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An amlodipine besylate composition used for direct tabletting and a preparing method of tablets of the composition

A technology of amlodipine besylate and its composition, which is applied in the field of preparation of amlodipine besylate composition and its tablets, which can solve the problems of large tablet weight differences, poor fluidity of medicinal powder, and splits, and achieve weight differences Improved, complete dissolution, high dissolution effect

Active Publication Date: 2015-07-01
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The product obtained by this invention has the disadvantages of poor fluidity of the medicinal material powder, large difference in tablet weight, and easy cracking caused by powder compression.

Method used

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  • An amlodipine besylate composition used for direct tabletting and a preparing method of tablets of the composition
  • An amlodipine besylate composition used for direct tabletting and a preparing method of tablets of the composition
  • An amlodipine besylate composition used for direct tabletting and a preparing method of tablets of the composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1 core prescription

[0019]

[0020] 2 Preparation methods

[0021] Weigh amlodipine besylate, microcrystalline cellulose 112, pregelatinized starch and crospovidone of 2 / 3 of the recipe amount according to the recipe, and mix them evenly. Then add the remaining crospovidone, silicon dioxide and magnesium stearate, mix evenly, press into tablets, and apply film coating to obtain the final product.

Embodiment 2

[0023] 1 core prescription

[0024]

[0025] 2 Preparation methods

[0026] Weigh amlodipine besylate, anhydrous lactose, mannitol, pregelatinized starch and 2 / 3 of the recipe amount of croscarmellose sodium according to the recipe, mix well, then add the remaining croscarmellose Sodium cellulose, silicon dioxide, magnesium stearate and talc are mixed uniformly, compressed into tablets, and film-coated to obtain the final product.

Embodiment 3

[0028] 1 core prescription

[0029]

[0030]

[0031] 2 Preparation methods

[0032] Weigh amlodipine besylate, microcrystalline cellulose 212, pregelatinized starch, calcium hydrogen phosphate, hypromellose and 2 / 3 of the croscarmellose sodium according to the recipe quantity, mix well , and then add the remaining croscarmellose sodium, silicon dioxide and magnesium stearate, mix evenly, press into tablets, and apply a film coating to obtain the final product.

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to an amlodipine besylate composition used for direct tabletting and a preparing method of tablets of the composition. The composition comprises 2-25% by mass of amlodipine besylate fine powder and 75-98% by mass of pharmaceutic adjuvants. The preparing method includes steps of: uniformly mixing the amlodipine besylate fine powder and the pharmaceutic adjuvants except a lubricant and a glidant, then mixing uniformly with the lubricant and the glidant, directly pressing the uniformly mixed powder into tablet cores by a tabletting machine, and coating the tablet cores with films. Compared with the prior art, tablets prepared by the method are thorough in dissolution, high in dissolution rate, improved in hardness and improved in weight difference.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparation, and in particular relates to an amlodipine besylate composition for direct compression and a tablet preparation method thereof. Background technique [0002] Amlodipine besylate Chemical name 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl Alkyl-3,5-pyridinedicarboxylate benzenesulfonate, white crystalline powder, soluble in methanol, slightly soluble in water. Amlodipine besylate is a commonly used drug for the treatment of high blood pressure and angina pectoris. It directly acts on vascular smooth muscle to reduce peripheral vascular resistance, thereby lowering blood pressure; by expanding peripheral arterioles, peripheral resistance is reduced, thereby reducing myocardial oxygen consumption, and in addition, coronary arteries and coronary arterioles in normal and ischemic areas are expanded, so that Increased myocardial oxygen supply in p...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4422A61P9/12A61P9/10A61J3/00
Inventor 石井岗王舒健王永霞陈昆鹏卢秀莲杜振新
Owner CISEN PHARMA
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