CN101766582B - Levamlodipine beaylate tablets and preparation method thereof - Google Patents
Levamlodipine beaylate tablets and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of medicament, and provides levamlodipine beaylate tablets and a preparation method thereof. The tablets consist of tablet cores using the levamlodipine beaylate as an active component and film coatings coated on the outer layer, wherein diluent in the tablet cores contains diatomite or aerosil, or a mixture of diatomite and aerosil, and contains other pharmaceutically acceptable supplementary materials; and the outer film coating accounts for 8 to 12 percent of the weight of the tablets, and can play a role in resisting humidity and avoiding light to ensure that the medicinal stability can be greatly improved, and related substances are obviously reduced. Furthermore, the tablets have small specification, so the tablets ensure uniform content, and improve dissolution; and the method is simple and controllable, and ensures that the hygroscopicity of the medicament is obviously reduced.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to tablet of a kind of Levamlodipine besylate and preparation method thereof.
Background technology
Cardiovascular disease is one of principal disease of harm humans health in the present world wide, only just there is the millions of people to die from cardiovascular disease every year in China, the incidence rate that shows cardiovascular disease according to up-to-date medical information is rising year by year, and the patient age rejuvenation.Cardiovascular disease has the characteristics of high incidence, high mortality, high disability rate, high relapse rate, and people more and more pay attention to the treatment of cardiovascular disease, and its medication market potential is huge.Hypertension is one of modal cardiovascular disease in the world today, be the dead and wounded or disabled main diseases of adult because of.Because the raising of people's living standard, work competition growing tension, the hypertension number of patients increases greatly, China's hypertension prevalence obviously rises, and shows that according to the China's Statistical data there are hyperpietic 600,000,000 people in the present whole world, and the hypertension prevalence is about 10%, China's hypertension prevalence is about 12%, existing hyperpietic's number surpasses 100,000,000 people, and annual speed increment with 3,000,000 people, and China has become the most serious country of hypertension harm in the world.
Norvasc (amlodipine besylate tablets) be up to now till the hypertensive brand medicine of treatment of world's recipe quantity maximum.Since nineteen ninety, it has surpassed 40,000,000,000 patient days in the use in the whole world.Amlodipine is a kind of racemoid, it contains the levo form and the d-isomer of equivalent, be racemic amlodipine, real and body generation drug action is levo form in amlodipine, d-isomer is not only invalid but also poisonous, therefore, and the Levamlodipine besylate that on the amlodipine basis, splits out, its drug effect is 2 times of raceme, and the untoward reaction of having avoided d-isomer to bring; Levamlodipine besylate is a dihydropyridine calcium ion antagonist, be used for the anginal control of hypertension clinically, Levamlodipine besylate optionally suppresses calcium ion strides film and enters smooth muscle cell and myocardial cell, to the effect of smooth muscle greater than cardiac muscle.Levamlodipine besylate is the peripheral arterial expander, directly acts on vascular smooth muscle, reduces peripheral vascular resistance, thereby brings high blood pressure down.It does not influence plasma calcium concentration, oral post-absorption is complete but slow, reached peak concentration in 6-12 hour, single oral 5mg, blood medicine peak value is 3.0ng/ml, single oral 10mg, blood medicine peak value is 5.9ng/ml, and absolute bioavailability is 64%-90%, not influenced by diet, medicine in the circulation combines with plasma protein more than 95%, reaches steady plasma-drug concentration behind the SM in 7-8 days; This product is eliminated from blood plasma in the mode of two-compartment model, in the extensive metabolism of liver is the metabolite (90%) of parmacodynamics-less activity, the t1/2 healthy patients is about 35 hours, the hypertensive patient extends to 50 hours, old people 65 hours, liver function sufferer 60 hours, the renal insufficiency person is unaffected, this product 10% is with prototype, 60% form discharge from urine with metabolite, 20%-25% discharges from bile or feces, Levamlodipine besylate is not removed by hemodialysis, the pharmacokinetic characteristics of renal insufficiency P-TOLUENE SULFO ACID 99 Levamlodipine has no significant effect, gerontal patient and hepatic insufficiency patient reduce the clearance rate of this product, and area under the drug-time curve (AUC) approximately increases 40%-60%, and the AUC rising amplitude of middle severe patients with heart failure is similar.
