CN105012340B - A kind of pharmaceutical composition containing calcium citrate and preparation method thereof - Google Patents
A kind of pharmaceutical composition containing calcium citrate and preparation method thereof Download PDFInfo
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- CN105012340B CN105012340B CN201510523328.6A CN201510523328A CN105012340B CN 105012340 B CN105012340 B CN 105012340B CN 201510523328 A CN201510523328 A CN 201510523328A CN 105012340 B CN105012340 B CN 105012340B
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Abstract
The present invention discloses a kind of pharmaceutical composition containing calcium citrate and preparation method thereof, which includes：Calcium citrate 157.5kg；Mannitol 93kg；Citric acid 6.3kg；Honey element 1.575kg；Lemon yellow 63g；Orange oil essence 540ml；Hydroxypropyl methylcellulose 1.8kg；Magnesium stearate 4.2kg.The pharmaceutical composition containing calcium citrate prepared by preparation method using the present invention, calcium source is good, and good absorbing, mouthfeel is good, easily digests.
Description
Technical field
The present invention relates to drug fields more particularly to a kind of pharmaceutical composition containing calcium citrate and preparation method thereof.
Background technology
Calcium is primarily present in bone, tooth in vivo.In human body in the 99% calcareous tooth there are bone, human body is supported
Movement and masticatory ability.For developmental teenager (needs of growth and development)；Vegetarian's (excessive dietary fiber in diet
Hinder the absorption of calcium)；The elderly (absorbs bad, calcium loss increase)；Women after pregnancy period, nursing period, climacteric and menopause
For (special physiological needs), replenish the calcium particularly important.
But existing calcium supplementing product, effect of supplemented calcium is simultaneously bad, such as calcium source is bad, and absorption is bad, and mouthfeel is bad, influences
The problems such as digestion etc..
Therefore, the prior art has yet to be improved and developed.
Invention content
In view of above-mentioned deficiencies of the prior art, the purpose of the present invention is to provide a kind of pharmaceutical compositions containing calcium citrate
Object and preparation method thereof, it is intended to which it is bad to solve existing calcium supplementing product its calcium source, absorbs bad, and mouthfeel is bad, influences digestion
Problem.
Technical scheme is as follows：
A kind of pharmaceutical composition containing calcium citrate, wherein, by mass percentage, including：
A kind of preparation method of the pharmaceutical composition containing calcium citrate as described above, wherein, including step：
A, purified water 60kg is weighed, adds in in liquid pot, the 1.8kg hydroxypropyl methylcelluloses weighed up addition is matched in liquid pot and is opened
Stirring is opened, is passed through and is steam heated to 50 DEG C, then stops heating, is dispersed with stirring uniformly, hydroxypropyl methylcellulose is made fully to be gelatinized into
For translucent slurry, it is cooled to room temperature spare；
B, by 157.5kg calcium citrates, 93kg mannitol, 6.3kg citric acids, 1.575kg honey elements, 63g lemon yellows and
540ml orange oil essences are put into wet granulator, are then stirred 8 minutes, the material of addition are sufficiently mixed uniformly, with 14
Mesh screen makes pellet in wet granulator；
C, particle is dried, at 70~80 DEG C, drying time is 3~4 hours for temperature control；
D, dried particle is added in pelletizing machine, carries out whole grain；
E, whole good particle and 4.2kg magnesium stearates are added in mixing machine, are sufficiently mixed；
F, it takes out particle and carries out tabletting；
G, it is finally wrapped inside and outsourcing.
The preparation method, wherein, in the step B, after stirring 8 minutes, translucent slurry is added in, is stirred for 2 minutes.
The preparation method, wherein, in the step C, the steam pressure in drying process is 0.4Mpa.
The preparation method, wherein, in the step C, by mass percentage, pellet moisture is controlled 2~3%.
The preparation method, wherein, in the step D, the sieve that whole grain uses is 14 mesh.
The preparation method, wherein, in the step E, incorporation time is 20 minutes.
Advantageous effect：A kind of pharmaceutical composition containing calcium citrate provided by the invention, including：Calcium citrate
157.5kg；Mannitol 93kg；Citric acid 6.3kg；Honey element 1.575kg；Lemon yellow 63g；Orange oil essence 540ml；Hydroxypropyl first
Cellulose 1.8kg；Magnesium stearate 4.2kg.The pharmaceutical composition containing calcium citrate prepared by preparation method using the present invention
Object, calcium source is good, and good absorbing, mouthfeel is good, easily digests.
Description of the drawings
Fig. 1 is a kind of flow chart of the preparation method preferred embodiment of the pharmaceutical composition containing calcium citrate of the present invention.
