CN105079815A - Azilsartan medoxomil potassium combination and preparation method thereof - Google Patents
Azilsartan medoxomil potassium combination and preparation method thereof Download PDFInfo
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Abstract
The invention provides an azilsartan medoxomil potassium combination which has angiotensin II receptor antagonism. Azilsartan medoxomill is enabled to have high stability and dissolubility by adding pH control agent. The invention further provides a method for preparing the combination.
Description
Technical field
The present invention relates to pharmaceutical field, be specifically related to a kind of composition and method of making the same comprising Azilsartan potassium, pH controlling agent and the acceptable adjuvant of pharmacy.
Background technology
Azilsartan potassium, its chemical name is (5-methyl-2-oxo-1,3-Dioxol-4-yl) methyl 2-ethyoxyl-1-[(2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazoles-3-base) biphenyl-4-base] methyl)-1H-benzimidazole-7-carboxylic acid, ethyl ester potassium salt.Its structure is as follows:
Azilsartan potassium is open in patent documentation (WO2005/080384, wherein correlation technique is quoted as a comparison), has angiotensin-ii-receptor antagonism, is the hypertensive medicine for the treatment of.
Azilsartan potassium is unstable in neutral conditions, and its dissolubility in solid pharmaceutical preparation is lower again under its stable pH condition.Azilsartan potassium in solid pharmaceutical preparation, have good stability simultaneously and stripping property is its safe and effective requirement.Prepare the method for preparation under common neutrallty condition under, the Azilsartan potassium pharmaceutical preparation that preparation meets above-mentioned requirements is more difficult thing.
Chinese patent CN101677961 discloses the solid pharmaceutical preparation comprising benzimidazole-7-carboxylate derivative, prepare as the fumaric acid of PH controlling agent and sodium hydroxide or monosodium fumarate and other adjuvants, and pH scope control is between 2-5.In its solid pharmaceutical preparation, there is excellent stability and stripping property by above-mentioned prior art benzimidazole-7-carboxylate derivative simultaneously.
Summary of the invention
The invention provides another pH controlling agent, be different from prior art (CN101677961B, wherein correlation technique is quoted as a comparison) pH condition under prepare Azilsartan potassium compositions, make Azilsartan potassium have excellent stability and stripping property in prepared solid preparation simultaneously.
Summary of the invention
The Azilsartan potassium compositions that a first aspect of the present invention provides stability and stripping property all excellent.
Another aspect of the present invention is to provide the preparation method of all excellent Azilsartan potassium compositions of a kind of stability and stripping property.
Term definition
In the present invention, room temperature refers to that temperature is at about 18 DEG C to about 35 DEG C, or about 20 DEG C to 30 DEG C, or about 25 DEG C.
In the present invention, the pH value of pH controlling agent: pH controlling agent is added in purified water and stirs to clarify, stir to clarify, the solution obtained.Above-mentioned solution measures with pH meter at 25 DEG C.
In the present invention, w/w refers to quality and mass ratio.
In the present invention, w/v refers to that every 1g substance dissolves is in 100ml solution.
In the present invention, mg represents milligram, and ml represents milliliter, and μ l represents microlitre.
Above of the present invention, no matter whether use the wording such as " approximately " or " about ", all numerals disclosed at this are approximation.The numerical value of each numeral likely there will be the difference of less than 10% according to general knowledge as well known to those skilled in the art, as the difference of 1%, 2%, 3%, 4% or 5%.
Detailed Description Of The Invention
The present inventor, in long-term developmental research, by constantly attempting the different pH controlling agent adjuvant different with screening, attempts to make Azilsartan potassium have excellent stability and stripping property in the composition.
Therefore first aspect present invention provides a kind of compositions of Azilsartan potassium, and said composition comprises Azilsartan potassium, pH controlling agent and pharmaceutically acceptable adjuvant.
In the present invention, described PH controlling agent is one or more that organic acid described in organic acidic substances can be selected from tartaric acid, citric acid, lactic acid, fumaric acid, malic acid, ascorbic acid, acetic acid, acidic amino acid.In some embodiments, described PH controlling agent is citric acid.The consumption of described PH controlling agent is that the mass percent accounted in whole compositions is about 0.20% to about 0.76%; In certain embodiments, about 0.20% to about 0.38%; In certain embodiments about 0.28%.
Described PH controlling agent, needs to be configured to the aqueous solution that pH value is about 2 to 3 and is sprayed in preparation system during use.
