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Solid dispersion tablet for treating cardiovascular disease and preparation method thereof

A solid dispersion tablet and cardiovascular technology, which is applied in the preparation of solid dispersion tablets and the field of solid dispersion tablets for the treatment of cardiovascular diseases, which can solve the problems of lower bioavailability, large differences in loading capacity, and small drug solubility. , to achieve high bioavailability, reduced dosage, and convenient transportation

Inactive Publication Date: 2008-09-24
广州市元通医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the company has only developed the capsule dosage form of probucol monosuccinate. We have conducted research on the capsules and found that the volume of the capsules varies greatly, and the quality stability is poor. Long-term exposure of the capsules to a high humidity environment will affect Their in vitro release may reduce their bioavailability, resulting in the need for larger doses when administered
In order to control the dosage and ensure the curative effect clinically, we have studied its tablet dosage form, but because probucol monosuccinate is a fat-soluble drug, when the tablet enters the stomach, the solubility of the drug in the stomach is very small, and the utilization rate is low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Composition of solid dispersible tablet:

[0024] Probucol Monosuccinate 250mg

[0025] pvp K30 400mg

[0026] Tween 80 70ml

[0027] Magnesium Stearate 5000mg

[0028] Preparation:

[0029] Weigh 400mg PVP K30 And measure 30ml of 95% ethanol and 1600ml of acetone into the thin film evaporator and keep the temperature at 50°C and rotate until completely dissolved, then add 70ml of Tween 80, 250mg of probucol monosuccinate and 5000mg of magnesium stearate, and continue to rotate, Raise the temperature, evaporate acetone under normal pressure; raise the temperature to 80°C and evaporate the solvent to dryness under reduced pressure, then quickly place the solid material in a cold pot and seal it, freeze it for 4 hours, dry it in vacuum for 2 hours, and use 1:15 ethanol The solution is granulated, finally sieved for granulation, the content is measured, and tabletted to make 1000 tablets, and then film-coated.

Embodiment 2

[0031] Composition of solid dispersible tablet:

[0032] Probucol Monosuccinate 300mg

[0033] pvp K30 500mg

[0034] Tween 80 60ml

[0035] Magnesium Stearate 8000mg

[0036] Preparation:

[0037] Weigh 500mg PVP K30 And measure 60ml of 95% ethanol and 2000ml of acetone into the thin film evaporator and keep the temperature at 60°C and rotate until completely dissolved, then add 60ml of Tween 80, 300mg of probucol monosuccinate and 8000mg of magnesium stearate, and continue to rotate, Raise the temperature, evaporate acetone under normal pressure; raise the temperature to 85°C and evaporate the solvent under reduced pressure to dryness, then quickly place the solid material in a cold pot and seal it, freeze it for 5 hours, dry it in vacuum for 2 hours, and use 1:15 ethanol The solution is granulated, finally sieved for granulation, the content is measured, and tabletted to make 1000 tablets, and then film-coated.

Embodiment 3

[0039] Composition of solid dispersible tablet:

[0040] Probucol Monosuccinate 270mg

[0041] pvp K30 300mg

[0042] Tween 80 120ml

[0043] Magnesium Stearate 9000mg

[0044] Preparation:

[0045] Weigh 300mg PVP K30 And measure 80ml 95% ethanol and 2600ml acetone and join in the thin-film evaporator, keep the temperature at 59 ℃ and rotate until fully dissolved, then add 120ml Tween 80, 270mg probucol monosuccinate and 9000mg magnesium stearate, continue to rotate, Raise the temperature, evaporate acetone under normal pressure; raise the temperature to 88°C and evaporate the solvent to dryness under reduced pressure, then quickly put the solid material in a cold pot and seal it, freeze for 5 hours, dry in vacuum for 3 hours, and use 1:15 ethanol The solution is granulated, finally sieved for granulation, the content is measured, and tabletted to make 1000 tablets, and then film-coated.

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PUM

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Abstract

The invention discloses a solid dispersible tab used for curing angiocardiopathy, which contains the constituents with the following part by weight: 250 to 300 shares of probucol mono-succinate, 300 to 800 shares of PVPK30, 60 to 120 shares of Tween 80 and 5000 to 16000 shares of magnesium stearate. The invention also discloses a preparation method of the solid dispersible tab: the probucol mono-succinate is prepared into the solid dispersion tab by adopting the solid dispersing technology, thereby leading the quality of the medicine to be guaranteed and having higher bioavailability. Meanwhile, the material quantity is saved, and the economic burden of the patient is relieved.

Description

technical field [0001] The invention relates to a tablet, in particular to a solid dispersion tablet for treating cardiovascular diseases. The invention also relates to a preparation method of the solid dispersion tablet. Background technique [0002] Probucol monosuccinate is a cardiovascular anti-inflammatory drug developed by AtheroGenics of the United States, and it is currently in Phase III clinical trials. However, the company has only developed the capsule dosage form of probucol monosuccinate. We have conducted research on the capsules and found that the volume of the capsules varies greatly, and the quality stability is poor. Long-term exposure of the capsules to a high humidity environment will affect Their in vitro release may reduce their bioavailability, resulting in the need for larger doses when administered. In order to control the dosage and ensure the curative effect clinically, we have studied its tablet dosage form, but because probucol monosuccinate is...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/22A61K47/34A61K47/12A61P9/00A61P29/00A61K47/26
Inventor 尹海滨
Owner 广州市元通医药科技有限公司
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