| Cefotiam hexetil hydrochloride,which should be prepared to oral antibiotics of cefotiam hexetil hydrochloride for it can not be administered orally,is the second generation of antibiotics for an esterification of cefotiam hydrochloride.In this subject,we expect to find out the best preparation process conditions and quality control of cefotiam hexetil hydrochloride through orthogonal test so as to making the production can achieve industrialization.In this synthesis reaction,the 1-cyclohexyl was prepared to 1-iodoethyl cyclohexyl carbonate,and then to cefotiam hexetil hydrochloride.In order to find the best conditions that was suitable for mass production of industrialization,the orthogonal experiment was under investigation of the reaction temperature,time and the reaction proportion of synthesis.Synthesis cefotiam hexetil hydrochloride of high purity,establishment of an RP-HPLC method for the determination of content and related substances of cefotiam hexetil hydrochloride was complied with the JP15.Target production was identified by MS and 1H-NMR and 13C-NMR.All the spectrum data of cefotiam hexetil hydrochloride are identical with literature.Synthesis of cefotiam hexetil hydrochloride can provide a good foundation for the industrial production,and it should be conquered with negative factors of cefotiam hydrochloride.Finally,we established the synthesis methods of process conditions and quality of research methods. |