In certain embodiments, described PH controlling agent is citric acid, and wherein the consumption of citric acid is account for mass percent about 0.20% in whole compositions to about 0.76%; In certain embodiments, about 0.20% to about 0.38%; In certain embodiments, about 0.28%.
In the present invention, described pharmaceutically acceptable adjuvant comprises disintegrating agent, binding agent, lubricant and excipient.Wherein said disintegrating agent can be selected from aminoacid, starch, corn starch, calcium carbonate, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose, one or more in low-substituted hydroxypropyl cellulose; Described binding agent can be selected from light propyl cellulose, HYDROXY PROPYL METHYLCELLULOSE, polyvinylpyrrolidone, gelatin, starch, arabic gum, Tragacanth, carboxy methyl cellulose, sodium alginate, one or more in amylopectin; Described lubricant can be selected from magnesium stearate, stearic acid, calcium stearate, Purified talc etc.; Described excipient can be selected from lactose, sucrose, glucose, starch, corn starch, sucrose, microcrystalline Cellulose, powdered Radix Glycyrrhizae, mannitol, sorbitol, sodium bicarbonate, calcium phosphate, calcium sulfate, one or more in calcium silicates.In some embodiments, the acceptable adjuvant of described pharmacy is selected from one or more in mannitol, hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and hard magnesium.
In certain embodiments, Azilsartan potassium compositions, count by weight percentage, the mass percent in whole compositions of each component is Azilsartan potassium is respectively about 23.0% to about 24.0%, mannitol is about 50.0% to about 60.0%, hydroxypropyl cellulose is about 2.0% to about 6.0%, microcrystalline Cellulose is about 5.0% to about 15.0%, cross-linking sodium carboxymethyl cellulose is about 2.0% to about 8.0%, magnesium stearate is about 0.5% to about 2.0%, and citric acid is about 0.20% to about 0.76%.
In certain embodiments, Azilsartan potassium compositions, count by weight percentage, the mass percent in whole compositions of each component is Azilsartan potassium is respectively about 23.0% to about 24.0%, mannitol is about 55.0%, and hydroxypropyl cellulose is about 2.0% to about 4.0%, and microcrystalline Cellulose is about 10.0%, cross-linking sodium carboxymethyl cellulose is about 5.0% to about 8.0%, and citric acid is about 0.20% to about 0.76%.Wherein the content of citric acid is preferably about 0.20% to about 0.38%, is more preferably about 0.28%.
Compositions is obtained in the present invention, using the hydrochloric acid solution of the 0.1M of the sodium lauryl sulphate containing 0.6% (w/v) as dissolution medium, 37 ± 0.5 DEG C, 900ml, basket method, 100rpm, in first 5 minutes that start to test, Azilsartan potassium total content dissolution is in the composition at least 34.7 ± 7.7%; In first 10 minutes that start to test, Azilsartan potassium total content dissolution is in the composition at least 52.6 ± 10.3%; In first 15 minutes that start to test, Azilsartan potassium total content dissolution is in the composition at least 62.8 ± 10.4%; In first 30 minutes that start to test, Azilsartan potassium total content dissolution is in the composition at least 78.6 ± 8.7%; In first 45 minutes that start to test, Azilsartan potassium total content dissolution is in the composition at least 90.3 ± 4.6%.
Azilsartan potassium compositions provided by the invention, owing to have employed citric acid as pH controlling agent, limit pH about 2 under the condition of about 3, make Azilsartan potassium obtain extraordinary stability in the composition, see the result in this description stability test 2.
Azilsartan potassium compositions provided by the invention, may be used for treating hypertension.
Azilsartan potassium compositions provided by the present invention can make the dosage forms such as medicinal tablets, granule and capsule.
The present invention provides the compositions method of a kind of Azilsartan potassium of preparation described in first aspect on the other hand.The method comprises the following steps:
1) weigh PH regulator to add in appropriate purified water and stir to clarify, measure pH value about 2 to about 3; Then add binding agent, make solution;
2) get appropriate excipient and cross 30 eye mesh screens, for subsequent use;
3) by Azilsartan potassium, appropriate disintegrating agent and appropriate 2) obtain excipient, mix homogeneously, obtain pre-composition;
4) get appropriate 2) obtain excipient and to pour in fluid bed preheating into 2 minutes, then pour in fluid bed by above-mentioned pre-composition, preheating, after temperature of charge reaches 40 DEG C, sprays 1 under 35 ± 3 DEG C of conditions) solution that obtains;
5) dry, treat that fluid bed endoparticle moisture is less than 1.0%, discharging;
6) with pelletizing machine to above-mentioned material granulate, cross screen cloth;
7) by 6) describedly prepare granule and appropriate lubricant and appropriate mixed with excipients is even, obtain whole mixture;
8) above-mentioned whole mixture is made the dosage forms such as tablet, granule and capsule.
