CN103585151B - Famotidine and dexibuprofen compound tablets and preparation method thereof - Google Patents
Famotidine and dexibuprofen compound tablets and preparation method thereof Download PDFInfo
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- CN103585151B CN103585151B CN201310603105.1A CN201310603105A CN103585151B CN 103585151 B CN103585151 B CN 103585151B CN 201310603105 A CN201310603105 A CN 201310603105A CN 103585151 B CN103585151 B CN 103585151B
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Abstract
The invention provides famotidine and dexibuprofen compound tablets and a preparation method thereof. The compound tablets consist of dexibuprofen, famotidine, a disintegrating agent, a diluent, a lubricant and a glidant, wherein the weight ratio of the famotidine to the dexibuprofen is 1: (29-31). The preparation method comprises the following steps: the famotidine is mixed with the diluent and the disintegrating agent, and is added with adhesive for palletizing by the wet method, then is dried to prepare famotidine particles; the dexibuprofen is mixed with the diluent and the disintegrating agent to prepare dexibuprofen particles; the famotidine particles are mixed with the dexibuprofen particles evenly to obtain mixed particles I; the lubricant and the glidant are added in the mixed particles I for evenly mixing to obtain mixed particles II; and the mixed particles II are compressed to form the tablets. The famotidine and dexibuprofen compound tablets have the advantages of better curative effect, quicker effect achievement and small dosage, and can be directly taken orally to treat adult rheumatic arthritis and osteoarthritis.
Description
Technical field
The present invention relates to a kind of complex tablet and preparation method thereof, be specifically related to complex tablet of a kind of famotidine and (S)-ibuprofen and preparation method thereof.
Background technology
Ibuprofen is the derivant of benzenpropanoic acid, being medicine safely and effectively in traditional NSAIDs, is the first ladder medicine that the medication of pain ladder is recommended, containing an asymmetric carbon atom in structure, there are two enantiomer in molecule, its active component is (S)-ibuprofen.Ibuprofen can cause gastritis, dyspepsia and gastric duodenal ulcer after taking.And famotidine is the medicine owing to treating heartburn, ulcer and esophagitis, can reduces after ibuprofen makes complex tablet together with famotidine and even eliminate this side effect.
In April, 2011, U.S. FDA have approved the complex tablet Duexis be made up of ibuprofen and famotidine developed by Horizon pharmaceutical Co. Ltd, for being reduced to the disease signs of human rheumatoid arthritis and Human Osteoarthritis and symptom and reducing upper gastrointestinal ulcer developing risk.
Summary of the invention
The object of the present invention is to provide and a kind of there is the famotidine of better curative effect and the complex tablet of (S)-ibuprofen and preparation method thereof.
Object of the present invention is achieved through the following technical solutions:
First aspect, the invention provides the complex tablet of a kind of famotidine and (S)-ibuprofen, be made up of (S)-ibuprofen, famotidine, disintegrating agent, diluent, binding agent, lubricant and fluidizer, the weight ratio of described famotidine and described (S)-ibuprofen is 1:(29 ~ 31).
Preferably, described disintegrating agent be selected from starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose one or more, the percentage ratio that the weight of described disintegrating agent accounts for described complex tablet gross weight is 2 ~ 20%.
Preferably, described diluent be selected from pregelatinized Starch, starch, microcrystalline Cellulose, lactose, sucrose one or more, the percentage ratio that the weight of described diluent accounts for described complex tablet gross weight is 10 ~ 90%.
Preferably, described binding agent be selected from starch, polyvidone, hydroxypropyl cellulose, hydroxypropyl emthylcellulose one or more, the percentage ratio that the weight of described binding agent accounts for described complex tablet gross weight is 0.2 ~ 10%.
Preferably, described lubricant be selected from magnesium stearate, calcium stearate, sodium benzoate, palmitic acid stearic acid ester of glycerol, Polyethylene Glycol, hydrogenated cottonseed oil, Oleum Ricini one or more, the percentage ratio that the weight of described lubricant accounts for described complex tablet gross weight is 0.2 ~ 2%.
Preferably, described fluidizer be selected from colloidal silica, Pulvis Talci, corn starch one or more, the percentage ratio that the weight of described fluidizer accounts for described complex tablet gross weight is 0.5 ~ 10%.
