CN108261396A - A kind of method of granulating - Google Patents
A kind of method of granulating Download PDFInfo
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- CN108261396A CN108261396A CN201611258988.7A CN201611258988A CN108261396A CN 108261396 A CN108261396 A CN 108261396A CN 201611258988 A CN201611258988 A CN 201611258988A CN 108261396 A CN108261396 A CN 108261396A
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- binder
- carrier gas
- filler
- raw material
- pelletized
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Glanulating (AREA)
Abstract
The present invention relates to drugs and food manufacture field, disclose a kind of method of granulating, and this method includes：(1) raw material to be pelletized with binder under fluidized state is mixed, obtains powder；(2) under the action of the carrier gas by humidification, the powder is made to continue to fluidize, method of granulating provided by the invention directly mixes raw material to be pelletized with binder, it ensure that binder adds in the accuracy of dosage, the issuable problem of non-uniform of sprinkling process is solved, and by way of humidification, it is possible to reduce because of the heat that evaporation latent heat is taken away in spray pattern, so as to reduce the operating time of whole flow process and energy consumption, there is good prospects for commercial application.
Description
Technical field
The present invention relates to drugs and food manufacture field, and in particular, to a kind of method of granulating.
Background technology
Pelletization is the important step in drug and food production.In pelletization, tiny powder is in binder
Cohesive action under by being nucleated, growing up, being molded and ultimately form particle.Can material porosity and most be improved by pelletization
The grain products of uniform particle sizes are obtained eventually.In pharmacy procedure, pelletization can improve the physical characteristic of powder drug so as to
In tabletting or encapsulated.Most common granulation mode includes wet granulation, dry granulation and fluidized bed granulation.Wherein fluidize
Bed granulation has apparent advantage compared to other two kinds of method of granulating：(1) fluidized bed granulation belongs to marumerization, can be single
Mixing, granulation, drying process are completed in equipment, avoids drug contamination；(2) fluid bed granulation high degree of automation is convenient for
Continuous production and automation control；(3) use of binder can be reduced using the mode of fluidized bed granulation, promotes drug
Safety simultaneously reduces cost.
The method of fluidized bed granulation has many advantages, such as thus to be widely adopted, but there is also some in practical applications
Problem.The problem of wherein main, is from the control of binder adding procedure.The binder used in pelletization can mix
In raw material of pelletizing or dissolve in a solvent.During fluidized bed granulation, most common mode is to pass through atomized spray
By the spray solution dissolved with binder on granulation raw material.During atomized spray, the dosage of binder is not easy accurately
Control can generate accidental deviation between different batches, while spraying uneven can cause caking even active ingredient part in part rich
Collection generates waste product.In addition to this, the spray rate of binder solution is the key parameter of process control, and spray rate height can cause
Collapse bed, and spray rate is low to influence granulating efficiency.Those skilled in the art is realizes better granulating efficiency to fluid bed system
Grain process has carried out correlative study.
Patent application CN103816838A, which is reported in, to be added in the mode of stirring and pelletized to improve in fluid bed granulation
The efficiency of journey；Patent application CN102198382A reports make pelletization stablize under high pressure using the mode of air sac sealing
It runs to improve granulation efficiency.
In conclusion although the prior art improves granulation efficiency to a certain extent, but still up for further improving,
And accurate control and avoid the error of products obtained therefrom and preferable granulation between different batches still without realize binder dosage
Effect.
Invention content
It is low for prior art granulation efficiency, binder dosage be difficult to control and different batches between product error is big lacks
It falls into, the present invention provides a kind of method of granulating, to obtain preferable granulating efficiency.
The present inventor has found in the course of the research, can improve and maintain by way of humidifying environment to fluidize
High relative humidity in bed granulating system, the principle for being condensed in gap that can be spontaneous using Environmental Water enter uniform moisture
Raw material to be pelletized can realize the full and uniform mixing of raw material and binder to be pelletized, and avoid a large amount of uses and the mist of binder
Change the non-uniformity problem that sprinkling is brought.
Based on this, the present invention provides a kind of method of granulating, this method includes：
(1) raw material to be pelletized with binder under fluidized state is mixed, obtains powder；
(2) under the action of the carrier gas by humidification, the powder is made to continue to fluidize.
