Fat-soluble vitamin composition for injection and preparation method thereof

Fat-soluble vitamin composition for injection and preparation method thereof

  • CN 102,525,959 B
  • Filed: 01/13/2012
  • Issued: 12/18/2013
  • Est. Priority Date: 01/13/2012
  • Status: Active Grant
First Claim
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1. a method for preparing the fat-soluble vitamin for injection compositions, is characterized in that comprising the steps:

  • Vitamin A palmitate 1.314gVitamin D2 0.01gVitamin E 6.4gVitamin k 1 0.15gPolyoxyethylene sorbitan monoleate 50gMannitol 75gWater for injection is to 3000mlA. take the vitamin K of formula ratio 1add in polyoxyethylene sorbitan monoleate, stirring and dissolving, obtain solution A;

    B. take the vitamin D of formula ratio 2join in solution A, stirring and dissolving, obtain solution B;

    C. the vitamin E that takes formula ratio joins in solution B, and stirring and dissolving, obtain solution C;

    D. the vitamin A palmitate that takes formula ratio joins in solution C, stirring and dissolving, and the water for injection that adds 1000 parts by volume temperature to be, stir to clarify, and obtains solution D;

    E. mannitol is dissolved in 30 ℃

    of-40 ℃

    of waters for injection of 1000 parts by volume, is stirred to dissolving;

    Add the solution D mix homogeneously, add the nearly full dose of water for injection, measure pH, use the 0.1mol/L sodium hydroxide solution to regulate pH value to 7.8-8.2, add water for injection to 3000 parts by volume, aseptic filtration, after the intermediate passed examination, sterile filling is in cillin bottle, every bottled amount is 3 parts by volume, press half plug, be placed in the freeze drying box lyophilization, tamponade, lock aluminium lid, the qualified rear packing of full inspection, obtain the fat-soluble vitamin for injection compositions.

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