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Silibinin meglumine salt oral disintegration tablet preparation and its preparing method

A technology of silibinin and meglumine salt, which is applied in the fields of pill delivery, antiviral agents, and medical preparations containing active ingredients, and can solve problems that have not yet been discovered

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

Orally disintegrating tablet preparations or related literature of silibinin meglumine salt have not been found

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment one direct flavoring method

[0034] 1. Prescription

[0035] 1. Raw material - silybin meglumine salt 100.0g;

[0036] 2. Adhesive - polyvinylpyrrolidone K-30 1.0g;

[0037] 3. Filling agent - mannitol 154.0g;

[0038] 4. Flavoring agent - aspartame 3.0g;

[0039] Orange essence 6.0g;

[0040] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0041] Croscarmellose sodium 16.0g;

[0042] 6. Glidant—micronized silica gel 3.0g;

[0043] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0044] The total weight is 300g, and a total of 2000 pieces are made.

[0045] 2. Preparation method

[0046] 1) The raw material of silibinin meglumine salt is crushed, granulated with polyvinylpyrrolidone K-30, water or ethanol is used as a wetting agent, passed through a 26-mesh sieve, dried, and set aside;

[0047] 2) Pass the cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate, o...

Embodiment 2

[0050] Example 2 Powder coating taste masking method

[0051] 1. Prescription

[0052] 1. Raw material - silybin meglumine salt 100.0g;

[0053] 2. Coating material - Eudragit  E100 20.0g;

[0054] 3. Filling agent - mannitol 132.0g;

[0055] 4. Flavoring agent - aspartame 3.0g;

[0056] Orange essence 6.0g;

[0057] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0058] Croscarmellose sodium 16.0g;

[0059] 6. Glidant—micronized silica gel 6.0g;

[0060] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0061] The total weight is 300g, and a total of 2000 pieces are made.

[0062] 2. Preparation method

[0063] 1) Take Eudragit  E100 is dissolved with more than 95% pharmaceutical industrial ethanol and diluted to a certain concentration for later use;

[0064] 2) Take silibinin meglumine salt and place it in an ebullating bed for boiling, spray the above solution at a certain speed for powder coating to obtain silibinin meglumine salt powder-coated gr...

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Abstract

The present invention relates to one kind of orally disintegrated silibinin-meglumine salt 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-meglumine salt tablet is prepared with silibinin-meglumine salt 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 invention relates to a silibinin meglumine salt 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 kind of silibinin meglumine salt preparation with quick release effect Orally disintegrating tablet preparation of silybin meglumine salt. [Background technique] [0002] Silybin meglumine salt is a combination of silybin and meglumine (1-methylamino-1-deoxysorbitol), and silybin meglumine salt is more soluble than silybin In water, so the absorption speed and curative effect are better than silybin. [0003] Silybin meglumine salt and silybin have the same indications and clinical efficacy. [0004] The bioavailability of silibinin meglumine salt is low due to its poor solubility. At present, the dosage forms of silybin meglumine salt preparation mainly include common tablet and capsul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/357A61P1/16A61P3/06A61P31/12
Inventor 蒋海松王红喜王锦刚
Owner COSCI MED TECH CO LTD
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