Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone sodium phosphate
A technology of dexamethasone sodium phosphate and tropane hydrochloride, applied in the field of medicine
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Embodiment 1
[0035] Example 1 Preparation of tropisetron hydrochloride freeze-dried powder injection for injection
[0036] prescription:
[0037]
[0038] Preparation Process:
[0039] (1) First add 2800ml water for injection into the container, and control the temperature at 10℃~20℃;
[0040] (2) Add 105g glycine, stir and dissolve completely;
[0041] (3) Add 7g of tropisetron hydrochloride (press C 17 H 20 N 2 O 2 Calculate), stir and dissolve completely, adjust the pH to 4.9 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;
[0042] (4) Add 0.7g of activated carbon for injection, add the remaining water for injection, dilute to 3500ml, stir and absorb for 30 minutes;
[0043] (5) The solution is coarsely filtered and decarbonized, filtered through a 0.45μm cartridge filter, and then sterilized and filtered with a 0.22μm microporous membrane until the visible foreign matter is qualified;
[0044] (6) Filling.
[0045] (7) Freeze drying
[0046] ① During the pre-freezing peri...
Embodiment 2
[0050] Example 2 Preparation of Tropisetron Hydrochloride Injection
[0051] prescription:
[0052]
[0053] Preparation Process:
[0054] (1) First add 5600ml water for injection into the container, and control the temperature at 10℃~20℃;
[0055] (2) Add 7g of tropisetron hydrochloride (press C 17 H 20 N 2 O 2 Calculate), stir to dissolve completely, adjust the pH to 5.0 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;
[0056] (4) Add 1.4g of activated carbon for injection, add the remaining water for injection, dilute to 7000ml, stir and absorb for 30 minutes;
[0057] (5) The solution is coarsely filtered and decarbonized, filtered through a 0.45μm cartridge filter, and then sterilized and filtered with a 0.22μm microporous membrane until the visible foreign matter is qualified;
[0058] (6) Filling, sealing and sterilization.
Embodiment 3
[0059] Example 3 Preparation of dexamethasone sodium phosphate injection
[0060] prescription:
[0061]
[0062] Preparation Process:
[0063] (1) Add 500ml of water for injection to the beaker, add 2g of sodium bisulfite and 300ml of propylene glycol, stir to dissolve, then add 1g of dexamethasone sodium phosphate, stir to completely dissolve, use 0.1mol / L hydrochloric acid solution or 0.1 Adjust the pH to 7.8 with mol / L sodium hydroxide solution, then add 0.5g of moistened medicinal charcoal, add water for injection to 1000ml, stir for 30 minutes, filter and decarbonize; filter with 0.22μm microporous membrane, Filling, 1ml / bottle, sealing; 121°C autoclave sterilization for 15 minutes, rapid spray cooling, come out of the cabinet, and naturally cool to room temperature.
[0064] (2) Add 500ml of water for injection to the beaker, add 2g of sodium bisulfite and 300ml of propylene glycol, stir to dissolve, then add 2g of dexamethasone sodium phosphate, stir to completely dissolve, ...
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