CN101658519B - Medicinal composition for treating hyperuricemia - Google Patents
Medicinal composition for treating hyperuricemia Download PDFInfo
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- CN101658519B CN101658519B CN2008100542813A CN200810054281A CN101658519B CN 101658519 B CN101658519 B CN 101658519B CN 2008100542813 A CN2008100542813 A CN 2008100542813A CN 200810054281 A CN200810054281 A CN 200810054281A CN 101658519 B CN101658519 B CN 101658519B
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- Prior art keywords
- febustat
- benzbromarone
- hyperuricemia
- pharmaceutical composition
- application
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- 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
Abstract
The invention relates to a medicinal composition for treating hyperuricemia, which comprises Febuxostat or derivate thereof, benzbromarone and a pharmaceutically acceptable medicinal carrier, wherein the ratio in weight portion of the Febuxostat or derivate thereof to the benzbromarone to the pharmaceutically acceptable medicinal carrier is 1:1-4:0.5-100. The medicinal composition can provide extremely beneficial effects of treating the hyperuricemia. Pharmacological tests prove that the medicinal composition has obviously synergistic action, can quickly reduce the concentration of purine trione in blood serum, remarkably improves effect of treating the hyperuricemia, greatly reduces medicament dosage of single component simultaneously, and effectively reduces toxic and side effect of medicament.
Description
Technical field
The present invention relates to be used for the treatment of the pharmaceutical composition of hyperuricemia Febustat and uricosuric eccritic treatment hyperuricemia, more particularly, the present invention relates to the pharmaceutical composition of Febustat or derivatives thereof and benzbromarone, it is used for the treatment of disease relevant with hyperuricemia and gout.
Background technology
Along with the raising of expanding economy and people's living standard, life style and dietary structure change and numerous disease all causes hyperuricemia (Hyperuricemia), and its sickness rate raises year by year, and the trend that becomes younger.Hyperuricemia is the same with other metabolic diseases, and sickness rate is in rising trend in recent years, and has increased the case fatality rate of cardiovascular and cerebrovascular disease.Hyperuricemia comprises former and secondary hyperuricemia.Will form urate when hyperuricemia reaches certain high value, crystallization causes the goat outbreak in tissue, articular cavity deposition.Hyperuricemia also can cause gouty arthritis, gouty nephropathy and renal calculus.Evidence show that simultaneously hyperuricemia and hypertension, coronary heart disease, diabetes, hyperlipemia, hypercoagulability, obesity etc. are closely related, is the important component part of metabolism syndrome.They can interact, and form vicious cycle, and people's healthy and life security in serious threat.
Reduce blood plasma and organize uric acid level to become the key link of containment gout and above-mentioned disease progression.The medicine of the gout of uric acid resisting treatment at present mainly contains two big class medicines:
(1) reduce the medicine of uricopoiesis, for example allopurinol, Febustat (febuxostat) etc., they are by the activity that suppresses xanthine oxidase uricopoiesis to be reduced, thereby reduce the uric acid content in blood and the urine.The important part that Febustat is different from allopurinol is that it has specific inhibitory effect to xanthine oxidase, and allopurinol is a competitive inhibition.But have data to show, heavy dose of Febustat has tangible detrimental effect to liver function.
(2) medicine of uricosuric eccritic, for example probenecid (probenecid), benzbromarone (benzbromarone) and sulphinpyrazone (sulfinpyrazone) or the like, but they all have in various degree side effect and toxicity, during particularly with heavy dose of the use, can damage human body.
Summary of the invention
Inventor of the present invention is surprised to find by zoopery: the pharmaceutical composition that Febustat or derivatives thereof and benzbromarone are formed with the ratio of 1:1-4 has beyond thought synergism, it to be single can reducing uric acid concentration in the serum fast and significantly with much lower dosage use than their, thereby treats hyperuricemia effectively.Therefore, this pharmaceutical composition be particularly suitable for treating hyperuricemia and with its diseases associated, for example acute and chronic gout.Therefore,
An object of the present invention is to provide a kind of pharmaceutical composition that is used for the treatment of hyperuricemia.
