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Silibinin double-layer slow-release tablets and preparation method thereof

A technology of silibinin and sustained-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., can solve the problems of low drug content, achieve good reproducibility, reduce the number of times of taking medicine, Effect of Uniform Effective Plasma Concentration

Inactive Publication Date: 2013-01-02
SICHUAN ACAD OF CHINESE MEDICINE SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cumulative drug release of the prepared solid dispersion was 69.3% at 2 hours, and the solubility of silibinin was improved. and in the in vitro release test of sustained-release preparations, it only shows that the cumulative release amount of 12h is more than 80%, and its technical scheme is not supported by the examples of sustained-release preparations, and it is not in accordance with the Chinese Pharmacopoeia on the application of sustained-release preparations. Select 3 points to characterize the drug release requirements of in vitro sustained-release preparations; the stability test has no examples and relevant data to support the conclusion

Method used

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  • Silibinin double-layer slow-release tablets and preparation method thereof
  • Silibinin double-layer slow-release tablets and preparation method thereof
  • Silibinin double-layer slow-release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0048]

[0049] Preparation process: Mix silibinin solid dispersion, MCC, PVPP, and L-HPC through an 80-mesh sieve, add 6g of micropowder silica gel and mix evenly to obtain immediate-release layer granules; Part of the raw material of Binbin is replaced by the same amount of lactose, and 20ml of 5% PVPk30 ethanol solution is added to make a soft material, passed through a 26-mesh sieve to granulate, dried at 45°C, granulated with a 24-mesh sieve, and added with 1% magnesium stearate Mix evenly to obtain blank slow-release layer granules. The sustained-release granules and immediate-release granules are punched into a double-layer sustained-release tablet with an 8 mm shallow concave.

Embodiment 3

[0051]

[0052] Preparation process: Mix the quick-release part of the excipients evenly by sieving, replace the SLB solid dispersion with an equivalent amount of MCC, and obtain the quick-release layer granules; mix the silybin raw material drug, HPMCk4M, and lactose evenly by grinding, add 20ml of 5% PVPk30 ethanol solution is used to make soft materials, passed through a 26-mesh sieve to granulate, dried at 45°C, sized with a 24-mesh sieve, added 1% magnesium stearate and mixed evenly to obtain sustained-release layer granules. The sustained-release granules and immediate-release granules are punched into a double-layer sustained-release tablet with an 8 mm shallow concave.

Embodiment 4

[0054]

[0055] Preparation process: First pass the main and all auxiliary materials through a 80-mesh sieve. Mix the silibinin solid dispersion in the quick-release layer with other excipients in the quick-release layer evenly by sieving, then add micropowdered silica gel and mix well to obtain the quick-release granules; take the silybin in the slow-release layer Mix thisbinin with HPMCk4M and lactose evenly by grinding, make soft material with 10ml of 5% PVPk30 ethanol solution, granulate through a 26-mesh sieve, dry at 45°C, granulate with a 24-mesh sieve, add magnesium stearate and mix evenly. Sustained-release granules are obtained. The sustained-release granules and immediate-release granules are punched into a double-layer sustained-release tablet with an 8 mm shallow concave.

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Abstract

The present invention discloses silibinin double-layer slow-release tablets, which comprise an immediate release layer and a slow-release layer, wherein the immediate release layer mainly comprise a silibinin solid dispersion, a filler, a disintegrating agent and a lubricant, the slow-release layer mainly comprises silibinin, a slow-release material, a filler, a lubricant and a binder, a weight ratio of the silibinin content in the immediate release layer to the silibinin content in the slow-release layer is 2:8-3:7, and a weight ratio of the immediate release layer to the slow-release layer is (1.5-2.4):1. A purpose of the present invention is to provide the silibinin double-layer slow-release tablets with characteristics of good patient compliance, low side effect, rapid effect, and lasting maintenance of stable effective blood drug level. The present invention further discloses a preparation method for the silibinin double-layer slow-release tablets. The method of the present invention has characteristics of good reproducibility and high production efficiency, and is suitable for industrial mass production. In addition, the prepared double-layer slow-release tablets have good release uniformity.

Description

technical field [0001] The invention relates to a silibinin double-layer sustained-release tablet and a preparation method thereof, in particular to a silibinin quick-release plus sustained-release double-layer sustained-release tablet and a preparation method thereof, belonging to the field of preparations. Background technique [0002] Silybin (SLB) is an active ingredient extracted from the herb of Compositae, milk thistle. It has obvious protective and stabilizing effects on liver cells, and has different degrees of therapeutic effects on various liver diseases. It is currently recognized as a liver injury repair drug with definite curative effects. Preparations based on it have been widely used in the treatment of acute and chronic hepatitis and liver cirrhosis. Clinically, it is mainly used to treat acute and chronic hepatitis, various liver injuries, liver fibrosis and early liver cirrhosis [Kaur M, Agarwal R. Silymarin and epithelial cancer chemoprevention: How to c...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/357A61P1/16
Inventor 徐超群阮佳袁志翔詹雁岑菁谭镭
Owner SICHUAN ACAD OF CHINESE MEDICINE SCI
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