The Study Of The Extraction Process Of Spiramycin From Europe

Spiramycin(SPM)is a commonly used class of 16-membered ring macrolide antibiotics.Spiramycin,which meets the European Pharmacopoeia 9.0 quality standard,is called Ophiopogon sp.Because of its strong antibacterial effect in vivo,low adverse reactions,and good anti-infective efficacy,it has broad application prospects.The current production process uses butyl acetate as the extractant,and uses venting to remove butyl acetate residues,Produce about 0.25 kg of gaseous acetic acid per kilogram of products.As the third organic solvent of the country,butyl acetate has the disadvantages of being light toxic,flammable and explosive,emitting large air pollution,and high safety hazards.In this thesis,gas chromatography,high performance liquid chromatography and other analytical methods,qualitative judgment and quantitative analysis of two research methods,the development of a activated carbon alternative venting method for the production of European standard spiramycin new extraction process route.The optimized process route is: pretreatment of Oedipidamycin fermentation broth,high-pressure plate frame filtration,butyl acetate extraction,and back extraction to obtain the back-extraction liquid;a certain proportion of activated carbon is added to the back-extracted liquid,activated carbon is filtered,and then crystallized.Centrifugal rejection,drying,comminution,and packaging yield the final product of European standard spiramycin.The results showed that the European standard of spiramycin obtained from the new extraction process had reduced its butyl acetate residue to less than 500 ppm and the product quality complied with the European Pharmacopoeia standard.At the same time,the total weight yield increased by 2.6% over the original process and the unit production cost decreased by ￥3.78/kg.The extraction process route equipment investment,personnel operation is simple,the quality of risk is small,safe and pollution-free,with good economic and social benefits.