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Oxymatrine or matrine sustained-release pellet and preparation method thereof

A technology of slow-release pellets and matrine, applied in the field of medicine, can solve the problems of not being suitable for clinical needs, not easy to control the release rate, and large differences between batches of products, so as to prolong maintenance and reduce side effects Response, the effect of reducing the peak and valley phenomenon

Inactive Publication Date: 2008-05-14
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparations of matrine mainly include injections, infusions, immediate-release capsules and suppositories. The existing dosage forms are far from being suitable for clinical needs. The development of sustained-release preparations once or twice a day meets the needs of the medical market.
[0004] Matrine and matrine have excellent water solubility, and it is not easy to control the drug release rate. The main difficulty is to control the long-term and stable release of the drug.

Method used

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  • Oxymatrine or matrine sustained-release pellet and preparation method thereof
  • Oxymatrine or matrine sustained-release pellet and preparation method thereof
  • Oxymatrine or matrine sustained-release pellet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0055] (1) Preparation of binder Magnetically stir 24 grams of hydroxypropyl methylcellulose in 800 ml of distilled water at room temperature for 2-8 hours, and filter through a 100-mesh sieve after completely dissolving.

[0056] (2) Preparation of slow-release coating solution Add 0.2 g of sodium lauryl sulfate and 9.24 g of talc powder into 100 mL of water, stir for 2 hours to make it uniform, and slowly pour the above suspension into 70 g of Eudragit NE 30D , add water to 250mL, stir well. Filter through 80 mesh sieve. Stir continuously during the coating process.

[0057] (3) Preparation of drug-containing layer 300 grams of dry blank pellet cores were sprinkled with 300 grams of matrine evenly and slowly under the atomized adhesive, and dried at room temperature.

[0058] (4) Preparation of the sealing layer Continue spray coating with 50ml of adhesive, and dry at room temperature.

[0059] (5) Preparation of sustained-release coating layer Take 300 grams of 24-20 mes...

Embodiment 2

[0061] (1) Preparation of the adhesive, using water as the adhesive

[0062] (2) Preparation of slow-release coating solution Add 0.21 gram of sodium lauryl sulfate, 9.95 gram of talcum powder, and 4.2 gram of triethyl citrate into 100 mL of water, stir for 2 hours, make uniform, and slowly dissolve the above suspension Pour into 50 grams of Eudragit RS30D, add water to 250mL and stir well. Filter through 80 mesh. Stir continuously during the coating process.

[0063] (3) Preparation of drug-containing layer 400 grams of dry blank pellet cores were sprinkled with 280 grams of matrine evenly and slowly under the atomized adhesive, and dried at room temperature.

[0064] (4) Preparation of the sealing layer Use 50 ml of 3% hydroxypropyl methylcellulose aqueous solution to continue spray coating, and dry at room temperature.

[0065] (5) Preparation of slow-release coating layer Take 300 grams of pill cores with 28-24 mesh, continue to spray coating with slow-release coating s...

Embodiment 3

[0067] (1) Preparation of binder Magnetically stir 16 g of hydroxypropyl methylcellulose in 800 ml of distilled water at room temperature for 2-8 hours, and filter through a 100-mesh sieve after completely dissolving.

[0068] (2) Preparation of sustained-release coating solution Dissolve 1.35 g of polyethylene glycol 6000 in 100 mL of water (heating to aid dissolution), add 0.22 g of sodium lauryl sulfate, and 10.5 g of talc, and stir for 2 hours to make it uniform. Slowly pour the above suspension into 60 grams of Eudragit RS 30D and Eudragit RL30D (10:1), add water to 250 mL and stir well. Filter through 80 mesh. Stir continuously during the coating process.

[0069] (3) Preparation of drug-containing layer 400 grams of dry blank pellet cores were sprinkled with 280 grams of matrine evenly and slowly under the atomized adhesive, and dried at room temperature.

[0070] (4) Preparation of the sealing layer Continue spray coating with 50ml of adhesive, and dry at room temper...

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Abstract

The invention discloses an oxymatrine sustained-release pellet, a matrine sustained-release pellet and a preparation method of the sustained-release pellets, belonging to the medicine technical field. The invention is characterized in that: the sustained-release preparation mainly comprises a oxymatrine or a matrine, a blank pill core, a coating material, a surface-active material, a hydroxypropyl methylcellulose, an antisticking agent and a plasticizing agent; the weight ratios are 10 to 70 percent for the oxymatrine or the matrine, 20 to 85 percent for the blank pill core, 2 to 20 percent for the coating material, 0.01 to 1 percent for the surface-active material, 1 to 3 percent for the adhesive, 1 to 5 percent for the antisticking agent and 0 to 1.5 percent for the plasticizing agent. The invention is reposefully released in different medium from the experiment results in vitro, and has the advantages of smooth blood concentration of drug in vivo, small side effect, few medication time and long duration of drug effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to matrine or matrine sustained-release pellets and a preparation process thereof. Background technique [0002] Oxymatrine (oxymatrine) is an active ingredient extracted from the traditional Chinese medicine Sophora alopecuroides L or Sophora flavescens Ait, and the content of oxymatrine (Oxymatrine) is more than 98%. Pharmacological and clinical studies have shown that it is It has the functions of anti-tumor, anti-bacterial, anti-virus, improving liver function, preventing liver fibrosis, reducing transaminase, and improving the body's immunity. At present, matrine has been identified as a key promotional engineering drug for the treatment of viral hepatitis. It can significantly inhibit the infection of hepatitis B virus. According to quantitative gene detection, after using matrine, the replication level of hepatitis B virus in infected cells is significantly reduced, which show...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4375A61P35/00A61P9/06A61P29/00
Inventor 何仲贵孙英华王永军孙进
Owner SHENYANG PHARMA UNIVERSITY
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