CN107951849A - A kind of amlodipine besylate tablets and preparation method thereof - Google Patents
A kind of amlodipine besylate tablets and preparation method thereof Download PDFInfo
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- CN107951849A CN107951849A CN201711351813.5A CN201711351813A CN107951849A CN 107951849 A CN107951849 A CN 107951849A CN 201711351813 A CN201711351813 A CN 201711351813A CN 107951849 A CN107951849 A CN 107951849A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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Abstract
The present invention provides a kind of amlodipine besylate tablets and preparation method thereof.The amlodipine besylate tablets include the component of following parts by weight：1~5 part of Amlodipine Besylate Tablet, 0.3~0.6 part of superfine silica gel powder, 30~70 parts of microcrystalline cellulose, 20~50 parts of calcium phosphate dibasic anhydrous, 1~3 part of magnesium stearate, 0.4~0.6 part of sodium carboxymethyl starch；This method is specially：Amlodipine Besylate Tablet and superfine silica gel powder are first mixed to get mixed material A；Microcrystalline cellulose and calcium phosphate dibasic anhydrous are dissolved in organic solvent, mixed material B is obtained after dry；Then A, B and magnesium stearate are placed in efficient wet mixer-granulator, obtain mixed material C；By C by dry granulation, particle I is obtained；I, magnesium stearate and sodium carboxymethyl starch are uniformly mixed, particle II is obtained, amlodipine besylate tablets is obtained after tabletting.The amlodipine besylate tablets being prepared by this method, have compared with high-dissolution and preferable stability.
Description
Technical field
The invention belongs to pharmaceutical technology field, more particularly to a kind of amlodipine besylate tablets and preparation method thereof.
Background technology
Amlodipine Besylate Tablet is dihydropyridine type calcium antagonists, the main storage for suppressing cardiac muscle and vascular smooth muscle cells film
Calcium ability and the ability with calcium binding, by expanding blood vessel parteriole, reducing peripheral resistance, reach antihypertensive effect.
It is easy to produce static electricity because of material and the contact and collision of device wall in the preparation process of amlodipine besylate tablets
Effect, on the one hand promotes particle mutually to assemble, and blocks sieve aperture, causes slow, sieving hardly possible of sieving；Another aspect particle is to device inner wall
Face is adhered to, and causes that yield is relatively low, cost improves.Meanwhile because of its effect easy to produce static electricity, and cause main ingredient Amlodipine Besylate Tablet
Dissolution and uniformity of dosage units agglomerating, and that influence main ingredient are easily gathered in the mixed process with other auxiliary materials.
Since Amlodipine Besylate Tablet is to light, wet, thermally labile, preparation obtained by general preparation method high temperature, high humidity,
Under the action of strong light, easily degrade, so as to influence the stability of medicine.
At present, preparing the common auxiliary material of amlodipine besylate tablets has calcium phosphate dibasic anhydrous, microcrystalline cellulose, but anhydrous phosphorus
Sour hydrogen is calcareously heavier, and the quality of microcrystalline cellulose is lighter, and it is difficult uniformly to mix to cause material, influences the dissolution rate of product,
Drug effect is caused to reduce.Therefore, there is an urgent need for research and develop a kind of to can guarantee that product yield, uniformity and dissolution rate so as to lifting drug effect
The preparation method of amlodipine besylate tablets.
The content of the invention
The technical problems to be solved by the invention are to overcome the shortcomings of to mention in background above technology and defect, there is provided one
The preparation method for the amlodipine besylate tablets that kind ensures product yield and dissolution rate, technique are simple, production efficiency is high, also provides
The high amlodipine besylate tablets of dissolution rate that this method is prepared.
In order to solve the above technical problems, technical solution proposed by the present invention is：
A kind of amlodipine besylate tablets, the amlodipine besylate tablets include the component of following parts by weight：
The amlodipine besylate tablets of the present invention, using Amlodipine Besylate Tablet as main ingredient, antistatic is used as using superfine silica gel powder
Agent, using microcrystalline cellulose and calcium phosphate dibasic anhydrous as filler, using magnesium stearate as lubricant, is made with sodium carboxymethyl starch
For adhesive, by the way that the content of each component is controlled within the scope of the invention, by the synergistic effect between each component, ensureing
Cost is reduced while drug effect.