In certain embodiments, adding PH regulator 1) is citric acid;
In certain embodiments, adding binding agent 1) is hydroxypropyl cellulose;
In certain embodiments 2), 3) and 4) in the excipient that adds be mannitol;
In certain embodiments 7) lubricant added is magnesium stearate, and the excipient added is microcrystalline Cellulose;
In certain embodiments 8) dosage form prepared is tablet.
Detailed description of the invention
In order to make those skilled in the art understand technical scheme of the present invention better, below disclose further some non-limiting embodiments the present invention is described in further detail.
Used herein to mannitol, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, hydroxypropyl cellulose and magnesium stearate meet Chinese Pharmacopoeia 2010 editions pharmaceutic adjuvant standards.
Embodiment 1
Take the mannitol of 335g, 44.8g cross-linking sodium carboxymethyl cellulose and 142.2g Azilsartan potassium mix homogeneously be placed on Chongqing son imperial fluid bed on be preheated to 40 DEG C; then start to spray under 35 ± 3 DEG C of conditions the mixed solution that 12.2g hydroxypropyl cellulose, 1.2g citric acid and suitable quantity of water make; pH value is about 2.53; and it is dry on fluid bed; then on QUADRO pelletizing machine, carry out granulate, cross 055R screen cloth.Add the magnesium stearate of 3.3g and the microcrystalline Cellulose of 62.4g, be mixed together evenly, obtain mixture.Finally gained mixture is pressed into the compositions that hardness is 90N.
The composition (every sheet 370.1mg) of preparation
Embodiment 2
Take the mannitol of 329.0g, 29.0g cross-linking sodium carboxymethyl cellulose and 144.7g Azilsartan potassium mix homogeneously be placed on Chongqing son imperial fluid bed on be preheated to 40 DEG C; then start to spray under 35 ± 3 DEG C of conditions the mixed solution that 24.1g hydroxypropyl cellulose, 1.7g citric acid and suitable quantity of water make; pH value is about 2.46; and it is dry on fluid bed; then on QUADRO pelletizing machine, carry out granulate, cross 055R screen cloth.Add the magnesium stearate of 12.1g and the microcrystalline Cellulose of 59.6g, be mixed together evenly, obtain mixture.Finally gained mixture is pressed into the sheet that hardness is 90N.
The composition (every sheet 359.5mg) of compositions
Embodiment 3
Take the mannitol of 325.6g, 53.3g cross-linking sodium carboxymethyl cellulose and 135.8g Azilsartan potassium mix homogeneously be placed on Chongqing son imperial fluid bed on be preheated to 40 DEG C; then start to spray under 35 ± 3 DEG C of conditions the mixed solution that 17.0g hydroxypropyl cellulose, 2.3g citric acid and suitable quantity of water make; pH value is about 2.38; and it is dry on fluid bed; then on QUADRO pelletizing machine, carry out granulate, cross 055R screen cloth.Add the magnesium stearate of 6.1g and the microcrystalline Cellulose of 60.0g, be mixed together evenly, obtain mixture.Finally gained mixture is pressed into the sheet that hardness is 90N.
The composition (every 365.0mg) of compositions
Embodiment 4
Take the mannitol of 329.8g, 37.2g cross-linking sodium carboxymethyl cellulose and 145.1g Azilsartan potassium mix homogeneously be placed on Chongqing son imperial fluid bed on be preheated to 40 DEG C; then start to spray under 35 ± 3 DEG C of conditions the mixed solution that 21.1g hydroxypropyl cellulose, 3.2g citric acid and suitable quantity of water make; pH value is about 2.30; and it is dry on fluid bed; then on QUADRO pelletizing machine, carry out granulate, cross 055R screen cloth.Add the magnesium stearate of 6.7g and the microcrystalline Cellulose of 57.1g, be mixed together evenly, obtain mixture.Finally gained mixture is pressed into sheet.
