CN107648229A - A kind of Febustat composition - Google Patents
A kind of Febustat composition Download PDFInfo
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- CN107648229A CN107648229A CN201710848020.8A CN201710848020A CN107648229A CN 107648229 A CN107648229 A CN 107648229A CN 201710848020 A CN201710848020 A CN 201710848020A CN 107648229 A CN107648229 A CN 107648229A
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- febustat
- unit dose
- glucosamine
- contain
- 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
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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
- A61K31/70—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
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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
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of Febustat composition and its manufacture method, belong to pharmaceutical technology field.The technical scheme is that：A kind of Febustat composition, in each unit dose, contain the 40mg of Febustat 10, the 600mg of Glucosamine 240.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 composition 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 raising of quality of life, the number and the incidence of disease of patient with gout have the trend gradually increased.Especially in
For the elderly, this has been a kind of relatively conventional metabolic disease.Swelling, stiff, lopsided occurs in the joint of morbidity, just
The first sample of image-stone, asymmetric, size is also inconsistent.The place 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 prescription.
Febustat is xanthine oxidase（XO）Inhibitor, suitable for the long-term of the hyperuricemia with gout symptom
Treatment.It is the preferably anti-ventilation medicine of Clinical practice effect, but long-term prescription can cause certain infringement, table to liver in recent years
It is the rise of total bilirubin and glutamic-pyruvic transaminase in present index.
The content of the invention
Goal of the invention：It is an object of the invention 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 to liver also reduces.
Technical scheme
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 formed by the extraction of natural shrimp and crab shells, cartilage cell can be activated and 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 there is therapeutic action to bone and joint diseases
Nutrient and healthcare products.
The present composition, its formulation can be tablet or capsule.Instructions of taking is one time a day, daily Fei Busi
His amount is 30-40mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
10-30mg, Glucosamine 240-400mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
10mg, Glucosamine 240mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
30mg, Glucosamine 400mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
15mg, Glucosamine 360mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
20mg, Glucosamine 360mg.
The auxiliary material of the present composition can be the auxiliary material of common dosage forms, such as：PVPP, cross-linked carboxymethyl cellulose
Sodium, lactose, hydroxymethyl cellulose, polyethylene pyrrole network alkanone etc..
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
10-30mg, Glucosamine 240-400mg, hydroxypropyl-β-cyclodextrin 10-30mg, lactose 10-30mg, microcrystalline cellulose 10-
30mg, PVP k30 10-20mg, lauryl sodium sulfate 1-3mg, magnesium stearate 4-8mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
10mg, Glucosamine 240mg, hydroxypropyl-β-cyclodextrin 10mg, lactose 10mg, microcrystalline cellulose 10mg, PVP k30
10mg, lauryl sodium sulfate 1mg, magnesium stearate 4mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
40mg, Glucosamine 600mg, hydroxypropyl-β-cyclodextrin 30mg, lactose 30mg, microcrystalline cellulose 30mg, PVP k30
20mg, lauryl sodium sulfate 3mg, magnesium stearate 8mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
10mg, Glucosamine 240mg.Hydroxypropyl-β-cyclodextrin 20mg, lactose 15mg, microcrystalline cellulose 15mg, PVP k30
12mg, lauryl sodium sulfate 1.5mg, magnesium stearate 4.5mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
30mg, Glucosamine 400mg.Hydroxypropyl-β-cyclodextrin 15mg, lactose 20mg, microcrystalline cellulose 18mg, PVP k30
15mg, lauryl sodium sulfate 2mg, magnesium stearate 5mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
15mg, Glucosamine 360mg.Hydroxypropyl-β-cyclodextrin 16mg, lactose 18mg, microcrystalline cellulose 16mg, PVP k30
13mg, lauryl sodium sulfate 1.8mg, magnesium stearate 4.7mg.
The preferential technical scheme of the present invention is：A kind of Febustat composition, in each unit dose, contain Febustat
20mg, Glucosamine 360mg.Hydroxypropyl-β-cyclodextrin 16mg, lactose 19mg, microcrystalline cellulose 23mg, PVP 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, comprises the following steps：
First step Febustat crosses 200 mesh sieves, and Glucosamine and other auxiliary materials cross 100 mesh sieves.
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, it is well mixed, with the PVP k30 water of half recipe quantity
Solution makees adhesive, granulation.
Particle obtained by 3rd step drying second step, crushes, crosses 40 mesh sieves.
