CN103271908B - Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet - Google Patents
Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet Download PDFInfo
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- CN103271908B CN103271908B CN201310204699.9A CN201310204699A CN103271908B CN 103271908 B CN103271908 B CN 103271908B CN 201310204699 A CN201310204699 A CN 201310204699A CN 103271908 B CN103271908 B CN 103271908B
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Abstract
The invention discloses a kind of oral tablet containing Telmisartan and Amlodipine Besylate Tablet, this feature are that the tablet includes Telmisartan label and Amlodipine coatings.This compound coated tablet solve Amlodipine and two main ingredient of Telmisartan it is incompatible caused by stability problem and dissolution curve matching problem.The unilateral beauty of Telmisartan amlodipine besylate tablets provided by the invention, quality are stablized.The present invention also provides the preparation methods of the oral tablet, and simple process, cost is relatively low, are more suitable for commercially producing.
Description
Technical field
The invention belongs to pharmaceutical technology fields, are specifically related to a kind of Telmisartan/Amlodipine Besylate Tablet oral tablet
Agent.
Background technique
Telmisartan is a kind of angiotensin-ii receptor antagonism developed for treatment hypertension and other medical symptoms
Agent.Have following structural formula:
Amlodipine Besylate Tablet is a kind of novel calcium ion antagonist, is clinically mainly used for hypertension and anginal
Treatment.Have following structural formula:
Telmisartan amlodipine tablets are developed by German Boehringer Ingelheim company, trade name Twynsta, said preparation with
Monolithic dosage form combines 2 kinds of common drugs for hypertension, ARB class drug Telmisartan and CCB class drug Amlodipine.For rice
The advantage of Sha Tan and Amlodipine drug combination include: 1) two kinds of drugs played anti-hypertension with different mechanisms from different perspectives
Synergistic effect, significantly reduce blood pressure, preferably protection target organ；2) be conducive to take into account Other Risk Factors existing for patient with
Cohesive disease；3) drug combination can reduce single pharmaceutical quantities, make to be substantially reduced with dose-dependent side effect or adverse reaction；4) solid
Determining compound preparation simplifies treatment, is administered once a day, can improve the compliance and quality of life of patient.
Telmisartan is manufactured and is supplied usually in the form of free acid.As disclosed in WO00/43370 patent, meter Sha is replaced in crystallization
Smooth existed with two kinds of polycrystalline forms with different melting points.Under the influence of heat and humidity, the polymorph b compared with low melting point can not
It is reverse into the polymorphic A of higher melt.Two kinds of form features exist excessively poor in the gastrointestinal physiology pH range of pH1 to 7
Water solubility.
Telmisartan formulations with good biological availability must include alkaline components such as sodium hydroxide or meglumine,
And Amlodipine with it is unstable when directly being contacted for the basic excipients in Telmisartan formulations, when being exposed to alkaline environment
When, the ester bond in Amlodipine molecule is easy hydrolysis.Therefore the method directly mixed with the excipient of meta-alkalescence cannot be applied
It is combined with the fixed dosage form of Amlodipine, preparation technique is needed to separate Telmisartan and the Amlodipine of alkalinity.It is Chinese special
Sharp CN101052381 is disclosed to be separated Amlodipine and Amlodipine to increase the compound preparation using the double-deck chip technology
Stability.But this tablet configuration needs special sheeting equipment bi-layer tablet press.
Document " research of Telmisartan Film coated tablets preparation process " (Tian Jingxuan, Wei Jianping modern biomedical progress,
2006,6 (10)；The prescription of stable Telmisartan Film coated tablets 42-45) is proposed, it is used using alkaline reagent solubilising
Spray-drying process.Using more time-consuming spray drying process when the document prepares telmisartan tablet, and
Need special equipment.
Therefore at present it is still necessary to provide a kind of new solution to overcome disadvantage mentioned above, so that Telmisartan ammonia chlorine
The unilateral beauty of plain film, it is up-to-standard, while Telmisartan and Amlodipine is with good stability and dissolved corrosion, and price
It is cheap, be conducive to commercially produce.
