In the present study, we aimed to assess the preparation method of sterile lansoprazole powder for injection, as well as its quality and stability. By cryodesiccation technology in combination with the control of its ...In the present study, we aimed to assess the preparation method of sterile lansoprazole powder for injection, as well as its quality and stability. By cryodesiccation technology in combination with the control of its quality and stability, the optimal formulation and preparation route were screened. Through small-scale and pilot-scale production validation, the formulation and preparation route were confirmed, in which mannitol was used as skeletal matter, meglumine was used as solubilizer and p H stabilizer, and sodium hydroxide was used as p H regulator. The formulation and preparation route were reasonable, showing good quality control and stability and fitting the pharmaceutical and clinical need.展开更多
文摘In the present study, we aimed to assess the preparation method of sterile lansoprazole powder for injection, as well as its quality and stability. By cryodesiccation technology in combination with the control of its quality and stability, the optimal formulation and preparation route were screened. Through small-scale and pilot-scale production validation, the formulation and preparation route were confirmed, in which mannitol was used as skeletal matter, meglumine was used as solubilizer and p H stabilizer, and sodium hydroxide was used as p H regulator. The formulation and preparation route were reasonable, showing good quality control and stability and fitting the pharmaceutical and clinical need.
