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Injectable stable pharmaceutical composition containing active ingredient silibinin and its salt

A technology of silibinin and active ingredients, which is applied in the field of stable pharmaceutical compositions, and can solve problems such as instability, easy oxidation, and human irritation

Inactive Publication Date: 2006-10-04
TIANJIN INSTITUTE OF PHARMA RESEARCH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, the physiological pH value tolerated by the human body in the preparation administered by injection is 4-9, and what the inventor emphasized in the example is PH10-12, which will inevitably cause irritation to the human body. accepted
On the other hand, silibinin and its salts are unstable under alkaline conditions and are easily oxidized

Method used

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  • Injectable stable pharmaceutical composition containing active ingredient silibinin and its salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Take 0.5 g of silibinin meglumine salt and add 10 ml of acetone. Heat in a water bath at 80°C, add 5ml of water, and gradually stir until clear. Add 30 mg of activated carbon and stir in a water bath for 5 minutes. Suction filtration, and the filtrate was placed at room temperature to precipitate naturally. Suction filtration, rinse the filter cake with an appropriate amount of water, and dry at 50°C to obtain the refined product.

Embodiment 2

[0050] Take 0.5g of silibinin sodium salt and add 5ml of acetone. Heat in a water bath at 80°C, then add 2.5ml of water and 1ml of acetone to clarify. Add 30 mg of activated carbon and stir in a water bath for 5 minutes. Suction filtration, and the filtrate was placed at room temperature to precipitate naturally. Suction filtration, rinse the filter cake with an appropriate amount of water, and dry at 50°C to obtain the refined product.

Embodiment 3

[0052] Take 0.5g of silibinin arginine salt, add 4ml of 1mol / l sodium hydroxide solution to dissolve, then add 2ml of ethanol and 3ml of water. Add 30 mg of activated carbon and stir in a water bath for 5 minutes. Suction filtration, and the filtrate was dried by rotary evaporation at 50°C. That is the refined product.

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Abstract

The invention relates to a pharmaceutical composition containing silybin or its salts as the active constituents, the composition also comprises water-soluble bulking agent, pH regulator, stabilizer, water for injection, and osmoregulation agent. The pH of the disclosed freeze-dried powder injection, injection and transfusion is between 7-9 under aqueous solution state, the stabilizing agent is preferably tris(hydroxymethylamino)methane. The pharmaceutical composition can be used for treating acute hepatitis.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a stable pharmaceutical composition via injection containing active ingredient silibinin and its salts. Background technique [0002] Hepatitis is inflammation of the liver. It includes a variety of hepatitis of different etiologies. But viral hepatitis is the most common in daily life, so people habitually refer to viral hepatitis as hepatitis for short. Viral hepatitis is a common clinical infectious disease mainly caused by liver damage and immune dysfunction. It has the characteristics of high morbidity, long course of disease, strong reproducibility and great harm. If effective and timely treatment is not carried out, it will easily turn into liver cirrhosis and liver cancer. At present, viral hepatitis is mainly divided into five types: A, B, C, D and E. In recent years, hepatitis C and hepatitis G have been discovered. Among them, hepatitis A ...

Claims

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Application Information

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IPC IPC(8): A61K31/357A61K9/08A61K9/19A61P1/16A61P31/14A61P31/20
Inventor 任晓文王文科连潇嫣李洪起
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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