Particle obtained by the step of 4th step the 3rd, lactose with 2/3rds recipe quantities, it is well mixed, with half prescription
The PVP k30 aqueous solution of amount makees adhesive, pelletizes, and dries, and crushes, and crosses 40 mesh sieves.
Particle obtained by the step of 5th step the 4th, mixed with the magnesium stearate of recipe quantity, tabletting or encapsulated.
Beneficial 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 plain 10g, PVP k30 1mg, lauryl sodium sulfate 1g, magnesium stearate 4g.As described in technical scheme prepared by preparation method
1000.
Embodiment 2, Febustat 40g, Glucosamine 600g, hydroxypropyl-β-cyclodextrin 30g, lactose 30g, crystallite are fine
Tie up plain 30g, PVP k30 2mg, lauryl sodium sulfate 3g, magnesium stearate 8g.As described in technical scheme prepared by preparation method
1000.
Embodiment 3, Febustat 10g, Glucosamine 240g.Hydroxypropyl-β-cyclodextrin 20g, lactose 15g, crystallite are fine
Tie up plain 15g, PVP k30 12g, lauryl sodium sulfate 1.5g, magnesium stearate 4.5g.The preparation method as described in technical scheme
Prepare 1000.
Embodiment 4, Febustat 30g, Glucosamine 400g.Hydroxypropyl-β-cyclodextrin 15g, lactose 20g, crystallite are fine
Tie up plain 18g, PVP k30 15g, lauryl sodium sulfate 2g, magnesium stearate 5g.As described in technical scheme prepared by preparation method
1000.
Embodiment 5, Febustat 15g, Glucosamine 360g.Hydroxypropyl-β-cyclodextrin 16g, lactose 18g, crystallite are fine
Tie up plain 16g, PVP k30 13g, lauryl sodium sulfate 1.8g, magnesium stearate 4.7g.The preparation method as described in technical scheme
Prepare 1000.
Embodiment 6, Febustat 20g, Glucosamine 360g.Hydroxypropyl-β-cyclodextrin 16g, lactose 19g, microcrystalline cellulose
23g, PVP k30 17g, lauryl sodium sulfate 2.3g, magnesium stearate 5.6g.As described in technical scheme prepared by preparation method
Capsule 1000.
Reference examples 1,
The prescription of embodiment 5, Febustat cross 200 mesh sieves, and Glucosamine crosses 100 mesh sieves with other auxiliary materials.By the following method
Prepare：
Febustat, Glucosamine, hydroxypropyl-β-cyclodextrin, the lactose of recipe quantity, microcrystalline cellulose, cornstarch, 12
Sodium alkyl sulfate is well mixed, and adhesive is made with the PVP k30 aqueous solution, is pelletized, and drying, lubricant is done with magnesium stearate, is made
It is standby 1000.
The prescription of reference examples 2, embodiment 5, hydroxypropyl-β-cyclodextrin is replaced with 16g lactose, such words lactose dosage is total to
It is same as Example 5 for 34g, other supplementary product consumptions and preparation method.
Test example 1, dissolution measure
Determine the dissolution situation of reference examples and embodiment.Specific implementation method is tested in dissolution：Paddle method 50r/min,
900mLpH5.5Mcllvaine buffer solutions are as dissolution medium, respectively in 15min and 60min sampling detections.Detection method：Adopt
It is measured with high performance liquid chromatography.
The dissolution measurement result such as table 1 below of reference examples and embodiment：
Table 1
| Sample time | Reference examples 1 | Reference examples 2 | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 |
| 15min | 41.3% | 71.6% | 84.6% | 82.9% | 80.7% | 83.4% | 84.2% | 83.7 |
| 60min | 58.2% | 74.2% | 100% | 98.6% | 97.9% | 98.4% | 98.6% | 99.1 |
The dissolution result of table 1 is shown：Embodiment 1-6 dissolution result illustrates that the present invention is non-in raising apparently higher than reference examples 1 and 2
Beneficial effect is generated 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
| Reference examples 1 | Reference examples 2 | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | |
| 0 day weight, mg | 8890.1 | 8890.1 | 5720.2 | 14860.4 | 6360.3 | 10100.3 | 8890.1 | 9258.3 |
| 20 days weight, mg | 9423.5 | 9807.6 | 5926.1 | 15395.5 | 6544.7 | 10372.9 | 9059.0 | 9443.4 |
| Weightening, mg | 533.4 | 917.5 | 205.9 | 535.1 | 184.4 | 272.6 | 168.9 | 185.1 |
| Water absorption rate % | 6.0 | 10.3 | 3.6 | 3.6 | 2.9 | 2.7 | 1.9 | 2.0 |
The data of table 2 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（Ill history is in 2 years）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, serum uric acid level is maintained to be less than 415 μ
Mol/L is effective, and liver function index is exceeded to be abnormal.
