CN101912390A - Medicinal composite containing irbesartan - Google Patents
Medicinal composite containing irbesartan Download PDFInfo
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- CN101912390A CN101912390A CN2010102537107A CN201010253710A CN101912390A CN 101912390 A CN101912390 A CN 101912390A CN 2010102537107 A CN2010102537107 A CN 2010102537107A CN 201010253710 A CN201010253710 A CN 201010253710A CN 101912390 A CN101912390 A CN 101912390A
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Abstract
The invention relates to a medicinal composite containing irbesartan, comprising irbesartan accounting for 30-70 wt% of preparation and pharmaceutical usable salt thereof, wherein the particle diameter of irbesartan D (V, 0.9), which is measured by a laser particle method is less than or equal to 200 mu m, and the composite is substantially micro powder free silica gel. The method of the invention can obtain a product with good dissolution and stability. The invention has the advantages that the invention chooses the irbesartan with certain range of particle diameter and auxiliary material to pelletize so as to obtain the particle with good flowability; meanwhile, the sticking problem generated by the electrostatic interaction of irbesartan can be solved; silica gel powder does not need to be added in a prescription, which omits the micro powder silica gel screening step, simplifies production technology, lowers production cost, improves production efficiency, lowers the production potential safety hazard brought by the micro powder silica gel and is more suitable for industrial production.
Description
Technical field
The invention belongs to medical technical field, relate to the hypertensive pharmaceutical composition of a kind of treatment, relate to a kind of irbesartan pharmaceutical composition more specifically.
Background technology
Irbesartan (irbesartan), be 2-normal-butyl-4-spiro cyclopentane-1-[(2-(tetrazolium-5-yl) biphenyl-4-yl) methyl]-2-imidazoline-5-ketone, it is the angiotensin ii receptor antagonist of long duration of action efficiently, be used in particular for the treatment of cardiovascular disease such as hypertension and heart failure, irbesartan has the following formula structure:
Hydrochlorothiazide is a kind of diuretic antihypertensive medicine, can cause that the sympathetic nervous system renin-angiotensin system of unifying activates, the antagonism hypotensive effect, and reduce the blood potassium level.
Irbesartan and hydrochlorothiazide therapeutic alliance hypertension have synergism, irbesartan can be offset the compensatory mechanism that is brought out by hydrochlorothiazide, thereby strengthen the antihypertensive effect of hydrochlorothiazide, simultaneously can also selective exclusion Angiotensin-Converting 1 subtype acceptor performance hypotensive effect.In addition, irbesartan can weaken serum uric acid rising and the blood potassium reduction effect that hydrochlorothiazide brings out.Irbesartan and hydrochlorthiazide can effectively reduce gently, in or severe hypertension patient's blood pressure, for for bring high blood pressure down must drug combination patient be rational selection.
It is a kind of lint shape material that EP0747050B1 proposes irbesartan, has low relatively bulk density, this character make its be difficult to high amount of drug made have the weight unanimity, the tabloid of hardness and ideal tablet character.In addition, irbesartan has static, can be adhered to the surface of tablet machine punch face and mould, causes the tabletting difficulty.Also there is a kind of challenge in the low soluble of irbesartan, keep the small size of slice, thin piece, only can add a spot of excipient to promote moistening, disintegrate and final drug release fast and completely.Diuretic such as hydrochlorothiazide also have stickum, very poor flowability and low soluble, and its adding further increases the difficulty of film-making.This method provides the prescription of adjuvants such as containing surfactant poloxamer, binding agent 30 POVIDONE K 30 BP/USP 30, anti stickness agent micropowder silica gel.
US5994348 discloses a kind of irbesartan pharmaceutical composition, and comprising active constituents of medicine irbesartan and hydrochlorothiazide, selection lactose, microcrystalline Cellulose in its prescription is that diluent, pregelatinized Starch or polyvidone k30 are that binding agent, cross-linked carboxymethyl cellulose sodium are disintegrating agent, antitack agent micropowder silica gel, magnesium stearate lubricant and optional surfactant and/or coloring agent.
US2009030052 discloses and has a kind ofly contained irbesartan and lactose but do not have the pharmaceutical preparation of surfactant, this prescription does not contain surfactant and lactose and principal agent ratio 1: 4-4: between 1, this used lactose yield of writing out a prescription is too big, and lactose itself is mobile bad, present patent application inventor did experiment in the side of Clicking here, particulate flowability is very poor, and easy bonding die during tabletting causes and produces difficulty.
