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Slow-release enteric-coated sodium ferulate preparation and preparation method thereof

A technology of sodium ferulate and slow-release preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of poor stability, great influence on stability, and low bioavailability of ordinary tablets, so as to improve bioavailability, reduce the number of times of taking medicine, Guarantee the effect of drug safety

Inactive Publication Date: 2016-12-07
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium ferulate is easily oxidized, and its stability is greatly affected by alkali, light and temperature. Although antioxidants are added to liquid injection preparations and lyophilized powder injections, antioxidants may interact with sodium ferulate to generate impurity peaks , its stability is still not ideal, and the improvement of stability is still limited
Ordinary tablets have poor stability, and the active ingredients often decrease during storage, and the color turns yellow
Its bioavailability is low, and it needs to be administered three times a day. It has poor compliance for long-term use and has serious side effects in the stomach.

Method used

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  • Slow-release enteric-coated sodium ferulate preparation and preparation method thereof
  • Slow-release enteric-coated sodium ferulate preparation and preparation method thereof
  • Slow-release enteric-coated sodium ferulate preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050]

[0051] Preparation method: pass sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose through a 100-mesh sieve respectively, weigh the sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose according to the prescription amount, and mix them in a mixer Evenly, place it in a centrifugal granulator, spray 75g of ethanol solution with a volume percentage of 80% to make small pellets, and prepare hypromellose slow-release coating solution according to the prescription of the slow-release coating solution to coat the core of the plain pill. Coating, sustained release coating liquid solid content 18% ~ 21%, weight gain 2.8% ~ 3.2%, dry air 60 ~ 80m 3 / h, the air inlet temperature is 55-60°C, the coating time is 3-3.5h, and then 800g of ethanol solution with a volume percentage of 75% is used to prepare the coating powder containing the enteric material cellulose acetate phthalate Dissolve the coating solution, and then coat...

Embodiment 2

[0053]

[0054] Preparation method: pass sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose through a 100-mesh sieve respectively, weigh the sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose according to the prescription amount, and mix them in a mixer Evenly, place it in a centrifugal granulator, spray 75g of ethanol solution with a volume percentage of 80% to make small pellets, and prepare hypromellose slow-release coating solution according to the prescription of the slow-release coating solution to coat the core of the plain pill. Coating, sustained release coating liquid solid content 18% ~ 21%, weight gain 2.8% ~ 3.2%, dry air 60 ~ 80m 3 / h, the air inlet temperature is 55-60°C, the coating time is 3-3.5h, and then 800g of ethanol solution with a volume percentage of 75% is used to prepare the coating powder containing the enteric material cellulose acetate phthalate Dissolve the coating solution, and then coat...

Embodiment 3

[0056]

[0057] Preparation method: pass sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose through a 100-mesh sieve respectively, weigh the sodium ferulate, polyvinylpyrrolidone, microcrystalline cellulose, and sucrose according to the prescription amount, and mix them in a mixer Uniformly, be placed in centrifugal granulator, spray into 75g volume percent and be the ethanol solution system pellet of 80%, be prepared into coating solution by slow-release material, prepare hypromellose slow-release coating solution according to prescription The core of the vegetarian pill is coated, the solid content of the slow-release coating liquid is 18% to 21%, the weight gain is 2.8% to 3.2%, and the dry air is 60 to 80m 3 / h, the air inlet temperature is 55-60°C, the coating time is 3-3.5h, and then 800g of ethanol solution with a volume percentage of 75% is used to prepare the coating powder containing the enteric material cellulose acetate phthalate Diss...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a sodium ferulate enteric-coated sustained-release preparation and a preparation method thereof. The invention provides an enteric-coated sustained-release preparation of sodium ferulate, comprising the following raw materials in parts by mass: 30-50 parts of sodium ferulate, 20-40 parts of sustained-release materials, 3-10 parts of enteric-coated materials, pharmaceutically 10-30 parts of acceptable excipients. The present invention adopts the technology of enteric-coated sustained-release capsules. Compared with ordinary tablets, the technology of enteric-coated sustained-release capsules can maintain a stable blood drug concentration, avoid burst release effects, not disintegrate in the stomach, and reduce side effects. Medium-release medicine, improve bioavailability, take it orally once a day, reduce the number of times of taking medicine, and improve patient compliance. The prepared enteric-coated slow-release content is loaded in the capsule, avoiding the influence of antioxidants and alkali light, etc., and effectively improving the stability of the drug.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sodium ferulate enteric-coated sustained-release preparation and a preparation method thereof. Background technique [0002] Sodium ferulate is the sodium salt of ferulic acid, an effective monomer component extracted from the traditional Chinese medicine Angelica sinensis and Chuanqiong. -Hydroxycinnamic acid sodium salt dihydrate, molecular formula: C 10 h 9 NaO 4 2H 2 O. Ferulic acid is a vascular endothelial protective agent, which can scavenge free radicals, prevent lipid peroxidation damage, antagonize endothelin-induced vasoconstriction, boost blood pressure and vascular smooth muscle cell proliferation, reduce vascular endothelial damage; increase NO synthesis, relax vascular smooth muscle ; Inhibit platelet aggregation, anticoagulation, improve hemorheology characteristics. It can also inhibit the synthesis of cholesterol, lower blood lipids, affect com...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/192A61P9/10A61P9/00A61P13/12A61P9/12A61P3/10A61P9/14A61P25/06A61P25/00
Inventor 戴荣欢徐春莲陶安进袁建成
Owner HYBIO PHARMA
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