Probucol solid dispersion

A technology of solid dispersion and probucol, which is applied in the field of preparation of probucol solid dispersion, can solve the problems that solid dispersion is easy to absorb moisture and disintegrate, unstable, and has no better solution

Inactive Publication Date: 2010-01-27
北京诺美生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Solid dispersions are easy to absorb moisture and disintegrate and are unstable, so far

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Feeding proportions are all percentages by weight (excluding solvents, the same below) that account for the total feeding amount, and Probucol is 5%-20%; PVP K 30 56%-88.5%; Tween 80 3%-15%; sodium lauryl sulfate 0.5%-1%; S40 3%-8%. The mixed solvent ratio is 100%-0% ethanol to 0%-100% acetone. Add all the drugs and auxiliary materials in proportion to the round bottom distillation flask of the rotary thin film evaporator, add the full amount of ethanol: acetone mixed solvent at one time (add 3ml of mixed solvent for every 1g of solid feeding amount), open the condensed water of the condenser, and turn on the rotary switch Rotate the distillation flask at a medium speed, and gradually heat the oil bath to an external temperature of about 60°C, distill acetone under normal pressure, and distill ethanol under reduced pressure to dryness. Quickly remove the distillation flask, quickly transfer the solid in the bottle to a pre-frozen clean and dry reagent bottle, quickly p...

Embodiment 2

[0019] Feeding ratio: 5% probucol, 88.5% PVP K 30 , 3% Tween 80, 0.5% Sodium Lauryl Sulfate, 3% S40. Add all the drugs and auxiliary materials in proportion to the round bottom distillation bottle of the rotary thin film evaporator, add the full amount of absolute ethanol at one time (add 3ml of absolute ethanol for every 1g of solid feeding amount), turn on the condensed water of the condenser, and turn on the rotary switch to make Rotate the distillation flask at a medium speed, and gradually heat the oil bath to an external temperature of about 60°C, and distill the ethanol to dryness under reduced pressure. Thereafter, the same operation as Example 1.

Embodiment 3

[0021] Feeding ratio: 20% probucol, 61% PVP K 30 , 10% Tween 80, 1% Sodium Lauryl Sulfate, 8% S40. Add all the drugs and auxiliary materials in proportion to the round bottom distillation flask of the rotary thin film evaporator, add the full amount of acetone at one time (add 3ml of acetone for every 1g of solid material), turn on the condensed water of the condenser, and turn on the rotary switch to make the distillation flask medium speed. Rotate, and gradually heat the oil bath to an external temperature of about 60°C, steam acetone at normal pressure, and steam to dryness under reduced pressure. Thereafter, the same operation as Example 1.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and in particular relates to probucol solid dispersion prepared by a solvent method. In the total charging amount, probucol accounts for 5 to 20 percent, PVP K30 accounts for 56 to 88.5 percent, tween-80 accounts for 3 to 15 percent, lauryl sodium sulfate accounts for 0.5 to 1 percent, and polyoxyethylene 40 monostearate accounts for 3 to 8 percent. The solid dispersion, 0.15 to 3 percent of superfine silica powder and 0.3 to 0.9 percent of magnesium stearate are mixed fully and evenly, and are subjected to compressing dry granulation and coating. The dissolution of the solid dispersion in 20 months is over 90 percent, and the bioavailability thereof is 580 percent.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to the preparation of a probucol solid dispersion and various dosage forms related thereto. Background technique [0002] Probucol's domestic and foreign marketed dosage forms are only tablets. Because it is a fat-soluble drug, its solubility in gastric and intestinal juices is small, so only 5-10% of the probucol in the tablet is absorbed and utilized by the human body. If it is too large (1g per day), it will cause the waste of raw materials and increase the financial burden on consumers. There are chemical means and preparation means to increase the solubility of this product in gastric and intestinal juice. Chemical means can transform the chemical structure of probucol into a water-soluble structure, but it is not the content of this research; the oil solution of probucol found in laboratory research literature in preparation means: WO92 / 10996, ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/10A61K47/32
Inventor 方树青
Owner 北京诺美生物科技有限公司
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