CN108653225A - A kind of aulin preparation and preparation method thereof - Google Patents
A kind of aulin preparation and preparation method thereof Download PDFInfo
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- CN108653225A CN108653225A CN201810930075.8A CN201810930075A CN108653225A CN 108653225 A CN108653225 A CN 108653225A CN 201810930075 A CN201810930075 A CN 201810930075A CN 108653225 A CN108653225 A CN 108653225A
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- aulin
- preparation
- disintegrant
- filler
- surfactant
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
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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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
The present invention provides a kind of aulin preparations and preparation method thereof.A kind of aulin preparation, is mainly formed by following component wet granulation：By weight percentage, aulin 19.0%~28.0%, surfactant 0.07%~0.50%, adhesive 1.0%~2.0%, disintegrant 4.0%~9.0%, filler 30.0%~70.0%, lubricant 0.5%~1.2%, water surplus.The present invention is obtained by wetting agent granulation of water, avoids crystal transfer that may be present and toxic side effect, it is ensured that preparation security and validity, and realize faster dissolution.
Description
Technical field
The present invention relates to drug fields, more particularly, to a kind of aulin preparation and preparation method thereof.
Background technology
Aulin (Nimesulide) is the patented product of Helsinn companies of Switzerland, 1985 Italy for the first time on
City is used in more than 50 countries at present, and market scale is more than 1,000,000,000 dollars, including France, Portugal, Greece, Switzerland, ratio
When sharp, Russia, Thailand and Brazil, tablet is listed with trade name Aulin and Mesulid, specification is 100mg (RLD).Ni Meishu
Profit never goes through the evaluation of (FDA) in the U.S., it is without the marketization.The trade name of aulin has Aulin and Mesulid, is
A kind of non-steroidal anti-inflammatory drugs, alternative inhibit cyclooxygenase II, so with significant anti-inflammatory, analgesia and refrigeration function.State
Inside and outside to have a large amount of clinical literature data to show, aulin antipyretic effect compared with brufen, paracetamol rises
Faster, adverse reaction is suitable for effect.
In late 1960s, aulin has been invented by 3M Pharmaceuticals companies of the U.S., and this is new chemical real
Body, synthesis technology obtained United States Patent (USP), Patent No. U.S.P.3856859 in 1974.1980, Helsinn companies of Switzerland
Aulin is obtained in worldwide patent exclusive right.1985, aulin was in Italian Initial Public Offering, at present 50
Multiple countries use, and market scale is more than 1,000,000,000 dollars.
Not soluble in water since aulin is the extremely strong drug of hydrophobicity, water-soluble at room temperature is about 0.01mg/mL.
The water solubility for overcoming aulin difference will bring significant meaning for the application of aulin.
Patent application CN102000050 prepares aulin preparation using ethyl alcohol as diluent, to improve dissolution rate.Due to
Crystal transfer can occur in ethanol solution for aulin, therefore the preparation drug effect that said program obtains reduces, and limits it and answers
With.
In view of this, special propose the present invention.
Invention content
The first object of the present invention is to provide a kind of aulin preparation, and said preparation is obtained by wetting agent granulation of water,
Avoid crystal transfer that may be present and toxic side effect, it is ensured that preparation security and validity, and realize faster dissolution.
The second object of the present invention is to provide the preparation method of above-mentioned aulin preparation, and this method is using non-organic molten
Agent carries out wet granulation, it is ensured that preparation security and validity improve the safety in production process；And preparation process letter
It is single, it is suitble to industrialized production.
In order to solve the above technical problems, the present invention provides following technical schemes：
A kind of aulin preparation, is mainly formed by following component wet granulation：By weight percentage,
Aulin 19.0%~28.0%,
Surfactant 0.07%~0.50%,
Adhesive 1.0%~2.0%,
Disintegrant 4.0%~9.0%,
Filler 30.0%~70.0%,
Lubricant 0.5~1.5%,
Water surplus.
The present invention adds the surfactants of special ratios, described adhesive, the filling using water as wetting agent
The pharmaceutical adjuncts such as agent, the disintegrant and lubricant, are formed by preparation and have the following effects that：
One, crystal transfer will not occur in water for aulin, therefore avoid drug effect reduction, poison that crystal transfer is brought
The problems such as side effect increases, while improving production security；
Two, there is faster dissolution rate, auxiliary material used can accelerate the dissolution of aulin.
