CN106074418A - A kind of amlodipine besylate tablets treating hypertension and preparation method thereof - Google Patents
A kind of amlodipine besylate tablets treating hypertension and preparation method thereof Download PDFInfo
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- CN106074418A CN106074418A CN201610463032.4A CN201610463032A CN106074418A CN 106074418 A CN106074418 A CN 106074418A CN 201610463032 A CN201610463032 A CN 201610463032A CN 106074418 A CN106074418 A CN 106074418A
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- amlodipine besylate
- stirring
- hypertension
- tablets
- besylate tablets
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- ZPBWCRDSRKPIDG-UHFFFAOYSA-N amlodipine benzenesulfonate Chemical compound OS(=O)(=O)C1=CC=CC=C1.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl ZPBWCRDSRKPIDG-UHFFFAOYSA-N 0.000 title claims abstract description 44
- 229960004005 amlodipine besylate Drugs 0.000 title claims abstract description 43
- 206010020772 Hypertension Diseases 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 239000003814 drug Substances 0.000 claims abstract description 12
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 9
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 9
- 239000008101 lactose Substances 0.000 claims abstract description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 9
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 9
- 239000002245 particle Substances 0.000 claims abstract description 9
- 229920000881 Modified starch Polymers 0.000 claims abstract description 8
- 238000003756 stirring Methods 0.000 claims description 52
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 14
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 8
- PASHVRUKOFIRIK-UHFFFAOYSA-L calcium sulfate dihydrate Chemical compound O.O.[Ca+2].[O-]S([O-])(=O)=O PASHVRUKOFIRIK-UHFFFAOYSA-L 0.000 claims description 8
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 8
- 238000004132 cross linking Methods 0.000 claims description 8
- 239000008187 granular material Substances 0.000 claims description 8
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 8
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 8
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 8
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 8
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 8
- 229940079593 drug Drugs 0.000 claims description 7
- 235000019359 magnesium stearate Nutrition 0.000 claims description 7
- 238000010298 pulverizing process Methods 0.000 claims description 6
- 239000002671 adjuvant Substances 0.000 claims description 5
- 238000007796 conventional method Methods 0.000 claims description 3
- 239000000203 mixture Substances 0.000 abstract description 2
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 abstract 1
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 31
- 230000000052 comparative effect Effects 0.000 description 8
- 238000005516 engineering process Methods 0.000 description 8
- 239000012567 medical material Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 238000013019 agitation Methods 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- YNGDWRXWKFWCJY-UHFFFAOYSA-N 1,4-Dihydropyridine Chemical compound C1C=CNC=C1 YNGDWRXWKFWCJY-UHFFFAOYSA-N 0.000 description 1
- 229940127291 Calcium channel antagonist Drugs 0.000 description 1
- 102000005701 Calcium-Binding Proteins Human genes 0.000 description 1
- 108010045403 Calcium-Binding Proteins Proteins 0.000 description 1
- 108091006146 Channels Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- VCOYRKXQRUGBKS-UHFFFAOYSA-N N.[Cl] Chemical compound N.[Cl] VCOYRKXQRUGBKS-UHFFFAOYSA-N 0.000 description 1
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
- 239000005864 Sulphur Substances 0.000 description 1
- URPQIUWADDATAL-UHFFFAOYSA-N [Cl].N.C1(=CC=CC=C1)S(=O)(=O)O Chemical compound [Cl].N.C1(=CC=CC=C1)S(=O)(=O)O URPQIUWADDATAL-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229960000528 amlodipine Drugs 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- WWLOCCUNZXBJFR-UHFFFAOYSA-N azanium;benzenesulfonate Chemical compound [NH4+].[O-]S(=O)(=O)C1=CC=CC=C1 WWLOCCUNZXBJFR-UHFFFAOYSA-N 0.000 description 1
- SRSXLGNVWSONIS-UHFFFAOYSA-N benzenesulfonic acid Chemical compound OS(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-N 0.000 description 1
- 229940092714 benzenesulfonic acid Drugs 0.000 description 1
- 239000000480 calcium channel blocker Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- RSXGUJLKWYUPMC-UHFFFAOYSA-N flordipine Chemical compound CC1=C(C(=O)OCC)C(C=2C(=CC=CC=2)C(F)(F)F)C(C(=O)OCC)=C(C)N1CCN1CCOCC1 RSXGUJLKWYUPMC-UHFFFAOYSA-N 0.000 description 1
- 229950009366 flordipine Drugs 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- DKXULEFCEORBJK-UHFFFAOYSA-N magnesium;octadecanoic acid Chemical compound [Mg].CCCCCCCCCCCCCCCCCC(O)=O DKXULEFCEORBJK-UHFFFAOYSA-N 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 210000004165 myocardium Anatomy 0.000 description 1
- 210000000107 myocyte Anatomy 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 230000036581 peripheral resistance Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000013049 sediment Substances 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 210000000329 smooth muscle myocyte Anatomy 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000007939 sustained release tablet Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
Classifications
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
- B01F27/112—Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades
- B01F27/1125—Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades with vanes or blades extending parallel or oblique to the stirrer axis
- B01F27/11251—Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades with vanes or blades extending parallel or oblique to the stirrer axis having holes in the surface
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
- B01F27/90—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with paddles or arms
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/10—Maintenance of mixers
- B01F35/12—Maintenance of mixers using mechanical means
- B01F35/123—Maintenance of mixers using mechanical means using scrapers for cleaning mixers
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of amlodipine besylate tablets treating hypertension, belong to Western medicine preparation technical field, consist of the following composition: Amlodipine Besylate Tablet 10 20 parts, microcrystalline Cellulose 20 50 parts, lactose 30 70 parts, 10 20 parts of L tyrosine, pregelatinized Starch 20 50 parts etc., using specific Particle mixer to mix, the tablet slow release of the present invention is steady.
