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Pantoprazole sodium freeze-dried medicinal composition and preparation method thereof

A pantoprazole sodium and composition technology, which is applied to the pantoprazole sodium freeze-dried pharmaceutical composition for injection and the field of preparation thereof, can solve the problems of unknown side effects, decreased preparation content, inconvenient patient medication safety and the like, and achieves the The effect of reducing side effects and efficacy problems, improving quality and stability, and improving drug safety

Active Publication Date: 2013-05-29
武汉天安医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the addition of too many excipients, these powder injections may cause unknown side effects and affect the safety of patients.
[0007] In summary, in view of the unstable characteristics of pantoprazole sodium to light, heat, oxygen and water, the common solution is to prepare pantoprazole sodium into a freeze-dried powder injection, but we found that even if it is prepared into a freeze-dried powder The dry preparation can not guarantee the stability of its preparation, transportation and storage process, the content of its preparation still drops obviously, but the relevant substances increase obviously, and there are strict requirements on preparation and infusion time during clinical use, which is extremely inconvenient pose a risk to patient safety

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] prescription:

[0061] 1 part by weight of pantoprazole sodium

[0062] 0.05 parts by weight of sodium citrate.

[0063] Preparation:

[0064] 1) Dissolve sodium citrate with water for injection to make a 30% (g / ml) sodium citrate solution;

[0065] 2) Dissolve pantoprazole sodium with water for injection, the amount of which is 50% of the total amount;

[0066] 3) adding the sodium citrate solution obtained in 1) to the pantoprazole sodium solution obtained in 2) until the pH value of the solution is about 10 to obtain a pantoprazole sodium citrate solution;

[0067] 4) Add activated carbon for needles to the solution obtained in 3), filter, and make up the filtrate with water for injection to the full amount;

[0068] 5) Fill the solution obtained in 4) into a freeze-drying bottle, and freeze-dry. The freeze-drying method is:

[0069] (1) Pre-freezing, bottle the solution in the freezer freezer and drop it to -3°C, stop cooling, let it stand for about 1 hour, then ...

Embodiment 2

[0076] 1 part by weight of pantoprazole sodium

[0077] 0.06 parts by weight of sodium citrate.

[0078] Preparation:

[0079] 1) Dissolve sodium citrate with water for injection to make 25% (g / ml) sodium citrate solution;

[0080] 2) Dissolve pantoprazole sodium with water for injection, the amount of which is 70% of the total amount;

[0081] 3) adding the sodium citrate solution obtained in 1) to the pantoprazole sodium solution obtained in 2) until the pH value of the solution is about 10 to obtain a pantoprazole sodium citrate solution;

[0082] 4) Add activated carbon for needles to the solution obtained in 3), filter, and make up the filtrate with water for injection to the full amount;

[0083] 5) Fill the solution obtained in 4) into a freeze-drying bottle, and freeze-dry. The freeze-drying method is:

[0084] (1) Pre-freezing, bottle the solution in a freeze-drying box, first drop to -3°C, stop cooling, let stand for 1 hour, then cool down to -5°C, let stand for ...

Embodiment 3

[0089] 1 part by weight of pantoprazole sodium

[0090] 0.04 parts by weight of sodium citrate.

[0091] Preparation:

[0092] 1) Dissolve sodium citrate with water for injection to make 25% (g / ml) sodium citrate solution;

[0093] 2) Dissolve pantoprazole sodium with water for injection, the amount of which is 45% of the total amount;

[0094] 3) adding the sodium citrate solution obtained in 1) to the pantoprazole sodium solution obtained in 2) until the pH value of the solution is about 10 to obtain a pantoprazole sodium citrate solution;

[0095] 4) Add activated carbon for needles to the solution obtained in 3), filter, and make up the filtrate with water for injection to the full amount;

[0096] 5) Fill the solution obtained in 4) into a freeze-drying bottle, and freeze-dry. The freeze-drying method is:

[0097] (1) Pre-freeze, bottle the solution, put it in the freeze-drying box of the freezer, first drop to -3°C, stop cooling, let stand, then cool down to -5°C, le...

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PUM

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Abstract

The invention provides a pantoprazole sodium freeze-dried medicinal composition for injection, comprising the following components by weight: 1 part of pantoprazole sodium and 0.01-0.1 part of sodium citrate. The invention also provides a preparation method of the freeze-dried medicinal composition. The pantoprazole sodium freeze-dried medicinal composition for injection is used for treating peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs and ulcer hemorrhoea in a stress state, as well as regurgitation of gastric juice and aspiration pneumonia of patients who are subjected to general anesthesia or a major operation and are weak and in coma.

Description

technical field [0001] The invention relates to a freeze-dried pharmaceutical composition of pantoprazole sodium for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)]-sulfinyl-1H-benzo Imidazole sodium salt. Pantoprazole sodium is a new generation of proton pump inhibitor (PPI) after omeprazole and lansoprazole, and it is the first-line treatment drug for peptic ulcer disease. After being marketed globally, it immediately became a specific drug for the treatment of acid-related digestive system dysfunction diseases due to its strong and long-lasting acid suppression effect, high ulcer healing rate, few adverse reactions and few drug interactions. Pantoprazole sodium injection is mainly used for peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drug...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/12A61P1/04
Inventor 李静李慧
Owner 武汉天安医药科技有限公司
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