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Pantoprazole sodium drug composition and preparation method thereof

A technology of pantoprazole sodium and its composition, which is applied in the pharmaceutical composition of benzimidazole drugs and its preparation field, and can solve the problems of poor drug stability, poor formability, and low product yield, etc.

Active Publication Date: 2012-06-27
SHANDONG LUYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the pantoprazole sodium for injection that the applicant prepares according to the embodiment recorded in its description, not only freeze-drying outward appearance is poor, and formability is bad, so that product yield is low, and cost increases, and the stability of medicine is poor simultaneously, especially in High temperature and long-term storage will lead to oxidative degradation so that the clarity of the drug does not meet the requirements

Method used

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  • Pantoprazole sodium drug composition and preparation method thereof
  • Pantoprazole sodium drug composition and preparation method thereof
  • Pantoprazole sodium drug composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0102] Take by weighing sodium sulfite 3g, disodium edetate 2.4g, 36g of sucrose dissolve with water for injection, adjust pH to 10 with appropriate 1mol / L sodium hydroxide, then add pantoprazole sodium monohydrate 60g (with pantoprazole meter), add water for injection to the specified volume, filter with a 0.2 μm microporous membrane after coarse filtration, and measure the content after the solution clarity is qualified, calculate the filling volume of each bottle to be 2ml, divide into 1000 bottles, and press freeze-drying after filling The process is freeze-drying, capping, and the freeze-dried powder is obtained. After inspection, all indicators meet the requirements.

Embodiment 2

[0104] Take by weighing sodium sulfite 1.2g, edetate disodium 1.0g, sucrose 18g dissolve with water for injection, adjust pH to 11.5 with appropriate 1mol / L sodium hydroxide, then add pantoprazole sodium sesquihydrate 40g (with pantoprazole Prazole meter), add water for injection to the specified volume, filter with a 0.2 μm microporous membrane after coarse filtration, measure the content after the solution clarity is qualified, calculate the filling volume of each bottle to be 2ml, divide into 1000 bottles, press the Freeze-drying process Freeze-dry, capping, and then get freeze-dried powder. After inspection, all indicators meet the requirements.

Embodiment 3

[0106] Take by weighing sodium sulfite 1.6g, calcium sodium edetate 0.8g, sucrose 40g dissolve with water for injection, adjust pH to 11 with appropriate 1mol / L sodium hydroxide, then add pantoprazole sodium monohydrate 80g (take pantoprazole azole meter), add water for injection to the specified volume, filter with 0.2 μm microporous membrane after coarse filtration, measure the content after the clarity of the solution is qualified, calculate the filling volume of each bottle to be 2ml, divide into 1000 bottles, press the frozen Drying process Freeze-drying, capping, to obtain freeze-dried powder. After inspection, all indicators meet the requirements.

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Abstract

The invention provides a pantoprazole sodium drug composition and a preparation method thereof. The pantoprazole sodium drug composition is characterized by comprising the raw materials in parts by weight as follows: 1 part of pantoprazole sodium, 0.3-0.6 parts of sucrose, 0.005-0.05 parts of metal ion complexing agent and a proper amount of inorganic base. Meanwhile, the invention further provides a preparation method of a pantoprazole sodium freeze-dried powder injection.

Description

technical field [0001] The invention relates to a pharmaceutical composition of benzimidazole drugs and a preparation method thereof, in particular to a pantoprazole sodium pharmaceutical composition 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 is a proton pump inhibitor antiulcer drug, suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and compound gastric ulcer. [0003] In the prior art, the relevant report of existing pantoprazole sodium freeze-dried powder injection, as used mannitol in CN101229138A, the ratio of its pantoprazole and mannitol is 1: 2-5, and mannitol itself has pharmacological Function, can increase plasma osmotic pressure, has dehydration and diuretic effect, and is clinically used to prevent acute renal failu...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K9/19A61K47/26A61K47/04A61P1/04
Inventor 孙丽芳张达磊孟莹郑胜国衣瑞玲陈娟
Owner SHANDONG LUYE PHARMA CO LTD
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