不同工艺制备注射用氨曲南的稳定性研究

Stability of aztrenam for injection by different preparations

目的探讨注射用氨曲南以不同工艺制备的稳定性。方法以冷冻干燥法和直接混合法制备了注射用氨曲南;考察光、热对其稳定性的影响。结果注射用氨曲南冷冻干燥品对热不稳定,有关物质明显增加,对光不稳定,外观变黄。注射用氨曲南的直接混合粉末受光、热的影响较小。结论冷冻干燥法制备得无定形粉末,稳定性次于β晶形的氨曲南与精氨酸直接混合所得的注射用氨曲南;水分偏高大大降低样品的热稳定性,故水分的限度要严格控制。

Objective To investigate the stability of aztrenam for injection by different preparations. Methods Aztreham for injection by freeze drying and mixing sterile powder was prepared. Its stability to heat and light was tested. Results The freeze dried sample bad low stability to heat with the raise of relevant substances, and to light with colour changing from white to yellow. The sample made by mixing sterile beta forms of aztrenam with L-argintina had better stability. Conclusion The amorphous form made by freeze drying process has worse stability than mixture powder of sterile beta forms of aztrenam and L-argintina. Water in the sample affects its stability to heat, so the limit of water must be controlled.