CN109260160A - A kind of valsartan amlodipine tablet and preparation method thereof - Google Patents

A kind of valsartan amlodipine tablet and preparation method thereof Download PDF

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Publication number
CN109260160A
CN109260160A CN201811009715.8A CN201811009715A CN109260160A CN 109260160 A CN109260160 A CN 109260160A CN 201811009715 A CN201811009715 A CN 201811009715A CN 109260160 A CN109260160 A CN 109260160A
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valsartan
amlodipine
lubricant
disintegrating agent
tablet
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孙超
左人杰
司宗为
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Tianjin Rensheng Pharmaceutical Technology Co Ltd
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Tianjin Rensheng Pharmaceutical Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention provides a kind of valsartan amlodipine tablet and preparation method thereof, the valsartan amlodipine piece includes plain piece and film coating, the plain piece includes main ingredient and auxiliary material, the main ingredient includes Amlodipine Besylate Tablet (with amlodipine) and Valsartan, the auxiliary material includes filler, disintegrating agent, glidant and lubricant, the preparation method is that dry granulation process, the present invention is using two kinds of main ingredients respectively and after auxiliary material dry granulation, compressed single piece after being mixed again with partial supplementary material, gained single-layer sheet adds film coating, finished product is made, the present invention requires production equipment low, it is easy to mass production, it can avoid the influence that Valsartan dissolves out Amlodipine simultaneously.

Description

A kind of valsartan amlodipine tablet and preparation method thereof
Technical field
The present invention provides a kind of valsartan amlodipine tablet and preparation method thereof, belongs to technical field of medicine preparation.
Background technique
Valsartan amlodipine piece (Exforge) is first, the whole world angiotensins that Switzerland's Novartis develops The monolithic compound preparation of receptor antagonist and calcium ion channel blocker (ARB and CCB).It obtains European Union and ratifies in January, 2007,6 Obtain U.S. FDA approval listing the moon, in June, 2010 is in Discussion on Chinese Listed, trade name " Bei Bote ".
Valsartan amlodipine piece covers two kinds of antihypertensive active constituents of Amlodipine and Valsartan, is suitable for treatment Gently, Moderate Essential Hypertension.Its mechanism of action be it is complementary, to control the blood pressure of hypertensive patient.Amlodipine: calcium channel Retarding agent prevents calcium ion influx across membrane from entering cardiac muscle cell and smooth vascular muscle cell, reduces peripheral vascular resistance, reduces blood Pressure;Valsartan: the antagonist of Angiotensin II, by angiotensin I converting for Angiotensin II and bradykinin of degrading.
CN 101237859A is disclosed using dry granulation technology, and blending powder single-layer sheet or respectively granulation double-layer tablets are matched Square technology obtains more specification compound preparations with independent assortment bioequivalence.
CN101507715B is disclosed using wet granulation technique, and Valsartan and Amlodipine are sieved respectively, then distinguishes Excipient is added to be uniformly mixed, uniformly mixed powder is separately added into appropriate adhesive and wetting agent, appropriate partial size is made Grain, it is dry.
CN103006649B is disclosed using dry granulation process, while being progressively increased mixing and skill of pelletizing twice using equivalent Art.
CN103083319B is disclosed using fluidized bed granulation technology, and the atomization of Amlodipine ethanol water is sent forth in containing In Valsartan and pharmaceutically acceptable auxiliary material, prepared.
CN104840460B discloses wet granulation technique, mixes again with Valsartan after Amlodipine wet granulation.
The prior art mainly uses two kinds of process flows, wet granulation technique and dry granulation technology, wet granulation technique It will affect the stability of raw material to a certain extent, and time-consuming for technique, increase production cost.Dry granulation technology is divided into blending powder Single layer chip technology and the double-deck chip technology of pelletizing respectively, wherein be blended single layer chip technology can not very good solution Valsartan for ammonia The influence of Flordipine piece dissolution;Although the double-deck chip technology solves the problems, such as that Valsartan influences Amlodipine dissolution, but for setting It is standby more demanding, it is not easy to realize.For this purpose, how to solve the influence that Valsartan dissolves out Amlodipine, and one kind is provided to production Equipment requirement is lower, and the prescription and process flow for being readily produced amplification are this field staff's urgent problems to be solved.