Compare with other depressor, it is long that Levamlodipine besylate also has drug effect, only took once in one day, hypotensive effect is slowly lasting, the unlikely rebound effect that causes after hypotension and the drug withdrawal, tissue selectivity vasoactive rather than heart, can safety the patient who is used for heart failure, the bioavailability height, can delay the process of left ventricular hypertrophy, can unite the advantages such as influence of using and not being subjected to dietary intake with other drug, this medicine also is a kind of effective antianginal drug, and especially more effective to the coronary spasm angina pectoris, he has higher affinity to blood vessel, and energy significant prolongation ischemic myocardial patient's movement time and the time that moves to angina pectoris attacks, reduce the angina pectoris attacks number of times.
Patent CN1981759A provides a kind of L-amlodipine besilate dripping pill and preparation method thereof, this drop pill is to be made by Levamlodipine besylate and drop pill substrate, has the bioavailability height, takes advantage such as molten fast, the rapid release of loosing of easy to carry, disintegrate.
Patent CN1899268A provides a kind of L-amlodipine besilate dripping pill and preparation method, and this drop pill is to splash in the drop pill substrate after Levamlodipine besylate and relevant auxiliary materials are made homodisperse liquid, makes the coating or the drop pill of coating not.
Patent CN101559043A provides a kind of Levamlodipine beaylate tablets and preparation method, and this tablet stripping meets the requirements, and stability better.
These patent documentations are made drop pill and conventional tablet respectively with Levamlodipine besylate, improved the dissolution of principal agent to a certain extent, yet this medicine specification is less, and have intensive hygroscopicity and unstability, adopt the conventional tablet stability of drug to can not get guaranteeing, and the drop pill technology also is difficult to really to make preparation to reach homogeneous, stable requirement, and each patent documentation all can not overcome the shortcoming of Levamlodipine besylate fully in a word.
Summary of the invention
In order to overcome the bibulous shortcoming of Levamlodipine besylate, improve stability of formulation, and guarantee that medicine has good absorption in vivo, the invention provides a kind of Levamlodipine beaylate tablets agent, can solve the problem that prior art exists, guaranteed the uniformity of dosage units of preparation, improved dissolution, by packaging technique stability of formulation is improved in addition, after coating membrane dissolves in gastrointestinal tract, label disintegrate rapidly, medicine stripping has fast improved bioavailability.Another object of the present invention has provided the preparation method of this tablet, it is at first Levamlodipine besylate to be made coating gained behind the active label, accelerated test showed in 6 months, and this product stability improves greatly than conventional tablet, and every investigation result shows that all this product is up to specification.
The invention provides a kind of Levamlodipine beaylate tablets agent, it is made up of the internal layer label and the outer membrane clothing that with the Levamlodipine besylate are active component, and wherein the internal layer label is made up of one or both diluent and pharmaceutically acceptable other adjuvants of containing in micropowder silica gel and the kieselguhr.
Levamlodipine beaylate tablets agent provided by the invention, diluent also contains one or more in dextrin, sucrose, lactose, mannitol, pregelatinized Starch, microcrystalline Cellulose, calcium carbonate and the calcium hydrogen phosphate.
Binding agent is selected from one or more in methylcellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose and the polyvidone, consumption be sheet heavy 5%～15%; Disintegrating agent is selected from one or more in carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium and the polyvinylpolypyrrolidone, consumption be sheet heavy 5%～15%; Lubricant is selected from one or more in Pulvis Talci, magnesium stearate and the micropowder silica gel, consumption be sheet heavy 0.1%～1%.
Every of Levamlodipine beaylate tablets agent provided by the invention contains Levamlodipine besylate 2～10mg.
Levamlodipine beaylate tablets agent provided by the invention, outer membrane clothing account for the heavy 8%-12% of sheet, the consisting of of outer membrane clothing:
(1) filmogen: be selected from hydroxypropyl cellulose, hypromellose, polyvinyl alcohol, polyethylene acetal diethylamine acetate and acrylic resin IV number one or more, consumption is 5%～15% of a coating solution weight;
(2) plasticizer: be selected from PEG6000, PEG4000, monoacetin and the triethyl citrate one or more, consumption is 0.5%～1.5% of a coating solution weight;
(3) antiblocking agent: be selected from micropowder silica gel, Pulvis Talci and the magnesium stearate one or more, consumption is 0.5%～2% of a coating solution weight;
(4) opacifier is a titanium dioxide, and consumption is 0.1%～1% of a coating solution weight.
