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Silybin dihemisuccinate disodium oral preparation and preparation method thereof

A technology of silibinin and succinate, applied in the field of medicine, can solve the problems that it is not suitable for the treatment of people with chronic liver diseases, and the injection preparation is not suitable for long-term administration, so as to achieve complete drug absorption and utilization, reduce individual differences in absorption and curative effect , the effect of less dosage

Inactive Publication Date: 2012-10-10
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

At present, the literature only records that silibinin succinate is mainly made into injection formulations. For example, patent document 200510080657.4 mentions that "silibinin dimetasuccinate can be used as powder for intravenous injection", but the injection preparations are not Suitable for long-term administration, especially not suitable for the treatment of people with chronic liver disease

Method used

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  • Silybin dihemisuccinate disodium oral preparation and preparation method thereof
  • Silybin dihemisuccinate disodium oral preparation and preparation method thereof
  • Silybin dihemisuccinate disodium oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Composition and preparation method of 60mg silibinin disodium succinate compressed tablet

[0040]Mix 60.0 g of disodium silibinin succinate, 100.0 g of microcrystalline cellulose, 40.0 g of calcium hydrogen phosphate, and 4.0 g of micropowder silica gel, and use 30% ethanol solution of hypromellose as a wetting agent to make soft material, granulated with a 20-mesh sieve, ventilated and dried at 55°C for 4 hours, granulated, added with 5.0 g of sodium carboxymethyl cellulose and 5.0 g of magnesium stearate, mixed evenly, and pressed into about 1000 tablets, each containing silibinin succinic acid Ester disodium 60mg, that is, compressed tablets.

Embodiment 2

[0041] Example 2 Composition and preparation method of 120mg silibinin disodium succinate compressed tablet

[0042] Mix 120.0 g of disodium silibinin succinate, 40.0 g of microcrystalline cellulose, 100.0 g of lactose, 40 g of pregelatinized starch, and 5 g of crospovidone, and use an aqueous solution containing 15% povidone as a moistening solution. Soft material made from aerosol, granulated with a 20-mesh sieve, ventilated and dried at 55°C for 3 hours, granulated, added with 3.0g of talc powder and 3.0g of magnesium stearate, mixed evenly and pressed into about 1000 capsule-shaped tablets, each containing milk thistle 120 mg of disodium benzyl succinate, to obtain compressed tablets.

Embodiment 3

[0043] Example 3 Composition and preparation method of 200mg silibinin disodium succinate compressed tablet

[0044] Mix 200.0 g of disodium silibinin succinate, 50.0 g of microcrystalline cellulose, 100.0 g of lactose, 50 g of starch, and 5.0 g of methyl cellulose, and use 30% aqueous ethanol as a wetting agent to make a soft material. Granulate with a 20-mesh sieve, ventilate and dry at 60°C for 3 hours, granulate, add 5.0 g of micropowder silica gel, and 5.0 g of magnesium stearate, mix well and press to obtain special-shaped tablets, each tablet contains 200 mg of silibinin disodium succinate, A compressed tablet is obtained.

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Abstract

The invention provides a silybin succinate preparation. The preparation contains 1 to 95 weight percent of silybin dihemisuccinate disodium. The preparation overcomes the defects of long-term administration inconvenience for injecting the preparation and poor stability of the medicament in a solution state, is particularly suitable for long-term administration of chronic liver disease patients, and has storage stability. In addition, the invention also provides a preparation method for the silybin dihemisuccinate disodium oral preparation. The preparation has excellent moistening and disintegrating properties, can quickly and fully release the medicament, and gives full play to the treatment effect of the silybin active component.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to an oral preparation containing active ingredient silibinin succinate disodium salt and a preparation method thereof. Background technique [0002] Hepatitis refers to liver inflammation due to different etiologies. Viral hepatitis is the most common in daily life. It has the characteristics of high incidence, long course, strong recurrence and great harm. If it is not treated in time, it may turn into liver cirrhosis and the possibility of liver cancer. my country is also a country with a high incidence of hepatitis. According to statistics, there are more than 120 million people infected with hepatitis B virus in my country, about 30 million chronic hepatitis B patients, and 38 million people carrying hepatitis C virus. In terms of the number of hepatitis B virus carriers, it accounts for almost 10% of the national population. one-third. [0003] At present, although there are many type...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/357A61P1/16A61P31/12
Inventor 汤立达孙歆慧吴疆任晓文张晓军李鹏旺
Owner 天津康鸿医药科技发展有限公司