注射用帕米膦酸二钠的处方与工艺研究

Formulation and preparation of pamidronate disodium for injection

目的确定注射用帕米膦酸二钠的制备处方及工艺。方法选择适宜赋形剂,进行处方筛选,对冻干工艺进行考察。结果以甘露醇为赋形剂,经过22 h的冻干过程,制得成形性好,质量可靠的注射用帕米膦酸二钠。结论注射用帕米膦酸二钠处方工艺可行。

Aim To study the reasonal formulation and preparation technique of pamidronate disodium for injection.Methods The formulation of pamidronate disodium for injection was optimized by choice of suitable vehicle.The preparation technique was subsequently observed.Results Mannitol as vehicle,pamidronate disodium for injection with good shape and quality can be made through 22 hours lyophilization.Conclusion Both the formulation and preparation technique of pamidronate disodium for injection were feasible.