Freeze-dried powder injection of pantoprazole sodium and its preparation

A technology of pantoprazole sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of side effects and large amount of pharmaceutical excipients, and achieve the effects of reducing side effects, simplifying prescriptions, and improving stability

Active Publication Date: 2005-10-12
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amount of pharmaceutical excipients used in this technical solution is relatively large, which brings some side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Weigh 5.0 g of sodium citrate and 1.5 g of disodium edetate, dissolve them in water for injection, adjust the pH to 10.0 with an appropriate amount of 1% sodium hydroxide, then add 40.0 g of pantoprazole sodium and 5.0 g of mannitol, and continue Add water for injection to the specified volume, filter it with a 0.2μ microporous sterile membrane after coarse filtration, measure the content after the solution clarity is qualified, calculate the filling volume of each bottle to be about 2ml, divide it into 1000 bottles, and follow the freeze-drying process after filling Freeze-dried, sealed and packaged. Each bottle contains 40mg of pantoprazole sodium. After inspection, the marked content is 97.8%, the water content is less than 6.0%, and the clarity and clarity are in compliance with the regulations.

Embodiment 2

[0039] Weigh 3.0 g of sodium carbonate and 1 g of edetate disodium, dissolve them with water for injection, adjust the pH to 10.4 with an appropriate amount of sodium bicarbonate, then add 40.0 g of pantoprazole sodium, continue to add water for injection to the specified volume, and after coarse filtration Filter with a 0.2μ microporous sterile membrane, measure the content after the clarity of the solution is qualified, calculate the filling volume of each bottle to be about 2ml, divide it into 1000 bottles, freeze-dry according to the freeze-drying process after filling, press the cap, seal and pack. Each bottle contains 40mg of pantoprazole sodium. After inspection, all indicators meet the requirements.

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PUM

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Abstract

A freeze-dried powder injection of pantorazole sodium is proportionally prepared from pantorazole sodium, excipient, weak-acdic strong-alkaline salt, edathamil disodiumk, and inorganic alkali.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to pantoprazole sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium), the chemical name is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl-1H- Benzimidazole Sodium Salt. Pantoprazole sodium is a proton pump inhibitor antiulcer drug. Pantoprazole Sodium for Injection is mainly used for acute bleeding and prevention of bleeding from gastric ulcer and duodenal ulcer. Because it is very sensitive to light, heat, oxygen, water, etc., it is not suitable for making water injections but suitable for powder injections. [0003] In previous literature, existing many relevant reports of pantoprazole sodium making freeze-dried powder injection, such as in Chinese patent " pantoprazole freeze-dried preparation and pantoprazole injection " (publication number CN14...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 潘福生方国林叶杉
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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