First aspect, the invention provides the preparation method of the complex tablet of a kind of above-mentioned famotidine and (S)-ibuprofen, comprises the following steps:
Step (1), adds binding agent, wet granulation after being mixed by famotidine with diluent, disintegrating agent, dries, prepares famotidine granule;
Step (2), (S)-ibuprofen and diluent, disintegrating agent are mixed with (s)-ibuprofen granules;
Step (3), mixes described famotidine granule and described (s)-ibuprofen granules, obtains hybrid particles I;
Step (4), adds lubricant and fluidizer in described hybrid particles I, and mixing, obtains hybrid particles II;
Step (5), compresses described hybrid particles II, forms tablet, to obtain final product.
Compared with prior art, the present invention has following beneficial effect: (S)-ibuprofen is compared with ibuprofen such as dosage such as grade, there is better curative effect, smaller dose can reach therapeutical effect, the therapeutic equivalence of the former dosage 300mg and 600mg and 400mg and 800mg of the latter, (S)-ibuprofen toleration is better, and before and after treatment, hemogram, hepatic and renal function are without significant change.Therefore, compared with ibuprofen, (S)-ibuprofen better efficacy, onset are faster, and small amount just can reach the curative effect of ibuprofen, meanwhile, in safety and medicine kinetics, is all better than ibuprofen.Famotidine can reduce the gastric acid secretion that can cause gastric duodenal ulcer, can improve the gastrointestinal safety of (S)-ibuprofen, but can not cut down the effect that this medicine reduces pain and inflammation.Diluent is to increase the unit weight for molding to reach desired wt and to add the excipient in pharmaceutical composition to.Binding agent is the excipient of the adhesion properties that the one-tenth giving pharmaceutical composition divides.Disintegrating agent is incorporated in pharmaceutical composition, that guarantee said composition has acceptable disintegration rate in environment for use excipient.Fluidizer in order to keep the flowing of component powders in film-making process, prevent the formation of luming and the excipient be included in pharmaceutical composition.The complex tablet that (S)-ibuprofen provided by the invention and famotidine are made, directly orally can be used for the treatment of adult rheumatoid arthritis and osteoarthritis, more can meet the requirement of patient treatment.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described in detail.Following examples will contribute to those skilled in the art and understand the present invention further, but not limit the present invention in any form.It should be pointed out that to those skilled in the art, without departing from the inventive concept of the premise, can also make certain adjustments and improvements.These all belong to protection scope of the present invention.
embodiment 1
| ? | Composition | Milligram/unit |
| 1 | Famotidine | 10 |
| 2 | Microcrystalline Cellulose PH101 | 73 |
| 3 | Starch | 5 |
| 4 | Hydroxypropyl cellulose | 2 |
| 5 | Purified water | In addition |
| Sub-total amount | 90 | |
| 6 | (S)-ibuprofen | 300 |
| 7 | Microcrystalline Cellulose PH102 | 70 |
| 8 | Low-substituted hydroxypropyl cellulose | 15 |
| 9 | Cross-linking sodium carboxymethyl cellulose | 15 |
| Sub-total amount | 400 | |
| 10 | Colloidal silica | 5 |
| 11 | Magnesium stearate | 5 |
| Total amount | 500 |
(1) by item 1-3(famotidine, microcrystalline Cellulose PH101, starch) cross 80 mesh sieves respectively, add in V-Mixer and mix 15 minutes;
(2) item 4 purified water dissolving is obtained binding agent;
(3) mixture in step (1) transfers to low shear granulation machine;
(4) under the low speed, start granulator, add binding agent, frequently check wet grain, until wet granulation reaches terminal, the amount of binder of interpolation is 200ml;
(5) adopt drying baker dry, baking temperature is set to 50 DEG C;
(6) basin is covered by aluminium foil, and wet grain is evenly deployed on aluminium foil, and dried at 50 DEG C, until water content is lower than 3% dry stopping;
(7) dry granule is crossed 30 mesh sieves and is carried out granulate, obtains famotidine granule;
(8) item 6-9 crosses 80 mesh sieves respectively and enters V-Mixer and mix 15 minutes, obtains (s)-ibuprofen granules;
(9) item 7 joins in the (s)-ibuprofen granules of mixing after weighing according to formula proportion, continues mixing 15 minutes;
(10) add micropowder silica gel and the magnesium stearate of formula ratio in item 9 again, mix 10 minutes;
(11) granule prepared carries out tabletting, obtains famotidine (S)-ibuprofen sheet.
