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Preparation method of clavulanic acid amine salt

The invention belongs to the technical field of pharmacy, and relates to a preparation method of clavulanic acid amine salt. The method comprises the following steps: (1) extraction of a clavulanic acid aqueous solution and concentration of extract liquor: acidizing the clavulanic acid aqueous solution, then adding a salting-out agent, and extracting by an organic solvent, thus obtaining the extract liquor containing clavulanic acid; nano-filtering and concentrating by using an organic solvent-resistant film, thus obtaining a clavulanic acid extraction concentrated solution; (2) preparation of the clavulanic acid amine salt: mixing the clavulanic acid extraction concentrated solution with an organic amine donor and a cosolvent, thus obtaining clavulanic acid amine salt crystals. The salting-out agent is introduced, and the extraction rate of the clavulanic acid is increased; the organic solvent-resistant roll film is innovatively adopted for nano-filtering and concentrating, so the energy consumption is lowered; the addition of the cosolvent can effectively reduce the content of various impurities in a final clavulanic acid amine salt product. Therefore, in the quality parameter aspects of the content, the impurities, light transmittance and the like, the clavulanic acid amine salt prepared by the preparation method is remarkably superior to clavulanic acid amine salt prepared by a conventional process.
Owner:SHANXI WEIQIDA PHARMA IND

The preparation method of clavulanic acid amine salt

The invention belongs to the technical field of pharmacy, and relates to a preparation method of clavulanic acid amine salt. The method comprises the following steps: (1) extraction of a clavulanic acid aqueous solution and concentration of extract liquor: acidizing the clavulanic acid aqueous solution, then adding a salting-out agent, and extracting by an organic solvent, thus obtaining the extract liquor containing clavulanic acid; nano-filtering and concentrating by using an organic solvent-resistant film, thus obtaining a clavulanic acid extraction concentrated solution; (2) preparation of the clavulanic acid amine salt: mixing the clavulanic acid extraction concentrated solution with an organic amine donor and a cosolvent, thus obtaining clavulanic acid amine salt crystals. The salting-out agent is introduced, and the extraction rate of the clavulanic acid is increased; the organic solvent-resistant roll film is innovatively adopted for nano-filtering and concentrating, so the energy consumption is lowered; the addition of the cosolvent can effectively reduce the content of various impurities in a final clavulanic acid amine salt product. Therefore, in the quality parameter aspects of the content, the impurities, light transmittance and the like, the clavulanic acid amine salt prepared by the preparation method is remarkably superior to clavulanic acid amine salt prepared by a conventional process.
Owner:SHANXI WEIQIDA PHARMA IND
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