Summary of the invention
The purpose of the present invention is to solve Amlodipines contacted with the basic excipients of Telmisartan caused by stablize
Property two component dissolution curve matching problem of problem and Telmisartan and Amlodipine, provide a kind of oral with superperformance
The drug of compound treatment hypertension.
Inventor is the study found that the telmisartan amlodipine double-layer tablet (commodity that German Boehringer Ingelheim company develops
Entitled Twynsta), in three kinds of pH1.0 hydrochloride buffer, pH4.5 acetate buffer, pH7.5 phosphate buffer media
Telmisartan and Amlodipine have completely different dissolved corrosion, and Telmisartan layer is a kind of corrosion state, and Amlodipine
Layer fater disintegration, Amlodipine 5min dissolution reach 90% or more.Therefore telmisartan amlodipine double-layer tablet is prepared not only
It can solve the incompatibility problem of Amlodipine Yu Telmisartan layer basic auxiliary, while being conducive to keep two components respectively independent
Dissolved corrosion.According to the dissolved corrosion of Telmisartan and Amlodipine that original is ground, inventor thinks the dissolved corrosion and common
Film coated tablets dissolved corrosion is similar, i.e., film-coating dissolves rapidly, and label remains relatively independent dissolved corrosion, uses simultaneously
Film coated tablets helps to reduce the contact area of Telmisartan synusia core and Amlodipine, to be conducive to the stabilization of Amlodipine
Property, therefore prepare telmisartan amlodipine coating tablet and can achieve purpose identical with double-layer tablets.Compacting double-layer tablets need spy
Different production equipment bi-layer tablet press, and telmisartan amlodipine coating tablet is able to satisfy life using tablet press machine common at present
It produces and needs, be conducive to commercially produce.
" research of Telmisartan Film coated tablets preparation process " is proposed using alkaline reagent solubilising, and using spray drying system
Grain prepares Telmisartan Tablets.Using more time-consuming spray drying process when the document prepares telmisartan tablet,
And need special equipment.The present inventor studies the preparation method for finding a kind of Telmisartan synusia core, comprising the following steps:
1) Telmisartan, alkaline reagent are dissolved in water, and obtain homogeneous solution
2) filler in Telmisartan label, disintegrating agent, adhesive sieving mixing are placed in fluidized bed, more than spray
Homogeneous solution granulation is stated, and dry；
3) pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, then carries out tabletting, makes
Obtain Telmisartan label；
Telmisartan layer is prepared using the technology and does not need special Spray granulation equipment, the used time needed for producing is also shorter, more
Be conducive to commercially produce.
Therefore present invention firstly provides a kind of Telmisartan label, contain:
Filler is selected from one of mannitol, sorbierite, xylitol, cornstarch or a variety of according to the present invention；Disintegration
Agent is selected from one of calcium carboxymethylcellulose, low-substituted hydroxypropyl cellulose, croscarmellose sodium or a variety of；Bonding
Agent is selected from one of hydroxypropyl cellulose, povidone, hydroxypropylcellulose or a variety of；It is rich that lubricant is selected from magnesium stearate, hard
One of horse acid sodium is a variety of.The Telmisartan Tablets of label have the feature of corrosion.
Oral tablet containing Telmisartan and Amlodipine Besylate Tablet according to the present invention, it is characterised in that the tablet includes
Telmisartan label and Amlodipine coatings composition, and separation layer is free of between the two.Due to Telmisartan of the invention
Amlodipine is made of Telmisartan label and Amlodipine coatings, and Telmisartan label and Amlodipine coatings connect
Contacting surface product is the contact area between two layers, and a large amount of coating material is contained in Amlodipine coatings, so as into one
Step reduces the contact ratio between Telmisartan layer and Amlodipine, therefore Telmisartan label and Amlodipine packet of the invention
Separation layer is not needed between clothing layer, that is, can reach the stable requirement of Amlodipine.In addition with reducing Telmisartan label and ammonia chlorine
Separation layer between flat coatings can reduce production craft step, improve production efficiency, reduce production cost.
