CN105106165A - Clopidogrel hydrogen sulphate tablets and preparation method thereof - Google Patents
Clopidogrel hydrogen sulphate tablets and preparation method thereof Download PDFInfo
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- CN105106165A CN105106165A CN201510510523.5A CN201510510523A CN105106165A CN 105106165 A CN105106165 A CN 105106165A CN 201510510523 A CN201510510523 A CN 201510510523A CN 105106165 A CN105106165 A CN 105106165A
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- clopidogrel
- hydrogen sulfate
- clopidogrel hydrogen
- hyprolose
- castor oil
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Abstract
The invention relates to clopidogrel hydrogen sulphate tablets. The clopidogrel hydrogen sulphate tablets are prepared from the following raw materials in percentage by weight: 30-43% of clopidogrel hydrogen sulfate, 15-45% of diluents, 5-30% of disintegrant, 0.1-8% of lubricant, 0.1-2% of glidants and 1-4% of powder for coating. The tablets are dissolved rapidly and released uniformly. The invention also relates to a preparation method of the clopidogrel hydrogen sulphate tablets. The preparation method comprises the following steps of mixing, tabletting and coating. The preparation method is simple and practicable; and the quality of prepared finished products is stable.
Description
Technical field
The present invention relates to pharmaceutical technology sectors, be specifically related to a kind of tablet and preparation method thereof.
Background technology
Population increases and Aging Problem will make Chinese cardiovascular disease event incidence rate increase by more than 50% within following 20 years, and the risk factors such as current hypertension, T-CHOL, diabetes and obesity will accelerate the pathogenetic ascendant trend of cardiovascular.Thrombotic disease is commonly encountered diseases and the frequently-occurring disease of the mankind, and harm humans is healthy.Cardiovascular inner film injury, blood flow slows down, and blood coagulability raises all can cause thrombosis.Clopidogrel is a kind of anticoagulant, and the activation of the Glycoprotein G P II b/ III a complex that Option stage ground suppresses two phosphorus enzyme adenosines (ADP) and its combination of platelet receptor and the ADP of secondary to mediate, therefore can anticoagulant.Treat thrombotic disease clinically at present, the most frequently used is aspirin, is secondly exactly clopidogrel.Because clopidogrel is rapid-action, the danger caused bleeding is little, and toxic and side effects is few, and market share is far away higher than other drug.
Clopidogrel hydrogen sulfate tablet matches Norfin, Inc's development and production by France the earliest, and on November 17th, 1997, U.S. food Drug Administration (FDA) ratifies bisulfate clopidogrel
after can be used for heart infarction, Post stroke and the peripheral arterial disease (PAD) made a definite diagnosis, state's listings such as a lot of country afterwards in Europe and Canada, Australia, Singapore, are widely used.
Bisulfate clopidogrel chemical name: S (+)-2-(2-chlorphenyl)-2-(4,5,6,7-Tetramethylene sulfide [3,2-c] pyridine-5) acetate hydrogensulfate
Chemical structural formula:
Clopidogrel is a kind of anticoagulant, and the activation of the Glycoprotein G Pllb/llla complex optionally suppressing adenosine diphosphate (ADP) (ADP) and its combination of platelet receptor and the ADP of secondary to mediate, therefore can anticoagulant.Clopidogrel must transform through biology could suppress hematoblastic gathering.Clopidogrel can also block the platelet aggregation that other agonist is caused by release ADP.The effect of clopidogrel to platelet ADP receptor is irreversible, and the hematoblastic whole life cycle being therefore exposed to clopidogrel is all influenced, and the regeneration rate of platelet normal function is consistent with hematoblastic renewal.
In prior art, clopidogrel hydrogen sulfate dissolubility is not good, not easy disintegrating and stripping.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of clopidogrel hydrogen sulfate sheet easily going out stripping.
Another one technical problem to be solved by this invention is to provide a kind of preparation method of clopidogrel hydrogen sulfate sheet, makes the method simple, and the end product quality made is controlled.
In order to solve the problems of the technologies described above, the present invention proposes following technical proposal:
A kind of clopidogrel hydrogen sulfate sheet, it is characterized in that described clopidogrel hydrogen sulfate sheet is made with the raw material of following weight percents: the bisulfate clopidogrel of 30-43%, the diluent of 15-45%, the disintegrating agent of 5-30%, the lubricant of 0.1-8%, the fluidizer of 0.1-2%, the coating powder of 1-4%.