Above-mentioned amlodipine besylate tablets, it is preferred that the magnesium stearate includes interior stiffened fatty acid magnesium and additional tristearin
Sour magnesium, the parts by weight of the interior stiffened fatty acid magnesium are 1.0~2.0 parts, and the parts by weight of the additional magnesium stearate are 0.5~1.5
Part.
Above-mentioned amlodipine besylate tablets, it is preferred that the amlodipine besylate tablets include the group of following parts by weight
Point：
Above-mentioned amlodipine besylate tablets, it is preferred that the particle diameter of the calcium phosphate dibasic anhydrous is 30 μm of D10 ＜, D90 ＜
100μm；The particle diameter of the microcrystalline cellulose is 30 μm of D10 ＜, 150 μm of D90 ＜.By calcium phosphate dibasic anhydrous and microcrystalline cellulose
Size controlling can promote its quick dissolving in organic solvent in the scope of the present invention.
Above-mentioned amlodipine besylate tablets, it is preferred that the particle diameter of the sodium carboxymethyl starch is 40 μm of D10 ＜, D90 ＜
180μm；The particle diameter of the magnesium stearate is 40 μm of D10 ＜, 180 μm of D90 ＜；The particle diameter of the superfine silica gel powder is 30 μm of D10 ＜,
150 μm of D90 ＜.By the size controlling of sodium carboxymethyl starch, magnesium stearate and superfine silica gel powder within the scope of the invention, Ke Yibao
Card main ingredient is evenly distributed when being mixed with auxiliary material.
Above-mentioned amlodipine besylate tablets, it is preferred that the particle diameter of the Amlodipine Besylate Tablet is 30 μm of D10 ＜, D90
150 μm of ＜.By the size controlling of main ingredient Amlodipine Besylate Tablet within the scope of the invention, can be to avoid main ingredient in mixed process
Pockets of phenomenon is gathered because of electrostatic interaction with auxiliary material, ensures to be uniformly distributed during main ingredient mixing, while improve the dissolution rate of main ingredient.
The inventive concept total as one, the present invention also provides a kind of preparation side of above-mentioned amlodipine besylate tablets
Method, comprises the following steps：
(1) first Amlodipine Besylate Tablet and superfine silica gel powder are uniformly mixed, obtain mixed material A；
(2) microcrystalline cellulose and calcium phosphate dibasic anhydrous are dissolved in organic solvent, stirring accelerates dissolving, is then done
It is dry, obtain mixed material B；
(3) due to main ingredient dosage is smaller and supplementary product consumption is larger, and each supplementary material is fine powder, easily produces electrostatic effect
And agglomerating influence dissolution rate is gathered, mixed material A, mixed material B and magnesium stearate need to be placed in efficient wet mixer-granulator
In, open stirring and mixed, obtain mixed material C；The magnesium stearate added in step (3) is interior stiffened fatty acid magnesium；
(4) mixed material C is added in dry granulating machine and pelletized, due to fine powder poor fluidity, die hole is flowed into tabletting
Amount when it is more when it is few, cause that tablet difference is big, content distribution is uneven, and dust from flying is easily led in tableting processes, after tabletting
Obtained tablet is also easy to produce phenomena such as sliver, sticking, drawing-die, need to sift out fine powder, fine powder pelletize again to grain diameter for 200~
300 μm, obtain particle I；
(5) particle I, magnesium stearate and sodium carboxymethyl starch are uniformly mixed, obtain particle II；Added in step (5)
Magnesium stearate is additional magnesium stearate；
(6) particle II is subjected to tabletting, obtains amlodipine besylate tablets.
The preparation method of above-mentioned amlodipine besylate tablets, it is preferred that further comprising the steps of in the step (1)：
Mixed material A is crossed into 100~120 mesh sieves, calcium phosphate dibasic anhydrous is crossed into 150~200 mesh sieves, microcrystalline cellulose is crossed 100~120
Mesh sieve, 80~100 mesh sieves are crossed by sodium carboxymethyl starch and magnesium stearate.
The preparation method of above-mentioned amlodipine besylate tablets, it is preferred that drying process is dry for spraying in the step (2)
Dry, in the spray-drying process, it is 80~100 DEG C to control intake air temperature；
Mixed process carries out in efficient wet mixer-granulator in the step (3), first control mixing speed for 79~
81r/min, cutter speed are 79~81r/min, and mixing time is 0.5~1min, then control again mixing speed for 100~
120r/min, cutter speed are 100~120r/min, and continuation mixing time is 3~5min；Due to Amlodipine Besylate Tablet quality
Relatively light and easy to produce static electricity, mixing time is long in mixed process or mixing speed is too fast, and particle high speed collision is also easy to produce quiet
Electricity, instead results in that mixing is uneven, therefore the parameter of mixed process need to control within the scope of the invention in step (3).
