CN1954814A - Medical composite with co-action for treating gout and its preparation method - Google Patents
Medical composite with co-action for treating gout and its preparation method Download PDFInfo
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- CN1954814A CN1954814A CNA2005100573485A CN200510057348A CN1954814A CN 1954814 A CN1954814 A CN 1954814A CN A2005100573485 A CNA2005100573485 A CN A2005100573485A CN 200510057348 A CN200510057348 A CN 200510057348A CN 1954814 A CN1954814 A CN 1954814A
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- febustat
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
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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
A synergistic composite medicine for treating gout is prepared from febuxostat or its medicinal salt, the uric acid excretion promoter chosen from benzbromarone, probenecid and sulfinpyrazone, and the pharmacologically acceptable carrier. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition with cooperation usefulness, specifically be pharmaceutical composition of the Febustat, uricosuric eccritic and pharmaceutically acceptable adjuvant or the carrier that contain effective therapeutic dose and preparation method thereof, and the utilization in the medicine of preparation treatment gout.
Background technology
Gout (GOUT) is because blood uric acid increases the one group of different substantiality disease that causes tissue injury.Blood uric acid increase mainly be with long-term purine metabolism obstacle and (or) urate excretion reduces relevant.Purine is a kind of composition in the nucleus, just contains purine as long as contain the food of cell, and purine content is more in animal food and the bean food.Therefore, the generation of gout and people's diet has much relations.Along with the raising of living standards of the people, employment competition pressure strengthens, and the amount of animal food heightens, and the gout sickness rate raises, and therefore, gout is also referred to as affluenza, and gout is also immediately following the workaholic.
The pathogenic factor of gout is that purine metabolic disturbance causes the uric acid concentration in the blood too high, forms uric acid crystal and is deposited in the tissue.Hyperuricemia is the prelude of gout.Gout when outbreak, big toe, instep, heel, ankle, refer to, little joint such as wrist all might red and swollen severe pain.Outbreak repeatedly, the joint becomes deformity, forms " tophus ".In the west and Japan become commonly encountered diseases already.It also became the disease in vogue of China (especially coastal open area) in recent years, and this disease mostly occurs in the city, and the rural area does not almost have; Coastal cities are more taller than inland city sickness rate.
Gout is to go up with the modal arthritis of male in 40 years old, the sickness rate height, cures difficult, outbreak repeatedly, and various difficulties and disease make the patient suffering can't bear, and this disease is classified as one of human ten big pertinacious diseases of 20th century by the United Nations's health organization.In the U.S. 5,100,000 people patients (1988-1994 investigation).Shown by China national Ministry of Public Health, the report of Chinese gout alliance organization latest domestic: in China, owing to weather, living standard problems such as (raisings), the sickness rate of gout surpasses the world average level, and (3-9%, national patient with gout surpasses 0.9 hundred million people.
Acute gout western medicine situation: treatment acute gout antiinflammatory Western medicine has three classes, first-selected colchicine, and the inferior nonsteroidal antiinflammatory drug that selects selects hormone at last.Acute stage, need the concentration of blood uric acid in the control volume later, at present, mainly contain 2 class medicines and be used for serum uric acid level in the control volume, the one, suppress the synthetic medicine of uric acid, the product that but patients is selected on the market has only one of allopurinol in decades, more and the patient of drug side effect is difficult to tolerance, as allopurinol allergic rash, stomachache, diarrhoea, leukocyte and thrombocytopenia, even side effect such as liver function injury; Another kind of is the excretory medicine of uricosuric.Promote urate excretion class medicine, great advantage is not influence purine and pyrimidine metabolic.Clinical application is based on benzbromarone and probenecid.
Probenecid: probenecid is benemid (probalan) again, is used for chronic gout, and acute gout is not had effect, and gastrointestinal absorbs fully, and its metabolite still has uricotelism.So its maximum therapy effect betides the back a few days of taking medicine, and gastrointestinal reaction can be arranged, the erythra heating seldom has infringement of Liver and kidney merit and blood system infringement.
