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Silibinin meglumine salt oral disintegration tablet and its preparing method

A technology for oral disintegrating tablets and silybin, which is applied in the field of oral disintegrating tablet preparations of silibinin meglumine salt and its preparation, and can solve the problems that have not yet been discovered.

Inactive Publication Date: 2006-05-03
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

[0031] Embodiment one direct flavoring method

[0032] 1. Prescription

[0033] 1. Raw material - silybin meglumine salt 100.0g;

[0034] 2. Adhesive - polyvinylpyrrolidone K-301.0g;

[0035] 3. Filling agent - mannitol 154.0g;

[0036] 4. Flavoring agent - aspartame 3.0g;

[0037] Orange essence 6.0g;

[0038] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0039] Croscarmellose sodium 16.0g;

[0040] 6. Glidant—micronized silica gel 3.0g;

[0041] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0042] The total weight is 300g, and a total of 2000 pieces are made.

[0043] 2. Preparation method

[0044] 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;

[0045] 2) Pass the cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate, or...

Embodiment 2

[0048] Embodiment two powder coating taste masking method

[0049] 1. Prescription

[0050] 1. Raw material - silybin meglumine salt 100.0g;

[0051] 2. Coating material - Eudragit E100 (Eudragit  E100) 20.0g;

[0052] 3. Filling agent - mannitol 132.0g;

[0053] 4. Flavoring agent - aspartame 3.0g;

[0054] Orange essence 6.0g;

[0055] 5. Disintegrant—cross-linked polyvinylpyrrolidone 14.0g;

[0056] Croscarmellose sodium 16.0g;

[0057] 6. Glidant—micronized silica gel 6.0g;

[0058] 7. Lubricant—sodium stearyl fumarate 3.0 g.

[0059] The total weight is 300g, and a total of 2000 pieces are made.

[0060] 2. Preparation method

[0061] 1) Take Eudragit E100 (Eudragit  E100) is dissolved with more than 95% medicinal industrial ethanol and diluted to a certain concentration for subsequent use;

[0062] 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 sili...

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PUM

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Abstract

The invention relates to a silibinin meglumine salt orally disintegrating tablet and a preparation process thereof. The silibinin meglumine salt is used as a raw material, and a filler, a disintegrating agent, a flavoring agent, a flow aid, and a lubricating agent are used. Agents, etc. are used as auxiliary materials. Adhesives can be used according to different situations, and an appropriate amount of effervescent agent can also be added as appropriate. It is characterized in that silibinin meglumine salt powder coating is obtained by powder coating coated granules, then mixed with other components and compressed into tablets to obtain disintegrating tablets. The orally disintegrating tablet of the present invention has good friability, rapid disintegration, good taste, no gritty feeling, and does not require special production conditions; it has the characteristics of low production cost, convenient carrying, storage, transportation and taking; it is especially suitable for swallowing Difficult patients or taking it under anhydrous conditions can improve patient compliance and improve the efficacy of the drug.

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 Silybin meglumine salt orally disintegrating tablet preparation and preparation method thereof. [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] At present, the dosage forms of silybin meglumine salt preparation mainly include common tablet and capsule dosage forms. There is no orally disintegrating table...

Claims

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Application Information

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