Pantoprazole sodium freeze-dried powder injection and preparing method thereof

A technology for freeze-dried powder injection and pantoprazole sodium, which is applied in the field of pharmaceutical preparations, can solve the problems of unknown side effects, affect patient safety, etc., and achieves the effects of simple formula, good redissolvability and good quality

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, too many excipients are added to the above-mentioned powder injection, which may cause unknown side effects and affect patient safety.

Method used

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  • Pantoprazole sodium freeze-dried powder injection and preparing method thereof
  • Pantoprazole sodium freeze-dried powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Pantoprazole sodium 40g (calculated as pantoprazole), mannitol 100g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolved, adjust pH to 9.5 with sodium bicarbonate, add water for injection To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product into Pre-freeze in the freeze-drying box, the temperature is -40°C, and the time is 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and heat the drug to keep the temperature of the frozen product at -40°C to 10°C; The time is 25 hours, the temperature of the drug is gradually raised to 25° C., and the heat preservation and vacuum drying are carried out for 3 hours. Obtain freeze-dried powder.

Embodiment 2

[0060] Pantoprazole sodium 40g (calculated as pantoprazole), mannitol 100g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolved, adjust pH to 11.0 with sodium hydroxide, add water for injection To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product Pre-freeze in a freeze-drying box at -40°C for 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10 Pa, turn off the freezer, and heat the drug to keep the temperature of the frozen product at -40°C to 10°C. ; The time is 25 hours, the temperature of the drug is gradually raised to 25° C., and the heat preservation and vacuum drying are carried out for 3 hours. Obtain freeze-dried powder.

Embodiment 3

[0062] Pantoprazole sodium 30g (in pantoprazole), mannitol 150g, pantoprazole sodium and mannitol are mixed, add water for injection and stir until fully dissolving, adjust pH to be 10.0 with sodium carbonate, add water for injection to To 1500ml, add a total of 0.05% activated carbon for needles, stir for 15 minutes, filter and decarbonize, filter the medicinal solution with a 0.22μm sterile microporous filter membrane, measure the pH value, content, and half stopper, and then put the medicinal product into Pre-freeze in the freeze-drying box, the temperature is -40°C, and the time is 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and heat the drug to keep the temperature of the frozen product at -40°C to 10°C; The time is 25 hours, the temperature of the drug is gradually raised to 25° C., and the heat preservation and vacuum drying are carried out for 3 hours. Obtain freeze-dried powder.

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Abstract

The invention aims at providing a pantoprazole sodium freeze-dried powder injection and comprises pantoprazole sodium and mannitol with the weight ratio of 1: 2 to 5. The invention is simple in formula and little in side effect; products prepared by the method are plump in appearance, good in complex solubility and excellent in quality with the adoption of an advanced freezing and drying process.

Description

technical field [0001] The invention provides a pantoprazole sodium freeze-dried powder injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Proton pump inhibitors are one of the most widely used basic drugs in the treatment of diseases related to abnormal gastric acid secretion in modern times. Pantoprazole sodium is a dialkylpyridylbenzimidazole compound, which is clinically used for duodenal ulcer and gastric ulcer , Zoe-Ellison syndrome, and relief of moderate to severe reflux esophagitis, its advantages are: high cure rate, fast cure speed, according to literature reports, this product has a 100% cure rate for duodenal and gastric ulcers in four weeks, and the cure rate is 100%. The rate and remission rate are all better than H2-receptor inhibitors, and the cure rate for reflux esophagitis is more than 80% in eight weeks. [0003] The pharmacological mechanism and characteristics of pantoprazol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 刘保起李明华宋显荣
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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