CN109044983A - A kind of tablet and preparation method thereof containing Febustat - Google Patents
A kind of tablet and preparation method thereof containing Febustat Download PDFInfo
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
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Abstract
The present invention relates to a kind of tablet and preparation method thereof containing Febustat, belongs to field of pharmaceutical preparations.Tablet provided by the invention containing Febustat, the tablet or label include active component Febustat, filler, disintegrating agent, adhesive and lubricant, aqueous solvent is first dissolved the binder in its preparation process or binder solution is made in ethanol water in the mixed solvent, then it mixes and pelletizes with active component, filler and partial disintegration agent, then carry out tabletting with remaining disintegrating agent and mix lubricant.Active component Febustat is A crystal form, is crushed using air-flow micropowder technology, and at 10 μm, hereinafter, the tablet of preparation has, dissolution is rapid, quality is stable, bioavilability is high for average grain diameter, and the advantages such as disintegration of tablet speed height grind product no less than original.The tablet prepared using method of the invention, tablet are stablized, simple process, strong operability.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of tablet and preparation method thereof containing Febustat.
Background technique
Febustat (Febuxostat) is first non-fast alcohols a new generation xanthine oxidase inhibitor of Huang, is passed through
Inhibit the activity of xanthine oxidase, preventing and reduce hypoxanthine, xanthine synthesis uric acid to reach reduces blood uric acid
Purpose；Clinical test shows that its tolerance is good, can be effectively controlled hematuria levels, clinically for treating the excessively high disease of uric acid (pain
Wind)；Usage and dosage is that once a day, a 40mg or 80mg, beginning recommended dose is daily 40mg, after medication 2 weeks, if serum is urinated
Acid value is higher than 6mg/dL, can increase dosage to 80mg/ days.
The medicine is listed in 2004 beginning of the years in Japanese publication by Japanese Di Ren company first, and the end of the year is on U. S. application
City, IPSEN company apply listing in Europe, and FDA is listed in approval in 2 months 2009 in the U.S..It is entitled in U.S.'s traded commodity
ULORIC, specification are 40mg and 80mg；In the entitled ADENURIC of European traded commodity, specification is 80mg and 120mg, and dosage form is
Tablet.
Summary of the invention
It is rapid, complete the purpose of the present invention is on the basis of existing technology, providing a kind of no surfactant additive, dissolution
Entirely, quality is stable, the high tablet containing Febustat of bioavilability.
Another mesh of the invention is to provide a kind of preparation method of above-mentioned tablet.
Technical scheme is as follows:
A kind of tablet containing Febustat, the tablet or label include active component Febustat, filler, disintegration
Agent, adhesive and lubricant, first dissolve the binder in aqueous solvent in its preparation process or ethanol water in the mixed solvent is made
Then binder solution is mixed and is pelletized with active component, filler and partial disintegration agent, then with remaining disintegrating agent and lubrication
Agent mixing carries out tabletting.
In a preferred embodiment, the active component Febustat that the present invention uses is A crystal form, using air-flow micropowder technology
It crushes, average grain diameter is at 10 μm or less.
The active component Febustat that the present invention uses is crushed, average grain diameter is 10 for A crystal form using air-flow micropowder technology
μm hereinafter, optimize the proportion between each component simultaneously, under the cooperation of other conditions, the tablet dissolution of preparation rapidly, completely, matter
Amount is stablized, bioavilability is high, grinds product no less than original.
In a kind of more preferable scheme, in the preparation process of Febustat tablet, dissolve the binder in aqueous solvent or
Binder solution is made in ethanol water in the mixed solvent.Herein, the ethyl alcohol water mixed solvent that ethyl alcohol water mixed solvent is 40~80%；
Further preferably 50~75% ethyl alcohol water mixed solvent；It is still more preferably 50% ethyl alcohol water mixed solvent.
Tablet provided by the invention containing Febustat, the tablet or label include active component Febustat and auxiliary
Material.The auxiliary material that the present invention uses includes filler, disintegrating agent, adhesive and lubricant.Wherein, filler is that lactose and crystallite are fine
Dimension element；Disintegrating agent is croscarmellose sodium；Adhesive is hydroxypropylcellulose；Lubricant is magnesium stearate.
