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Pharmaceutical preparation containing silymarin and preparation method thereof

A pharmaceutical preparation, the technology of silymarin, which is applied in the field of pharmaceutical preparations, can solve the problems that no specific reports on similar prescriptions and production processes have been found, and that silymarin preparations are difficult to be absorbed and utilized.

Active Publication Date: 2014-10-22
SHANGHAI BIO MEDICINE PUBLIC TECH SERVICE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The silymarin preparation produced by this process is difficult to be absorbed and utilized
[0004] Although there are many studies on the dissolution and bioavailability tests of silymarin preparations, there are no specific reports on similar prescriptions and production processes of the present invention

Method used

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  • Pharmaceutical preparation containing silymarin and preparation method thereof
  • Pharmaceutical preparation containing silymarin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Dissolve 1000g of silymarin and 25g of Tween 80 with 8L of absolute ethanol, dissolve 150g of polyvinylpyrrolidone K30 and 500g of mannitol with 5.5L of water, spray into 475g of microcrystalline cellulose step by step, granulate, and dry until the loss on drying is 3 % below, made into dry granules. After inspection, in the silymarin granules prepared in this example, the silymarin content (calculated as silybin) is 37.3%, and the silybin content is 14.5%. The dissolution rate of silibinin measured in phosphate buffer solution was 93%.

Embodiment 2

[0034] The granules obtained in the above example 1 were filled into hard capsules to obtain silymarin capsules, the silymarin content was 140 mg (calculated as silybin), and the measured silybin dissolution rate was 93%.

Embodiment 3

[0036] Mix 1000 g of the granules obtained in the above example 1 into 340 g of microcrystalline cellulose, 80 g of polyvinylpolypyrrolidone, 10 g of sodium lauryl sulfate, and 5 g of magnesium stearate, mix well, and screen the granules with a particle size of 20-30 mesh. The granules are made into tablets by a tabletting machine, and the silymarin content is 70mg / tablet (calculated as silybin), and the obtained tablet is wrapped with a coating powder and coated with a film, and the weight of the tablet after coating is increased by 3%, to obtain silymarin Tablets, the measured silybin dissolution rate is 81%.

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Abstract

The present invention discloses a pharmaceutical preparation containing silymarin, comprising the following components, by weight, 1 part of silymarin, 0.05 to 1.0 part of polyvinylpyrrolidone, 0.1 to 1.0 part of sugar alcohol, 0.1 to 1.0 part of microcrystalline cellulose, 0.005 to 0.05 part of nonionic surfactant, and the pharmaceutical preparation containing silymarin can be granules, capsules or tablets. The preparation method of the pharmaceutical preparation containing silymarin is further disclosed, comprising: dissolving silymarin using a solvent, adding some auxiliary materials and uniformly mixing them to give a homogeneous solution, adding the homogeneous solution to auxiliary materials to prepare granules capable of being filled into capsules, and then preparing tablets by further mixing with some auxiliary materials. The pharmaceutical preparation containing silymarin has high dissolution and bioavailability, and can be easily absorbed after oral administration.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a pharmaceutical preparation containing silymarin; in addition, the present invention also relates to a preparation method of the pharmaceutical preparation containing silymarin. Background technique [0002] Silymarin is a flavonoid lignan compound extracted and refined from the fruit of the Compositae plant milk thistle, which has a good curative effect on acute and chronic hepatitis, liver cirrhosis and metabolic poisoning liver damage. However, silymarin has poor water solubility and low oral bioavailability, so certain methods must be adopted to make water-soluble preparations to improve its water solubility and dissolution rate, thereby increasing its bioavailability. Therefore, the investigation of the dissolution rate of the main components of silymarin in the preparation is one of the important indicators for its quality evaluation. [0003] The preparation method of dome...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/357A61K47/38A61K47/32A61P1/16
Inventor 花逾冬张瑞雯阮克萍刘娟
Owner SHANGHAI BIO MEDICINE PUBLIC TECH SERVICE
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