Mixed process carries out in three-dimensional motion mixer in the step (5), and it is 10~15r/min to control rotating speed, mixes
The conjunction time is 15~30min.
The preparation method of above-mentioned amlodipine besylate tablets, it is preferred that organic solvent is anhydrous second in the step (2)
Alcohol；In the step (4) fine powder is sifted out with 60 mesh sieves.
Compared with prior art, the advantage of the invention is that：
(1) method of the invention, re-sieving after Amlodipine Besylate Tablet is uniformly mixed with superfine silica gel powder on the one hand can be with
During reducing sieving, Amlodipine Besylate Tablet is in the absorption of screen surface, raising yield；On the other hand, preparation can be reduced
During Amlodipine Besylate Tablet building-up effect, improve the uniformity of dosage units and dissolution rate of product.
(2) method of the invention, using dry granulation, powder vertical compression, avoids Amlodipine Besylate Tablet and light, wet, hot ring
Border contacts, and is conducive to improve the stability of product.
(3) method of the invention, is dissolved in anhydrous second by calcium phosphate dibasic anhydrous and microcrystalline cellulose in prescription ratio is heated
In alcohol, soluble solution is made, then it is spray-dried composite auxiliary material is made, be conducive to both being uniformly mixed, so as to ensure that
The dissolution rate of product.
(4) method of the invention, being blended in efficient wet mixer-granulator for supplementary material carry out, its mixing velocity pole
It hurry up, material high-speed is mixed into swirling, to ensure that material is dispersed, and the high speed leaf slurry contained by it can be thorough by block
Bottom is smashed, and ensures grainless after material mixing, so as to ensure the uniformity and dissolution rate of the component of medicine.
(5) amlodipine besylate tablets that the present invention is prepared, have higher dissolution rate and preferable stability.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to embodiment or existing
There is attached drawing needed in technology description to be briefly described, it should be apparent that, drawings in the following description are the present invention
Some embodiments, for those of ordinary skill in the art, without creative efforts, can also basis
These attached drawings obtain other attached drawings.
Fig. 1 is the related material chromatogram of sample 1 in comparative example 1 of the present invention；
Fig. 2 is the related material chromatogram of sample 2 in comparative example 2 of the present invention；
Fig. 3 is the related material chromatogram of sample 3 in the embodiment of the present invention 1；
Fig. 4 is the related material chromatogram of starting material medicine Amlodipine Besylate Tablet in the present invention.
Embodiment
For the ease of understanding the present invention, below in conjunction with Figure of description and preferred embodiment to invent herein do it is more complete
Face, meticulously describe, but protection scope of the present invention is not limited to specific examples below.
Unless otherwise defined, all technical terms used hereinafter are generally understood that implication phase with those skilled in the art
Together.Technical term used herein is intended merely to the purpose of description specific embodiment, is not intended to the limitation present invention's
Protection domain.
Unless otherwise specified, various raw material, reagent, the instrument and equipment etc. used in the present invention can pass through city
Field is commercially available or can be prepared by existing method.
Comparative example 1：
A kind of amlodipine besylate tablets, the amlodipine besylate tablets include following components in percentage by weight：
The preparation method of the amlodipine besylate tablets of this comparative example, comprises the following steps：
The supplementary material in above-mentioned formula is taken, Amlodipine Besylate Tablet is crossed into 120 mesh sieves, calcium phosphate dibasic anhydrous crosses 200 mesh sieves,
Microcrystalline cellulose crosses 100 mesh sieves, and sodium carboxymethyl starch and magnesium stearate cross 80 mesh sieves；It is first that Amlodipine Besylate Tablet, crystallite is fine
Dimension element PH101, calcium phosphate dibasic anhydrous, interior stiffened fatty acid magnesium are placed in efficient wet mixer-granulator, elder generation using mixing speed as
80r/min, cutter speed stir 1min for 80r/min, then using mixing speed as 120r/min, cutter speed be 120r/min after
Continuous stirring 4min；Uniformly mixed supplementary material is added in dry granulating machine again and is pelletized；According to yield convert additional magnesium stearate,
Sodium carboxymethyl starch dosage, and be placed in three-dimensional motion mixer and be uniformly mixed together with the particle after granulation, setting rotating speed is
15r/min, incorporation time 20min；Tabletting is finally carried out, obtains amlodipine besylate tablets (sample 1).
