Belonging to the technical field of
drug preparation, the invention relates to a
voriconazole freeze-dried
powder injection for injection and a preparation method thereof. The invention provides a pharmaceutical preparation that treats invasive fungal infections and has good
solubility and high stability for clinical practice. According to a prescription, the
voriconazole freeze-dried
powder injection for injection provided in the invention is composed of
voriconazole, hydroxypropyl-beta-
cyclodextrin,
mannitol,
hydrochloric acid,
sodium hydroxide, and water for injection. The preparation process includes: subjecting an
aqueous solution of hydroxypropyl-beta-
cyclodextrin and an acid solution of voriconazole to clathration, adding
mannitol, then conducting stirring dissolving, using a
sodium hydroxide solution to adjust the pH value, carrying out
activated carbon adsorption, decarbonization, fine
filtration by a
microfiltration membrane and semi-finished
product inspection, if the semi-finished product is qualified, performing subpackaging, freeze-
drying, and conducting complete inspection. The cruxes of the preparation method are proportioning of voriconazole and hydroxypropyl-beta-
cyclodextrin in the prescription, control of clathration temperature and time, charging sequence and other technical parameters. At the same time, the invention also provides a method for determination of the inclusion encapsulation efficiency.