According to the present invention, Amlodipine partial size D (V, 0.9) >=60 μm has following meaning according to the present invention, that is, works as D
When (V, 0.9)=60 μm, indicate in described entire particles populations there is the partial size for the particle for accounting for total volume 90% to be less than etc.
In 60 μm.
Amlodipine coatings, i.e., the film coating that can be disintegrated rapidly containing Amlodipine active constituent；The layer includes living
Property substance Amlodipine Besylate Tablet and coating material, or one of it is additionally added auxiliary material plasticizer, antiplastering aid, colorant or several
Kind；The active material is Amlodipine Besylate Tablet；Coating material be pharmaceutically acceptable auxiliary material HPMC with film forming,
HPC, PVA or PVP.Film-coating, which is matched, can have faintly acid, neutrality or alkalinity, preferably neutral film-coating formula.Preparing ammonia chlorine
In the Coating Solution of Horizon coatings, optional coating solvent has a purified water, ethyl alcohol and ethyl alcohol water mixed solution etc., preferably
Ethanol water.Selectable coating material has HPMC, HPC, PVP, PVA etc..In addition coating auxiliary material is still added for example to be plasticized
Agent, antiplastering aid, colorant, disintegrating agent etc..The Coating Solution of Amlodipine coatings includes the active matter of 1%~15% weight ratio
Matter, the preferably active material of 3%~5% mass ratio；The filmogen of 2%~35% weight ratio, preferably 7%~15% weight ratio
Filmogen；The volatile solvent of 50%~97% weight ratio, the volatile solvent of preferably 80%~90% weight ratio；
It or also may include a small amount of coating auxiliary material such as plasticizer, antiplastering aid, colorant, disintegrating agent.
Protective clothing layer is free of outside Amlodipine layer coatings according to the present invention.
Telmisartan containing 20~100mg in Telmisartan label of the present invention, preferred dose are 40mg to 80mg；It is described
Containing the Amlodipine of 1~15mg in Amlodipine coatings, preferred dose is 5mg to 10mg., current preferred combination includes
The Telmisartan of 40/5mg, 40/10mg, 80/5mg, 80/10mg and the coated tablet of Amlodipine.
The present invention prepares Telmisartan label using conventional top spray granulating process, then Telmisartan label outsourcing ammonia chlorine
The Telmisartan amlodipine besylate tablets of Horizon coatings, do not need special production equipment, simple process, cost savings,
It is more suitable for commercially producing.
Specific embodiment
In order to more fully understand the present invention, spy provides following specific embodiments, but the present invention is not limited to following embodiments.
Embodiment 1:
The preparation method comprises the following steps: Telmisartan, alkaline reagent are dissolved in water, it is spare that homogeneous solution is made；By Telmisartan Tablets
Filler, disintegrating agent, adhesive sieving mixing in core are placed in fluidized bed, and spray is pelletized with above-mentioned homogeneous solution, and dry；
The pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, tabletting is then carried out, Telmisartan is made
Label；Telmisartan label is coated after Amlodipine is uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH7.5 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 1.
Table 1:
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH1.0 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 2.
Table 2:
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH4.5 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 3.
Table 3:
Embodiment 1, original are ground into piece while being placed under high temperature and humidity and is saved 10 days, meter Sha is replaced using high-efficient liquid phase technique detection
Smooth and Amlodipine Besylate Tablet impurity situation of change, and compare Amlodipine Besylate Tablet total impurities situation of change.Acquired results are shown in
Table 4.
Table 4:
| Time | Embodiment 1 | Original is ground |
| 0 day | 0.34 | 0.37 |
| 10 days | 0.45 | 0.53 |
Stability result shows that the total impurities of 1 10 days Amlodipine Besylate Tablets of high temperature and humidity of prescription are less than principle, while total
The increasing degree of impurity is ground again smaller than original.
