CN109820831A - A kind of method of granulating of mecobalamin dispersible tables - Google Patents
A kind of method of granulating of mecobalamin dispersible tables Download PDFInfo
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- CN109820831A CN109820831A CN201910230772.7A CN201910230772A CN109820831A CN 109820831 A CN109820831 A CN 109820831A CN 201910230772 A CN201910230772 A CN 201910230772A CN 109820831 A CN109820831 A CN 109820831A
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- mecobalamin
- granulating
- raw material
- main ingredient
- dispersible tables
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Abstract
The invention discloses a kind of method of granulating of mecobalamin dispersible tables, comprising the following steps: (1) pre-processes: raw material is handled through sieving；(2) it mixes: microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and low-substituted hydroxypropyl cellulose being put into granulator and are uniformly mixed；(3) binder solution containing main ingredient is prepared: Mecobalamin raw material and hydroxypropyl methylcellulose being added in purified water, the binder solution of the main ingredient containing Mecobalamin is made；(4) it pelletizes: the binder solution of the main ingredient containing Mecobalamin is added in the mixture obtained to step (2) in a manner of hydrojet atomization, after addition, wet granular is made in shear granulation；(5) dry；(6) whole grain；(7) total mix.The present invention simplifies preparation process, improves preparation efficiency, raw material is uniformly mixed, to ensure that the quality of final products instead of the technique for preparing mecobalamin dispersible tables particle in such a way that equivalent is progressively increased in the prior art without repeatedly weighing and repeatedly mixing.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular to a kind of method of granulating of mecobalamin dispersible tables.
Background technique
Methylamines drug is used for peripheral nerve disease, due to a lack of megaloblastic anemia caused by vitamin B12 etc.
Treatment.Compared with other vitamin B12 class drugs, Mecobalamin transitivity in nervous system is good, can promote nucleic acid, albumen and rouge
The metabolism of fat.It is pharmacologically the synthesis by promoting nerve cell nucleic acid and protein and neural myelin, to repair
The peripheral nerve being damaged.Clinically, methylamines drug is to the peripheral nerves disease such as diabetes nerve obstacle, polyneuritis
Disease especially has positive effect to numb, pain and paralysis, is the active drug of current such disease of clinical treatment, and secondary
It acts on minimum.In addition, some researches show that, Mecobalamin be effective treatment parkinsonism, Alzheimer syndrome, muscular atrophy and
Neurasthenic potential drug.
In existing mecobalamin dispersible tables, every contains Mecobalamin only 0.5mg, therefore is necessary to ensure that in the actual production process
The mixture homogeneity of product.The pelletization of existing mecobalamin dispersible tables is generally prepared in such a way that equivalent is progressively increased.
This mode is more traditional, needs repeatedly weighing and multiple hybrid manipulation to realize, production process is cumbersome, and production efficiency is lower.
If needing directly prepare using equipment the mixing of raw material, then Mecobalamin raw material can go out not in such a way that equivalent is progressively increased
The phenomenon that now reuniting not can guarantee the quality of final products to influence the homogeneity of product.
Summary of the invention
In order to solve the above technical problems, being replaced the purpose of the present invention is to provide a kind of method of granulating of mecobalamin dispersible tables
For the technique for preparing mecobalamin dispersible tables by the equivalent mode of progressively increasing, and without repeatedly weighing and repeatedly mixing, life is improved
Efficiency is produced, and realizes being uniformly mixed for entire mechanization, product quality is made to have obtained better guarantee.