Comparative example 2：
A kind of amlodipine besylate tablets, the amlodipine besylate tablets include following components in percentage by weight：
The preparation method of the amlodipine besylate tablets of this comparative example, comprises the following steps：
The supplementary material in above-mentioned formula is taken, Amlodipine Besylate Tablet is crossed into 120 mesh sieves, calcium phosphate dibasic anhydrous crosses 200 mesh sieves,
Microcrystalline cellulose crosses 100 mesh sieves, and sodium carboxymethyl starch and magnesium stearate cross 80 mesh sieves；It is first that Amlodipine Besylate Tablet, crystallite is fine
Dimension element PH101, calcium phosphate dibasic anhydrous, interior stiffened fatty acid magnesium are placed in efficient wet mixer-granulator, elder generation using mixing speed as
80r/min, cutter speed stir 1min for 80r/min, then using mixing speed as 120r/min, cutter speed be 120r/min after
Continuous stirring 4min；Uniformly mixed supplementary material is added in the ethanol that mass fraction is 75% again and is uniformly mixed, then through wet
Method is pelletized；Additional magnesium stearate, sodium carboxymethyl starch dosage are converted according to yield, and three-dimensional is placed in together with the particle after granulation
It is uniformly mixed in movement mixer, setting rotating speed is 15r/min, incorporation time 20min；Tabletting is finally carried out, obtains benzene sulphur
Sour amlodipine (sample 2).
Embodiment 1：
A kind of amlodipine besylate tablets, the amlodipine besylate tablets include following components in percentage by weight：
In the amlodipine besylate tablets of the present embodiment, the particle diameter of calcium phosphate dibasic anhydrous is D10=28 μ in the component of selection
M, D90=100 μm, the particle diameter of microcrystalline cellulose is D10=29 μm, and D90=136 μm, the particle diameter of sodium carboxymethyl starch is D10=
38 μm, D90=171 μm, the particle diameter of magnesium stearate (including interior stiffened fatty acid magnesium and additional magnesium stearate) is D10=38 μm, D90
=159 μm, the particle diameter of superfine silica gel powder is D10=28 μm, and D90=127 μm, the particle diameter of Amlodipine Besylate Tablet is D10=28 μm,
D90=125 μm.
The preparation method of the amlodipine besylate tablets of the present embodiment, comprises the following steps：
(1) supplementary material in above-mentioned formula is taken, is first uniformly mixed Amlodipine Besylate Tablet and superfine silica gel powder, is mixed
Material A, after 120 mesh sieves；Then calcium phosphate dibasic anhydrous is crossed into 200 mesh sieves, microcrystalline cellulose crosses 100 mesh sieves, carboxymethyl starch
Sodium and magnesium stearate cross 80 mesh sieves；
(2) microcrystalline cellulose and calcium phosphate dibasic anhydrous are dissolved in absolute ethyl alcohol, stirring accelerates dissolving, then sprays
Dry, it is 100 DEG C to control intake air temperature, and air outlet temperature is 80 DEG C, obtains mixed material B；
(3) mixed material A, mixed material B and magnesium stearate are placed in efficient wet mixer-granulator, unlatching stir into
Row mixing, is first that 80r/min stirs 1min using mixing speed as 80r/min, cutter speed, then using mixing speed as 120r/
Min, cutter speed continue to stir 4min for 120r/min, obtain mixed material C；
(4) will mixed material C add dry granulating machine in pelletize, then with 60 mesh sieves sift out fine powder (>250 μm), fine powder
Again it is 250~300 μm to pelletize to grain diameter, obtains particle I；
(5) particle I, magnesium stearate and sodium carboxymethyl starch are added in three-dimensional motion mixer together and are uniformly mixed, control
Rotating speed processed is 15r/min, and incorporation time 20min, obtains particle II；
(6) particle II is subjected to tabletting, obtains amlodipine besylate tablets (sample 3).
The amlodipine besylate tablets sample being prepared in comparative example 1,2 and embodiment 1 is detected by following experiment
Correlated performance：
1st, the related content of material of sample, yield, dissolution rate and uniformity of dosage units compare：
The related content of material for the amlodipine besylate tablets sample being prepared in test comparison example 1,2 and embodiment 1,
Yield, dissolution rate and uniformity of dosage units, test result are shown in Table 1.
