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Pantoprazole sodium freeze-dried powder injection and preparation method thereof

A technology of pantoprazole sodium and freeze-dried powder injection, which is applied in the field of pharmacy, can solve problems such as blood calcium drop and calcium reduction, and achieve the effect of increasing pH value and avoiding low calcium phenomenon

Inactive Publication Date: 2012-07-11
成都金典药物科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The metal ion complexing agent used in the above report is edetate disodium, which can combine with calcium ions to form a soluble complex to cause a decrease in calcium. The use of edetate disodium in intravenous preparations will lead to a decrease in blood calcium

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Weigh 40.0g of mannitol and 2.0g of calcium sodium edetate, dissolve it with 75% full amount of water for injection, add 2.1g of sodium hydroxide, adjust the pH value of the water for injection to between 11-12, and then add pantola Sodium azole 42.3g (40.0g as pantoprazole), dissolved completely. Replenish to full volume. Add activated carbon for needles, stir for adsorption, and filter to sterilize with 0.45 μm and 0.22 μm filter membranes. Measure and calculate content, every bottle containing pantoprazole is 40mg, and the filling volume of every bottle is about 2ml l (the pH value of the solution before freeze-drying is between 11-12), is divided into 1000 bottles, half-pressed rubber stopper , freeze-drying, vacuumizing, capping, and rolling an aluminum cap to obtain the freeze-dried powder of pantoprazole sodium. After inspection, all the indicators are in compliance with the regulations, especially the content of impurities A, C, and DF are in compliance with t...

Embodiment 2

[0079] Weigh 40.0g of glucose and 2.0g of calcium sodium edetate, dissolve with 75% full amount of water for injection, add 1.9g of sodium hydroxide, adjust the pH value of the water for injection to between 11-12, and then add pantoprazole Sodium 42.3g (40.0g as pantoprazole), dissolved completely. Replenish to full volume. Add activated carbon for needles, stir for adsorption, and filter to sterilize with 0.45 μm and 0.22 μm filter membranes. Measure and calculate content, every bottle containing pantoprazole is 40mg, and the filling volume of every bottle is about 2ml (the pH value of the solution before freeze-drying is between 11-12), is divided into 1000 bottles, half-pressed rubber stopper, Freeze-drying, vacuumizing, capping, rolling an aluminum cap to obtain freeze-dried powder of pantoprazole sodium. After inspection, all the indicators are in compliance with the regulations, especially the content of impurities A, C, and DF are in compliance with the regulations.

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Abstract

The invention belongs to the field of pharmacy and in particular relates to a pantoprazole sodium freeze-dried powder injection and a preparation method thereof. The invention achieves the purposes of increasing the pH value of the solution before freeze-drying, reducing the production of foreign substances before freeze-drying of the product, and improving stability. The freeze-dried powder injection contains the following components in parts by weight: 1 part of pantoprazole sodium, 0 to 3 parts of cyoprotectants, 0.025 to 0.1 part of sodium calcium edetate and an appropriate amount of pH regulators. The pH value of the solution before freeze-drying is increased to aid the control of foreign substances before freeze-drying of the product. Besides, sodium calcium edetate is used as a metal ion complexing agent for the preparation of pantoprazole sodium freeze-dried powder injection, which protects the product from metal complexation and prevents the injection from chelating with calcium ions during intravenous infusion to avoid low calcium levels.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to pantoprazole sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Pantoprazole sodium (Pantoprazole sodium) is a dialkylpyridine compound, which is the third generation of gastric parietal cell proton pump inhibitor after omeprazole and lansoprazole, under neutral and slightly acidic conditions Relatively stable, rapidly activated under strong acidic conditions, can specifically inhibit the secretion of microtubules formed by the apical membrane of parietal cells and the H on tubular vesicles in the cytoplasm + , K + -ATPase, causing an irreversible inhibition of this enzyme, thereby effectively inhibiting the secretion of gastric acid. It can not only non-competitively inhibit gastric acid secretion caused by gastrin, histamine, and choline, but also inhibit gastric acid secretion that is not affected by choline or H 2 Partia...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
Inventor 孙毅田阿娟秦观红
Owner 成都金典药物科技开发有限公司
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