Method of granulating provided by the invention makes the moisture in environment make via capillary under the action of the carrier gas by humidification
With condensing between powder surface and gap, under the collision effect provided in fluid bed granulation, into powder surface and powder
The moisture and binder in gap, which interact to be formed, to be cohered.Method provided by the invention directly mixes raw material to be pelletized with binder
It closes, ensure that binder adds in the accuracy of dosage；Secondly, the issuable problem of non-uniform of sprinkling process is solved；Finally, lead to
Cross the mode of humidification, it is possible to reduce because of the heat that evaporation latent heat is taken away in spray pattern, so as to reduce the operation of whole flow process
Time and energy consumption.
Other features and advantages of the present invention will be described in detail in subsequent specific embodiment part.
Specific embodiment
The specific embodiment of the present invention is described in detail below.It is it should be understood that described herein specific
Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or
Value should be understood to comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively
It between the endpoint value of a range and individual point value and can be individually combined with each other between point value and obtain one or more
New numberical range, these numberical ranges should be considered as specific open herein.
The present invention provides a kind of method of granulating, and this method includes：
(1) raw material to be pelletized with binder under fluidized state is mixed, obtains powder；
(2) under the action of the carrier gas by humidification, the powder is made to continue to fluidize.
A preferred embodiment of the invention, the mass ratio of raw material and binder to be pelletized is 1-100：1, preferably
For 2-76：1.Method using the present invention can effectively control the addition of binder and can have to the binder of addition
Effect utilizes, and for same binder, using method provided by the invention, the usage amount of binder is compared with the side of the prior art
Method can save half, and can reach identical or better granulating efficiency.
There is no particular limitation for type of the present invention to the binder, such as can be selected from dextrin, polyvinylpyrrolidine
Ketone, sodium carboxymethylcellulose, methylcellulose, cellulose acetate phthalate, hydroxypropyl cellulose, Arabic gum, peach gum
At least one of with starch.
In the present invention, for the process that mixes raw material to be pelletized with binder, there is no particular limitation, it is preferable that will
The process that raw material to be pelletized is mixed with binder includes：Raw material to be pelletized is placed in binder in fluid bed, is passed through carrier gas.
The present invention is wider to the range of choice of the condition of the mixing, as long as raw material to be pelletized is mixed completely with binder
, those skilled in the art can the specification according to the fluid bed of use and the requirement to mixing select, the present invention
It is not particularly limited, for example, when the volume of fluid bed used is 10L, empty tower gas velocity range 0-2m/s, fluid bed holds
During device diameter 400mm, the time of the mixing can be 3-20min, further preferably 3-10min.
In the present invention, it is preferred in step (2), the carrier gas by humidification by introduced into carrier gas water and/or
Organic solvent is humidified and is made.Water and/or organic solvent are introduced into carrier gas can make water and/or organic solvent by capillary
Effect is condensed between powder surface and gap, under the collision effect provided in fluid bed granulation, into powder surface and powder
Water and/or organic solvent and the binder of body space, which interact to be formed, to be cohered.And the method generally used in the prior art is
Binder and water and/or organic solvent are thoroughly mixed to form binder solution, then by atomized spray on raw material to be pelletized.
Method provided by the invention is not limited by atomized spray rate, and will not collapse bed caused by spray rate height, will not be because of sprinkling
The low influence granulating efficiency of rate.
In the present invention, for the organic solvent, there is no particular limitation, as long as with capillarity, but from molten
Agent volatilization and security standpoint consider that preferably described organic solvent is ethyl alcohol.
In the present invention, there is no particular limitation for the mode of introducing water and/or organic solvent in opposite carrier gas, may be used
The mode of ultrasonic humidifying, can also be by the way of electrical heating humidification.
A preferred embodiment of the invention, fluid mapper process described in step (2) are 80- in relative humidity
It is carried out in the environment of 100%, preferably 90-100%.This kind of preferred embodiment is more advantageous to giving full play to capillary condensation work
With, and then improve granulating efficiency.