The related content of material of amlodipine besylate tablets, yield, dissolution rate and contain in 1 comparative example 1,2 of table and embodiment 1
Amount is equal
Evenness
As shown in Table 1, compared with sample 1, sample 2, yield, dissolution rate and the uniformity of dosage units of sample 3 have significantly
Ground improves, and the content in relation to material is relatively low；As it can be seen that method using the present invention prepares amlodipine besylate tablets, can
To significantly improve the yield of product, dissolution rate and uniformity of dosage units, while effectively reduce related content of material in product.
2nd, hot test：
By the amlodipine besylate tablets sample being prepared in comparative example 1,2 and embodiment 1 in 60 DEG C of insulating box
Place 10 days, (0d) and placement the 10th day (10d) sample afterwards before placement respectively, observe the change in relation to content of material, test
It the results are shown in Table shown in 2.
Test result (%) of each sample in relation to content of material in 2 hot test of table
As shown in Table 2, when placing 0 day, related content of material is higher than sample 1 and sample 3 in sample 2, this mainly due to
There is the intervention of moisture in wet-granulation process, make part Amlodipine Besylate Tablet that hydrolysis occur and produce impurity；In hot conditions
After persistently placing 10 days down, related content of material is apparently higher than sample 1 and sample 3 in sample 2, this is mainly due to wet granulation
It need under the high temperature conditions be dried, cause Amlodipine Besylate Tablet that degraded occurs and produces impurity；It is as it can be seen that using the present invention
Method prepares amlodipine besylate tablets, can effectively reduce related content of material in product, and place one under hot conditions
Related content of material is only slowly increased after the section time, illustrates that product stability is good.
3rd, high wet test：
By the amlodipine besylate tablets sample being prepared in comparative example 1,2 and embodiment 1 relative humidity be 90%
Constant-temperature enclosed container in place 10 days, respectively before placement (0d), place the 5th day (5d) and place the 10th day and taken after (10d)
Sample, observes the change in relation to content of material, and test result is shown in Table 3.
Test result (%) of each sample in relation to content of material in 3 high wet test of table
As shown in Table 3, after placing 0 day, 5 days and 10 days under conditions of high humidity, related content of material is obvious low in sample 3
In sample 1 and sample 2, it is seen then that method using the present invention prepares amlodipine besylate tablets, and can effectively reduce in product has
Content of material is closed, and is only slowly increased in relation to content of material after a period of time is placed under super-humid conditions, illustrates product stability
It is good.
4th, strong illumination is tested：
The amlodipine besylate tablets sample being prepared in comparative example 1,2 and embodiment 1 is placed under light intensity 4500Lx
Place 10 days, (0d), placement the 5th day (5d) and placement the 10th day (10d) sample afterwards before placement respectively, observe related material and contain
The change of amount, test result are shown in Table 4.
Test result (%) of each sample in relation to content of material in table semi-finals phototesting
As shown in Table 4, after intense light conditions decentralization sets to 0 day, 5 days and 10 days, related content of material is obvious low in sample 3
In sample 1 and sample 2, it is seen then that method using the present invention prepares amlodipine besylate tablets, and can effectively reduce in product has
Content of material is closed, and is only slowly increased in relation to content of material after a period of time is placed under intense light conditions, illustrates product stability
It is good.
5th, stability test：
The amlodipine besylate tablets sample being prepared in comparative example 1,2 and embodiment 1 is placed in temperature as 40 DEG C ± 2
DEG C, relative humidity be 75% ± 5% under conditions of places 6 months, respectively at six month sampling, observe related content of material
Change, wherein, the related material chromatogram of sample 1 as shown in Figure 1, the related material chromatogram of sample 2 as shown in Fig. 2, sample 3
Related material chromatogram as shown in figure 3, the related material chromatogram of starting material medicine Amlodipine Besylate Tablet is as shown in Figure 4.
From Fig. 1 to Fig. 4, dopant species and the equal highest of impurity content of sample 2, sample 1, sample 3 contrast containing for 2 each impurity of sample
Amount significantly reduces, wherein minimum with the impurity content of sample 3.Therefore the benzene sulfonic acid that method using the present invention is prepared
Amlodipine, good stable state is still kept after placing 6 months.
