Medicament for preventing and treating acute liver damnification and preparation thereof

A technology for chemical substances and water for injection, which is applied in powder delivery, freeze-drying delivery, etc., can solve the problems of reduced clinical efficacy, low bioavailability, unstable absorption, etc., and achieves the effects of good water solubility and simple process.

Active Publication Date: 2008-08-20
西安安健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor water solubility and fat solubility of SIL, low bioavailability and unstable absorption, the clinical efficacy is greatly reduced, and the clinical application of conventional dosage forms such as Yiganling tablets (ie silymarin tablets) is greatly limited.

Method used

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  • Medicament for preventing and treating acute liver damnification and preparation thereof
  • Medicament for preventing and treating acute liver damnification and preparation thereof
  • Medicament for preventing and treating acute liver damnification and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Take 50g of silibinin sodium succinate raw material, add it into 5000ml of water for injection to obtain a solution, then add 50g of mannitol, stir well to dissolve it, heat it with 1% (w / v) activated carbon at 40°C for decolorization and oxidize it with 1M hydroxide The pH of the sodium solution is adjusted to 9.0, cooled to room temperature, filtered, aseptically dispensed into vials, cooled and dried, and then plugged to obtain silibinin sodium succinate freeze-dried powder injection of the present invention.

Embodiment 2

[0018] Take 30g of silibinin sodium succinate raw material, add it into 1000ml of water for injection to obtain a solution, then add 60g of lactose, stir well to dissolve it, heat it with 3% (w / v) activated carbon at 50°C and decolorize it with 0.5M dilute hydrochloric acid Solution Adjust the pH of the above solution to 7.0, cool to room temperature, filter, aseptically dispense into vials, freeze-dry, press the stopper, and press the cap to obtain the silybin sodium succinate freeze-dried powder of the present invention. Needle.

[0019] Pharmacodynamic test

[0020] 1. The effect of silibinin sodium succinate freeze-dried powder for injection on acute liver injury caused by carbon tetrachloride in mice

[0021] 1 Test drug: silybin-sodium succinate freeze-dried powder for injection of Example 1, sodium chloride injection.

[0022] 2 Test animals: Kunming SPF grade mice, female, weighing 18g-22g, provided by Guangdong Medical Animal Experiment Center.

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PUM

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Abstract

The invention discloses a preparation method of silybin sodium succinate frozen powder injection for preventing and treating acute liver damage, comprising the following steps: (1) Dissolve the silybin sodium succinate material in the water for injection to prepare into a solution; (2) Dissolve the mannite or lactose in the above solution; (3) Use the active carbon to heat and discolor the above solution, adjust PH 7 to 9 and filter; (4) Fill separately and axenically, freeze and dry the filtrate. The preparation method has the advantage of simple technology in virtue of being used via dissolution in water for injection and can be used for preventing and treating acute liver damage caused by medicine, spirthe of wine and poison.

Description

technical field [0001] The present invention relates to a preparation method of silibinin succinate sodium salt for preventing and treating acute liver damage caused by drugs, alcohol and poisons, more specifically, a silibinin succinate sodium salt The preparation method of the sodium dioxate freeze-dried powder injection. Background technique [0002] The liver is the main organ for drug metabolism. Most drugs are eliminated through biotransformation in the liver. During this process, a certain amount of drugs, alcohol, poisons and their metabolites can cause acute liver damage and lesion. In recent years, with the continuous increase of drug varieties, the increasing number of alcohol consumers, the frequent use of synthetic pesticides in crops, and the incidence of acute liver damage caused by people's accidental consumption of poisonous mushrooms have also increased accordingly. Among them, drug-induced liver disease accounts for 2% to 5% of all hospitalized jaundice ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19
Inventor 傅卫国王伟王佩贤黄伟静
Owner 西安安健药业有限公司
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