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Sodium ferulate enteric preparation and preparation method

A technology of sodium ferulate and enteric-coated preparations, which is applied in the fields of antidote, pill delivery, and pharmaceutical formulations. It can solve problems such as low bioavailability and gastric mucosal bleeding, and achieve the effect of reducing the potential risk of bleeding

Inactive Publication Date: 2009-10-07
成都亨达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium ferulate gastric-soluble capsules have low bioavailability in gastric acid environment, and there is a potential gastric mucosal bleeding problem in long-term use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Tablets made by methods known in the pharmaceutical industry (also can be other oral solid preparations), contain the following components by weight percentage:

[0013] 53.2% of sodium ferulate, 31.9% of starch, 14.8% of dextrin, polyacrylic acid resin II and magnesium stearate are made into tablets in appropriate amounts. The cellulose acetate phthalate (CPA) is formulated into an 8%-12% solution with a mixed solvent of acetone and ethanol, sprayed and coated on ordinary sodium ferulate tablets to form enteric-coated tablets.

[0014] Cellulose acetate phthalate (CPA) is insoluble when the pH is below 6, and dissolves when the pH is above 6, so that the active ingredient sodium ferulate can be dissolved only after the tablet enters the intestinal tract.

Embodiment 2

[0016] Tablets made by methods known in the pharmaceutical industry (also can be other oral solid preparations), contain the following components by weight percentage:

[0017] 40.3% of sodium ferulate, 20.0% of sucrose, 18.1% of dextrin, 21.4% of oxidized starch, sodium carboxymethyl cellulose and magnesium stearate are made into ordinary tablets in appropriate amount. The polyvinyl alcohol phthalate (PVAP) is prepared into a 12%-18% solution with a mixed solvent of acetone and ethanol, sprayed and coated on ordinary tablets of sodium ferulate to form enteric-coated tablets.

[0018] Polyvinyl alcohol phthalate (PVAP) is an enteric-coated material in the preparation, and the tablet wrapped is insoluble in the stomach, and the active ingredient sodium ferulate is dissolved only after reaching the intestinal tract, thereby achieving intestinal absorption.

Embodiment 3

[0020] Tablets made by methods known in the pharmaceutical industry (also can be other oral solid preparations), contain the following components by weight percentage:

[0021] 50.0% of sodium ferulate, 35.5% of microcrystalline cellulose, 10.2% of pregelatinized starch, 3.9% of dextrin and magnesium stearate, etc. are made into ordinary tablets in appropriate amounts. Hydroxypropylmethylcellulose phthalate (HPMCP) is prepared into a 6%-10% solution with a mixed solvent of acetone and ethanol, sprayed and coated on ordinary tablets of sodium ferulate to form enteric-coated tablets.

[0022] Hydroxypropylmethylcellulose phthalate (HPMCP) can only be dissolved between PH5-6, and it dissolves in the duodenum. The wrapped tablet is insoluble in the stomach, and the active ingredient Ferulicum is dissolved in the duodenum Sodium acid, so as to achieve intestinal absorption.

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PUM

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Abstract

The invention relates to a sodium ferulate enteric preparation and preparation method. The sodium ferulate enteric preparation is composed of enteric film material layer and sodium ferulate medical preparation filled in the enteric film material layer. The invention overcomes the low bioavailability of gastric sodium ferulate capsule in the gastric acid environment and bleeding of gastric mucosa after taking for a long time. The sodium ferulate enteric preparation has better bioavailability in the small intestine alkalescence environment (intestinal juice is alkalescence) than that of gastric acid environment and greatly reduces the bleeding risk.

Description

technical field [0001] The invention relates to a sodium ferulate enteric-coated preparation and a preparation method thereof. Background technique [0002] Sodium ferulic acid is also known as chuanxiong element. Ferulic acid is the main active ingredient of the famous traditional Chinese medicine Chuanxiong and Angelica for promoting blood circulation and removing blood stasis. Improve microcirculation, scavenge free radicals, protect vascular endothelium, etc. Sodium ferulate is a type of chemical drug independently developed and synthesized by my country on the basis of clarifying the molecular structure of the functional components of traditional Chinese medicine. [0003] At present, the oral preparations of sodium ferulate are mainly gastric-dissolved tablets and gastric-dissolved capsules. Sodium ferulate gastric-soluble capsules have low bioavailability in gastric acid environment, and there is a potential gastric mucosal bleeding problem in long-term administrati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K9/32A61K9/36A61K9/48A61K47/32A61K47/36A61K47/38A61K47/42A61K47/46A61K31/192A61P7/02A61P39/06
Inventor 李志强唐楷
Owner 成都亨达药业有限公司
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