Specific embodiment
The present invention provides a kind of pharmaceutical composition containing calcium citrate and preparation method thereof, for make the purpose of the present invention,
Technical solution and effect are clearer, clear and definite, and the present invention is described in more detail below.It should be appreciated that described herein
Specific embodiment is only used to explain the present invention, is not intended to limit the present invention.
A kind of pharmaceutical composition containing calcium citrate provided by the invention, by mass percentage, including：
As shown in Figure 1, a kind of preparation side of pharmaceutical composition containing calcium citrate as described above provided by the invention
Method, including step：
S1, purified water 60kg is weighed, adds in in liquid pot, the 1.8kg hydroxypropyl methylcelluloses weighed up are added in in liquid pot
Stirring is opened, is passed through and is steam heated to 50 DEG C, then stops heating, is dispersed with stirring uniformly, hydroxypropyl methylcellulose is made fully to be gelatinized
As translucent slurry, it is cooled to room temperature spare；
S2, by 157.5kg calcium citrates, 93kg mannitol, 6.3kg citric acids, 1.575kg honey elements, 63g lemon yellows and
540ml orange oil essences are put into wet granulator, are then stirred 8 minutes, the material of addition are sufficiently mixed uniformly, with 14
Mesh screen makes pellet in wet granulator；
S3, particle is dried, at 70~80 DEG C, drying time is 3~4 hours for temperature control；
S4, dried particle is added in pelletizing machine, carries out whole grain；
S5, whole good particle and 4.2kg magnesium stearates are added in mixing machine, are sufficiently mixed；
S6, particle progress tabletting is taken out；
S7, it is finally wrapped inside and outsourcing.
First in step sl, 60kg purified waters are first added in liquid pot, then weigh 1.8kg hydroxypropyl methylcelluloses,
It is added to and matches in liquid pot, and open stirring, be passed through and be steam heated to 50 DEG C, then stop heating, be stirred for being uniformly dispersed, make hydroxyl
Third methylcellulose is fully gelatinized as translucent slurry, is cooled to room temperature spare；
In step s 2, by 157.5kg calcium citrates, 93kg mannitol, 6.3kg citric acids, 1.575kg honey elements, 63g
Lemon yellow and 540ml orange oil essences are put into wet granulator, then 8 minutes (low-speed running) are stirred, by the object of addition
Material is uniformly mixed, and is made pellet in wet granulator with 14 mesh screens；In addition, after stirring 8 minutes, addition has been gelatinized semi-transparent
Bright slurry is stirred for 2 minutes.
Calcium citrate and mannitol therein can be added to Highefficientpulverizer (installing 80 mesh screens), crush respectively.
In step s3, particle is dried, at 70~80 DEG C, drying time is 3~4 hours, dry for temperature control
Steam pressure in the process is 0.4Mpa.It when being dried, needs uniformly to spread out particle, such as temperature is controlled at 75 DEG C,
Drying time is 3.5 hours.
It needs to control vapor (steam) temperature, steam flow in drying process, checks for ramming material phenomenon at any time.In drying process,
It is sampled at any time using sampler, examines each drying stage particle proterties, and result adjustment drying parameter according to the observation, most
Qualified products are obtained eventually.The control of temperature is paid attention in particle drying procedures, is avoided too high or too low for temperature.Pass through electromagnetism valve regulation
Steam flow；Exhaust steam valve is closed when drying process starts, when temperature is raised to set temperature, exhaust steam valve is opened and excludes baking oven
Interior water vapour periodically stirs wet granular, and record up and down.
The later stage of drying notices that particle drying moisture controls.5g or so is sampled, is contained using moisture teller detection moisture
Amount, with the terminal that control is dry.By mass percentage, pellet moisture control is 2~3%, such as 2.5%.
If steam pressure is inadequate in drying process, without closing wind turbine, extend drying time.
In step s 4, dried particle is added in pelletizing machine, pelletizing machine is then opened and carries out whole grain.Whole grain uses
Sieve be 14 mesh.To check whether the abrasion condition of sieve and the specification of sieve are consistent with technological requirement before and after whole grain.
In step s 5, whole good particle and 4.2kg magnesium stearates are added in mixing machine, are sufficiently mixed；
To reach well-mixed purpose, mixing machine loading amount is advisable with 1/3~1/2 no more than the 2/3 of its capacity, example
Such as 1/2.Incorporation time was controlled at 20 minutes, you can achievees the purpose that mixing.