Levamlodipine beaylate tablets agent provided by the invention, its preparation method comprises following step:
(1) take by weighing the Levamlodipine besylate and the micropowder silica gel of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with diluent, binding agent and part disintegrating agent again, place and mix 30min in the high efficient mixed machine, mistake 100 mesh sieves, standby;
(2) do wetting agent to mixed powder system soft material with 95% ethanol, cross 16～18 mesh sieves, drying, granulate, tabletting behind adding residue disintegrating agent and the lubricant makes active label;
(3) coating material is dissolved in the alcoholic solution, add plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion, active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Levamlodipine beaylate tablets agent provided by the invention, its another preparation method comprises following step:
(1) take by weighing the Levamlodipine besylate and the kieselguhr of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with other adjuvants of residue again, place and mix 15min in the high efficient mixed machine, direct compression behind 100 mesh sieves, make active label;
(2) coating material is dissolved in the alcoholic solution, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion.Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Beneficial effect of the present invention:
(1) Levamlodipine beaylate tablets agent provided by the invention is made parcel outer membrane clothing behind the label with active component, has improved stability of formulation, and related substance reduces; This tablet enters the stripping fast of gastrointestinal tract coating membrane dissolving back medicine, has improved bioavailability.
(2) Levamlodipine beaylate tablets agent provided by the invention efficiently solves formulation content heterogeneity, shortcoming that dissolution is low by adding micropowder silica gel or diatomaceous method.
(3) packaging technique is adopted in Levamlodipine beaylate tablets agent provided by the invention, and it is strong successfully to have solved this active component hygroscopicity, easily the shortcoming of degraded.
(4) Levamlodipine beaylate tablets agent provided by the invention, preparation process is comparatively simple, is fit to suitability for industrialized production.
The specific embodiment
The invention is further illustrated by the following examples, for a person skilled in the art, should be understood to the following example and do not constitute limiting the scope of the invention.
Embodiment 1
1, prescription is formed
(1) Levamlodipine beaylate tablets core prescription
The composition consumption
Levamlodipine besylate 5g
Micropowder silica gel 20g
Microcrystalline Cellulose 45g
Hydroxypropyl cellulose 10g
Carboxymethylstach sodium 20g
Magnesium stearate 3g
95% ethanol is an amount of
Make 1000 altogether
(2) coating material prescription
The composition consumption
Polyethylene acetal diethylamine acetate 5g
Hypromellose 1g
PEG4000 1g
Pulvis Talci 1.5g
Titanium dioxide 1.5g
5% ethanol 125ml
2, preparation method
(1) take by weighing the Levamlodipine besylate and the micropowder silica gel of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, the disintegrating agent with binding agent and 1/2 recipe quantity mixes again, place to mix 30min in the high efficient mixed machine, and mistake 100 mesh sieves, standby;
(2) do wetting agent to mixed powder system soft material with 95% ethanol, cross 16～18 mesh sieves, drying, granulate, tabletting behind adding residue disintegrating agent and the lubricant makes active label;
(3) coating material is dissolved in 5% alcoholic solution, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion.Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Embodiment 2
1, prescription is formed
(1) Levamlodipine beaylate tablets core prescription
The composition consumption
Levamlodipine besylate 2.5g
Kieselguhr 10g
Lactose 40g
Hydroxypropyl cellulose 30g
Polyvinylpolypyrrolidone 15g
Magnesium stearate 2.54g
Make 1000 altogether
(2) coating material prescription
The composition consumption
Hypromellose 6g
PEG6000 1g
Pulvis Talci 1.5g
Titanium dioxide 1.5g
Purified water 100ml
2, preparation method
(1) take by weighing the micropowder silica gel of the Levamlodipine besylate and 2/3 recipe quantity of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with the residue adjuvant again, place and mix 30min in the high efficient mixed machine, direct compression behind 100 mesh sieves, make active label;
(2) coating material is dissolved in the purified water, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion.Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Embodiment 3
1, prescription is formed
(1) Levamlodipine beaylate tablets core prescription
The composition consumption
Levamlodipine besylate 5g
Micropowder silica gel 20g
Pregelatinized Starch 50g
Hydroxypropyl cellulose 10g
Cross-linked carboxymethyl cellulose sodium 12g
Pulvis Talci 3g
95% ethanol is an amount of
Make 1000 altogether
(2) coating material prescription
The composition consumption
Acrylic resin IV 8g
Pulvis Talci 2g
Titanium dioxide 2g
95% alcoholic solution 100ml
2, preparation method
(1) take by weighing the Levamlodipine besylate and the kieselguhr of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with residue adjuvant and 50% disintegrating agent again, place and mix 30min in the high efficient mixed machine, 100 mesh sieves, standby;