Summary of the invention
The present invention is directed to solve to a certain extent it is above-mentioned in the related technology the technical issues of one of.Therefore, mesh of the invention Be propose a kind of valsartan amlodipine piece and preparation method thereof, there is production equipment to require low, be easy to mass production It is raw, production cost can be reduced, while can avoid the advantages of influence that Valsartan dissolves out Amlodipine.
On the one hand, the present invention provides a kind of valsartan amlodipine tablet, including plain piece and film coating, the plain piece packet Main ingredient and auxiliary material are included, the main ingredient includes Amlodipine Besylate Tablet (with amlodipine) and Valsartan, and the auxiliary material includes filling out Fill agent, disintegrating agent, glidant and lubricant, the composition of the plain piece, in parts by weight:
On the other hand, the present invention provides a kind of valsartan amlodipine tablet, it is preferable that the composition of the plain piece, In parts by weight:
The filler is selected from one or more of microcrystalline cellulose, lactose, starch;
Preferably, microcrystalline cellulose (model are as follows: one or more of PH101/102/301/302/112/113) conduct Filler.
The disintegrating agent be selected from one of croscarmellose sodium, crospovidone, sodium carboxymethyl starch or Several, the adding manner of the disintegrating agent includes the interior additional two ways of adduction, interior plus disintegrating agent and additional disintegrating agent quality Than for 3:1-1:1;
Preferably, crospovidone is as disintegrating agent.
The glidant is selected from one or more of magnesium stearate, calcium stearate colloidal silicon dioxide;
Preferably, colloidal silicon dioxide is as glidant.
The lubricant is selected from one or more of magnesium stearate, calcium stearate, colloidal silicon dioxide, the profit The adding manner of lubrication prescription includes the interior additional two ways of adduction, and the interior mass ratio for adding lubricant and additional lubricant is that mass ratio is 2:1-1:1;
Preferably, magnesium stearate is as lubricant.
In another aspect, the present invention provides a kind of preparation method of valsartan amlodipine tablet, the preparation method is that dry Method granulating process, is prepared using following steps:
1. supplementary material is weighed respectively, it is spare;
2. by recipe quantity Amlodipine Besylate Tablet, filler, interior plus disintegrating agent, the sieving of interior plus lubricant, mixing and dry method Granulation is preferably first sieved, mixes Amlodipine Besylate Tablet, filler, interior plus disintegrating agent, finally add individually be sieved it is interior Add mix lubricant dry granulation again, dry granulating machine whole grain sieve selects 0.8mm~1.8mm, it is preferable that the selection of whole grain sieve 1.2-1.7mm;
3. by recipe quantity Valsartan, filler, interior plus disintegrating agent, glidant, the sieving of interior plus lubricant, mixing and dry method system Grain, be preferably first sieved filler, interior plus disintegrating agent, glidant, adds main ingredient sieving, mixing, is eventually adding independent sieving Interior plus mix lubricant dry granulation, dry granulating machine whole grain sieve select 0.8mm~1.8mm again, it is preferable that whole grain sieve Select 1.2-1.7mm;
4. particle obtained by step " 2,3 " is mixed, and additional disintegrating agent and additional lubricant is added, is uniformly mixed, preferably Ground, the additional disintegrating agent that step " 2,3 " are first mixed gains and are individually sieved mix, and are eventually adding the additional profit being individually sieved Lubrication prescription mixing;
5. using step " 4 " resulting material tabletting, tablet hardness is controlled in 30-130N, preferably 50-90N;
6. gained tablet film coating is obtained finished product.
Further, dry granulation process uses multi granulating, controls the ratio of particle and fine powder, the above particle ratio of 60 mesh Example is 40%-80%, and preferably particle fraction is 50%-75%.
The beneficial effects of the present invention are:
It in tablet manufacture, is pelletized respectively using dry granulation process using two kinds of main ingredient raw materials, with appropriate auxiliary material Compressed single piece after mixing, two kinds of raw materials in the medium can fater disintegration form independent drug delivery unit, using being provided in the present invention The hardness of tablet of method for preparing tablet thereof preparation in turn ensure and not will form too closely between different material particle or fine powder Combination;It is low to production equipment requirement, and avoid the influence that Valsartan dissolves out Amlodipine.