Embodiment 2
The preparation method comprises the following steps: Telmisartan, alkaline reagent are dissolved in water, it is spare that homogeneous solution is made；By Telmisartan Tablets
Filler, disintegrating agent, adhesive sieving mixing in core are placed in fluidized bed, and spray is pelletized with above-mentioned homogeneous solution, and dry；
The pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, tabletting is then carried out, Telmisartan is made
Label；Telmisartan label is coated after Amlodipine is uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH7.5 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 5.
Table 5:
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH1.0 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 6.
Table 6:
According to dissolution determination method (2010 editions the second methods of annex XC of Chinese Pharmacopoeia), pH4.5 buffer is situated between as dissolution
Matter, revolving speed 75m, to 1 son of embodiment and telmisartan amlodipine (manufacturer: German Boehringer Ingelheim)
Dissolution measurement is carried out, measurement result is shown in Table 7.
Table 7:
Embodiment 2, original are ground into piece while being placed under high temperature and humidity and is saved 10 days, meter Sha is replaced using high-efficient liquid phase technique detection
Smooth and Amlodipine Besylate Tablet impurity situation of change, and compare Amlodipine Besylate Tablet total impurities situation of change.Acquired results are shown in
Table 8.
Table 8:
| Time | Prescription 1 | Original is ground |
| 0 day | 0.44 | 0.40 |
| 10 days | 067 | 0.65 |
Stability result shows, the total impurities and impurity of 2 high temperature and humidity of embodiment, 10 days Amlodipine Besylate Tablets increase width
Degree is all ground unanimously with original.
Embodiment 3:
The preparation method comprises the following steps: Telmisartan, alkaline reagent are dissolved in water, it is spare that homogeneous solution is made；By Telmisartan Tablets
Filler, disintegrating agent, adhesive sieving mixing in core are placed in fluidized bed, and spray is pelletized with above-mentioned homogeneous solution, and dry；
The pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, tabletting is then carried out, Telmisartan is made
Label；Telmisartan label is coated after Amlodipine is uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
Embodiment 4:
The preparation method comprises the following steps: Telmisartan, alkaline reagent are dissolved in water, it is spare that homogeneous solution is made；By Telmisartan Tablets
Filler, disintegrating agent, adhesive sieving mixing in core are placed in fluidized bed, and spray is pelletized with above-mentioned homogeneous solution, and dry；
The pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, tabletting is then carried out, Telmisartan is made
Label；Telmisartan label is coated after Amlodipine is uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
Embodiment 5
The preparation method comprises the following steps: Telmisartan, alkaline reagent are dissolved in water, it is spare that homogeneous solution is made；By Telmisartan Tablets
Filler, disintegrating agent, adhesive sieving mixing in core are placed in fluidized bed, and spray is pelletized with above-mentioned homogeneous solution, and dry；
The pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, tabletting is then carried out, Telmisartan is made
Label；Telmisartan label is coated after Amlodipine is uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
Claims (5)
1. the oral tablet containing Telmisartan and Amlodipine Besylate Tablet, it is characterised in that the tablet by Telmisartan label and
Amlodipine coatings composition, and separation layer is free of between the two, wherein the Telmisartan Tablets core includes:
Protective clothing layer is wherein free of except Amlodipine coatings；
Wherein the filler of Telmisartan label is selected from one of mannitol, sorbierite, xylitol, cornstarch or a variety of；
Disintegrating agent is selected from one of calcium carboxymethylcellulose, low-substituted hydroxypropyl cellulose, croscarmellose sodium or a variety of；
Adhesive be selected from hydroxypropyl cellulose, povidone it is one or more；Lubricant is in magnesium stearate, sodium stearyl fumarate
It is one or more；
Wherein Amlodipine coatings include active material Amlodipine Besylate Tablet and coating material；Coating material is with film forming
Pharmaceutically acceptable auxiliary material HPMC, HPC, PVA or PVP of property.
2. oral tablet according to claim 1, it is characterised in that the filler of Telmisartan label be selected from mannitol and
Cornstarch；Disintegrating agent is selected from calcium carboxymethylcellulose；Adhesive is selected from povidone；Lubricant is selected from magnesium stearate.
