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Slow-released dosage form of sodium ferulate and preparation process thereof

A technology of sodium ferulate and sustained-release agent, applied in the field of medicine, can solve the problems of large fluctuation of drug concentration, and achieve the effect of reducing the number of administrations and overcoming the large fluctuation.

Inactive Publication Date: 2006-01-11
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the short biological half-life of sodium ferulate and fast absorption after oral administration, the elimination in the body is also fast. In order to maintain a stable blood concentration, it is necessary to increase the number of administrations, usually 3 to 4 times a day, so it is recommended for patients, especially long-term medication. It brings a lot of inconvenience to the patients, and the high frequency of taking the medicine often causes the defect that the drug concentration fluctuates greatly in the body

Method used

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  • Slow-released dosage form of sodium ferulate and preparation process thereof
  • Slow-released dosage form of sodium ferulate and preparation process thereof
  • Slow-released dosage form of sodium ferulate and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] The preparation of embodiment 1 sodium ferulate HPMC sustained-release tablet

[0014] Get 1.6kg of HPMC (product of Colorcon Company), 1kg of sodium ferulate (product of Chengdu Hengda Pharmaceutical Factory, the same below), pass through 80 mesh sieve respectively, and mix well. Use 1000mL of 10% polyvinylpyrrolidone ethanol solution as a binder, granulate with a 14-mesh sieve, dry at 60°C, add 27g of lubricant magnesium stearate, mix well, and compress with a rotary tablet machine. The HPMC sustained-release tablets of sodium ferulate were obtained, and each tablet contained 100 mg of sodium ferulate.

[0015] Detection of sustained release effect:

[0016] According to the "Chinese Pharmacopoeia" 2000 edition, the basket method for in vitro drug release testing of sustained-release preparations was carried out. Get 6 tablets of Sodium Ferulate HPMC Sustained-release Tablets, simulate in vivo conditions (temperature 37°C, rotating speed 50 rpm), use 900mL water as ...

Embodiment 2

[0017] Example 2 Preparation of Sodium Ferulate Compritol 888 ATO Sustained Release Tablets

[0018] Take 1.5kg of Compritol 888 ATO (French Jiafasai company product, the same below) and 1.5kg of sodium ferulate, pass through 80-mesh sieve respectively, and mix well. Use 200mL of 95% ethanol as a binder, granulate with a 14-mesh sieve, dry at 35°C, add 30g of magnesium stearate, mix well, and compress with a rotary tablet machine to obtain Sodium Ferulate Compritol 888 ATO sustained-release tablets, each containing 150mg of sodium ferulate.

[0019] Detection of sustained release effect:

[0020] Detection method is with embodiment 1, and the results are shown in figure 2 , indicating that the Compritol 888 ATO sustained-release tablets of sodium ferulate have obvious sustained-release characteristics, and the release of the drug can be maintained for 12 hours. Carry out animal test with embodiment 1, sodium ferulate Compritol 888 ATO slow release tablet all can maintain e...

Embodiment 3

[0021] Example 3 Preparation of Sodium Ferulate Compritol 888 ATO Sustained Release Tablets and Capsules by Solid Dispersion Technology

[0022] Take 1.5kg of Compritol 888 ATO, heat and melt it in a water bath at 80°C, add 1.5kg of sodium ferulate, and keep stirring to make it fully mixed with Compritol 888 ATO to form a solid dispersion. After natural cooling, use a pulverizer (upper Haidian Jiu Traditional Chinese Medicine Machinery Manufacturing Co., Ltd.) pulverized, passed through a 30-mesh sieve, then made granules with 200 mL of 95% ethanol as a binder, dried at 35°C, and used to prepare sustained-release tablets or capsules. When preparing tablets, add 30 g of magnesium stearate, mix well, and compress with a rotary tablet machine to obtain Compritol 888 ATO sustained-release tablets of sodium ferulate, each containing 150 mg of sodium ferulate. If capsules are prepared, the dried granules are directly filled into capsules, such as No. 1 hard capsules, to obtain Comp...

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Abstract

The present invention uses hydroxypropyl methylcellulose or glycerol behenate as slow-seleased auxiliary material, and adopts tableting process and solid dispersion technique to make sodium ferulate into various slow-released dosage forms whose slow-releasing effect can be up to 12-24 hr, so as to reduce frequency of administration and make blood medicine concentration retain smoothly and stably in longer time.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and relates to a slow-release dosage form of sodium ferulate and a preparation method thereof. Background technique: [0002] Sodium ferulate is a water-soluble active ingredient extracted from angelica or chuanxiong, also known as angelica or chuanxiong. Commonly used medicines, its pharmaceutical dosage form has conventional dosage forms such as common tablet, powder and aqueous solution. Due to the short biological half-life of sodium ferulate and fast absorption after oral administration, the elimination in the body is also fast. In order to maintain a stable blood concentration, it is necessary to increase the number of administrations, usually 3 to 4 times a day, so it is recommended for patients, especially long-term medication. It brings a lot of inconvenience to the patients, and the high frequency of taking medicine often causes the defect that the drug concentration fluctuates great...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/19A61K9/22A61P9/10
Inventor 胡晋红李凤前
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY