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Stable potassium sodium dehydroandroan drographolide succinate compound and pharmaceutical composition thereof

A compound, the technology of Yanhuning, applied in the field of Yanhuning compound and its preparation, can solve problems such as more than 0.2%, and achieve the effects of long storage time, strong stability and low impurity content

Inactive Publication Date: 2012-03-07
河北三禾实创生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prior art uses 95% ethanol as the recrystallization solvent. Although the content of Yanhuning after recrystallization is greater than 99%, the content of one related impurity with unknown structure is greater than 0.2%.

Method used

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  • Stable potassium sodium dehydroandroan drographolide succinate compound and pharmaceutical composition thereof
  • Stable potassium sodium dehydroandroan drographolide succinate compound and pharmaceutical composition thereof
  • Stable potassium sodium dehydroandroan drographolide succinate compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Add 300ml of 95% ethanol to a 1000ml round bottom bottle, add 100g of Chuanhuning into the reaction bottle, stir to obtain a white suspension, add 5% aqueous sodium bicarbonate solution dropwise at room temperature and normal pressure, and replace with nitrogen during the dropping process The air in the reaction bottle was stirred until the reaction became clear, and a yellow solution was obtained. The solution was placed in a 4-degree refrigerator for 12 hours to precipitate crystals, and 88.5 g of crystals were obtained by filtration. Activated carbon was heated to reflux for 2 hours, and after cooling, it was placed in a 4-degree refrigerator for 12 hours to precipitate crystals. After filtration, crystals were obtained. Repeat the above recrystallization steps, and after filtration, it was washed with water and dried to obtain 79.2 g of white crystals with a purity of 99.45%. Each impurity content is less than 0.1%.

Embodiment 2

[0043] The Yanhuning pure product 100g that embodiment 1 obtains

[0044] Sodium bisulfite 10g

[0045] Edetate Disodium 5g

[0046] PEG-400 50g

[0047] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10L

[0048] Its preparation method is as follows:

[0049] Take 100g of Yanhuning, mix and grind it with PEG-400, dissolve the ground material of Yanhuning and PEG-400 with 8000ml of prepared disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH value of 6.5, add 0.5% Activated carbon, heated to 80°C and maintained for 15 minutes, filtered to remove carbon, then added sodium bisulfite, disodium edetate, stirred to dissolve, added disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 10000ml, added 0.5% activated carbon, boiled, finely filtered with a 0.45 μm microporous membrane, and sterilized with a 0.20 μm microporous membrane, canned, sterilized, and labeled.

Embodiment 3

[0051] Yanhuning 100g

[0052] Sodium bisulfite 10g

[0053] Edetate Disodium 5g

[0054] PEG-400 50g

[0055] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10L

[0056] Its preparation method is as follows:

[0057] Take 100g of Yanhuning, mix and grind it with PEG-400, dissolve the ground material of Yanhuning and PEG-400 with 8000ml of prepared disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH value of 6.5, add 0.5% Activated carbon, heated to 80°C and maintained for 15 minutes, filtered to remove carbon, then added sodium bisulfite, disodium edetate, stirred to dissolve, added disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 10000ml, added 0.5% Activated carbon, boiled, finely filtered with a 0.45 μm microporous membrane, and sterilized with a 0.20 μm microporous membrane, canned, semi-sealed, placed in a freeze-drying box, freeze-dried, sealed, and labeled , ready to pack.

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PUM

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Abstract

The invention relates to a stable potassium sodium dehydroandroan drographolide succinate compound and a pharmaceutical composition thereof. The compound is prepared by the following steps: adding potassium dehydroandrograpolide succinate in an ethanol solution, and stirring to obtain a white suspending liquid; at room temperature under normal pressure adding sodium bicarbonate solution dropwisely with introducing nitrogen and stirring for reacting until clear to obtain a yellow solution; cooling the yellow solution, then precipitating crystals; carrying out recrystallization 1-3 times on thecrystals with a mixed solution, and simultaneously decoloring with active carbon to obtain white crystals, wherein, the mixed solution comprises ethyl acetate and ethanol, and the ratio of ethyl acetate to ethanol is 2 to 1.

Description

Technical field: [0001] The invention relates to a pharmaceutical compound, in particular to a yanhuning compound and its preparation. Background technique: [0002] The chemical name of Yanhuning is: 14-dehydroxyl-11,12-didehydroandrographolide-3,19-disuccinic acid half ester potassium sodium salt, [0003] [0004] Yanhuning is refined from the traditional Chinese medicine Andrographis paniculata through extraction, esterification, dehydration, and salt formation. It is generally prepared from Chuanhuning. Can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically stimulate the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; it has inactivated adenovirus, influenza in vitro The role of viruses, respiratory viruses and other viruses. Animal experiments have anti-early and middle-pregnancy effects. [0005] The products currently on the market ...

Claims

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Application Information

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IPC IPC(8): C07D307/58A61K31/365A61P9/14A61P29/00A61P7/10A61P5/06A61P5/40A61P31/12A61P31/16A61P15/00
Inventor 贺金凤
Owner 河北三禾实创生物科技有限公司
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