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Danshinone II A sodium sulphonate freeze dried powder injection agent and its preparation method

A technology of freeze-dried powder injection and sodium sulfonate, which is applied in the field of tanshinone IIA sodium sulfonate freeze-dried powder injection and its preparation, can solve problems such as easy adverse reactions, easy oxidation, and clinical application limitations, so as to avoid side effects and Adverse reactions, stable content, good effect

Inactive Publication Date: 2005-10-26
刘歆
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, Tanshinone IIA Sodium Sulfonate Injection has poor stability and is prone to oxidation, which reduces the effectiveness of the product and easily causes adverse reactions, thereby limiting its clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: the preparation of the freeze-dried powder injection that every bottle contains 20mg tanshinone IIA sodium sulfonate

[0023] Component Content

[0024] Sodium Tanshinone IIA Sulfonate 10g

[0025] Mannitol 25g

[0026] Cysteine ​​hydrochloride 1g

[0027] Add water for injection to 1000ml *

[0028] * removed during processing

[0029] Preparation:

[0030] Weigh the above-mentioned amount of sodium tanshinone IIA sulfonate, mannitol and cysteine ​​hydrochloride, add 900ml of water for injection, stir to dissolve, adjust the pH to about 4.0, add water for injection to 1000ml, and filter it out with a 0.22 μm microporous membrane. bacteria. Subpackage, freeze the subpackaged filtrate to -38°C in a refrigerated environment, slowly heat up to -17°C over 5 hours, until the sample is basically dry; pack, and obtain a freeze-dried powder injection containing 20mg of tanshinone IIA sodium sulfonate per bottle .

Embodiment 2

[0031] Embodiment 2: the preparation of the freeze-dried powder injection that every bottle contains 20mg tanshinone IIA sodium sulfonate

[0032] Component Content

[0033] Sodium Tanshinone IIA Sulfonate 10g

[0034] Sorbitol 25g

[0035] Cysteine ​​hydrochloride 1g

[0036] Add water for injection to 1000ml *

[0037] * removed during processing

[0038] Preparation:

[0039] Weigh the above-mentioned amount of sodium tanshinone IIA sulfonate, sorbitol and cysteine ​​hydrochloride, add 900ml of water for injection, stir to dissolve, adjust the pH to about 4.0, add water for injection to 1000ml, and filter it out with a 0.22 μm microporous membrane. bacteria. Subpackaged, freeze-dried according to the description in Example 1; packaged to obtain a freeze-dried powder injection containing 20 mg of sodium tanshinone IIA sulfonate per bottle.

Embodiment 3

[0040] Embodiment 3: the preparation of the lyophilized powder injection that every bottle contains 20mg tanshinone IIA sodium sulfonate

[0041] Component Content

[0042] Sodium Tanshinone IIA Sulfonate 10g

[0043] Lactose 20g

[0044] Sodium bisulfite 0.5g

[0045] Add water for injection to 1000ml *

[0046] * removed during processing

[0047] Preparation:

[0048] Weigh the above amount of sodium tanshinone IIA sulfonate, lactose and sodium bisulfite, add 900ml of water for injection, stir to dissolve, adjust the pH to about 4.0, add water for injection to 1000ml, filter and sterilize with a 0.22μm microporous membrane . Subpackaged, freeze-dried according to the description in Example 1; packaged to obtain a freeze-dried powder injection containing 20 mg of sodium tanshinone IIA sulfonate per bottle.

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PUM

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Abstract

A freeze-dried powder injection of danshinone IIA-sodium sulfonate for treating coronary heart disease, angina pectoris, palpitation, chest distress, etc and its preparing process are disclosed.

Description

technical field [0001] The invention relates to tanshinone IIA sodium sulfonate freeze-dried powder injection and a preparation method thereof. Background of the invention [0002] Tanshinone IIA (also known as Tanshinone IIA, Tanshinone II, Tanshinonne IIA, Tashione) is one of the main active ingredients in Danshen. It has been found to have various pharmacological effects and can be used to treat various diseases. For example, studies have found that tanshinone IIA can improve coronary circulation and inhibit the occurrence of thrombotic diseases; it can significantly expand coronary arteries, increase coronary blood flow, reduce myocardial oxygen consumption, slow down heart rate and increase myocardial contractility, which can effectively treat and prevention of coronary heart disease. In addition, it has been confirmed in animal experiments that tanshinone IIA can significantly prolong the hypoxia tolerance time of mice, reduce myocardial damage caused by hypoxia, and ...

Claims

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Application Information

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IPC IPC(8): A61K31/343
Inventor 刘歆
Owner 刘歆
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