It should be noted that in the present invention, when introducing water into carrier gas, the relative humidity refers to fluid bed ring
The percentage of vapour pressure and saturation vapour pressure in border；The measure of the relative humidity is carried out using hygrometer.When drawing into carrier gas
When entering the aqueous solution of organic solvent or organic solvent, the relative humidity is referred in fluidized bed environments, in unit volume gas
Under the quality and saturation state of water and organic solvent in unit volumes of gas the quality of water and organic solvent ratio；It is described opposite
Humidity is calculated according to the decrement of solvent in humidifier.
In the present invention, it is preferred to the temperature of the carrier gas by humidification is 20-60 DEG C, further preferably 30-50
℃.Using this kind of preferred embodiment, it is more advantageous to increasing wetting agent (water and/or the second for entering raw material to be pelletized by condensation
Alcohol) absolute magnitude, and then improve granulating efficiency.
A preferred embodiment of the invention, the time fluidized described in step (2) are 10-20min；Further
Preferably, the time of the fluidisation does not include causing fluidized bed environments relative humidity for 80-100%, preferably 90-100% institutes
The time of consumption, that is, after the relative humidity in fluidized bed environments reaches requirement, continue to fluidize 10-20min.
, according to the invention it is preferred to the raw material to be pelletized includes active component and auxiliary material.The present invention is to the active component
There is no particular limitation with the type of auxiliary material, can be various active components and auxiliary material commonly used in the art.Active component
Also there is no particular limitation with the relative usage of auxiliary material, and those skilled in the art according to the effect of drug and can use drug
Type suitably selected.
In the present invention, it is preferred to contain filler in the auxiliary material, the addition and type of the filler can bases
The requirements such as active component, medicinal effects, disintegrative are chosen, and belong to the exploitation link of drug formulation, the present invention is to it without spy
Other restriction.Conventional use of filler include but not limited to starch, dextrin, lactose, mannitol, microcrystalline cellulose, calcium sulfate,
Silica, calcium carbonate and light magnesium oxide.
Conventional use of filler includes hydrophilic filler and hydrophobic filler, it is preferable that the hydrophilic filler is selected from
At least one of starch, dextrin, lactose, mannitol, microcrystalline cellulose and calcium sulfate；The hydrophobic filler is selected from titanium dioxide
At least one of silicon, calcium carbonate and light magnesium oxide.
A preferred embodiment of the invention when the filler is hydrophobic filler, is introduced into carrier gas
Water is humidified；When the filler is hydrophilic filler, introduced into carrier gas organic solvent or aqueous solutions of organic solvent into
Row humidification.
It should be noted that some fillers (such as dextrin), while also there is bonding, it can also make as binder
With being not required to additionally add in other binders.
In the present invention, the carrier gas can be various carrier gas commonly used in the art, be examined in terms of cost and simplicity
Consider, preferably described carrier gas is air and/or nitrogen.It should be noted that when active component reacts with air and influences it
During performance, then preferred nitrogen is as carrier gas；It is when active component and air do not react on its performance without influencing, then preferred empty
Gas is as carrier gas.
According to the present invention, this method can also include：After step (2), material is dried.To the drying
There is no particular limitation for mode, such as can be to stop humidifying carrier gas, is continually fed into carrier gas 5-15min.
It should be noted that after step (2), if material is dried to be had with drug formulation and shape of product
Relationship.If for example, the material needs that step (2) obtains further mixed with other substances after tabletting, can not be into
Row drying, without the dry progress for being more advantageous to follow-up tabletting.If the material that step (2) obtains includes all groups of product
Point, then material can be dried after step (2), obtain product.
The present invention will be described in detail by way of examples below.
In following embodiment and comparative example, the granulation is 10L in volume, is carried out in the fluid bed of diameter 400mm.
In following embodiment and comparative example, raw material and binder to be pelletized are sieved to obtain by 100 mesh sieve.
Embodiment 1
The present embodiment is used for the method for granulating for illustrating the present invention, is related to the method for granulating of Paracetamol piece.
