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Tanshinone II A sodium sulfonate powder injection agent and its preparation method

A technology of sodium sulfonate and tanshinone, applied in powder delivery, cardiovascular system diseases, drug combination and other directions, can solve the problems of affecting application, difficulty in storage, reducing stability and quality of preparations, etc., to improve drug quality and stability , Increase the effect of drug stability, clarity and stability improvement

Inactive Publication Date: 2004-12-22
昆明同持医药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since tanshinone IIA is a highly oxidized polyphenyl ring structure, tanshinone IIA sodium sulfonate injection needs to be stored in an airtight, cool and dark place, which is difficult to store
Oxidation and polymerization are easy to occur in the solution state, thereby reducing the stability and quality of the preparation, and it also brings a variety of side effects in clinical practice, especially with the prolongation of the preparation storage time, the greater the probability of allergic reactions, which seriously affects its application in clinical

Method used

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  • Tanshinone II A sodium sulfonate powder injection agent and its preparation method
  • Tanshinone II A sodium sulfonate powder injection agent and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Weigh 10g sodium tanshinone IIA sulfonate, 10g mannitol, 0.1g vitamin C and add 800ml of water for injection to dissolve, adjust the pH value to 4.5, filter through a 0.45μm microporous membrane; place the filtrate at 0°C for 6 hours, 0.1 μm microporous membrane filtration, diluted with water for injection to 1000ml, filled (2ml / bottle), freeze-dried, sterilized by radiation, and packaged.

Embodiment 2

[0045] Weigh 10g sodium tanshinone IIA sulfonate, 10g mannitol, 0.1g vitamin C and add 100ml water for injection to dissolve, adjust the pH value to 5, filter through a 0.45μm microporous membrane; place the filtrate at 1°C for 10 hours, 0.1 μm microporous membrane filtration, diluted with water for injection to 200ml, spray-dried, potted (40mg / bottle), sterilized by radiation, and packaged.

Embodiment 3

[0047] Weigh 10g of sodium tanshinone IIA sulfonate and 10g of mannitol, add 100ml of water for injection to dissolve, adjust the pH value to 5.5, filter through a 0.45μm microporous membrane; place the filtrate at 2°C for 12 hours, filter through a 0.1μm microporous membrane Membrane filtration, diluted with water for injection to 200ml, spray-dried, potted (20mg / bottle), sterilized by radiation, and packed.

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PUM

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Abstract

A tanshinone IIAsodium sulfonate injection in the form of powder is prepared from tanshinone IIA sodium sulfonate (50-100 wt.%) and medical auxiliaries (0-50 wt.%) including skeleton supporting agent and antioxidizing agent.

Description

technical field [0001] The invention relates to a pharmaceutical preparation. More specifically, it is a powder injection medicament prepared from tanshinone IIA sodium sulfonate as a raw material, and the invention also relates to a preparation method of the powder injection medicament. Background technique [0002] Tanshinone IIA (also known as Tanshinone IIA, Tanshinone II, Tanshinone IIA, Tanshinone) is one of the main active ingredients in Salvia miltiorrhiza, and the structure made from it is sodium tanshinone IIA sulfonate shown in formula I, which can be Reduce the blood perfusion injury in the ischemic heart area; sodium tanshinone IIA sulfonate has a stabilizing effect on the red blood cell membrane and can inhibit the hemolysis of red blood cells; improve the body's ability to withstand hypoxia and slow down the rate of oxygen consumption; it has a good anti-inflammatory effect Oxidative activity, has protective effect on myocardium ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/343A61P9/10
Inventor 周春香
Owner 昆明同持医药研究有限公司
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