摘要
本文试用活性炭除去含糖输液中的5—羟甲基呋喃甲醛(5—HMF)及相关杂质,并对其处理条件进行了考察。我们在 pH4.00、加炭量0.3%、置待脱炭溶液于室温或稍高温度下(低于50℃)搅拌20 min 左右的条件下,即可较理想地除去5—HMF 及其基相关杂质。对5—HMF 不合格产品按上述条件处理,过滤后滤液分装于输液瓶中,按规定灭菌处理后,在284nm 处测定的吸收度符合药典规定(A_(284nm)<0.32)。
In this study 5—HMF and its relevant impurities of infusion involving in dextrose are gotten rid of by the active—charcoal on trial.The conditions of the process are also observed and studied.It showed that the 5—HMF and its relevant impurities can be ideally taken off in the condition by pH 4.00,adding 0.3% of active—charcoal,the solution to be treated in the room—temperature or a little higher(below 50℃)and the time for stirring about 20 min.For the products which are below the standard,after treating in the condition given previously then pouring the filtrate into the bottle and sterilizing.The absorbances are determined in 284 nm,they are conformable to the pharmacopoeia(A_(284nm)<0.32).
