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Monomer salvianolic acid B injection and preparation method thereof

A salvianolic acid and injection technology, which is applied in the field of injections for the treatment of cardiovascular and cerebrovascular diseases, can solve the problems such as the lack of high-content salvianolic acid B monomer injections, the low content of salvianolic acid B, and the inability to clarify the ingredients, etc. To achieve the effect of high pharmacological activity, less impurities and improving memory

Inactive Publication Date: 2009-06-10
苑立超
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, there are only Chinese medicine compound preparations such as Danshen injection and Xiangdan injection in the market, and there is no high-content salvianolic acid B monomer injection (western medicine) for clinical use.
However, the content of salvianolic acid B in traditional Chinese medicine injections is not high, and there are still a large part of the ingredients that cannot be clearly stated, so it is unstable in actual use and has many adverse reactions

Method used

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  • Monomer salvianolic acid B injection and preparation method thereof
  • Monomer salvianolic acid B injection and preparation method thereof
  • Monomer salvianolic acid B injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Monomer salvianolic acid B injection, the preparation process is: take 0.02g of sodium bisulfite and dissolve it in 10ml of water for injection, add 10mg of disodium edetate to dissolve and mix, and then dissolve 0.1g of salvianolic acid B in Add appropriate amount of dilute hydrochloric acid solution to the above solution to adjust the pH to 3.0. Add 0.1% activated carbon for injection and stir at 60°C for 20 minutes, filter, add water for injection to 20ml, pass through a 0.22μm membrane, make 10 tubes, fill in ampoules, fill with nitrogen, and sterilize at 100°C for 30 minutes to obtain the finished product.

Embodiment 2

[0038] For the monomeric salvianolic acid B injection described in Example 1, 0.06 g of sodium bisulfite, 0.2 g of vitamin C, and 5 mg of disodium edetate were dissolved in 30 ml of water for injection, and then 0.5 g of salvianolic acid B was dissolved in 30 ml of water for injection. g was dissolved in the above solution, and adjusted to pH 3.5 with an appropriate amount of dilute phosphoric acid, then added 0.05% activated carbon for injection and stirred at 60°C for 20 minutes, filtered water for injection to a total volume of 50ml, and passed through a 0.22μm membrane to make 10 sticks. Fill in ampoules, fill with nitrogen, and sterilize at 100°C for 30 minutes to obtain the finished product.

Embodiment 3

[0040] In the monomeric salvianolic acid B injection described in Example 1, 20 mg of calcium sodium edetate, 0.5 g of D-isoascorbic acid were dissolved in 30 ml of water for injection, and then 1 g of salvianolic acid B was dissolved in the above solution, and dissolved in L -Cysteine ​​hydrochloride solution and 0.1mol / L hydrochloric acid solution to adjust the pH to 4.0, add 0.2% activated carbon for injection and stir at 60°C for 20 minutes, filter water for injection to a total volume of 50ml, and pass through a 0.22μm membrane to prepare 10 tubes, filled in ampoules, filled with nitrogen, and sterilized at 100°C for 30 minutes to get the finished product.

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PUM

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Abstract

Provided is a monomer danshinolic acid B injection comprising water injection and freeze-dried powder injection and preparing method thereof, the danshinolic acid B injection comprises danshinolic acid B, pH regulating substance of pharmacological action, stabilizing agent, excipient, the concentration of the danshinolic acid B is as follows: the water injection is 2 mg / ml-200mg / ml or the freeze-dried powder injection is 2mg-400mg / bottle, the pH regulating substance has the adding amount when the pH value is regulated for 2. 5-6. 5, the concentration of the stabilizing agent is 0. 0001 mg / ml-0. 1 g / ml. The invention can provide a medicament capable of treating cardiovascular and cerebrovascular diseases and being safely used on clinical.

Description

Technical field: [0001] The invention relates to an injection for treating cardiovascular and cerebrovascular diseases, in particular to chemical medicine salvianolic acid B water injection, powder injection and preparation method thereof. Background technique: [0002] At present, there are only Chinese medicine compound preparations such as Danshen injection and Xiangdan injection in the market, and there is no high-content salvianolic acid B monomer injection (western medicine) for clinical use. However, the content of salvianolic acid B in traditional Chinese medicine injections is not high, and a large part of the ingredients cannot be clearly stated, so it is unstable in actual use and has many adverse reactions. Salvianolic acid B is a monomer extracted from the dry root of Salvia miltiorrhiza, the main active ingredient in Salvia miltiorrhiza, molecular formula: C 36 h 30 o 16 , molecular weight: 718.614, has a clear chemical structure: [0003] Invention con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K9/08A61K9/19A61P9/10
Inventor 苑立超
Owner 苑立超
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