Pantoprazole sodium medicine composition for injection

A technology of pantoprazole sodium and composition, applied in the field of pantoprazole sodium pharmaceutical composition for injection and its preparation field, can solve problems such as poor compatibility and poor stability, achieve good stability, stable quality, improved Yield effect

Inactive Publication Date: 2013-12-25
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the stability of its preparation is poor and the compatibility is poor

Method used

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  • Pantoprazole sodium medicine composition for injection
  • Pantoprazole sodium medicine composition for injection
  • Pantoprazole sodium medicine composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] The described pantoprazole sodium pharmaceutical composition of every 1000 bottles, its formula consists of:

[0104]

[0105] Preparation methods include:

[0106] 1) Take 70% of the prescribed amount of water for injection, at a temperature of 50-70°C, add the prescribed amount of sodium hydroxide, meglumine, calcium sodium edetate and stir until dissolved, then add the prescribed amount of pantola to the solution Sodium azole, stirred until completely dissolved, then added the prescribed amount of mannitol, stirred until completely dissolved;

[0107] 2) Add 0.1% medicinal charcoal by the volume of the liquid medicine to item 1), stir well, and let stand for 30 minutes;

[0108] 3) Filter item 2) with a filter, decarbonize, add water for injection to 97%, mix well, and measure the initial pH value. According to the initial pH value, use 10% sodium hydroxide solution to adjust the pH value range to 10.0± 0.2;

[0109] 4) Central control: carry out intermediate p...

Embodiment 2

[0125] The described pantoprazole sodium pharmaceutical composition of every 1000 bottles, its formula consists of:

[0126]

[0127] The preparation method is the same as in Example 1.

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Abstract

The invention aims at providing a pantoprazole sodium medicine composition for injection and a preparation method thereof. A certain amount of sodium calcium edentate, meglumine and sodium hydroxide are selected and used, the pH value of the solution is firstly regulated, then the pantoprazole sodium is dissolved in the solution. The stability of the medicine composition can be effectively improved, the medicine composition is not easy to dissolve out, and related substances do not change. According to the new pantoprazole sodium medicine composition, the problem of stability of the solution of the pantoprazole sodium in clinical application is thoroughly solved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of pantoprazole sodium for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Pantoprazole Sodium (PantoprazoleSodium.l) was developed by BykGulden of Germany and first launched in South Africa in 1994. It is the third proton pump inhibitor in the world after Omeprazole and Lansoprazole , mainly for the treatment of duodenal and gastric ulcers and relief of moderate to severe reflux esophagitis. Compared with other proton pump inhibitors, pantoprazole sodium is stable under weak acid conditions, can be activated quickly under strong acid conditions, and has little interaction with other drugs. Pantoprazole sodium ranked No. 14 in the sales of the best-selling drugs in the world in 2005, and the global sales in 2006 reached 3.621 billion US dollars. The bulk drug of pantoprazole sodium is white or off-white loose lump or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/18A61K31/4439A61K9/19A61P1/04
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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