The Manufacture And The Quality Research Of Framycetin Sulfate

Framycetin sulfate is an amino glycoside antibiotic.In this paper,the manufacturing process and the quality of framycetin sulfate have been studied.First,we have established a method for the derivation of the crude framycetin sulfate(neomycin sulfate),which can accurately and rapidly detect the content of neomycin sulfate.The experiment proved that the yield of neomycin sulfate extracted from the fermentation broth of neomycin reached 97%;Second,the method for the impurity detection of framycetin sulfate is validated,and the validate items include specifity,system suitability,precision,limit of detection and quantitation limit,linearity and range,accuracy and robustness,all the validated results meet the requirements;Third,we selected resin with good separation and large adsorption capacity through resin selection and transformation.At the same time,we studied the separation and purification process.The process parameters were determined,and the analytical solution was concentrated,salted,decolorized and sprayed to prepare flresin sulfate.The experimental results show that the product yield researched 60%,and quality meets the European Pharmacopoeia 9.0 and reaches the domestic first-class level;Finally,we conduct structural verification and quality studies on three batches of the authentic batches of framycetin sulfate.The results showed that the structure of the verification batches was consistent with that of the control.Besides,the stability of the product at neutral,alkaline and 80? was good.However,framycetin sulfate was degraded to neamine at pH 2.Through the establishment of the derivatization testing method,we make the material balance of the crude framycetin sulfate in the process of extraction,and the material balance can be used to guide the production to improve yield.By studying the preparation process and the product quality of framycetin sulfate,we have mastered the trend of the impurities in the preparation process of framycetin sulfate,which is beneficial to the preparation of different specifications of products and high quality products and to improve the competitiveness of the product.