The invention belongs to the technical field of medicines, and particularly relates to a dantrolene
sodium freeze-dried
powder injection for injection and a preparation method thereof. The freeze-dried
powder injection is prepared by
freeze drying dantrolene
sodium, lactobiose, a pH
regulator and water for injection, wherein a
mass ratio of the dantrolene
sodium to the lactobiose is (1:0.5) to (1:2.5). The preparation method comprises the following steps of: adding the dantrolene sodium to the lactobiose in a prescription amount into the water for the injection, stirring, regulating the pH value to 9.0 to 10.5 by using the pH
regulator, adding
active carbon for injection, removing a heat source, decolorizing, filtering for decarburizing, performing fine filtering by using a filter membrane, packaging in separate bags, freezing and
drying. The dantrolene sodium freeze-dried
powder injection is studied on the basis of a freeze-dried process, namely the dantrolene sodium freeze-dried
powder injection is cooled, heated by a small margin and is cooled again, so that the
moisture of the freeze-dried product is reduced, and the freeze-dried product is high in redissolution and visible foreign matters and does not have insoluble granules. The dantrolene sodium freeze-dried
powder injection for the injection is high in resolubility,
clarity and stability, and low
impurity content.