The present invention is in the preparation process of Febustat tablet, and wherein auxiliary material disintegrating agent (croscarmellose sodium) divides
It is added twice, before granulation, the partial disintegration agent of addition adds to be interior, the remaining disintegrating agent after granulation, with mix lubricant addition
It is additional.
The invention patent solves raw material easy to reunite by optimization formulation technique, poor fluidity, is not easy the problems such as dispersing, and examines
It is poor to consider Febustat dissolution of raw material, and be pH dependence, it has been disclosed that patent of invention In Vitro Dissolution evaluation method do not have
Certain distinction now filters out a plurality of dissolution medium with distinction and evaluates this preparation invention prescription, through long-term
And acceleration for stabilization Journal of Sex Research, the results showed that finished dosage form quality is stablized, reliably.
In a preferred embodiment, the tablet containing Febustat that the present invention mentions, the tablet include label and coating,
Wherein label includes the component of following parts by weight: 15~45 parts of Febustat, 15~60 parts of lactose, and microcrystalline cellulose 30~105
Part, 3~30 parts of croscarmellose sodium (interior to add 1.5~15 parts, additional 1.5~15 parts), hydroxypropylcellulose 0.15~15
Part, 0.15~3 part of magnesium stearate.
In a kind of more preferable scheme, the tablet containing Febustat that the present invention mentions, which includes label and packet
Clothing, wherein label includes the component of following parts by weight: 30~45 parts of Febustat, 30~50 parts of lactose, microcrystalline cellulose 70~
100 parts, 10~30 parts of croscarmellose sodium (interior to add 5~15 parts, additional 5~15 parts), 0.5~2 part of hydroxypropylcellulose,
0.5~2 part of magnesium stearate.
In a kind of particularly preferred scheme, the tablet containing Febustat that the present invention mentions, the tablet include label and
Coating, wherein label includes the component of following parts by weight: 40 parts of Febustat, 40 parts of lactose, 85~90 parts of microcrystalline cellulose, being handed over
Join 15~20 parts of sodium carboxymethylcellulose (interior to add 10 parts, additional 5~10 parts), 1.0 parts of hydroxypropylcellulose, 1.0 parts of magnesium stearate.
Further, croscarmellose sodium (interior to add) and croscarmellose sodium (additional) weight ratio are 1:
1~5:1, preferably 1:1~2:1.
A kind of preparation method of the tablet containing Febustat, it includes the following steps:
(1) it pre-processes: active component is crushed using micropowder technology, it is spare after auxiliary material sieving；
(2) preparation of binder solution: dissolving the binder in aqueous solvent or adhesive is made in ethanol water in the mixed solvent
Solution；
(3) pelletizing press sheet is coated: after mixing by active component, filler and partial disintegration agent (interior to add), slowly being added
Enter softwood processed in binder solution, then pelletize, after the drying of obtained wet granular, with remaining disintegrating agent (additional) and lubricant
Mixing, tabletting, coating.
The auxiliary material that the present invention uses includes filler, disintegrating agent, adhesive and lubricant.Wherein, filler be lactose and
Microcrystalline cellulose；Disintegrating agent is croscarmellose sodium；Adhesive is hydroxypropylcellulose；Lubricant is magnesium stearate.
The active component Febustat that the present invention uses is crushed, average grain diameter is 10 for A crystal form using air-flow micropowder technology
μm or less.
In the preparation process of Febustat tablet, dissolves the binder in aqueous solvent or ethanol water in the mixed solvent is made
Binder solution.In a preferred embodiment, the ethyl alcohol water mixed solvent that ethyl alcohol water mixed solvent is 40~80%；It is further excellent
It is selected as 50~75% ethyl alcohol water mixed solvent；It is still more preferably 50% ethyl alcohol water mixed solvent.