embodiment 2
| ? | Composition | Milligram/unit |
| 1 | Famotidine | 9 |
| 2 | Microcrystalline Cellulose PH101 | 72 |
| 3 | Starch | 5 |
| 4 | Hydroxypropyl cellulose | 2 |
| 5 | Purified water | In addition |
| Sub-total amount | 90 | |
| 6 | (S)-ibuprofen | 310 |
| 7 | Microcrystalline Cellulose PH102 | 60 |
| 8 | Low-substituted hydroxypropyl cellulose | 15 |
| 9 | Cross-linking sodium carboxymethyl cellulose | 15 |
| Sub-total amount | 400 | |
| 10 | Colloidal silica | 5 |
| 11 | Magnesium stearate | 5 |
| Total amount | 500 |
(1) by item 1-3(famotidine, microcrystalline Cellulose PH101, starch) cross mesh sieve respectively, add in V-Mixer and mix 15 minutes;
(2) item 4 purified water dissolving is obtained binding agent;
(3) mixture in step (1) is transferred to low shear granulation machine;
(4) under the low speed, start granulator, add binding agent, frequently check wet grain, until wet granulation reaches terminal, the amount of binder of interpolation is 200ml;
(5) adopt drying baker dry, baking temperature is set to 50 DEG C;
(6) basin is covered by aluminium foil, and wet grain is evenly deployed on aluminium foil, and dried at 50 DEG C, until water content is lower than 3% dry stopping;
(7) dry granule is crossed 30 mesh sieves and is carried out granulate, obtains famotidine granule;
(8) item 6-9 crosses 80 mesh sieves respectively and enters V-Mixer and mix 15 minutes, obtains (s)-ibuprofen granules;
(9) item 7 joins in the (s)-ibuprofen granules of mixing after weighing according to formula proportion, continues mixing 15 minutes;
(10) add micropowder silica gel and the magnesium stearate of formula ratio in item 9 again, mix 10 minutes;
(11) granule prepared carries out tabletting, obtains famotidine (S)-ibuprofen sheet.
embodiment 3
| ? | Composition | Milligram/unit |
| 1 | Famotidine | 11 |
| 2 | Microcrystalline Cellulose PH101 | 71 |
| 3 | Starch | 5 |
| 4 | Hydroxypropyl cellulose | 2 |
| 5 | Purified water | In addition |
| Sub-total amount | 90 | |
| 6 | (S)-ibuprofen | 320 |
| 7 | Microcrystalline Cellulose PH102 | 60 |
| 8 | Low-substituted hydroxypropyl cellulose | 10 |
| 9 | Cross-linking sodium carboxymethyl cellulose | 10 |
| Sub-total amount | 400 | |
| 10 | Colloidal silica | 5 |
| 11 | Magnesium stearate | 5 |
| Total amount | 500 |
(1) by item 1-3(famotidine, microcrystalline Cellulose PH101, starch) cross 80 mesh sieves respectively, add in V-Mixer and mix 15 minutes;
(2) item 4 purified water dissolving is obtained binding agent;
(3) mixture in step (1) is transferred to low shear granulation machine;
(4) under the low speed, start granulator, add binding agent, frequently check wet grain, until wet granulation reaches terminal, the amount of binder of interpolation is 200ml;
(5) adopt drying baker dry, baking temperature is set to 50 DEG C;
(6) basin is covered by aluminium foil, and wet grain is evenly deployed on aluminium foil, and dried at 50 DEG C, until water content is lower than 3% dry stopping;
(7) dry granule is crossed 30 mesh sieves and is carried out granulate, obtains famotidine granule;
(8) item 6-9 crosses 80 mesh sieves respectively and enters V-Mixer and mix 15 minutes, obtains (s)-ibuprofen granules;
(9) item 7 joins in the (s)-ibuprofen granules of mixing after weighing according to formula proportion, continues mixing 15 minutes;
(10) add micropowder silica gel and the magnesium stearate of formula ratio in item 9 again, mix 10 minutes;
(11) granule prepared carries out tabletting, obtains famotidine (S)-ibuprofen sheet.
