CN108186634A - A kind of Febustat composition - Google Patents
A kind of Febustat composition Download PDFInfo
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- CN108186634A CN108186634A CN201810000507.5A CN201810000507A CN108186634A CN 108186634 A CN108186634 A CN 108186634A CN 201810000507 A CN201810000507 A CN 201810000507A CN 108186634 A CN108186634 A CN 108186634A
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- CN
- China
- Prior art keywords
- febustat
- unit dose
- glucosamine
- composition according
- lactose
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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
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
Abstract
The present invention relates to a kind of Febustat composition and its manufacturing methods, belong to pharmaceutical technology field.The technical scheme is that：A kind of Febustat composition in each unit dose, contains 10 40mg of Febustat, 240 600mg of Glucosamine.By rational compatibility, on the basis of curative effect is ensured, the side effect of Febustat is reduced；By rational preparation method, the characteristic of Febustat piece is changed, while its dissolution rate is ensured, obtains the stable tablet of the resistance to moisture absorption.
Description
Technical field
The present invention relates to a kind of Febustat compositions and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Gout is the disease caused by a kind of metabolic system dysfunction, is increased with uric acid as one of distinctive marks.It is several recently
Nian Lai, with the improvement of the quality of life, the number and incidence of patient with gout have the tendency that gradually increasing.Especially in
For the elderly, this has been a kind of relatively conventional metabolic disease.The joint of morbidity will appear swelling, stiff, lopsided, just
The first sample of image-stone, asymmetric, size is also inconsistent.The places such as it is more common between ear profile, toe, finger, patient suffering is abnormal,
Severe patient's action is limited.Ventilation patient needs long-term administration.
Febustat is xanthine oxidase（XO）Inhibitor, suitable for having the long-term of the hyperuricemia of gout symptom
Treatment.It is the preferably anti-ventilation drug of Clinical practice effect, but long-term administration can cause liver in certain damage, table in recent years
It is the raising of total bilirubin and glutamic-pyruvic transaminase in present index.
Invention content
Goal of the invention：The object of the present invention is to provide a kind of Febustat composition, while treatment is provided for patient,
Lower the side effect of Febustat.
Present inventors have surprisingly found that a certain amount of Glucosamine is added in Febustat composition, treatment ventilation
Effect increase, meanwhile, the side effect of liver is also reduced.
Technical solution
The technical scheme is that：A kind of Febustat composition, in each unit dose, containing Febustat 10-40mg,
Glucosamine 240-600mg.
Glucosamine：It is to be extracted by natural shrimp and crab shells, cartilage cell can be activated to synthesize polysaccharide and collagenous fibres,
Cartilage matrix is generated, repairing articular cartilage expedites the emergence of knuckle synovia.After the 1970s, American-European, Japan and other countries are risen
" ammonia sugar " therapy, as the preferred specific drug for the treatment of osteoarthritis, ammonia sugar is widely used in the treatment of bone and joint diseases
With prevention, significant effect is achieved.European ammonia sugar be medical field uniquely approve to bone and joint diseases have therapeutic effect
Nutrient and healthcare products.
The present composition, dosage form can be tablet or capsule.Instructions of taking is one time a day, daily Fei Busi
His amount is 30-40mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
10-30mg, Glucosamine 240-400mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
10mg, Glucosamine 240mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
30mg, Glucosamine 400mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
15mg, Glucosamine 360mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
20mg, Glucosamine 360mg.
The auxiliary material of the present composition can be the auxiliary material of common dosage forms, such as：Crospovidone, cross-linked carboxymethyl cellulose
Sodium, lactose, hydroxymethyl cellulose, polyethylene pyrrole network alkanone etc..
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
10-30mg, Glucosamine 240-400mg, hydroxypropyl-β-cyclodextrin 10-30mg, lactose 10-30mg, microcrystalline cellulose 10-
30mg, povidone k30 10-20mg, lauryl sodium sulfate 1-3mg, magnesium stearate 4-8mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
10mg, Glucosamine 240mg, hydroxypropyl-β-cyclodextrin 10mg, lactose 10mg, microcrystalline cellulose 10mg, povidone k30
10mg, lauryl sodium sulfate 1mg, magnesium stearate 4mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
40mg, Glucosamine 600mg, hydroxypropyl-β-cyclodextrin 30mg, lactose 30mg, microcrystalline cellulose 30mg, povidone k30
20mg, lauryl sodium sulfate 3mg, magnesium stearate 8mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
10mg, Glucosamine 240mg.Hydroxypropyl-β-cyclodextrin 20mg, lactose 15mg, microcrystalline cellulose 15mg, povidone k30
12mg, lauryl sodium sulfate 1.5mg, magnesium stearate 4.5mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
30mg, Glucosamine 400mg.Hydroxypropyl-β-cyclodextrin 15mg, lactose 20mg, microcrystalline cellulose 18mg, povidone k30
15mg, lauryl sodium sulfate 2mg, magnesium stearate 5mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
15mg, Glucosamine 360mg.Hydroxypropyl-β-cyclodextrin 16mg, lactose 18mg, microcrystalline cellulose 16mg, povidone k30
13mg, lauryl sodium sulfate 1.8mg, magnesium stearate 4.7mg.
