CN105395495A - Composition containing amlodipine besylate and preparation method of composition - Google Patents
Composition containing amlodipine besylate and preparation method of composition Download PDFInfo
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- CN105395495A CN105395495A CN201510866403.9A CN201510866403A CN105395495A CN 105395495 A CN105395495 A CN 105395495A CN 201510866403 A CN201510866403 A CN 201510866403A CN 105395495 A CN105395495 A CN 105395495A
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- amlodipine besylate
- tablet
- besylate tablet
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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
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Abstract
The invention relates to the technical field of medicine preparation, in particular to a composition containing amlodipine besylate and a preparation method of the composition. The composition consists of the following components in parts by weight: 5 parts of amlodipine besylate, 90-195 parts of a filling agent, 0.4-2.7 parts of a disintegrating agent and 1.1-3.1 parts of a lubricating agent; and the method for preparing the composition containing the amlodipine besylate comprises the following steps: preparing materials, adding 3/4 of the filling agent to the amlodipine besylate and premixing for the first time, sieving, premixing for the second time, adding the rest 1/4 of the filling agent, premixing for the third time, adding the disintegrating agent to a material 4 and premixing for the fourth time, adding the lubricating agent and premixing for the fifth, and tabletting. According to the preparation method disclosed by the invention, the uniformly mixed powder is directly compressed into a tablet core by virtue of a tablet press; and compared with an existing wet-process granulation process, the tablet prepared by the method disclosed by the invention is dissolved out more thoroughly, simple in production process, simple in equipment, low in production cost and stable in product property, and the hardness of the tablet core is enhanced and weight difference is significantly improved.
Description
Technical field
The present invention relates to technical field of medicine preparation, particularly a kind of composition and method of making the same containing Amlodipine Besylate Tablet.
Background technology
Amlodipine Besylate Tablet chemical name 3-ethyl-5-methyl-2-(2_ ammonia ethoxymethyl)-4-(2 monochloro-benzene base)-Isosorbide-5-Nitrae-dihydro-6-methyl-3,5--pyridine dicarboxylate benzene sulfonate, is white crystalline powder, is dissolved in methanol, be slightly soluble in water.Amlodipine Besylate Tablet is treatment hypertension and anginal common drug.It directly acts on vascular smooth muscle, reduces peripheral vascular resistance, thus reduces blood pressure; By expansion periphery small artery, Peripheral resistance is reduced, thus reduce myocardial oxygen consumption, expansion normally and the coronary artery of ischemic region and coronary arterioles in addition, the myocardial oxygen delivery amount of coronary vasospasm patient increased, reaches the object of allevating angina pectoris.
Because Amlodipine Besylate Tablet is insoluble in water, it is made into tablet, the shake of dispersible tablet Dian glue and drop pill etc. more, wherein, accounts for the overwhelming majority with tablet.Tablet often will relate to granulation in routine preparation.In the process of granulating, medicated powder often relates to again wet-mixed and drying.Amlodipine Besylate Tablet belongs to dihydropyridine series products, and this series products is easily oxidized, and oxidation occurs than being easier under high temperature has wet and illumination condition, therefore answers lucifuge when operating and avoid high temperature and wet steam.The disintegration of tablet adopting dry granulation tablet forming technique to produce is slow, is unfavorable for the stripping of medicine; The common technique of tablet technique will be granulated, and pelletization will solve exactly and material fluidity is improved, and tableting processes tablet weight variation is diminished.Be generally adopt wet granulation, this technique traditional classical is reliable, but this method equipment is many, and process route is long, and cost is high, and dry granulation directly becomes solid with high pressure sheeted product and smashes, and is screened into granule, simpler than wet granulation technology, but apparatus expensive.
Summary of the invention
The invention provides a kind of composition and method of making the same containing Amlodipine Besylate Tablet, improve the stability of medicine.