embodiment 4
| ? | Composition | Milligram/unit |
| 1 | Famotidine | 11 |
| 2 | Microcrystalline Cellulose PH101 | 72 |
| 3 | Starch | 4 |
| 4 | Hydroxypropyl cellulose | 2 |
| 5 | Purified water | In addition |
| Sub-total amount | 90 | |
| 6 | (S)-ibuprofen | 330 |
| 7 | Microcrystalline Cellulose PH102 | 50 |
| 8 | Low-substituted hydroxypropyl cellulose | 15 |
| 9 | Cross-linking sodium carboxymethyl cellulose | 15 |
| Sub-total amount | 400 | |
| 10 | Colloidal silica | 5 |
| 11 | Magnesium stearate | 5 |
| Total amount | 500 |
(1) by item 1-3(famotidine, microcrystalline Cellulose PH101, starch) cross 80 mesh sieves respectively, add in V-Mixer and mix 15 minutes;
(2) item 4 purified water dissolving is obtained binding agent;
(3) mixture in step (1) is transferred to low shear granulation machine;
(4) under the low speed, start granulator, add binding agent, frequently check wet grain, until wet granulation reaches terminal, the amount of binder of interpolation is 200ml;
(5) adopt drying baker dry, baking temperature is set to 50 DEG C;
(6) basin is covered by aluminium foil, and wet grain is evenly deployed on aluminium foil, and dried at 50 DEG C, until water content is lower than 3% dry stopping;
(7) dry granule is crossed 30 mesh sieves and is carried out granulate, obtains famotidine granule;
(8) item 6-9 crosses 80 mesh sieves respectively and enters V-Mixer and mix 15 minutes, obtains (s)-ibuprofen granules;
(9) item 7 joins in the (s)-ibuprofen granules of mixing after weighing according to formula proportion, continues mixing 15 minutes;
(10) add micropowder silica gel and the magnesium stearate of formula ratio in item 9 again, mix 10 minutes;
(11) granule prepared carries out tabletting, obtains famotidine (S)-ibuprofen sheet.
embodiment 5
| ? | Composition | Milligram/unit |
| 1 | Famotidine | 11 |
| 2 | Microcrystalline Cellulose PH101 | 72 |
| 3 | Starch | 4 |
| 4 | Hydroxypropyl cellulose | 2 |
| 5 | Purified water | In addition |
| Sub-total amount | 90 | |
| 6 | (S)-ibuprofen | 330 |
| 7 | Microcrystalline Cellulose PH102 | 50 |
| 8 | Low-substituted hydroxypropyl cellulose | 20 |
| 9 | Cross-linking sodium carboxymethyl cellulose | 10 |
| Sub-total amount | 400 | |
| 10 | Colloidal silica | 5 |
| 11 | Magnesium stearate | 5 |
| Total amount | 500 |
(1) by item 1-3(famotidine, microcrystalline Cellulose PH101, starch) cross 80 mesh sieves respectively, add in V-Mixer and mix 15 minutes;
(2) item 4 purified water dissolving is obtained binding agent;
(3) mixture in step (1) is transferred to low shear granulation machine;
(4) under the low speed, start granulator, add binding agent, frequently check wet grain, until wet granulation reaches terminal, the amount of binder of interpolation is 200ml;
(5) adopt drying baker dry, baking temperature is set to 50 DEG C;
(6) basin is covered by aluminium foil, and wet grain is evenly deployed on aluminium foil, and dried at 50 DEG C, until water content is lower than 3% dry stopping;
(7) dry granule is crossed 30 mesh sieves and is carried out granulate, obtains famotidine granule;
(8) item 6-9 crosses 80 mesh sieves respectively and enters V-Mixer and mix 15 minutes, obtains (s)-ibuprofen granules;
(9) item 7 joins in the (s)-ibuprofen granules of mixing after weighing according to formula proportion, continues mixing 15 minutes;
(10) add micropowder silica gel and the magnesium stearate of formula ratio in item 9 again, mix 10 minutes;
(11) granule prepared carries out tabletting, obtains famotidine (S)-ibuprofen sheet.
