Method for preparing telmisartan and amlodipine double-layer tablets

A technology of amlodipine besylate layer and telmisartan, which is applied in directions such as medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problem of the stability of amlodipine besylate. Influence and other issues, to achieve good dissolution behavior, ensure quality, and ensure the effect of curative effect

Active Publication Date: 2017-06-13
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technology is that amlodipine besylate is prepared into a solid dispersion by solid-state dispersion technology and then mixed with telmisartan, but alkaline substances such as sodium hydroxide and telmisartan are still used to prepare telmisartan particles Meglumine, to a certain extent, will still have a certain impact on the stability of amlodipine besylate

Method used

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  • Method for preparing telmisartan and amlodipine double-layer tablets
  • Method for preparing telmisartan and amlodipine double-layer tablets
  • Method for preparing telmisartan and amlodipine double-layer tablets

Examples

Experimental program
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Effect test

Embodiment 1

[0055] Embodiment 1: the screening of solid dispersion carrier Eudragit E100 dosage

[0056] The composition of the prescription of a solid dispersion containing Telmisartan and Eudragit E100 in different proportions is as follows:

[0057]

[0058] The preparation process of the solid dispersion: According to the prescription amount, add the telmisartan raw material drug into ethanol, stir and dissolve until the solution is clear, then add Eudragit E100, continue to stir and dissolve until the solution is clear. Then, under the condition that the temperature does not exceed 40°C, vacuumize, quickly distill off the organic solvent under reduced pressure, dry under reduced pressure overnight, and pass through a 40-mesh sieve after crushing to obtain a solid dispersion of telmisartan, which is sealed and stored for future use.

[0059] Solubility test: Weigh a certain amount of telmisartan solid dispersion and telmisartan raw material prepared by the above prescriptions 1 to ...

Embodiment 2

[0062] Embodiment 2: the preparation of telmisartan amlodipine bilayer tablet

[0063] The prescription of telmisartan and amlodipine double-layer tablet is composed as follows (making 1000 tablets altogether):

[0064]

[0065] The preparation process of telmisartan amlodipine bilayer tablet is as follows:

[0066] Add Telmisartan into ethanol according to the prescribed amount, stir and dissolve until the solution is clear, then add Eudragit E100, continue stirring and dissolving until the solution is clear. Under the condition that the temperature does not exceed 40°C, vacuumize, quickly evaporate the organic solvent under reduced pressure, dry under reduced pressure overnight, pass through a 40-mesh sieve after crushing, and then fully mix with sorbitol and microcrystalline cellulose, then add stearic acid After the magnesium is fully mixed again, the mixed granules of the telmisartan layer are obtained, and the content of the mixed granules is detected for subsequent ...

Embodiment 3

[0069] Embodiment 3: the preparation of telmisartan amlodipine bilayer tablet

[0070] The prescription of telmisartan and amlodipine double-layer tablet is composed as follows (making 1000 tablets altogether):

[0071]

[0072] The preparation process of telmisartan amlodipine bilayer tablet is as follows:

[0073] Add Telmisartan into ethanol according to the prescribed amount, stir and dissolve until the solution is clear, then add Eudragit E100, continue stirring and dissolving until the solution is clear. Under the condition that the temperature does not exceed 40°C, vacuumize, quickly evaporate the organic solvent under reduced pressure, dry under reduced pressure overnight, pass through a 40-mesh sieve after crushing, and then fully mix with sorbitol and microcrystalline cellulose, then add stearic acid After the magnesium is fully mixed again, the mixed granules of the telmisartan layer are obtained, and the content of the mixed granules is detected for subsequent ...

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Abstract

The invention discloses a method for preparing telmisartan and amlodipine double-layer tablets. The double-layer tablets comprise a telmisartan layer and an amlodipine besylate layer, wherein the telmisartan exists in a solid dispersion form. According to the method for preparing telmisartan and amlodipine double-layer tablets provided by the invention, good dissolution behaviors of the telmisartan and amlodipine besylate are guaranteed, and high stability of the amlodipine besylate is also guaranteed, so that the quality and curative effects of the telmisartan and amlodipine double-layer tablets are ensured. The preparation method is simple and feasible and is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of a telmisartan amlodipine double-layer tablet, belonging to the field of pharmaceutical preparations. Background technique [0002] Telmisartan is an angiotensin II receptor antagonist, chemical name: 4'-{[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2 -n-propyl-1H-benzimidazol-1-yl]methyl}biphenyl-2-carboxylic acid, the chemical structure is as follows: [0003] [0004] Amlodipine is a dihydropyridine calcium channel blocker, chemical name: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl )-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, its benzenesulfonate is often used in medicine, and its chemical structure is as follows: [0005] [0006] Telmisartan and amlodipine bilayer tablets include two antihypertensive active ingredients, telmisartan and amlodipine besylate, and telmisartan selectively blocks angiotensin II and AT 1 Binding of receptors in multiple tissues, such as vascular ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61K31/4422A61K9/24A61K47/32A61P9/12
CPCA61K9/2027A61K9/2086A61K31/4184A61K31/4422A61K2300/00
Inventor 陈再新徐丽洁陆旭芳黄侃周慧琴
Owner JIANGSU YABANG AIPUSEN PHARMA
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