The present invention is in the preparation process of Febustat tablet, and wherein auxiliary material disintegrating agent (croscarmellose sodium) divides
It is added twice, before granulation, the partial disintegration agent of addition adds to be interior, the remaining disintegrating agent after granulation, with mix lubricant addition
It is additional.
Further, croscarmellose sodium (interior to add) and croscarmellose sodium (additional) weight ratio are 1:
1~5:1, preferably 1:1~2:1.
In a kind of more preferable scheme, 20 mesh are pelletized after softwood is obtained in step (3), 16~20 mesh whole grains after drying, packet
Clothing uses stomach dissolution type thin film coating material.
In the preparation method of tablet, preferred pelletization is as follows: take hydroxypropylcellulose, be added appropriate aqueous solvent or
50% ethanol water in the mixed solvent, it is spare after stirring and dissolving；By Febustat, microcrystalline cellulose, lactose, the interior crosslinking carboxylic first added
Base sodium cellulosate is uniformly mixed, and is slow added into above-mentioned binder solution, the granulation of 20 mesh, 16 mesh or 20 mesh whole grains.
In the preparation method of tablet, drying mode is forced air drying technique, and drying temperature is 50~70 DEG C, drying time
For 3~5h, moisture is not higher than 5%.
In a preferred embodiment, drying temperature is 50~60 DEG C.
Tablet provided by the invention containing Febustat uses in reasonable proportional region and disintegrating agent is added twice,
Improve disintegration rate, the dissolution rate of tablet, active principle content and the uniformity, bioavilability.
For the present invention in granulation, using forced air drying technique, not only drying time is short, but also particle compressibility is preferable, piece
Agent disintegration is very fast, improves the dissolution rate of active constituent.
Using technical solution of the present invention, advantage is as follows:
Tablet provided by the invention containing Febustat, active component Febustat is A crystal form, using air-flow micro mist skill
Art crushing, at 10 μm, hereinafter, the tablet of preparation has, dissolution is rapid, complete, quality is stable, bioavilability is high for average grain diameter,
The advantages such as disintegration of tablet speed height, grind product no less than original.The tablet prepared using method of the invention, tablet are stablized, technique
Simply, strong operability.
Specific embodiment
The tablet of the invention containing Febustat is further described by following embodiment, but these embodiments
It does not form any restrictions to the present invention.
Embodiment 1
Tablet formulation (1000 preparation unit amount):
Preparation method:
1, it pre-processes
1.1 ingredients: being weighed the Febustat raw material crossed through air-flow crushing by formula ratio, and crystal form is A crystal form, and average grain diameter exists
10 μm hereinafter, auxiliary material, lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate cross 80 meshes respectively, spare.
The preparation of 1.2 binder solutions: taking formula ratio hydroxypropylcellulose to be added in 99g purified water, standby after stirring and dissolving
With.
2, it pelletizes, dry, whole grain
2.1 are uniformly mixed Febustat, lactose, microcrystalline cellulose, the interior croscarmellose sodium added, slowly add
Enter hydroxypropylcellulose aqueous solution softwood, the granulation of 20 mesh.
2.2 are placed in wet granular in air dry oven, and 60 DEG C of dryings to pellet moisture are not higher than 5%, 20 mesh whole grains.
3, total mix
Particle is taken to mix 10 minutes with the additional croscarmellose sodium and magnesium stearate of formula ratio, intermediate physical examination
It surveys.4, tabletting
According to intermediate testing result stator weight, the formed punch tabletting of Ф 8.0mm scrobicula, hardness: 60N~100N are selected；Slice weight
Difference: ± 5.0%.
5, it is coated
The preparation of 5.1 coating solutions: weighing 7.5g stomach dissolution type film coating powder, be slowly added into 86.25g purified water, to
After coating powder is all added and is uniformly dispersed, continue stirring 45 minutes to get；
5.2 set plain piece in high-efficiency coating machine, coating weight gain to 2%~4%.
Comparative example 1
Tablet formulation (1000 preparation unit amount):
Preparation method:
1, it pre-processes
1.1 ingredients: being weighed the Febustat raw material crossed through air-flow crushing by formula ratio, and crystal form is A crystal form, and average grain diameter exists
10 μm hereinafter, auxiliary material, lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate cross 80 meshes respectively, spare.
