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Amlodipine besylate-containing pharmaceutical composition

A technology of amlodipine besylate and composition, which is applied in the field of medicine, can solve the problems of poor stability of amlodipine besylate preparations, and achieve the effects of rapid dissolution, good stability and improved dissolution rate

Active Publication Date: 2015-03-18
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention proposes a kind of amlodipine besylate tablet, solves the problem of poor stability of the amlodipine besylate preparation, obtains the amlodipine besylate tablet with good stability, rapid dissolution and reliable quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Amlodipine Besylate 6g

[0033] Microcrystalline Cellulose 70g

[0034] Macrogol 600 25g

[0035] Sodium carboxymethyl starch (internal addition method) 18 g

[0036] Magnesium Stearate 1g

[0037] Preparation:

[0038] 1) Sieve all auxiliary materials with an 80-mesh sieve;

[0039] 2) Weigh amlodipine besylate according to the prescription amount, add equal weight microcrystalline cellulose and mix five times according to the method of equal increment, add the remaining microcrystalline cellulose, sodium starch glycolate and polyethylene glycol 600, and mix well , to obtain a mixture 1 of amlodipine besylate and some auxiliary materials;

[0040] 3) Take the mixture 1 and place it in a swinging granulator to granulate it through a 18-mesh nylon sieve and dry it;

[0041] 4) Place the dried granulated granules in a rotary vibrating sieve and granulate with an 18-mesh sieve;

[0042] 5) Put the above-mentioned granulated granules in a V-shaped mixer, add the pre...

Embodiment 2

[0045] Amlodipine Besylate 5 g

[0046] Starch 68g

[0047] Macrogol 600 23g

[0048] Carmellose sodium (internal addition method) 1g

[0049] Sodium carmellose (additional method) 0.4 g

[0050] Talc powder 0.8g

[0051] Preparation:

[0052] 1) Sieve all auxiliary materials with an 80-mesh sieve;

[0053] 2) Weigh amlodipine besylate according to the prescription amount, add equal weight microcrystalline cellulose and mix five times according to the method of equal increase, add the remaining microcrystalline cellulose, polyethylene glycol 600 and carmellose sodium, fully Mix to obtain a mixture 1 of amlodipine besylate and some auxiliary materials;

[0054] 3) Take the mixture 1 and place it in a swinging granulator to granulate it through a 18-mesh nylon sieve and dry it;

[0055] 4) Place the dried granulated granules in a rotary vibrating sieve and granulate with an 18-mesh sieve;

[0056] 5) Put the above-mentioned granulated granules in a V-shaped mixer, add t...

Embodiment 3

[0059] Amlodipine Besylate 5g

[0060] Starch 65g

[0061] Macrogol 600 80g

[0062] Hypromellose (internal addition method) 1.2g

[0063] Magnesium stearate 2 g

[0064] Preparation:

[0065] 1) Sieve all auxiliary materials with an 80-mesh sieve;

[0066] 2) Weigh amlodipine besylate according to the prescription amount, add equal weight starch and mix five times according to the method of equal increase, add the remaining starch, hydroxypropyl cellulose and polyethylene glycol 600, and mix thoroughly. The total mixing time is 10 min, to obtain the mixture 1 of amlodipine besylate and some auxiliary materials;

[0067] 3) Take the mixture 1 and place it in a swinging granulator to granulate it through a 18-mesh nylon sieve and dry it at 50°C;

[0068] 4) Place the dried granulated granules in a rotary vibrating sieve and granulate with an 18-mesh sieve;

[0069]5) Put the above-mentioned granulated granules in a V-shaped mixer, add the prescribed amount of magnesium ...

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PUM

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Abstract

The invention belongs to the medical technicial field, and discloses an amlodipine besylate composition which comprises the following components in parts by weight: 3-6 parts by weight of amlodipine besylate, 1-1.8 parts by weight of a disintegrating agent, 65-70 parts by weight of a filler, 20-25 parts by weight of polyethylene glycol 600, and 0.05-0.1 part by weight of a lubricant. An amlodipine besylate tablet is prepared, the 5 min dissolution rate can reach up to more than 80%, the content of stability testing total impurities is less than 0.30%, the amlodipine besylate tablet having stable main drug content and high bioavailability is prepared, and besides, the preparation process has the advantages of being simple to operate, low in equipment requirement, low in production cost and suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an amlodipine besylate composition. Background technique [0002] Calcium antagonists (CAS) are recognized effective antihypertensive drugs and arterial dilators, which block Ca 2+ Into the cells, thereby relaxing vascular smooth muscle, expanding peripheral arterioles, reducing peripheral resistance, and lowering blood pressure. In addition, calcium antagonists can also help improve myocardial ischemia and relieve angina by reducing cardiac afterload and increasing coronary blood flow. [0003] Amlodipine besylate is the third-generation 1,4-dihydropyridine calcium ion antagonist successfully developed by Pfizer Pharmaceuticals Co., Ltd. in the mid-1980s. Its chemical name is 3-ethyl-5-methyl- 2-(2-Aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate. It has mild and long-lasting effects, is convenient to take, and has mild adverse reac...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/20A61K47/34A61P9/12A61P9/10
CPCA61K9/0053A61K9/20A61K31/4422A61K47/34A61K2300/00
Inventor 徐璐王小雪郝昕张春苗田晶孙晓霞
Owner 长春海悦药业股份有限公司
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