Benzbromarone (benzbronarone): be narcaricin again, the composition benzbromarone, benzofuran derivatives has very strong reduction blood uric acid effect, and mechanism of action mainly is by the heavily absorption of inhibition renal tubules to uric acid, thereby reduces uric acid concentration in the blood.Benzbromarone does not obstruct metabolism of purine nucleotide, is applicable to chronicity treatment hyperuricemia and goat.The less idol of side effect can cause hepatitis gravis and granulocytopenia.Benzbromarone is succeeded in developing in the sixties by French Labaz company the earliest, and 1971 in Germany's listing, after this respectively in multinational listings such as Australia, Belgium, France, China.
Sulfinpyrazone (Sulfinpyrazone): powerful promotion uricosuric drug, once take sustainable 10 hours of back uricotelism, be used for chronic gout, faint anti-inflammatory and analgesic effect is arranged, can suppress platelet and condense.
Febustat (English general by name: being the synthetic blood uric acid medicine that falls of another inhibition uric acid near market febuxostat), also is the fast alcohols xanthine oxidase inhibitor of first non-Huang, and its chemical structural formula is as follows:
Chemistry is by name: 2-[3-cyano group-4-(2-methyl propoxyl group) phenyl]-4-methyl-5-thiazole carboxylic acid.
U.S. Pat 5614520 discloses the method for Febustat and preparation thereof, and is used for the treatment of the purposes because of the gout of blood uric acid due to raising.Febustat is by suppressing the activity of xanthine oxidase, thereby prevention or reduction hypoxanthine, the synthetic uric acid of xanthine reach the effect that reduces blood uric acid, external contrast test and clinical trial show, it is stronger than allopurinol to fall blood uric acid (SUA) effect, better tolerance, can effectively control serum uric acid level, thereby reach the purpose of treatment gout.Febustat is developed by Japanese Supreme Being people's pharmaceutical companies, just in U.S. FDA registration listing.
Benzbromarone, probenecid, sulfinpyrazone three mainly drain control system serum uric acid level to reach the purpose of treatment gout by uricosuric, Febustat then is to control the effect that serum uric acid level reaches the treatment gout by the generation that suppresses uric acid, though they can both reduce serum uric acid level separately, but its dynamics is not enough, can't reach gratifying degree, and dosage is big, causes many side effect, and patient's toleration is poor.Therefore, clinically need better efficacy, side effect still less, toleration is better, the medicine that suitable patient takes for a long time.Febustat makes the different mechanism of action drug synergisms of two classes with the pharmaceutical composition that the medicine for improving uric acid excretion combination obtains, and can improve action intensity and effectiveness, can reduce the dosage of active medicine simultaneously, reduces drug side effect.Prove through animal experiment, contain the effect of uric acid level in the reduction blood of compound preparation of Febustat and medicine for improving uric acid excretion and the effect that drug effect obviously is better than its single-dose thing, finished the present invention for this reason.
Summary of the invention
The invention provides a kind of pharmaceutical composition, comprise Febustat or its pharmaceutical salts or its solvate, uricosuric eccritic and the pharmaceutically acceptable adjuvant or the carrier of effective therapeutic dose with synergistic treatment gout.
Uricosuric eccritic of the present invention is selected from least a in the following chemical compound: benzbromarone, probenecid, sulfinpyrazone.Preferred uricosuric eccritic is benzbromarone, probenecid.Preferred uricosuric eccritic is a benzbromarone, specifically is meant the compound preparation that contains Febustat and benzbromarone.
The pharmaceutical salts of Febustat can be alkali metal or alkali salt such as sodium salt, potassium salt, calcium salt etc., and ammonia salt, organic ammonium salt.
Pharmaceutical composition of the present invention, the weight ratio of its Febustat and uricosuric eccritic is 1: 50-10: 1, the weight ratio of preferred Febustat and uricosuric eccritic is preferably 1: 25-3: 1, and the weight ratio of preferred Febustat and uricosuric eccritic more preferably 1: 7-2: 1.
Pharmaceutical composition of the present invention, the wherein weight ratio 1 of Febustat and benzbromarone: 2.5-4.8: 1
Pharmaceutical composition of the present invention, the weight ratio 1 of Febustat and benzbromarone: 2.5-2.4: 1, be preferably 1: 1-2: 1
According to above-mentioned weight ratio, in per 1 agent medicine compositions, the content of active component Febustat can be 20mg, 40mg, 80mg, 120mg, and the content of benzbromarone can be 25mg, 40mg, 50mg, 80mg, 100mg, but these two kinds of absorption of active ingredient combination in any.Preferred Febustat is 80mg or 120mg, and corresponding benzbromarone is 50mg.
