The invention relates to the technical field of
medicine technology, in particular to
sugammadex sodium freeze-dried
powder injection and a preparation method thereof. The preparation method of the
sugammadex sodium freeze-dried
powder injection comprises the following steps: adding
sugammadex sodium into water for injection according to a prescription dosage, and stirring until sugammadex
sodium is completely dissolved; adding a prescription amount of freeze-
drying protection solution into the solution, stirring until the solution is completely dissolved, adjusting the pH value, stirring, filtering, filling and freeze-
drying to obtain the target product. according to the method, the sugammadex
sodium freeze-dried
powder injection for injection is provided, and the problems that API serving as a cyclic molecular structure is unstable, and a large number of impurities are easily generated after high-temperature sterilization are solved;
inert gas (
nitrogen) is filled for protection after freeze-
drying is finished, so that
oxygen is effectively isolated, and the prepared sugammadex
sodium freeze-dried
powder injection has fewer impurities and is more stable; through optimization of a freeze-drying process, the prepared freeze-dried powder is shortest in redissolution time, the
clarity and insoluble particles meet the requirements, the stability is higher, and the freeze-dried powder is suitable for industrial production.