The composition (every 353.3mg) of compositions
Embodiment 5
Take the mannitol of 330.1g, 43.3g cross-linking sodium carboxymethyl cellulose and 158.9g Azilsartan potassium mix homogeneously be placed on Chongqing son imperial fluid bed on be preheated to 40 DEG C; then start to spray under 35 ± 3 DEG C of conditions the mixed solution that 11.8g hydroxypropyl cellulose, 4.6g citric acid and suitable quantity of water make; pH value is about 2.22 and drying on fluid bed; then on QUADRO pelletizing machine, carry out granulate, cross 055R screen cloth.Add the magnesium stearate of 9.7g and the microcrystalline Cellulose of 57.3g, be mixed together evenly, obtain mixture.Finally gained mixture is pressed into the sheet that hardness is 90N.
The composition (every 362.1mg) of compositions
Dissolution test 1
Embodiment 1-5 resulting composition is carried out In Vitro Dissolution experiment exam, and leaching condition is as follows: using the hydrochloric acid solution of the 0.1M of the sodium lauryl sulphate containing 0.6% (w/v) as dissolution medium, 37 ± 0.5 DEG C, 900ml, basket method, 100rpm.This experiment is carried out according to Chinese Pharmacopoeia 2010 editions two annex XC dissolution determination first methods (basket method).Inspect by random samples experimental solutions at different time points, by measuring the content of the Azilsartan potassium of the solution of sampling observation, calculation composition is stripping situation under leaching condition.
Put in the corresponding sample time and pipette suitable solution preparation containing Azilsartan potassium in stripping rotor and be about 0.044mg/ml need testing solution, adopt UV method to detect, undertaken by Chinese Pharmacopoeia 2010 editions two annex VD high performance liquid chromatography.Chromatographic condition is as follows:
Instrument: AgilentHPLC1260series
Chromatographic column: YMC-PackProC18,4.6 × 150mm, 5 μm
Mobile phase: the mixed solution of 0.025mol/L potassium dihydrogen phosphate (with phosphorus acid for adjusting pH to 2.0)-acetonitrile (35:65, v/v)
Column temperature: 30 DEG C
Flow velocity: 1.0ml/min
Determined wavelength: 260nm
Sampling volume: 10ul
Running time: 1.5 times (about 6min) of Azilsartan main peak retention time
Testing result, in table 1, proves that the compositions prepared by embodiment 1-5 has excellent stripping property.
Table 1
| The sampling observation time | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 |
| 5min | 34.7±7.7 | 38.7±6.3 | 46.4±2.1 | 44.8±1.1 | 44.0±2.9 |
| 10min | 52.6±10.3 | 59.7±3.4 | 65.6±1.7 | 65.4±0.9 | 65.0±3.5 |
| 15min | 62.8±10.4 | 69.7±3.4 | 75.2±1.3 | 76.3±0.9 | 76.4±3.1 |
| 30min | 78.6±8.7 | 81.8±3.7 | 87.8±1.5 | 90.0±1.7 | 89.9±2.7 |
| 45min | 92.2±7.8 | 90.3±4.6 | 93.8±1.5 | 98.8±2.7 | 99.0±3.6 |
Stability test 2
Just embodiment 1-5 resulting composition carries out carrying out stability experiment examination according to Chinese Pharmacopoeia 2010 editions annex XIX crude drug and pharmaceutical preparation stability guideline, experiment condition is as follows: sample is packaged in high density polyethylene (HDPE) (HDPE) bottle, inside adds desiccant; Temperature 40 DEG C, relative humidity 75%; Place after 1 month and inspect by random samples, investigate the impurity situation of sample, and compared with the comparative example 1 more similar with prescription dosage form disclosed in Chinese patent CN101677961, embodiment 1,6,16,17, (for the ease of difference, below disclosed above-described embodiment being represented with embodiment 1A, embodiment 6A, embodiment 16A, embodiment 17A) further stability investigating Azilsartan potassium compositions.
