CN102440993B - Amlodipine benazepril pharmaceutical composition - Google Patents
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Abstract
The invention relates to an amlodipine and benazepril composition which is a tablet. The amlodipine benazepril tablet is obtained by treating amlodipine besylate and benazepril hydrochloride as active components, aerosil as a lubricant, lactose and microcrystalline cellulose as fillers and sodium carboxymethyl starch as a disintegrant and adopting a direct powder tabletting technology. The method has the advantages of simple process, and energy and time saving; and the prepared tablet has the advantages of stable quality, high dissolvability, and good disintegration.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to the pharmaceutical composition of a kind of amlodipine and benazepril, described pharmaceutical composition is tablet.
Background technology
Hypertension is a Major Risk Factors in the cardiovascular disease death incident, its prevalence accounts for adult's 10%～30%, it only is 40% that single drug is treated hypertensive effective percentage, can improve curative effect although increase dosage, but also increased the incidence rate of untoward reaction simultaneously, for improving curative effect, reduce the incidence rate of cardiovascular event, reduce target organ damage, usually with angiotensin converting enzyme inhibitor and calcium antagonist drug combination treatment hypertension, safe and effective, have good toleration.
Amlodipine Besylate Tablet (amlodipine besylate) is the long-acting bihydropyridine type calcium antagonists of 2nd generation, but diastole coronary vasodilator and whole body blood vessel increase coronary flow, reduce blood pressure, and are mainly used in clinically treating hypertension and angina pectoris.Be hydrolyzed to benazeprilat in benazepril hydrochloride (benazepril hydrochloride) liver, become a kind of emulative angiotensin converting enzyme inhibitor, vascular resistance is reduced, Aldosterone Secretion reduces, serum renin activity increases, also by suppressing the Kallidin I degraded vascular resistance is reduced, produce hypotensive effect.Amlodipine benazepril sheet is two kinds of highly effectively compound formulations of antihypertensive drugs, and antihypertensive effect is better than single leading medicine.
The preparation technology of existing amlodipine benazepril sheet mostly is wet granule compression tablet.Also have first by wet granulation prepare the benazepril compositions, dry process prepares the amlodipine compositions, rear mixing adds the technique that pharmaceutical excipient is made amlodipine/benazepril compound preparation, but at present, domestic not yet have the direct powder compression of employing technology to prepare amlodipine benazepril sheet.
Mainly there is following defective in the amlodipine benazepril sheet that existing technique prepares:
1, the dissolution of Amlodipine Besylate Tablet is lower in the amlodipine benazepril sheet for preparing, and is unsuitable for the medicine quick acting, and clinical practice is had certain influence.Thereby, need to adopt Innovative method to prepare amlodipine benazepril sheet, for example, can improve its stripping by micronization, when reality prepares, behind the hydrophobicity crushing material, along with reducing of particle diameter, surface free energy increases, the phenomenon that particle easily reassembles, so the actual benefit of pulverizing is not high; On the other hand, because the hydrophobicity material particular diameter is too little, the increase of specific surface area, the hydrophobicity of tablet is strengthened, be unfavorable on the contrary the stripping of tablet;
2, general preparation technology adopts magnesium stearate as lubricant, magnesium stearate is lyophobic dust, after the excessive or excessive agitation of consumption, can cover particle surface affects the infiltration of water, cause amlodipine benazepril sheet disintegrate (or stripping) to postpone, be unfavorable for that medicine brings into play therapeutic effect fast;
3, adopt traditional wet granule compression tablet technique to prepare amlodipine benazepril sheet: process is complicated, consider the factors such as adhesive addition, particle drying time, the pure time of sieving of granulating, the machine quantity of need of production is many, the space is large, and because some factor need to rely on micro-judgment, therefore may cause unstable product quality, difference is large etc. between batch.
Summary of the invention
It is high that one of purpose of the present invention provides a kind of dissolution, the amlodipine benazepril tablet that disintegrative is good.
The technical scheme that realizes above-mentioned purpose is as follows:
A kind of amlodipine benazepril tablet, take Amlodipine Besylate Tablet and benazepril hydrochloride as active component, with micropowder silica gel as lubricant, with lactose and microcrystalline Cellulose as filler, as disintegrating agent, the percentage by weight of wherein said each raw material components is with Sodium Hydroxymethyl Stalcs:
Preferably, the percentage by weight of described each raw material components is:
Most preferably, the percentage by weight of described each raw material components is:
Preferably, the weight ratio of lactose and microcrystalline Cellulose is 1-4:1 in the described filler.
Another object of the present invention provides a kind of preparation method of above-mentioned amlodipine benazepril tablet.
The technical scheme that realizes above-mentioned purpose is as follows:
A kind of method for preparing amlodipine benazepril tablet may further comprise the steps:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, the 15-20% that gets described lactose total amount and Amlodipine Besylate Tablet place high efficient mixer to rotate mix homogeneously, obtain the batch mixing I;
C, in the batch mixing I, be sequentially added into remaining lactose and benazepril hydrochloride, rotate mix homogeneously, obtain the batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer to rotate mix homogeneously in order, obtain whole batch mixing III;
E, whole batch mixing III direct compression namely get described amlodipine benazepril tablet;
Preferably, the rotating speed of high efficient mixer and automatic lifting hopper mixer is 12r/min in described step b, c, the d mixed process.
