Sarafloxacin hydrochloride injection and preparation method thereof
A technology for salafloxacin hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor stability, easy oxidation and discoloration, and achieve good stability. , the composition is reasonable, the preparation process is simple effect
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preparation example 1
[0019] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:
[0020] Sarafloxacin Hydrochloride 5g
[0021] Sodium glycinate 7g
[0022] Propylene glycol 35g
[0023] EDTA-2Na 0.05g
[0024] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5
[0025] water for injection balance
[0026] Preparation method: Dissolve 7g of sodium glycinate and 0.05g of EDTA-2Na in an appropriate amount of water for injection, then add 35g of propylene glycol, and stir to obtain solution A; add 5g of sarafloxacin hydrochloride to solution A, stir to dissolve, and use hydrochloric acid or Adjust the pH value to 9.5~10.5 with sodium hydroxide solution, then dilute to 100ml with water for injection, filter with an organic filter membrane, fill the filtrate with nitrogen, subpackage, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride injection 1.
preparation example 2
[0028] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:
[0029] Sarafloxacin Hydrochloride 2.5g
[0030] Sodium glycinate 7g
[0031] α-Pyrrolidone 35g
[0032] EDTA-2Na 0.05g
[0033] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5
[0034] water for injection balance
[0035] Preparation method: Dissolve 7 g of sodium glycinate and 0.05 g of EDTA-2Na in an appropriate amount of water for injection, then add 35 g of α-pyrrolidone, and stir to obtain solution A; add 2.5 g of sarafloxacin hydrochloride to solution A, stir to dissolve, Use hydrochloric acid or sodium hydroxide solution to adjust the pH value to 9.5~10.5, then dilute to 100ml with water for injection, filter with an organic filter, fill the filtrate with nitrogen, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride injection 2.
preparation example 3
[0037] Sarafloxacin hydrochloride injection, each 100ml consists of the following components:
[0038] Sarafloxacin Hydrochloride 2.5g
[0039] Sodium glycinate 7g
[0040] Dimethylformamide 35g
[0041] EDTA-2Na 0.05g
[0042] Hydrochloric acid or sodium hydroxide to adjust the pH value of the system to 9.5~10.5
[0043] water for injection balance
[0044] Preparation method: Dissolve 7 g of sodium glycinate and 0.05 g of EDTA-2Na in an appropriate amount of water for injection, then add 35 g of dimethylformamide, and stir to obtain solution A; add 2.5 g of sarafloxacin hydrochloride to solution A, and stir to make Dissolve, adjust the pH value to 9.5~10.5 with hydrochloric acid or sodium hydroxide solution, then dilute to 100ml with water for injection, filter with an organic filter membrane, fill the filtrate with nitrogen, and steam sterilize for 15~30 minutes to obtain sarafloxacin hydrochloride Injection 3.
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