According to above-mentioned weight ratio, in per 1 agent medicine compositions, the content of active component Febustat can be 20mg, 40mg, 80mg, 120mg, and the content of probenecid can be 250mg, 500mg, but the selectable consumption combination in any of these two kinds of active component.Preferred Febustat is 80mg or 120mg, and corresponding probenecid is 250mg.
According to above-mentioned weight ratio, in per 1 agent medicine compositions, the content of active component Febustat can be 20mg, 40mg, 80mg, 120mg, and the content of sulfinpyrazone can be 100mg, 200mg, but the selectable consumption combination in any of these two kinds of active component.
Above-mentioned said 1 dose is to can be regarded as 1,1 capsules, 1 bag, injection according to different dosage forms to can be 1 or the like.Pharmaceutical composition of the present invention, its dosage form can be tablet or capsule, buccal tablet, oral cavity disintegration tablet, oral instant-dissolving tablet, dispersible tablet, masticatory, granule, dry suspension, injection, solution etc., also can be slow releasing agent, controlled release agent, quick-release and slow-release preparation, as slow releasing tablet, capsule etc.Preferred dosage form is tablet or capsule.
Pharmaceutical composition of the present invention, said adjuvant or carrier are selected from: filler, disintegrating agent, binding agent, lubricant, wetting agent or their combination.Other adjuvant also can comprise correctives, other surfactant and adjuvant that can be used for injecting or carrier.The different dosage form of root pick pharmaceutical composition can be selected corresponding auxiliary material, just can finish the preparation of corresponding dosage forms preparation according to the existing routine techniques of formulation preparation, also can carry out coating in case of necessity.
The application of pharmaceutical composition of the present invention in the airy medicine of preparation treatment.Can be used for treating gout because of uric acid concentration in the blood raises and other reason causes.
Pharmaceutical composition of the present invention, described filler can be starch, modified starch, mannitol, sorbitol, lignocellulose, microcrystalline Cellulose, lactose and calcium carbonate, they can use separately also can mix use, its consumption is about the 10%-95.4% of pharmaceutical composition gross weight, be preferably 20%-94.2%, more preferably 40%-92.4%.
Described binding agent can be hydroxypropyl methylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, and they can use separately also can mix use, and its consumption is about the 0-20% of pharmaceutical composition gross weight, is preferably 0%-15%, more preferably 0%-10%.
Described disintegrating agent can be low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, carboxymethylcellulose calcium, starch, modified starch, cross-linking sodium carboxymethyl cellulose and crospolyvinylpyrrolidone, they can use separately also can mix use, preferred low-substituted hydroxypropyl cellulose and crospolyvinylpyrrolidone, its consumption is about the 0%-40% of pharmaceutical composition gross weight, be preferably 1%-30%, more preferably 3%-20%.
Described lubricant can be magnesium stearate, stearic acid, Palmic acid, calcium stearate and Pulvis Talci, and they can use separately also can mix use, and its consumption is about the 0.01%-10% of pharmaceutical composition gross weight, more preferably 0.1%-3%.
Described wetting agent can be water or ethanol; Correctives such as A Siba sweet or glucide and sodium salt thereof etc.
Animal experiment proves: it is stronger than their arbitrary single-dose things that the compound preparation that Febustat and medicine for improving uric acid excretion (benzbromarone, probenecid or sulfinpyrazone) are formed reduces the effect of uric acid level in the blood, faster, wherein Febustat makes by U.S. Pat 5614520 disclosed methods, and benzbromarone, probenecid, sulfinpyrazone are buied from the market.Gained compound preparation administration every day 1 time, each 1.
Embodiment
Following examples are in order to sets forth in detail and understand the present invention, but are not limited to scope of embodiments.
Embodiment 1
Febustat 80g
Benzbromarone 50g
Lactose 80g
Microcrystalline Cellulose 30g
10% polyvinylpyrrolidonesolution solution is an amount of
Carboxymethyl starch sodium 10g
Magnesium stearate 2.5g
Make 1000
Technology: Febustat, benzbromarone, lactose and the microcrystalline Cellulose of recipe quantity are mixed, add an amount of 10% polyvinylpyrrolidonesolution solution carboxylic stir, after sieving, oven dry, tabletting behind adding methyl starch sodium and the magnesium stearate mix homogeneously.