The preferential technical solution of the present invention is：A kind of Febustat composition in each unit dose, contains Febustat
20mg, Glucosamine 360mg.Hydroxypropyl-β-cyclodextrin 16mg, lactose 19mg, microcrystalline cellulose 23mg, povidone k30
17mg, lauryl sodium sulfate 2.3mg, magnesium stearate 5.6mg.
The preparation method of the present composition, the preparation method of Febustat of the present invention, includes the following steps：
First step Febustat crosses 200 mesh sieve, and Glucosamine and other auxiliary materials sieve with 100 mesh sieve.
Second step weigh the Febustat after the sieving of recipe quantity, Glucosamine, hydroxypropyl-β-cyclodextrin, three/
The lactose of one recipe quantity, the lauryl sodium sulfate of recipe quantity are uniformly mixed, with the povidone k30 water of half recipe quantity
Solution makees adhesive, granulation.
Particle obtained by third step drying second step, crushes, crosses 40 mesh sieve.
4th step third step gained particle, with the lactose of 2/3rds recipe quantities, be uniformly mixed, with half prescription
The povidone k30 aqueous solutions of amount make adhesive, pelletize, and dry, and crush, and cross 40 mesh sieve.
Particle obtained by the 4th step of 5th step, the magnesium stearate mixing with recipe quantity, tabletting or encapsulated.
Advantageous effect：By rational compatibility, on the basis of curative effect is ensured, the side effect of Febustat is reduced；It is logical
Rational preparation method is crossed, changes the characteristic of Febustat piece, while its dissolution rate is ensured, obtains the steady of the resistance to moisture absorption
Stator agent.
Embodiment 1, Febustat 10g, Glucosamine 240g, hydroxypropyl-β-cyclodextrin 10g, lactose 10g, crystallite are fine
Tie up element 10g, povidone k30 1mg, lauryl sodium sulfate 1g, magnesium stearate 4g.As described in technical solution prepared by preparation method
1000.
Embodiment 2, Febustat 40g, Glucosamine 600g, hydroxypropyl-β-cyclodextrin 30g, lactose 30g, crystallite are fine
Tie up element 30g, povidone k30 2mg, lauryl sodium sulfate 3g, magnesium stearate 8g.As described in technical solution prepared by preparation method
1000.
Embodiment 3, Febustat 10g, Glucosamine 240g.Hydroxypropyl-β-cyclodextrin 20g, lactose 15g, crystallite are fine
Tie up element 15g, povidone k30 12g, lauryl sodium sulfate 1.5g, magnesium stearate 4.5g.The preparation method as described in technical solution
Prepare 1000.
Embodiment 4, Febustat 30g, Glucosamine 400g.Hydroxypropyl-β-cyclodextrin 15g, lactose 20g, crystallite are fine
Tie up element 18g, povidone k30 15g, lauryl sodium sulfate 2g, magnesium stearate 5g.As described in technical solution prepared by preparation method
1000.
Embodiment 5, Febustat 15g, Glucosamine 360g.Hydroxypropyl-β-cyclodextrin 16g, lactose 18g, crystallite are fine
Tie up element 16g, povidone k30 13g, lauryl sodium sulfate 1.8g, magnesium stearate 4.7g.The preparation method as described in technical solution
Prepare 1000.
Embodiment 6, Febustat 20g, Glucosamine 360g.Hydroxypropyl-β-cyclodextrin 16g, lactose 19g, microcrystalline cellulose
23g, povidone k30 17g, lauryl sodium sulfate 2.3g, magnesium stearate 5.6g.As described in technical solution prepared by preparation method
Capsule 1000.
Reference examples 1,
The prescription of embodiment 5, Febustat cross 200 mesh sieve, and Glucosamine is sieved with 100 mesh sieve with other auxiliary materials.By the following method
It prepares：
Febustat, Glucosamine, hydroxypropyl-β-cyclodextrin, the lactose of recipe quantity, microcrystalline cellulose, cornstarch, 12
Sodium alkyl sulfate is uniformly mixed, and adhesive is made with povidone k30 aqueous solutions, is pelletized, and drying does lubricant with magnesium stearate, makes
It is 1000 standby.
The prescription of reference examples 2, embodiment 5 replaces hydroxypropyl-β-cyclodextrin with 16g lactose, and such words lactose dosage is total to
For 34g, other supplementary product consumptions and preparation method are same as Example 5.
Test example 1, dissolution measure
Measure the dissolution situation of reference examples and embodiment.Dissolution experiment specific implementation method：Paddle method 50r/min,
900mLpH5.5Mcllvaine buffer solutions are as dissolution medium, respectively in 15min and 60min sampling detections.Detection method：It adopts
It is measured with high performance liquid chromatography.