Get the compositions of above-mentioned acceleration for stabilization experiment sampling observation, with acetonitrile-water-glacial acetic acid (80:20:1, v/v/v) be diluent, prepare the need testing solution that Azilsartan potassium concn is about 1mg/ml, detect according to the sample of Chinese Pharmacopoeia 2010 editions two annex VD high performance liquid chromatography to regularly sampling observation, chromatographic condition is as follows:
Instrument: AgilentHPLC1260series
Chromatographic column: AgilentZORBAXSB-C18,4.6 × 250mm, 5 μm
Column temperature: 25 DEG C
Sample injection disc temperature: 8 DEG C
Flow velocity: 1.0ml/min
Determined wavelength: 240nm
Sampling volume: 10ul
Running time: 50min
Rear running time: 5min
Gradient elution
| Running time (min) | Mobile phase A % (v/v) | Mobile phase B % (v/v) |
| 0 | 68.5 | 31.5 |
| 10 | 68.5 | 31.5 |
| 22 | 52.5 | 47.2 |
| 30 | 52.5 | 47.5 |
| 40 | 22.0 | 78.0 |
| 50 | 22.0 | 78.0 |
Mobile phase A: the mixed solution of 0.050mol/L potassium dihydrogen phosphate (be 3.5 by phosphoric acid adjust ph)-acetonitrile (19:1, v/v)
Mobile phase B: acetonitrile
The stability data of embodiment disclosed in Chinese patent CN101677961 is in table 2 (Detailed Experimental method is see CN101677961B), and example stability data of the present invention is in table 3.Known through stability data contrast, the compositions that embodiment 1-5 obtains has excellent stability within the stable the effects phase.
Table 2
| Comparative example 1 | Embodiment 1A | Embodiment 6A | Embodiment 16A | Embodiment 17A | |
| Catabolite recruitment (%) | 3.84 | 0.52 | 1.28 | 0.56 | 0.84 |
Table 3
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | |
| 0 day total assorted content (%) | 0.72 | 0.64 | 0.81 | 0.79 | 0.79 |
| Total assorted content (%) after 1 month | 1.73 | 0.81 | 1.42 | 1.39 | 1.39 |
| Catabolite recruitment (%) | 1.01 | 0.17 | 0.61 | 0.60 | 0.60 |
In sum, the Azilsartan potassium compositions given by the present invention has excellent stability or dissolution.
Method of the present invention is described by preferred embodiment, and related personnel obviously can change methods and applications as herein described or suitably change and combination in content of the present invention, spirit and scope, realizes and applies the technology of the present invention.Those skilled in the art can use for reference present disclosure, and suitable improving technique parameter realizes.Special needs to be pointed out is, all similar replacements and change apparent to those skilled in the art, they are all deemed to be included in the present invention.
Claims (12)
1. a compositions for Azilsartan potassium, described compositions comprises Azilsartan potassium, pH controlling agent and pharmaceutically acceptable adjuvant; Described PH controlling agent is organic acidic substances, and described organic acid can be selected from one or more in tartaric acid, citric acid, lactic acid, fumaric acid, malic acid, ascorbic acid, acetic acid, acidic amino acid; Described PH controlling agent, needs to be configured to the aqueous solution that pH value is about 2 to 3 and is sprayed in preparation system during use.
2. compositions according to claim 1, described PH controlling agent is citric acid.
3. compositions according to claim 1 and 2, the consumption of described PH controlling agent is that the mass percent accounted in whole compositions is about 0.20% to about 0.76%; Or about 0.20% to about 0.38%; Or about 0.28%.
4., according to the arbitrary described compositions of claim 1-3, described pharmaceutically acceptable adjuvant comprises disintegrating agent, binding agent, lubricant and excipient.
5. compositions according to claim 4, described disintegrating agent can be selected from aminoacid, starch, corn starch, calcium carbonate, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose, one or more in low-substituted hydroxypropyl cellulose; Described binding agent can be selected from light propyl cellulose, HYDROXY PROPYL METHYLCELLULOSE, polyvinylpyrrolidone, gelatin, starch, arabic gum, Tragacanth, carboxy methyl cellulose, sodium alginate, one or more in amylopectin; Described lubricant can be selected from magnesium stearate, stearic acid, calcium stearate, Purified talc etc.; Described excipient can be selected from lactose, sucrose, glucose, starch, corn starch, sucrose, microcrystalline Cellulose, powdered Radix Glycyrrhizae, mannitol, sorbitol, sodium bicarbonate, calcium phosphate, calcium sulfate, one or more in calcium silicates.
6., according to the arbitrary described compositions of claim 1-3, described pharmaceutically acceptable adjuvant is selected from one or more in mannitol, hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and magnesium stearate.
7. compositions according to claim 6, count by weight percentage, the mass percent in whole compositions of each component is Azilsartan potassium is respectively about 23.0% to about 24.0%, mannitol is about 50.0% to about 60.0%, hydroxypropyl cellulose is about 2.0% to about 6.0%, and microcrystalline Cellulose is about 5.0% to about 15.0%, and cross-linking sodium carboxymethyl cellulose is about 2.0% to about 8.0%, magnesium stearate is about 0.5% to about 2.0%, and citric acid is about 0.20% to about 0.76%.
