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Amlodipine benzenesulfonate tablet and preparation method thereof

A technology of amlodipine besylate tablets and amlodipine besylate, applied in pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of poor stability of amlodipine besylate, Achieve the effects of good stability, reduced dosage, and rapid dissolution

Active Publication Date: 2013-07-10
广东彼迪药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problem of poor stability of amlodipine besylate, the inventor unexpectedly found that hydroxypropyl beta-cyclodextrin and amlodipine besylate were dissolved in absolute ethanol as a coating solution on the pellets coating, and then directly compressed with pharmaceutically acceptable adjuvants to obtain amlodipine besylate tablets with good stability and rapid dissolution.

Method used

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  • Amlodipine benzenesulfonate tablet and preparation method thereof
  • Amlodipine benzenesulfonate tablet and preparation method thereof
  • Amlodipine benzenesulfonate tablet and preparation method thereof

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Effect test

Embodiment 1

[0026]

[0027] Preparation Process:

[0028] (1) Dissolve amlodipine besylate and hydroxypropyl beta cyclodextrin in 3000mL absolute ethanol;

[0029] (2) In the fluidized bed, the inlet air temperature is 30°C, and the above solution is coated on the microcrystalline cellulose pellets;

[0030] (3) Mix the drug-coated pellets with lactose, sodium carboxymethyl starch and magnesium stearate evenly, and directly compress into tablets.

Embodiment 2

[0032]

[0033] Preparation Process:

[0034] (1) Dissolve amlodipine besylate and hydroxypropyl beta cyclodextrin in 5000mL absolute ethanol;

[0035] (2) In the fluidized bed, the air inlet temperature is 30°C, and the above solution is coated on the starch pellets;

[0036] (3) Mix the drug-containing coated pellets with microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate evenly, and directly compress into tablets.

Embodiment 3

[0038]

[0039]

[0040] Preparation Process:

[0041] (1) Dissolve amlodipine besylate and hydroxypropyl beta cyclodextrin in 4000mL absolute ethanol;

[0042] (2) In the fluidized bed, the inlet air temperature is 30°C, and the above solution is coated on the microcrystalline cellulose pellets;

[0043] (3) Mix the drug-coated pellets with microcrystalline cellulose, crospovidone, and sodium stearyl fumarate evenly, and press into tablets.

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PUM

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Abstract

The invention discloses an amlodipine benzenesulfonate tablet which is prepared by dissolving amlodipine benzenesulfonate and hydroxypropyl betadex into absolute ethyl alcohol so as to prepare a coating solution, coating blank pellets, subsequently uniformly mixing with pharmaceutically acceptable auxiliaries, and directly tabletting. An inclusion technique and a coating technique are combined, so that the influence of moisture to medicines in the production process of the preparation is avoided, and the tablet is coated and at the same time a hydroxypropyl betadex amlodipine benzenesulfonate clathrate compound is prepared, therefore, the stability is good; and meanwhile, as the clathrate compound is uniformly dispersed on the surface of the pellets, the contact area of dissolved mediums in dissolution measurement is increased, and the dissolution is rapid.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an amlodipine besylate tablet and a preparation method thereof. Background technique [0002] Calcium antagonists (CAS) are recognized as effective antihypertensive drugs and arterial dilators, which prevent Ca by blocking specific L-type calcium channels on cardiac muscle and vascular smooth muscle cells. 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 long-acting dihydropyridine calcium channel antagonist, which mainly inhibits the calcium storage capacity of myocardial and vascular smooth muscle cell membranes and the ability to co...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/40A61P9/12A61P9/08
Inventor 蒋林波司孝清刘小兰杨新明
Owner 广东彼迪药业有限公司
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