(2) do wetting agent to mixed powder system soft material with 95% ethanol, cross 16～18 mesh sieves, drying, granulate, tabletting behind adding residue disintegrating agent and the lubricant makes active label;
(3) coating material is dissolved in 95% ethanol, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion.Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Embodiment 4
1, prescription is formed
(1) Levamlodipine beaylate tablets core prescription
The composition consumption
Levamlodipine besylate 2.5g
Kieselguhr 15g
Pregelatinized Starch 60g
Hydroxypropyl cellulose 20g
Magnesium stearate 2.5g
Make 1000 altogether
(2) coating material prescription
The composition consumption
Polyvinyl alcohol 10g
PEG6000 1g
Pulvis Talci 2g
Titanium dioxide 1g
75% ethanol 100ml
2, preparation method
(1) take by weighing the micropowder silica gel of the Levamlodipine besylate and 2/3 recipe quantity of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with the residue adjuvant again, place and mix 30min in the high efficient mixed machine, direct compression behind 100 mesh sieves, make active label;
(2) coating material is dissolved in the alcoholic solution, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion.Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
Further specify effect of the present invention below by experiment
1, Levamlodipine beaylate tablets agent study on the stability
(1) influence factor's test
The Levamlodipine beaylate tablets that embodiment of the invention 1-4 is made strong illumination (place under 4500lx ± 500lx), high temperature (60 ℃), high humidity (90%) condition, respectively at the 5th day and the 10th day related substance of taking a sample to check, the result was as follows:
Table 1 Levamlodipine beaylate tablets influence factor result of the test
| High humidity | 0.18 | 0.18 | 0.16 | 0.15 |
(2) accelerated test
Levamlodipine beaylate tablets agent and Levamlodipine besylate conventional tablet that the embodiment of the invention 1 and embodiment 2 are made, under 40 ℃, the environment of RH75%, placed 6 months under the commercially available back, difference is indexs such as sampling and measuring sample size, related substance, dissolution at the appointed time, and result of the test sees the following form.
Table 2 Levamlodipine beaylate tablets accelerated test result
Levamlodipine beaylate tablets is in influence factor and accelerated test process, appearance character does not change substantially, by table 1 and table 2 as can be seen, it is big that the ordinary tablet related substance obviously becomes, and content descends very fast, and its content of tablet of the present invention meets the requirements, dissolution obviously raises after adding kieselguhr or micropowder silica gel, related substance is lower than conventional tablet, illustrates that tablet provided by the invention can improve bioavailability of medicament and stability, prolongs the preparation storage life.
2, the Levamlodipine beaylate tablets agent content uniformity is investigated
Embodiment 1-4 is made three batch samples respectively, measure uniformity of dosage units, the result is as follows:
Table 3 Levamlodipine beaylate tablets uniformity of dosage units is investigated the result
As can be seen from Table 3, each 3 batch sample of embodiment 1-4, uniformity of dosage units all meets the requirements.
Claims (1)
1. Levamlodipine beaylate tablets agent, it is characterized in that being made up of the internal layer label and the outer membrane clothing that with the Levamlodipine besylate are active component, wherein the internal layer label is made up of one or both diluent and pharmaceutically acceptable other adjuvants of containing in micropowder silica gel and the kieselguhr; The outer membrane clothing accounts for the heavy 8%-12% of sheet; Consisting of of outer membrane clothing:
(1) filmogen: be selected from hydroxypropyl cellulose, hypromellose, polyvinyl alcohol, polyethylene acetal diethylamine acetate and the Eudragit one or more, consumption is 5% ~ 15% of a coating solution weight;
(2) plasticizer: be selected from PEG6000, PEG4000, monoacetin and the triethyl citrate one or more, consumption is 0.5% ~ 1.5% of a coating solution weight;
(3) antiblocking agent: be selected from micropowder silica gel, Pulvis Talci and the magnesium stearate one or more, consumption is 0.5% ~ 2% of a coating solution weight;
(4) opacifier is a titanium dioxide, and consumption is 0.1% ~ 1% of a coating solution weight.
2, Levamlodipine beaylate tablets agent according to claim 1 is characterized in that diluent also contains one or more in dextrin, sucrose, lactose, mannitol, pregelatinized Starch, microcrystalline Cellulose, calcium carbonate and the calcium hydrogen phosphate.
3, Levamlodipine beaylate tablets agent according to claim 1, it is characterized in that pharmaceutically acceptable other adjuvants comprise: binding agent is selected from one or more in methylcellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose and the polyvidone, consumption be sheet heavy 5% ~ 15%; Disintegrating agent is selected from one or more in carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium and the polyvinylpolypyrrolidone, consumption be sheet heavy 5% ~ 15%; Lubricant is selected from one or more in Pulvis Talci, magnesium stearate and the micropowder silica gel, consumption be sheet heavy 0.1% ~ 1%.
