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Pantoprazole sodium freeze-dried powder injection and preparation method thereof

A technology for pantoprazole sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve problems such as unfavorable large-scale production, difficult quality control, and complicated process steps, and achieves low content of related substances, simple preparation process and high stability. Effect

Active Publication Date: 2013-02-13
LIAONING NIRVANA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this preparation effectively solves the problem of quality stability, yet it needs pantoprazole sodium to be prepared into liposomes, and the process steps are loaded down with trivial details, and quality control is difficult, is unfavorable for industrialized large-scale production

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 1-6

[0027] The preparation of embodiment 1-6 pantoprazole sodium freeze-dried powder

[0028] The prescription composition of table 1 pantoprazole sodium freeze-dried powder

[0029] components

Example 1

Example 2

Example 3

Example 4

Example 5

Example 6

Pantoprazole Sodium

40g

40g

40g

40g

40g

40g

Soy Lecithin

50g

55

60

65

70

80

α-tocopherol

0.03g

0.02g

0.03g

0.04g

0.04g

0.05g

sodium citrate

3g

6g

5g

4g

4g

3g

sodium hydroxide

Appropriate amount

Appropriate amount

Appropriate amount

Appropriate amount

Appropriate amount

Appropriate amount

[0030] Preparation Process:

[0031] (1) Weigh pantoprazole sodium, lecithin and α-tocopherol, stir and dissolve in 500mL absolute ethanol, evaporate the ethanol under reduced pressure to obtain pantoprazole...

Embodiment 7

[0034] The stability investigation test of embodiment 7 pantoprazole sodium freeze-dried powder

[0035] Get respectively the pantoprazole sodium freeze-dried powder finished product prepared by the embodiment of the present invention 1-6, place high temperature 60 ℃ ± 2 ℃, place 10 days under the condition of light 4500Lx, investigate its character, acidity and solution clarity, related substance , content changes, test results are shown in Table 2.

[0036] Table 2 Test results of influencing factors (high temperature 60°C±2°C, light 4500Lx)

[0037]

[0038] Get respectively the pantoprazole sodium freeze-dried powder finished product prepared by the embodiment of the present invention 1-6, place temperature 40 ℃, place 6 months under the condition of humidity 75%, carry out accelerated test investigation, record its proterties, acidity and solution clarity Changes in degree, related substances and content, the test results are shown in Table 3.

[0039] Table 3 Accele...

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PUM

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Abstract

The invention discloses pantoprazole sodium freeze-dried powder injection and a preparation method thereof. The prazole sodium is racemate or levorotatory form prazole sodium, and the freeze-dried powder injection comprises prazole sodium, phosphatidylcholine, Alpha-tocopherol, sodium citrate and sodium hydroxide. The pantoprazole sodium freeze-dried powder injection is high in stability, simple in preparation process and beneficial to industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pantoprazole sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium) is a new type of proton pump inhibitor after omeprazole and lansoprazole. It is mainly used for anti-digestive ulcer, spasm, and treatment of gastric-duodenal ulcer. , Esophagitis, gastroesophageal reflux disease. After taking it, it can accumulate in the tubular membrane of gastric parietal cells and convert it into an active metabolite - sulfenamide. The active substance inhibits the H that stimulates gastric parietal cells to secrete gastric acid + / K + -ATPase, which plays an acid-inhibiting role. The invention has the advantages of being safe, reliable and having little toxic and side effects. [0003] The chemical name of pantoprazole sodium is difluoromethoxy-2-[(3,4-dimethoxy-2-py...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/24A61P1/04
Inventor 不公告发明人
Owner LIAONING NIRVANA PHARMA
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