The preparation of 1.2 binder solutions: taking formula ratio hydroxypropylcellulose to be added in 99g purified water, standby after stirring and dissolving
With.
2, it pelletizes, dry, whole grain
2.1 are uniformly mixed Febustat, lactose, microcrystalline cellulose, the interior croscarmellose sodium added, slowly add
Enter hydroxypropylcellulose aqueous solution softwood, the granulation of 20 mesh.
2.2 are placed in wet granular in air dry oven, and 60 DEG C of dryings to pellet moisture are not higher than 5%, 20 mesh whole grains.
3, total mix
Particle is taken to mix with the magnesium stearate of formula ratio 10 minutes, intermediate detection.
4, tabletting
According to intermediate testing result stator weight, the formed punch tabletting of Ф 8.0mm scrobicula, hardness: 60N~100N are selected；Slice weight
Difference: ± 5.0%.
5, it is coated
The preparation of 5.1 coating solutions: weighing 7.5g stomach dissolution type film coating powder, be slowly added into 86.25g purified water, to
After coating powder is all added and is uniformly dispersed, continue stirring 45 minutes to get；
5.2 set plain piece in high-efficiency coating machine, coating weight gain to 2%~4%.
Comparative example 2
Tablet formulation (1000 preparation unit amount):
Preparation method:
1, it pre-processes
1.1 ingredients: being weighed the Febustat raw material crossed through air-flow crushing by formula ratio, and crystal form is A crystal form, and average grain diameter exists
10 μm hereinafter, auxiliary material, lactose, microcrystalline cellulose, magnesium stearate crosses 80 meshes respectively, spare.
The preparation of 1.2 binder solutions: formula ratio hydroxypropylcellulose is taken to be added in 50% ethanol water of 99g, stirring and dissolving
Afterwards, spare.
2, it pelletizes, dry, whole grain
2.1 are uniformly mixed Febustat, lactose, microcrystalline cellulose, are slowly added to the ethanol water of hydroxypropylcellulose
Softwood processed, the granulation of 20 mesh.
2.2 are placed in wet granular in air dry oven, and 60 DEG C of dryings to pellet moisture are not higher than 5%, 20 mesh whole grains.
3, total mix
Particle is taken to mix 10 minutes with the additional croscarmellose sodium and magnesium stearate of formula ratio, intermediate physical examination
It surveys.4, tabletting
According to intermediate testing result stator weight, the formed punch tabletting of Ф 8.0mm scrobicula, hardness: 60N~100N are selected；Slice weight
Difference: ± 5.0%.
5, it is coated
The preparation of 5.1 coating solutions: weighing 7.5g stomach dissolution type film coating powder, be slowly added into 86.25g purified water, to
After coating powder is all added and is uniformly dispersed, continue stirring 45 minutes to get；
5.2 set plain piece in high-efficiency coating machine, coating weight gain to 2%~4%.
Comparative example 3
Tablet formulation (1000 preparation unit amount):
Preparation method:
1, it pre-processes
1.1 ingredients: being weighed the Febustat raw material crossed through air-flow crushing by formula ratio, and crystal form is A crystal form, and average grain diameter exists
10 μm hereinafter, auxiliary material, lactose, microcrystalline cellulose, magnesium stearate crosses 80 meshes respectively, spare.
The preparation of 1.2 binder solutions: formula ratio hydroxypropylcellulose is taken to be added in 50% ethanol water of 99g, stirring and dissolving
Afterwards, spare.
2, it pelletizes, dry, whole grain
2.1 are uniformly mixed Febustat, lactose, microcrystalline cellulose, are slowly added to the ethanol water of hydroxypropylcellulose
Softwood processed, the granulation of 20 mesh.
2.2 are placed in wet granular in air dry oven, and 60 DEG C of dryings to pellet moisture are not higher than 5%, 20 mesh whole grains.
3, total mix
Particle is taken to mix with the magnesium stearate of formula ratio 10 minutes, intermediate detection.
