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Medicine composition containing salvianolic acid A, preparation method and application thereof as well as freeze-dried powder injection and water injection containing composition

A technology of salvianolic acid and composition, applied in the field of pharmaceutical composition containing salvianolic acid A, its preparation, use and freeze-dried powder injection and water injection containing the composition, which can solve the problem of stability of injection water injection Solve problems such as difficulty in formulation stability and achieve stable aqueous solution, improved water solubility, and good stability

Inactive Publication Date: 2009-12-09
YANTAI TARGET DRUG RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The water solubility of high-purity salvianolic acid A is less than 5 mg / ml, so it cannot be directly used for injection administration, and salvianolic acid A is the strongest antioxidant currently known, and its preparation stability is a very difficult problem. Its injection water Injection stability is more difficult to solve

Method used

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  • Medicine composition containing salvianolic acid A, preparation method and application thereof as well as freeze-dried powder injection and water injection containing composition
  • Medicine composition containing salvianolic acid A, preparation method and application thereof as well as freeze-dried powder injection and water injection containing composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Dissolve 5.0g (0.01mol) of salvianolic acid A in 250ml ethanol, dissolve 0.9803g (0.0033mol) of sodium citrate in 100ml water for injection, mix the two solutions, and continue stirring for 30min until the reaction completely. Freeze-dried.

Embodiment 2

[0022] Example 2: Weigh 5.98 g of the salvianolic acid A composition prepared in Example 1 and dissolve it in 300 ml of water for injection, and continue stirring to completely dissolve. Then add 4.0g mannitol, 0.6g sodium bisulfite, 0.6g disodium calcium edetate, stir to dissolve, add 0.35g of activated carbon for needles and stir for 30min at room temperature, filter, set the solution to 400ml, subpackage, pack The amount is that each bottle contains 25 mg of salvianolic acid A, freeze-dried at -50 to 30°C, capped, sealed, and packaged to obtain the freeze-dried powder for injection. Embodiment three, get salvianolic acid A 5.0g (0.01mol) and disperse in 250ml water for injection, get disodium hydrogen phosphate 0.7099g (0.005mol) and dissolve in 100ml water for injection, two kinds of solutions are mixed, continue stirring 30min until The response is complete. Then add 4.0g of lactose and 0.6g of sodium bisulfite, stir to dissolve, add 0.35g of activated carbon for needles...

Embodiment 4

[0023] Example 4: Get 5.0 g (0.01 mol) of salvianolic acid A and disperse it in 250 ml of water for injection, get 1.411 g (0.01 mol) of sodium benzoate and dissolve it in 100 ml of water for injection, mix the two solutions, and continue stirring for 30 min until the reaction is complete . Then add 4.0g of lactose, 0.6g of sodium bisulfite, and 0.6g of disodium edetate, stir to dissolve, add 0.35g of activated carbon for needles and stir for 30min at room temperature, filter, and dissolve to 400ml. Each bottle contains 25mg of salvianolic acid A, freeze-dried at -50-30°C, capped, sealed, and packaged to obtain the product.

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Abstract

The invention relates to a medicine composition containing salvianolic acid A, the application and a preparation method thereof as well as freeze-dried powder injection and water injection containing the composition. The preparation method of the medicine composition comprises the following steps: taking salvianolic acid A to dissolve or disperse into water or ethanol, taking one or a plurality of alkaline sodium salt and alkaline kali salt to dissolve into water, mixing and fully stirring two solutions to be settled completely, and generally freeze-drying or decompression-drying by distillation to obtain a finished product, or directly adding water solution into pharmaceutic adjuvant to make the freeze-dried powder injection or water injection. The salvianolic acid A composition provided by the invention has strong stability, high dissolubility and uneasy oxidation in the water solution; the preparation method has good manufacturability, simple operation and low cost and can be used for preparing medicines for curing ischemic cardiovascular and cerebrovascular diseases; and the freeze-dried powder injection and water injection containing the salvianolic acid A have good stability and high uniformity and are accordant with requirements of medicines.

Description

technical field [0001] The present invention relates to a pharmaceutical composition and its use. The composition contains a certain proportion of salvianolic acid A weakly basic sodium or potassium salt, and also relates to a preparation method of the composition, and a freeze-dried product containing the pharmaceutical composition. Powder injection, water injection. Background technique [0002] Salvianolic acid A (Salvianolic acid A) is a phenolic acid compound present in Salvia miltiorrhiza Bge, a drug commonly used in traditional Chinese medicine for promoting blood circulation and removing stasis. The natural content is about 0.01% to 0.08%. [Li LN et al.Salvianolic acid A, a new depside from roots of Salviamiltiorrhiga, Planta Medica, 1984; 50:227] Subsequently, Professor Li Lianniang and others found that the water-soluble phenolic acid compounds in Salvia miltiorrhiza have antithrombotic properties and improve blood circulation , anti-oxidative damage, improving le...

Claims

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Application Information

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IPC IPC(8): A61K31/216A61K9/19A61K9/08A61P9/10A61P9/00
Inventor 马玲君刘军锋刘珂陈猛
Owner YANTAI TARGET DRUG RES
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