8. compositions according to claim 7, count by weight percentage, the mass percent in whole compositions of each component is Azilsartan potassium is respectively about 23.0% to about 24.0%, mannitol is about 55.0%, hydroxypropyl cellulose is about 2.0% to about 4.0%, microcrystalline Cellulose is about 10.0%, and cross-linking sodium carboxymethyl cellulose is about 5.0% to about 8.0%, and citric acid is about 0.20% to about 0.76%.
9., according to the arbitrary described compositions of claim 1-8, the dosage forms such as medicinal tablets, granule and capsule can be made.
10. the purposes of the compositions as described in as arbitrary in claim 1-9 in treatment hypertension.
Prepare according to the arbitrary described compositions method of claim 1-9 for 11. 1 kinds, the method comprises the following steps:
1) weigh PH regulator to add in appropriate purified water and stir to clarify, measure pH value about 2 to about 3; Then add binding agent, make solution;
2) get appropriate excipient and cross 30 eye mesh screens, for subsequent use;
3) by Azilsartan potassium, appropriate disintegrating agent and appropriate 2) obtain excipient, mix homogeneously, obtain pre-composition;
4) get appropriate 2) obtain excipient and to pour in fluid bed preheating into 2 minutes, then pour in fluid bed by above-mentioned pre-composition, preheating, after temperature of charge reaches 40 DEG C, sprays 1 under 35 ± 3 DEG C of conditions) solution that obtains;
5) dry, treat that fluid bed endoparticle moisture is less than 1.0%, discharging;
6) with pelletizing machine to above-mentioned material granulate, cross screen cloth;
7) by 6) describedly prepare granule and appropriate lubricant and appropriate mixed with excipients is even, obtain whole mixture;
8) above-mentioned whole mixture is made the dosage forms such as tablet, granule and capsule.
12. methods according to claim 11, wherein PH regulator is citric acid; Binding agent is hydroxypropyl cellulose; Excipient is mannitol; Lubricant is magnesium stearate, and excipient is microcrystalline Cellulose; The dosage form of preparation is tablet.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106074416A (en) * | 2016-08-30 | 2016-11-09 | 佛山市弘泰药物研发有限公司 | A kind of preparation method of Azilsartan potassium salt dispersible tablet |
| CN106214649A (en) * | 2016-08-30 | 2016-12-14 | 佛山市弘泰药物研发有限公司 | A kind of Azilsartan potassium salt solid dispersion preparation and preparation method thereof |
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| CN101677961A (en) * | 2007-03-28 | 2010-03-24 | 武田药品工业株式会社 | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent |
| CN101381366B (en) * | 2004-02-25 | 2011-06-15 | 武田药品工业株式会社 | Benzimidazole derivative and its use as a ii receptor antagonist |
| CN104306344A (en) * | 2014-10-22 | 2015-01-28 | 南京正大天晴制药有限公司 | Azilsartan tablets and preparation process thereof |
| CN104490835A (en) * | 2014-12-23 | 2015-04-08 | 广东东阳光药业有限公司 | Azilsartan medoxomil tablets and preparation method thereof |
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2015
- 2015-04-30 CN CN201510214474.0A patent/CN105079815A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101381366B (en) * | 2004-02-25 | 2011-06-15 | 武田药品工业株式会社 | Benzimidazole derivative and its use as a ii receptor antagonist |
| CN101677961A (en) * | 2007-03-28 | 2010-03-24 | 武田药品工业株式会社 | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent |
| CN104306344A (en) * | 2014-10-22 | 2015-01-28 | 南京正大天晴制药有限公司 | Azilsartan tablets and preparation process thereof |
| CN104490835A (en) * | 2014-12-23 | 2015-04-08 | 广东东阳光药业有限公司 | Azilsartan medoxomil tablets and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106074416A (en) * | 2016-08-30 | 2016-11-09 | 佛山市弘泰药物研发有限公司 | A kind of preparation method of Azilsartan potassium salt dispersible tablet |
| CN106214649A (en) * | 2016-08-30 | 2016-12-14 | 佛山市弘泰药物研发有限公司 | A kind of Azilsartan potassium salt solid dispersion preparation and preparation method thereof |
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Application publication date: 20151125 |