Extraction and separation process of rapamycin/sirolimus
Column:Separation and purification process Time:2019-08-21
Rapamycin (RAPA, trade name Sirolimus) is a novel macrolide immunosuppressant with high immunosuppressive effects. From the clinical application point of view, rapamycin has a good anti-rejection effect

Rapamycin (RAPA, trade name Sirolimus) is a novel macrolide immunosuppressant with high immunosuppressive effects. From the clinical application point of view, rapamycin has a good anti-rejection effect, and has a good synergistic effect with immunosuppressive agents such as cyclosporine A (CsA) and tacrolimus (FK506). Good, low toxicity, no nephrotoxic new immunosuppressive agents. In recent years, the American Renamed Committee has named Rapamycin as Sirolimus (SRL) and its market name is Rapamune (RAPA). RAPA is a macrolide compound extracted from the fermentation broth of Streptomyces hygroscopicus. Its relative molecular mass is 914.2. It is similar to another immunosuppressant FK506. It is easily soluble in hexanol, chloroform. , organic solvents such as acetone, very slightly soluble in water.

Rapamycin derivatives are marketed by the US Food and Drug Administration (FDA), such as temsirolimus, which was approved by the FDA in May 2007 for advanced renal cell carcinoma (RCC) therapy, everolimus ( Everolimus was approved by the FDA in March 2009 for the treatment of late RCC with failed sunitinib or sorafenib treatment, and several clinical studies on deforolimus are ongoing.

The structure of rapamycin is similar to that of tacrolimus. The extraction, separation and purification methods are similar. Based on the foreign separation and purification methods, the process has been greatly improved. Jinan Bona Bio has developed a process more suitable for industrial production. :

The fermentation broth is added with a filter aid to filter the cells - ethanol or acetone leaching - concentrate - extraction decolorization - alumina chromatography column (SKS-30-200 acid alumina) - ethyl acetate hexane - Acetone n-hexane - chromatography system - concentrated SKP-10-4300 chromatography medium ethanol acetone acetonitrile system gradient - purity greater than 99%, can achieve effective separation of rapamycin and FR901556 impurities.

At the same time, the SKP-10-4300 chromatography medium developed by the company has also been successfully applied to the separation and purification of the temsirolimus isomer and the everolimus product related substances.

If you purchase SKP-10-4300 chromatography packing, SKS-30-200 acid alumina or request samples, please call our company 0531-88804339, our company will provide you with detailed technical support.

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