Method for purifying acarbose from solution containing acarbose

An acarbose and solution technology is applied in the field of purifying acarbose from solutions containing acarbose, can solve the problems of increased A component, large batch consumption and high resin breakage rate, and achieves easy operation, The effect of improving the total yield and suitable for large-scale industrial production

Inactive Publication Date: 2017-04-19
CHENGDU UNIV
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the neutralization process, neutralization with alkaline solution or static neutralization with weak alkaline resin (in the resin treatment method, the resin damage rate is high and the batch consumption is large), both are prone to local over-alkali, resulting in abnormality of component A Increase

Method used

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  • Method for purifying acarbose from solution containing acarbose

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prepare 50 liters of fermented liquid containing 212.0 g of acarbose, in which the content of impurity A is 1.25% (external standard method, relative to acarbose), adjust pH 4.5 with 40% (v / v) acetic acid solution, and plate frame Filtrate to obtain the filtrate containing acarbose, over-equipped with DK110 (H + type) ion-exchange column, the flow rate is controlled at 1.5 times the column volume / hour. 3 -2 type) weakly basic resin column to neutralize to pH 4.0, and neutralize the solution through CT151 strong acid resin (H + Type) column ion exchange column for rough extraction, the flow rate is controlled at 1.1 times the column volume / hour, after the column is loaded, it is eluted with 0.4mol / L hydrochloric acid, the effluent containing acarbose is collected, and the D301 (CO 3 -2 type) weakly basic resin to neutralize to pH 4.5, and then pass the neutralization solution through PT151 (H + type) strong acid resin column ion exchange column for chromatography, th...

Embodiment 2

[0024] Prepare the fermented liquid that contains 304.0 grams of acarbose, wherein A impurity content 0.85% (external standard method, relative to acarbose), adjust pH 4.0 with oxalic acid, obtain the filtrate that contains acarbose by plate and frame filtration, pass Equipped with DK110 (H + type) ion exchange column, the flow rate is controlled at 1.0 times the column volume / hour. 3 -2 type) weakly basic resin column to neutralize to pH 4.6, and neutralize the solution through CT151 strong acid resin (H + Type) column ion exchange column for rough extraction, the flow rate is controlled at 1.3 times the column volume / hour, after the column is loaded, it is eluted with 0.4mol / L hydrochloric acid, the effluent containing acarbose is collected, and the D301 (CO 3 -2 type) Weakly basic resin to neutralize to pH 4.8 and then pass the neutralization solution through PT151 (H + type) strong acid resin column ion exchange column for chromatography, the flow rate is controlled at...

Embodiment 3

[0026] Prepare the fermented liquid that contains 250.4 grams of acarbose, wherein A impurity content 0.98% (external standard method, with respect to acarbose), adjust pH 5.0 with 40% lactic acid (v / v), plate frame filtration obtains containing Acarbose The filtrate of carbose was packed with DK110 (H + type) ion-exchange column, the flow rate is controlled at 0.9 times the column volume / hour. 3 -2 type) weakly basic resin column to neutralize to pH 4.2, and neutralize the solution through CT151 strong acid resin (H + Type) column ion exchange column for rough extraction, the flow rate is controlled at 1.3 times the column volume / hour, after the column is loaded, it is eluted with 0.36mol / L hydrochloric acid, the effluent containing acarbose is collected, and the A845 (CO 3 -2 type) weakly basic resin to neutralize to pH 4.7 and then pass the neutralization solution through PT151 (H + type) strong acid resin column ion exchange column for chromatography, the flow rate is ...

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Abstract

The invention provides a method for purifying acarbose from an acarbose-containing solution and aims at solving the problem of effectively controlling and reducing the content of impurities A in the acarbose production process. The neutralization of an acidic acarbose eluate is performed on a weakly alkali ion exchange column and the operation is simple and convenient; meanwhile, the abnormal increase of the component A of the acarbose due to partially excessive alkali in the process of neutralization by use of an alkaline solution or by use of a static state is avoided. The method comprises the following specific operation process: treating the acarbose-containing solution by use of a weakly acidic solution to obtain the filtrate containing the acarbose, putting the filtrate through a weak-acid ion exchange column, neutralizing by use of a weakly alkaline resin, next, separating and purifying by use of a strong acidic resin, and then concentrating by use of a nanofiltration membrane and performing spray drying, thereby finally obtaining the finished acarbose product having the component A content of lower than 0.6%. The method is simple in separation process; besides, the component A content of the crude product of the acarbose is effectively controlled, the process of independently separating the component A is avoided and the total yield is greatly increased; in short, the method is suitable for industrialized production.

Description

[0001] Technical field: [0002] The present invention relates to a method for producing acarbose, in particular to a method for producing acarbose with a low A-component content from a solution containing acarbose. [0003] Background technique: [0004] Acarbose (Acarbose ) is an α-glucose inhibitor, which can be taken orally to control the postprandial blood sugar rise in patients with type II diabetes. Acarbose produced by Actinomycetes uthaensis ( Actinoplanes utahensis) produced by fermentation, separated and purified by ion exchange resin. In the industrial production of acarbose, impurity A (impurity A) is an isomer of acarbose, the structure and properties are very close to acarbose, it is difficult to separate through ion exchange chromatography, 2010 edition The Chinese Pharmacopoeia stipulates that the impurity should not exceed 1.5%. The United States Pharmacopoeia USP35-NF30, European Pharmacopoeia EP8.0 and British Pharmacopoeia BP201 all require that the con...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/203C07H1/06
CPCC07H1/06C07H15/203
Inventor 王欣荣杨渊杨赞李旭航孙敏翟龙飞徐明琴
Owner CHENGDU UNIV
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