Chinese medicine granule containing silymarin and preparation method thereof

A technology of silymarin and traditional Chinese medicine granules, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, and medical preparations with no active ingredients, etc. It can solve the problems of lack of immediate release characteristics, low drug loading of granules, and unsightly appearance, etc. problems, to achieve the effect of good physical properties, small specific surface area and regular particle size distribution

Active Publication Date: 2009-05-27
天津天士力圣特制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Several common granule preparation processes and their existing defects: 1. Traditional granule preparation process, due to the high viscosity of traditional Chinese medicine extracts, most of the traditional granule preparation methods have low drug loading, unsightly appearance, and poor taste , easy to absorb moisture and other problems
5. In the field of preparations, there are also fluidized bed bottom spraying or side spraying techniques to manufacture western medicine pellets or spherical granules, which are mostly used in the development of sustained release preparations. Therefore, the developed products generally have slow and controlled release characteristics, and do not have immediate release characteristics.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Take appropriate amount of silymarin;

[0044] Preparation of masterbatch: Take the mixture of dextrin and starch with a weight ratio of 1:1 and pass it through a 200-mesh sieve, 65% of which is used as the base material and put into the side spray pot of the fluidized bed, and the starch slurry (15%) is prepared by adding water to the starch Spray it in as a slurry, and sieve out small particles (180-250μ) as the mother nucleus, then put the mother nucleus into the pot, continue to spray the starch slurry, and at the same time, use the remaining 35% dextrin from the powder gun Sprinkle with fine powder of starch to make the particle size of the mother core grow, and screen out the master batch with a particle size of 450μ-600μ for later use.

[0045] Preparation of the product: Take 150g of masterbatch, 50g of microcrystalline cellulose (200 mesh), 80g of polyethylene glycol 6000 (heating and melting), 720g of silymarin; add microcrystalline cellulose and micropowder s...

Embodiment 2

[0047] Take appropriate amount of silymarin;

[0048] Preparation of masterbatch: Take a mixture of micropowder silica gel and chitosan with a weight ratio of 1:1 to pass through a 200-mesh sieve, 65% of which is used as the base material and put into the side spray pot of the fluidized bed, and another PVP K30 is added with water, extract, and prepared The sticky agent is sprayed in as a slurry, and the small particles with a particle size of 120-180 μ are screened out as the mother nucleus, and then the mother nucleus is put into the pot, and the starch slurry is continued to be sprayed, and the remaining 35% of the starch is sprayed from the powder gun. The fine powder of micronized silica gel and chitosan is sprinkled in to make the particle size of the mother core grow, and the master particle with a particle size of 200μ-300μ is screened out for future use.

[0049] Preparation of the product: Take 160g of masterbatch, 50g of microcrystalline cellulose (200 mesh), 10g of...

Embodiment 3

[0051] Take appropriate amount of silymarin;

[0052] Preparation of masterbatch: take a mixture of dextrin and starch with a weight ratio of 1:1 and pass through a 200-mesh sieve, 65% of which is put into the side spray pot of the fluidized bed as the bottom material, and starch and extract (after being folded and dried to account for the mother batch) 15% of the grain weight) and water to make a slurry and spray it in, and sieve out small particles (180-250μ) as the mother nucleus, then put the mother nucleus into the pot, continue to spray the starch slurry, and at the same time, spray it from the powder gun Sprinkle the remaining 35% dextrin and starch fine powder to make the particle size of the mother core grow, and screen out the master batch with a particle size of 300μ-400μ for future use.

[0053] Preparation of the product: Take 450g of masterbatch, 50g of microcrystalline cellulose (200 mesh), 300g of polyethylene glycol 6000 (heating and melting), 700g of silymari...

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Abstract

The invention provides a traditional Chinese medicine granular preparation with silymarin and a preparation method thereof. Traditional Chinese medicine spheroidized particles are prepared by using a silymarin extract and a pharmaceutically acceptable carrier. The shapes of the traditional Chinese medicine spheroidized particles are spherical or similar to spheres, and the density of the traditional Chinese medicine spheroidized particles ranges from 0.6 g / ml to 1.3 g / ml. A single dose of the spheroidized particles is small, the medicine taking is convenient, and the granular preparation can be used as a semifinished product of capsules and can also be used for developing sustained and controlled release preparations of traditional Chinese medicine.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation and a preparation method thereof, in particular to a traditional Chinese medicine granule containing silymarin and a preparation method thereof. Background technique [0002] Silymarn (Silymarn) is a loose powder obtained by extracting and refining the fruit of Silybum marianum (L)Gaertn, a plant of the Compositae family. It has a slightly bitter taste, hygroscopicity, insoluble in water, and has obvious protection and stability. Liver cell membrane function; it has different degrees of protective and therapeutic effects on various types of liver damage caused by carbon tetrachloride, acetamide sulfide, muscarine, hyostigmine, etc. Elevation of alanine aminotransferase has a certain blocking effect. It is clinically used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early liver cirrhosis, liver poisoning and other diseases, and it can significantly improv...

Claims

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Application Information

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IPC IPC(8): A61K36/28A61K31/352A61K9/16A61K47/02A61K47/34A61K47/38A61P1/16A61K131/00A61K47/10
Inventor 李永强郑永锋
Owner 天津天士力圣特制药有限公司
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