The invention relates to a
polyene phosphatidyl choline intravenous preparation (comprising infusion and freeze-
drying) and a preparation method thereof. The raw materials of the
polyene phosphatidyl choline intravenous preparation comprise
polyene phosphatidyl choline,
sodium cholate and
xylitol which can accept the adjustment
osmotic pressure. The process comprises the following steps: preparing a colloidal dispersion
system from the polyene phosphatidyl
choline and the
sodium cholate according to the prescription under the conditions required by the process; carrying out
active carbon decoloration on the colloidal dispersion
system, then carrying out rough
filtration on the obtained product under the condition of adding
nitrogen, adding the
xylitol according to the prescription into the obtained solution to prepare concentrated solution for later use; and adding water for injection to make up to volume, and preparing the infusion by the
processing procedures of filtering, filling, adding the stopper, pressing the cover, sterilizing, detecting leakage and the like, or preparing the freeze-
drying preparation by the
processing procedures of filtering, filling, freeze-
drying, adding the stopper, pressing the cover and sterilizing. The prepared
infusion solution finished product has convenient clinical use, better stability on low temperature storage or clinical use, no
turbidity or emulsification phenomenon, and better safety performance.