Lubricant is combined using the interior additional two ways of adduction, that is, be ensure that the mixture homogeneity of raw material, in turn avoided Over-lubrication in material preparation process, dry granulation caused by viscosity reduces or tabletting are not easy phenomenon in blocks.
By the particle fraction after control dry granulation whole grain aperture and dry granulation, determines granulation end point, that is, ensure that The mobility of material, and the more smooth tablet in surface can be obtained.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is only this Some embodiments of invention for those of ordinary skill in the art without creative efforts, can be with It obtains other drawings based on these drawings.
Fig. 1 0.1N amlodipine hydrochloride dissolution curve
Fig. 2 PH6.8 buffer Valsartan dissolution curve
Specific embodiment:
Embodiment 1:
Plain piece prescription:
Numerical value shown in 1 table of table is the plain piece recipe quantity of monolithic valsartan amlodipine piece, and the pharmaceutical specifications of tablet are 80mg:5mg。
Preparation method:
1. supplementary material, which is weighed, weighs supplementary material according to prescription.
Prepare amlodipine granule
2. sieving
2.1. Amlodipine Besylate Tablet, crospovidone and microcrystalline cellulose 1 cross 40 mesh screens together;
2.2. independent 40 mesh screen of mistake of magnesium stearate.
3. mixing
3.1. mixing machine is added in the material of " 2.1 ", middling speed mixes 15 minutes;
3.2. " 3.1 " are added in the material of " 2.2 ", middling speed mixes 3 minutes.
4. compressing dry granulation
The mixture of " 3.2 " is pressed into embryo piece with rolling process.
5. whole grain is sieved
5.1. embryo piece middling speed is crushed with 1.5mm stainless steel mesh.
5.2. the material of 60 mesh above and below is separately loaded on double-layer plastic bag.60 mesh fine powder below is again passed by Dry granulating machine granulation;
5.3. such as the 40% of the above particle deficiency total amount of 60 mesh, repeats step " 4,5.1., 5.2. ";
5.4. by it is more than all 60 mesh particle and 60 mesh fine powder below be added to the mixer speed mixing 5 minutes.
Further, record amlodipine granule yield, if yield less than 97%, it is corresponding reduce valsartan particles and The dosage of additional auxiliary material;Real income particle accounting is 70%.
Prepare valsartan particles
6. sieving
6.1. microcrystalline cellulose 2, crospovidone and colloidal silicon dioxide cross 40 mesh screens together;
6.2. Valsartan and the material of " 6.1 " cross 20 mesh screens together;
6.3. independent 40 mesh screen of mistake of magnesium stearate.
7. mixing
7.1. mixing machine is added in the material of " 6.2 ", middling speed mixes 15 minutes;
7.2. " 7.1 " are added in the material of " 6.3 ", middling speed mixes 3 minutes.
8. compressing dry granulation
The mixture of " 7.2 " is pressed into embryo piece with rolling process.
9. whole grain is sieved
9.1. embryo piece middling speed is crushed with 1.5mm stainless steel mesh.
9.2. the material of 60 mesh above and below is separately loaded on double-layer plastic bag.60 mesh fine powder below is again passed by Dry granulating machine granulation;
9.3. such as the 40% of the above particle deficiency total amount of 60 mesh, repeats step " 8,9.1., 9.2. ";
9.4. by it is more than all 60 mesh particle and 60 mesh fine powder below be added to the mixer speed mixing 5 minutes.
Further, valsartan particles yield is recorded, it is corresponding to reduce figured silk fabrics amlodipine granule if yield is less than 97% With the dosage of additional auxiliary material;Real income particle accounting is 70%.
10. additional auxiliary material sieving
10.1. crospovidone is crossed 40 meshes and is collected into double-layer plastic bag;
10.2. magnesium stearate is crossed 40 meshes and is collected into double-layer plastic bag.
11. mixing and pre-lubrication
The material of about half " 9.4 " is packed into mixing machine, is reloaded into the material of " 5.4 " and the material of " 10.1 ".Then it fills Enter the material of remaining " 9.4 ", middling speed mixes 15 minutes.
