有效降低阿莫西林中残留溶剂的试验研究

Experimental Research on Effectively Reducing Residual Solvents in Amoxicillin

基于中国药典对阿莫西林原药中残留溶剂限度的规定,通过试验考察了不同的搅拌器型式、氨水加入速度、干燥方式等对阿莫西林中残留溶剂的影响,得出了分阶段调速流加氨水方式,选用桨式搅拌器,在电热恒温鼓风干燥箱中采用氨气反吹方式效果较好,降低了阿莫西林中残留溶剂的含量,提升了产品质量,满足了各国法规的要求。

Based on the Chinese Pharmacopeia specification of residual solvents in amoxiciUin drug substance,the experiments were designed and conducted to evaluate the influence factors on residual solvents, including different type of stirring paddles, ammonia water adding speed, drying pattern, etc.The results showed that adding ammonia water with varying speed in different phases using paddle agitator, and drying with ammonia gas back flushing in electro- thermostatic blast oven can the solvent residue in amoxicillin could be reduced and the product quality could be improved to meet the requirements in different countries.