3. oral tablet according to claim 1, it is characterised in that Amlodipine coatings are additionally added auxiliary material plasticizer, resist
One or more of stick, colorant.
4. oral tablet according to claim 3, it is characterised in that the Coating Solution of Amlodipine coatings include 1%~
The active material Amlodipine Besylate Tablet of 15% weight ratio, the filmogen of 2%~35% weight ratio and 50%~97% weight
The volatile solvent of ratio, or further include coating auxiliary material；Other in active material Amlodipine Besylate Tablet and Coating Solution are solid
The mass ratio of body substance is 1:0.5~1:5.
5. a kind of preparation method of telmisartan amlodipine tablets oral tablet as described in claim 1, comprising the following steps:
1) Telmisartan, alkaline reagent are dissolved in water, and obtain homogeneous solution
2) filler in Telmisartan label, disintegrating agent, adhesive sieving mixing are placed in fluidized bed, spray is with above-mentioned equal
Even solution granulation, and it is dry；
3) pharmaceutic adjuvant that Extra Section is added after dry particle sieving whole grain is uniformly mixed, then carries out tabletting, is made and replaces
Meter Sha Tan label；
4) Telmisartan label is coated after Amlodipine being uniformly dispersed in Coating Solution, is done after the completion of coating
Dry telmisartan amlodipine tablets to obtain the final product.
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| CN201310204699.9A CN103271908B (en) | 2013-05-23 | 2013-05-23 | Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet |
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| CN201310204699.9A CN103271908B (en) | 2013-05-23 | 2013-05-23 | Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet |
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| CN103271908B true CN103271908B (en) | 2019-02-12 |
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| CN104000821B (en) * | 2014-06-02 | 2020-06-19 | 浙江华海药业股份有限公司 | Oral double-layer tablet containing telmisartan and amlodipine besylate and preparation method thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007001067A2 (en) * | 2005-06-27 | 2007-01-04 | Daiichi Sankyo Company, Limited | Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker |
| CN101528203A (en) * | 2006-10-10 | 2009-09-09 | 韩兀制药株式会社 | Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory |
| CN102114015A (en) * | 2010-01-05 | 2011-07-06 | 浙江华海药业股份有限公司 | Solid oral preparation containing telmisartan and preparation method thereof |
| CN102348455A (en) * | 2009-01-14 | 2012-02-08 | 力奇制药公司 | Active coating of pharmaceutical dosage forms |
| WO2012055941A1 (en) * | 2010-10-27 | 2012-05-03 | Krka,Tovarna Zdravil, D. D., Novo Mesto | Multilayer pharmaceutical composition comprising telmisartan and amlodipine |
| US20130022676A1 (en) * | 2010-03-05 | 2013-01-24 | University Of Strathclyde | Pulsatile drug release |
-
2013
- 2013-05-23 CN CN201310204699.9A patent/CN103271908B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007001067A2 (en) * | 2005-06-27 | 2007-01-04 | Daiichi Sankyo Company, Limited | Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker |
| CN101528203A (en) * | 2006-10-10 | 2009-09-09 | 韩兀制药株式会社 | Combined preparation for the treatment of cardiovascular diseases based on chronotherapy theory |
| CN102348455A (en) * | 2009-01-14 | 2012-02-08 | 力奇制药公司 | Active coating of pharmaceutical dosage forms |
| CN102114015A (en) * | 2010-01-05 | 2011-07-06 | 浙江华海药业股份有限公司 | Solid oral preparation containing telmisartan and preparation method thereof |
| US20130022676A1 (en) * | 2010-03-05 | 2013-01-24 | University Of Strathclyde | Pulsatile drug release |
| WO2012055941A1 (en) * | 2010-10-27 | 2012-05-03 | Krka,Tovarna Zdravil, D. D., Novo Mesto | Multilayer pharmaceutical composition comprising telmisartan and amlodipine |
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