Legalon mastication patch and method of preparing the same

A technology of silymarin and chewable tablets, which is applied in the field of silymarin chewable tablets and its preparation, can solve undiscovered problems and achieve the effects of low production cost, simple operation and improved dissolution rate

Active Publication Date: 2012-07-04
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No silymarin chewable tablet preparation or related literature has been found

Method used

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  • Legalon mastication patch and method of preparing the same
  • Legalon mastication patch and method of preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Take 200g of silymarin and dissolve it in 1500ml of 70°C absolute ethanol; take another 50g of mannitol and 40g of povidone K30, stir and dissolve it with 500ml of 55°C water, add it to the above alcohol solution after dissolution, stir evenly, and use it as silymarin Binder solution (60°C heat preservation). At the same time, take 150g of mannitol, 80g of starch, 10g of stevioside and 10g of pineapple essence to pass through a 80-mesh sieve and place them in a one-step granulator, boil evenly, and then spray the above-mentioned binding liquid at a constant speed for one-step granulation. Dry the water to less than 3.0%, take out the dry granules and use a 24-mesh sieve to granulate, add 2g of magnesium stearate, mix well, take samples to detect the content of intermediates, calculate the tablet weight (specification: 140mg / tablet), and press into tablets to obtain .

Embodiment 2

[0035] Example 2: Take 200g of silymarin and dissolve it in 1500ml of absolute ethanol at 70°C; take another 60g of sorbitol, 30g of povidone K30 and 10g of sodium bicarbonate, stir and dissolve it with 600ml of 55°C water, and add it to the alcohol solution after dissolving. Stir evenly, and use it as a silymarin binder solution (60°C heat preservation). At the same time, take 140g of sorbitol, 80g of starch, 15g of stevioside and 10g of pineapple essence to pass through a 80-mesh sieve and place them in a one-step granulator, boil evenly, and then spray the above-mentioned binding liquid at a constant speed for one-step granulation. Dry the water to less than 3.0%, take out the dry granules and use a 24-mesh sieve to granulate, add 2g of magnesium stearate, mix well, take samples to detect the content of intermediates, calculate the tablet weight (specification: 140mg / tablet), and press into tablets to obtain .

Embodiment 3

[0036]Example 3: Take 200g of silymarin and dissolve it in 1800ml of ethanol above 70°C; take another 50g of mannitol, 30g of povidone K30 and 10g of sodium bicarbonate, stir and dissolve it with 500ml of 55°C water, add it to the above alcohol solution after dissolving, and stir Evenly, as a silymarin binder solution (60°C heat preservation). At the same time, take 150g of mannitol, 80g of starch, 10g of aspartame, and 10g of orange essence to pass through a 80-mesh sieve and put them in a one-step granulator, boil evenly, then spray the above-mentioned binding liquid at a constant speed, and carry out one-step granulation. When the moisture content of the granules is less than 3.0%, take out the dry granules and sieve them with a 24-mesh sieve, add 1g of magnesium stearate and 1g of talc, mix well, take samples to detect the content of intermediates, and calculate the tablet weight (specification: 140mg / tablet) , pressed into tablets, ready to use.

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PUM

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Abstract

The invention discloses a silybin chewing pill and preparing method, which comprises the following parts: 10-40% silybin, 20-60% filler, 0. 01-10% acid-base modifier, 1-10% binder, 1-10% corrective and 0. 01-5% lubricant. The making method comprises the following steps: adopting organic solvent as solvent to make silybin solution to blend with binder and solution of acid-base modifier; placing fitful quantity of filler and corrective in the boiling bed to blend findings evenly; injecting the binding liquid into the findings at constant speed to grain further; drying the particle to blend withfitful quantity of lubricant evenly. The invention has good taste and high solubility of silybin to protect liver from damaging, which stimulates biological synthesis of protein in the liver cell, especially for difficultly swallowing patient or non-water intake.

Description

technical field [0001] The invention relates to a method for making silymarin into a chewable tablet through a one-step granulation method, and the method can better improve the dissolution rate of the drug. Background technique [0002] Silymarin (silymarin) is an active ingredient extracted from the fruit of the botanical drug silymarin. Its main component is silybin, and there are also isosilibinin, silymarin, and silymarin, all of which are flavonoids. Silymarin is a liver cell membrane stabilizer, which has the function of protecting and strengthening the liver cell membrane, and can avoid the degradation of liver function caused by exposure to harmful substances. Milk thistle has been used as a hepatoprotective drug in Europe for more than 100 years. The drug has a definite curative effect and very few side effects. Silymarin has been clinically used in China for more than 20 years and has a broad clinical basis. The latest research shows that silymarin has obvious a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A23L1/28A23L1/30A61K31/357A61P37/02A61P1/16A23L33/00A23L33/10A23P10/28
Inventor 张正艮孙海胜张丽君顾孝红尹必喜
Owner YANGTZE RIVER PHARM GRP CO LTD
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