A kind of preparation method of betamethasone sodium phosphate freeze-dried powder injection
A technology of sodium metasone phosphate and freeze-dried powder injection is applied in freeze-dried delivery, medical preparations containing active ingredients, pharmaceutical formulations, etc., which can solve problems such as low production efficiency and high impurities, and achieve improved production efficiency and stability. Good, the effect of accelerated sublimation speed
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Embodiment 1
[0032] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:
[0033] Prepare materials :
[0034] Betamethasone Sodium Phosphate 2.63g
[0035] Mannitol 20g
[0036] Dilute hydrochloric acid or sodium hydroxide solution
[0037] Water for injection up to 1000ml,
[0038] preparation :
[0039] (1) Add 800ml of water for injection to dissolve mannitol,
[0040] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,
[0041] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,
[0042] (4) Freeze-drying is performed as follows:
[0043] (4.1) Pre-freezing: set the ...
Embodiment 2
[0048] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:
[0049] Prepare materials :
[0050] Betamethasone Sodium Phosphate 5.26g
[0051] Mannitol 40g
[0052] Dilute hydrochloric acid or sodium hydroxide solution
[0053] Water for injection up to 1000ml,
[0054] preparation :
[0055] (1) Add 800ml of water for injection to dissolve mannitol,
[0056] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,
[0057] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,
[0058] (4) Freeze-drying is performed as follows:
[0059] (4.1) Pre-freezing: The set te...
Embodiment 3
[0064] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:
[0065] Prepare materials :
[0066] Betamethasone Sodium Phosphate 5.26g
[0067] Lactose 20g
[0068] Dilute hydrochloric acid or sodium hydroxide solution
[0069] Water for injection up to 1000ml,
[0070] preparation :
[0071] (1) Add 800ml of water for injection to dissolve lactose,
[0072] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,
[0073] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,
[0074] (4) Freeze-drying is performed as follows:
[0075] (4.1) Pre-freezing: set the te...
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