In addition, the raw material used in the above preparation can also advanced optimize, it is specific as follows.
For the proportioning of each ingredient in preparation, it is preferable that by weight percentage,
Aulin 23.0%~28.0%, preferably 19%~25.0%, preferably 19%~23.0% or 19%~
22.0% or 19%~22.0% or 19%~21.0% etc.；
Surfactant 0.20%~0.50%, preferably 0.2%~0.23%, preferably 0.20%~0.40%, 0.20%
~0.30% or 0.20%~0.25% or 0.20%~0.22% etc.,
Adhesive 1.3%~2.0%, preferably 1.3%~1.5%, preferably 1.3%~1.45% or 1.3%~1.4%；
Disintegrant 4.5%~9.0%, preferably 4.6%~7%, preferably 4.6%~6% or 4.6%~5%,
Filler 30.0%~70.0%, preferably 48%~50%, preferably 48%~49%,
Lubricant 0.5~1.2%, preferably 0.5~0.7%, preferably 0.5~0.6%,
Water preferably 24%~35%, preferably 24%~28% or 24%~27% or 24%~28% or 24%~
25%.
The combined effect of selection for auxiliary material, different type auxiliary material is different, main to influence dissolution rate and particle dispersion
Degree, safety and ingredient etc..By screening, preferably with Types Below.
Preferably, described adhesive be sodium carboxymethylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose,
It is one or more in gelatin and polyvinylpyrrolidone etc., preferred hydroxypropyl cellulose.
Preferably, the lubricant is magnesium stearate, superfine silica gel powder, talcum powder, hydrogenated vegetable oil, polyethylene glycol and bay
It is one or more in alcohol magnesium sulfate, preferred magnesium stearate；
Preferably, the disintegrant is low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone
With one or more in croscarmellose sodium, preferred sodium carboxymethyl starch；
Preferably, the filler is microcrystalline cellulose, calcium sulfate, calcium monohydrogen phosphate, medicinal calcium carbonate, mannitol and lactose
In it is one or more, it is one or more in preferably microcrystalline cellulose and lactose；Preferably microcrystalline cellulose PH101, PH102,
PH103, PH 105, PH301 or PH302 etc., preferably lactose 200M, while lactose and microcrystalline cellulose is added can generate collaboration
Effect greatly improves drug-eluting rate.
Preferably, the Surfactant SDS, neopelex, amino acid pattern surface-active
It is one or more in agent, betaine type amphoteric surfactant and docusate sodium, preferably sodium dodecyl sulfate.
In addition, the granularity of aulin itself can also influence dissolution rate, through screening, preferably particle diameter distribution is：Grain size 5~
20 μm of accounting 90wt% or more.
The production technology of the preparation of the present invention is wet granulation, following sequence can be used in mixed raw material, to improve original
The dispersion degree of material：
Step A：According to formula ratio, first described adhesive is mixed with water, binder solution is made；
Step B：By the disintegrant of aulin, the surfactant, the filler and partial amount and institute
Binder solution mixing is stated, wet granulation is dry, obtains medicine-containing particle；
Step C：The medicine-containing particle is mixed with the lubricant and remaining disintegrant.
Adhesive dissolving first can be improved into dispersion degree between raw material, make bonding between particle evenly, conducive to making
Grain.
Disintegrant is divided into two steps to be added to improve the dissolution rate and disintegration of drug, when actual production can also be in step
The disintegrant of whole amount is added in rapid B.
In addition, the preparation type of the present invention is not limited only to granule, tablet, capsule etc. can also be made.It is preferred that in step C
Tablet is made in tabletting later.Tablet is easier out storage and transport.
The flow of above method is simple, easily industrialization promotion.
Wherein, stirring shearing condition can influence the physical chemical characteristics such as size, porosity and the frangible performance of particle, therefore shear
Condition is also critically important for preparation, through screening, using the following conditions.
Preferably, the method for wet granulation is in the step B：3~5min of stirring shearing at 20HZ~30HZ.
It preferably, can be with whole grain after drying.
Preferably, the method for the drying is：Fluidized bed drying, drying temperature is 60~95 DEG C, preferably 60~65 DEG C, excellent
Select 80~95 DEG C；It is preferred that drying to water content is 4wt% or less.
The present invention uses the drying mode of fluid bed, can reach following technique effect：
One, drying efficiency is high；
Two, grain graininess is evenly；
Three, energy loss is reduced；
Four, reduce the quality of the pharmaceutical preparations caused by crossing drying for a long time to change.
Preferably, further include tabletting after the step C.
Preferably, in the step B, by the disintegrant of aulin, surfactant, filler and partial amount and institute
Stating the method that binder solution mixes is：First the disintegrant of aulin, surfactant, filler and partial amount is done
It is mixed, then it is mixed with described adhesive solution.
To sum up, compared with prior art, invention achieves following technique effects：
(1) quality risk that avoids drug crystal forms transformation and may bring；
(2) drug-eluting rate is improved；
(3) production security is improved；
(4) production efficiency is improved；
(5) pharmaceutical adjunct for using general type, improves safety, reduces production cost.
Specific implementation mode
Technical scheme of the present invention is clearly and completely described below in conjunction with specific implementation mode, but ability
Field technique personnel will be understood that following described embodiments are some of the embodiments of the present invention, instead of all the embodiments,
It is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.Based on the embodiments of the present invention, the common skill in this field
The every other embodiment that art personnel are obtained without making creative work belongs to the model that the present invention protects
It encloses.The person that is not specified actual conditions in embodiment, carries out according to conventional conditions or manufacturer's recommended conditions.Agents useful for same or instrument
Production firm person is not specified, is the conventional products that can be obtained by commercially available purchase.
Aulin particle diameter distribution used in following embodiment is：5~20 μm of accounting 90wt% or more of grain size.
Embodiment 1
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
Sodium mixing after, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred,
25HZ shear granulations 4min, 24 mesh sieve wet granular whole grain, 60-65 DEG C of drying to moisture less than 40 mesh sieves after 4.0% and with
Lubricant and additional disintegrant are mixed, and tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection
It is qualified.
This preparation dissolves out result such as the following table 1.
Stripping curve result in 1 embodiment of table, 1 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 15min | 20min | 45min |
| PH7.4+0.5%tween80 | 59.60 | 75.01 | 80.86 | 84.12 | - |
| PH6.8+1.0%tween80 | 45.81 | 67.82 | 76.33 | - | 88.09 |
Embodiment 2
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
Sodium mixing after, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred,
25HZ shear granulations 4min, 24 mesh sieve wet granular whole grain, 60-65 DEG C of drying to moisture less than 40 mesh sieves after 4.0% and with
Lubricant and additional disintegrant are mixed, and tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection
It is qualified.
This preparation dissolves out result such as the following table 2.
Stripping curve result in 2 embodiment of table, 2 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 15min | 45min |
| PH6.8+1.0%tween80 | 51.75 | 75.60 | 79.72 | 86.31 |
Embodiment 3
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
Sodium mixing after, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred,
25HZ shear granulations 4min, 24 mesh sieve wet granular whole grain, 80-95 DEG C of drying to moisture less than 40 mesh sieves after 4.0% and with
Lubricant and additional disintegrant are mixed, and tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection
It is qualified.
This preparation dissolves out result such as the following table 3.
Stripping curve result in 3 embodiment of table, 3 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 15min | 20min | 45min |
| PH7.4+0.5%tween80 | 65.31 | 79.38 | 84.72 | 87.54 | - |
| PH6.8+1.0%tween80 | 49.42 | 69.88 | 76.45 | - | 88.99 |
Embodiment 4
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
Sodium mixing after, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred,
30HZ shear granulations 4min, 24 mesh sieve wet granular whole grain, 80-95 DEG C of drying to moisture less than 40 mesh sieves after 4.0% and with
Lubricant and additional disintegrant are mixed, and tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection
It is qualified.
This preparation dissolves out result such as the following table 4.
4 embodiment of table, 4 nimesulide dispersible tablet stripping curve result
| Dissolution medium | 5min | 10min | 15min | 45min |
| PH6.8+1.0%tween80 | 51.78 | 77.69 | 86.03 | 96.36 |
Embodiment 5
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
Sodium mixing after, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred,
20HZ shear granulations 3min, after 80-95 DEG C of drying to moisture is less than 4.0% 40 mesh concussion sieve whole grain and with lubricant and additional collapse
Solution agent is mixed, and tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 5.
