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Oral silybin sustained release agent and preparation thereof

A technology for oral administration of silymarin and silymarin, applied in the field of medicine, can solve the problems of low bioavailability, affecting clinical efficacy, difficulty of silymarin, etc., achieve the effects of reducing the dosage, increasing drug dissolution, and improving oral bioavailability

Inactive Publication Date: 2004-11-10
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Silymarin is poorly soluble in water and general organic solvents, and has poor oral absorption and low bioavailability, thus affecting clinical efficacy

Method used

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  • Oral silybin sustained release agent and preparation thereof
  • Oral silybin sustained release agent and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The present embodiment 1 tablet that adopts the known method of pharmaceutical industry to make contains following composition by weight percentage:

[0026] Silymarin Solid Dispersion 50%

[0027] HPMC K4M 9%

[0028] Lactose 39%

[0029] Sodium Lauryl Sulfate 1%

[0030] Magnesium Stearate 1%

[0031] Anhydrous ethanol amount

[0032] Preparation method: prepare silymarin-PVP K15 solid dispersion: mix silymarin and PVPK15 in absolute ethanol in proportion, and prepare silymarin-PVP K15 solid dispersion by solvent method. Add blockers, fillers, lubricants and other pharmaceutical excipients to the silymarin-PVP K15 solid dispersion, process according to a certain process, mix evenly, and directly compress the powder into tablets to obtain silymarin sustained-release tablets. HPMCK15M is a hydrophilic polymer, which is a skeleton material in this preparation, which swells with water or digestive juice to form a gel barrier to control the diffusion of silymarin and ...

Embodiment 2

[0034] The present embodiment 2 tablet that adopts the known method of pharmaceutical industry to make contains following composition by weight percentage:

[0035] Silymarin Solid Dispersion 40%

[0036] HPMC K100 15%

[0037] Lactose 20%

[0038] Microcrystalline Cellulose 23%

[0039] Sodium Lauryl Sulfate 1%

[0040] Magnesium Stearate 1%

[0041] Anhydrous ethanol amount

[0042] Preparation method: mix silymarin, PVP K15 and the prescribed amount of blocker in absolute ethanol in proportion, and then add the prescribed amount of other excipients that have been mixed evenly, and process according to a certain process to prepare Make soft material, granulate, dry below 60°C, granulate, take the granule and check if it is qualified, add appropriate amount of magnesium stearate, mix evenly and press into tablet to obtain silymarin sustained-release tablet.

[0043] The silymarin sustained-release tablet prepared by this method has simple process, low requirements on eq...

Embodiment 3

[0045] The present embodiment 3 tablet that adopts the known method of pharmaceutical industry to make contains following composition by weight percentage:

[0046] Silymarin Solid Dispersion 50%

[0047] Ethylcellulose 5%

[0048] Lactose 10%

[0049] Sodium Lauryl Sulfate 2%

[0050] Microcrystalline Cellulose 32%

[0051] Talc 1%

[0052] Anhydrous ethanol amount

[0053] Preparation method: mix silymarin, PVP K15 and the prescribed amount of blocker in absolute ethanol in proportion, and then add the prescribed amount of other excipients that have been mixed evenly, and process according to a certain process to prepare Make soft material, granulate, dry below 60°C, granulate, take the granule and check it to pass, add appropriate amount of talcum powder, mix evenly, and press into tablet to obtain silymarin sustained-release tablet.

[0054] Ethyl cellulose is an insoluble matrix material, and the drug is dispersed in the insoluble matrix material. The drug release rat...

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Abstract

The invention relates to an oral silymarin slow release preparation and process of making, wherein the preparation comprises silymarin solubilized composition 10%-80%, retarding agent 5%-80%, and balancing medicinal adjuvant. The silymarin can be prepared into solid dispersion and capsule. Compared with the existing common tablets, the preparation is characterized by the substantial curative effect for treating diseases including chronic hepatitis, persisting type hepatitis and alcohol liver.

Description

Technical field: [0001] The invention relates to the technical field of medicine, specifically, it is a technique for preparing silymarin into a solid dispersion with PVP K15 as a carrier and then into an oral sustained-release preparation—an oral silymarin sustained-release preparation and a preparation method thereof. Background technique: [0002] Silymarin is poorly soluble in water and common organic solvents, and has poor oral absorption and low bioavailability, thus affecting clinical efficacy. [0003] Chinese patent application 1391894 (application number 02125823) discloses a "silymarin injection containing cyclodextrin or its derivatives". The process is to dissolve silymarin in water under the inclusion action of cyclodextrin or its derivatives , so as to prepare the injection solution. [0004] Chinese patent application 1397277 (application number 02125820) discloses a "preparation method of silymarin injection". The process is to react silymarin with alkali t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/52A61K31/357A61P1/16A61P31/12
Inventor 潘卫三姜华威刘宏飞何仲贵
Owner SHENYANG PHARMA UNIVERSITY
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