Dissolution measurement result such as the following table 1 of reference examples and embodiment：
Table 1
Table 1 dissolves out result and shows：The dissolution result of embodiment 1-6 is apparently higher than reference examples 1 and 2, illustrates that the present invention is non-in raising
Beneficial effect is produced in terms of Bu Sita dissolutions
2 high wet test of test example
Embodiment 1-6 samples and reference examples sample are respectively taken 20, opening is placed in constant humidity closed container, in 25 DEG C of difference
Under the conditions of relative humidity 75% ± 5%, place 20 days, respectively at 0 day and the 20th day precise example weight, be as a result recorded in
Table 2.
Table 2
2 data of table illustrate that sample of embodiment of the present invention water absorption rate is significantly lower than reference examples.
The patient with gout for suffering from hyperuricemia is accepted in test example 3, outpatient service for medical treatment（Illness history is in 2 year）840 people, are randomly divided into
7 groups, every group of 120 people, respectively original grind group and embodiment 1-6 groups, take original respectively and grind 40mg Febustats piece and this hair
Bright embodiment 1-6 samples, once a day medication, the diet of continuous medication 3 months, during which control purine-containing food.Experiment process
Table 3 is recorded in result.With the 3rd the end of month, continuous one week detection blood uric acid and liver function maintain serum uric acid level to be less than 415 μ
Mol/L is effective, and exceeded liver function index is abnormal.
Table 3
3 data explanation of table：Product of the embodiment of the present invention alleviates Febustat to liver while effectively treatment hyperuricemia
Dirty damage.
Claims (9)
1. a kind of Febustat composition, which is characterized in that in each unit dose, contain Febustat 10-40mg, amino Portugal
Grape sugar 240-600mg.
2. composition according to claim 1, which is characterized in that in each unit dose, containing Febustat 10-30mg,
Glucosamine 240-400mg.
3. composition according to claim 1, which is characterized in that in each unit dose, contain Febustat 10mg, amino
Glucose 240mg.
4. composition according to claim 1, which is characterized in that in each unit dose, contain Febustat 30mg, amino
Glucose 400mg.
5. composition according to claim 1, which is characterized in that in each unit dose, contain Febustat 15mg, amino
Glucose 360mg.
6. composition according to claim 1, which is characterized in that in each unit dose, contain Febustat 20mg, amino
Glucose 360mg.
7. composition according to claim 1, which is characterized in that in each unit dose, containing Febustat 10-20mg,
Glucosamine 240-400mg, hydroxypropyl-β-cyclodextrin 10-30mg, lactose 10-30mg, microcrystalline cellulose 10-30mg, poly- dimension
Ketone k30 10-20mg, lauryl sodium sulfate 1-3mg, magnesium stearate 4-8mg.
8. composition according to claim 1, which is characterized in that in each unit dose, contain Febustat 30mg, amino
Glucose 400mg, hydroxypropyl-β-cyclodextrin 15mg, lactose 20mg, microcrystalline cellulose 18mg, povidone k30 15mg, dodecane
Base sodium sulphate 2mg, magnesium stearate 5mg.
9. the preparation method of composition described in claim 1, which is characterized in that include the following steps：
First step Febustat crosses 200 mesh sieve, and Glucosamine and other auxiliary materials sieve with 100 mesh sieve；
Second step weigh the Febustat after the sieving of recipe quantity, Glucosamine, hydroxypropyl-β-cyclodextrin, at 1/3rd
The lactose just measured, the lauryl sodium sulfate of recipe quantity are uniformly mixed, with the povidone k30 aqueous solutions of half recipe quantity
Adhesive is made, is pelletized；
Particle obtained by third step drying second step, crushes, crosses 40 mesh sieve；
4th step third step gained particle, with the lactose of 2/3rds recipe quantities, be uniformly mixed, with gathering for half recipe quantity
Dimension ketone k30 aqueous solutions make adhesive, pelletize, and dry, and crush, and cross 40 mesh sieve；
Particle obtained by the 4th step of 5th step, the magnesium stearate mixing with recipe quantity, tabletting or encapsulated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810000507.5A CN108186634A (en) | 2018-01-02 | 2018-01-02 | A kind of Febustat composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810000507.5A CN108186634A (en) | 2018-01-02 | 2018-01-02 | A kind of Febustat composition |
Publications (1)
| Publication Number | Publication Date |
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| CN108186634A true CN108186634A (en) | 2018-06-22 |
Family
ID=62588015
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| Application Number | Title | Priority Date | Filing Date |
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| CN201810000507.5A Pending CN108186634A (en) | 2018-01-02 | 2018-01-02 | A kind of Febustat composition |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107648229A (en) * | 2017-09-19 | 2018-02-02 | 迪沙药业集团（天津）药物研究有限公司 | A kind of Febustat composition |
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- 2018-01-02 CN CN201810000507.5A patent/CN108186634A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107648229A (en) * | 2017-09-19 | 2018-02-02 | 迪沙药业集团（天津）药物研究有限公司 | A kind of Febustat composition |
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Application publication date: 20180622 |
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