Description
Technical field
The invention belongs to Western medicine preparation technical field, particularly to a kind of amlodipine besylate tablets treating hypertension.
Background technology
Amlodipine Besylate Tablet is the long-acting dihydropyridine calcium channel antagonist of the third generation, and it mainly suppresses cardiac muscle and blood vessel
The storage calcium ability of smooth muscle cell membrane and the ability with calcium binding, make extracellular calcium flow myocyte in slow channel and subtract
Few, direct vasodilator smooth muscle, expand blood vessel small artery, reduce peripheral resistance, reach antihypertensive effect.Its long half time, raw
Thing availability is high, effect action temperature and, the most persistently, side effect is little, evident in efficacy, easy to use does not affect blood fat, blood glucose generation
Thank, harmless to hepatic and renal function.Existing amlodipine besylate tablets all uses compressing dry granulation technique or uses the methods such as inclusion to increase
Adding the stability of preparation, dissolution is unstable, usually produces some side effect when patient takes clinically.
Summary of the invention
In order to overcome the deficiencies in the prior art, adjuvant screening, process optimization and equipment are changed by the present invention by lot of experiments
Enter, it is provided that a kind of amlodipine besylate tablets.This tablet slow release, gastrointestinal side-effect are little, and preparation technology is simple.
The object of the present invention is achieved like this:
A kind of amlodipine besylate tablets treating hypertension, by tablet total weight amount percentages, consists of the following composition:
Amlodipine Besylate Tablet 10-20 part, microcrystalline Cellulose 20-50 part, lactose 30-70 part, TYR 10-20 part, pregelatinated form sediment
Powder 20-50 part, calcium sulphate dihydrate 15-25 part, cross-linking sodium carboxymethyl cellulose 5-10 part, polyvinylpolypyrrolidone 5-10 part, stearic acid
Magnesium 0.5-2.0 part.
The amlodipine besylate tablets of described treatment hypertension, the formula of amlodipine besylate tablets is as follows: benzenesulfonic acid ammonia
Flordipine 15g, microcrystalline Cellulose 35g, lactose 50g, TYR 15g, pregelatinized Starch 35g, calcium sulphate dihydrate 20g, crosslinking
Sodium carboxymethyl cellulose 8g, polyvinylpolypyrrolidone 8g, magnesium stearate 1g.
The amlodipine besylate tablets of described treatment hypertension, preparation method comprises the following steps: to take benzenesulfonic acid ammonia chlorine
Horizon crude drug, is placed in disintegrating apparatus pulverizing by Amlodipine Besylate Tablet crude drug；Benzenesulfonic acid ammonia chlorine after pulverizing according to quantity
Horizon crude drug is mixed homogeneously in Particle mixer with above-mentioned adjuvant, pelletizes according to a conventional method, tabletting, packs to obtain finished product.
The amlodipine besylate tablets of described treatment hypertension, Particle mixer in preparation method, including agitator, setting
Shaft in described agitator be arranged on described agitator the stirring motor being connected with described shaft, described
Shaft is provided with stirring paddle, it is characterised in that: on described stirring paddle, it is provided with open-work, the inwall of described open-work is provided with ring
Connected in star, is provided with ring rotation block in described annular groove, is provided with and is connected with described annular groove in described stirring paddle
Driving chamber, be provided with micro-machine at described driving intracavity, the main shaft of described micro-machine be provided with driving fluted disc, described
The outer ring surface of ring rotation block is provided with the teeth groove mutually ratcheting with described driving fluted disc, on the inner ring surface of described ring rotation block
Be uniformly provided with at least three stirring bar, described stirring bar under the drive of described micro-machine in described open-work Stirring.
