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A kind of amlodipine besylate tablet and preparation method thereof

A technology of amlodipine besylate tablets and amlodipine besylate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of amlodipine besylate Unstable quality of tablet products, high content of related substances, etc., to improve stability and use safety, improve uniformity, and ensure uniformity

Active Publication Date: 2022-02-15
江西制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the technical problem to be solved in the present invention is to overcome the defects of unstable product quality and high content of related substances in amlodipine besylate tablets prepared by existing methods, thereby providing a product that can significantly reduce impurities and improve product quality. The preparation method of stable amlodipine besylate tablet

Method used

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  • A kind of amlodipine besylate tablet and preparation method thereof

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Effect test

Embodiment 1

[0029] The present embodiment provides a kind of amlodipine besylate tablet, and its raw material is made up of following composition:

[0030] Amlodipine besylate 1.74kg; Microcrystalline cellulose PH101 29.52kg; Anhydrous calcium hydrogen phosphate 15kg; Add carboxymethyl starch sodium 0.75kg; Add carboxymethyl starch sodium 1.25kg; Mixed magnesium stearate 0.25kg; total mixed magnesium stearate 0.25kg.

[0031] The method for preparing amlodipine besylate sheet by adopting above-mentioned raw material composition comprises the steps:

[0032] (1) each component is taken by weighing according to above-mentioned formula, and amlodipine besylate is passed through a 100 mesh sieve, and the bulk drug under the sieve is taken for subsequent use;

[0033] (2) Microcrystalline cellulose PH101, anhydrous calcium hydrogen phosphate and sodium carboxymethyl starch added in the formula amount are placed in a wet granulator, mixed uniformly, then 18.1kg of purified water is added there...

Embodiment 2

[0038] This embodiment provides a kind of amlodipine besylate tablet, its raw material is composed of the same as embodiment 1 by the following composition.

[0039] The method for preparing amlodipine besylate sheet by adopting above-mentioned raw material composition comprises the steps:

[0040] (1) each component is taken by weighing according to above-mentioned formula, and amlodipine besylate is passed through a 100 mesh sieve, and the bulk drug under the sieve is taken for subsequent use;

[0041] (2) Place microcrystalline cellulose PH101, anhydrous calcium hydrogen phosphate and sodium carboxymethyl starch in a formula amount in a wet granulator, mix well, then add 19kg of purified water to it to make a soft material, and pass 30 Shake granulation with a mesh nylon sieve, dry the obtained granules in an oven at 55°C for 5 hours to make the moisture content <3.0%, and pass through a 20-mesh sieve for granulation to obtain the first granules;

[0042] (3) Amlodipine be...

Embodiment 3

[0046] This embodiment provides a kind of amlodipine besylate tablet, its raw material is composed of the same as embodiment 1 by the following composition.

[0047] The method for preparing amlodipine besylate sheet by adopting above-mentioned raw material composition comprises the steps:

[0048] (1) each component is taken by weighing according to above-mentioned formula, and amlodipine besylate is passed through a 100 mesh sieve, and the bulk drug under the sieve is taken for subsequent use;

[0049] (2) Place microcrystalline cellulose PH101, anhydrous calcium hydrogen phosphate and sodium starch glycolate in the wet granulator in the formula quantity, mix well, then add 18kg of purified water to it, make soft material, pass 30 Shake granulation with a mesh nylon sieve, dry the obtained granules in an oven at 65°C for 4 hours to make the moisture content <3.0%, and pass through a 20-mesh sieve for granulation to obtain the first granules;

[0050] (3) Amlodipine besylate...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and discloses an amlodipine besylate tablet and a preparation method thereof. In the method, microcrystalline cellulose, anhydrous calcium hydrogen phosphate and carboxymethyl starch sodium are mixed evenly, and then added Purified water wetting agent is used for wet granulation to obtain the first granule, then the first granule is mixed with amlodipine besylate, microcrystalline cellulose, carboxymethyl starch sodium and magnesium stearate, and finally stearic acid is added Magnesium, mixed evenly and compressed into tablets. The present invention obtains first granules through wet granulation, and then mixes the dried first granules with amlodipine besylate and other auxiliary materials, which not only possesses the advantages of traditional wet granulation, but also facilitates subsequent tabletting, and avoids the traditional The high temperature of wet granulation can easily lead to the decomposition of amlodipine besylate bulk drug to produce related substances and moisture affecting the stability of the drug. The method of the present invention effectively reduces or avoids the generation and increase of related substances, and improves the stability of the preparation product sex and safety of use.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an amlodipine besylate tablet and a preparation method thereof. Background technique [0002] Hypertension is a chronic disease characterized by increased systemic arterial blood pressure, which may be complicated by a series of cardiovascular and cerebrovascular or kidney and other organ damage. The current clinical treatment cannot directly cure it. Long-term use of drugs and lifestyle modification are required to control the blood pressure of patients. Therefore, the choice of antihypertensive drugs is very critical, and their toxicity and side effects also need to be taken into consideration. Antihypertensive drugs widely used at present include diuretics, β receptor blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and other drugs, amlodipine besylate as a calcium Channel blockers, by inhibiting the calcium storage capacity of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61K47/36A61K47/02A61P9/12
CPCA61K9/2077A61K9/2059A61K9/2054A61K9/2009A61K31/4422A61P9/12
Inventor 黄斌辉黎俊揭秉华熊水莲宋军邹国辉
Owner 江西制药有限责任公司
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