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Diammonium glycyrrhizinate freeze dried powder ampoul agent and its preparation method

A technology of diammonium glycyrrhizinate and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, pharmaceutical formulations, etc. It can solve the problems of decreased drug efficacy, poor stability, and increased costs, so as to reduce the damage rate and enhance stability. , the effect of easy transportation

Inactive Publication Date: 2004-05-05
NANJING KEFEIPING MEDICINE SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the injection solution made of α-diammonium glycyrrhizinate has poor stability, and after a period of placement, the efficacy of the drug drops significantly, and the dosage cannot be accurately determined during clinical application, so that the excellent effect cannot be brought into play; and the injection The damage rate of liquid preparations during transportation is high, which virtually increases the cost, and the shaking and vibration of the solution also affects the quality and effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Weigh 150 g of diammonium glycyrrhizinate, add 1500 ml of water for injection, stir to dissolve the diammonium glycyrrhizinate; add mannitol, and stir until dissolved according to the 1:1 ratio of diammonium glycyrrhizinate: mannitol; Adjust the pH value to 6.6 with sodium solution; add 2g of carbon for needles, heat to 80°C and keep it warm for 30 minutes, and decarbonize when cooled to 45°C; add water for injection to the full amount, and measure the content of intermediates; Filter, fill in 7ml vials, about 2ml per bottle, cover with butyl rubber stopper, keep air outlet, put into freeze dryer and carry out freeze-drying according to the freeze-drying curve designed; When the vacuum degree of the pump port is close to and the temperature of the product coincides with the temperature of the plate, close the refrigeration system and the vacuum system, press the cork tightly, deflate, take out the sample, and press the aluminum cap to obtain the diammonium glycyrrhizinat...

Embodiment 2

[0026] Skeleton material selects sodium chloride, by diammonium glycyrrhizinate and the ratio of skeleton material 1: 1.5, diammonium glycyrrhizinate takes 150g with embodiment 1, and sodium chloride is 225g, and all the other are the same as embodiment 1.

Embodiment 3

[0028] Glucose is selected as the skeleton material, and the ratio and amount are the same as those in Example 1.

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PUM

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Abstract

A freeze dried powder injection of diammonium glycyrrhetate is prepared from diammonium glycyrrhetate and mannitol or sodium chloride or glucose in ratio of 1:(0.5-2) through dissolving the diammonium glycyrrhetate in water, adding mannitol, stirring for dissolving, regulating pH value, adding carbon for injection, heating to 80 deg.C and holding the temp for 30 min, cooling to 45 deg.C, decarbonizing, adding the water for injection, fine filter, pouring in bottles, and freeze drying. Its advantage is high curative effect.

Description

technical field [0001] The invention relates to a diammonium glycyrrhizinate freeze-dried powder injection and a preparation method. Background technique [0002] Before the present invention is made, α-body diammonium glycyrrhizinate is extracted from licorice to make injection. Since the α-diammonium glycyrrhizinate can prevent and treat liver damage caused by various hepatotoxic agents, it can significantly prevent the increase of serum ALT caused by galactosamine, carbon tetrachloride and thioacetamide, and the liver damage tissue has also been correspondingly improved; Liver slices showed that diammonium glycyrrhizinate could resist damage to liver cell mitochondria and nucleoli caused by GaIN, increase liver glycogen and nucleic acid content, reduce liver cell necrosis, and accelerate liver cell recovery; Chronic liver damage in rats can significantly increase the survival rate and improve liver function; it can significantly inhibit the arachidonic acid metabolites l...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/56A61P1/16
Inventor 颜培玲
Owner NANJING KEFEIPING MEDICINE SCI & TECH
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