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight: Amlodipine Besylate Tablet 5 parts; Filler 90-195 part; Disintegrating agent 0.4-2.7 part; Lubricant 1.1-3.1 part.
Described compositions comprises following component by weight: Amlodipine Besylate Tablet 5 parts; Filler 95-185 part; Disintegrating agent 0.6-2.4 part; Lubricant 1.3-2.8 part.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose or dicalcium phosphate dehydrate or starch or its combination.
Described disintegrating agent is carboxymethyl starch sodium or cross-linking sodium carboxymethyl cellulose or polyvinylpolypyrrolidone or its combination.
Described lubricant is magnesium stearate or micropowder silica gel or Pulvis Talci or its combination.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 3-6min, obtains material 1;
3) sieve: material 1 is crossed 14-18 object sieve, obtain material 2;
4) premix 2: material 2 is mixed 8-12min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 8-12min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 8-12min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 3-6min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 2) middle mixing 5min; Described step 4) middle mixing 10min; Described step 5) middle mixing 10min; Described step 6) middle mixing 10min; Described step 7) middle mixing 5min.
Described step 3) material 1 16 objects sieves excessively.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 6 ~ 10kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.10% ~ 3.50% in material 5.
Beneficial effect of the present invention is as follows:
1, the powder of mix homogeneously of the present invention obtains label by tablet machine direct compression, compared with existing wet granulation technology, adopts the tablet that the method for the invention is obtained, its stripping is more thorough, tablet hardness strengthens, weight differential significantly improves;
2, direct compression production process of the present invention is few, and equipment is simple, decreases supplementary product consumption, and product disintegrate or stripping comparatively fast, are applicable to wet heat-labile Amlodipine Besylate Tablet;
3, production technology is simpler, decreases the investment of corresponding equipment Factory Building, saves production cost;
4, Amlodipine Besylate Tablet is the medicine that dissolubility is little, and what adopt technique of direct powder compression to produce has good stability, and disintegrate is faster, contributes to the stripping improving medicine, can guarantee that Amlodipine Besylate Tablet mixes with the mixed powder of gained more even;
5, the present invention is by the addition sequence of the incorporation time in Controlling Technology process, drug prescription material, and the size of raw material, ensures the abundant mixing of raw material, ensures the smooth molding of tablet;
6, patent of the present invention can reduce the tablet stripping of impurity in storage again, and product property is stablized.
Detailed description of the invention
Further illustrate the present invention below in conjunction with embodiment, but the scope of protection of present invention is not limited to the scope of embodiment statement.
Embodiment 1
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 90 parts; Disintegrating agent 0.4 part; Lubricant 1.1 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose.
Described disintegrating agent is carboxymethyl starch sodium.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 3min, obtains material 1;
3) sieve: material 1 is crossed 14 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 12min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 8min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 8min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 3min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 6kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.10% in material 5.
Embodiment 2
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 195 parts; Disintegrating agent 2.7 parts; Lubricant 3.1 parts.
Described compositions is prepared as tablet.
Described filler is dicalcium phosphate dehydrate.
Described disintegrating agent is cross-linking sodium carboxymethyl cellulose.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 6min, obtains material 1;
3) sieve: material 1 is crossed 18 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 12min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 12min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 12min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 6min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 10kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.50% in material 5.
Embodiment 3
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 95 parts; Disintegrating agent 0.6 part; Lubricant 1.3 parts.
Described compositions is prepared as tablet.
Described filler is dicalcium phosphate dehydrate.
Described disintegrating agent is cross-linking sodium carboxymethyl cellulose 0.2 part, polyvinylpolypyrrolidone 0.4 part.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 5min, obtains material 1;
3) sieve: material 1 is crossed 16 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 10min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 10min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 10min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 10kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.50% in material 5.
Embodiment 4
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Sulfonic acid amlodipine 5 parts; Filler 185 parts; Disintegrating agent 2.4 parts; Lubricant 2.8 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose 100 parts, dicalcium phosphate dehydrate 85 parts.