12. lubrication
The magnesium stearate of " 10.2 " is added into the material of " 11 ", middling speed mixes 3 minutes.
13. tabletting
Powder tabletting will be mixed after lubrication.
14. coating
The film coating pre-mix dose of stomach dissolution type is slowly added in purified water under agitation, be configured to 13% it is mixed Suspension, with coating pan coating, weight gain 3% obtains finished product.The filler is selected from one of microcrystalline cellulose, lactose, starch Or it is several.
Embodiment 2
Plain piece prescription is the same as " embodiment 1 "
Preparation method:
1. supplementary material weighs
Supplementary material is weighed according to prescription.
Prepare valsartan amlodipine particle
2. sieving
2.1. Amlodipine Besylate Tablet, Valsartan, crospovidone colloidal silicon dioxide and microcrystalline cellulose 1 and crystallite are fine Dimension element 2 crosses 40 mesh screens together;
2.2. independent 40 mesh screen of mistake of magnesium stearate.
3. mixing
3.1. mixing machine is added in the material of " 2.1 ", middling speed mixes 15 minutes;
3.2. " 3.1 " are added in the material of " 2.2 ", middling speed mixes 3 minutes.
4. compressing dry granulation
The mixture of " 3.2 " is pressed into embryo piece with rolling process.
5. whole grain is sieved
5.1. embryo piece middling speed is crushed with 1.5mm stainless steel mesh.
5.2. the material of 60 mesh above and below is separately loaded on double-layer plastic bag.60 mesh fine powder below is again passed by Dry granulating machine granulation;
5.3. such as the 40% of the above particle deficiency total amount of 60 mesh, repeats " 4,5.1,5.2 ", makes real income particle accounting 70%;
5.4. by it is more than all 60 mesh particle and 60 mesh fine powder below be added to the mixer speed mixing 5 minutes.
6. additional auxiliary material sieving
6.1. crospovidone is crossed 40 meshes and is collected into double-layer plastic bag;
6.2. magnesium stearate is crossed 40 meshes and is collected into double-layer plastic bag.
7. mixing and pre-lubrication
The material of " 5.4 " of about half amount is packed into mixing machine, the material of " 6.1 " is reloaded into, is then charged into remaining The material of " 5.4 ", middling speed mix 15 minutes.
8. lubrication
The magnesium stearate of " 6.2 " is added into the material of " 7 ", middling speed mixes 3 minutes.
9. tabletting
Powder tabletting will be mixed after lubrication.
10. coating
The film coating pre-mix dose of stomach dissolution type is slowly added in purified water under agitation, be configured to 13% it is mixed Suspension, with coating pan coating, weight gain 3% obtains finished product.
Embodiment 3
It is compared according to the valsartan amlodipine piece of the prescription of embodiment 1 and embodiment 2 preparation and dissolution curve measures.
The prescription of 2 embodiment 1 of table and embodiment 2 compares
The prescription and preparation method provided according to embodiment 1 and embodiment 2, prepares valsartan amlodipine piece respectively, Embodiment 1 and embodiment 2 are measured in the 0.1N hydrochloric acid solution of simulate the gastric juice environment and in the pH6.8 buffer of simulated intestinal fluid environment Dissolution curve, as the result is shown: two embodiment Valsartan dissolved corrosions are similar, but embodiment 2 is compared to 1 benzene sulfonic acid of embodiment Not exclusively, dissolution is influenced by Valsartan (Valsartan hardly dissolves out in 0.1N hydrochloric acid), and then is pushed away for Amlodipine dissolution Its internal release behavior that breaks would also vary from, i.e., the Amlodipine Besylate Tablet of embodiment 1 could discharge completely in gastric juice, see Fig. 1-2.
Embodiment 4
Plain piece prescription is the same as " embodiment 1 "
Preparation method:
1. supplementary material weighs
Supplementary material is weighed according to prescription.
Prepare amlodipine granule
2. sieving
Amlodipine Besylate Tablet, crospovidone and microcrystalline cellulose 1, magnesium stearate cross 40 mesh screens together.
