兰索拉唑冻干粉针制备工艺及稳定性研究

摘要

研究兰索拉唑冻干粉针的制备方法,并对其进行质量稳定性考察.运用冷冻干燥技术制备注射用兰索拉唑,结合制剂的外观和稳定性考察结果,证明该制备工艺的可行性.经过小试和中试放大生产的实践验证,确定了以甘露醇为骨架剂、葡甲胺为增溶剂和p H稳定剂、氢氧化钠为p H调节剂组成的处方及其冻干粉针的制备工艺.该制备工艺合理,质量可控,产品稳定性好,所制备的兰索拉唑冻干粉针能够满足制剂学及临床需要.%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.