To realize above-mentioned technical purpose and the technique effect, the invention is realized by the following technical scheme: Yi Zhongjia
The method of granulating of cobalt amine dispersible tablet, wherein prepare the dosage of the raw material of the mecobalamin dispersible tables particle are as follows: 1000 first of every preparation
Cobalt amine dispersible tablet, it is raw materials used include Mecobalamin raw material 0.5g, 2.0~4.0g of hydroxypropyl methylcellulose, microcrystalline cellulose 65.0~
80.0g, 0.2~0.4g of Steviosin, 2.0~4.0g of cross-linked carboxymethyl cellulose sodium, 14.0~16.0g of low-substituted hydroxypropyl cellulose,
50~90ml of purified water, 0.5~2.0g of magnesium stearate；
The method of granulating of the mecobalamin dispersible tables is to carry out under the conditions of being protected from light comprising following steps:
(1) it pre-processes: by Mecobalamin raw material, hydroxypropyl methylcellulose, microcrystalline cellulose, Steviosin, Croscarmellose
Sodium, low-substituted hydroxypropyl cellulose are handled through 80~100 mesh sievings respectively, then accurately weigh sieving according to dosage treated and is each
A raw material；
(2) mix: will by above-mentioned steps (1) treated microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and
Low-substituted hydroxypropyl cellulose is put into granulator and is uniformly mixed；
(3) binder solution containing main ingredient is prepared: will be by step (1) treated Mecobalamin raw material and hypromellose
Element is slowly added in purified water, and is stirred evenly, and the binder solution of the main ingredient containing Mecobalamin is made；
(4) it pelletizes: under the stirring condition of granulator, in the mixture that is obtained to step (2) in a manner of hydrojet atomization
The binder solution for the main ingredient containing Mecobalamin that step (3) are prepared is added, after the binder solution of the main ingredient containing Mecobalamin is added,
Continue to stir, and shear granulation, wet granular is made；
(5) dry: wet granular made from above-mentioned steps (4) is dried with boiling drier；
(6) particle after above-mentioned steps (5) are dry whole grain: is subjected to whole grain using whole grain sieve；
(7) total mix: in above-mentioned steps (6) resulting particle, magnesium stearate is added, is lubricated, after mixing, obtains
To mecobalamin dispersible tables particle.
Preferably, in step (2), the revolving speed of the agitating paddle of granulator is 120~180rpm, shear knife revolving speed is 1200~
2000rpm, the time being stirred are 5~10 minutes.
Preferably, in step (3), the mixing speed in whipping process is 100~150rpm, stirring to Mecobalamin raw material
After being completely dissolved with hydroxypropyl methylcellulose, continue stirring 30~60 minutes.
Preferably, in step (4), the hydrojet speed in hydrojet atomization process is 240~300ml/min, and atomisation pressure is
0.4~0.6bar.
Preferably, the drying temperature in step (5) is 50~70 DEG C, and drying time is 10~30 minutes, after dry, particle
Moisture content be not higher than 4.0%.
Preferably, in step (6), the whole grain revolving speed during whole grain is 2500~3000rpm.
Preferably, lubrication revolving speed is 10~40rpm, and incorporation time is 3~8 minutes.
The beneficial effects of the present invention are: the present invention first by microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and low takes
It is uniformly mixed in granulator for hydroxypropylcellulose, then prepares the binder solution of the main ingredient containing Mecobalamin again, then by the uniform velocity
Mecobalamin main ingredient is added in the mixture of granulator by the mode of hydrojet atomization, the few Mecobalamin main ingredient of this mode amount of making
Relatively uniform is mixed with other raw materials, is dispersed instead of Mecobalamin is prepared in such a way that equivalent is progressively increased in the prior art
The technique of piece particle simplifies preparation process, improves preparation efficiency, raw material mixing is equal without repeatedly weighing and repeatedly mixing
It is even, to ensure that the quality of final products, and the entire mechanization during being uniformly mixed is realized, more improves production
Efficiency.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
Embodiment 1
A kind of method of granulating of mecobalamin dispersible tables, wherein prepare the dosage of the raw material of the mecobalamin dispersible tables particle are as follows:
1000 mecobalamin dispersible tables of every preparation, raw materials used includes Mecobalamin raw material 0.5g, hydroxypropyl methylcellulose 2.0g, microcrystalline cellulose
Plain 80.0g, Steviosin 0.2g, cross-linked carboxymethyl cellulose sodium 2.0g, low-substituted hydroxypropyl cellulose 14.0g, purified water 50ml, it is stearic
Sour magnesium 2g；
The method of granulating of the mecobalamin dispersible tables is to carry out under the conditions of being protected from light stringent comprising following steps:
(1) it pre-processes: by Mecobalamin raw material, hydroxypropyl methylcellulose, microcrystalline cellulose, Steviosin, Croscarmellose
Sodium, low-substituted hydroxypropyl cellulose are handled through 100 mesh sievings respectively, and sieving treated each original is then accurately weighed according to dosage
Material；
(2) mix: will by above-mentioned steps (1) treated microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and
Low-substituted hydroxypropyl cellulose is put into granulator according to dosage and is uniformly mixed, wherein in this process, the stirring of granulator
The revolving speed of paddle is 180rpm, and shear knife revolving speed is 2000rpm, and the time being stirred is 10 minutes；
(3) binder solution containing main ingredient is prepared: will be by step (1) treated Mecobalamin raw material and hypromellose
Element is slowly added in purified water, and is stirred evenly, and the binder solution of the main ingredient containing Mecobalamin is made, wherein in this process, stir
Mixing speed is 150rpm, after stirring is completely dissolved to Mecobalamin raw material and hydroxypropyl methylcellulose, continues stirring 60 minutes；
(4) it pelletizes: under the stirring condition of granulator, in the mixture that is obtained to step (2) in a manner of hydrojet atomization
The binder solution for the main ingredient containing Mecobalamin that step (3) are prepared is added, after the binder solution of the main ingredient containing Mecobalamin is added,
Continue to stir, and shear granulation, wet granular is made；Wherein, the hydrojet speed in hydrojet atomization process is 300ml/min, hydrojet
Pressure is 0.6bar；
(5) dry: wet granular made from above-mentioned steps (4) is dried with boiling drier, drying temperature is 70 DEG C,
Drying time is 30 minutes, and after dry, the moisture content of particle is not higher than 4.0%；
(6) whole grain: carrying out whole grain using the whole grain sieve of pelletizing machine for the particle after above-mentioned steps (5) are dry, whole
Whole grain revolving speed during grain is 3000rpm；
(7) total mix: in above-mentioned steps (6) resulting particle, being added magnesium stearate, be lubricated, and lubrication revolving speed is
40rpm, incorporation time are 8 minutes, after mixing, obtain mecobalamin dispersible tables particle, then carry out tabletting, obtain Mecobalamin
Dispersible tablet.
Embodiment 2
A kind of method of granulating of mecobalamin dispersible tables, wherein prepare the dosage of the raw material of the mecobalamin dispersible tables particle are as follows:
1000 mecobalamin dispersible tables of every preparation, raw materials used includes Mecobalamin raw material 0.5g, hydroxypropyl methylcellulose 4.0g, microcrystalline cellulose
Plain 65.0g, Steviosin 0.4g, cross-linked carboxymethyl cellulose sodium 4.0g, low-substituted hydroxypropyl cellulose 16.0g, purified water 90ml, it is stearic
Sour magnesium 0.5g；
The method of granulating of the mecobalamin dispersible tables is to carry out under the conditions of being protected from light stringent comprising following steps:
(1) it pre-processes: by Mecobalamin raw material, hydroxypropyl methylcellulose, microcrystalline cellulose, Steviosin, Croscarmellose
Sodium, low-substituted hydroxypropyl cellulose are handled through 80 mesh sievings respectively, and sieving treated each original is then accurately weighed according to dosage
Material；
(2) mix: will by above-mentioned steps (1) treated microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and
Low-substituted hydroxypropyl cellulose is put into granulator according to dosage and is uniformly mixed, wherein in this process, the stirring of granulator
The revolving speed of paddle is 120rpm, and shear knife revolving speed is 1200rpm, and the time being stirred is 5 minutes；
(3) binder solution containing main ingredient is prepared: will be by step (1) treated Mecobalamin raw material and hypromellose
Element is slowly added in purified water, and is stirred evenly, and the binder solution of the main ingredient containing Mecobalamin is made, wherein in this process, stir
Mixing speed is 100rpm, after stirring is completely dissolved to Mecobalamin raw material and hydroxypropyl methylcellulose, continues stirring 30 minutes；
(4) it pelletizes: under the stirring condition of granulator, in the mixture that is obtained to step (2) in a manner of hydrojet atomization
The binder solution for the main ingredient containing Mecobalamin that step (3) are prepared is added, after the binder solution of the main ingredient containing Mecobalamin is added,
Continue to stir, and shear granulation, wet granular is made；Wherein, the hydrojet speed in hydrojet atomization process is 240ml/min, hydrojet
Pressure is 0.4bar；
(5) dry: wet granular made from above-mentioned steps (4) is dried with boiling drier, drying temperature is 50 DEG C,
Drying time is 10 minutes, and after dry, the moisture content of particle is not higher than 4.0%.