The amlodipine besylate tablets of described treatment hypertension, granule stirs evenly two sides of stirring paddle in device and is loudspeaker
Shape is arranged and trumpet-shaped center is connected with open-work.
The amlodipine besylate tablets of described treatment hypertension, granule stirs evenly shaft in device and is provided with upset motor,
The main shaft of described upset motor is connected with the end of described stirring paddle, drives stirring paddle to realize turning over during described upset electric motor starting
Turn operation.
The amlodipine besylate tablets of described treatment hypertension, granule stirs evenly stirring cylinder in device and is provided with little with described
The speed governing knob that the control knob that type motor is connected is connected with described upset motor.
Compared with prior art, the amlodipine besylate tablets that the present invention relates to has a most useful technique effect:
(1) release is steadily.(2) preparation technology is simple, Particle mixer simple in construction, simple operation, passes through when stirring
Medical material is stirred by stirring paddle, it is possible to make medicine pass from open-work, rotarily drives stirring bar now by ring rotation block
Rotate, thus the medicine through open-work is stirred further, such that it is able to be greatly improved the efficiency of stirring and be easier to medicine
Thing stirs, and stability in use is strong and practicality good.The amlodipine besylate tablets of present invention screening is suitable for the big life of industrialization
Produce.
Accompanying drawing explanation
Fig. 1 is the structural representation of Particle mixer
Detailed description of the invention
The foregoing of the present invention is described in further detail by form more by the following examples, but should this not managed
The scope for the above-mentioned theme of the present invention that solves is only limitted to Examples below, and all technology realized based on foregoing of the present invention all belong to
In the scope of the present invention.
Embodiment 1
Weigh Amlodipine Besylate Tablet 15g, microcrystalline Cellulose 35g, lactose 50g, TYR 15g, pregelatinized Starch
35g, calcium sulphate dihydrate 20g, cross-linking sodium carboxymethyl cellulose 8g, polyvinylpolypyrrolidone 8g, magnesium stearate 1g.
Preparation technology: Amlodipine Besylate Tablet crude drug is placed in disintegrating apparatus pulverizing；Benzene sulphur after pulverizing according to quantity
Acid amlodipine crude drug is mixed homogeneously in Particle mixer with above-mentioned adjuvant, pelletizes according to a conventional method, and tabletting is packed
Product.
Above-mentioned Particle mixer, is shown in Fig. 1, the shaft 2 that including agitator 1, is arranged in described agitator 1 and being arranged on
The stirring motor 3 being connected with described shaft 2 on described agitator 1, is provided with stirring paddle 4, described on described shaft 2
Stirring paddle 4 is provided with open-work 5, is provided with annular groove 6 on the inwall of described open-work 5, is provided with annular in described annular groove 6
Spill spin block 7, is provided with the driving chamber 8 being connected with described annular groove 6 in described stirring paddle 4, is provided with in described driving chamber 8
Micro-machine 9, is provided with driving fluted disc 10 on the main shaft of described micro-machine 9, sets on the outer ring surface of described ring rotation block 7
There is the teeth groove 11 mutually ratcheting with described driving fluted disc 10, the inner ring surface of described ring rotation block 7 is uniformly provided with at least three
Stirring bar 12, described stirring bar under the drive of described micro-machine in described open-work Stirring.When stirring by stirring
Mixing oar to be stirred by medical material, it is possible to make medical material pass from open-work, the stirring bar that rotarily drives now by ring rotation block revolves
Turn, thus the medical material through open-work is stirred further, such that it is able to be greatly improved the efficiency of stirring and be easier to medical material
Stir.
Two sides of described stirring paddle 4 are horn-like setting and trumpet-shaped center is connected with open-work.Use loudspeaker
Shape, make stirring paddle agitation time, medical material can try one's best more than pass through in open-work.
Described shaft 2 is provided with upset motor 13, the main shaft of described upset motor 13 and the end of described stirring paddle 4
It is connected, during described upset electric motor starting, drives stirring paddle to realize turning operation.As required stirring paddle can also be turned over
Turn, thus be greatly improved the efficiency of agitation.
