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Salvianolic acid B magnesium injection, preparation method and use thereof

A technology of salvianolic acid and injection, which is applied in the field of injections for the treatment of cardiovascular and cerebrovascular diseases, and can solve problems such as light and heat sensitivity, unstable aqueous solution, and increased impurities

Inactive Publication Date: 2009-07-29
苑立超
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Magnesium salvianolic acid B can be dissolved in water, but its aqueous solution is unstable, easily oxidized, and sensitive to light and heat, resulting in a decrease in content and an increase in impurities. The guarantee of its stability is a technical difficulty

Method used

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  • Salvianolic acid B magnesium injection, preparation method and use thereof
  • Salvianolic acid B magnesium injection, preparation method and use thereof
  • Salvianolic acid B magnesium injection, preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation process of salvianolic acid B magnesium injection is as follows: take 0.1 g of sodium bisulfite and dissolve it in 50 ml of water for injection, add 80 mg of disodium edetate to dissolve and mix, and then dissolve 1 g of salvianolic acid B magnesium 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 50°C for 20 minutes, filter, add water for injection to the full volume of 100ml, and pass through a 0.22μm membrane to make 100 tubes, fill in ampoules, fill with nitrogen, and sterilize at 100°C for 30 minutes to obtain the finished product.

Embodiment 2

[0045] For the magnesium salvianolic acid B injection described in Example 1, take 0.1 g of sodium bisulfite and dissolve it in 100 ml of water for injection, add 80 mg of disodium edetate to dissolve and mix, then dissolve 1 g of magnesium salvianolic acid B Add an appropriate amount of acidic buffer salt to the above solution to adjust the pH to 3.5. Add 0.1% activated carbon for injection and stir at 50°C for 20 minutes, filter, add water for injection to 200ml, pass through a 0.22μm membrane, make 100 tubes, fill in ampoules, fill with nitrogen, and sterilize at 100°C for 30 minutes to obtain the finished product.

Embodiment 3

[0047]The magnesium salvianolic acid B injection described in embodiment 1, gets sodium bisulfite 0.5g, vitamin C 1.5g, disodium edetate 50mg is dissolved in 300ml water for injection, then the magnesium salvianolic acid B 5g Dissolve in the above solution, adjust the pH to 3.5 with an appropriate amount of dilute phosphoric acid, add 0.05% activated carbon for injection and stir at 50°C for 20 minutes, filter water for injection to a total volume of 500ml, and pass through a 0.22μm membrane to make 100 sticks. Fill in ampoules, fill with nitrogen, and sterilize at 100°C for 30 minutes to obtain the finished product.

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Abstract

The invention relates to a salvianolic acid B magnesium injection and a preparation method and application of the salvianolic acid B magnesium injection. The injection comprises a water injection and a lyophilized powder injection. Currently, relevant salivae miltiorrhizae extract injections only comprise a salivae miltiorrhizae injection, a chambertin injection and other Chinese medicine composite preparations. A product comprises the following compositions: salvianolic acid B magnesium, a pharmacologically allowable pH regulation substance and a stabilizing agent; when the lyophilized powder injection also needs to be added with an excipient, when the injection is in a water injection form, the concentration of the salvianolic acid B magnesium is between 2 and 200mg / ml; in the product, the concentration of the stabilizing agent is between 0.0001 and 0.1g / ml; when the injection is in a lyophilized powder injection form, in each piece, namely each 42 to 1,300 mg of a dry substance, the salvianolic acid B magnesium is between 2 and 400 mg; the addition amount of the excipient is between 0.04 and 0.8 g; the addition amount of the stabilizing agent is between 0.0001 and 0.1g / piece; and in two substances, the addition amount of the pH regulation substance is equal to the addition amount when pH value is regulated to be between 2.5 and 7.5. The salvianolic acid B magnesium injection is used for treating cardiovascular and cerebrovascular diseases and other diseases.

Description

Technical field: [0001] The invention relates to an injection for treating cardiovascular and cerebrovascular diseases, in particular to salvianolic acid B magnesium 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 related to Danshen extract injection, and there is no salvianolic acid B magnesium injection for clinical use. Salvianolic acid B magnesium is a water-soluble substance isolated and extracted from Danshen. It is the main active ingredient in Danshen. Its molecular formula: C36H28O16Mg, molecular weight: 740.924, and has a clear chemical structure: [0003] [0004] According to the current domestic extraction process, the purity of magnesium salvianolic acid B raw material can reach more than 98.5%, and the injection made into it has the characteristics of high purity, high pharmacologic...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/343A61P9/00A61P35/00A61P13/12A61P3/10
Inventor 苑立超
Owner 苑立超
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