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Slow-release tablets containing felodipine and metoprolo salt, and preparation method thereof

A technology for felodipine and sustained-release tablets, applied in the field of sustained-release tablets containing felodipine and metoprolol salts and its preparation, can solve the problems of immature technology and complex preparation process of double-layer tablets, and achieve technological Simple and Actionable Effects

Active Publication Date: 2012-10-17
SHANDONG UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of double-layer tablets is complicated and the technology is not yet mature, which may easily lead to many quality problems such as content uniformity in the industrial production process

Method used

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  • Slow-release tablets containing felodipine and metoprolo salt, and preparation method thereof
  • Slow-release tablets containing felodipine and metoprolo salt, and preparation method thereof
  • Slow-release tablets containing felodipine and metoprolo salt, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Tablet prescription:

[0027]

[0028] Drug-containing layer prescription:

[0029]

[0030] Sustained release layer prescription:

[0031] Ethyl Cellulose Aqueous Dispersion (Su Li) 300g

[0032] Purified water 200g

[0033] Gastric-soluble film coating layer:

[0034] Gastric Opadry 12g

[0035] Purified water 68g

[0036] Preparation:

[0037] b. Mix metoprolol succinate, ethyl cellulose 45cps, microcrystalline cellulose, and stearyl alcohol evenly, add 75% ethanol solution to prepare soft material, granulate, dry, granulate, add magnesium stearate and mix Uniformly, pressed into tablets, used as tablet cores, for later use.

[0038] b. Micronize felodipine so that its average particle size is less than 50um, add poloxamer F188 and povidone K30 into purified water in the prescribed amount, and stir for 30 minutes to disperse evenly. The prepared solution is coated on the tablet core by traditional coating method, and during this process, the speed of t...

Embodiment 2

[0042] Tablet prescription:

[0043]

[0044] Drug-containing layer prescription:

[0045]

[0046]

[0047] Sustained release layer prescription:

[0048] Ethyl cellulose aqueous dispersion (Su Li) 300g

[0049] Purified water 200

[0050] Gastric-soluble film coating layer:

[0051] Gastric Opadry 12g

[0052] Purified water 68g

[0053] Preparation method: with embodiment 1.

Embodiment 3

[0055] Tablet prescription:

[0056]

[0057] Drug-containing layer prescription:

[0058]

[0059] Sustained release layer prescription:

[0060]

[0061] Gastric-soluble film coating layer:

[0062] Gastric Opadry 12g

[0063] Purified water 68ml

[0064] Preparation:

[0065] a. Mix metoprolol succinate, Eudragit RS PO, and microcrystalline cellulose evenly, add Eudragit NE 30D to prepare a soft material, granulate, dry, granulate, add magnesium stearate, mix evenly, press Tablets, as cores, spare.

[0066] b. Micronize felodipine so that its average particle size is less than 50um, add polyoxyethylene hydrogenated castor oil and hypromellose E5 into purified water in the prescribed amount, and stir for 30 minutes to disperse evenly. The prepared solution is coated on the tablet core by traditional coating method, and during this process, the speed of the coating pan is controlled at 6-8 rpm, the tablet bed temperature is 40-45°C, and the spray speed is 3-5g...

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Abstract

The present invention provides slow-release tablets containing felodipine and a metoprolo salt, and a preparation method thereof. The slow-release tablets comprise a tablet core, a drug-containing layer, a slow-release coating layer and a film coating layer from the inside to the outside, wherein the tablet core is prepared by tableting a metoprolol salt, an insoluble slow-release framework material, and other pharmaceutically-acceptable excipients, and the drug-containing layer comprises micronized felodipine, a solubilizing agent and a binder. According to the present invention, the process is simple and feasible, the characteristic of 24-hour continuous release is provided, the direct tablet core coating manner is adopted to prepare the slow-release tablet, the production process can be completed in the traditional production workshop, and disadvantage of requirement of the fluidized bed and other equipment in the original process is overcome.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a slow-release tablet containing felodipine and metoprolol salt and a preparation method thereof. Background technique: [0002] Felodipine (Felodipine) is a vascular selective calcium antagonist for the treatment of hypertension and stable angina. Felodipine belongs to dihydropyridine derivatives, which inhibits the electrical behavior and contraction behavior of vascular smooth muscle by acting on calcium ion channels on the cell membrane, thereby reducing peripheral vascular resistance, especially arterial vascular resistance. Felodipine has extremely low solubility in water, and becomes an obstacle affecting absorption due to incomplete or slow dissolution in the body, making it a difficult problem to control its release by preparing its slow and controlled release preparation, and to be absorbed and utilized by the human body for a long time. Pharm...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K9/22A61K31/4422A61P9/12A61P9/10A61K31/138
Inventor 常建晖张义智陈芹利江玉娟宋洋王京凯
Owner SHANDONG UNIV
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