Another object of the present invention provides this pharmaceutical composition at the preparation treatment hyperuricemia various diseases relevant with it, the application in the medicine of particularly acute and chronic gout.
The invention provides a kind of pharmaceutical composition that is used for the treatment of hyperuricemia, said composition comprises Febustat or derivatives thereof and benzbromarone and pharmaceutically useful carrier; Febustat or derivatives thereof wherein: benzbromarone: the ratio of weight and number of acceptable pharmaceutical carrier is 1:1～4:0.5～100.The ratio of weight and number of preferred Febustat or derivatives thereof and benzbromarone is 1:1-4, preferred especially 1:2-4.
In a particularly preferred example of the present invention, the ratio of weight and number of Febustat or derivatives thereof and benzbromarone is 1:2.
In another particularly preferred example of the present invention, the ratio of weight and number of Febustat or derivatives thereof and benzbromarone is 1:4.
Febustat derivant of the present invention not only comprises Febustat and alkali metal and the officinal salt that forms with ammonia or organic amine, sodium salt for example, potassium salt, calcium salt, ammonia salt or the like; The solvate that also comprises Febustat and its officinal salt, hydrate for example, alcohol adduct, and the polycrystal of Febustat and its officinal salt, Febustat polycrystal for example, Febustat sodium salt polycrystal, Febustat potassium salt polycrystal or the like.
Pharmaceutical composition of the present invention can be intestinal and parenterai administration form.The intestinal canal administration form comprises: various oral solids and liquid preparation, the parenterai administration form comprises sublingual administration preparation, percutaneous drug administration preparation, injection, membrane or aerosol etc.Preferably active component and any or several pharmaceutically acceptable carrier fully are mixed and made into oral solid preparation.Preferred oral solid formulation is various tablets, granule, drop pill, pill or capsule.
Pharmaceutically suitable carrier is an excipient commonly used in the pharmacy in the pharmaceutical composition of the present invention, comprising: filler, for example, lactose, sucrose, starch, microcrystalline Cellulose, sorbitol or calcium phosphate; Binding agent, for example, syrup, gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, PEG (Polyethylene Glycol), starch or dextrin; Disintegrating agent, for example, microcrystalline Cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose or crospolyvinylpyrrolidone; Lubricant, for example, magnesium stearate; The high-molecular bone frame material, for example, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil or acrylic resin; Filmogen, for example, hydroxypropyl emthylcellulose, polyvinylpyrrolidone or acrylic resin or the like.
Another aspect of the present invention is to disclose the application of described pharmaceutical composition in the medicine of preparation treatment hyperuricemia and relevant various diseases thereof.Described hyperuricemia comprises former and secondary hyperuricemia.The various diseases that described hyperuricemia is relevant comprise the acute and chronic gout that is caused by hyperuricemia, gouty arthritis, gouty nephropathy and renal calculus.
Preferably, become the tablet of unit dose or capsule for oral administration preparation of pharmaceutical compositions of the present invention, every day 1 time, each 1.The dosage of per day for adults is: the Febustat or derivatives thereof for 20-80mg, preferred 20-40mg; Benzbromarone is 20-120mg, preferred 40-80mg.
In a preferred embodiment, preparation of pharmaceutical compositions of the present invention becomes tablet, 1 of per day for adults, and every contains Febustat or derivatives thereof 20mg; Benzbromarone 80mg.
In another preferred embodiment, preparation of pharmaceutical compositions of the present invention becomes capsule, 1 of per day for adults, and every contains Febustat or derivatives thereof 20mg; Benzbromarone 40mg.
In another preferred embodiment, preparation of pharmaceutical compositions of the present invention becomes tablet, 1 of per day for adults, and every contains Febustat or derivatives thereof 40mg; Benzbromarone 60mg.
In a preferred embodiment again, preparation of pharmaceutical compositions of the present invention becomes tablet, 1 of per day for adults, and every contains Febustat or derivatives thereof 20mg; Benzbromarone 60mg.
Clinical research confirms: pharmaceutical composition of the present invention can drop to normal level or following with the metabolic arthritis concentration in the serum apace apace, thereby treat hyperuricemia effectively and related disorders is arranged, particularly acute and chronic gout, gouty arthritis, gouty nephropathy and renal calculus.
In clinical research of the present invention, the present composition that will contain Febustat 20mg and benzbromarone 80mg is given and the hyperuricemia patient of serum uric acid concentration at 550-680 μ mol/L, 1 of every day, uric acid concentration is reduced to normal value or is lower than normal value in 2 all backs serum, does not find that the patient of administration has any untoward reaction.
In a clinical case of the present invention, the present composition that will contain Febustat 20mg and benzbromarone 40mg is given and the chronic gout patient of serum uric acid concentration at 671 μ mol/L, 1 of every day, uric acid concentration is reduced to normal value in the 15 back serum, keep treatment 45 days, gout is cured, and does not find that patient has any untoward reaction.
In a clinical case of the present invention, the present composition that will contain Febustat 40mg and benzbromarone 40mg is given and the chronic gout patient of serum uric acid concentration at 690 μ mol/L, 1 of every day, uric acid concentration is reduced to normal value following (109 μ mol/L) in the 15 back serum, keep treatment 45 days, gout is cured, and the sedimentary urate crystal dissolving of toe joint, does not find that patient has any untoward reaction.
Pharmaceutical composition of the present invention reduces fast and obviously the metabolic arthritis level in the serum, and the consumption of Febustat is 1/6 to 1/4 of an independent consumption, the toxicity and the side effect of Febustat have been reduced widely, particularly reduced the detrimental effect of Febustat, increased patient's adaptability and toleration liver.But long-term safety is used.
The following compositions that studies have shown that Febustat and benzbromarone has the obvious synergistic effect aspect the uric acid concentration in reducing serum.
1 experiment material
1.1 medicine and reagent
Febustat, white powder, Taipu Medicine Science ﹠ Technology Development Co., Ltd., Tianjin provides.Face with the preceding suspendible medicinal liquid that is configured to desired concn with 0.5% sodium carboxymethyl cellulose (CMC-Na) and use for the animal gastric infusion.
Benzbromarone, white powder, Taipu Medicine Science ﹠ Technology Development Co., Ltd., Tianjin provides.Face with the preceding suspendible medicinal liquid that is configured to desired concn with 0.5% sodium carboxymethyl cellulose (CMC-Na) and use for the animal gastric infusion.
Uric acid detection kit, Nanjing are built up bio-engineering research institute product, lot number 20080516.
1.2 animal
Kunming mouse, SPF, Institute of Radiation Medicine, Chinese Academy of Medical Sciences's Experimental Animal Center provides, and credit number is SCXK Tianjin 2005-0001.
1.3 instrument
PK121R freezing centrifuge, Italian ALC company produces.
722 grating spectrophotometers, Shanghai the 3rd analytical tool factory produces.
2 methods and result
2.1 influence to normal animal urine acid
Behind the mice overnight fasting, by the body weight random packet.Give Febustat, the benzbromarone of various dose, Febustat and benzbromarone, by the compound recipe that different proportionings are formed, the administration volume is 20ml/kg.6h after the administration plucks eyeball and gets blood 0.5mL, and after room temperature left standstill 1h, the centrifugal preparation serum of 3000rpm was got serum kit measurement uric acid level, adopts the compound recipe of the more different proportionings of method of analysis of variance whether to have synergism.
2.1.1 the synergism of Febustat and benzbromarone
Normal mouse Guan Wei Give gives Febustat and benzbromarone compound recipe proportioning produces tangible anti-uric acid effect between 2:1～1:8, has certain addition and synergism between two medicines; Have synergism between 1:1～1:4, inhibitory action has improved 23.7% than the sum total that they use separately with dosage during 1:1, and inhibitory action has improved 60.0% during 1:2, and inhibitory action has improved 322.0% during 1:4; Credit is analysed by statistics proves that synergism is very obvious between 1:2～1:4.The results are shown in Table 1.
The Febustat of the different proportionings of table 1 and benzbromarone share the influence of normal mice serum uric acid (x ± s)
Annotate: 1. compare (variance analysis) with matched group:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
2.
☆Expression is compared (variance analysis) with folk prescription and is had synergism.