Claims (10)
1. a kind of amlodipine besylate tablets, it is characterised in that the amlodipine besylate tablets include the group of following parts by weight
Point：
2. amlodipine besylate tablets according to claim 1, it is characterised in that the magnesium stearate includes interior stiffened fat
Sour magnesium and additional magnesium stearate, the parts by weight of the interior stiffened fatty acid magnesium are 1.0~2.0 parts, the weight of the additional magnesium stearate
It is 0.5~1.0 part to measure part.
3. amlodipine besylate tablets according to claim 1 or 2, it is characterised in that the amlodipine besylate tablets
Include the component of following parts by weight：
4. amlodipine besylate tablets according to claim 1, it is characterised in that the particle diameter of the calcium phosphate dibasic anhydrous is
100 μm of 30 μm of D10 ＜, D90 ＜；The particle diameter of the microcrystalline cellulose is 30 μm of D10 ＜, 150 μm of D90 ＜.
5. amlodipine besylate tablets according to claim 1, it is characterised in that the particle diameter of the sodium carboxymethyl starch is
180 μm of 40 μm of D10 ＜, D90 ＜；The particle diameter of the magnesium stearate is 40 μm of D10 ＜, 180 μm of D90 ＜；The superfine silica gel powder
Particle diameter is 30 μm of D10 ＜, 150 μm of D90 ＜.
6. amlodipine besylate tablets according to claim 1, it is characterised in that the particle diameter of the Amlodipine Besylate Tablet
For 30 μm of D10 ＜, 150 μm of D90 ＜.
It is 7. a kind of such as the preparation method of amlodipine besylate tablets according to any one of claims 1 to 3, it is characterised in that
Comprise the following steps：
(1) first Amlodipine Besylate Tablet and superfine silica gel powder are uniformly mixed, obtain mixed material A；
(2) microcrystalline cellulose and calcium phosphate dibasic anhydrous are dissolved in organic solvent, stirring accelerates dissolving, is then dried, obtains
To mixed material B；
(3) mixed material A, mixed material B and magnesium stearate are placed in efficient wet mixer-granulator, open stirring and mixed
Close, obtain mixed material C；
(4) mixed material C is added in dry granulating machine and pelletized, then sift out fine powder, fine powder is pelletized again is to grain diameter
200~300 μm, obtain particle I；
(5) particle I, magnesium stearate and sodium carboxymethyl starch are uniformly mixed, obtain particle II；
(6) particle II is subjected to tabletting, obtains amlodipine besylate tablets.
8. the preparation method of amlodipine besylate tablets according to claim 7, it is characterised in that in the step (1)
It is further comprising the steps of：Mixed material A is crossed into 100~120 mesh sieves, calcium phosphate dibasic anhydrous is crossed into 150~200 mesh sieves, by crystallite
Cellulose crosses 100~120 mesh sieves, and sodium carboxymethyl starch and magnesium stearate are crossed 80~100 mesh sieves.
9. the preparation method of amlodipine besylate tablets according to claim 7, it is characterised in that in the step (2)
Drying process is is spray-dried, and in the spray-drying process, it is 80~100 DEG C to control intake air temperature；
Mixed process carries out in efficient wet mixer-granulator in the step (3), and it is 79~81r/ first to control mixing speed
Min, cutter speed are 79~81r/min, and mixing time is 0.5~1min, and it is 100~120r/ then to control mixing speed again
Min, cutter speed are 100~120r/min, and continuation mixing time is 3~5min；
Mixed process carries out in three-dimensional motion mixer in the step (5), and it is 10~15r/min to control rotating speed, during mixing
Between be 15~30min.
10. the preparation method of amlodipine besylate tablets according to claim 7, it is characterised in that in the step (2)
Organic solvent is absolute ethyl alcohol；In the step (4) fine powder is sifted out with 60 mesh sieves.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110644A (en) * | 2020-01-15 | 2020-05-08 | 江西制药有限责任公司 | Amlodipine besylate tablet and preparation method thereof |
| CN114191402A (en) * | 2022-01-17 | 2022-03-18 | 成都恒瑞制药有限公司 | Preparation method of amlodipine besylate tablets |
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| CN111110644A (en) * | 2020-01-15 | 2020-05-08 | 江西制药有限责任公司 | Amlodipine besylate tablet and preparation method thereof |
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| CN114191402A (en) * | 2022-01-17 | 2022-03-18 | 成都恒瑞制药有限公司 | Preparation method of amlodipine besylate tablets |
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| CN107951849B (en) | 2020-07-07 |
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