Study On Synthetic Process Improvement Of Octyl α-Cyanoacrylate And The Quality Control

This paper reviewed the properties and preparation methods of octyl α-cyanoacrylate medical adhesive,and improved the synthetic process of octyl α-cyanoacrylate medical adhesive monomer.The new process first cancels the methanol solution preparation steps of formaldehyde,does not use the toxic solvent methanol,takes paraformaldehyde as the reaction material,petroleum ether as the reaction medium,and reacts in a set of sealed containers once,which directly eliminates the toxic risks of formaldehyde and methanol to the operators,and shortens the duration of the whole synthetic process;Secondly,the influence of raw material ratio,amount of catalyst,dehydrating agent and other factors on the yield of the reaction was investigated.The process parameters were optimized and the optimal reaction conditions were determined.The yield of the product was about 60%-65%,and the yield was about 3%higher than that of the traditional process.Finally,the structure of the reaction products was confirmed by infrared spectrometer（IR）,gas chromatograph（GC）,nuclear magnetic resonance instrument(¹H NMR,¹³C NMR,DEPT135,¹H-¹H COSY,HSQC,HMBC).The product had no residual influence of methanol,and the purity was over98%,which was 1%higher than that of the traditional process.The paper describes the quality inspection technique of octyl α-cyanoacrylate,includes purity test,sterility test,viscosity test,curing time and flexibility test,and partial impurity limit test.For biological safety of octyl α-cyanoacrylate,we performed the chronic systemic toxicity tests and Biological reaction test of embolization of rabbit vein with medical adhesive.The results showed that there was no toxicological effect on SD rats and the New Zealand rabbit by using octyl α-cyanoacrylate.