Embodiment 2
Febustat 120g
Benzbromarone 50g
Lactose 80g
Microcrystalline Cellulose 30g
10% polyvinylpyrrolidonesolution solution is an amount of
Carboxymethyl starch sodium 10g
Magnesium stearate 2.9g
Make 1000
Technology: the prepared by embodiment 1 becomes 1000.
Embodiment 3
Febustat 80g
Sulfinpyrazone 100g
Lactose 80g
Microcrystalline Cellulose 30g
10% polyvinylpyrrolidonesolution solution is an amount of
Carboxymethyl starch sodium 10g
Magnesium stearate 3g
Make 1000
Technology: the prepared of pressing embodiment 1.
Embodiment 4
Febustat 120g
Sulfinpyrazone 100g
Lactose 80g
Microcrystalline Cellulose 30g
10% polyvinylpyrrolidonesolution solution is an amount of
Carboxymethyl starch sodium 10g
Magnesium stearate 3g
Make 1000
Technology: the prepared of pressing embodiment 1.
Embodiment 5
Febustat 80g
Probenecid 250g
Lactose 80g
Microcrystalline Cellulose 60g
10% polyvinylpyrrolidonesolution solution is an amount of
Carboxymethyl starch sodium 20g
Magnesium stearate 5g
Make 1000
Technology: the prepared of pressing embodiment 1.
Claims (11)
1, a kind of have a synergistic pharmaceutical composition, comprises Febustat or its pharmaceutical salts or its solvate, uricosuric eccritic and the pharmaceutically acceptable adjuvant or the carrier of effective therapeutic dose.
2, pharmaceutical composition according to claim 1, said uricosuric eccritic is selected from: benzbromarone, probenecid, sulfinpyrazone.
3, pharmaceutical composition according to claim 2, said uricosuric eccritic is preferably benzbromarone, probenecid.
4, pharmaceutical composition according to claim 3, said uricosuric eccritic is a benzbromarone.
5, pharmaceutical composition according to claim 1, the weight ratio of its Febustat and uricosuric eccritic is 1: 50-10: 1.
6, pharmaceutical composition according to claim 5, the weight ratio of its Febustat and uricosuric eccritic is preferably 1: 25-3: 1.
7, pharmaceutical composition according to claim 6, the weight ratio of its Febustat and uricosuric eccritic more preferably 1: 7-2: 1.
8, pharmaceutical composition according to claim 4, the weight ratio 1 of Febustat and benzbromarone: 2.5-4.8: 1
9, pharmaceutical composition according to claim 9, the weight ratio 1 of Febustat and benzbromarone: 2.5-2.4: 1
10, pharmaceutical composition according to claim 1, said adjuvant or carrier are selected from: filler, disintegrating agent, binding agent, lubricant, wetting agent or their combination.
11, the application of pharmaceutical composition according to claim 1 in the airy medicine of preparation treatment.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005100573485A CN1954814A (en) | 2005-10-26 | 2005-10-26 | Medical composite with co-action for treating gout and its preparation method |
| CNA2006800400510A CN101296696A (en) | 2005-10-26 | 2006-10-23 | Medicine composition for treating gout, method for making the same and the use thereof |
| PCT/CN2006/002827 WO2007048332A1 (en) | 2005-10-26 | 2006-10-23 | A pharmaceutical composition for treating gout and its preparation and use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005100573485A CN1954814A (en) | 2005-10-26 | 2005-10-26 | Medical composite with co-action for treating gout and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1954814A true CN1954814A (en) | 2007-05-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2005100573485A Pending CN1954814A (en) | 2005-10-26 | 2005-10-26 | Medical composite with co-action for treating gout and its preparation method |
| CNA2006800400510A Pending CN101296696A (en) | 2005-10-26 | 2006-10-23 | Medicine composition for treating gout, method for making the same and the use thereof |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006800400510A Pending CN101296696A (en) | 2005-10-26 | 2006-10-23 | Medicine composition for treating gout, method for making the same and the use thereof |