Described disintegrating agent is carboxymethyl starch sodium.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 4min, obtains material 1;
3) sieve: material 1 is crossed 16 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 11min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 11min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 11min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 8kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.2% in material 5.
Embodiment 5
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 100 parts; Disintegrating agent 1.8 parts; Lubricant 1.8 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose 70 parts, dicalcium phosphate dehydrate 30 parts.
Described disintegrating agent is carboxymethyl starch sodium 0.6 part, cross-linking sodium carboxymethyl cellulose 0.2 part, polyvinylpolypyrrolidone 1 part.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 3-6min, obtains material 1;
3) sieve: material 1 is crossed 16 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 10min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 9min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 9min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 9kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.2% in material 5.
Embodiment 6
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 150 parts; Disintegrating agent 2.3 parts; Lubricant 2.5 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose 120 parts, dicalcium phosphate dehydrate 30 parts.
Described disintegrating agent is carboxymethyl starch sodium 2.1 parts, cross-linking sodium carboxymethyl cellulose 0.2 part.
Described lubricant is magnesium stearate 1.2 parts, micropowder silica gel 1.3 parts.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 4min, obtains material 1;
3) sieve: material 1 is crossed 14 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 10min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 11min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 12min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 9kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.3% in material 5.
Embodiment 7
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 185 parts; Disintegrating agent 0.8 part; Lubricant 1.8 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose.
Described disintegrating agent is carboxymethyl starch sodium 0.5 part, polyvinylpolypyrrolidone 0.3 part.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 5min, obtains material 1;
3) sieve: material 1 is crossed 16 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 8-12min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 10min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 10min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 10kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.3% in material 5.
Embodiment 8
A compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 165 parts; Disintegrating agent 2.2 parts; Lubricant 2.4 parts.
Described compositions is prepared as tablet.
Described filler is microcrystalline Cellulose 140 parts, dicalcium phosphate dehydrate 25 parts.
Described disintegrating agent is carboxymethyl starch sodium 0.5 part, cross-linking sodium carboxymethyl cellulose 0.5 part, polyvinylpolypyrrolidone 1.2 parts.
Described lubricant is magnesium stearate.
The method of the compositions containing Amlodipine Besylate Tablet described in preparation, is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 4.5min, obtains material 1;
3) sieve: material 1 is crossed 16 object sieves, obtain material 2;
4) premix 2: material 2 is mixed 11min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 10min, obtains material 4;
6) premix 4: add described step 1 in material 4) in disintegrating agent, mixing 10min, obtain material 5;
7) always mix: in material 5, add described step 1) in lubricant, mixing 5min, obtain material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
Described step 8) tabletting is by the Hardness Control of slice, thin piece at 9kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
Described step 6) Amlodipine Besylate Tablet content percentage by weight is 3.40% in material 5.
The comparing result of the present invention and prior art:
The every Data Comparison of table 1 the old and new prescription
From above-mentioned table 1: the Amlodipine Besylate Tablet composition tablet of patent of the present invention is relative to prior art, and dissolution improves, tablet weight variation reduces, and hardness range can be pressed to significantly improve, good fluidity, storage endurance, and pharmaceutical properties is stablized.
The above embodiments are only the preferred technical solution of the present invention, and should not be considered as restriction of the present invention, and the embodiment in the application and the feature in embodiment, can combination in any mutually when not conflicting.The technical scheme that protection scope of the present invention should be recorded with claim, the equivalents comprising technical characteristic in the technical scheme of claim record is protection domain.Namely the equivalent replacement within the scope of this improves, also within protection scope of the present invention.
Claims (10)
1. the compositions containing Amlodipine Besylate Tablet, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 90-195 part; Disintegrating agent 0.4-2.7 part; Lubricant 1.1-3.1 part.
