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

The technology of pefloxacin mesylate and freeze-dried powder injection is applied in the field of small-volume pefloxacin mesylate freeze-dried powder injection and its preparation, and can solve the problems of increasing filling volume, easy oxidation of products, adding Large water volume and other problems, to achieve the effect of reducing packaging volume, improving product quality and increasing output

Inactive Publication Date: 2015-04-15
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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 antioxidant

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Add water for injection, pefloxacin mesylate, mannitol and antioxidant, start stirring and dissolving, control the temperature at 20°C to 25°C, control Ph at 3.5, fully stir and dissolve evenly, and make a concentrated solution; add total Decarburization with 0.1% activated carbon for 30 minutes. Turn on the second Grundfos pump 9 and use the titanium rod filter 2 to decarburize and filter the feed liquid through the second sterilizing filter element 8 to sterilize and transport it to the sterile liquid storage tank 3 for storage. After sterilizing and filtering, keep warm at 20°C, turn on the feed liquid circulation pump of the aseptic liquid storage tank 3, the feed liquid passes through the first Grundfos pump 6, the first sterilizing filter element 7, and is filled by the filling machine 5 at a rate of 2ml / The bottle is filled in a 7ml control vial, then freeze-dried by a freeze dryer, corked, capped, and packaged.

[0025] For lyophilization, the temperature of t...

Embodiment 2

[0028] The preparation method of this example is the same as that of Example 1, except that cysteine ​​hydrochloride is used as the antioxidant.

Embodiment 3

[0030] The preparation method of this example is the same as that of Example 1, except that sodium pyrosulfite is used as the antioxidant.

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K47/04A61J3/02
Inventor 苗得足张光明白先杰司吉晖张国明宋忠国
Owner REYOUNG PHARMA
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