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Freeze dried preparation of diammonium glycyrrhizinate and its preparation

A technology of diammonium glycyrrhizinate and freeze-dried preparations, applied in freeze-dried delivery, antiviral agents, pharmaceutical formulations, etc., can solve the problems of unfavorable preservation and transportation of injections, affecting the quality and curative effect of injections, and turbid solutions, and achieves a satisfactory solution. Conducive to large-scale production, rapid and sufficient dissolution, and stable performance

Active Publication Date: 2004-11-17
广东宏远集团药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the dosage forms of diammonium glycyrrhizinate are injections and capsules. Due to the quick onset and strong effect of injections, it is easier to be clinically accepted, but injections are not conducive to storage and transportation.
In addition, diammonium glycyrrhizinate is relatively viscous and difficult to dissolve when preparing an aqueous solution. Therefore, injections can only be produced in small doses of water injections. For example, 5-50 mg can be dissolved in 10 ml of small and medium-sized injections. It will make the solution cloudy and affect the quality and curative effect of the injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Take an appropriate amount of diammonium glycyrrhizinate (manufactured by Tianjin Zifu Pharmaceutical Technology Development Co., Ltd.) and appropriate amount of mannitol (produced by Shandong Jiejing Group), add appropriate amount of water for injection, stir to make it completely dissolve, add sodium hydroxide solution to adjust the pH value of the solution To about 8.4, a solution containing 75 mg of diammonium glycyrrhizinate and 100 mg of mannitol per milliliter was obtained. Activated carbon was added according to the dosage of 0.05% (g / ml), stirred at 20°C for 50 minutes, decarbonized and filtered, and the resulting filtrate was sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, freeze-dried in a freeze dryer for about 25 hours, and aseptically sealed to obtain the diammonium glycyrrhizinate freeze-dried powder preparation A of the present invention.

Embodiment 2～4

[0032] Take appropriate amount of diammonium glycyrrhizinate (manufactured by Tianjin Zifu Pharmaceutical Technology Development Co., Ltd.) and appropriate amount of mannitol (produced by Shandong Jiejing Group), add appropriate amount of water for injection, stir to make it completely dissolve, add sodium hydroxide solution to adjust the pH of the solution Value to about 6.8, obtain every milliliter containing diammonium glycyrrhizinate 75mg and mannitol 150mg solution three parts. According to the amount of 1%, 2%, 2.5% (g / ml), add activated carbon respectively, stir at 20°C, 23°C, and 25°C for 50, 45, and 40 minutes respectively, decarbonize and filter, and filter the obtained filtrate through a 0.22 μm microporous filter. Sterilize by membrane fine filtration. Under aseptic conditions, the gained solution is put in sterile vials, put in a lyophilizer and freeze-dry according to the method of Example 8, and aseptically seal to obtain the diammonium glycyrrhizinate freeze-dr...

Embodiment 5

[0034] Take an appropriate amount of diammonium glycyrrhizinate and lactose (imported), add appropriate amount of water for injection, stir to dissolve completely, add ammonia solution to adjust the pH value of the solution to about 7.45, and obtain a solution containing 75 mg of diammonium glycyrrhizinate and 75 mg of lactose per ml. Add activated carbon according to the dosage of 1% (g / ml), stir at 30° C. for 30 minutes, decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. Under aseptic conditions, the resulting solution is placed in a sterile vial, put in a lyophilizer and freeze-dried according to the method of Example 8, and then aseptically sealed to obtain the diammonium glycyrrhizinate lyophilized powder preparation E of the present invention.

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Abstract

The invention relates to a Diammonium Glycyrrhizinate freeze-drying preparation and process for preparing it, wherein the preparation is prepared from Diammonium Glycyrrhizinate, mannitol, sorbitol, sodium chloride, glucose, cane sugar, lactose, sulfo-aminolactic acid, or pharmacologically accepted expanding material of other amino acids through freeze drying.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of diammonium glycyrrhizinate and a preparation method thereof. technical background [0002] Diammonium Glycyrrhizinate (Diammonium Glycyrrhizinate) is an active ingredient extracted from the traditional Chinese medicine licorice, which has the functions of stimulating the reticuloendothelial system, anti-virus, inducing γ-interferon, and enhancing the activity of NK cells. It has a preventive effect, can reduce the elevation of serum alanine aminotransferase and aspartate aminotransferase caused by carbon tetrachloride, thioacetamide and D-galactosamine, and the liver damage tissue can also be improved accordingly. It can be used for the treatment of acute and chronic hepatitis. Hepatitis B and C can significantly improve clinical symptoms and liver function. Because diammonium glycyrrhizinate injection is safe and effective in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/56A61P1/16A61P31/12
Inventor 石秀伟邵梅
Owner 广东宏远集团药业有限公司
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