2. the compositions containing Amlodipine Besylate Tablet according to claim 1, is characterized in that: described compositions comprises following component by weight:
Amlodipine Besylate Tablet 5 parts; Filler 95-185 part; Disintegrating agent 0.6-2.4 part; Lubricant 1.3-2.8 part.
3. the compositions containing Amlodipine Besylate Tablet according to claim 1 and 2, is characterized in that: described compositions is prepared as tablet.
4. the compositions containing Amlodipine Besylate Tablet according to claim 1, is characterized in that: described filler is microcrystalline Cellulose or dicalcium phosphate dehydrate or starch or its combination.
5. the compositions containing Amlodipine Besylate Tablet according to claim 1, is characterized in that: described disintegrating agent is carboxymethyl starch sodium or cross-linking sodium carboxymethyl cellulose or polyvinylpolypyrrolidone or its combination.
6. the compositions containing Amlodipine Besylate Tablet according to claim 1, is characterized in that: described lubricant is magnesium stearate or micropowder silica gel or Pulvis Talci or its combination.
7. prepare the method for the compositions containing Amlodipine Besylate Tablet described in claim 1,2,4,5,6 any one, it is characterized in that, said method comprising the steps of:
1) prepare burden: take each component by recipe quantity;
2) premix 1: add the filler of 3/4 in Amlodipine Besylate Tablet, mixing 3-6min, obtains material 1;
3) sieve: material 1 is crossed 14-18 object sieve, obtain material 2;
4) premix 2: material 2 is mixed 8-12min, obtains material 3;
5) premix 3: the filler of remaining 1/4 is added in material 3, mixing 8-12min, obtains material 4;
6) premix 4: add the disintegrating agent in described step 1) in material 4, mixing 8-12min, obtains material 5;
7) always mix: add the lubricant in described step 1) in material 5, mixing 3-6min, obtains material 6;
8) tabletting: material 6 is carried out tabletting, the described pharmaceutical composition containing Amlodipine Besylate Tablet.
8. method according to claim 7, is characterized in that: described step 2) middle mixing 5min; 10min is mixed in described step 4); 10min is mixed in described step 5); 10min is mixed in described step 6); 5min is mixed in described step 7).
9. method according to claim 7, is characterized in that: described step 8) tabletting is by the Hardness Control of slice, thin piece at 6 ~ 10kgf, single tablet weight variation ± 5.0%, average tablet weight variation ± 1.5%.
10. method according to claim 7, is characterized in that: in described step 6) material 5, Amlodipine Besylate Tablet content percentage by weight is 3.10% ~ 3.50%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510866403.9A CN105395495A (en) | 2015-11-30 | 2015-11-30 | Composition containing amlodipine besylate and preparation method of composition |
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| CN201510866403.9A CN105395495A (en) | 2015-11-30 | 2015-11-30 | Composition containing amlodipine besylate and preparation method of composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110215436A (en) * | 2019-07-04 | 2019-09-10 | 沈阳达善医药科技有限公司 | A kind of preparation method improving amlodipine besylate tablets intermediate mixture homogeneity |
| CN111110639A (en) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | Pharmaceutical composition containing amlodipine besylate |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN87102493A (en) * | 1986-04-04 | 1987-10-14 | 菲泽有限公司 | Improvements in or relating to pharmaceutically acceptable salts |
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2015
- 2015-11-30 CN CN201510866403.9A patent/CN105395495A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN87102493A (en) * | 1986-04-04 | 1987-10-14 | 菲泽有限公司 | Improvements in or relating to pharmaceutically acceptable salts |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110639A (en) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | Pharmaceutical composition containing amlodipine besylate |
| CN111110639B (en) * | 2018-10-31 | 2022-03-22 | 长春海悦药业股份有限公司 | Pharmaceutical composition containing amlodipine besylate |
| CN110215436A (en) * | 2019-07-04 | 2019-09-10 | 沈阳达善医药科技有限公司 | A kind of preparation method improving amlodipine besylate tablets intermediate mixture homogeneity |
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Application publication date: 20160316 |