Described diluent is microcrystalline Cellulose, and described disintegrating agent is hyprolose, and described lubricant is castor oil hydrogenated, and described fluidizer is silicon dioxide, and described coating powder is Opadry.
Preferably, described coating powder consist of titanium dioxide, hypromellose, polyvinyl alcohol, Pulvis Talci, Polyethylene Glycol.
A kind of preparation method of clopidogrel hydrogen sulfate sheet, it is characterized in that, described method is made up of the following step: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80-100 mesh sieve respectively, and microcrystalline Cellulose crosses the dispersion of 60-80 mesh sieve, for subsequent use; First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 10-30%, coating weight gain to 1%, obtains product.
Preferably, every sheet is containing 75mg hydrogen chlorine pyrroles thunder.
Bisulfate clopidogrel is mixed homogeneously with diluent, disintegrating agent, lubricant, fluidizer by the present invention, and adopt the technique of direct compression to make clopidogrel bisulfate tablet, compared with prior art, simple process, stripping property are high, production efficiency is high; Reduce the requirement to equipment and operator's technical merit, product yield is high.
In order to better set forth technical scheme of the present invention, below in conjunction with detailed description of the invention, the present invention is further illustrated, but protection domain of the presently claimed invention is not limited to the following example.
Detailed description of the invention
The preparation specification 75mg (by clopidogrel) of embodiment 1 clopidogrel hydrogen sulfate tablet
Table 1 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 1 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 2:
Embodiment 1
The preparation specification 75mg (by clopidogrel) of embodiment 2 clopidogrel hydrogen sulfate tablet
Table 3 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 2 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 4:
Embodiment 2
The preparation specification 75mg (by clopidogrel) of embodiment 3 clopidogrel hydrogen sulfate tablet
Table 5 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 3 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 6:
Embodiment 3
The preparation specification 75mg (by clopidogrel) of embodiment 4 clopidogrel hydrogen sulfate tablet
Table 7 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 4 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 8:
Embodiment 4
The preparation specification 75mg (by clopidogrel) of embodiment 5 clopidogrel hydrogen sulfate tablet
Table 9 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 5 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 10:
Embodiment 5
The preparation specification 75mg (by clopidogrel) of embodiment 6 clopidogrel hydrogen sulfate tablet
Table 11 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 6 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 12:
Embodiment 6
The preparation specification 75mg (by clopidogrel) of embodiment 7 clopidogrel hydrogen sulfate tablet
Table 13 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 7 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 14:
Embodiment 7
The preparation specification 75mg (by clopidogrel) of embodiment 8 clopidogrel hydrogen sulfate tablet
Table 15 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
The bisulfate clopidogrel agent prepared by inventive embodiments 8 is measured according to dissolution determination method (Chinese Pharmacopoeia version in 2010 two annex), with pH2.0 buffer solution for dissolution medium, volume is 1000ml, rotating speed is 50 revs/min, sample dissolution is detected in sampling in 15 minutes, investigate mobility (angle of repose), mouldability, tablet character, the friability of mixed-powder simultaneously, the results are shown in Table 16:
Embodiment 8
The preparation specification 75mg (by clopidogrel) of embodiment 9 clopidogrel hydrogen sulfate tablet
Table 17 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
Investigate the mobility (angle of repose) of mixed-powder and the blanking situation of powder, the results are shown in Table 18:
Embodiment 9
The preparation specification 75mg (by clopidogrel) of embodiment 10 clopidogrel hydrogen sulfate tablet
Table 19 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
Investigate the mobility (angle of repose) of mixed-powder and the blanking situation of powder, the results are shown in Table 20:
Embodiment 10
The preparation specification 75mg (by clopidogrel) of embodiment 11 clopidogrel hydrogen sulfate tablet
Table 21 is with every 1000 gauge
Preparation technology: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80 mesh sieves respectively, microcrystalline Cellulose crosses 60 mesh sieve dispersions, takes above-mentioned supplementary material respectively by recipe quantity, for subsequent use.First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 16%, coating weight gain to 1%, obtains product.
