Cefotiam hydrochloride compound, and preparation method and pharmaceutical composition thereof
A technology for cefotiam hydrochloride and a compound, which is applied in the field of cefotiam hydrochloride compounds, can solve problems such as poor storage stability of cefotiam hydrochloride, and achieve the effects of good storage stability, high safety performance and low impurity content
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Embodiment 1
[0045] The preparation of cefotiam hydrochloride compound:
[0046] Dissolve 50 g of cefotiam hydrochloride crude drug in dimethyl sulfoxide at 60°C to make a saturated solution, keep warm and stir for 20 minutes, then slowly add water at 60°C, the volume of water used is 1 / 1 of the volume of dimethyl sulfoxide 10. Continue to heat and stir for 20 minutes, and flow the solution through a 0.5T DC magnetic field at a speed of 5m / s. The direction of the magnetic field is perpendicular to the flow direction of the solution. Activated carbon is added to the treated solution for decolorization. 0.2% g / ml by volume, stirred for 20 minutes, filtered to obtain a clear solution, and acetone was added dropwise to the clear solution, the volume ratio of acetone to dimethyl sulfoxide was 5:1, cooled to 5°C, filtered, Obtain a filter cake, wash the filter cake, and then dry under reduced pressure for 4 hours to obtain a light yellow microcrystalline powder. The yield is 68.8%, and the HPLC...
Embodiment 2
[0049] The preparation of cefotiam hydrochloride compound:
[0050] Dissolve 50 g of cefotiam hydrochloride crude drug in dimethyl sulfoxide at 70°C to make a saturated solution, keep warm and stir for 30 minutes, then slowly add water at 70°C, the volume of water used is 1 / 1 of the volume of dimethyl sulfoxide 12. Continue to heat and stir for 30 minutes, and flow the solution through a 0.5T DC magnetic field at a speed of 10m / s. The direction of the magnetic field is perpendicular to the flow direction of the solution. Add activated carbon to the treated solution for decolorization. 0.3% g / ml by volume, stirred for 20min, filtered to obtain a clear solution, decolorized by activated carbon, filtered, and acetone was added dropwise to the clear solution, the volume ratio of the acetone to dimethyl sulfoxide was 3:1, and the temperature was lowered to Filter at 0°C to obtain a filter cake, wash the filter cake, and dry under reduced pressure for 2 hours to obtain a light yello...
Embodiment 3
[0053] Preparation of Cefotiam Hydrochloride Sterile Powder Injection:
[0054] Weigh 100 g of cefotiam hydrochloride and 20 g of sodium carbonate prepared in Example 1 under aseptic conditions, place them in a solid powder mixer and mix them evenly, and the raw materials obtained are transferred to a sterile preparation workshop for precise metering and packaging. Each bottle contains hydrochloric acid Cefotiam 0.25g, stoppered and capped, the finished product is packaged for storage and sent for inspection.
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