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Benzenesulfonate amlodipine tablet and preparation method thereof

A technology of amlodipine besylate tablet and amlodipine besylate tablet, which is applied in the field of amlodipine besylate tablet and its manufacture, and can solve problems such as crystal form and preparation method limitations, and the influence of active ingredients , to reduce costs, improve content uniformity, and improve dissolution

Inactive Publication Date: 2013-10-23
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, both the crystal form and the preparation method are limited in implementation, requiring additional equipment and production processes, and the more commonly used excipient—lactose also affects the active ingredient (CN102697743)

Method used

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  • Benzenesulfonate amlodipine tablet and preparation method thereof
  • Benzenesulfonate amlodipine tablet and preparation method thereof
  • Benzenesulfonate amlodipine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Formula: Calculated on the basis of 1000 plain tablets

[0034]

[0035] Preparation:

[0036] (1) Put the raw materials and other internally added auxiliary materials into the fluidized bed, and mix in the fluidized bed for 5 minutes to mix well.

[0037] (2) Spray 300g of starch slurry with a concentration of 1wt% into the mixed powder to make wet granules. After drying, pass through a 24-mesh sieve, add lubricant and mix evenly in a mixer. The measured moisture content reaches the standard of 1.5% to 2.5%, the particle size distribution is 30±5%, and the bulk density is 0.65±0.02g / ml;

[0038] (3) Tablet production: compress the above granules with a tablet machine.

[0039] (4) Measure the related substances contained in the prepared tablet and the dissolution rate, the results are shown in Table 1.

Embodiment 2

[0041] Formula: Calculated on the basis of 1000 plain tablets

[0042]

[0043]

[0044] (1) Put the raw materials and other internally added auxiliary materials into the fluidized bed, and mix in the fluidized bed for 5 minutes to mix well.

[0045] (2) Spray 300g of starch slurry with a concentration of 1wt% into the mixed powder to make wet granules. After drying, pass through a 24-mesh sieve, add lubricant and mix evenly in a mixer. The measured moisture content reaches the standard of 1.5% to 2.5%, the particle size distribution is 30±5%, and the bulk density is 0.65±0.02g / ml;

[0046] (3) Tablet production: compress the above granules with a tablet machine.

[0047] (4) Measure the related substances contained in the prepared tablet and the dissolution rate, the results are shown in Table 1.

Embodiment 3

[0049] Formula: Calculated on the basis of 1000 plain tablets

[0050]

[0051] (1) Put the raw materials and other internally added auxiliary materials into the fluidized bed, and mix in the fluidized bed for 5 minutes to mix well.

[0052] (2) Spray 100g of starch slurry with a concentration of 3wt% into the mixed powder to make wet granules. After drying, pass through a 24-mesh sieve, add lubricant and mix evenly in a mixer. The measured moisture content reaches the standard of 1.5% to 2.5%, the particle size distribution is 30±5%, and the bulk density is 0.65±0.02g / ml;

[0053] (3) Tablet production: compress the above granules with a tablet machine.

[0054] (4) Measure the related substances contained in the prepared tablet and the dissolution rate, the results are shown in Table 1.

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Abstract

The invention provides a benzenesulfonate amlodipine tablet. The benzenesulfonate amlodipine tablet is prepared by using benzenesulfonate amlodipine as an active component; adding starch slurry having a concentration of 0.8wt%-3.5wt%; using microcrystalline cellulose and calcium hydrophosphate dosages of which are in conventional dosage ranges, as fillers; using magnesium stearate as a lubricant; and using sodium carboxymethyl starch as a disintegrating agent. According to the benzenesulfonate amlodipine tablet, by addition of the starch slurry having a concentration far lower than the conventional concentrations, an increase of the dissolution rate of the benzenesulfonate amlodipine is achieved. In addition, the benzenesulfonate amlodipine tablet is adapted to conventional production technologies and equipment at present which are used for similar tablets-producing without needs of configuring extra equipment or changing production processes, and has high universality.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to an amlodipine besylate tablet containing starch slurry and a manufacturing method thereof. Background technique [0002] Amlodipine besylate, chemical name: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6 -Methyl-3,5-pyridinedicarboxylate benzenesulfonate, a calcium ion antagonist, has antihypertensive effects and relieves angina pectoris, and has been used clinically. For example: the oral tablet named Norvasc has several specifications such as 2.5mg, 5mg and 10mg. The excipients in the tablet include microcrystalline cellulose, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate and the like. At present, the absolute bioavailability of some amlodipine besylate products on the market can reach 64%-90%. [0003] Amlodipine besylate is slightly soluble in water, so the dissolution rate of amlodipine besylate prepared by the ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/36A61P9/12A61P9/10
Inventor 郑璐戴学中郑凤庚吴斌姚书扬郭晓静张益波赵婷李玲玲叶龙高苇
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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