CN200810126745 discloses a kind of irbesartan-hydrochlorothiazide drug combination and preparation method thereof.This method disclose with lactose, microcrystalline Cellulose, cross-linked carboxymethyl cellulose receive, hypromellose, micropowder silica gel, magnesium stearate be the pharmaceutical composition of adjuvant.
CN101370484 discloses a kind of irbesartan pharmaceutical composition, wherein contains active constituents of medicine and at least a disintegrating agent.Used disintegrating agent low-substituted hydroxypropyl methylcellulose is divided into Nei Jia and adds among this method embodiment, and consumption is very big, and present patent application inventor is easy to moisture absorption according to this prescription gained tablet makes tablet very unstable.
In sum, because the Electrostatic Absorption of irbesartan is stronger, raw material and adjuvant are in conjunction with insecure, the granule that wet granulation is made is often mobile very poor, and in the tabletting process, is easy to generate the bonding die phenomenon, therefore prior art has mostly been used micropowder silica gel in prescription at present, this material can weaken Electrostatic Absorption on the one hand, alleviates the bonding die problem, can increase material fluidity on the other hand.And micropowder silica gel is more fluffy because of it, and conglomeration is arranged, and therefore in actual use, often needs to mix the use of sieving with other adjuvants.In screening process, usually can produce a large amount of particulate matters that in air, disseminates.These particulate matters that disseminate at air are a kind of potential potential safety hazards, and the workman needs equipment safe in utilization and other safety measures to handle these particulate matters, otherwise can be detrimental to health, and causes workman's respiratory tract.And the step of sieving of micropowder silica gel is carried out in total operation of mixing often, generally can adopt screen cloth to sieve by hand, and this also increases the material contamination of heavy, and the quality of medicine can not get guaranteeing.
Moreover, because the granule of micropowder silica gel is very little, for such material, the total surface area of its sample is very big with respect to its volume.Have reason to think that the fluidizer material that contains this small size high surface area may cause the unstability of effective ingredient.This unstability may be the direct interaction between fluidizer granule and the effective ingredient and causing, and perhaps fluidizer has promoted to cause the unsettled interaction of effective ingredient as catalyst.
In addition, by constantly discovering, because irbesartan has very strong static, the selection of its particle diameter has very big influence to the complexity of producing.Particle diameter is too big, and the irbesartan surface area is little, because electrostatic interaction, the crude drug irbesartan can not well combine with adjuvant in pelletization, and the particulate flowability of making is bad, also the sticking phenomenon can occur during tabletting.Prior art is improved particulate flowability by adding micropowder silica gel, and the sticking that material static causes in the minimizing tabletting process, but the inventor finds when the irbesartan particle diameter is chosen in a small range, again under the effect of binding agent with other adjuvant mixing granulations, can obtain mobile well granule, and the electrostatic interaction of material also obviously weakens in the tabletting process, the sticking problem is solved, need not add micropowder silica gel again, so both reduced the micropowder silica gel step of sieving, simplify production technology, reduced the potential safety hazard of using micropowder silica gel to bring simultaneously again.
In addition, the content of disintegrating agent influences the stability of pharmaceutical preparation to a certain extent, Tai Gao or too lowly all can produce very big influence to the stripping of pharmaceutical preparation.The large usage quantity of disintegrating agent in prescription influences its product stability probably in the prior art.
Therefore, for solving particulate flowability and sticking problem, reduce potential safety hazard, guarantee product quality, the invention provides a kind of irbesartan pharmaceutical composition, this pharmaceutical composition that does not contain micropowder silica gel can guarantee safety in production, simplify production technology, reduce production costs, be fit to commercially produce.
Summary of the invention
The object of the present invention is to provide a kind of irbesartan pharmaceutical composition, the particle diameter of the irbesartan that this pharmaceutical composition adopts is at D (V, 0.9)≤200 μ m, preferred D (V, 0.9)≤100 μ m, more preferably D (V, 0.9)≤50 mu m range and adjuvant mixing granulation, get final product mobile good granule, even if do not contain micropowder silica gel in the compositions in addition, the sticking that material static causes also can effectively weaken in the tabletting process because can guarantee to produce and normally carry out.Adjuvant is formed and ratio obtains product stripping and stability in pharmaceutical composition provided by the present invention are all fine.The present invention writes out a prescription simply, and supplementary product consumption is reasonable, can guarantee safety in production, reduces processing step, reduces production costs, and enhances productivity, and is fit to more commercially produce.
