Cefamandole nafate compound and pharmaceutical composition thereof
A technology of cefamandole sodium and its compounds, applied in the field of medicine, can solve the problems of unstable crystal water, many insoluble particles, and decreased stability, and achieve the effect of reducing insoluble particles, less insoluble particles, and high stability
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Embodiment 1
[0024] The preparation of embodiment 1 cefamandole sodium compound
[0025] At 20°C, dissolve 200 g of cefamandole sodium in a mixed solution of 1000 g of water and methanol (volume ratio 10:1), add 8 g of activated carbon, stir for 20 minutes, filter to remove carbon, and filter the filtrate through a 0.22 μm filter membrane; 28 ℃, at a stirring speed of 200 rpm, slowly (20ml / min) add 100g methanol to the filtrate while stirring, and stir for 30 minutes; at 20℃, at a stirring speed of 100 rpm, slowly (10ml / min) while stirring min) Add 12,000g of a mixed solution of ethanol and isopropanol (volume ratio 5:1), cool down to 0°C at a constant rate of 1°C / min, let stand for 12 hours, filter, and use 3 times the weight of the filter cake with a volume ratio of 5: Wash twice with a mixed solution of ethanol and isopropanol in 1, and dry in vacuum at 35°C for 6 hours to obtain the cefamandole sodium compound with a melting point of 205-210°C. X-ray powder diffraction pattern see at...
Embodiment 2
[0026] The preparation of embodiment 2 cefamandole sodium compound
[0027] At 25°C, dissolve 200 g of cefamandole sodium in a mixed solution of 1600 g of water and methanol (volume ratio 10:1), add 8 g of activated carbon, stir for 20 minutes, filter to remove carbon, and filter the filtrate through a 0.22 μm filter membrane; 30 ℃, at a stirring speed of 250 rpm, slowly (30ml / min) add 160g methanol to the filtrate while stirring, and stir for 30 minutes; at 22℃, at a stirring speed of 150 rpm, slowly (20ml / min) min) Add 24,000g of a mixed solution of ethanol and isopropanol (volume ratio 5:1), cool down to 2°C at a constant speed of 0.8°C / min, let stand for 12 hours, filter, and use 3 times the weight of the filter cake with a volume ratio of 5: Wash twice with a mixed solution of ethanol and isopropanol in 1, and dry in vacuum at 40°C for 6 hours to obtain the cefamandole sodium compound with a melting point of 205-210°C. The X-ray powder diffraction pattern is consistent w...
Embodiment 3
[0028] Example 3 Preparation of Cefamandole Sodium Powder for Injection
[0029] Precisely weigh 80g of the cefamandole sodium compound under 100-grade aseptic conditions, pass through a 120-mesh sieve, and carry out aseptic sub-packaging according to the loading requirements, and the loading volume of each bottle is 0.5g.
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