(1) by 250g paracetamol (active component), 43g starch (hydrophilic filler), 10g carboxymethyl celluloses
Sodium (binder) is placed in fluid bed and opens air inlet (being passed through air), and material is made to be in incipient fluidizing state, mixes 5min；
(2) air (carrier gas) is humidified using electric heater heating ethanol water (mass concentration 95%), made
It obtains the relative humidity in fluid bed and maintains 95%, and 40 DEG C are maintained by the air themperature of humidification, relative humidity reaches will
After asking, 15min is kept；
(3) stop humidifying air, continue to be passed through dry air 5min, then discharge.
Embodiment 2
The present embodiment is used for the method for granulating for illustrating the present invention, is related to the method for granulating of promoting blood circulation and stopping pain electuary.
(1) by 250g elder medicinal extract (active component), 250g dextrin (hydrophilic filler and binder) is placed in fluid bed
In and open air inlet (being passed through air), material is made to be in incipient fluidizing state, mixes 7min；
(2) air (carrier gas) is humidified using electric heater heating ethanol water (mass concentration 90%), made
It obtains the relative humidity in fluid bed and maintains 90%, and 30 DEG C are maintained by the air themperature of humidification, relative humidity reaches will
After asking, 20min is kept；
(3) stop humidifying air, continue to be passed through dry air 5min, then discharge.
Embodiment 3
The present embodiment is used for the method for granulating for illustrating the present invention, is related to the method for granulating of levo morpholine nitre azoles.
(1) by 180g levo morpholine nitre azoles (active component), 200g calcium carbonate (hydrophobicity filler), 5g polyvinyl pyrroles
Alkanone (binder) is placed in fluid bed and opens air inlet (being passed through air), and material is made to be in incipient fluidizing state, mixes 5min；
(2) water is heated using electric heater, and then air (carrier gas) is humidified so that the phase in fluid bed
90% is maintained to humidity, and 30 DEG C, after relative humidity reaches requirement are maintained by the air themperature of humidification, keeps 15min；
(3) stop humidifying air, continue to be passed through dry air 5min, then discharge.
Embodiment 4
According to the method for embodiment 1, the difference is that, in step (2), air is humidified so that the phase in fluid bed
80% is maintained to humidity.
Embodiment 5
According to the method for embodiment 1, the difference is that, in step (2), ethanol water is replaced with to the water of phase homogenous quantities.
Comparative example 1
(1) by 180g levo morpholine nitre azoles (active component), 200g calcium carbonate (hydrophobicity filler) is placed in fluid bed
And air inlet (being passed through air) is opened, material is made to be in incipient fluidizing state, mixes 5min；
(2) stop air inlet, the polyvinylpyrrolidone (binder) that sprinkling (speed 5g/min) mass concentration is 10%
Aqueous solution 50g pelletize；
(3) dry air 5min is passed through, is then discharged.
Comparative example 2
(1) by 180g levo morpholine nitre azoles (active component), 200g calcium carbonate (hydrophobicity filler) is placed in fluid bed
And air inlet (being passed through air) is opened, material is made to be in incipient fluidizing state, mixes 5min；
(2) aqueous solution for the polyvinylpyrrolidone (binder) that sprinkling (speed 6g/min) mass concentration is 10%
120g pelletizes；
(3) dry air 5min is passed through, is then discharged.
Test example 1
The above embodiment of the present invention 1-5 and comparative example 1-2 products obtained therefroms are analyzed by way of grain size screening.Tool
Body analysis method is as follows：
The product that embodiment 1, embodiment 4 and embodiment 5 obtain is sieved using the sieve of 18 mesh and 20 mesh；Embodiment
2 obtained products are sieved using the sieve of 14 mesh and 16 mesh；The product that embodiment 3, comparative example 1-2 are obtained using 18 mesh and
The sieve of 20 mesh is sieved.The effect (particle size uniformity) pelletized by the effect expedition of sieving, concrete outcome are listed in table 1.
Table 1
Method of granulating provided by the invention ensure that binder add in dosage accuracy, solve sprinkling process there may be
Problem of non-uniform, and by way of humidification, it is possible to reduce because of the heat that evaporation latent heat is taken away in spray pattern, so as to drop
The operating time of low whole flow process and energy consumption.
By the comparison of embodiment 1 and embodiment 4 and embodiment 5 it can be found that using the present invention preferably relative humidity
And the mode that specific filler is used cooperatively with specific humidification medium achieves better granulating efficiency.
