Lyophilized injection powder using Lanluodier and its salt as active ingredients and preparing technique therefor
A technology of freeze-dried powder injection and preparation process, which is applied in the field of medicine
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Embodiment 1
[0021] Example 1 Lamloridil hydrochloride freeze-dried powder for injection
[0022] prescription:
[0023] Component Dosage
[0024] Lamlordil Hydrochloride 50g
[0025] Mannitol 50g
[0026] 0.5% sodium bicarbonate solution appropriate amount
[0027] Add water for injection to 2000ml
[0028] A total of 1000 bottles were made
[0029] Preparation:
[0030] Weigh the prescribed amount of lanlopil hydrochloride and dissolve it with 80% water for injection to make a lanlopil hydrochloride solution, add the prescribed amount of mannitol, adjust the pH value to 3.0-6.0, heat the liquid to about 60°C, press Add 0.1% activated carbon for needles to the prepared amount, stir for 30 minutes, filter and decarbonize, and then use a 0.22 μm microporous membrane for fine filtration. After the intermediate is qualified, it is aseptically filled in a 5ml vial (theoretical volume of each bottle is 2ml) , put the medicinal solution in a freeze-drying box and freeze for 4 hours, so th...
Embodiment 2
[0031] Embodiment 2: Lanodil hydrochloride freeze-dried powder injection
[0032] prescription:
[0033] Component Dosage
[0034] Lamlordil Hydrochloride 25g
[0035] Dextran 50g
[0036] 1% sodium hydroxide solution appropriate amount
[0037] Add water for injection to 1000ml
[0038] A total of 1000 bottles were made
[0039] Preparation:
[0040] Weigh the prescribed amount of lanlordil hydrochloride and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of dextran to adjust the pH value to 3.0-6.0, add 0.1% activated carbon for needles according to the prepared amount, and keep stirring for 30 minutes , filtered, decarbonized, and finely filtered with a 0.22μ.m microporous membrane. After the intermediate is qualified, it is aseptically filled in a 2.7ml vial (theoretical amount of each bottle is 1ml), and the medicinal solution is placed in a freezer. Dry box, freeze for 3 hours, so that the temperature drops to abo...
Embodiment 3
[0041] Embodiment 3: Lanodil hydrochloride freeze-dried powder injection
[0042] prescription:
[0043] Component Dosage
[0044] Lamlordil Hydrochloride 50g
[0045] Glycine 25g
[0046] Sodium Metabisulfite 2g
[0048] 1% sodium hydroxide solution appropriate amount
[0049]Add water for injection to 2000ml
[0050] A total of 1000 bottles were made
[0051] Preparation:
[0052] Weigh the prescribed amount of lanolodil hydrochloride and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of glycine, sodium metabisulfite, sodium calcium edetate, stir to dissolve and adjust the pH value to 3.0-6.0 , add 0.1% activated carbon for needles according to the prepared amount, heat and stir for 30 minutes, filter, decarbonize, and then finely filter with a 0.22 μm microporous membrane. After the intermediate is qualified, it is aseptically filled in a 5ml vial (each bottle Theoretical amount is ...
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