Amlodipine besylate tablet and preparation method thereof

A technology of amlodipine besylate tablets and magnesium stearate, which is applied in the field of medicine, can solve the problems of reduced drug efficacy, low yield, and easy accumulation into agglomerates, so as to improve content uniformity and dissolution rate, and reduce aggregation effect, the effect of ensuring dissolution rate

Active Publication Date: 2018-04-24
HUNAN QIANJIN XIELI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] During the preparation process of amlodipine besylate tablets, due to the contact and collision between the material and the wall of the device, electrostatic effects are likely to occur. On the one hand, the particles are urged to aggregate and block the sieve holes, resulting in slow and difficult sieving; Particles adhere to the inner wall of the device, resulting in low yield and high cost
At the same time, because it is prone to electrostatic interaction, the main drug amlodipine besylate is easy to accumulate into agglomerates during the mixing process with other excipients, which affects the dissolution and content uniformity of the main drug.
[0004] Because amlodipi

Method used

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  • Amlodipine besylate tablet and preparation method thereof
  • Amlodipine besylate tablet and preparation method thereof
  • Amlodipine besylate tablet and preparation method thereof

Examples

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Embodiment 1

[0054] A kind of amlodipine besylate tablet, this amlodipine besylate tablet comprises the following components by weight percentage:

[0055]

[0056] In the amlodipine besylate tablet of this embodiment, the particle diameter of anhydrous calcium hydrogen phosphate in the selected components is D10=28 μm, D90=100 μm, and the particle diameter of microcrystalline cellulose is D10=29 μm, D90=136 μm , the particle size of sodium carboxymethyl starch is D10=38 μm, D90=171 μm, the particle size of magnesium stearate (including internally added magnesium stearate and externally added magnesium stearate) is D10=38 μm, D90=159 μm, fine powder The particle size of silica gel is D10=28 μm, D90=127 μm, the particle size of amlodipine besylate is D10=28 μm, D90=125 μm.

[0057] The preparation method of the amlodipine besylate sheet of the present embodiment may further comprise the steps:

[0058] (1) Take the raw and auxiliary materials in the above formula, first mix amlodipine b...

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Abstract

The invention provides an amlodipine besylate tablet and a preparation method thereof. The amlodipine besylate tablet comprises the following components in parts by weight: 1-5 parts of amlodipine besylate, 0.3-0.6 part of aerosil, 30-70 parts of microcrystalline celluloses, 20-50 parts of calcium phosphate dibasic, 1-3 parts of magnesium stearate and 0.4-0.6 part of sodium carboxymethyl starch. The method comprises the following specific steps: mixing the amlodipine besylate with the aerosil at first to obtain a mixed material A; dissolving the microcrystalline celluloses and the calcium phosphate dibasic in an organic solvent, and drying to obtain a mixed material B; then placing the mixed material A, the mixed material B and the magnesium stearate in an efficient wet-process mixing granulator to obtain a mixed material C; granulating the mixed material C by a dry process to obtain particles I; and uniformly mixing the particles I, the magnesium stearate and the sodium carboxymethylstarch to obtain particles II, and carrying out tabletting to obtain the amlodipine besylate tablet. The amlodipine besylate tablet prepared by the method has high dissolution rate and good stability.

Description

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Claims

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Application Information

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Owner HUNAN QIANJIN XIELI PHARMA CO LTD
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