Injectable drug combination and preparation method thereof
A composition and injection technology, which can be used in drug combinations, antipyretics, antitumor drugs, etc., can solve problems such as affecting cardiovascular function, long-term safety inspection of stabilizers and excipients, and reduce potential safety hazards. , good safety, the effect of preventing side effects
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Embodiment 1
[0031] Preparation of freeze-dried powder injection:
[0032] 29.5g Na 3 PO 4 Dissolve in 1800ml water for injection to make 0.1mol / L Na 3 PO 4 solution; another appropriate amount of 1mol / L NaOH solution was prepared for subsequent use; 200g salvianolic acid B was weighed, and the above-mentioned 0.2mol / L NaOH solution was added 3 PO 4 Solution 1800ml, after stirring evenly, then add dropwise the above 1mol / L NaOH solution to pH 4.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.
[0033] Freeze-drying curve:
[0034] -40°C, 5h (minimum eutectic point -12.3°C)
[0035] -25℃, 14h
[0036] 0°C, 3h
[0037] 20℃, 2h
[0038] Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug a...
Embodiment 2
[0040] Dissolve 14.4g NaOH in 1800ml water for injection to make a 0.2mol / L NaOH solution; prepare an appropriate amount of 1mol / L NaOH solution for later use; weigh 200g salvianolic acid B and add the above 0.2mol / L NaOH solution 1800ml, after stirring evenly, then dropwise add the above 1mol / L NaOH solution to pH 5.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.
[0041] Freeze-drying curve:
[0042] -40°C, 5h (minimum eutectic point -8.3°C)
[0043] -20℃, 14h
[0044] 0°C, 3h
[0045] 20℃, 2h
[0046] Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug as the standard, the content of salvianolic acid B in the sample was determined by the HPLC external standard method, and it ...
Embodiment 3
[0048] Dissolve 14.4g NaOH in 1800ml water for injection to make a 0.2mol / L NaOH solution; prepare an appropriate amount of 1mol / L NaOH solution for later use; weigh 200g salvianolic acid B and add the above 0.2mol / L NaOH solution 1800ml, after stirring evenly, then dropwise add the above 1mol / L NaOH solution to pH 7.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.
[0049] Freeze-drying curve:
[0050] -40°C, 5h (minimum eutectic point -8.3°C)
[0051] -20℃, 14h
[0052] 0°C, 3h
[0053] 20℃, 2h
[0054]Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug as the standard, the content of salvianolic acid B in the sample was determined by the HPLC external standard method, and the ...
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