(6) whole grain: carrying out whole grain using the whole grain sieve of pelletizing machine for the particle after above-mentioned steps (5) are dry, whole
Whole grain revolving speed during grain is 2500rpm；
(7) total mix: in above-mentioned steps (6) resulting particle, magnesium stearate is added, is lubricated, lubricate revolving speed
10rpm incorporation time 3 minutes, after mixing, obtains mecobalamin dispersible tables particle, then carries out tabletting, obtains Mecobalamin point
Discrete piece.
Embodiment 3
A kind of method of granulating of mecobalamin dispersible tables, wherein prepare the dosage of the raw material of the mecobalamin dispersible tables particle are as follows:
1000 mecobalamin dispersible tables of every preparation, raw materials used includes Mecobalamin raw material 0.5g, hydroxypropyl methylcellulose 3.0g, microcrystalline cellulose
Plain 70.0g, Steviosin 0.3g, cross-linked carboxymethyl cellulose sodium 3.0g, low-substituted hydroxypropyl cellulose 15.0g, purified water 80ml, it is stearic
Sour magnesium 1g；
The method of granulating of the mecobalamin dispersible tables is to carry out under the conditions of being protected from light stringent comprising following steps:
(1) it pre-processes: by Mecobalamin raw material, hydroxypropyl methylcellulose, microcrystalline cellulose, Steviosin, Croscarmellose
Sodium, low-substituted hydroxypropyl cellulose are handled through 90 mesh sievings respectively, and sieving treated each original is then accurately weighed according to dosage
Material；
(2) mix: will by above-mentioned steps (1) treated microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and
Low-substituted hydroxypropyl cellulose is put into granulator according to dosage and is uniformly mixed, wherein in this process, the stirring of granulator
The revolving speed of paddle is 150rpm, and shear knife revolving speed is 1500rpm, and the time being stirred is 8 minutes；
(3) binder solution containing main ingredient is prepared: will be by step (1) treated Mecobalamin raw material and hypromellose
Element is slowly added in purified water, and is stirred evenly, and the binder solution of the main ingredient containing Mecobalamin is made, wherein in this process, stir
Mixing speed is 120rpm, after stirring is completely dissolved to Mecobalamin raw material and hydroxypropyl methylcellulose, continues stirring 40 minutes；
(4) it pelletizes: under the stirring condition of granulator, in the mixture that is obtained to step (2) in a manner of hydrojet atomization
The binder solution for the main ingredient containing Mecobalamin that step (3) are prepared is added, after the binder solution of the main ingredient containing Mecobalamin is added,
Continue to stir, and shear granulation, wet granular is made；Wherein, the hydrojet speed in hydrojet atomization process is 280ml/min, hydrojet
Pressure is 0.5bar；
(5) dry: wet granular made from above-mentioned steps (4) is dried with boiling drier, drying temperature is 60 DEG C,
Drying time is 20 minutes, and after dry, the moisture content of particle is not higher than 4.0%.
(6) whole grain: carrying out whole grain using the whole grain sieve of pelletizing machine for the particle after above-mentioned steps (5) are dry, whole
Whole grain revolving speed during grain is 2800rpm；
(7) total mix: in above-mentioned steps (6) resulting particle, magnesium stearate is added, is lubricated, lubricate revolving speed
20rpm incorporation time 5 minutes, after mixing, obtains mecobalamin dispersible tables particle, then carries out tabletting, obtains Mecobalamin point
Discrete piece.
