Small-volume pefloxacin mesylate freeze-dried powder injection, preparation method and producing device thereof

Abstract

The invention relates to a small-volume pefloxacin mesylate freeze-dried powder injection, a preparation method and a producing device thereof. An anti-oxidant is added to raw materials and then a 7ml tube-made penicillin bottle is filled with the raw materials to obtain the freeze-dried powder injection. The preparation method includes following steps: (1) mixing, stirring and dissolving water for injection, pefloxacin mesylate, mannitol and the anti-oxidant; (2) adding activated charcoal, performing filtration and precision filtration to obtain a solution; and (3) adding the water for injection to prepare a diluted solution, maintaining the temperature, filling the 7ml tube-made penicillin bottle with the diluted solution, freeze-drying the diluted solution, pressing a plug on the bottle and capping the bottle to obtain the freeze-dried powder injection. The producing device includes a thermal-insulating drug-blending pot, a second Grundfos pump, a pump stick filter, a second sterilization filter core, a sterilized thermal-insulating liquid storage tank, a first Grundfos pump, a first sterilization filter core, a filling machine and a freeze-drying machine, wherein the units are connected through thermal-insulating pipelines successively. The preparation method and the producing device improve quality of the freeze-dried powder injection, effectively increase yield and reduce energy consumption, reduce package size, reduce costs during packaging and transportation, reduce a filling amount, greatly reduce energy consumption during a freeze-drying step and further reduce the cost.

Description

technical field [0001] The invention belongs to the field of freeze-dried powder injection, and in particular relates to a small-volume pefloxacin mesylate freeze-dried powder injection, a preparation method and production equipment thereof. Background technique [0002] The currently commercially available (specification 0.2g) pefloxacin mesylate freeze-dried powder injection is filled with 10ml controlled vials, which has the disadvantage of large inner packaging container, resulting in low yield of each batch of products produced. The original preparation The process does not use antioxidants, the product is easily oxidized after freeze-drying, and the amount of water added is also large, which is 20 times the water of the main drug, thus increasing the filling amount, resulting in a decrease in product output, and increased energy consumption due to more water in freeze-drying Larger, packaging and shipping costs increase. Contents of the invention [0003] The invent...

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Problems solved by technology

[0002] The currently commercially available (specification 0.2g) pefloxacin mesylate freeze-dried powder injection is filled with 10ml controlled vials, which has the disadvantage of large inner packaging container, resulting in low yield of each batch of products produced. The original preparation The process does not use antioxidants, the product is easily oxidized after freeze-drying, and the amount of water added is also large, which is 20 times the water of the main drug, thus increasing the filling amount, resulting in a decrease in product output, and increased energy consumption due to more water in freeze-drying Increased bulk, packaging and shipping costs

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