Digestive system medicine freeze-dried powder and preparation process
A technology of digestive system and preparation process, which is applied in the field of freeze-dried powder and preparation of digestive system medicines to achieve the effects of perfect and stable crystal skeleton, improvement of reconstitution performance, and guarantee of effectiveness and safety
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Embodiment 1
[0039] prescription:
[0040]
[0041] Preparation Process:
[0042] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11, and add water for injection to the prescribed amount. Add 0.01% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;
[0043] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;
[0044] (3) Pre-freezing: the inlet tempe...
Embodiment 2
[0048] prescription:
[0049]
[0050] Preparation Process:
[0051] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11.5, and add water for injection to the prescribed amount. Add 0.01% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;
[0052] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;
[0053] (3) Pre-freezing: the inlet tem...
Embodiment 3
[0057] prescription:
[0058]
[0059] Preparation Process:
[0060] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11, and add water for injection to the prescribed amount. Add 0.025% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;
[0061] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;
[0062] (3) Pre-freezing: the inlet temper...
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