2.2 influence to hyperuricemia mice uric acid
Behind the mice overnight fasting, by the body weight random packet.Give Febustat, the benzbromarone of various dose, Febustat and the compound recipe of benzbromarone by different proportionings compositions, the administration volume is 20ml/kg.3h after the administration, irritate stomach and give hypoxanthine 1000mg/kg, and subcutaneous injection Oteracil Potassium 300mg/kg causes hyperuricemia model simultaneously, after 3h, pluck eyeball and get blood 0.5ml, after room temperature leaves standstill 1h, the centrifugal preparation serum of 3000rpm, get serum kit measurement uric acid level, adopt the compound recipe of the more different proportionings of method of analysis of variance whether to have synergism.
2.2.1 the synergism of Febustat and benzbromarone
The hyperuricemia mouse stomach gives Febustat and benzbromarone compound recipe proportioning produces tangible anti-uric acid rising effect between 2:1～1:8, has certain addition and synergism between two medicines; The compound recipe of proportioning between 1:1～1:4, proof is analysed in credit by statistics obvious synergism, and anti-uric acid rising effect has improved 23.6% than the sum total that they use separately with dosage during 1:1, has improved 23.6% during 1:2, has improved 43.3% during 1:4.The results are shown in Table 2.
The Febustat of the different proportionings of table 2 and benzbromarone share the influence of hyperuricemia mice serum uric acid (x ± s)
Annotate: 1. compare (variance analysis) with model control group:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
2.
☆Expression is compared (variance analysis) with folk prescription and is had synergism.
3. experiment conclusion
Uricopoiesis depressant Febustat and uricosuric agent benzbromarone are formed compound recipe can reduce normal mouse and hyperuricemia mice serum uric acid level, and test shows: the compound recipe that Febustat and benzbromarone are formed has very obvious synergistic effect in proportioning is 1:1～1:4 scope.
The specific embodiment
Following embodiment is to further explanation of the present invention rather than limitation of the scope of the invention.Wherein can prepare Febustat with reference to U.S. Pat 5614529.Can prepare corresponding sodium salts, potassium salt by conventional method.Benzbromarone can be buied from market.
Embodiment 1
The preparation of tablet: with benzbromarone 50g, Febustat 20g adds lactose 43g, microcrystalline Cellulose 16g, mix homogeneously adds an amount of 10%PEG6000 solution and granulates, and drying adds carboxymethyl starch sodium 5.3g again, magnesium stearate 1.5g, mixing, tabletting, bag film-coat.
Embodiment 2
The preparation of tablet: with benzbromarone 80g, Febustat 20g adds lactose 397g, starch,pregelatinized 93g, and hydroxypropyl cellulose 15g, cross-linking sodium carboxymethyl cellulose 29.8g, magnesium stearate 7.5g, mix homogeneously, pure water is granulated, drying, tabletting, bag film-coat.
Embodiment 3
The preparation of tablet: with benzbromarone 40g, Febustat 20g adds lactose 28.5g, microcrystalline Cellulose 10.5g, mix homogeneously adds an amount of 10%PEG4000 solution and granulates, and drying adds carboxymethyl starch sodium 4.7g again, magnesium stearate 1.2g, mixing, tabletting, bag film-coat.
Embodiment 4
Febustat potassium salt (quite Febustat 40g), benzbromarone 60g adds dextrin 100g, and lactose 270g granulates with pure water, and drying is encapsulated, makes 1000 seed lac wafers.
Embodiment 5
Febustat 20g, benzbromarone 60g adds lactose 45g, microcrystalline Cellulose 18g, mix homogeneously adds an amount of 10%PEG6000 and granulates, and drying adds carboxymethyl starch sodium 58g again, magnesium stearate 1.8g, mixing, tabletting, bag film-coat.
Embodiment 6
Febustat 20g; Benzbromarone 20g (1:1) adds in the fused Macrogol 4000 of 100g, in the fused Macrogol 4000, stirs and makes whole dissolvings and mix homogeneously, keep splashing in the liquid paraffin (5～10 ℃) under 60 ℃ of constant temperatures, be condensed into drop pill, exhaust liquid paraffin, the choosing grain, promptly.
