Potassium sodium dehydroandroandrographolide succinates and their preparations

A technology of andrographolide and disuccinic acid half ester, which is applied in antiviral agents, medical preparations containing active ingredients, organic active ingredients, etc. It can solve the problems of easy precipitation, side effects, and short storage time of preparations, etc. problems, to achieve the effect of good clinical curative effect, stable quality, excellent purity and solubility

Inactive Publication Date: 2004-12-29
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because the potassium salt of andrographolide succinate half ester is unstable, it is easy to precipitate during the preparation process, resulting in short storage time of the preparation, and side effects have occurred during use, which has produced some adverse effects on patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of Yanhuning, raw material consumption is as follows:

[0037] Chuanhuning 0.956g

[0038] Sodium bicarbonate for injection 0.17g

[0039] Activated carbon for injection 33g

[0040] Water for injection 9L

[0041] Mannitol 98g

[0042] 1kg

[0043] 1. Take the prescribed amount of Chuanhuning and add 20% water for injection to make a suspension.

[0044] 2. Preparation of 2-4% NaHCO3 solution: weigh the NaHCO3 of the prescribed amount, add water for injection to make 6500ml of NaHCO3 solution.

[0045] 3. Control the temperature of the above suspension at 35±5°C, and keep stirring under N2, slowly add 2-4% NaHCO3 to make it completely dissolved until clear, add mannitol and mix well, and adjust the pH with NaHCO3 solution To the range of 6.5-7.5, continue to pass N2 to measure the pH value of the solution, then make up the volume with water for i...

Embodiment 2

[0047] Preparation of freeze-dried powder injection

[0048] Take 200g of Yanhuning and add 500ml of about 80% of the total volume of water for injection to dissolve, measure the pH, adjust the pH to 6.5-7.5 with 4% NaHCO3 solution, add water for injection to the full amount, add activated carbon for decolorization, filter out the carbon, and measure the pH. After the content is qualified, it is sterile filtered, and after the clarity is qualified, it is filled into 1000 bottles, half-stoppered, and put into a box for freeze-drying. Box out, capping, crimping, light inspection, packaging

Embodiment 3

[0050] Preparation of Injection

[0051] Dissolve 200g of Yanhuning powder in 1800ml of water for injection, adjust the pH to 6.5-7.5 with 4% NaHCO3 solution, decarbonize, filter, add water to 2000ml, fill into 1000 bottles, and sterilize.

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PUM

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Abstract

The present invention relates to one kind of sodium-potassium andrographolide-semisuccinate and its preparations. On the basis of potassium andrographolide-semisuccinate, which is not enough stable and is likely to produce precipitate and negative effect, sodium-potassium andrographolide-semisuccinate is developed and has relatively high stability and less side effect. The sodium-potassium andrographolide-semisuccinate is prepared into injection, powder for injection and other forms.

Description

Technical field: [0001] The invention relates to a sodium potassium salt of andrographolide half succinate and a preparation thereof. Background technique: [0002] Andrographolide succinate half ester potassium salt (also known as Chuanhuning), the main component is andrographolide, which is a kind of medicine with heat-clearing, anti-bacterial, anti-inflammatory and anti-viral effects. Its injection market has been sold. [0003] Because the potassium salt of andrographolide succinate half ester is unstable, it is easy to precipitate during the preparation process, resulting in short storage time of the preparation, side effects have occurred during use, and some adverse effects have been produced on patients. [0004] On the basis of the potassium salt of andrographolide half-ester succinate, the present invention solves the defects existing in the preparation by forming sodium potassium salt, and prepares a sodium potassium half-ester of andrographolide succinate with s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/365A61P31/04A61P31/12C07D307/58
Inventor 王琦周翠兰
Owner YAOPHARMA CO LTD
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