Method for improving purity of acarbose

Abstract

The invention discloses a method for improving the purity of acarbose. According to the method, impurities A in acarbose extracting solution are removed by an aluminum oxide chromatographic column. In the regenerating process, acid and base are utilized and organic solvents are not related, and compared with the traditional aluminum oxide regenerating process, the method has the following differences: the high-temperature activation is not needed, so that the process operation is simplified. According to the method, the impurities A in the acarbose extracting solution are removed by the aluminum oxide chromatographic column, and the high-purity acarbose bulk drug can be produced; the acarbose is purified by aluminum oxide, so that the content of the impurities A in the acarbose can be reduced effectively, part of pigments can be removed, and compared with the other method for preparing the high-purity acarbose, the method has the advantages that the purity of the acarbose is improved by 2%, the pigments in feed liquid are removed effectively, the safety and the stability of drug use of a patient can be improved finally. According to the method, the total yield is increased obviously, and the yield is high and is more than 88.95%.

Description

technical field [0001] The invention relates to a method for improving the purity of acarbose, which belongs to the technical field of medicine. Background technique [0002] Acarbose (Acarbose) is an alpha-glucose inhibitor, an orally administered antidiabetic drug for the treatment of type 2 diabetes. Acarbose is obtained through bacterial culture and fermentation. In the industrial production of acarbose, impurity A ( impurity A ) is an isomer of acarbose. In high performance liquid phase detection, due to the retention time of HPLC (High Performance Liquid Chromatography) It is very close and difficult to separate during the extraction of acarbose. At the same time, in the high-end market of acarbose, the requirements for impurity A are very high. For example, the European Pharmacopoeia requires the content of impurity A to be less than 0.6%. Therefore, how to effectively control and reduce the content of impurity A in the production process of acarbose is an importan...

AI Technical Summary

Problems solved by technology

But among these two methods, the former needs to use a large amount of cooling water and wastes a lot of energy, while the latter uses membrane filtration technology, which is not good for cost control

[0006] In the existing technology, the quality of the fermentation broth in the early stage will directly affect the quality of the finished product. In terms of extraction, the existing technology uses macroporous adsorption resin to reduce A impurities, and the yield is only about 60%, and when the acarbose feed liquid When the content of impurity A in the medium is high, even if the above process is used, the impurity A cannot be effectively removed, so that the product quality cannot meet the high standard requirements

Moreover, in the regeneration process, solvents are needed, which increases safety hazards for production. Therefore, it is the key to production control to find an alternative resource and reduce the content of impurity A in the process of acarbose extraction.

Images