The particle diameter of irbesartan adopts the laser particle size method to measure among the present invention.
The inventor finds according to the particulate flowability of prescription production gained of irbesartan pharmaceutical composition provided by the invention fabulous, there is no need to add fluidizer fully and increase its flowability, can simplify prescription so on the one hand, reduce production costs, can reduce the use of fluidizer such as micropowder silica gel on the other hand, reduce it in process of production to the harm of human body and to the pollution of environment, moreover can also reduce the interaction of active constituents of medicine and adjuvant, guarantee stability of drug.The inventor finds in addition, compares with prior art disintegrating agent consumption is very big, and recipe quantity disintegrating agent of the present invention can make product reach qualified stripping and product in the 0.5-2% scope to stablize fine.
The discovery that the inventor is surprised, irbesartan makes its particle diameter D (V, 90)≤200 μ m through pulverizing, and is preferred≤100 μ m, more preferably≤50 during μ m, the granule that can obtain to have better flowability.This may be that bonded agent solution fully soaks into when granulating, and has improved its surface property because the irbesartan after pulverizing has bigger specific surface area, can better combine with adjuvant, thus the granule that acquisition has better flowability.Because in the pelletization, the granulating effect improves, the inventor finds that static also diminishes, and can add micropowder silica gel and carry out fluidizer and antistatic when tabletting in addition.
Therefore the present invention adopts following technical scheme:
The invention provides a kind of irbesartan Pharmaceutical composition stable, no micropowder silica gel, preferably, contain and account for weight of formulation percentage ratio 30-70% irbesartan or its pharmacy acceptable salts, preferred, contain 50-60% irbesartan or its pharmacy acceptable salts, wherein the particle diameter of irbesartan is controlled at D (90)≤200 μ m, preferred D (V, 0.9)≤100 μ m, more preferably≤50 μ m.Do not contain micropowder silica gel in the Pharmaceutical composition of the present invention.
Irbesartan Pharmaceutical composition provided by the invention can also comprise one or more excipient, as filler, disintegrating agent, binding agent, lubricant etc.
Disintegrant content accounts for the 0.5-2% of total weight percent in the irbesartan Pharmaceutical composition of the present invention, preferred 0.5-1.5%, preferred 0.5-1%.
The optional self-crosslinking carmethose of disintegrating agent among the present invention, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose one or more mixture wherein, preferred cross-linked carboxymethyl cellulose sodium.
Concrete, according to foregoing irbesartan Pharmaceutical composition, the label of described compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 30-70%, microcrystalline Cellulose 10-50%, single water and milk sugar 1-20%, cross-linked carboxymethyl cellulose sodium 0.5-2%, hydroxypropyl methylcellulose 0.5-10%, magnesium stearate 0.5-3%.
Preferred, according to above-mentioned irbesartan Pharmaceutical composition, the label of described compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 50-60%, microcrystalline Cellulose 20-40%, single water and milk sugar 5-15%, cross-linked carboxymethyl cellulose sodium 0.5-1.5%, hydroxypropyl methylcellulose 1-5%, magnesium stearate 1-2%.
Can further contain the 2-5% diuretic in the irbesartan Pharmaceutical composition of the present invention, used diuretic can be any suitable diuretic, as hydrochlorothiazide, chlorothiazide, chlortalidone, hydroflumethiazide, trichlormethiazide, preferred diuretic is a hydrochlorothiazide.
Further, irbesartan Pharmaceutical composition of the present invention, the label of compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 50-60%, hydrochlorothiazide 2-5%, microcrystalline Cellulose 25-40%, single water and milk sugar 5-15%, cross-linked carboxymethyl cellulose sodium 0.5-2%, hydroxypropyl methylcellulose 1-5%, magnesium stearate 1-2%.
In addition, irbesartan Pharmaceutical composition of the present invention does not also contain surfactant, as poloxamer, sodium lauryl sulphate etc.
Irbesartan Pharmaceutical composition of the present invention, preferably dosage form is a tablet.
Irbesartan Pharmaceutical composition of the present invention in addition, the preferred wet granulation of its preparation method.Selected adjuvant of the present invention and active constituents of medicine can obtain flowability granule preferably by granulating, and can satisfy the tabletting requirement, do not need to add fluidizer again.
Irbesartan Pharmaceutical composition of the present invention, the wherein preferred A crystal formation of irbesartan.