In step s 6, the mold of tabletting is installed first：Erection sequence is middle mould, low punch, upper punch.Install with
Afterwards, rotation handwheel checks whether mold installation is normal.Check it is intact after, unload handwheel, into lubricating cup add lubricating oil (addition
It is the 1/3~1/2 of lubricating cup total capacity, after making equipment normal operation, lubricating oil can uniformly smear punch head surface, and will not mistake up and down
Oozing to drop on turntable drug granule under multithread is advisable).Then power supply, low speed trial operation machine, observation device working order are opened
It is whether normal, while uniformly lubricate punch head surface using lubricating oil.Trial operation 2 minutes fills powder-scraper and loading hopper after normal
It is good, you can to carry out sheeting operation.
Unit dust catcher is adjusted before tabletting, tablet screening machine and weighing balance are carried out at the same time balance adjustment review.
Situations such as pressure testing piece is carried out before formal tabletting, and observes particle compression mouldability, hardness, appearance, pressure testing on a small quantity into
Product, formal tabletting could be started by normally meeting the requirements, and then every 15 minutes, separately sampled 20 of left and right track is weighed, according to
The result weighed adjusts two track loadings, pressure in time, closes lid after setting, need not be readjusted if parameter constant
Filling and pressure.The tablet pressed removes fine powder so that subsequent processing operates through drug tablet screening machine.
Finally in the step s 7, it is wrapped inside and outsourcing.
It should be understood that the application of the present invention is not limited to the above, it for those of ordinary skills, can
To be improved or converted according to the above description, all these modifications and variations should all belong to the guarantor of appended claims of the present invention
Protect range.
Claims (3)
1. a kind of pharmaceutical composition containing calcium citrate, which is characterized in that by mass percentage, including：
The preparation method of the pharmaceutical composition containing calcium citrate includes step：
A, purified water 60kg is weighed, adds in in liquid pot, the 1.8kg hydroxypropyl methylcelluloses weighed up addition is matched to open in liquid pot and is stirred
It mixes, is passed through and is steam heated to 50 DEG C, then stop heating, be dispersed with stirring uniformly, hydroxypropyl methylcellulose is made fully to be gelatinized as half
Interspongioplastic substance is cooled to room temperature spare；
B, by 157.5kg calcium citrates, 93kg mannitol, 6.3kg citric acids, 1.575kg honey elements, 63g lemon yellows and 540ml
Orange oil essence is put into wet granulator, is then stirred 8 minutes, and the material of addition is sufficiently mixed uniformly, is sieved with 14 mesh
Net makes pellet in wet granulator；
C, particle being dried, at 70~80 DEG C, drying time is 3~4 hours for temperature control, by mass percentage,
Grain moisture control is 2~3%；
D, dried particle is added in pelletizing machine, carries out whole grain；The sieve that whole grain uses is 14 mesh；
E, whole good particle and 4.2kg magnesium stearates are added in mixing machine, are sufficiently mixed, incorporation time is 20 points
Clock；
F, it takes out particle and carries out tabletting；
G, it is finally wrapped inside and outsourcing.
2. preparation method according to claim 1, which is characterized in that in the step B, after stirring 8 minutes, add in semi-transparent
Bright slurry is stirred for 2 minutes.
3. preparation method according to claim 1, which is characterized in that in the step C, the steam pressure in drying process
For 0.4Mpa.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510523328.6A CN105012340B (en) | 2015-08-21 | 2015-08-21 | A kind of pharmaceutical composition containing calcium citrate and preparation method thereof |
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| CN201510523328.6A CN105012340B (en) | 2015-08-21 | 2015-08-21 | A kind of pharmaceutical composition containing calcium citrate and preparation method thereof |
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| CN105012340A CN105012340A (en) | 2015-11-04 |
| CN105012340B true CN105012340B (en) | 2018-07-06 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1132626A (en) * | 1994-09-26 | 1996-10-09 | 美国氰胺公司 | Improved calcium dietary supplement |
| CN1634010A (en) * | 2004-10-25 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Calcium gluconate oral disintegrating tablet and its preparation process |
| CN101040874A (en) * | 2006-03-22 | 2007-09-26 | 西南大学 | Compound medicine took orally for treating osteoporosis |
-
2015
- 2015-08-21 CN CN201510523328.6A patent/CN105012340B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1132626A (en) * | 1994-09-26 | 1996-10-09 | 美国氰胺公司 | Improved calcium dietary supplement |
| CN1634010A (en) * | 2004-10-25 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Calcium gluconate oral disintegrating tablet and its preparation process |
| CN101040874A (en) * | 2006-03-22 | 2007-09-26 | 西南大学 | Compound medicine took orally for treating osteoporosis |
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| CN105012340A (en) | 2015-11-04 |
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