Stripping curve result in 5 embodiment of table, 5 each medium of nimesulide dispersible tablet
Embodiment 6
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
After sodium mixing, stirring 4min in wet granulator, which is added, to be made to be uniformly mixed, and hydroxypropyl cellulose aqueous solution is added and is stirred, cuts
Cutting grain 3min, after 80-95 DEG C of drying to moisture is less than 4.0% 40 mesh concussion sieve whole grain and with lubricant and additional disintegrant into
Row mixing, tabletting is carried out according to theoretical content piece again.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 6.
Stripping curve result in 6 embodiment of table, 6 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 15min | 20min |
| PH7.4+0.5%tween80 | 60.20 | 75.22 | 81.34 | 85.25 |
Embodiment 7
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
After sodium mixing, stirring 4min in wet granulator, which is added, to be made to be uniformly mixed, and hydroxypropyl cellulose aqueous solution is added and is stirred, cuts
Cutting grain 3min, after 80-95 DEG C of drying to moisture is less than 4.0% 40 mesh concussion sieve whole grain and with lubricant and additional disintegrant into
Row mixing, tabletting is carried out according to theoretical content piece again.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 7.
Stripping curve result in 7 embodiment of table, 7 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 15min | 20min |
| PH7.4+0.5%tween80 | 61.25 | 76.58 | 83.24 | 86.25 |
Embodiment 8
Difference lies in pharmaceutical adjunct used is different from embodiment 5：
Preparation process：By aulin raw material and lactose, microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxymethylstarch
After sodium mixing, stirring 4min in wet granulator, which is added, to be made to be uniformly mixed, and hydroxypropyl methylcellulose aqueous solution is added and is stirred, cuts
Cutting grain 3min, after 80-95 DEG C of drying to moisture is less than 4.0% 40 mesh concussion sieve whole grain and with lubricant and additional disintegrant into
Row mixing, tabletting is carried out according to theoretical content piece again.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 8.
Stripping curve result in 8 embodiment of table, 8 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 20min |
| PH7.4+0.5%tween80 | 60.21 | 79.64 | 88.45 |
Embodiment 9
Preparation process：Aulin raw material and microcrystalline cellulose, lauryl sodium sulfate, interior plus carboxyrnethyl starch sodium are mixed
Afterwards, be added wet granulator in stirring 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred, shear granulation
The concussion of 40 mesh is sieved whole grain and is mixed with lubricant and additional disintegrant after 3min, 80-95 DEG C of dryings are less than 4.0% to moisture
It closes, tabletting is carried out again according to theoretical content piece.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 9.
Stripping curve result in 9 embodiment of table, 9 each medium of nimesulide dispersible tablet
Embodiment 10
Preparation process：After aulin raw material and lactose, lauryl sodium sulfate, interior plus carboxyrnethyl starch sodium are mixed, add
Enter in wet granulator stir 4min make to be uniformly mixed, be added hydroxypropyl cellulose aqueous solution be stirred, shear granulation 3min,
The concussion of 40 mesh is sieved whole grain and is mixed with lubricant and additional disintegrant after 80-95 DEG C of drying is less than 4.0% to moisture, according to
Theoretical content piece carries out tabletting again.Plain piece uniformity of dosage units, friability detection are qualified.
This preparation dissolves out result such as the following table 10.
Stripping curve result in 10 embodiment of table, 10 each medium of nimesulide dispersible tablet
| Dissolution medium | 5min | 10min | 20min |
| PH7.4+0.5%tween80 | 63.21 | 79.45 | 87.46 |
Comparing embodiment 5 is with embodiment 9 and 10 it is found that lactose and microcrystalline cellulose have synergistic effect, the two in preparation
The dissolution rate of drug is faster when using simultaneously.