The present invention is instead of the technique for preparing mecobalamin dispersible tables particle in such a way that equivalent is progressively increased in the prior art, nothing
It need to repeatedly weigh and repeatedly mix, simplify preparation process, improve preparation efficiency, raw material is uniformly mixed, to ensure that most
The quality of finished product, and the entire mechanization during being uniformly mixed is realized, more improve production efficiency.
The above description is only an embodiment of the present invention, is not intended to limit the scope of the invention, all to utilize this hair
Equivalent structure or equivalent flow shift made by bright description is applied directly or indirectly in other relevant technology necks
Domain is included within the scope of the present invention.
Claims (7)
1. a kind of method of granulating of mecobalamin dispersible tables, which is characterized in that prepare the use of the raw material of the mecobalamin dispersible tables particle
Amount are as follows: 1000 mecobalamin dispersible tables of every preparation, it is raw materials used including Mecobalamin raw material 0.5g, hydroxypropyl methylcellulose 2.0~
4.0g, 65.0~80.0g of microcrystalline cellulose, 0.2~0.4g of Steviosin, 2.0~4.0g of cross-linked carboxymethyl cellulose sodium, low substitution hydroxyl
Third 14.0~16.0g of cellulose, 50~90ml of purified water, 0.5~2.0g of magnesium stearate；
The method of granulating of the mecobalamin dispersible tables is to carry out under the conditions of being protected from light comprising following steps:
(1) it pre-processes: by Mecobalamin raw material, hydroxypropyl methylcellulose, microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium, low
Replace hydroxypropylcellulose to handle respectively through 80~100 mesh sievings, sieving treated each original is then accurately weighed according to dosage
Material；
(2) it mixes: by above-mentioned steps (1) treated microcrystalline cellulose, Steviosin, cross-linked carboxymethyl cellulose sodium and low will take
It is put into granulator and is uniformly mixed for hydroxypropylcellulose；
(3) binder solution containing main ingredient is prepared: will be slow by step (1) treated Mecobalamin raw material and hydroxypropyl methylcellulose
It is slow to be added in purified water, and stir evenly, the binder solution of the main ingredient containing Mecobalamin is made；
(4) it pelletizes: under the stirring condition of granulator, being added in a manner of hydrojet atomization in the mixture that is obtained to step (2)
The binder solution for the main ingredient containing Mecobalamin that step (3) is prepared continues after the binder solution of the main ingredient containing Mecobalamin is added
Wet granular is made in stirring, and shear granulation；
(5) dry: wet granular made from above-mentioned steps (4) is dried with boiling drier；
(6) particle after above-mentioned steps (5) are dry whole grain: is subjected to whole grain using whole grain sieve；
(7) total mix: in above-mentioned steps (6) resulting particle, magnesium stearate is added, is lubricated, after mixing, obtains first
Cobalt amine dispersible tablet particle.
2. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that in step (2), granulation
The revolving speed of the agitating paddle of machine is 120~180rpm, and shear knife revolving speed is 1200~2000rpm, and the time being stirred is 5~10
Minute.
3. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that in step (3), stir
The mixing speed for mixing process is that 100~150rpm continues to stir after stirring is completely dissolved to Mecobalamin raw material and hydroxypropyl methylcellulose
It mixes 30~60 minutes.
4. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that in step (4), hydrojet
Hydrojet speed in atomization process is 240~300ml/min, and hydrojet pressure is 0.4~0.6bar.
5. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that dry in step (5)
Dry temperature is 50~70 DEG C, and drying time is 10~30 minutes, and after dry, the moisture content of particle is not higher than 4.0%.
6. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that whole in step (6)
Whole grain revolving speed during grain is 2500~3000rpm.
7. a kind of method of granulating of mecobalamin dispersible tables according to claim 1, which is characterized in that in step (7), profit
Speed of trackslipping is 10~40rpm, and incorporation time is 3~8 minutes.
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| JP2008280268A (en) * | 2007-05-09 | 2008-11-20 | Taisho Pharmaceutical Co Ltd | Mecobalamin-containing powder |
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| EP0029534A2 (en) * | 1979-11-22 | 1981-06-03 | Eisai Co., Ltd. | Solid preparation comprising cobamamide or mecobalamin and process for preparing same |
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Application publication date: 20190531 |