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Tanshinone óÄA sodium sulfonate for injection and its preparation method

A technology of tanshinone and sodium sulfonate, which is applied in the field of tanshinone IIA sodium sulfonate, can solve problems such as poor stability, patient loss, and easy turbidity, and achieve good stability, accurate treatment and rescue effects

Inactive Publication Date: 2005-07-06
昆明希捷医药研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the research on the stability of the preparation has not been fully developed. Because the solid of tanshinone II A sodium sulfonate is relatively stable, the aqueous solution is easily desulfonated by the influence of light and shaking for a long time and decomposed into tanshinone IIA. Tanshinone IIA is a fat-soluble component. , so the aqueous solution of sodium tanshinone IIA sulfonate has poor stability and becomes turbid
The injection made of tanshinone IIA sodium sulfonate has the same poor stability as the aqueous solution of tanshinone IIA sodium sulfonate, and the preparation is prone to turbidity after being placed for a long time, which leads to the failure of normal clinical application of the preparation and causes great losses in production. If this kind of water needle containing solid particles is used clinically by negligence for a moment, it will cause incalculable losses to patients
Moreover, since the diseases treated by sodium tanshinone IIA sulfonate involve cardiovascular and cerebrovascular diseases, its importance is self-evident, and the damage rate of injection preparations is high during transportation, which virtually increases the cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Weigh 40g of sodium tanshinone IIA sulfonate, add 1600ml of water for injection, stir to dissolve sodium tanshinone IIA sulfonate; add 40g of mannitol, stir until dissolved; add 2g of carbon for needles, heat to 80°C and keep it warm for 30 minutes, cool to 45°C Decarbonize at ℃; add water for injection to the full amount, measure the content of intermediates; fine filter with a 0.22μ microporous membrane, fill in 7ml vials, about 2ml per bottle, cover with butyl rubber stoppers, and keep air holes, Put it into the freeze dryer and carry out freeze-drying according to the designed freeze-drying curve; when the vacuum degree in the drying box is close to the vacuum degree of the pump port and the temperature of the product coincides with the temperature of the plate, close the freezing system and the vacuum system, and press the bottle stopper tightly. Deflate, take out the sample, press the aluminum cap to get the tanshinone IIA sodium sulfonate freeze-dried powder injec...

Embodiment 2

[0025] Sodium chloride is selected as the framework material, according to 150g of sodium tanshinone IIA sulfonate and 225g of framework material, the rest are the same

[0026] Example 1.

Embodiment 3

[0028] Glucose is selected as the skeleton material, and the ratio and amount are the same as those in Example 1.

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PUM

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Abstract

The invention relates to a dosage type of tanshinone III sodium sulfonate, and the process for preparing the dosage type, which comprises tanshinone IIA sodium sulfonate and framework material, and the weight ratio of the tanshinone IIA sodium sulfonate and framework material is, tanshinone IIA sodium sulfonate 10-70% and framework material 30-90%. The invention has the advantages of accurate dosage, good stability, thus can be applied to the treatment and rescue for patients.

Description

technical field [0001] The invention relates to a dosage form of sodium tanshinone IIA sulfonate and a preparation method of the dosage form. Background technique [0002] At present, Tanshinone IIA sodium sulfonate injection has been produced in China, and its national standard has been announced. The standard number is WS-10001-(HD-1014)-2002, and the specification is 2ml: 10mg. Collateral circulation and local blood supply in ischemic myocardium. Improve the metabolic disorder of hypoxic myocardium, improve the hypoxia tolerance of myocardium, inhibit platelet aggregation and anti-thrombosis, reduce the area of ​​ischemic myocardial infarction in experimental animals, and enhance myocardial contractility at a certain dose. Can be used for coronary heart disease, angina pectoris, chest tightness. [0003] The drug standards for Tanshinone IIA Sodium Sulfonate Injection on the market are the national drug standards with rising local drug standards, although the overall le...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/343A61P9/10
Inventor 秦引林颜培玲何龙其
Owner 昆明希捷医药研发有限公司
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