Described stirring cylinder 1 is provided with the control knob 14 being connected with described micro-machine and described upset motor
The speed governing knob 15 being connected.Line for convenience in the present embodiment, can centrally disposed for hollow by shaft, then will
Wear from shaft centrally through, it can be configured line according to the technical experience of technical staff, and it also requires arrange
Bucket door.
Comparative example 2
Weigh Amlodipine Besylate Tablet 10g, microcrystalline Cellulose 50g, lactose 30g, TYR 20g, pregelatinized Starch
20g, calcium sulphate dihydrate 25g, cross-linking sodium carboxymethyl cellulose 5g, polyvinylpolypyrrolidone 10g, magnesium stearate 0.5g.
Preparation technology is ibid.
Comparative example 3
Weigh Amlodipine Besylate Tablet 20g, microcrystalline Cellulose 20g, lactose 70g, TYR 10g, pregelatinized Starch
50g, calcium sulphate dihydrate 15g, cross-linking sodium carboxymethyl cellulose 10g, polyvinylpolypyrrolidone 5g, magnesium stearate 2.0g.
Preparation technology is ibid.
Comparative example 4
Weigh Amlodipine Besylate Tablet 15g, microcrystalline Cellulose 35g, lactose 50g, TYR 15g, pregelatinized Starch
35g, calcium sulphate dihydrate 20g, cross-linking sodium carboxymethyl cellulose 8g, polyvinylpolypyrrolidone 8g, magnesium stearate 1g.
Using plain particles blender in preparation technology, other steps are ibid.
The release research of embodiment 5 amlodipine besylate tablets
Take the embodiment of the present invention 1 respectively, tablet prepared by comparative example 2-4, according to dissolution method (" Chinese Pharmacopoeia >
Two annex X c the second methods of version in 2010), with hydrochloric acid solution (0.9 → 1000mL) as solvent, rotating speed is 75 turns per minute, depends on
Method operates, and through 15 minutes time, takes solution appropriate, filters, take subsequent filtrate as need testing solution；Another precision weighs to be done through 105 DEG C
The dry Amlodipine Besylate Tablet standard substance to constant weight are appropriate, add hydrochloric acid solution and make molten containing 10g Amlodipine Besylate Tablet of every 1ml
Liquid, as reference substance solution.It is each in right amount that precision measures above two solution, according to spectrophotography (" Chinese Pharmacopoeia > 2010 years versions
Two annex VI A), at the wavelength of 237nm, measure trap respectively, calculate dissolution.Dissolution determination result adds table
Dissolution of sustained-release tablets measurement result prepared by each embodiment of table 1
| Sample source | 1h (%) | 3h (%) | 6h (%) | 9h (%) | 12h (%) | 24h (%) |
| Embodiment 1 | 21.9 | 54.2 | 70.5 | 82.8 | 93.4 | 102.5 |
| Comparative example 2 | 56.4 | 92.3 | 94.1 | 96.7 | 99.1 | 99.4 |
| Comparative example 3 | 65.2 | 91.6 | 97.4 | 101.3 | 98.4 | 97.3 |
| Comparative example 4 | 60.5 | 92.1 | 95.8 | 100.1 | 97.3 | 99.5 |
According to the result of the test of table 1, the amlodipine besylate tablets release of the embodiment of the present invention 1 preparation is steadily；Right
More different due to supplementary material ratio than embodiment 2-3, discharge too fast, Amlodipine Besylate Tablet is used common by comparative example 4
Grain blender mixing, owing in the granule of preparation, Amlodipine Besylate Tablet is not fully wrapped up by adjuvant, therefore discharges too fast.
Claims (7)
1. the amlodipine besylate tablets treating hypertension, it is characterised in that by tablet total weight amount percentages, by following
One-tenth is grouped into: Amlodipine Besylate Tablet 10-20 part, microcrystalline Cellulose 20-50 part, lactose 30-70 part, TYR 10-20 part,
Pregelatinized Starch 20-50 part, calcium sulphate dihydrate 15-25 part, cross-linking sodium carboxymethyl cellulose 5-10 part, polyvinylpolypyrrolidone 5-10
Part, magnesium stearate 0.5-2.0 part.
2. treat the amlodipine besylate tablets of hypertension as claimed in claim 1, it is characterised in that amlodipine besylate tablets
Formula as follows: Amlodipine Besylate Tablet 15g, microcrystalline Cellulose 35g, lactose 50g, TYR 15g, pregelatinized Starch 35g,
Calcium sulphate dihydrate 20g, cross-linking sodium carboxymethyl cellulose 8g, polyvinylpolypyrrolidone 8g, magnesium stearate 1g.