Investigate the mobility (angle of repose) of mixed-powder and the blanking situation of powder, the results are shown in Table 22:
Embodiment 11
Claims (4)
1. a clopidogrel hydrogen sulfate sheet, it is characterized in that described clopidogrel hydrogen sulfate sheet is made with the raw material of following weight percents: the bisulfate clopidogrel of 30-43%, the diluent of 15-45%, the disintegrating agent of 5-30%, the lubricant of 0.1-8%, the fluidizer of 0.1-2%, the coating powder of 1-4%.
Described diluent is microcrystalline Cellulose, and described disintegrating agent is hyprolose, and described lubricant is castor oil hydrogenated, and described fluidizer is silicon dioxide, and described coating powder is Opadry.
2. a kind of clopidogrel hydrogen sulfate sheet according to claim 1, is characterized in that, described coating powder consist of titanium dioxide, hypromellose, polyvinyl alcohol, Pulvis Talci, Polyethylene Glycol.
3. the preparation method of a kind of clopidogrel hydrogen sulfate sheet described in claim 1, it is characterized in that, described method is made up of the following step: bisulfate clopidogrel, hyprolose, castor oil hydrogenated, silicon dioxide are crossed 80-100 mesh sieve respectively, microcrystalline Cellulose crosses the dispersion of 60-80 mesh sieve, for subsequent use; First bisulfate clopidogrel, hyprolose, silicon dioxide and microcrystalline Cellulose are pre-mixed, then add castor oil hydrogenated mix homogeneously, direct powder compression, obtain plain sheet, Opadry is made into the aqueous solution of 10-30%, coating weight gain to 1%, obtains product.
4. a kind of clopidogrel hydrogen sulfate sheet according to claim 1-3, is characterized in that every sheet is containing 75mg chlorine pyrroles thunder.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112999180A (en) * | 2019-12-20 | 2021-06-22 | 青岛黄海制药有限责任公司 | Clopidogrel hydrogen sulfate crystal form II tablet and preparation method thereof |
| CN117503720A (en) * | 2024-01-02 | 2024-02-06 | 济南舜景医药科技有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
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| WO2008059298A2 (en) * | 2006-11-14 | 2008-05-22 | EGIS GYÓGYSZERGYÁR Nyilvánosan Müködö Részvénytársaság | Pharmaceutical composition containing clopidogrel hydrogenesulphate of polymorph 1 form |
| EP1970054A2 (en) * | 2007-03-14 | 2008-09-17 | Ranbaxy Laboratories Limited | Clopidogrel tablets |
| CN101396350A (en) * | 2008-10-29 | 2009-04-01 | 深圳海王药业有限公司 | Clopidogrel hydrogen sulfate dispersible tablets and preparation method thereof |
| CN102961355A (en) * | 2012-11-29 | 2013-03-13 | 河南润弘制药股份有限公司 | Clopidogrel hydrogen sulfate tablet and preparation method thereof |
-
2015
- 2015-08-19 CN CN201510510523.5A patent/CN105106165A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008059298A2 (en) * | 2006-11-14 | 2008-05-22 | EGIS GYÓGYSZERGYÁR Nyilvánosan Müködö Részvénytársaság | Pharmaceutical composition containing clopidogrel hydrogenesulphate of polymorph 1 form |
| EP1970054A2 (en) * | 2007-03-14 | 2008-09-17 | Ranbaxy Laboratories Limited | Clopidogrel tablets |
| CN101396350A (en) * | 2008-10-29 | 2009-04-01 | 深圳海王药业有限公司 | Clopidogrel hydrogen sulfate dispersible tablets and preparation method thereof |
| CN102961355A (en) * | 2012-11-29 | 2013-03-13 | 河南润弘制药股份有限公司 | Clopidogrel hydrogen sulfate tablet and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112999180A (en) * | 2019-12-20 | 2021-06-22 | 青岛黄海制药有限责任公司 | Clopidogrel hydrogen sulfate crystal form II tablet and preparation method thereof |
| CN112999180B (en) * | 2019-12-20 | 2022-08-30 | 青岛黄海制药有限责任公司 | Clopidogrel hydrogen sulfate crystal form II tablet and preparation method thereof |
| CN117503720A (en) * | 2024-01-02 | 2024-02-06 | 济南舜景医药科技有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
| CN117503720B (en) * | 2024-01-02 | 2024-03-15 | 济南舜景医药科技有限公司 | Clopidogrel bisulfate tablet and preparation method thereof |
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