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Silibinin oral disintegration tablet and its preparing method

A technology for oral disintegrating tablets and silibinin, which is applied in the field of silibinin preparations and can solve problems such as undiscovered

Inactive Publication Date: 2005-03-02
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No orally disintegrating tablet preparations or related literature of silibinin have been found

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment one direct flavoring method

[0033] 1. Prescription

[0034] 1. Raw material - 70.0g of silybin;

[0035] 2. Adhesive - polyvinylpyrrolidone K-30 1.0g;

[0036] 3. Filling agent - mannitol 184.0g;

[0037] 4. Flavoring agent - aspartame 3.0g;

[0038] Orange essence 6.0g;

[0039] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0040] Croscarmellose sodium 16.0g;

[0041] 6. Glidant—micronized silica gel 3.0g;

[0042] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0043] The total weight is 300g, and a total of 2000 pieces are made.

[0044] 2. Preparation method

[0045] 1) Take the silibinin raw material and pulverize it, granulate it with polyvinylpyrrolidone K-30, use water or ethanol as a wetting agent, pass it through a 26-mesh sieve, dry it, and set aside;

[0046] 2) Pass the cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate, orange flavor and asp...

Embodiment 2

[0049] Example 2 Powder coating taste masking method

[0050] 1. Prescription

[0051] 1. Raw material - 70.0g of silybin;

[0052] 2. Coating material - Eudragit  E100 20.0g;

[0053] 3. Filling agent - mannitol 162.0g;

[0054] 4. Flavoring agent - aspartame 3.0g;

[0055] Orange essence 6.0g;

[0056] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0057] Croscarmellose sodium 16.0g;

[0058] 6. Glidant—micronized silica gel 6.0g;

[0059] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0060] The total weight is 300g, and a total of 2000 pieces are made.

[0061] 2. Preparation method

[0062] 1) Take Eudragit E100 is dissolved with more than 95% pharmaceutical industrial ethanol and diluted to a certain concentration for later use;

[0063] 2) Take silibinin and place it in a fluidized bed to boil, spray the above-mentioned solution at a certain speed for powder coating to obtain silybin powder-coated granules, and dry them for later use;

[0...

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Abstract

The present invention relates to one kind of orally disintegrated silibinin tablet for protecting liver cell, stimulating the biological synthesis of protein inside liver cell, promoting recovery of damaged liver cell, resisting fibrillation, capturing free oxygen radical and inhibiting the deposition and infiltration of fat in liver, and its preparation. The orally disintegrated silibinin tablet is prepared with silibinin as main material, and through adding stuffing, disintegrating agent, corrective, flow assistant and other supplementary material, pressing into tablet and other steps. The present invention has the features of low production cost, fast disintegration, good taste, etc.

Description

[technical field] [0001] The present invention relates to a silibinin preparation which has the obvious effect of protecting and stabilizing liver cells and is used for treating acute and chronic hepatitis, liver cirrhosis, liver poisoning and other diseases, especially relates to a silybin preparation with quick release effect Orally disintegrating tablet formulation. [Background technique] [0002] Silybin is a monomeric compound extracted from silymarin, which has the same indications and clinical efficacy as silymarin. [0003] Silibinin has low bioavailability due to its poor solubility. At present, the dosage forms of silibinin preparations mainly include common tablet and capsule dosage forms. Orally disintegrating tablet preparations or related literature of silybin have not been found. The silibinin is made into an orally disintegrating tablet, which is convenient for patients to carry and take, and is conducive to improving the patient's compliance, thereby ensu...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/357A61P1/16A61P31/12
Inventor 蒋海松王红喜王锦刚
Owner COSCI MED TECH CO LTD