Finally it should be noted that：The above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Present invention has been described in detail with reference to the aforementioned embodiments for pipe, it will be understood by those of ordinary skill in the art that：Its according to
So can with technical scheme described in the above embodiments is modified, either to which part or all technical features into
Row equivalent replacement；And these modifications or replacements, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (10)
1. a kind of aulin preparation, which is characterized in that mainly formed by following component wet granulation：By weight percentage,
Aulin 19.0%~28.0%,
Surfactant 0.07%~0.50%,
Adhesive 1.0%~2.0%,
Disintegrant 4.0%~9.0%,
Filler 30.0%~70.0%,
Lubricant 0.5~1.5%,
Water surplus.
2. aulin preparation according to claim 1, which is characterized in that by weight percentage,
Aulin 23.0%~28.0%, preferably 19%~25.0%,
Surfactant 0.20%~0.50%, preferably 0.2%~0.23%,
Adhesive 1.3%~2.0%, preferably 1.3%~1.5%,
Disintegrant 4.5%~9.0%, preferably 4.6%~7%,
Filler 30.0%~70.0%, preferably 48.0%~50.0%,
Lubricant 0.5~1.2%, preferably 0.5~0.7%,
Water surplus.
3. aulin preparation according to claim 1, which is characterized in that described adhesive be sodium carboxymethylcellulose,
It is one or more in hydroxypropyl cellulose, methylcellulose, ethyl cellulose, gelatin and polyvinylpyrrolidone etc., preferably
Hydroxypropyl cellulose.
4. aulin preparation according to claim 1, which is characterized in that the lubricant is magnesium stearate, micro mist silicon
It is one or more in glue, talcum powder, hydrogenated vegetable oil, polyethylene glycol and magnesium laurylsulfate, preferred magnesium stearate；
Preferably, the disintegrant is low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone and friendship
Join one or more in sodium carboxymethylcellulose, preferred sodium carboxymethyl starch；
Preferably, the filler is in microcrystalline cellulose, calcium sulfate, calcium monohydrogen phosphate, medicinal calcium carbonate, mannitol and lactose
It is one or more, it is one or more in preferably microcrystalline cellulose and lactose；
Preferably, the Surfactant SDS, neopelex, amino acid type surfactant,
It is one or more in betaine type amphoteric surfactant and docusate sodium, preferably sodium dodecyl sulfate.
5. aulin preparation according to claim 1, which is characterized in that the particle diameter distribution of aulin is：Grain size 5~
20 μm of accounting 90wt% or more.
6. the preparation method of claim 1-5 any one of them aulin preparations, which is characterized in that include the following steps：
Step A：According to formula ratio, first described adhesive is mixed with water, binder solution is made；
Step B：The disintegrant of aulin, the surfactant, the filler and partial amount is glued with described
Mixture solution mixes, wet granulation, dry, obtains medicine-containing particle；
Step C：The medicine-containing particle is mixed with the lubricant and remaining disintegrant.
7. preparation method according to claim 6, which is characterized in that the method for wet granulation is in the step B：
3~5min of stirring shearing under 20HZ~30HZ.
8. preparation method according to claim 6, which is characterized in that the method for the drying is：Fluidized bed drying, it is dry
Temperature is 60~95 DEG C, preferably 60~65 DEG C, preferably 80~95 DEG C；It is preferred that drying to water content is 4wt% or less.
9. preparation method according to claim 6, which is characterized in that after the step C further include tabletting.
10. preparation method according to claim 6, which is characterized in that in the step B, by aulin, surface-active
The method that the disintegrant of agent, filler and partial amount is mixed with described adhesive solution is：First by aulin, surface-active
The disintegrant of agent, filler and partial amount is dry-mixed, then mixes it with described adhesive solution.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114105839A (en) * | 2020-08-27 | 2022-03-01 | 湖北舒邦药业有限公司 | Pretreatment method of bulk drug and composition thereof |
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| CN101431992A (en) * | 2006-04-24 | 2009-05-13 | 万能药生物有限公司 | Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof |
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|---|---|---|---|---|
| WO2002067894A2 (en) * | 2001-02-27 | 2002-09-06 | Ranbaxy Laboratories Limited | Fast dissolving tablets of cyclooxygenase-2 enzyme inhibitors |
| CN101431992A (en) * | 2006-04-24 | 2009-05-13 | 万能药生物有限公司 | Novel low dose pharmaceutical compositions comprising nimesulide, preparation and use thereof |
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