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Phospholipid complex of silybin dihemisuccinate disodium and preparation method and application thereof

A dimesuccinate and phospholipid complex technology, applied in the field of medicine, can solve the problems of low bioavailability and poor water solubility, and achieve the effect of expanding the scope of application, increasing fat solubility, and expanding the route of drug delivery

Inactive Publication Date: 2010-12-29
天津康鸿医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main ingredient of Cilibenan Tablets is silybin meglumine, but it still has the disadvantage of low bioavailability
The main ingredient of Shuilinjia is silybin lecithin complex, although the bioavailability has been improved to a certain extent by improving the fat solubility, but its water solubility is still poor

Method used

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  • Phospholipid complex of silybin dihemisuccinate disodium and preparation method and application thereof
  • Phospholipid complex of silybin dihemisuccinate disodium and preparation method and application thereof
  • Phospholipid complex of silybin dihemisuccinate disodium and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of embodiment 1 silibinin succinate disodium salt phospholipid complex

[0037] Weigh 530.0 g of silibinin succinate disodium salt and mix them with 1000.0 g of soybean lecithin, dissolve in 20000 ml of methanol, heat at 50°C, the solution is clear after 1h, concentrate and dry under reduced pressure at 75°C to obtain silibinin succinate di Sodium Salt Phospholipid Complex.

Embodiment 2

[0038] Example 2 Preparation of silibinin succinate disodium salt phospholipid complex compressed tablet

[0039] Mix 530.0g of silibinin succinate disodium salt and 500.0g of soybean lecithin, dissolve in 20000ml of absolute ethanol, heat at 50°C, the solution is clear after 1h, concentrate under reduced pressure at 70°C until viscous, add microcrystalline 18.0g of cellulose, 450.0g of lactose, 180g of pregelatinized starch, and 22.5g of crospovidone are mixed evenly, and the aqueous solution containing 15% of povidone is used as a wetting agent to make a soft material, granulated with a 20-mesh sieve, 55°C Ventilate and dry for 3 hours, granulate, add 13.5.0 g of talcum powder and 13.5.0 g of magnesium stearate, mix and press to obtain about 10,000 tablets, each containing 35 mg of silibinin, to obtain compressed tablets.

Embodiment 3

[0040] Example 3 Preparation of silibinin succinate disodium salt phospholipid complex capsule

[0041] Mix 530.0g of silibinin succinate disodium salt and 1000.0g of soybean lecithin, dissolve in 20000ml of absolute ethanol, heat at 50°C, the solution is clear after 1h, concentrate under reduced pressure at 70°C until viscous, add lactose 450.0 g, 360.0g of mannitol, 72g of carboxymethyl starch sodium, put into the fast stirring granulator KJZ-IO, spray 30% ethanol aqueous solution to granulate, ventilate and dry at 60°C for 3 hours, granulate with 20 mesh sieve, add stearic acid Magnesium 27.0g is mixed evenly, and No. 1 gelatin hard capsule is filled, so that each capsule contains silybin 35mg.

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Abstract

The invention discloses a medicinal composition containing silybin dihemisuccinate disodium and a preparation method and application thereof. Silybin dihemisuccinate disodium and phospholipid are dissolved into an organic solvent according to a certain proportion, and a product is obtained by heating reflux, drying and concentration. The composition increases the dissolution of silybin, improves the lipid solubility, and obviously solves the problem of low bioavailability of the silybin. The composition has the effect of protecting liver, and can be used for treating acute or chronic hepatitis, fatty liver and other liver function injury.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a phospholipid complex containing the active ingredient silybin dimesuccinate salt. The specific characteristics of the complex are that its fat solubility is obviously improved while water solubility is increased, and its bioavailability is improved. It has a better curative effect in protecting the liver. Background technique [0002] In recent years, with the improvement of people's living standards and changes in dietary structure, the incidence of fatty liver in my country has approached the carrier rate of hepatitis B virus, and it is showing a clear upward trend. Among them, men aged 30 to 40 are the "main force" in the army of fatty liver patients, basically accounting for 1 / 4 of all fatty liver patients. It is estimated that the incidence of fatty liver is now about 30 times higher than that before the 1980s. It is reported that 15% of patients with fatty liver will...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/357A61K47/24A61P1/16
Inventor 李鹏旺吴疆邹美香张彩霞孙歆慧
Owner 天津康鸿医药科技发展有限公司
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