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Sodium sulfonate injection of tanshinone óÄA, and preparation method

A technology of sodium sulfonate and tanshinone, which is applied in the field of tanshinone II A sodium sulfonate pharmaceutical preparations, can solve problems such as long dissolution time, unsmooth dissolution, and increased impurities, and achieve the effect of improving drug stability

Active Publication Date: 2007-02-21
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adding some antioxidants to the injection will cause the main active ingredient Tanshinone II A sodium sulfonate to react chemically with the antioxidant, resulting in a decrease in the content of the main drug in the injection and an increase in impurities.
Tanshinone II A sodium sulfonate injection small injections and powder injections have been troubled by relevant researchers because of poor dissolution and long dissolution time during production and formulation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Take 80g of hydroxypropyl β-cyclodextrin, add 1500ml of water for injection and stir to dissolve, then add 10g of sodium tanshinone IIA sulfonate, and dissolve quickly after stirring. Make up water for injection to 2000ml, then add citric acid or sodium citrate to adjust the pH value to about 4.5, add 10g of activated carbon for injection, keep warm at 40°C for 30 minutes, filter and decarbonize, and measure the content of intermediates. 0.22um microporous membrane filtration, 2ml of the filtrate was filled into ampoules, filled with nitrogen, and sealed by fusing. Sterilize with steam at 100°C to get the finished product. For clinical use, add 40mg to 80mg (that is, 4-8 sticks of this product) into 500ml of 5% glucose injection, dilute and infuse intravenously.

Embodiment 2

[0046] Take 3.0 g of calcium sodium edetate and 60 g of hydroxypropyl β-cyclodextrin, add 1600 ml of water for injection and stir to dissolve, then add 10 g of sodium tanshinone II A sulfonate, and stir to dissolve at 60°C. Make up water for injection to 2000ml, then add citric acid or sodium citrate to adjust the pH value to about 4.5, add 10g of activated carbon for injection, keep warm at 40°C for 30 minutes, filter and decarbonize, and measure the content of intermediates. 0.22um microporous membrane filtration, 2ml of the filtrate was filled into an ampoule, filled with nitrogen, and sealed by fusion. Sterilize with steam at 100°C to get the finished product. For clinical use, add 40mg to 80mg (that is, 4-8 sticks of this product) into 500ml of 5% glucose injection, dilute and infuse intravenously.

Embodiment 3

[0048]Take 1.0 g of calcium sodium edetate and 600 g of hydroxypropyl β-cyclodextrin, add 9,000 ml of water for injection and stir to dissolve, then add 40 g of sodium tanshinone IIA sulfonate, stir and dissolve at 60°C, and make up water for injection to 10,000 ml. Then add citric acid or sodium citrate to adjust the pH value to about 4.5, add 50 g of activated carbon for injection, keep warm at 50°C for 30 minutes, filter and decarbonize, and measure the content of the intermediate. 0.22um microporous membrane filtration, 10ml of filtrate was filled into ampoules, filled with nitrogen, and sealed by melting. Sterilize with steam at 100°C to get the finished product. For clinical use, add 40mg to 80mg (that is, 1-2 sticks of this product) into 500ml of 5% glucose injection, dilute and infuse intravenously.

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PUM

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Abstract

An injection of tanshinone IIA-sodium sulfonate with high effect and stability contains tanshinone IIA-sodium sulfonate and hydroxypropyl-beta-dextrin in weight ratio of 1: (1-150). its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a tanshinone II A sodium sulfonate pharmaceutical preparation, in particular to a tanshinone II A sodium sulfonate injection and a preparation method thereof. Background technique [0002] Before the present invention was made, there had been small injections of Tanshinone II A Sodium Sulfonate Injection on the market, produced by Barrymore Pharmaceutical (Tonghua) Co., Ltd., with the trade name "Xinnuobangsheng", used for the treatment of cardiovascular and cerebrovascular diseases And prevention, its specification is that every 2ml contains main drug tanshinone II A sodium sulfonate 10mg, when in use, add 40mg~80mg into 500ml of 5% glucose injection and dilute it and inject it intravenously. After the injection was introduced to the market, its definite curative effect was welcomed by the majority of doctors and patients. However, it will oxidize and cause discoloration after being placed for a long time, thereby affecting t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/58A61K47/40A61P9/00
Inventor 秦引林
Owner JIANGSU CAREFREE PHARM CO LTD
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