生产工艺对氨苄西林钠质量的影响

Effects of Manufacturing Process on the Quality of Ampicillin Sodium

目的考察溶媒结晶和冷冻干燥两种工艺生产的氨苄西林钠的杂质水平和稳定性情况,判断两种工艺产品的质量优劣。方法通过6个月的加速稳定性实验[实验温度(40±2)℃;相对湿度(75±5)%]和6个月的长期稳定性实验[实验温度(30±2)℃;相对湿度(65±5)%],考察两种工艺产品的含量、有关物质、水分、晶形特征等。结果采用溶媒结晶法生产的氨苄西林钠比冷冻干燥法的产品杂质水平低,稳定性高;同为溶媒结晶法的产品,稳定性与其水分活度的关系密切。结论采用溶媒结晶法生产的氨苄西林钠的质量优于冷冻干燥法的产品;生产过程中严格控制水分活度有利于得到高稳定性的产品。

OBJECTIVE To compare the impurities and stability of ampieillin sodium produced by solvent crystallization process with that produced by freeze-drying process, thus to determine which manufacturing process can obtain products with higher quality. METHODS The contents, related substances, water and charateristics of crystal forms of ampicillin sodium were studied in the accelerated stability test [ （40 ± 2）℃, （75 ± 5 ） % RH for 6 months ] and long term stability test [ （ 30 ± 2）℃, （ 65 ± 5 ） % RH for 6 months ]. RESULTS Ampicillin sodium produced by solvent crystallization process had less impurities and higher stability than that produced by freeze-drying process. Moreover, the stability of the products obtained by solvent crystallization process was closely corre- lated with water activity of the samples. CONCLUSION Ampicillin sodium produced by solvent crystallization process has higher quality than that produced by freeze-drying process, and quality product can be obtained when the water activity of the samples is con- trolled strictly during the manufacturing process.