Rabeprazole sodium composition and preparation method thereof

A technology of rabeprazole sodium and composition, applied in the field of rabeprazole sodium composition and preparation thereof, can solve the problems of large number of insoluble particles, slow dissolution, inconvenient injection and use, etc., and achieves excellent appearance and reduction of insoluble particles. , composed of simple effects

Active Publication Date: 2010-01-20
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to improve the stable performance of rabeprazole sodium, it is also convenient for storage and transportation, and it is made into the dosage form of rabeprazole sodium freeze-dried powder injection, but the injection rabeprazole sod...

Method used

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  • Rabeprazole sodium composition and preparation method thereof
  • Rabeprazole sodium composition and preparation method thereof
  • Rabeprazole sodium composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Rabeprazole sodium composition prescription:

[0060] Rabeprazole Sodium 20g

[0061] Disodium diethylamine tetraacetate 5.0g

[0062] Mannitol 150g

[0063] 1000 bottles

[0064] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0065] Dissolve 5.0g of disodium diethylamine tetraacetate in 4000ml of water for injection, then add 20g of rabeprazole sodium at a temperature of 30°C, stir to dissolve, then add 150g of mannitol, stir to dissolve Cool to room temperature, adjust the pH of the solution to 11.5; add 0.1% g / ml activated carbon to the above-prepared solution, stir for 15 minutes, filter and decarbonize; rapidly cool the filtrate from room temperature to -22°C, and maintain -22°C for a period of time for 2.5 hours, then lowered to -40°C, pre-frozen for 3 hours, vacuumized, raised the temperature of the frozen rabeprazole sodium to 5°C within 6 hours, maintained at 5°C for 1...

Embodiment 2

[0067] Rabeprazole sodium composition prescription:

[0068] Rabeprazole Sodium 20g

[0069] Disodium diethylamine tetraacetate 3.0g

[0070] Mannitol 200g

[0071] 1000 bottles

[0072] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0073] Dissolve 3.0g of disodium diethylamine tetraacetate in 4000ml of water for injection, then add 20g of rabeprazole sodium at a temperature of 25°C, stir to dissolve, then add 200g of mannitol, stir to dissolve Cool to room temperature, adjust the pH of the solution to 12.0; add 0.15% g / ml activated carbon to the above-prepared solution, stir for 15 minutes, filter and decarbonize; rapidly cool the filtrate from room temperature to -20°C, and maintain -20°C for a period of time for 2.5 hours, then lowered to -45°C, pre-frozen for 3 hours, vacuumed, raised the temperature of the frozen rabeprazole sodium to 8°C within 5 hours, maintained at 8°C for 18 hour...

Embodiment 3

[0075] Rabeprazole sodium composition prescription:

[0076] Rabeprazole Sodium 20g

[0077] Disodium diethylamine tetraacetate 6.0g

[0078] Mannitol 100g

[0079] 1000 bottles

[0080] Rabeprazole sodium composition is prepared into the preparation method of rabeprazole sodium powder injection:

[0081] Dissolve 6.0g of disodium diethylamine tetraacetate in 4000ml of water for injection, then add 20g of rabeprazole sodium at a temperature of 35°C, stir to dissolve, then add 100g of mannitol, stir to dissolve Cool to room temperature, adjust the pH of the solution to 12.5; add 0.05% g / ml activated carbon to the above-prepared solution, stir for 15 minutes, filter and decarbonize; quickly cool the filtrate from room temperature to -25°C, and maintain -25°C for a period of time 3.0 hours, then lower to -43°C, pre-freeze for 4 hours, vacuumize, raise the temperature of the frozen rabeprazole sodium to -5°C within 5 hours, continue to heat up to, mainta...

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Abstract

The invention provides a rabeprazole sodium composition which comprises the active ingredients of rabeprazole, mannitol and ethylene diamine tetraacetic acid, wherein the weight ratio of ethylene diamine tetraacetic acid to rabeprazole sodium is 0.05-0.5:1. The method for preparing the composition into solid powder-needle preparation comprises the following steps: dissolving the ethylene diamine tetraacetic acid solution with the prescription amount into injection water, adding and stirring the rabeprazole sodium with the prescription amount at a temperature of 25-35 DEG C for dissolving, then adding mannitol with the prescription amount, stirring the mannitol for dissolving, cooling to a room temperature, and regulating the pH value of the solution to 11.5-12.5; adding active carbon intothe confected solution, stirring and filtering for decarburization, and freezing and drying the obtained filtrate to obtain the rabeprazole frozen powder needle. The rabeprazole frozen powder needle has full appearance, favorable stability and solubility and little insoluble grains in the injection.

Description

technical field [0001] The present invention relates to a rabeprazole sodium composition, in particular to a rabeprazole sodium composition and a preparation method thereof. Background technique [0002] Ulcer disease is a common type of disease, and it is prone to recurrent clinically, often accompanied by serious complications, such as gastric and duodenal ulcers, which can be complicated by upper gastrointestinal bleeding and perforation, which seriously threaten people's health. Proton pump inhibitors are powerful weapons in the fight against ulcer disease. Japan's Eisai Company's proton pump inhibitor (Proton Pump Inhibitors, PPI) anti-ulcer drug rabeprazole is following Astra's omeprazole, Takeda's lansorazole (lansorazole) and Byk Gulden's panax The fourth PPI developed after pantoprazole. [0003] The chemical name of Rabeprazole Sodium is: 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]- 1H-Benzimidazole Sodium. [0004] Chemical Structure: [000...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/18A61K9/14A61K9/19A61P1/04
Inventor 李明华郭忠明张明法
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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