Sodium aescinate preparation method

A technology of sodium aescinate and ethanol solution, which is applied to the preparation of sugar derivatives, chemical instruments and methods, steroids, etc., can solve the problems of limiting clinical application, toxicity of sodium aescinate, etc., and achieve simple process and short production cycle Short, safe effect

Active Publication Date: 2015-03-11
WUHAN AIMIN PHARMA
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Problems solved by technology

[0008] Sodium aescinate has certain toxicity, and the most common adverse reactions include phlebitis, anaphylactic shock, liver and kidney damage, etc., which limits its clinical application

Method used

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Experimental program
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Embodiment 1

[0028] Embodiment 1 Ultrafiltration process research

[0029] 1) Aescin sodium A, B, C, D content determination method

[0030] Chromatographic conditions and system suitability: use octadecylsilane bonded silica gel as filler; acetonitrile-phosphoric acid solution (take 5.5ml of 85% phosphoric acid, dilute to 1000ml with water) (33:67) as mobile phase, adjust the pH value to 2.1; The detection wavelength is 220nm. The number of theoretical plates shall not be less than 3500 based on the aescin A peak, and the resolution of the aescin A peak and aescin B peak, as well as the aescin B peak and aescin C peak shall meet the requirements.

[0031] Determination method: Accurately weigh an appropriate amount of aescin reference substance, dissolve and dilute with methanol to make a solution containing 2.5mg per 1ml, as the reference substance solution. Precisely measure 20 μl, inject it into a liquid chromatograph, and record the chromatogram. There are 4 main component peaks in ...

Embodiment 2

[0052] A preparation method of sodium aescinate, the steps are as follows:

[0053] 1) Take 50Kg of Sala seeds, add 200Kg of ethanol solution with a weight concentration of 50% for reflux extraction, the extraction time is 3 hours, and collect the extract;

[0054]2) After high-speed centrifugation and slag removal, the extract is filtered with a polysulfone ultrafiltration membrane with a molecular weight cut-off of 12,000 Daltons, the temperature of the filter is 35°C, the pressure is 0.4MPa, and the pH value of the feed solution is 5.8;

[0055] 3) Recover the ethanol from the filtrate and add 2 times the volume of water to dissolve it, then apply it to the NKA macroporous resin column for adsorption, and use pure water, 30% ethanol solution, and 60% ethanol solution to elute successively, and collect the elution of 60% ethanol solution liquid;

[0056] 4) Recover the collected eluate under reduced pressure until the solvent has no alcohol smell, add 2 times of water to di...

Embodiment 3

[0060] A preparation method of sodium aescinate, the steps are as follows:

[0061] 1) Take 50Kg of Sala seeds, add 150Kg of ethanol solution with a weight concentration of 70% to carry out reflux extraction, the extraction time is 2 hours, and collect the extract;

[0062] 2) After the extract is deslagging by high-speed centrifugation, it is filtered with a polysulfone ultrafiltration membrane with a molecular weight cut-off of 10,000 Daltons, the temperature of the filtration is 40°C, the pressure is 0.3 MPa, and the pH value of the feed solution is 5.0;

[0063] 3) Recover the ethanol from the filtrate and add 1 times the volume of water to dissolve it, then absorb it on a D101 macroporous resin column, elute it with pure water, 20% ethanol solution, and 50% ethanol solution successively, and collect the elution of 50% ethanol solution liquid;

[0064] 4) Recover the collected eluate under reduced pressure until the solvent has no alcohol smell, add 1 times water to disso...

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Abstract

The invention discloses a sodium aescinate preparation method. According to the invention, Chinese buckeye seed is extracted with 30%-70% ethanol; an extraction liquid is filtered with an ultrafiltration membrane with molecular weight cutoff of 10000-15000Dalton; a filtrate is sequentially purified with a macroporous resin column and a polyamide resin column; purified aescine is subjected to a reaction with sodium hydroxide, such that sodium aescinate is produced; and crystallization is carried out, such that a sodium aescinate pure product is obtained. The purity of the sodium aescinate provided by the invention reaches 100%, wherein the content of sodium aescinate A is 30-40%, the content of sodium aescinate B is 15-20%, the content of sodium aescinate C is 25-30%, the content of sodium aescinate D is 10-15%, and the total content of sodium aescinate A, B, C and D accounts for 85-90% of that of total saponins. As a toxicity test result, with the sodium aescinate provided by the invention, intravenous administration in mice LD50 is 12.45mg/Kg, such that the safety of the sodium aescinate is relatively high.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of sodium aescinate. Background technique [0002] Aescin, also known as aescinic acid, is a general term for total saponins, β-aescin or isoaescin, etc. extracted from the seeds of Aesculus in the family Aescinaceae, belonging to triterpenoid saponins. The water solubility of aescin is poor. In order to increase its solubility, it is often made into sodium salt. Sodium aescin has anti-inflammatory and anti-edema effects, and can be used for the treatment of cerebral edema, trauma and other diseases. [0003] Aescin mainly contains 4 components. According to the national standard of our country, it is named as aescin A, aescin B, aescin C and aescin D successively according to the peak of liquid chromatography. Wherein aescin A and B are β-type aescins, and their structures are basically the same, so aescin A and B can be combined to represent with struc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J63/00C07H15/256C07H1/08
CPCC07H1/08C07H15/256C07J63/008
Inventor 刘享平石召华关小羽董慧君叶利春谢健
Owner WUHAN AIMIN PHARMA
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