4, tabletting
According to intermediate testing result stator weight, the formed punch tabletting of Ф 8.0mm scrobicula, hardness: 60N~100N are selected；Slice weight
Difference: ± 5.0%.
5, it is coated
The preparation of 5.1 coating solutions: weighing 7.5g stomach dissolution type film coating powder, be slowly added into 86.25g purified water, to
After coating powder is all added and is uniformly dispersed, continue stirring 45 minutes to get；
5.2 set plain piece in high-efficiency coating machine, coating weight gain to 2%~4%.
It test data and is analyzed as follows:
1, dissolution curve comparative study of the embodiment 1 in a plurality of dissolution medium
Detection method: according to dissolution method (four general rules of Chinese Pharmacopoeia version in 2015,0,931 second method) respectively with
PH5.5 phosphate buffer, 0.1NHCL+0.5%SDS solution, 0.15% aqueous solution, pH4.5 acetate buffer+0.3%
SDS solution is dissolution medium, and volume 900ml, revolving speed is 75 turns per minute, is operated according to methods, respectively at 5,10,15,30,45,
60,90 minutes, sample detection ground product with original(A24189) as a comparison, as shown in table 1.
1 embodiment of table, 1 dissolution curve testing result
1 prescription of embodiment detects through a plurality of dissolution curve and grinds comparison with original, and similar factors illustrate this 70 or more
Preparation prescription technique is preferable, reliable in quality, and it is suitable to grind quality with original, and technique is relatively easy, strong operability.
2, the disintegration time limited (2015 editions four general rules 0921 of Chinese Pharmacopoeia) of Examples and Comparative Examples sample is detected, it is specific to tie
Fruit is shown in Table 2.
2 Examples and Comparative Examples sample disintegration time limited testing result of table
3, embodiment dissolution determination is detected, concrete outcome is shown in Table 3.
Detection method: according to dissolution method (four general rules of Chinese Pharmacopoeia version in 2015,0,931 second method) with 0.05M phosphorus
Phthalate buffer (takes potassium dihydrogen phosphate 68.05g, adds 1mol/L sodium hydroxide solution 56ml, be diluted with water to 10000ml, shake
Even, pH value should be 6.0 ± 0.05) 900ml be dissolution medium, revolving speed be 75 turns per minute, operate according to methods, when through 30 minutes, take
Sample detection.
3 embodiment sample dissolution rate testing result of table
4, stability study
4 embodiment of table, 1 stability study Acceleration study
5 embodiment of table, 1 stability study long-term experiment
By disintegration time limited, dissolution rate, uniformity of dosage units, stability data the result shows that, in the invention patent select filling
The dosage and adding manner of agent, disintegrating agent, adhesive etc. be optimal selection, the tablet quality stable homogeneous of preparation,
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of tablet containing Febustat, which is characterized in that the tablet or label include active component Febustat, fill
Agent, disintegrating agent, adhesive and lubricant first dissolve the binder in aqueous solvent or ethyl alcohol water mixed solvent in its preparation process
In binder solution is made, then mix and pelletize with active component, filler and partial disintegration agent, then with remaining disintegrating agent
Tabletting is carried out with mix lubricant.
2. the tablet according to claim 1 containing Febustat, which is characterized in that the Febustat is A crystal form, is put down
Equal partial size is at 10 μm or less.
3. the tablet according to claim 1 containing Febustat, which is characterized in that the ethyl alcohol water mixed solvent is 40
~80% ethyl alcohol water mixed solvent；Preferably 50~75% ethyl alcohol water mixed solvent；More preferably 50% ethanol water is mixed
Bonding solvent；The filler is lactose and microcrystalline cellulose；The disintegrating agent is croscarmellose sodium；Described adhesive
For hydroxypropylcellulose；The lubricant is magnesium stearate.
4. the tablet according to claim 1,2 or 3 containing Febustat, which is characterized in that the tablet include label and
Coating, wherein label includes the component of following parts by weight: 15~45 parts of Febustat, 15~60 parts of lactose, and microcrystalline cellulose 30
~105 parts, 3~30 parts of croscarmellose sodium, 0.15~15 part of hydroxypropylcellulose, 0.15~3 part of magnesium stearate.
