The invention discloses a preparation process of
vitamin K1 injection mixed micelles, which belongs to the technical field of pharmaceutical preparations, and comprises the following preparation steps: under the protection of
inert gas, taking part of water for injection, adding
glycocholic acid, stirring and dispersing; s2, under the stirring condition,
soybean lecithin and
vitamin K1 in the prescription dosage are added into the solution obtained in the S2 at the same time, the stirring rotating speed is controlled to be 800-1000 rpm, and stirring is continuously conducted till the solution becomes a uniform and clear
micelle solution; supplementing the water for injection to full
dose, and adjusting the pH value of the
system to 5.5-6.5 by using a
sodium hydroxide solution; performing
sterile filtration on the liquid
medicine obtained in the step S4 through a 0.22 mu m filter membrane; and filling the filtered liquid
medicine into a sealed container under the protection of
inert gas, and carrying out
terminal sterilization. The process parameters are clear and easy to control, key
quality control points are clear, the process transfer and amplification process from
laboratory test to industrial
mass production is stable and reliable, and batch-to-batch consistency is high.