3. mixing
Mixing machine is added in the material of " 2 ", middling speed mixes 15 minutes.
4. compressing dry granulation
The mixture of " 3 " is pressed into embryo piece with rolling process.
As a result: step " (4) " adjusts dry granulating machine parameter, is unable to get shaping block piece always.
Prepare valsartan particles
5. sieving
Microcrystalline cellulose 2, crospovidone and colloidal silicon dioxide, Valsartan, magnesium stearate cross 40 mesh screens together.
6. mixing
Mixing machine is added in the material of " 5 " by 6.1, and middling speed mixes 15 minutes.
7. compressing dry granulation
The mixture of " 6.1 " is pressed into embryo piece with rolling process.
As a result: step " 5 " is sieved slower, and Valsartan raw material not easily passs through 40 mesh screens;Step " 4,7 " adjusts dry method system Grain machine parameter, is unable to get shaping block piece always.
Test process and result and embodiment 1 compare, and lubricant mixes the preparation side of long period together with unclassified stores Formula causes over-lubrication in material preparation process, and viscosity, which reduces, causes dry granulation or tabletting to be not easy phenomenon in blocks.
Embodiment 5
Plain piece prescription:
Numerical value shown in 3 table of table is the plain piece recipe quantity of monolithic valsartan amlodipine piece, and the pharmaceutical specifications of tablet are 80mg:5mg。
Preparation method is with " embodiment 1 ", and valsartan particles and amlodipine granule mixture real income particle accounting are about It is 75%.
Test process and result are similar to Example 1
Embodiment 6
Plain piece prescription:
Numerical value shown in 4 table of table is the plain piece recipe quantity of monolithic valsartan amlodipine piece, and the pharmaceutical specifications of tablet are 80mg:5mg。
Preparation method is with " embodiment 1 ", and valsartan particles and amlodipine granule mixture real income particle accounting are about It is 50%.
Test process and result are similar to Example 1
Embodiment 7
Plain piece prescription:
Numerical value shown in 5 table of table is the plain piece recipe quantity of monolithic valsartan amlodipine piece, and the pharmaceutical specifications of tablet are 80mg:5mg。
Preparation method is with " embodiment 1 ", and valsartan particles and amlodipine granule mixture real income particle accounting are about It is 40%.
Test process and result are similar to Example 1, but mixed powder mobility is slightly poor after preceding and granulation of pelletizing, and compressing dry granulation Flakiness is slightly poor.
Embodiment 8
Plain piece prescription:
Numerical value shown in 6 table of table is the plain piece recipe quantity of monolithic valsartan amlodipine piece, and the pharmaceutical specifications of tablet are 80mg:5mg。
Preparation method is with " embodiment 1 ", and valsartan particles and amlodipine granule mixture real income particle accounting are about It is 80%.
Test process and result are similar to Example 1, but it is slightly poor that powder mobility is mixed before pelletizing, and compressing dry granulation flakiness is omited Difference, gained plain piece surface is slightly coarse compared to embodiment 1, and disintegration time limited slightly extends compared with embodiment 1, and dissolution rate is also slightly slower than Embodiment 1.
A kind of valsartan amlodipine tablet provided by the present invention and preparation method thereof is described in detail above. Used herein a specific example illustrates the principle and implementation of the invention, and the explanation of above embodiments is only used In facilitating the understanding of the method and its core concept of the invention.It should be understood that those skilled in the art, not taking off , can be with several improvements and modifications are made to the present invention under the premise of from the principle of the invention, these improvement and modification also fall into this In invention scope of protection of the claims.

Claims (8)

1. a kind of valsartan amlodipine tablet and preparation method thereof, it is characterised in that: including plain piece and film coating, the element Piece includes main ingredient and auxiliary material, and the main ingredient includes Amlodipine Besylate Tablet (with amlodipine) and Valsartan, the accessory package Include filler, disintegrating agent, glidant and lubricant, the composition of the plain piece, in parts by weight:
The preparation method of the valsartan amlodipine tablet is dry granulation process, is prepared using following steps:
(1) by main ingredient, auxiliary material, sieving is handled respectively, spare;
(2) by recipe quantity Amlodipine Besylate Tablet, filler, interior plus disintegrating agent, interior plus mix lubricant and dry granulation.
