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Small-volume pantoprazole sodium freeze-dried powder injection and preparation method and production device thereof

A technology of pantoprazole sodium and freeze-dried powder injection, applied in the field of small-volume pantoprazole sodium freeze-dried powder injection and its preparation, can solve the problems of shortened product validity period, poor product resolubility, easy oxidation and discoloration, etc. Achieve the effects of reducing packaging and transportation costs, optimizing product technology, and increasing the concentration of the preparation

Inactive Publication Date: 2013-09-04
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pantoprazole is insoluble in water, and the stability of pantoprazole itself is poor, and it is easy to oxidize and change color in aqueous solution, resulting in poor resolubility of the product. The longer the storage time, the darker the color, and the shorter the validity period of the product

Method used

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  • Small-volume pantoprazole sodium freeze-dried powder injection and preparation method and production device thereof
  • Small-volume pantoprazole sodium freeze-dried powder injection and preparation method and production device thereof
  • Small-volume pantoprazole sodium freeze-dried powder injection and preparation method and production device thereof

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Embodiment 1

[0027] The preparation method of 40mg small-volume pantoprazole sodium freeze-dried powder injection:

[0028] The formula is as follows:

[0029]

[0030] Before production, flush the device with edetate disodium with a concentration of 0.01%, and complex for 30 minutes. After the complexation is completed, rinse with water for injection, and then prepare. Nitrogen passes through the nitrogen sterilization filter to replace the feed liquid with air. Weigh Add the prescribed amount of water for injection into the thermal insulation mixing tank, cool down to 17°C, weigh the prescribed amount of pantoprazole sodium and add it, start stirring, and adjust the pH to 10.85, and control the temperature at 17°C. After the preparation is completed, weigh 1g Activated carbon is added, stirred and adsorbed for 30 minutes, the first Grundfos pump is turned on to decarbonize and filter with a titanium rod filter, and the feed liquid is sterilized by the first sterilizing filter element ...

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Abstract

The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-volume pantoprazole sodium freeze-dried powder injection and a preparation method and a production device thereof. The small-volume pantoprazole sodium freeze-dried powder injection is prepared by filling pantoprazole sodium freeze-dried powder in a 7ml pipe type penicillin bottle, wherein the content of pantoprazole sodium in the pantoprazole sodium freeze-dried powder injection is 40mg. The preparation method comprises the steps as follows: firstly flushing the device with a metal complexing agent before preparation, then flushing with water for injection, and simultaneously filling nitrogen gas; adding pantoprazole sodium into a container, starting stirring, adding activated carbon, decarbonizing and filtering with a titanium bar, and carrying out refined filtration; and filling into the 7ml pipe type penicillin bottle, freeze-drying, pressing stoppers, and rolling caps to obtain the pantoprazole sodium freeze-dried powder injection. According to the small-volume pantoprazole sodium freeze-dried powder injection and the preparation method and the production device thereof, the product technology can be optimized, the volume of the small-volume pantoprazole sodium freeze-dried powder injection is reduced, the yield of products can be improved, and the package and transportation cost can be lowered; and by utilizing the metal complexing agent to flush the device, the quality of the product can be improved, and the medicine administration safety can be ensured.

Description

technical field [0001] The invention belongs to the technical field of preparation of freeze-dried powder injection, and relates to a small-volume pantoprazole sodium freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] The specification of the currently commercially available pantoprazole sodium freeze-dried powder injection is that 40 mg is filled with 10 ml molded vials, and the volume of the inner packaging container is large, and the area occupied by each bottle in the freeze-drying box is large, causing The disadvantage of low product yield per batch; and the large volume of the product, the cost of packaging and transportation will increase. [0003] The commercially available freeze-dried powder of pantoprazole sodium has poor stability and immature preparation process, which results in shortened product validity period. Because pantoprazole sodium is obtained by forming a salt of pantoprazole and sodium ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61J3/02C23G5/036
Inventor 何茂群苗得足张光明白先杰司吉晖张国明
Owner REYOUNG PHARMA
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