A kind of aescin A injection and preparation method thereof

A technique for aescin and injection, applied in the field of pharmaceutical preparations, can solve problems such as inability to reduce nephrotoxicity, and achieve the effects of good resolubility and quality stability, strong anti-inflammatory, and full appearance

Active Publication Date: 2019-05-14
WUHAN AIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN 1931176A discloses a pharmaceutical composition of aescin, which is composed of total aescin and lysine and other drug carriers, the combination of the two has a significant synergistic effect, and reduces the effect of aescin on blood vessels and muscle irritation, but does not reduce nephrotoxicity

Method used

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  • A kind of aescin A injection and preparation method thereof
  • A kind of aescin A injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1) 30g aescin A, 2g glycine, 200g mannitol are dissolved in 2000ml water for injection to prepare a mixed solution, the concentration of mannitol in the mixed solution is 10g / 100ml, and the concentration of aescin A is 1.5g / 100ml , the concentration of glycine is 0.1g / 100ml;

[0030] 2) adjust the pH value of the mixed solution to 6.5 with lactic acid;

[0031] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;

[0032] 4) Freeze drying after filling.

[0033] The freeze-drying procedure is as follows:

[0034] Pre-freezing: quickly lower the temperature of the material to -20°C and keep it for 1 hour, then slowly lower the temperature of the material to -40°C and keep it warm for 4 hours;

[0035] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -10°C and keep it warm for 4 hours;

[0036] Re-drying: Raise the temperature of the material to 35°C and keep it warm for 12 hours.

Embodiment 2

[0038] 1) 40g aescin A, 6g lysine, 800g mannitol are dissolved in 4000ml water for injection to make a mixed solution, the concentration of mannitol in the mixed solution is 20g / 100ml, and the concentration of aescin A is 1g / 100ml, the concentration of lysine is 0.15g / 100ml;

[0039] 2) adjust the pH value of the mixed solution to 4.5 with lactic acid;

[0040] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;

[0041] 4) Freeze drying after filling.

[0042] The freeze-drying procedure is as follows:

[0043] Pre-freezing: first quickly lower the temperature of the material to -25°C and keep it for 0.5 hours, then slowly lower the temperature of the material to -35°C and keep it warm for 5 hours;

[0044] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -5°C and keep it warm for 3 hours;

[0045] Re-drying: Raise the material temperature to 40°C and keep it warm for 10 hours.

Embodiment 3

[0047] 1) 25g aescin A, 5g aspartic acid, 150g mannitol are dissolved in 1250ml water for injection to prepare a mixed solution, the concentration of mannitol in the mixed solution is 12g / 100ml, and the concentration of aescin A is 2g / 100ml, the concentration of aspartic acid is 0.4g / 100ml;

[0048] 2) adjust the pH value of the mixed solution to 5.5 with lactic acid;

[0049] 3) Filter the solution after adjusting the pH value with a 0.22 μm filter membrane;

[0050] 4) Freeze drying after filling.

[0051] The freeze-drying procedure is as follows:

[0052] Pre-freezing: first rapidly lower the temperature of the material to -22°C and keep it for 0.5 hours, then slowly lower the temperature of the material to -38°C and keep it warm for 3 hours;

[0053] Primary sublimation: control the vacuum degree below 20 Pa, raise the temperature of the material to -15°C and keep it warm for 5 hours;

[0054] Re-drying: Raise the material temperature to 30°C and keep it warm for 15 ...

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Abstract

The invention discloses an aescine A injection. The aescine A injection comprises aescine A and amino acid at the weight ratio of 10-50 to 1-10. The invention also discloses a preparation method for the injection. Compared with the prior art, the aescine A injection has stronger anti-inflammatory effect and anti-effusion activity, and lower vascular irritation and liver and kidney toxicity.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an injection of aescin A, and also relates to a preparation method. Background technique [0002] Aescin is the total saponin extracted from the seeds of Aesculus Aesculus. 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. At present, it is mostly administered by intravenous injection. CN 102836133A discloses a sodium aescinate freeze-dried powder injection and a preparation method thereof, which is made of sodium aescinate,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/704A61K47/18A61K47/22A61P29/00A61P7/10F26B5/06
CPCA61K9/0019A61K9/19A61K31/704A61K47/183A61K47/22F26B5/06
Inventor 石召华关小羽叶利春覃勤沈倩颖李群刘享平
Owner WUHAN AIMIN PHARMA
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