implementation result
Find that the pharmacologically active of ibuprofen comes from d-isomer through research, compared with ibuprofen such as dosage such as grade, it has better curative effect, smaller dose can reach therapeutical effect, the therapeutic equivalence of the former dosage 300mg and 600mg and 400mg and 800mg of the latter, is all better than ibuprofen in safety and medicine kinetics.Therefore, compared with ibuprofen, (S)-ibuprofen better efficacy, onset are faster.Meanwhile, to the improvement of the indexs such as rest pain, articular pain, arthroncus and joint-improving also higher than ibuprofen, illustrate that (S)-ibuprofen has stronger pain relieving, antiinflammatory, detumescence effect, more can relief of symptoms effectively, curative effect is better than ibuprofen, and toleration is better; Before and after treatment, hemogram, hepatic and renal function are without significant change, illustrate that its safety is better.Therefore, (S)-ibuprofen has antiinflammatory and analgesic effect and small amount just can reach the curative effect of ibuprofen.Famotidine can reduce the gastric acid secretion that can cause gastric duodenal ulcer, can improve the gastrointestinal safety of (S)-ibuprofen, but can not cut down the effect that this medicine reduces pain and inflammation.Diluent is to increase the unit weight for molding to reach desired wt and to add the excipient in pharmaceutical composition to.Binding agent is the excipient of the adhesion properties that the one-tenth giving pharmaceutical composition divides.Disintegrating agent is incorporated in pharmaceutical composition, that guarantee said composition has acceptable disintegration rate in environment for use excipient.Fluidizer is to keep the flowing of component powders in film-making process, prevents the formation of luming and the excipient be included in pharmaceutical composition.The invention provides (S)-ibuprofen and famotidine makes complex tablet, directly orally can be used for the treatment of adult rheumatoid arthritis and osteoarthritis, more can meet the requirement of patient treatment.
Above specific embodiments of the invention are described.It is to be appreciated that the present invention is not limited to above-mentioned particular implementation, those skilled in the art can make various distortion or amendment within the scope of the claims, and this does not affect flesh and blood of the present invention.
Claims (1)
1. the preparation method of the complex tablet of famotidine and (S)-ibuprofen, is characterized in that, comprises the following steps:
Step (1), adds binding agent, wet granulation after being mixed by famotidine with diluent, disintegrating agent, dries, prepares famotidine granule; Described diluent is selected from the one in pregelatinized Starch, starch, microcrystalline Cellulose, lactose, sucrose, and the percentage ratio that the weight of described diluent accounts for complex tablet gross weight is 10%; Described disintegrating agent is selected from the one in starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, and the percentage ratio that the weight of described disintegrating agent accounts for complex tablet gross weight is 20%; Described binding agent is selected from the one in starch, polyvidone, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, and the percentage ratio that the weight of described binding agent accounts for complex tablet gross weight is 0.2%;
Step (2), (S)-ibuprofen and diluent, disintegrating agent are mixed with (s)-ibuprofen granules; Described diluent is selected from the one in pregelatinized Starch, starch, microcrystalline Cellulose, lactose, sucrose, and the percentage ratio that the weight of described diluent accounts for complex tablet gross weight is 10%; Described disintegrating agent is selected from the one in starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, and the percentage ratio that the weight of described disintegrating agent accounts for complex tablet gross weight is 20%;
Step (3), mixes described famotidine granule and described (s)-ibuprofen granules, obtains hybrid particles I;
Step (4), adds lubricant and fluidizer in described hybrid particles I, and mixing, obtains hybrid particles II; Described lubricant is selected from the one in magnesium stearate, calcium stearate, sodium benzoate, palmitic acid stearic acid ester of glycerol, Polyethylene Glycol, hydrogenated cottonseed oil, Oleum Ricini, and the percentage ratio that the weight of described lubricant accounts for complex tablet gross weight is 2%; Described fluidizer is selected from the one in colloidal silica, Pulvis Talci, corn starch, and the percentage ratio that the weight of described fluidizer accounts for complex tablet gross weight is 0.5%;
Step (5), compresses described hybrid particles II, and form tablet, obtaining final product, the weight ratio of wherein said famotidine and described (S)-ibuprofen is 1:29.
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|---|---|---|---|
| CN201310603105.1A CN103585151B (en) | 2013-11-26 | 2013-11-26 | Famotidine and dexibuprofen compound tablets and preparation method thereof |
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| CN103585151B true CN103585151B (en) | 2015-03-04 |
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Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080020040A1 (en) * | 2006-07-18 | 2008-01-24 | Horizon Therapeutics, Inc. | Unit dose form for administration of ibuprofen |
| US20130236538A1 (en) * | 2007-11-30 | 2013-09-12 | Horizonpharma Usa, Inc. | Pharmaceutical compositions of ibuprofen and famotidine |
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