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Water soluble silymarin composition and its preparation method

A technology of silymarin and its composition, which is applied in the field of drug synthesis, can solve problems such as no discovery, and achieve the effects of improved water solubility, low toxicity, and enhanced water-soluble effect

Inactive Publication Date: 2009-09-23
李宝
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the silybin meglumine salt given in the above technical scheme can improve the bioavailability of the silybin meglumine inclusion compound, it still needs to be further improved in water solubility and stability, and no water-soluble salt has been found in the market. Related reports on silymarin composition as medicine

Method used

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  • Water soluble silymarin composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045]First put 3 kg of silymarin into the synthesis tank, dissolve it completely with ethanol and filter it, then dissolve 1.5 kg of meglumine, 0.7 kg of polyvinylpyrrolidone (PVP), and 0.3 kg of poloxamer 188 with ethanol, then filter it and add it while it is hot Mix and stir in the silymarin solution for 30 minutes, the temperature of the solution in the tank is 78°C, and reflux for 30 minutes after stirring, the temperature of reflux is 78°C, after the reaction, the solvent in the synthesis tank is concentrated in vacuum to obtain 7.3 kg of fluid extract, the temperature 60°C, vacuum degree -0.05Mpa, then put the liquid extract into the drying tank, preheat at 70-75°C for 30 minutes, start vacuuming, when the vacuum degree reaches -0.09Mpa, the temperature in the tank is 60-65 5.5 kg of dry extract of water-soluble silymarin composition was obtained after drying for 3 hours at ℃, and the obtained dry extract of water-soluble silymarin composition was put back into the synt...

Embodiment 2

[0048] First put 5 kg of silymarin into the synthesis tank, dissolve it completely with ethanol and filter it, dissolve 2 kg of meglumine, 1 kg of polyvinylpyrrolidone (PVP), and 0.5 kg of poloxamer 188 with ethanol, then filter it and add it while it is hot Mix and stir in the silymarin solution for 30 minutes. The temperature of the solution in the tank is 78°C. After stirring, it is refluxed for 30 minutes. The temperature of reflux is 78°C. After the reaction, the solvent in the synthesis tank is vacuum concentrated to obtain 11.6 kg of liquid extract. 60°C, vacuum degree -0.05Mpa, then put the liquid extract into the drying tank, preheat at 70-75°C for 30 minutes, start vacuuming, when the vacuum degree reaches -0.09Mpa, the temperature in the tank is 60-65 8.6 kilograms of dry extracts of water-soluble silymarin compositions were obtained after drying for 3 hours at ℃, and the obtained dry extracts of water-soluble silymarin compositions were put back into the synthesis t...

Embodiment 3

[0051] First put 7 kg of silymarin into the synthesis tank, dissolve it completely with ethanol and filter it, then dissolve 3 kg of meglumine, 1.5 kg of polyvinylpyrrolidone (PVP), and 0.8 kg of poloxamer 188 with ethanol, then filter it and add it while it is hot Mix and stir in the silymarin solution for 30 minutes, the temperature of the solution in the tank is 78°C, and reflux for 30 minutes after stirring, the temperature of reflux is 78°C, after the reaction, the solvent in the synthesis tank is concentrated in vacuum to obtain 16.5 kg of fluid extract, the temperature 60°C, vacuum degree -0.05Mpa, then put the liquid extract into the drying tank, preheat at 70-75°C for 30 minutes, start vacuuming, when the vacuum degree reaches -0.09Mpa, the temperature in the tank is 60-65 12.5 kg of dry extract of water-soluble silymarin composition was obtained after drying for 3 hours at ℃, and the obtained dry extract of water-soluble silymarin composition was put back into the syn...

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Abstract

The water soluble silymarin preparation consists of silymarin, meglumine, PVP and poloxamer. It is prepared through dissolving silymarin and cosolvent in ethanol, filtering, reflux reaction and concentrating to obtain extractum; drying to obtain dry paste; redissolving, vacuum concentrating to crystallize, suction filtering to obtain crystal; ethanol washing, suction filtering, re-crystallizing and drying to obtain crystal; crushing, mixing and packing to obtain the water soluble silymarin preparation. The present invention features high water solubility, high stability and high bioavailability.

Description

technical field [0001] The invention relates to a medicinal derivative and a preparation method thereof, in particular to a water-soluble silymarin composition and a preparation method thereof, belonging to the technical field of drug synthesis. Background technique [0002] Silymarin is a lignin flavonoid compound extracted and isolated from the fruit of Silybum marianum, a plant of the genus Milk thistle in the family Asteraceae. It has obvious functions of protecting and stabilizing liver cell membranes, and can promote liver cell regeneration. The damage has protective and therapeutic effects in different degrees, and the Yiganling tablet sold on the market is a single preparation of silymarin. Since silymarin itself is a flavonoid compound that is insoluble in water, there are problems affecting the dissolution rate and bioavailability of the drug after it is made into a preparation, which seriously affects the efficacy of the drug. There is also a silybin meglumine ta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/357A61K47/18A61K47/34A61P1/16A61K47/10A61K47/32
Inventor 李宝
Owner 李宝