Sterile andrographolide and preparation method thereof

A technology of Yanhuning and Chuanhuning, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of increased solvent usage, increased production costs, and easy occurrence of adverse reactions, and achieves the production cycle The effect of shortening, saving production cost and shortening production cycle

Active Publication Date: 2014-04-16
HEILONGJIANG ZBD PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the solvent for dissolving Chuanhuning is water, resulting in a large increase in the amount of solvent used for subsequent crystallization, and a corresponding increase in production costs, and acetone is used for solvent crystallization, and acetone remains in the raw material of Yanhuning obtained, which is prone to adverse reactions

Method used

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  • Sterile andrographolide and preparation method thereof
  • Sterile andrographolide and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: the preparation method of sterile Yanhuning

[0044] 1. Dissolve 300g (0.526mol) of Chuanhuning in 750ml of 50% ethanol, slowly add 557ml of 8% sodium bicarbonate aqueous solution (0.526mol) dropwise into the Chuanhuning suspension, control the temperature in a water bath at 35°C, and add dropwise for 15 minutes Complete, continue to stir for 30min, the white suspension solution turns into a yellow clear solution;

[0045] 2. Add 6g of activated carbon (2% of the weight of Chuanhuning) and stir for adsorption for 20min, filter through a 0.22μm filter membrane, and concentrate under reduced pressure (-0.095Mpa) at 55°C to a density of 1.05. Control the stirring speed to 190 rpm, add 3000 ml of absolute ethanol to the concentrated solution to precipitate crystals, and continue stirring for 10 min. Filter, wash with absolute ethanol three times, filter to obtain the wet product of Yanhuning, and vacuum-dry at 40° C. for 2 hours to obtain 268.5 g of Yanhuning...

Embodiment 2

[0046] Embodiment 2: the preparation method of sterile Yanhuning

[0047] 1. Dissolve 300g (0.53mol) of Chuanhuning in 900ml of 49% ethanol, slowly add 468ml of 6% sodium carbonate aqueous solution (0.265mol) dropwise into the Chuanhuning suspension, the temperature of the water bath is 39°C, and the dropwise addition is completed in 15 minutes. Continue to stir for 40min, the white suspension solution turns into a yellow clear solution;

[0048] 2. Add 3g of activated carbon (1% of the weight of Chuanhuning) and stir for 20min to absorb, filter through a 0.22μm membrane, and concentrate under reduced pressure (-0.095Mpa) at 60°C to a density of 1.08. Control the stirring speed to 210rpm, add 3600ml of absolute ethanol to the concentrated solution to precipitate crystals, and continue stirring for 10min. Filter, wash twice with absolute ethanol, filter to obtain the wet product of Yanhuning, and vacuum-dry at 45° C. for 1.5 hours to obtain 259 g of Yanhuning, with a yield of ...

Embodiment 3

[0049] Embodiment 3: the preparation method of sterile Yanhuning

[0050] 1. Dissolve 300g (0.526mol) of Chuanhuning in 1200ml of 60% ethanol, slowly add 530ml of 4% sodium hydroxide solution (0.526mol) dropwise into the Chuanhuning suspension, the temperature of the water bath is 37°C, and the dropwise addition is completed in 17 minutes , continue to stir for 20min, the white suspension solution turns into a yellow clear solution;

[0051] 2. Add 6 g of activated carbon (2% of the weight of Chuanhuning) and stir for 20 minutes to absorb, filter through a 0.22 μm membrane, and concentrate under reduced pressure (-0.095Mpa) at 50°C to a density of 1.06. Control the stirring speed to 210rpm, add 3300ml of absolute ethanol to the concentrated solution to precipitate crystals, and continue stirring for 10min. Filter, wash twice with absolute ethanol, filter to obtain the wet product of Yanhuning, and vacuum-dry at 45° C. for 1.5 hours to obtain 256 g of Yanhuning, with a yield o...

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Abstract

The invention relates to sterile andrographolide and a preparation method thereof. The method comprises the following steps of: dissolving andrographolide into a 30-99 percent ethanol solution; and reacting with a sodium-containing weak alkali salt or alkali to obtain andrographolide. An andrographolide raw material produced with the method is of a pure white color, and has a stable pH value, yield of over 85 percent, high purity and a short synthesis period.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sterile Yanhuning and a preparation method thereof. Background technique [0002] Yanhuning (Potassium Sodium Dehydroandrographolide Succinate, PSDS), is 14-dehydroxy-11,12-didehydroandrographolide-3,19-disuccinic acid half ester potassium sodium salt hydrate, its structure is shown in formula I . The preparation of Yanhuning was recorded in the National Drug Standards in 2002. The dosage form on the market is Yanhuning for injection, which is the sodium salt of potassium half-ester succinate of andrographolide. It is an antiviral drug and is clinically used for viral pneumonia and viral pneumonia. Sexual upper respiratory tract infection, definite curative effect, widely used. [0003] [0004] Formula I Formula II [0005] At present, many commercially available Yanhuning preparations use Chuanhuning as the raw material and are directly prepared through the pr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D307/58A61K31/365A61K9/19A61P31/12
Inventor 方同华
Owner HEILONGJIANG ZBD PHARMA
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