The preparation of embodiment 7 injection
Febustat potassium salt (quite Febustat 2g), benzbromarone 8g, ethanol 200mI, propylene glycol 150ml, polysorbate 35g.Get Febustat potassium salt, benzbromarone joins in the water for injection that dissolves sorbitol and propylene glycol, and dissolving back after-teeming is penetrated water to 1000ml, filters embedding, sterilization.
Claims (11)
1. pharmaceutical composition that is used for the treatment of hyperuricemia, it is characterized in that said composition is made up of Febustat and benzbromarone and pharmaceutically acceptable pharmaceutical carrier, wherein Febustat: benzbromarone: the ratio of weight and number of pharmaceutically acceptable pharmaceutical carrier is 1: 3～4: 0.5～100.
2. the pharmaceutical composition of claim 1, wherein the ratio of weight and number of Febustat and benzbromarone is: 1: 3.
3. the pharmaceutical composition of claim 1, wherein the ratio of weight and number of Febustat and benzbromarone is: 1: 4.
4. each pharmaceutical composition of claim 1-3, it is intestinal or parenterai administration form.
5. the pharmaceutical composition of claim 4, wherein said intestinal canal administration form is tablet, granule, pill or Capsule form.
6. each the application of pharmaceutical composition in preparation treatment antihyperuricemic disease drug of claim 1-3.
7. the application of claim 6, wherein said hyperuricemia comprises constitutional and secondary hyperuricemia.
8. the application of claim 6, the oral dose of wherein said medicine per day for adults are Febustat 20-80mg, benzbromarone 20-120mg.
9. the application of claim 8, the oral dose of wherein said medicine per day for adults are Febustat 20-40mg, benzbromarone 40-80mg.
10. the application of claim 9, the oral dose of wherein said medicine per day for adults are Febustat 20mg, benzbromarone 60mg.
11. the application of claim 9, the oral dose of wherein said medicine per day for adults are Febustat 20mg, benzbromarone 80mg.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100542813A CN101658519B (en) | 2008-08-26 | 2008-08-26 | Medicinal composition for treating hyperuricemia |
| PCT/CN2009/000837 WO2010022580A1 (en) | 2008-08-26 | 2009-07-27 | Medical composition for treating hyperuricemia and the use thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100542813A CN101658519B (en) | 2008-08-26 | 2008-08-26 | Medicinal composition for treating hyperuricemia |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101658519A CN101658519A (en) | 2010-03-03 |
| CN101658519B true CN101658519B (en) | 2011-06-08 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008100542813A Expired - Fee Related CN101658519B (en) | 2008-08-26 | 2008-08-26 | Medicinal composition for treating hyperuricemia |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN101658519B (en) |
| WO (1) | WO2010022580A1 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102429881B (en) * | 2011-12-01 | 2013-11-27 | 常州康普药业有限公司 | Method for preparing benzbromarone tablets |
| CN103070878B (en) * | 2012-12-11 | 2014-10-22 | 上海浦东高星生物技术研究所 | Compound Caulis Sinomenii tablet |
| CN105832729A (en) * | 2016-05-30 | 2016-08-10 | 青岛云天生物技术有限公司 | Pharmaceutical composition for treating hyperuricemia and application of pharmaceutical composition for treating hyperuricemia |
| CN107693519A (en) * | 2017-11-15 | 2018-02-16 | 全椒先奇医药科技有限公司 | A kind of Lansoprazole tablet composition |
| CN113425718A (en) * | 2021-05-13 | 2021-09-24 | 浙江歌文达生物医药科技有限公司 | Compound preparation for treating hyperuricemia and gout |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1954814A (en) * | 2005-10-26 | 2007-05-02 | 重庆医药工业研究院有限责任公司 | Medical composite with co-action for treating gout and its preparation method |
-
2008
- 2008-08-26 CN CN2008100542813A patent/CN101658519B/en not_active Expired - Fee Related
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2009
- 2009-07-27 WO PCT/CN2009/000837 patent/WO2010022580A1/en active Application Filing
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| Publication number | Publication date |
|---|---|
| WO2010022580A1 (en) | 2010-03-04 |
| CN101658519A (en) | 2010-03-03 |
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