3. treat the amlodipine besylate tablets of hypertension as claimed in claim 1, it is characterised in that preparation method includes following
Step: take Amlodipine Besylate Tablet crude drug and be placed in disintegrating apparatus pulverizing；Amlodipine Besylate Tablet after pulverizing according to quantity
Crude drug is mixed homogeneously in Particle mixer with above-mentioned adjuvant, pelletizes according to a conventional method, tabletting, packs to obtain finished product.
4. treat the amlodipine besylate tablets of hypertension as claimed in claim 3, it is characterised in that in preparation method, granule stirs
Mix machine, the shaft that including agitator, is arranged in described agitator and being arranged on described agitator and described shaft phase
The stirring motor connected, is provided with stirring paddle on described shaft, it is characterised in that: on described stirring paddle, it is provided with open-work,
The inwall of described open-work is provided with annular groove, is provided with ring rotation block in described annular groove, sets in described stirring paddle
There is the driving chamber being connected with described annular groove, be provided with micro-machine at described driving intracavity, the master of described micro-machine
Axle is provided with driving fluted disc, is provided with the teeth groove mutually ratcheting with described driving fluted disc on the outer ring surface of described ring rotation block,
Being uniformly provided with at least three stirring bar on the inner ring surface of described ring rotation block, described stirring bar is in the drive of described micro-machine
Under in described open-work Stirring.
Treat the amlodipine besylate tablets of hypertension the most according to claim 4, it is characterised in that granule stirs evenly in device
Two sides of stirring paddle are horn-like setting and trumpet-shaped center is connected with open-work.
Treat the amlodipine besylate tablets of hypertension the most according to claim 4, it is characterised in that granule stirs evenly in device
Shaft is provided with upset motor, and the main shaft of described upset motor is connected with the end of described stirring paddle, described upset motor
Stirring paddle is driven to realize turning operation during startup.
Treat the amlodipine besylate tablets of hypertension the most according to claim 4, it is characterised in that granule stirs evenly in device
Stirring cylinder is provided with the speed governing knob that the control knob being connected with described micro-machine is connected with described upset motor.
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| CN105997929A (en) * | 2016-06-23 | 2016-10-12 | 南京华宽信息咨询中心 | Roxithromycin capsule and preparation method thereof |
| CN107754645A (en) * | 2017-12-09 | 2018-03-06 | 乔欢欢 | A kind of construction coating mixing component |
| CN108969495A (en) * | 2017-06-01 | 2018-12-11 | 江苏黄河药业股份有限公司 | A kind of amlodipine besylate tablets and preparation method thereof |
| CN111905623A (en) * | 2020-06-23 | 2020-11-10 | 江苏弘盛新材料股份有限公司 | High diffusion type nylon 6's polymerization agitator based on synchronous motion is inhaled to magnetism |
| CN114504980A (en) * | 2022-03-16 | 2022-05-17 | 李华生 | Celadon production and processing equipment capable of improving mixing efficiency during reduction of material mixing |
| US12465599B2 (en) | 2017-01-25 | 2025-11-11 | The George Institute for Global Health | Compositions for the treatment of hypertension |
| US12521380B2 (en) | 2017-01-25 | 2026-01-13 | The George Institute for Global Health | Compositions for the treatment of hypertension |
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| CN105997929A (en) * | 2016-06-23 | 2016-10-12 | 南京华宽信息咨询中心 | Roxithromycin capsule and preparation method thereof |
| US12465599B2 (en) | 2017-01-25 | 2025-11-11 | The George Institute for Global Health | Compositions for the treatment of hypertension |
| US12521380B2 (en) | 2017-01-25 | 2026-01-13 | The George Institute for Global Health | Compositions for the treatment of hypertension |
| CN108969495A (en) * | 2017-06-01 | 2018-12-11 | 江苏黄河药业股份有限公司 | A kind of amlodipine besylate tablets and preparation method thereof |
| CN107754645A (en) * | 2017-12-09 | 2018-03-06 | 乔欢欢 | A kind of construction coating mixing component |
| CN111905623A (en) * | 2020-06-23 | 2020-11-10 | 江苏弘盛新材料股份有限公司 | High diffusion type nylon 6's polymerization agitator based on synchronous motion is inhaled to magnetism |
| CN111905623B (en) * | 2020-06-23 | 2022-08-19 | 江苏弘盛新材料股份有限公司 | High diffusion type nylon 6's polymerization agitator based on synchronous motion is inhaled to magnetism |
| CN114504980A (en) * | 2022-03-16 | 2022-05-17 | 李华生 | Celadon production and processing equipment capable of improving mixing efficiency during reduction of material mixing |
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