Preparation method of amlodipine besylate tablets

A technology of amlodipine besylate tablets and amlodipine besylate, which is applied in the field of medicine and can solve the problem of affecting product yield, active ingredient content and dissolution rate, level to light, humidity, heat instability, and affecting products. Dissolution and other issues, to achieve the effect of improving content uniformity and dissolution, ensuring dissolution and high dissolution

Inactive Publication Date: 2019-07-02
HUNAN QIANJIN XIELI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the preparation process of amlodipine besylate tablets, there is a phenomenon that the raw materials are easily aggregated or adhered to the inner wall of the container due to electrostatic effects, thereby affecting the product yield and the content and dissolution rate of active ingredients.
Among the required raw materials, the main component amlodipine besylate is unstable to light, humidity and heat, and the auxiliary material anhydrous calcium hydrogen phosphate is heavy, while microcrystalline cellulose is light in texture, which makes it difficult to mix evenly. Thereby further affecting the dissolution rate of the product, resulting in a reduction in drug efficacy

Method used

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  • Preparation method of amlodipine besylate tablets
  • Preparation method of amlodipine besylate tablets
  • Preparation method of amlodipine besylate tablets

Examples

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Embodiment 1

[0020] The amlodipine besylate tablet of the present invention comprises the following components in weight percent: 25 parts of amlodipine besylate, 5 parts of micropowder silica gel, 62 parts of microcrystalline cellulose, 32 parts of anhydrous calcium hydrogen phosphate, stearic acid 25 parts of magnesium, 5 parts of sodium carboxymethyl starch.

[0021] The preparation method of amlodipine besylate sheet of the present invention may further comprise the steps:

[0022] (1) First mix amlodipine besylate and micropowder silica gel evenly to obtain mixture A, and then pass through a 120-mesh sieve; then pass anhydrous calcium hydrogen phosphate through a 200-mesh sieve, microcrystalline cellulose through a 100-mesh sieve, carboxylate Sodium methyl starch and magnesium stearate are passed through a 80-mesh sieve;

[0023] (2) Dissolving microcrystalline cellulose and anhydrous calcium hydrogen phosphate in absolute ethanol, stirring to accelerate the dissolution, and then spr...

Embodiment 2

[0051] A kind of amlodipine besylate tablet, this amlodipine besylate tablet comprises the following components by weight percentage:

[0052] Amlodipine Besylate 2.5%,

[0053] Micropowder silica gel 0.5%,

[0054] Microcrystalline Cellulose 62%,

[0055] Dicalcium Phosphate Anhydrous 32%,

[0056] Magnesium stearate 2% added,

[0057] Sodium carboxymethyl starch 0.5%,

[0058] Plus magnesium stearate 0.5%.

[0059] The preparation method of the amlodipine besylate sheet of the present embodiment may further comprise the steps:

[0060] (1) Take the raw and auxiliary materials in the above formula, first mix amlodipine besylate and micropowder silica gel evenly to obtain the mixed material A, and then pass through a 120-mesh sieve; then pass anhydrous calcium hydrogen phosphate through a 200-mesh sieve, microcrystalline Cellulose is passed through a 100-mesh sieve, sodium carboxymethyl starch and magnesium stearate are passed through a 80-mesh sieve;

[0061] (2) Disso...

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Abstract

The invention relates to a preparation method of amlodipine besylate tablets. The preparation method is mainly used for solving the technical problems that existing products are low in yield and poorin dissolution rate. The technical scheme adopted by the invention lies in that the preparation method of amlodipine besylate tablets is characterized by comprising the steps of (1) firstly uniformlymixing amlodipine besylate with gum acacia to obtain a mixed material A; enabling microcrystalline cellulose and calcium phosphate dibasic anhydrous to dissolve in anhydrous ethanol, performing stirring, and then performing spray drying so as to obtain a mixed material B; placing the mixed material A, the mixed material B and magnesium stearate in a high-efficiency wet-method mixed granulating machine, and performing stirring to obtain a mixed material C; adding the mixed material C to a dry-method granulating machine, and screening out fine powder so as to obtain granules I; adding the granules I, magnesium stearate and sodium carboxymethyl starch to a three-dimensional movement mixing machine together, and performing mixing so as to obtain granules II; and tabletting the granules II so as to obtain the amlodipine besylate tablets. The amlodipine besylate tablets are mainly applied to the technical field of medicines.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a preparation method of amlodipine besylate tablets. Background technique [0002] Amlodipine besylate is a dihydropyridine calcium antagonist, which mainly inhibits the calcium storage capacity of the myocardial and vascular smooth muscle cell membranes and the ability to combine with calcium ions, and achieves the antihypertensive effect by dilating vascular arterioles and reducing peripheral resistance. [0003] In the preparation process of amlodipine besylate tablets, there is a phenomenon that the raw materials are easily aggregated or adhered to the inner wall of the container due to electrostatic effects, thereby affecting the product yield and the content and dissolution rate of active ingredients. Among the required raw materials, the main component amlodipine besylate is unstable to light, humidity and heat, and the auxiliary material anhydrous calcium hydrogen phosp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/04A61K47/38A61K47/02A61P9/12
CPCA61K9/2009A61K9/2054A61K9/2095A61K31/4422
Inventor 叶胜利
Owner HUNAN QIANJIN XIELI PHARMA CO LTD
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