A kind of amlodipine besylate composition and tablet preparation method thereof for direct compression

The technology of amlodipine besylate and composition is applied in the field of preparation of amlodipine besylate composition and tablet thereof, can solve the problems of poor fluidity of splinter, medicinal powder, large difference in tablet weight and the like, and achieves dissolution rate High, complete dissolution, weight difference improvement effect

Active Publication Date: 2018-01-05
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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  • A kind of amlodipine besylate composition and tablet preparation method thereof for direct compression
  • A kind of amlodipine besylate composition and tablet preparation method thereof for direct compression
  • A kind of amlodipine besylate composition and tablet preparation method thereof for direct compression

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1 core prescription

[0019]

[0020] 2 Preparation method

[0021] Weigh amlodipine besylate, microcrystalline cellulose 112, pregelatinized starch and crospovidone of prescription quantity 2 / 3 according to prescription quantity, mix evenly. Then add the remaining crospovidone, silicon dioxide and magnesium stearate, mix evenly, compress into tablets, and coat with a film to obtain the product.

Embodiment 2

[0023] 1 core prescription

[0024]

[0025] 2 Preparation method

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

Embodiment 3

[0028] 1 core prescription

[0029]

[0030]

[0031] 2 Preparation method

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

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Abstract

The invention belongs to the technical field of medicine preparation, and in particular relates to an amlodipine besylate composition for direct tablet compression and a tablet preparation method thereof. The amlodipine besylate composition of the present invention is composed of 2-25% amlodipine besylate fine powder and 75-98% pharmaceutical adjuvant according to the mass ratio. The specific steps of the preparation method of the tablet are: get amlodipine besylate fine powder and mix uniformly with other pharmaceutical excipients except lubricant and glidant, then mix uniformly with lubricant and glidant, and mix all The uniform powder is directly compressed into a tablet core by a tablet press, and the tablet core is coated with a film. Compared with the prior art, the tablet prepared by adopting the method of the invention has complete dissolution, high dissolution rate, enhanced hardness and improved weight difference.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to an amlodipine besylate composition for direct tablet 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 Base-3,5-pyridinedicarboxylate benzenesulfonate, white crystal powder, soluble in methanol, slightly soluble in water. Amlodipine besylate is a commonly used drug for the treatment of hypertension and angina pectoris. It directly acts on vascular smooth muscle to reduce peripheral vascular resistance, thereby lowering blood pressure; by dilating peripheral arterioles, peripheral resistance is reduced, thereby reducing myocardial oxygen consumption, and in addition, coronary arteries and coronary arteries in normal and ischemic areas are expanded to make In patients with coronary artery spasm, the myocardial...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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