Advantage of the present invention and good effect
1, the present invention adopts technique of direct powder compression to prepare amlodipine benazepril tablet, and its disintegrating agent is different from the disintegrating agent in the wet granulation, not can owing to early stage contact wetting reduce disintegrating property, thereby guaranteed good disintegration properties.In addition, owing to do not carry out the granule tabletting, can not form large bulk granule behind the disintegration of tablet, but form the relatively large fine powder of specific surface area, can distribute preferably in vivo, improve the dispersed homogeneous degree of tablet, help release, the absorption of medicine.Therefore technique of direct powder compression provided by the invention has improved dissolution and the disintegrative of amlodipine benazepril sheet greatly;
2, technique of direct powder compression provided by the invention, after the powder of medicine sieved respectively with suitable adjuvant and mixing, direct pressing is in blocks without granulating (wet grain or dried granule).Preparation process is simple, the energy-and time-economizing, and mass discrepancy between reducing batch makes medicine more stable;
Therefore 3, amlodipine benazepril tablet provided by the invention, as lubricant, it has hydrophilic with micropowder silica gel, does not affect the profit of invading of water, and the stripping of medicine is had great facilitation.
The specific embodiment
The present invention is further elaborated below in conjunction with embodiment.
Embodiment 1
Each raw material components amount that present embodiment prepares amlodipine benazepril tablet is:
The concrete steps that present embodiment prepares amlodipine benazepril tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain the batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain the batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III is carried out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet;
In above-mentioned steps b, c, d, every add a kind of raw material in efficient mixing machine or the automatic lifting hopper mixer after, need the material face spread out to pat as far as possible can add next raw material after whole; Before adding raw material, beginning to mix, need the material face spread out to pat as far as possible can begin to mix after whole; Need the sampling detection level uniformity after mix finishing, before sampling, also need the material face spread out to pat as far as possible can begin sampling after whole.
Embodiment 2
Each raw material components amount that present embodiment prepares amlodipine benazepril tablet is:
Present embodiment prepares the concrete steps of amlodipine benazepril tablet with embodiment 1.
Embodiment 3
Each raw material components amount that present embodiment prepares amlodipine benazepril tablet is:
Present embodiment prepares the concrete steps of amlodipine benazepril tablet with embodiment 1.
Embodiment 4
Each raw material components amount that present embodiment prepares amlodipine benazepril tablet is:
Present embodiment prepares the concrete steps of amlodipine benazepril tablet with embodiment 1.
Embodiment 5
Each raw material components amount that present embodiment prepares amlodipine benazepril tablet is:
Present embodiment prepares the concrete steps of amlodipine benazepril tablet with embodiment 1.
Embodiment 6
Stability experiment
According to " chemicals stability study technological guidance principle " and " Chinese pharmacopoeia version in 2010 two ones " appendix XIX C crude drug and pharmaceutical preparation stability test guidelines " is carried out stability test to sample.Get 3 batches in the sample of embodiment 1 preparation, lot number is respectively 11032401,11032402 and 11032403, places respectively lower 6 months of the condition of 40 ℃+2 ℃ of temperature, relative humidity 75%+5%.Investigate indices respectively at the 1st, 2,3,6 sampling at the end of month, the results are shown in following table:
Table 1 amlodipine benazepril tablet stability measurement result
As seen from the above table, the prepared amlodipine benazepril tablet of the present invention has good stability, places after 6 months, and its property indices still remains unchanged substantially, and batch between mass discrepancy very little.
The described amlodipine benazepril of embodiment 2-5 tablet has all been carried out similar experiment, the result is similar to the test result of embodiment 1 sample, show that all amlodipine benazepril tablet provided by the invention has good stability, the mass discrepancy between each batch is also very little.
Embodiment 7
Get respectively the amlodipine benazepril tablet that four kinds of different modes obtain, wherein compressing dry granulation and wet method tabletting add the sample proportioning raw materials of micropowder silica gel with embodiment 1, the proportioning of other raw material of sample that does not add micropowder silica gel is identical, and placing temperature is lower 18 months of 40 ℃+2 ℃, the condition of relative humidity 75%+5%.Respectively at the 1st, 3,6,12,18 the end of month sampling and measuring stripping property and disintegration, carry out stripping property and disintegrative experiment contrast:
The test result contrast is as follows:
Table 2 amlodipine benazepril Dissolution of Tablet and disintegration comparing result
By the test comparison result of upper table as can be known, technique of direct powder compression provided by the present invention effectively raises dissolution and the disintegrating property of medicine, because technique of direct powder compression not can owing to early stage contact wetting guaranteed good disintegrative, in addition, direct powder compression does not carry out granule tabletting process, can not reunite behind the disintegration of tablet and form the larger fine powder of surface area ratio, Effective Raise dispersed homogeneous degree and the dissolution of tablet.And under the same preparation technology, the adding of micropowder silica gel effectively raises stripping property and the disintegrative of amlodipine benazepril tablet, because micropowder silica gel has hydrophilic as the fluidizer of direct powder compression, therefore do not affect the profit of invading of water, promoted the stripping of medicine.