Table 3
The data explanation of table 3：Product of the embodiment of the present invention alleviates Febustat to liver while effectively treatment hyperuricemia
Dirty infringement.
Claims (9)
1. a kind of Febustat composition, it is characterised in that in each unit dose, contain Febustat 10-40mg, amino Portugal
Grape sugar 240-600mg.
2. composition according to claim 1, it is characterised in that in each unit dose, containing Febustat 10-30mg,
Glucosamine 240-400mg.
3. composition according to claim 1, it is characterised in that in each unit dose, contain Febustat 10mg, amino
Glucose 240mg.
4. composition according to claim 1, it is characterised in that in each unit dose, contain Febustat 30mg, amino
Glucose 400mg.
5. composition according to claim 1, it is characterised in that in each unit dose, contain Febustat 15mg, amino
Glucose 360mg.
6. composition according to claim 1, it is characterised in that in each unit dose, contain Febustat 20mg, amino
Glucose 360mg.
7. composition according to claim 1, it is characterised 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, it is characterised in that in each unit dose, contain Febustat 30mg, amino
Glucose 400mg, hydroxypropyl-β-cyclodextrin 15mg, lactose 20mg, microcrystalline cellulose 18mg, PVP k30 15mg, dodecane
Base sodium sulphate 2mg, magnesium stearate 5mg.
9. the preparation method of composition described in claim 1, it is characterised in that comprise the following steps：
First step Febustat crosses 200 mesh sieves, and Glucosamine and other auxiliary materials cross 100 mesh sieves；
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, it is well mixed, with the PVP k30 aqueous solution of half recipe quantity
Adhesive is made, is pelletized；
Particle obtained by 3rd step drying second step, crushes, crosses 40 mesh sieves；
Particle obtained by the step of 4th step the 3rd, lactose with 2/3rds recipe quantities, it is well mixed, with half recipe quantity
The PVP k30 aqueous solution makees adhesive, pelletizes, and dries, and crushes, and crosses 40 mesh sieves；
Particle obtained by the step of 5th step the 4th, mixed with the magnesium stearate of recipe quantity, tabletting or encapsulated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710848020.8A CN107648229B (en) | 2017-09-19 | 2017-09-19 | A kind of Febustat composition |
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| CN201710848020.8A CN107648229B (en) | 2017-09-19 | 2017-09-19 | A kind of Febustat composition |
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| CN107648229A true CN107648229A (en) | 2018-02-02 |
| CN107648229B CN107648229B (en) | 2019-06-07 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108186634A (en) * | 2018-01-02 | 2018-06-22 | 迪沙药业集团（天津）药物研究有限公司 | A kind of Febustat composition |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640890A (en) * | 2014-11-27 | 2016-06-08 | 华东理工大学 | Sparingly soluble active component particle, particle preparation and preparation method thereof |
-
2017
- 2017-09-19 CN CN201710848020.8A patent/CN107648229B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640890A (en) * | 2014-11-27 | 2016-06-08 | 华东理工大学 | Sparingly soluble active component particle, particle preparation and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 杨雪 等: "非布司他临床应用及不良反应", 《药物不良反应杂志》 * |
| 金黎明等: "氨基葡萄糖对CCl4所致小鼠肝损伤的改善作用", 《郑州大学学报(医学版)》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108186634A (en) * | 2018-01-02 | 2018-06-22 | 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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| CN107648229B (en) | 2019-06-07 |
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Effective date of registration: 20200327 Address after: 300450 building 26, Green Valley Health Industrial Park, No. 59, Taikang Avenue, Binhai hi tech park, Binhai New Area, Tianjin Co-patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee after: Tianjin Disha Pharmaceutical Technology Development Co., Ltd. Address before: 300457 chamber No. 220, Dongting Road, Tianjin economic and Technological Development Zone, Tianjin peace zone, Tianjin International Institute of biology and medicine, 17 layer N1701-1 room Co-patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: DISHA PHARMACEUTICAL GROUP (TIANJIN) MEDICINE RESEARCH Co.,Ltd. |
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Effective date of registration: 20210622 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: 300450 building 26, Green Valley Health Industrial Park, 59 Taikang Avenue, Binhai science and Technology Park, Binhai New Area, Tianjin Patentee before: Tianjin Disha Pharmaceutical Technology Development Co.,Ltd. Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. |
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