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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 pharmaceutical preparations, can solve the problems of excipients affecting product pre-freezing and drying, and unsatisfactory medicinal effects of powder injections, and achieve good clarity, stable quality and reliable control and avoid side effects

Active Publication Date: 2011-06-08
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned pantoprazole sodium freeze-dried powder injection has a simple formula and few side effects, but due to the excessive amount of excipients, the medicinal effect of the powder injection is not ideal, and there have been cases of significant side effects in actual clinical practice
At the same time, the excessive amount of auxiliary materials also affects the pre-freezing and drying of the product, so the freeze-drying process of the above-mentioned freeze-dried powder preparation is more than 30h

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

[0099] (1) Prescription: Specification 40mg:1.2ml

[0100] Pantoprazole Sodium (as Pantoprazole) 40g

[0101] Mannitol 40g

[0102] Add water for injection to 1200ml

[0103]

[0104] 1000 bottles

[0105] (2) Preparation process:

[0106] Weigh the prescription amount of pantoprazole sodium and mannitol, add 80% of the total amount of water for injection (15℃) in the preparation tank, add the prescription amount of mannitol and pantoprazole sodium in turn, stir to make Dissolve into a clear solution; add water for injection to the full amount, mix well, adjust the pH value of the solution to 10.8 with 5mol / L sodium hydroxide solution, add 0.10% (g / ml) of the total amount of the prepared medicinal activated carbon, stir and absorb 30 Minutes, after decarbonization and the first 0.22μm sterilization filtration, after the intermediates pass the test, the medicine is hydraulically filtered to the medicine storage tank in the medicine receiving room, and then ...

Embodiment 2

[0112] (1) Prescription: Specification 80mg:2.4ml

[0113] Pantoprazole Sodium (as Pantoprazole) 80.0g

[0114] Mannitol 80.0g

[0115] Add water for injection to 2400ml

[0116]

[0117] Made into 1000 bottles

[0118] (2) Preparation process:

[0119] Weigh the prescription amount of pantoprazole sodium and mannitol, add 80% of the total amount of water for injection (15℃) in the preparation tank, add the prescription amount of mannitol and pantoprazole sodium in turn, stir to make Dissolve into a clear solution; add water for injection to the full amount, mix well, adjust the pH value of the solution to 10.8 with 5mol / L sodium hydroxide solution, add 0.10% (g / ml) medicinal activated carbon of the total solution, stir and absorb 30 Minutes, after decarbonization and the first 0.22μm sterilization filtration, after the intermediates pass the test, the medicine is hydraulically filtered to the medicine storage tank in the medicine receiving room, and th...

Embodiment 3

[0125] (1) Prescription: Specification 80mg:2.4ml

[0126] Pantoprazole Sodium (as Pantoprazole) 80.0g

[0127] Mannitol 64.0g

[0128] Add water for injection to 2400ml

[0129]

[0130] 1000 bottles

[0131] (2) Preparation process:

[0132] Weigh the prescription amount of pantoprazole sodium and mannitol, first add 80% of the total amount of water for injection (18°C) in the preparation tank, add the prescription amount of mannitol and pantoprazole sodium in turn, stir to make Dissolve into a clear solution; replenish the water for injection to the full amount, mix well, adjust the pH of the solution to 10.5 with 4mol / L sodium hydroxide solution, add 0.10% (g / ml) medicinal activated carbon of the total solution, stir and absorb 30 Minutes, after decarbonization and the first 0.22μm sterilization filtration, after the intermediates pass the test, the medicine is hydraulically filtered to the medicine storage tank in the medicine receiving room, an...

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Abstract

The invention relates to a pantoprazole sodium freeze-dried powder injection and a preparation method thereof. The powder injection is prepared from pantoprazole sodium and mannitol, wherein the consumption ratio of the pantoprazole sodium to the mannitol is (1:0.8)-(1:1.6), and the PH value is 10.5-11.0. In the invention, by lowering the pre-freezing temperature, properly lowering the freezing temperature, maintaining the lowered freezing temperature for a proper time, properly shortening two-stage drying time and carrying out other adjustment processes, good appearance and quality of the product can be kept under the condition that the content of the mannitol is low, the processes are reliable and feasible, and the effect is obvious. The prepared product has low content of related substances and has controllable quality, and the freeze-dried product has good clarity and formability after being redissolved.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations. More specifically, the invention provides a pantoprazole sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Pantoprazole Sodium, English name: Pantoprazole Sodium, its chemical name is: 5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridyl)-methyl]sulfinic acid Acyl]-1H-benzimidazole sodium monohydrate. Pantoprazole Sodium for Injection is suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal disease, compound gastric ulcer. Pantoprazole is a proton pump inhibitor that interacts with the H of gastric parietal cells + -K + The two sites of the ATPase system covalently bind to inhibit the final step of gastric acid production. The effect is dose-dependent and inhibits the secretion of gastric acid in both basal and stimulated states. This product and H + -K + The combination of ATPase can ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61P1/04
Inventor 马鹰军钟正明
Owner HAINAN JINRUI PHARMA CO LTD
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