Preparation method of cefoxitin sodium powder-needle preparation for injection
A technology of sodium citrate powder and cefoxitin acid, applied in the field of medicine, can solve the problems of low purity of cefoxitin sodium, uneven particle size distribution, vitamin B deficiency, etc., achieve good medicinal effect, improve purity, impurities low content effect
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[0027] A preparation method of cefoxitin sodium powder for injection, characterized in that it comprises the following steps:
[0028] (1) Prepare a sodium solution for later use: add a certain amount of solvent in the reaction tank, add anhydrous sodium acetate at the specified reaction temperature and stir to dissolve completely. After the dissolution is complete, add the adsorbent and stir for 25 to 35 minutes to decolorize. After completion, obtain aseptic sodium agent solution through aseptic filtration for subsequent use;
[0029] Among them, the mass ratio of anhydrous sodium acetate to solvent is 1:9-9.5; the mass ratio of adsorbent to anhydrous sodium acetate is 1:3-4, and the reaction temperature is strictly controlled to keep it between 10-15 degrees to ensure no Sodium acetate has good solubility.
[0030] (2) Prepare sterile cefoxitin solution for later use: add a certain amount of solvent for dissolving cibutinic acid in the dissolving tank, stir and cool to 0-8...
Embodiment 1
[0038] Step (1): Prepare a sodium solution for later use. Add 163Kg of methanol to the reaction tank, add 18Kg of anhydrous sodium acetate at a reaction temperature of 10 degrees and stir to dissolve completely. After the dissolution is complete, add 5Kg of activated carbon and stir for 30 minutes to decolorize , after the decolorization is completed, sterile filtration is performed to obtain a sterile sodium forming agent solution for future use; wherein, the mass ratio of anhydrous sodium acetate to methanol is 1:9; the mass ratio of adsorbent to anhydrous sodium acetate is 1:3.6.
[0039] Step (2), prepare sterile cefoxitin acid solution for subsequent use: add the mixed solution of acetone and methanol for dissolving cibutinic acid in the dissolving tank, wherein the add-on of acetone is 750L, the add-on of methyl alcohol is 180L, wherein The volume ratio of alcohol to acetone is controlled at 1:4.3, stirred and cooled to 5 degrees, and 90Kg of cibutyric acid is added under...
Embodiment 2
[0046] Step (1): Prepare a sodium solution for later use. Add 165Kg of methanol to the reaction tank, add 18Kg of anhydrous sodium acetate at a reaction temperature of 12 degrees and stir to dissolve completely. After the dissolution is complete, add 5Kg of adsorbent and stir to decolorize After 28 minutes, after the decolorization is completed, a sterile sodium-forming solution is obtained through sterile filtration, which is set aside;
[0047] Among them, the mass ratio of anhydrous sodium acetate to methanol is 1:9.2; the mass ratio of adsorbent to anhydrous sodium acetate is 1:3.2.
[0048] Step (2), prepare sterile cefoxitin acid solution for subsequent use: add the mixed solution of acetone and methanol for dissolving cefoxitin acid in the dissolving tank, wherein the addition of acetone is 745L, the addition of methyl alcohol is 175L, methanol The volume ratio with acetone is controlled at 1:4.2, stirred and cooled to 2 degrees, and 85Kg of cibutyric acid is added unde...
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