Country Status (2)
| Country | Link |
|---|---|
| CN (2) | CN1954814A (en) |
| WO (1) | WO2007048332A1 (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010022580A1 (en) * | 2008-08-26 | 2010-03-04 | 天津泰普药品科技发展有限公司 | Medical composition for treating hyperuricemia and the use thereof |
| WO2010022581A1 (en) * | 2008-08-26 | 2010-03-04 | 天津泰普药品科技发展有限公司 | Medical composition for treating hyperuricemia and the use thereof |
| CN101953814A (en) * | 2009-07-17 | 2011-01-26 | 北京本草天源药物研究院 | Febuxostat solid preparation |
| CN101716132B (en) * | 2008-10-09 | 2012-01-11 | 北京方策方程医药科技有限公司 | Febuxostat enteric preparation |
| CN102372679A (en) * | 2010-08-27 | 2012-03-14 | 北京润德康医药技术有限公司 | Febuxostat water-soluble derivative and preparation method thereof |
| CN101862326B (en) * | 2009-04-20 | 2013-12-04 | 北京德众万全药物技术开发有限公司 | Medicine compound containing febuxostat |
| CN101929988B (en) * | 2009-06-26 | 2014-05-07 | 北京德众万全药物技术开发有限公司 | Method for detecting febuxostat-associated matters by using high performance liquid chromatography |
| CN104042577A (en) * | 2014-06-13 | 2014-09-17 | 安徽省逸欣铭医药科技有限公司 | Stable topiroxostat tablet and preparation method thereof |
| CN104856975A (en) * | 2015-05-26 | 2015-08-26 | 青岛海之星生物科技有限公司 | Probenecid slow release capsule and preparation method thereof |
| 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 |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2881116A1 (en) | 2013-12-05 | 2015-06-10 | Ranbaxy Laboratories Limited | Febuxostat composition |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE122008000051I1 (en) * | 1990-11-30 | 2009-02-05 | Teijin Ltd | 2-ARYLTHIAZOL DERIVATIVE AND MEDICAMENT CONTAINING THEREOF |
| CN1615875A (en) * | 2004-09-10 | 2005-05-18 | 武汉健民中药工程有限责任公司 | Dispersive tablet having allopurinol and benzbromarone |
-
2005
- 2005-10-26 CN CNA2005100573485A patent/CN1954814A/en active Pending
-
2006
- 2006-10-23 CN CNA2006800400510A patent/CN101296696A/en active Pending
- 2006-10-23 WO PCT/CN2006/002827 patent/WO2007048332A1/en active Application Filing
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010022580A1 (en) * | 2008-08-26 | 2010-03-04 | 天津泰普药品科技发展有限公司 | Medical composition for treating hyperuricemia and the use thereof |
| WO2010022581A1 (en) * | 2008-08-26 | 2010-03-04 | 天津泰普药品科技发展有限公司 | Medical composition for treating hyperuricemia and the use thereof |
| CN101658520B (en) * | 2008-08-26 | 2011-07-27 | 天津泰普药品科技发展有限公司 | Medicinal composition for treating hyperuricemia |
| CN101716132B (en) * | 2008-10-09 | 2012-01-11 | 北京方策方程医药科技有限公司 | Febuxostat enteric preparation |
| CN101862326B (en) * | 2009-04-20 | 2013-12-04 | 北京德众万全药物技术开发有限公司 | Medicine compound containing febuxostat |
| CN101929988B (en) * | 2009-06-26 | 2014-05-07 | 北京德众万全药物技术开发有限公司 | Method for detecting febuxostat-associated matters by using high performance liquid chromatography |
| CN101953814A (en) * | 2009-07-17 | 2011-01-26 | 北京本草天源药物研究院 | Febuxostat solid preparation |
| CN102372679A (en) * | 2010-08-27 | 2012-03-14 | 北京润德康医药技术有限公司 | Febuxostat water-soluble derivative and preparation method thereof |
| CN104042577A (en) * | 2014-06-13 | 2014-09-17 | 安徽省逸欣铭医药科技有限公司 | Stable topiroxostat tablet and preparation method thereof |
| CN104042577B (en) * | 2014-06-13 | 2016-08-24 | 安徽省逸欣铭医药科技有限公司 | A kind of stable Topiroxostat tablet and preparation method thereof |
| CN104856975A (en) * | 2015-05-26 | 2015-08-26 | 青岛海之星生物科技有限公司 | Probenecid slow release capsule and preparation method thereof |
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2007048332A1 (en) | 2007-05-03 |
| CN101296696A (en) | 2008-10-29 |
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