(3) by recipe quantity Valsartan, filler, interior plus disintegrating agent, glidant, interior plus mix lubricant and dry granulation;
(4) particle obtained by " step (2) and (3) " is mixed, and additional disintegrating agent and additional lubricant is added, be uniformly mixed;
(5) by " step (4) " resulting material tabletting;
(6) by gained tablet film coating, finished product.
2. according to the composition of plain piece described in claims 1, in parts by weight:
3. filler according to claim 1, it is characterised in that: filler is in microcrystalline cellulose, lactose, starch One or more.
4. disintegrating agent according to claim 1, it is characterised in that: disintegrating agent is selected from croscarmellose sodium, hands over Join one or more of povidone, sodium carboxymethyl starch.
5. glidant according to claim 1, it is characterised in that: glidant is selected from magnesium stearate, calcium stearate, colloidal state One or more of silica.
6. lubricant according to claim 1, it is characterised in that: lubricant is selected from magnesium stearate, calcium stearate, colloidal state One or more of silica.
7. the disintegrating agent according to claims 1 or 4, it is characterised in that: the adding manner of the disintegrating agent includes interior adds With additional two ways, the mass ratio of interior plus disintegrating agent and additional disintegrating agent is 3:1~1:1.
8. the lubricant according to claims 1 or 6, it is characterised in that: the adding manner of the lubricant includes interior adds With additional two ways, it is 2:1~1:1 that the mass ratio of interior plus lubricant and additional lubricant, which is mass ratio,.
CN201811009715.8A 2018-08-30 2018-08-30 A kind of valsartan amlodipine tablet and preparation method thereof Withdrawn CN109260160A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110917160A (en) * 2019-12-04 2020-03-27 北京悦康科创医药科技股份有限公司 Cefalexin tablet and preparation method thereof
CN112826819A (en) * 2021-01-20 2021-05-25 海南皇隆制药股份有限公司 Preparation method of valsartan amlodipine tablets and valsartan amlodipine tablets
CN113712927A (en) * 2021-09-16 2021-11-30 北京阳光诺和药物研究股份有限公司 Compound valsartan levoamlodipine tablet and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101237859A (en) * 2005-08-17 2008-08-06 诺瓦提斯公司 Solid dosage forms of valsartan and amlo dipine and method of making the same
CN101862328A (en) * 2010-06-21 2010-10-20 天津市汉康医药生物技术有限公司 Valsartan amlodipine capsule medicine compound and preparation method thereof
CN103006649A (en) * 2012-12-27 2013-04-03 石家庄市华新药业有限责任公司 Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101237859A (en) * 2005-08-17 2008-08-06 诺瓦提斯公司 Solid dosage forms of valsartan and amlo dipine and method of making the same
CN101862328A (en) * 2010-06-21 2010-10-20 天津市汉康医药生物技术有限公司 Valsartan amlodipine capsule medicine compound and preparation method thereof
CN103006649A (en) * 2012-12-27 2013-04-03 石家庄市华新药业有限责任公司 Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof

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CN110917160A (en) * 2019-12-04 2020-03-27 北京悦康科创医药科技股份有限公司 Cefalexin tablet and preparation method thereof
CN112826819A (en) * 2021-01-20 2021-05-25 海南皇隆制药股份有限公司 Preparation method of valsartan amlodipine tablets and valsartan amlodipine tablets
CN112826819B (en) * 2021-01-20 2022-03-04 海南皇隆制药股份有限公司 Preparation method of valsartan amlodipine tablets and valsartan amlodipine tablets
CN113712927A (en) * 2021-09-16 2021-11-30 北京阳光诺和药物研究股份有限公司 Compound valsartan levoamlodipine tablet and preparation method thereof
CN115869274A (en) * 2021-09-16 2023-03-31 北京阳光诺和药物研究股份有限公司 Compound valsartan levoamlodipine tablet and preparation method thereof
CN115869274B (en) * 2021-09-16 2024-03-12 北京阳光诺和药物研究股份有限公司 Compound valsartan and levamlodipine tablet and preparation method thereof

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Application publication date: 20190125