By the comparison of embodiment 3 and comparative example 1 it can be found that using method of granulating provided by the invention using smaller
The amount of binder can obtain preferable granulating efficiency, and the method that the prior art provides then can not granulating.
By the comparison of embodiment 3 and comparative example 2 it can be found that being reached using method of granulating provided by the invention than existing
The not bad granulating efficiency of technology, it is only necessary to less than half of the quality of binder used using the prior art.
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above
Detail, within the scope of the technical concept of the present invention, a variety of simple variants can be carried out to technical scheme of the present invention, this
A little simple variants all belong to the scope of protection of the present invention.
It is further to note that specific technical features described in the above specific embodiments, in not lance
In the case of shield, can be combined by any suitable means, in order to avoid unnecessary repetition, the present invention to it is various can
The combination of energy no longer separately illustrates.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally
The thought of invention, it should also be regarded as the disclosure of the present invention.
Claims (10)
1. a kind of method of granulating, which is characterized in that this method includes：
(1) raw material to be pelletized with binder under fluidized state is mixed, obtains powder；
(2) under the action of the carrier gas by humidification, the powder is made to continue to fluidize.
2. according to the method described in claim 1, wherein, the mass ratio of raw material and binder to be pelletized is 1-100：1, preferably
2-76：1.
3. according to the method described in claim 1, wherein, the process that raw material to be pelletized is mixed with binder is included：It will wait to make
Grain raw material is placed in binder in fluid bed, is passed through carrier gas.
4. according to the method described in claim 1, wherein, in step (2), the carrier gas by humidification into carrier gas by drawing
Enter water and/or organic solvent is humidified and is made；
Preferably, the organic solvent is ethyl alcohol.
5. the method according to claim 1 or 4, wherein, fluid mapper process described in step (2) is 80- in relative humidity
It is carried out in the environment of 100%, preferably 90-100%；
Preferably, the time fluidized described in step (2) is 10-20min.
6. according to the method described in claim 1,4 or 5, wherein, the temperature of the carrier gas by humidification is 20-60 DEG C, excellent
It is selected as 30-50 DEG C.
7. according to the method described in any one in claim 4-6, wherein, the raw material to be pelletized includes active component and auxiliary
Expect, contain filler in the auxiliary material；
The filler includes hydrophilic filler and hydrophobic filler, and the hydrophilic filler is selected from starch, dextrin, lactose, sweet
Reveal at least one of alcohol, microcrystalline cellulose and calcium sulfate；The hydrophobic filler is selected from silica, calcium carbonate and lightweight oxygen
Change at least one of magnesium；
Preferably, when the filler is hydrophobic filler, into carrier gas, introducing water is humidified；When the filler is parent
During water filler, introduce organic solvent into carrier gas or aqueous solutions of organic solvent is humidified.
8. according to the method described in any one in claim 1-7, wherein, the carrier gas is air and/or nitrogen.
9. according to the method described in any one in claim 1-8, wherein, the binder is selected from dextrin, polyvinyl pyrrole
Alkanone, sodium carboxymethylcellulose, methylcellulose, cellulose acetate phthalate, hydroxypropyl cellulose, Arabic gum, peach
At least one of glue and starch.
10. according to the method described in any one in claim 1-9, wherein, this method further includes：It is right after step (2)
Material is dried.
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| CN201611258988.7A CN108261396B (en) | 2016-12-30 | 2016-12-30 | Granulation method |
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| CN201611258988.7A CN108261396B (en) | 2016-12-30 | 2016-12-30 | Granulation method |
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| CN108261396B CN108261396B (en) | 2021-12-24 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113304117A (en) * | 2021-04-30 | 2021-08-27 | 山东京卫制药有限公司 | Preparation method of sodium valproate sustained-release tablets |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113304117A (en) * | 2021-04-30 | 2021-08-27 | 山东京卫制药有限公司 | Preparation method of sodium valproate sustained-release tablets |
| CN113304117B (en) * | 2021-04-30 | 2023-05-12 | 山东京卫制药有限公司 | Preparation method of sodium valproate sustained release tablet |
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| CN108261396B (en) | 2021-12-24 |
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