To sum up, the present invention has overcome the defective of prior art with the adding of as a result micropowder silica gel of technique of direct powder compression, the energy-and time-economizing, and the amlodipine benazepril tablet quality for preparing is stable, dissolution is high, disintegrative good.
Be specific embodiments of the invention only below, do not limit protection scope of the present invention with this; Any replacement and the improvement done on the basis of not violating the present invention's design all belong to protection scope of the present invention.
Claims (5)
1. the pharmaceutical composition of an amlodipine and benazepril is characterized in that described pharmaceutical composition is tablet, and the weight of each component is:
Prepare altogether 500,000 of amlodipine benazepril sheets;
The concrete steps of preparation tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III carries out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet.
2. the pharmaceutical composition of an amlodipine and benazepril is characterized in that described pharmaceutical composition is tablet, and the weight of each component is:
Prepare altogether 500,000 of amlodipine benazepril sheets;
The concrete steps of preparation tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III carries out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet.
3. the pharmaceutical composition of an amlodipine and benazepril is characterized in that described pharmaceutical composition is tablet, and the weight of each component is:
Prepare altogether 500,000 of amlodipine benazepril sheets;
The concrete steps of preparation tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III carries out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet.
4. the pharmaceutical composition of an amlodipine and benazepril is characterized in that described pharmaceutical composition is tablet, and the weight of each component is:
Prepare altogether 500,000 of amlodipine benazepril sheets;
The concrete steps of preparation tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III carries out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet.
5. the pharmaceutical composition of an amlodipine and benazepril is characterized in that described pharmaceutical composition is tablet, and the weight of each component is:
Prepare altogether 500,000 of amlodipine benazepril sheets;
The concrete steps of preparation tablet are as follows:
A, with Amlodipine Besylate Tablet and benazepril hydrochloride crushing screening, take by weighing respectively in proportion Amlodipine Besylate Tablet, benazepril hydrochloride, micropowder silica gel, lactose, microcrystalline Cellulose and Sodium Hydroxymethyl Stalcs;
B, in the lactose that takes by weighing, get wherein 20% lactose and Amlodipine Besylate Tablet mix homogeneously in high efficient mixer, the rotating speed of high efficient mixer is 12r/min, mix 5min, the uniformity of sampling detection level, uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing I;
C, add successively remaining lactose and benazepril hydrochloride in the batch mixing I, mix homogeneously, the rotating speed of high efficient mixer are 12r/min, mix 13min, the uniformity of sampling and testing content, and uniformity of dosage units is up to standard, finishes to mix namely to obtain batch mixing II;
D, successively batch mixing II, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs, micropowder silica gel are placed automatic lifting hopper mixer mix homogeneously in order, the rotating speed of high efficient mixer is 12r/min, mix 13min, the uniformity of sampling and testing content, uniformity of dosage units is up to standard, finishes to mix namely to obtain whole batch mixing III;
E, get the content detection that whole batch mixing III carries out benazepril hydrochloride and amlodipine, determine that sheet is heavy, whole batch mixing III tabletting on tablet machine, content uniformity is ± 5%, hardness 〉=23N namely gets described amlodipine benazepril tablet.
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|---|---|---|---|---|
| CN1526398A (en) * | 2003-09-19 | 2004-09-08 | 启东盖天力药业有限公司 | Compound blood pressure reducing prepn containing angiotonin converzyme inhibitor, calcium ion agonist and Estazolam |
| CN1827111A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using benazepril hydrochloride amlodipine besylate as active ingredients, its preparation method and use |
| CN101137367A (en) * | 2003-10-20 | 2008-03-05 | 诺瓦提斯公司 | Benazapril and amlodipine besylate for reducing cardiovascular morbidity |
| CN102114017A (en) * | 2011-01-05 | 2011-07-06 | 王定豪 | Medicinal composition containing amlodipine and perindopril and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2005336956A1 (en) * | 2005-09-28 | 2007-04-12 | Teva Pharmaceutical Industries Ltd. | Stable combinations of amlodipine besylate and benazepril hydrochloride |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1526398A (en) * | 2003-09-19 | 2004-09-08 | 启东盖天力药业有限公司 | Compound blood pressure reducing prepn containing angiotonin converzyme inhibitor, calcium ion agonist and Estazolam |
| CN101137367A (en) * | 2003-10-20 | 2008-03-05 | 诺瓦提斯公司 | Benazapril and amlodipine besylate for reducing cardiovascular morbidity |
| CN1827111A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using benazepril hydrochloride amlodipine besylate as active ingredients, its preparation method and use |
| CN102114017A (en) * | 2011-01-05 | 2011-07-06 | 王定豪 | Medicinal composition containing amlodipine and perindopril and application thereof |
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