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目前,不少胶囊制造厂,采用环氧乙烷进行灭菌,效果理想.但据报道,环氧乙烷毒性比氯仿及四氯化碳强.将其水溶液给大白鼠灌胃,LD为0.35g/kg,并发现有致畸作用.为考察灭菌后空心胶囊中环氧乙烷残留情况,我们试用了气相色谱法,定量测定了胶囊中环氧乙烷残留量.平均回收率100.56%±0.1263,结果满意.一、仪器与试剂我们是采用日本岛津Gc-5A(配CRIB处理机)气相色谱仪.玻璃柱规格:内
At present, many capsule manufacturers, the use of ethylene oxide sterilization, the effect is satisfactory, but it is reported that ethylene oxide toxicity than chloroform and carbon tetrachloride. The aqueous solution to the rats gavage, LD 0.35 g / kg, and found to be teratogenic effect.In order to investigate the residual of ethylene oxide in hollow capsules after sterilization, we tried gas chromatography to quantitatively determine the residual amount of ethylene oxide in the capsules.The average recovery was 100.56% ± 0.1263, the results are satisfactory. First, the instrument and reagent We are using Japan Shimadzu Gc-5A (with CRIB processor) gas chromatograph Glass column size: