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Novel potassium sodium dehydroandrographolide succinate compound and pharmaceutical composition thereof

A technology of Yanhuning and its compounds, which is applied in the field of new Yanhuning compounds and their pharmaceutical compositions, can solve the problems of general medicinal effect of powder injections, increased adverse reactions, and affecting the quality of preparations, so as to achieve superior drug efficacy, Excellent medicinal effect and immunity-enhancing effect

Inactive Publication Date: 2017-06-16
ZHUHAI TONGYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the actual application process, it was found that although the stability of the obtained freeze-dried preparation was improved to a certain extent, due to the excessive amount of excipients in the prescription, the medicinal effect of the powder injection was general, and the stability after long storage time will still drop significantly
In addition, the addition of excipients increases the probability of adverse reactions, and the type and amount of excipients will also affect the quality of the preparation, thereby limiting its application.

Method used

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  • Novel potassium sodium dehydroandrographolide succinate compound and pharmaceutical composition thereof
  • Novel potassium sodium dehydroandrographolide succinate compound and pharmaceutical composition thereof
  • Novel potassium sodium dehydroandrographolide succinate compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The preparation of the new Yanhuning compound of embodiment 1

[0048] (1) Dissolve 5g of Chuanhuning in a mixed solution of 17.5ml of water and 2.5ml of absolute ethanol to obtain solution 1;

[0049] (2) Stir and add 0.5mol / L sodium bicarbonate aqueous solution to solution 1 at a rate of 20mL / min at 20°C, adjust the pH to 6.5, then raise the temperature to 25°C at a rate of 0.2°C / min, add activated carbon, and continue Stir the reaction for 1 hour, filter with suction, collect the filtrate, and obtain solution 2;

[0050] (3) Decrease the temperature of solution 2 to 3°C at a rate of 0.2°C / min, stop stirring, let the crystal grow for 5 hours, filter with suction, wash the filter cake with absolute ethanol, and dry at 70°C for 4 hours to obtain Yanhuning compound.

[0051] The characteristic peaks in the X-ray powder diffraction pattern of the Yanhuning compound measured by Cu-Kα rays are 7.3°, 9.6°, 12.0°, 13.4°, 15.9°, 17.5°, 18.0°, 19.8°, 23.4°, 23.8°, 24.6°, 27....

Embodiment 2

[0052] The preparation of the new Yanhuning compound of embodiment 2

[0053] (1) Dissolve 5g of Chuanhuning in a mixed solution of 17.5ml of water and 2.5ml of absolute ethanol to obtain solution 1;

[0054] (2) Stir and add 0.5 mol / L sodium bicarbonate aqueous solution to solution 1 at a rate of 30 mL / min at 20°C, adjust the pH to 7.0, then raise the temperature to 30°C at a rate of 0.3°C / min, add activated carbon, and continue Stir the reaction for 2 hours, filter with suction, collect the filtrate to obtain solution 2;

[0055] (3) Decrease the temperature of solution 2 to 5°C at a rate of 0.3°C / min, stop stirring, let the crystal grow for 6 hours, filter with suction, wash the filter cake with absolute ethanol, and dry at 80°C for 4 hours to obtain Yanhuning compound.

[0056] The X-ray powder diffraction pattern obtained by measuring the Yanhuning compound using Cu-Kα rays is consistent with Example 1, and its melting point is 202°C.

Embodiment 3

[0057] The preparation of the new Yanhuning compound of embodiment 3

[0058] (1) Dissolve 5g of Chuanhuning in a mixed solution of 17.5ml of water and 2.5ml of absolute ethanol to obtain solution 1;

[0059] (2) Stir and add 0.5mol / L sodium bicarbonate aqueous solution to solution 1 at 20°C at a rate of 20mL / min, adjust the pH to 7.0, then raise the temperature to 25°C at a rate of 0.3°C / min, add activated carbon, continue Stir the reaction for 2 hours, filter with suction, collect the filtrate to obtain solution 2;

[0060] (3) Decrease the temperature of solution 2 to 5°C at a rate of 0.2°C / min, stop stirring, let the crystal grow for 5 hours, filter with suction, wash the filter cake with absolute ethanol, and dry at 80°C for 4 hours to obtain Yanhuning compound.

[0061] The X-ray powder diffraction pattern obtained by measuring the Yanhuning compound using Cu-Kα rays is consistent with Example 1, and its melting point is 202°C.

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Abstract

The invention specifically relates to a novel potassium sodium dehydroandrographolide succinate compound and a pharmaceutical composition thereof, belonging to the technical field of medicines. The novel potassium sodium dehydroandrographolide succinate compound is a crystal. In an X-ray powder diffraction pattern obtained after measurement of the crystal with Cu-Kalpha rays, characteristic peaks appear when 2theta is equal to 7.3 DEG, 9.6 DEG, 12.0 DEG, 13.4 DEG, 15.9 DEG, 17.5 DEG, 18.0 DEG, 19.8 DEG, 23.4 DEG, 23.8 DEG, 24.6 DEG and 27.1 DEG. The pharmaceutical composition comprises the novel potassium sodium dehydroandrographolide succinate compound, glutamine, potassium sorbate and injection water. The dosage form of the pharmaceutical composition is a freeze-dried powder injection. The freeze-dried powder injection of potassium sodium dehydroandrographolide succinate has better stability and superior drug effect.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a new yanhuning compound and its pharmaceutical composition. Background technique [0002] Yanyuning, the chemical name is: 14-dehydroxyl-11,12-didehydroandrographolide-3,19-disuccinic acid half ester potassium sodium salt-hydrate, and the molecular formula is: C 28 h 34 KNaO 10 ·H 2 O. Yanhuning is a diterpene compound andrographolide extracted from the traditional Chinese medicine Andrographis paniculata, which is dehydrated andrographolide half-ester potassium succinate sodium salt, which is obtained by esterification, dehydration, and salt formation. Function and sedative effect, it is one of the commonly used drugs in TCM emergency. [0003] Yanhuning can inhibit early capillary permeability increase and inflammatory exudation edema, can specifically stimulate the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis...

Claims

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Application Information

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IPC IPC(8): C07D307/58A61K31/365A61K9/19A61K47/18A61K47/12A61P29/00A61K31/198
CPCC07D307/58A61K9/0019A61K9/19A61K31/198A61K31/365A61K47/12A61K47/183C07B2200/13A61K2300/00
Inventor 黄毅陈敏钱国佩陈戟曾炎科
Owner ZHUHAI TONGYUAN PHARMA CO LTD
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