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Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet

A technology of fenofibric acid and physiology, applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of preparation method of fenofibric acid enteric-coated sustained-release tablets not mentioned , Suspensions are unfavorable for patients to take, and the dosage is not easy to control, etc., to achieve good effects, high production efficiency, and good stability

Active Publication Date: 2013-05-08
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the micropellet process requires fluidized bed bottom spray coating technology, multiple coatings on the micropellets, long processing time, the prepared suspension is not conducive to patients taking, and the dosage is not easy to control
[0007] None of the above materials mentioned enteric-coated sustained-release tablets of fenofibric acid and its physiologically acceptable salts and their preparation methods

Method used

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  • Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet
  • Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet
  • Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Among them, 178.69mg choline fenofibric acid is equivalent to 135mg fenofibric acid.

[0049] Preparation:

[0050]Weigh each material in the prescription, and mix the weighed choline fenofibric acid, hypromellose (K100LV), hypromellose (E50) and lactose in a granulator evenly. Spray 95% ethanol into the granulator during stirring. The prepared soft material is sieved through a granulator, dried, and the moisture content of the granules is controlled below 3%. Add the prescribed amount of magnesium stearate into the above-mentioned materials, and mix well. The tablets are punched with 9mm dimples to obtain sustained-release tablets.

Embodiment 2

[0053] Among them, 59.57mg of choline fenofibric acid is equivalent to 45mg of fenofibric acid.

[0054] Preparation:

[0055] Weigh each material in the prescription, and mix the weighed choline fenofibric acid, hypromellose (K100LV), hypromellose (E50) and lactose in a granulator evenly. Spray 95% ethanol into the granulator during stirring. The prepared soft material is sieved through a granulator, dried, and the moisture content of the granules is controlled below 3%. Add the magnesium stearate of prescription quantity in the above-mentioned material, mix well. The tablets are punched with 6mm dimples to obtain sustained-release tablets.

Embodiment 3

[0057] Tablet prescription:

[0058] material

mg / tablet

Proportion

Choline Fenofibric Acid

178.69

59.57%

Hypromellose (K100LV) (sustained release material)

37

12.33%

Hypromellose (E50) (sustained release material)

31.5

10.50%

Lactose (filler)

49.7

16.57%

Magnesium Stearate (Lubricant)

3.1

1.03%

total

300.0

100%

[0059] Enteric Coating Prescription

[0060] Acryl (enteric coating material)

73.44g

water

293.76g

Coating weight gain about 15%

[0061] Preparation of enteric coating solution: Add Acryl to the stirring water, keep stirring until fully mixed and set aside.

[0062] Preparation:

[0063] Weigh each material in the prescription, and mix the weighed choline fenofibric acid, hypromellose (K100LV), hypromellose (E50) and lactose in a granulator evenly. Spray 95% ethanol into the granulator during stirring. The...

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PUM

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Abstract

The invention discloses an enteric-coated sustained release tablet of fenofibric acid or physiologically acceptable salts and a preparation method of the enteric-coated sustained release tablet. The enteric-coated sustained release tablet is prepared form the following components: the fenofibric acid or physiologically acceptable salts, a sustained-release material, a filling agent, a lubricant, an enteric coating material and alternatively plasticizer and / or an anti-sticking agent. The enteric-coated sustained release tablet of the fenofibric acid or the physiologically acceptable salts and the preparation method of the enteric-coated sustained release tablet have the advantages of a simple process, taking convenience and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. It specifically relates to an enteric-coated preparation containing fenofibric acid and a physiologically acceptable salt thereof and a preparation method thereof. Background technique [0002] Fenofibric acid, that is, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propionic acid, commonly used as a salt formed with choline, is a blood lipid-lowering drug, with diet Control is used for patients with dyslipidemia to reduce triglyceride and low-density cholesterol levels and increase high-density cholesterol levels. [0003] Fenofibrate is a commonly used lipid regulator, which is converted into the active molecule fenofibric acid in the body after being absorbed; the mechanism of action of choline fenofibric acid is the same as that of fenofibrate, but due to the The acid is the actual active ingredient, so the specification of choline fenofibric acid is much smaller than that of f...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K31/192A61K47/38A61K47/40A61K47/36A61K47/32A61P3/06
Inventor 陆芳路珊珊李浩冬路显锋
Owner YANGTZE RIVER PHARM GRP CO LTD
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