Oxiracetam freeze-drying preparation for injection and preparation method thereof

2013 
The invention relates to an oxiracetam freeze-drying preparation for injection and a preparation method thereof, belonging to the technical field of medicines. The freeze-drying preparation is a crystal form compound formed by oxiracetam, D-sorbitol and mannitol in a weight ratio of 1: (0.2-0.25): (0.05-0.1). The oxiracetam freeze-drying preparation has the beneficial effects that the production cycle is shortened by about 20 hours, the rate of finished products is increased by above 99%, the phenomena such as the upward shifting and the eruption of the product are avoided, medicine molecules are constrained in crystal lattices, the water content is extremely low and can be controlled below 0.1%, the preparation is difficult to degrade and has relatively good stability, the period of validity is up to 36 months, the impurity content is greatly reduced, the single maximum impurity is less than 0.1%, and the total impurities are less than 0.5%; no organic solvents are involved in the production process, the energy consumption and the cost are substantially reduced, and the technology has environmentally-friendly effect and is suitable for large-scale industrialization production. Compared with the prior art, the oxiracetam freeze-drying preparation provided by the invention has obviously improved curative effect and is suitable for clinical application.
    • Correction
    • Source
    • Cite
    • Save
    • Machine Reading By IdeaReader
    0
    References
    0
    Citations
    NaN
    KQI
    []