4, Levamlodipine beaylate tablets agent according to claim 1 is characterized in that every contains Levamlodipine besylate 2 ~ 10mg.
5, a kind of method for preparing the described Levamlodipine beaylate tablets agent of claim 1 comprises following step:
(1) take by weighing the Levamlodipine besylate and the micropowder silica gel of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with other diluent, binding agent and part disintegrating agent again, place and mix 30min in the high efficient mixed machine, mistake 100 mesh sieves, standby;
(2) do wetting agent to mixed powder system soft material with 95% ethanol, cross 16 ~ 18 mesh sieves, drying, granulate, tabletting behind adding residue disintegrating agent and the lubricant makes active label;
(3) coating material is dissolved in the alcoholic solution, adding plasticizer, opacifier and antiblocking agent again is placed in the blender and stirs, make into uniform dispersion, active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
6, a kind of method for preparing the described Levamlodipine beaylate tablets agent of claim 1 comprises following step:
(1) take by weighing the Levamlodipine besylate and the kieselguhr of recipe quantity, adopt equivalent to progressively increase behind the method mix homogeneously, mixes with other adjuvants of residue again, place and mix 15min in the high efficient mixed machine, direct compression behind 100 mesh sieves, make active label;
(2) coating material is dissolved in the alcoholic solution, adds plasticizer, opacifier and antiblocking agent again and be placed in the blender and stir, make into uniform dispersion; Active label is placed in the high efficiency levels coating pan, spray into coating solution and carry out coating, make the Levamlodipine besylate coated tablet.
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104739799B (en) * | 2013-12-27 | 2018-01-05 | 辰欣药业股份有限公司 | A kind of Amlodipine Besylate Tablet composition and its method for preparing tablet thereof for direct tablet compressing |
| CN104109326A (en) * | 2014-06-26 | 2014-10-22 | 华南理工大学 | Anti-blocking polyvinyl alcohol film, and preparation method and application thereof |
| CN105412029A (en) * | 2015-12-03 | 2016-03-23 | 南京多宝生物科技有限公司 | Anti-hypertension benzene sulfonic acid levamlodipine besylate tablet |
| CN107375222A (en) * | 2017-07-23 | 2017-11-24 | 南京正宽医药科技有限公司 | A kind of Levamlodipine beaylate tablets agent and preparation method thereof |
| CN107951849B (en) * | 2017-12-15 | 2020-07-07 | 湖南千金协力药业有限公司 | Amlodipine besylate tablet and preparation method thereof |
| CN110433163B (en) * | 2019-06-17 | 2022-08-16 | 北京汉典制药有限公司 | Levamlodipine besylate composition and preparation method thereof |
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| CN1546024A (en) * | 2003-12-09 | 2004-11-17 | 成都圣诺科技发展有限公司 | Orally disintegrating tablet of amlodipine besylate and its preparation process |
| CN1686121A (en) * | 2005-04-19 | 2005-10-26 | 昆明金殿制药有限公司 | Phenylsulfonic acid amido chloro diping dispersion tablet and its preparation method |
| CN1899268A (en) * | 2006-07-13 | 2007-01-24 | 北京国仁堂医药科技发展有限公司 | L-amlodipine besilate dripping pill and its preparing method |
| CN1981759A (en) * | 2005-12-14 | 2007-06-20 | 陈茜 | Levamlodipine besylate dropping balls and their making method |
| CN101559043A (en) * | 2009-06-09 | 2009-10-21 | 南昌弘益药业有限公司 | Benzene sulfonic acid levo-amlodipine pill and preparation method thereof |
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| CN1546024A (en) * | 2003-12-09 | 2004-11-17 | 成都圣诺科技发展有限公司 | Orally disintegrating tablet of amlodipine besylate and its preparation process |
| CN1686121A (en) * | 2005-04-19 | 2005-10-26 | 昆明金殿制药有限公司 | Phenylsulfonic acid amido chloro diping dispersion tablet and its preparation method |
| CN1981759A (en) * | 2005-12-14 | 2007-06-20 | 陈茜 | Levamlodipine besylate dropping balls and their making method |
| CN1899268A (en) * | 2006-07-13 | 2007-01-24 | 北京国仁堂医药科技发展有限公司 | L-amlodipine besilate dripping pill and its preparing method |
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