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Rabeprazole sodium powder injection and preparation method thereof

A technology of rabeprazole sodium and powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of stability and related substances that have not been tested in experiments, and achieve good stability effects, good stability, and unique process effects

Active Publication Date: 2010-08-18
JUMPCAN PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no experimental investigation on the stability and related substances

Method used

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  • Rabeprazole sodium powder injection and preparation method thereof
  • Rabeprazole sodium powder injection and preparation method thereof
  • Rabeprazole sodium powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prescription of Rabeprazole Sodium Powder Injection:

[0038] Rabeprazole Sodium 20g

[0039] Mannitol 40g

[0040] Appropriate amount of sodium hydroxide

[0041] The preparation method is:

[0042] 1) Accurately weigh the prescribed amount of rabeprazole sodium and mannitol into a sterile container, add 1800ml of water for injection, stir to dissolve, and adjust the pH value of the solution to 10.5-11.5 with 0.1mol / L sodium hydroxide solution, Stir, add water for injection to 2000ml, then add 0.02%-0.04% activated carbon, stir for 30 minutes, and decarbonize. Filter through a 0.22 μm microporous membrane. Measure the solution content, determine the filling volume, and fill. A total of 1000 bottles were made.

[0043] 2) Freeze drying.

[0044] The sample is pre-frozen at -40°C for 9-11 hours; vacuumize, keep the vacuum at 10-30Pa, slowly raise the temperature to -20°C-25°C, and keep it for about 10-12 hours; then slowly raise the temperature to 30°C-35°C, Keep...

Embodiment 2

[0046] Prescription of Rabeprazole Sodium Powder Injection:

[0047] Rabeprazole Sodium 20g

[0048] Mannitol 40g

[0049] Appropriate amount of sodium hydroxide

[0050] Preferably, the preparation method of powder injection of the present invention is:

[0051] 1) Accurately weigh the prescribed amount of rabeprazole sodium and mannitol in a sterile container, add 1800ml of water for injection, stir to dissolve, adjust the pH value of the solution to 11 with 0.1mol / L sodium hydroxide solution, stir, Add water for injection to 2000ml, then add 0.03% activated carbon, stir for 30 minutes, and decarbonize. Filter through a 0.22 μm microporous membrane. Measure the solution content, determine the filling volume, and fill. A total of 1000 bottles were filled.

[0052] 2) Freeze drying.

[0053]The samples were pre-frozen at -40°C for 10 hours; evacuated and kept at 20 Pa, slowly raised to -20°C and kept for about 10 hours; then slowly raised to 30°C and kept for 6 hours, t...

Embodiment 3

[0055] Prescription of Rabeprazole Sodium Powder Injection:

[0056] Rabeprazole Sodium 20g

[0057] Mannitol 45g

[0058] Appropriate amount of sodium hydroxide

[0059] Preparation method is the same as embodiment 2

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Abstract

Rabeprazole sodium is developed by Eisai Co., Ltd. Japan, and is mainly used for treating active duodenal ulcer and optimum active gastric ulcer. The invention provides a rabeprazole sodium freeze-dried powder injection, which has the advantages of high stability, unique technology and few insoluble grains dissolved in transfusion liquid. The invention is superior to the existing technical schemein the aspects of impurities and relevant substances, so good curative effect and low adverse reaction rate are obtained. Excipients of the invention adopt mannite, and have the concrete weight ratio of rabeprazole sodium / mannite=1 / 2 to 2.5, and preferably, the weight ratio of rabeprazole sodium / mannite=1 / 2. PH regulating agents of the injection of the invention adopt sodium hydroxide, the PH value regulation range before the freeze drying is between 10.5 and 11.5, and preferably, the PH value is regulated to 11.

Description

technical field [0001] The invention relates to a powder injection of rabeprazole sodium and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Rabeprazole sodium (Sodium rabeprazole) was developed by Japan's Eisai Company and is mainly used for the treatment of active duodenal ulcer, benign active gastric ulcer, erosive or ulcerative gastroesophageal reflux with clinical symptoms Helicobacter pylori-positive duodenal ulcer, maintenance treatment of erosive or ulcerative gastroesophageal reflux syndrome, etc. In 2004, Rabeprazole Sodium for Injection, which was developed and successfully marketed in India, is mainly used clinically for patients who cannot take oral medication temporarily for some reason, with bleeding or severe erosive active duodenal ulcer, and with Short-term treatment of bleeding or severely erosive active gastric ulcer, erosive or ulcerative gastroesophageal reflux disease (GERD),...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61P1/04
Inventor 曹龙祥董自波王林
Owner JUMPCAN PHARMA GRP
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