Andrographolidi natrii bisulfis and preparation method thereof

A technology of andrographolide and sodium bisulfite, applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, antibacterial drugs, etc., can solve the problems of increasing the difficulty of operation and increasing costs, and achieve good stability and impurity The effect of less, high purity

Active Publication Date: 2008-03-26
吉林省长源药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, although freeze-dried powder injection is convenient for preservation, it increases the cost in production and increases the difficulty of clinical operation.

Method used

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  • Andrographolidi natrii bisulfis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take andrographolide 6kg, and add 120L of 95% ethanol, heat and stir to dissolve, and maintain at 70°C; then take 2.2Kg of sodium bisulfite, add water to 73L, stir and dissolve; Pour the solution into the aqueous sodium bisulfate solution in step 2), mix evenly and heat to 70°C; then reflux for 36 minutes, recover the ethanol until there is no alcohol smell, and place it in a refrigerator at 1°C to 9°C for 12 to 48 hours. And extract 3 times with appropriate amount of chloroform, after filtration, concentrate the filtrate in vacuum; place the concentrated solution in step 3) in a crystallization pot with stirring paddle, cool with jacketed cooling water, stir with the paddle paddle at 3°C ​​to 19°C and let stand Crystallize, then filter with suction, and dry the filter cake in vacuum to obtain white sodium bisulfite andrographolide adduct. Its purity is 99.6% as measured by liquid chromatography.

Embodiment 2

[0020] Weigh andrographolide 10kg, and add 145L of 95% ethanol, heat and stir to dissolve, and maintain at 80°C; then take 2.5Kg of sodium bisulfite, add water to 80L, stir and dissolve; Pour the solution into the aqueous solution of sodium bisulfate in step 2), mix evenly and heat to 85°C; then reflux for 30 minutes, recover the ethanol until there is no alcohol smell, and place it in a refrigerator at 1°C to 9°C for 12 to 48 hours. And extract 4 times with appropriate amount of chloroform, after filtration, concentrate the filtrate in vacuum; place the concentrated solution in step 3) in a crystallization pot with stirring paddle, cool with jacketed cooling water, stir with the paddle paddle at 3°C ​​to 19°C and let stand Crystallize, then filter with suction, and dry the filter cake in vacuum to obtain white sodium bisulfite andrographolide adduct. Its purity is 99.8% as measured by liquid chromatography.

Embodiment 3

[0022] Weigh andrographolide 12kg, add 95% ethanol 165L, heat and stir to dissolve, and maintain at 85°C; then take sodium bisulfite 3.2Kg, add water to 86L, ​​stir and dissolve; and the andrographolide ethanol of step 1) Pour the solution into the aqueous solution of sodium bisulfate in step 2), mix evenly and heat to 65°C; then reflux for 36 minutes, recover ethanol until there is no alcohol smell, and place it in a refrigerator at 1°C to 9°C for 12 to 48 hours. And extract 4 times with an appropriate amount of chloroform, after filtration, concentrate the filtrate in vacuum; place the concentrated solution in step 3) in a crystallization pot with a stirring paddle, cool with jacketed cooling water, stir with a paddle paddle at 3°C ​​to 19°C and let stand After crystallization, suction filtration, and vacuum drying of the filter cake, a white sodium bisulfite andrographolide adduct was obtained, and its purity was 99.74% as measured by liquid chromatography (as shown in Figur...

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Abstract

The present invention provides one kind of sodium bisulfite andrographolide, which is prepared through adding water solution of sodium bisulfite into alcohol solution of andrographolide, heating to reflux, recovering alcohol, cooling, extracting with chloroform for several times, filtering, vacuum concentrating the filtrate, crystallizing the concentrated solution, suction filtering, and vacuum drying the filter cake to obtain the white sodium bisulfite andrographolide addition compound. The sodium bisulfite andrographolide product has high purity, high stability, high curative effect and wide use.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an antibacterial and anti-inflammatory drug sodium bisulfite andrographolide and a preparation method thereof. Background technique [0002] Sodium bisulfite andrographolide (also known as Lianbizhi) is a water-soluble sulfonate obtained by adding andrographolide, a medicinal active ingredient extracted from the traditional Chinese medicine Andrographis paniculata, with sodium bisulfite. Pharmacological research and clinical application have shown that it has antibacterial and antiviral effects, and it has a good clinical effect on bacillary dysentery, mumps, laryngitis, tonsillitis, gastroenteritis, pneumonia, cholecystitis and upper respiratory tract infection. Natural antibiotic medicine. [0003] At present, the specific technique that sodium bisulfite andrographolide is produced is: 1) get andrographolide 100g, add 95% ethanol 1500ml heating and dissolving; 2) get 1mol / L Na 2 SO 4...

Claims

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Application Information

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IPC IPC(8): C07D307/58A61K31/365A61P31/04
Inventor 孙克吴凌云夏冰
Owner 吉林省长源药业有限公司
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