The gained irbesartan pharmaceutical composition according to the present invention is pressed into and can selects coating or coating not behind the tablet, preferred coating, and coating material is selected from Opadry
Be more preferably Opadry
85G68918, Opadry
85G64757, Opadry
85G66705.
The method according to this invention can guarantee safety in production, obtains all better products of stripping and stability.The present invention writes out a prescription simply, and supplementary product consumption is reasonable, and the adding that reduces micropowder silica gel both can reduce potential safety hazard, has simplified processing step again simultaneously, reduces production costs, and enhances productivity, and is fit to more commercially produce.
The specific embodiment
The embodiment of the indefiniteness that provides below only is used for illustrating the preferred specific embodiment of the present invention, should not be used for limiting the present invention, and scope of the present invention is determined by additional claim.
Embodiment 1 irbesartan different-grain diameter contrast experiment:
*Irbesartan adopts two kinds of particle diameters, and the prescription 1 irbesartan particle diameter that uses is D (V, 0.9)=150 μ m, and the prescription 2 irbesartan particle diameters that use are D (V, 0.9)=312 μ m.
Preparation technology: earlier the recipe quantity hypromellose is dissolved in an amount of purified water, it is standby to make binding agent; Irbesartan, single water and milk sugar, microcrystalline Cellulose, cross-linked carboxymethyl cellulose received put into the pot of granulating and mix, mixture A; Granulate among the mixture A in the standby binding agent adding granulation pot, get wet granular, wet granular granulate after drying must be done granule B, and then the recipe quantity magnesium stearate is added among the dried granule B, mix homogeneously gets mixture C, the angle of repose of mensuration mixture C.On tablet machine, mixture C is suppressed in flakes at last.
Particulate flowability represents that angle of repose, numerical value was more little available angle of repose, and flowability is good more.Prescription 1 is all identical with technology with the prescription of prescription 2, has only the particle diameter difference of irbesartan crude drug, and be respectively 40 ° and 53 ° angle of repose that records prescription 1 gained mixture C 1 and prescription 2 gained mixture C 2.During with mixture C 1 and mixture C 2 difference tablettings, can feel obviously that mixture C 2 particulate flowabilities are bad, and in the tabletting process, static is bigger, easily bonding die.And mixture C 1 has good mobility, and static is little, can satisfy the tabletting requirement.This shows that irbesartan crude drug particle diameter is very big to the influence of pelletize.Further experimental results show that irbesartan crude drug particle diameter at D (V, 90)≤200 μ m, preferred≤100 μ m, more preferably≤50 during μ m, the granule that can obtain to have better flowability.
Embodiment 2 folk prescription irbesartan sheets:
*The particle diameter of irbesartan is respectively D (V, 90)=37 μ m, D (V, 90)=200 μ m, D (V, 90)=84 μ m among the prescription 3-5.
Preparation technology:
1, the recipe quantity hypromellose is dissolved in an amount of purified water, makes binding agent;
2, recipe quantity irbesartan, single water and milk sugar, microcrystalline Cellulose, cross-linked carboxymethyl cellulose are received put into the pot of granulating and mix, must mix A;
3, will the binding agent in the step 1 add among the mixture A in the pot of granulating and granulate, wet granular B;
4, with wet granular granulate after drying, must do granule C;
5, the recipe quantity magnesium stearate is added among the dried granule C, mix homogeneously must be done granule D;
6, dried granule D is suppressed, obtain the heavy tablet of respective flap;
7, adopt the high-efficiency coating pot that tablet is carried out coating and make tablet weightening finish 3.0%.
Embodiment 3 compound recipe irbesartan sheets:
*The particle diameter of irbesartan is respectively D (V, 90)=50 μ m, D (V, 90)=84 μ m, D (V, 90)=84 μ m among the prescription 6-8.
Preparation technology:
1. the recipe quantity hypromellose is dissolved in an amount of purified water, makes binding agent;
2. recipe quantity irbesartan, hydrochlorothiazide, single water and milk sugar, microcrystalline Cellulose, cross-linked carboxymethyl cellulose are received and put into the pot mixing of granulating, get mixture A;
3. the binding agent in the step 1 is added among the mixture A in the pot of granulating and granulate, get wet granular B;
4. with wet granular B granulate after drying, must do granule C;
5. the recipe quantity magnesium stearate is added among the dried granule C, mix homogeneously must be done granule D;
6. dried granule D is suppressed, obtain the heavy tablet of respective flap;
7. adopt the high-efficiency coating pot that tablet is carried out coating and make tablet weightening finish 3.0%.
