, VD3 carriers are mixed in wet granulator and add 65% ethanol softwood,
With 20 mesh sieve whole grains.50% top spray granulation solution will be configured in maltodextrin 19D, citric acid addition purified water, fluidized
Control temperature pelletizes softwood top spray at 40-50 DEG C in bed top spray granulator, and moisture is controlled after drying in 1%-3%.With 20 mesh
Whole grain is sieved, adds sorbierite, sodium carboxymethylcellulose 7H4XF, citric acid, Sucralose, orange taste agent, mixes 5min.
Wherein, 60 mesh are crossed after 80 mesh sieves, citric acid crushing are crossed after sorbierite crushes.
Finished particle is homogeneous, and taste is micro- cool, swallows smoothly, taste masking effect is good.
Embodiment 3
By 400 system of unit dosage, fed intake：
Prescription：
Preparation technology：
Preparation technology is identical with embodiment 2.
Wherein：Wet granulation part sorbierite particle diameter is crossed below 80 mesh sieves；Fluid bed granulation, taste masking auxiliary material is to particle
Coated.Particle size requirements cross 60 mesh after flavoring part citric acid, sorbierite crushing.
As a result：Mouthfeel is homogeneous, and anhydrous to swallow smoothly, flavoring works well.
Claims (10)
1. a kind of Calcichew D3 composition, including calcium carbonate, vitamine D3 and pharmaceutically acceptable auxiliary material, its feature
It is that described composition is made with vitamine D3 carrier format and calcium carbonate and pharmaceutically acceptable auxiliary material for vitamine D3.
2. composition according to claim 1, wherein vitamine D3 carrier is made up of vitamine D3 and auxiliary material, the auxiliary material
In hydrogenated vegetable oil, gelatin, starch, sucrose, tocopherol it is one or two kinds of more than.
3. according to the composition described in claim 1-2, wherein, in unit formulation, the dosage of calcium carbonate is calculated by calcium, can be with
For 200mg, 250mg, 500mg, preferably 500mg；The dosage of vitamine D3 carrier by vitamine D3 calculate, can be 3ug,
5ug, preferably 5ug.
A kind of 4. calcium carbonate vitamin D3It is anhydrous to swallow particle, including granules of main drug and flavouring, wherein described granules of main drug by
Composition described in claim 1-3 is made.
5. calcium carbonate vitamin D according to claim 43It is anhydrous to swallow particle, wherein described pharmaceutically acceptable auxiliary material
Selected from adhesive (being selected from sodium carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose etc.), auxiliary sweetener (example
Such as selected from sorbierite, maltodextrin, sucrose), one kind or two in sweetener (being selected from Aspartame, Sucralose etc.)
More than kind.
6. the calcium carbonate vitamin D according to claim 4-53It is anhydrous to swallow particle, wherein described composition presses wet method
Described granules of main drug is made in granulation.
7. the calcium carbonate vitamin D according to claim 4-63It is anhydrous to swallow particle, wherein described granules of main drug and rectify
Taste agent weight ratio is 3:1、2:1、1：1 etc., preferably 3：1.
8. the calcium carbonate vitamin D according to claim 4-73It is anhydrous to swallow particle, wherein described flavouring is selected from acid
Taste agent (being selected from citric acid, malic acid, tartaric acid etc.), auxiliary sweetener (are selected from sorbierite, maltodextrin, sucrose
Deng), sweetener (being selected from Aspartame, Sucralose etc.), one kind or two in flavor enhancement (being selected from orange taste agent etc.)
More than kind.
9. the calcium carbonate vitamin D according to claim 4-83It is anhydrous to swallow particle, wherein in unit formulation, Ca2+
500mg, vitamin D35ug。
10. the calcium carbonate vitamin D according to claim 4-93Anhydrous to swallow particle, wherein vitamine D3 carrier is DSM
Vitamine D3 carrier.
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Cited By (6)
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| CN109260220A (en) * | 2018-11-28 | 2019-01-25 | 重庆华森制药股份有限公司 | A kind of preparation method of oyster shell calcium particle |
| CN111494408A (en) * | 2020-04-28 | 2020-08-07 | 广东润源中天生物科技有限公司 | Calcium vitamin D3 tablet and production method thereof |
| CN111617042A (en) * | 2020-02-26 | 2020-09-04 | 安士制药（中山）有限公司 | Composite calcium carbonate vitamin D3Water-free swallow granule and preparation method thereof |
| CN114081888A (en) * | 2020-08-24 | 2022-02-25 | 山西好医生药业有限公司 | Preparation process and application of oral five-vitamin glucose |
| CN114129521A (en) * | 2021-11-05 | 2022-03-04 | 昆明源瑞制药有限公司 | Calcium carbonate D3Granule and preparation method thereof |
| CN115804759A (en) * | 2022-12-09 | 2023-03-17 | 江苏扬新生物医药有限公司 | A granule containing coenzyme Q10 and calcium |
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Effective date of registration: 20220424 Address after: 274000 7th floor, Bencao building, No. 2999, Changjiang East Road, development zone, Heze City, Shandong Province Applicant after: Shandong Kecheng Pharmaceutical Technology Co.,Ltd. Address before: 100083 room 15, 15 / F, block a, Tiangong building, 30 Xueyuan Road, Haidian District, Beijing Applicant before: COSCI MED-TECH Co.,Ltd. |