Preparation method of cetrorelix freeze-dried pharmaceutical composition
A technology of cetrorelix and cetrorelix acetate, which is applied in the field of preparation of cetrorelix freeze-dried pharmaceutical composition, can solve the problems of unqualified substances, low yield of finished products, rise of freeze-dried powder cake, etc., and achieve product The effect of quality improvement, product yield improvement, and batch-to-batch variation reduction
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Embodiment 1
[0024] Embodiment 1: Cetrorelix acetate for injection
[0025] Prescription Components Dosage effect Cetrorelix 250mg active ingredient Mannitol 54.8g Excipients, lyoprotectants Add water for injection to 1000ml solvent
[0026] 1) Dissolve 250mg cetrorelix in 500ml water for injection;
[0027] 2) Dissolve 54.8g of mannitol in 1) in the cetrorelix aqueous solution, and stir to dissolve;
[0028] 3) Set the volume to the total weight of the prescription amount, and measure the pH value;
[0029] 4) Constant temperature protection of the liquid medicine, maintaining the temperature at 25°C;
[0030] 5) Use a 0.45 μm + 0.2 μm polyethersulfone capsule filter to sterilize and filter, and control the pressure at 0.5 bar to 2.0 bar.
[0031] 6) Divide into 2ml vials, lyophilize, and obtain.
Embodiment 2
[0032] Embodiment 2: Cetrorelix acetate for injection
[0033] Prescription Components Dosage effect Cetrorelix 250mg active ingredient Mannitol 54.8g Excipients, lyoprotectants Add water for injection to 1000ml solvent
[0034] 1) Dissolve 250mg cetrorelix in 300ml water for injection;
[0035] 2) Dissolve 54.8g of mannitol in 1) in the cetrorelix aqueous solution, and stir to dissolve;
[0036] 3) Set the volume to the total weight of the prescription amount, and measure the pH value;
[0037] 4) Constant temperature protection of the liquid medicine, maintaining the temperature at 15°C;
[0038] 5) Use a 0.45 μm + 0.2 μm polyethersulfone capsule filter to sterilize and filter, and control the pressure at 0.5 bar to 2.0 bar.
[0039] 6) Divide into 2ml vials, lyophilize, and obtain.
Embodiment 3
[0040] Embodiment 3: Cetrorelix acetate for injection
[0041] Prescription Components Dosage effect Cetrorelix 250mg active ingredient Mannitol 54.8g Excipients, lyoprotectants Add water for injection to 1000ml solvent
[0042] 1) Dissolve 250mg cetrorelix in 900ml water for injection;
[0043] 2) Dissolve 54.8g of mannitol in 1) in the cetrorelix aqueous solution, and stir to dissolve;
[0044] 3) Set the volume to the total weight of the prescription amount, and measure the pH value;
[0045] 4) Constant temperature protection of the liquid medicine, maintaining the temperature at 10°C;
[0046] 5) Use a 0.45 μm + 0.2 μm polyethersulfone capsule filter to sterilize and filter, and control the pressure at 0.5 bar to 2.0 bar.
[0047] 6) Divide into 2ml vials, lyophilize, and obtain.
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