Analisis And Safety Evaluation Of Pharmaceutical And Food Contact Materials Migration

Food contact materials and pharmaceutical plastic packaging are essential components of food and drug production,circulation and use.The small molecule compound may be transferred to food and medicine under certain conditions,which can cause harm to human body.Therefore,it is imperative to study these potential migrations.In this paper,the detection method of solvent residue of pharmaceutical packaging materials was established by headspace-gas chromatography.The migration of oligomers in PET materials was studied by Ultra high performance liquid chromatography-quadrupole time of flight mass spectrometry.The toxicity of food and pharmaceutical plastic packaging was predicted and verified.The main research contents and results are as follows.1.A method for the determination of residual solvents in pharmaceutical package by headspace gas chromatography(HS-GC)was established.To compare WondaCAP5 capillary column with InertCap WAX capillary column,12 kinds of organic solvents were well separated on InertCap WAX capillary column using gradient temperature programming.Inlet temperature was at 150? and flame ionization detector performed at 150?.The samples were heated at 100? for 60min in the headspace sampler.The results showed that the correlation coefficients r of 12 kinds of organic solvents were more than 0.9995,the linearity ranges were in the range of 0.3mg/m2?37.0mg/m2,the detection limits were in the range of 0.002 mg/m2?0.004 mg/m2 and the limits of quantification were in the range of 0.005 mg/m2?0.01 mg/m2,the recoveries were in the range of 98.4%?105.2%,and the RSD were in the range of 1.3%?4.9%(n=6).10 sets of pharmaceutical packages were tested.This method was proved that it was suitable for detection of residual solvents in pharmaceutical packaging materials.2.Three kinds of PET materials were subjected to mild and severe migration tests using four different food simulants.The simulants obtained from the transfer experiment was condensed and the Ultra high performance liquid chromatography-quadrupole time of flight mass spectrometry was used to detect it.The oligomers were migrated in all four simulants.The migration amount in 95%ethanol and n-hexane was greater than that of water and 4%acetic acid.The amount of migration under harsh conditions is greater than that under moderate conditions.The migration amount of the low polymer of low crystallinity is greater than that of the high crystallinity.Using UNIFI software,the structure of the four oligomers was determined according to its precise molecular weight and structure matching.3.Toxtree software was used to predict the toxicity of 4 oligomers.Bacterial toxicity test was carried out on 9 kinds of food contact materials.The pharmaceutical packages and 3 kinds of PET materials were investigated with abnormal toxicity.The migration of food contact materials and pharmaceutical packages had no serious effect on mice,and the food contact material migration had a certain inhibition on enterococcus faecalis,may cause intestinal health problems.