5. the tablet according to claim 4 containing Febustat, which is characterized in that the label includes following parts by weight
Component: 30~45 parts of Febustat, 30~50 parts of lactose, 70~100 parts of microcrystalline cellulose, croscarmellose sodium 10
~30 parts, 0.5~2 part of hydroxypropylcellulose, 0.5~2 part of magnesium stearate.
6. the tablet according to claim 4 containing Febustat, which is characterized in that the label includes following parts by weight
Component: 40 parts of Febustat, 40 parts of lactose, 85~90 parts of microcrystalline cellulose, 15~20 parts of croscarmellose sodium, hydroxyl
Third 1.0 parts of cellulose, 1.0 parts of magnesium stearate.
7. a kind of preparation method of the tablet containing Febustat as described in claim 1, which is characterized in that it includes as follows
Step:
(1) it pre-processes: active component is crushed using micropowder technology, it is spare after auxiliary material sieving；
(2) preparation of binder solution: dissolving the binder in aqueous solvent or binder solution is made in ethanol water in the mixed solvent；
(3) pelletizing press sheet is coated: after mixing by active component, filler and partial disintegration agent, it is molten to be slowly added to adhesive
Softwood processed, then pelletizes in liquid, after the drying of obtained wet granular, with remaining disintegrating agent and mix lubricant, tabletting, coating.
8. the preparation method of the tablet according to claim 8 containing Febustat, which is characterized in that the active component
For the Febustat of A crystal form, crushed using air-flow micropowder technology, average grain diameter is at 10 μm or less；The ethyl alcohol water mixed solvent
For 40~80% ethyl alcohol water mixed solvent；Preferably 50~75% ethyl alcohol water mixed solvent；More preferably 50% ethyl alcohol
Water mixed solvent；The filler is lactose and microcrystalline cellulose；The disintegrating agent is croscarmellose sodium；It is described viscous
Mixture is hydroxypropylcellulose；The lubricant is magnesium stearate.
9. the preparation method of the tablet according to claim 8 containing Febustat, which is characterized in that mistake in step (1)
80 meshes；The weight ratio for the remaining disintegrating agent being added after the partial disintegration agent and granulation that are added before granulation in step (3) be 1:1~
5:1；Preferably 1:1~2:1；20 mesh are pelletized after obtaining softwood in step (3), and 16~20 mesh whole grains after drying, coating uses stomach
Molten type thin film coating material.
10. the preparation method of the tablet according to claim 8 containing Febustat, which is characterized in that in step (3)
In, drying mode is forced air drying, and drying temperature is 50~70 DEG C, and drying time is 3~5h, and moisture is not higher than 5%；It is preferred that dry
Dry temperature is 50~60 DEG C.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111419814A (en) * | 2020-04-22 | 2020-07-17 | 广东一力罗定制药有限公司 | Febuxostat tablet and preparation process thereof |
| CN111759817A (en) * | 2020-05-22 | 2020-10-13 | 南京海纳医药科技股份有限公司 | Febuxostat-containing tablet and preparation method thereof |
| CN111789819A (en) * | 2020-07-14 | 2020-10-20 | 南京海纳医药科技股份有限公司 | Tablet containing Cetilistat and preparation method thereof |
| CN113577079A (en) * | 2021-07-28 | 2021-11-02 | 山东裕欣药业有限公司 | Preparation method and composition of phosphodiesterase inhibitor |
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| CN111759817A (en) * | 2020-05-22 | 2020-10-13 | 南京海纳医药科技股份有限公司 | Febuxostat-containing tablet and preparation method thereof |
| CN111789819A (en) * | 2020-07-14 | 2020-10-20 | 南京海纳医药科技股份有限公司 | Tablet containing Cetilistat and preparation method thereof |
| CN111789819B (en) * | 2020-07-14 | 2023-01-31 | 南京海纳医药科技股份有限公司 | Tablet containing Cetilistat and preparation method thereof |
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