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Aescine A injection and preparation method therefor

A escin and injection technology, which is applied in the field of pharmaceutical preparations, can solve the problems of inability to reduce nephrotoxicity, and achieve good resolubility and quality stability, no atrophy, and strong anti-inflammatory effects

Active Publication Date: 2017-03-22
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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  • Aescine A injection and preparation method therefor
  • Aescine A injection and preparation method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1) A mixed solution prepared by dissolving 30g aescin A, 2g glycine, and 200g mannitol in 2000ml water for injection, 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 of the mixed solution to 6.5 with lactic acid;

[0031] 3) Filter the pH-adjusted solution with a 0.22μm filter membrane;

[0032] 4) Freeze drying after filling.

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

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

[0035] Sublimation at one time: control the vacuum degree below 20 Pa, raise the temperature of the material to -10℃ and keep it for 4 hours;

[0036] Dry again: Raise the temperature of the material to 35°C and keep it for 12 hours.

Embodiment 2

[0038] 1) A mixed solution was prepared by dissolving 40 g aescinate A, 6 g lysine, and 800 g mannitol in 4000 ml water for injection. The concentration of mannitol in the mixed solution was 20 g / 100 ml, and the concentration of aescin A was 1 g / 100ml, the concentration of lysine is 0.15g / 100ml;

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

[0040] 3) Filter the pH-adjusted solution with a 0.22μm filter membrane;

[0041] 4) Freeze drying after filling.

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

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

[0044] One 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] Dry again: Raise the temperature of the material to 40°C and keep it for 10 hours.

Embodiment 3

[0047] 1) 25g aescinate 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 of the mixed solution to 5.5 with lactic acid;

[0049] 3) Filter the pH-adjusted solution with a 0.22μm filter membrane;

[0050] 4) Freeze drying after filling.

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

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

[0053] Sublimation once: control the vacuum degree below 20 Pa, raise the temperature of the material to -15℃ and keep it for 5 hours;

[0054] Dry again: Raise the temperature of the material to 30°C and keep it warm for 15 hours.

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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 specifically relates to an aescin A injection. The invention also relates to a preparation method. Background technique [0002] Aescin is the total saponins extracted from the seeds of the Aescinaceae in the Aescinaceae family. Aescin has poor water solubility. In order to increase its solubility, it is often made into sodium salt. Aescin is mainly composed of 4 components. According to the national standards of my country, before and after the peak of liquid chromatography, they are named Aescin A, Aescin B, Aescin C and Aescin D in sequence. [0003] Sodium aescinate has various effects such as anti-inflammatory and anti-edema, and can be used for the treatment of brain edema, trauma and other diseases. At present, intravenous injection is mostly used. CN 102836133A discloses a sodium aescinate freeze-dried powder injection and a preparation method thereof. It is made of sodium aescina...

Claims

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Application Information

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Patent Type & Authority Applications(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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