Preparation method for sodium aescinate freeze-dried emulsion for injection

A technology of sodium aescinate and freeze-dried emulsion, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, drying, etc., and can solve the problem of low content of sodium aescinate, instability of aescinate, and influence on curative effect, etc. problem, to achieve the effect of good resolubility, less irritation, and low cost

Active Publication Date: 2015-09-02
WUHAN AIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, due to the instability of aescin, the stability of the existing sodium aescinate freeze-dried emulsion for inject

Method used

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  • Preparation method for sodium aescinate freeze-dried emulsion for injection
  • Preparation method for sodium aescinate freeze-dried emulsion for injection
  • Preparation method for sodium aescinate freeze-dried emulsion for injection

Examples

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Comparison scheme
Effect test

Embodiment 1

[0022] A preparation method of sodium aescinate freeze-dried emulsion for injection: 2g sodium aescinate is dissolved in 20ml acetone, then added to 100ml soybean oil for injection together with 6g lecithin and 0.15g oleic acid, stirred evenly, and then Remove acetone by rotary evaporation to obtain the oil phase; dissolve 12g glycerin and 0.025g EDTA-2Na in 400ml water for injection to obtain the water phase; add the oil phase to the water phase and shear at 70°C and 8000rpm 30min to obtain colostrum; adjust the pH of colostrum to 5, and homogenize 8 times under 800bar pressure to obtain emulsion; take 80g of lyoprotectant (lactose 24g, trehalose 40g, sulfobutyl ether-β-cyclodextrin 16g) into the homogeneous emulsion, stirred until the lyoprotectant is completely dissolved, then filtered through a 0.22 μm filter membrane, subpackaged, and lyophilized to obtain the product.

[0023] Described freeze-drying comprises the following steps:

[0024] 1) Pre-freezing: place the fil...

Embodiment 2

[0028] A preparation method of sodium aescinate freeze-dried emulsion for injection: 0.1g sodium aescinate is dissolved in 10ml tetrahydrofuran, then added to 50ml olive oil together with 2g lecithin and 0.05g oleic acid, stirred evenly, and then rotated Remove tetrahydrofuran by evaporation to obtain an oil phase; dissolve 5g glycerin and 0.01g EDTA-2Na in 200ml water for injection to obtain a water phase; add the oil phase to the water phase and cut for 60min at 80°C and 3000rpm , to obtain colostrum; adjust colostrum pH to 6, and homogenize 10 times under 600bar pressure to obtain emulsion; get 25g lyoprotectant (lactose 12.5g, trehalose 7.5g, sulfobutyl ether-β-cyclodex 5g of essence) was added to the homogeneous emulsion, stirred until the freeze-dried protective agent was completely dissolved, then filtered through a 0.1 μm filter membrane, subpackaged, and freeze-dried to obtain final product.

Embodiment 3

[0030] Dissolve 5g of sodium aescinate in 50ml of acetone, then add it together with 10g of lecithin and 0.35g of oleic acid into 200ml of oil for injection, stir evenly, then remove the acetone by rotary evaporation to obtain the oil phase; mix 20g of glycerin, 0.05g of EDTA -2Na was dissolved in 600ml of water for injection to obtain the water phase; the oil phase was added to the water phase, and sheared at 40°C for 10 minutes at a speed of 12000rpm to obtain colostrum; the pH of the colostrum was adjusted to 7, and the Homogenize 5 times under pressure to obtain an emulsion; take 150g of lyoprotectant (lactose 30g, trehalose 75g, sulfobutyl ether-β-cyclodextrin 45g) into the homogenized emulsion, stir until freeze-dried The protective agent is completely dissolved, then filtered through a 0.5 μm filter membrane, subpackaged and freeze-dried.

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Abstract

The invention discloses a preparation method for a sodium aescinate freeze-dried emulsion for injection. The preparation method comprises the following steps: dissolving sodium aescinate in a non-polar organic solvent, then adding to oil for injection together with lecithin and oleic acid, uniformly stirring, and then removing the non-polar organic solvent to obtain an oil phase; dissolving glycerin and EDTA (Ethylene Diamine Tetraacetic Acid)-2Na to water for injection to obtain an aqueous phase; adding the oil phase to the aqueous phase, and shearing to obtain a primary emulsion; adjusting pH of the primary emulsion to 5-7 and homogenizing to obtain an emulsion; adding a freeze-drying protective agent to the homogenized emulsion, stirring till the freeze-drying protective agent is completely dissolved, then filtering with a micropore filter membrane, subpackaging and freeze-drying to obtain a finished product. The freeze-dried emulsion prepared by the preparation method is stable in property and good in product redissolution property; the emulsion with uniform and stable particle size can be formed after redissolution, and no demulsification phenomenon happens; sodium aescinate in the preparation is stable in contents of components A and B.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of sodium aescinate freeze-dried emulsion for injection. Background technique [0002] Aescin, also known as aescinic acid, is a general term for total saponins, β-aescin or isoaescin, which are extracted from the seeds of Aescinaceae Aesculus, and belongs to triterpenoid saponins. The water solubility of aescin is poor, in order to increase its solubility, it is often made into sodium salt. Aescin mainly contains 4 kinds of components, which are named as aescin A, aescin B, aescin C and aescin D in sequence according to the national standard of my country before and after the peak of liquid chromatography. [0003] Sodium aescinate has anti-inflammatory, anti-edema and other effects, and can be used for the treatment of cerebral edema, trauma and other diseases. Because the main adverse reactions of sodium aescinate are vascular irrit...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/704A61P29/00A61P7/10F26B5/06
Inventor 刘享平石召华杨祥良叶利春周小顺倪婷婷牟东升
Owner WUHAN AIMIN PHARMA
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