Claims (10)
1. a Pharmaceutical composition that contains irbesartan is characterized in that, (1) compositions comprises and accounts for weight of formulation percentage ratio 30-70% irbesartan or its pharmacy acceptable salts, and wherein the particle diameter of irbesartan adopts D (V, 0.9)≤200 μ m that the laser particle size method is measured; (2) compositions does not have micropowder silica gel in fact.
2. irbesartan Pharmaceutical composition as claimed in claim 1, wherein the particle diameter of the irbesartan D (V, 0.9) that adopts the laser particle size method to measure preferred≤100 μ m, more preferably≤50 μ m.
3. irbesartan Pharmaceutical composition as claimed in claim 1 wherein contains at least a disintegrating agent that is selected from cross-linked carboxymethyl cellulose sodium, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose of 0.5-2% in the compositions.
4. irbesartan Pharmaceutical composition as claimed in claim 1, the label of described compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 30-70%, microcrystalline Cellulose 10-50%, single water and milk sugar 1-20%, cross-linked carboxymethyl cellulose sodium 0.5-2%, hydroxypropyl methylcellulose 0.5-10%, magnesium stearate 0.5-3%.
5. irbesartan Pharmaceutical composition as claimed in claim 4, the label of described compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 50-60%, microcrystalline Cellulose 20-40%, single water and milk sugar 5-15%, cross-linked carboxymethyl cellulose sodium 0.5-2%, hydroxypropyl methylcellulose 1-5%, magnesium stearate 1-2%.
6. irbesartan Pharmaceutical composition as claimed in claim 1, described compositions further comprises the 2-5% diuretic.
7. irbesartan Pharmaceutical composition as claimed in claim 6, described diuretic is selected from hydrochlorothiazide.
8. irbesartan Pharmaceutical composition as claimed in claim 7, the label of described compositions is made up of the material of following percentage by weight: irbesartan or its officinal salt 50-60%, hydrochlorothiazide 2-5%, microcrystalline Cellulose 25-40%, single water and milk sugar 5-15%, cross-linked carboxymethyl cellulose sodium 0.5-2%, hydroxypropyl methylcellulose 1-5%, magnesium stearate 1-2%.
9. as claim 1 or 6 described irbesartan Pharmaceutical compositions, the preferred wet granulation of its preparation method.
10. as claim 1 or 6 described irbesartan Pharmaceutical compositions, the wherein preferred A crystal formation of irbesartan.
Priority Applications (1)
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| CN2010102537107A CN101912390A (en) | 2010-08-08 | 2010-08-08 | Medicinal composite containing irbesartan |
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| CN2010102537107A CN101912390A (en) | 2010-08-08 | 2010-08-08 | Medicinal composite containing irbesartan |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105055362A (en) * | 2015-08-28 | 2015-11-18 | 江苏福邦药业有限公司 | Irbesartan hydrochlorothiazide tablet and preparation method thereof |
| WO2016114725A1 (en) * | 2015-01-12 | 2016-07-21 | İlko İtaç Sanayi Ve Ticaret Anonim Şirketi | A stable bilayer pharmaceutical tablet compositions comprising fixed dose of irbesartan and amlodipine |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101370484A (en) * | 2006-01-09 | 2009-02-18 | 新梅斯托克尔克公司 | Solid pharmaceutical composition comprising irbesartan |
-
2010
- 2010-08-08 CN CN2010102537107A patent/CN101912390A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101370484A (en) * | 2006-01-09 | 2009-02-18 | 新梅斯托克尔克公司 | Solid pharmaceutical composition comprising irbesartan |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016114725A1 (en) * | 2015-01-12 | 2016-07-21 | İlko İtaç Sanayi Ve Ticaret Anonim Şirketi | A stable bilayer pharmaceutical tablet compositions comprising fixed dose of irbesartan and amlodipine |
| CN105055362A (en) * | 2015-08-28 | 2015-11-18 | 江苏福邦药业有限公司 | Irbesartan hydrochlorothiazide tablet and preparation method thereof |
| CN105055362B (en) * | 2015-08-28 | 2017-09-15 | 江苏福邦药业有限公司 | A kind of irbesartan and hydrochlorthiazide piece and preparation method thereof |
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Application publication date: 20101215 |