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Lansoprazole lyophilized powder injection preparation and its preparing method

A technology of lansoprazole and freeze-dried powder injection, which is applied in the field of lansoprazole freeze-dried powder injection and its preparation, can solve problems such as unstable quality of lansoprazole freeze-dried powder preparation, and achieve appearance properties Good, stable appearance, stable content

Active Publication Date: 2012-07-11
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by this invention is the unstable problem of the quality of lansoprazole freeze-dried powder injection in the prior art, and then provide a kind of by rationally adjusting the weight proportion between components, make its quality stable, easy Lansoprazole formulations that are storage stable

Method used

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  • Lansoprazole lyophilized powder injection preparation and its preparing method
  • Lansoprazole lyophilized powder injection preparation and its preparing method
  • Lansoprazole lyophilized powder injection preparation and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] (1) Add 3200ml of water for injection at room temperature to 60°C into the preparation tank, add 8g of meglumine, 0.05g of calcium sodium edetate, 4.9g of sodium carbonate, and 210g of mannitol, stir to dissolve, and then add 29g of lansoprazole , and stir until completely dissolved.

[0033] (2) Adjust the pH value of the solution to 11.4-12.0 with 50 ml of 1 mol / L sodium hydroxide aqueous solution. Add 5g of medicinal activated carbon to the solution to absorb impurities, add water for injection to 4000ml, stir at room temperature for 30 minutes, filter and decarbonize, then sterilize and filter with a 0.22μm microporous filter membrane, and fill it evenly in a sterile environment There are about 1000 bottles in glass bottles.

[0034] (3) Put the medicinal glass bottle into a freeze-drying box, lower the temperature to -45°C, and gradually increase the temperature in a vacuum state to implement freezing and drying. During the freezing process, the following tempera...

Embodiment 2

[0037] (1) Add 3200ml of water for injection at room temperature to 60°C into the preparation tank, add 8g of meglumine, 0.02g of calcium sodium edetate, 5.3g of sodium carbonate, and 215g of mannitol, stir to dissolve, and then add 30g of lansoprazole , and stir until completely dissolved.

[0038] (2) Adjust the pH value of the solution to 11.4-12.0 with 50 ml of 1 mol / L sodium hydroxide aqueous solution. Add 5g of medicinal activated carbon to the solution to absorb impurities, add water for injection to 4000ml, stir at room temperature for 30 minutes, filter and decarbonize, then sterilize and filter with a 0.22μm microporous filter membrane, and fill it evenly in a sterile environment Glass bottle of 1000 bottles.

[0039] (3) Put the medicinal glass bottle into a freeze-drying box, lower the temperature to -45°C, and gradually increase the temperature in a vacuum state to implement freezing and drying. During the freezing process, the following temperature program is use...

Embodiment 3

[0042] (1) Add 3200ml of water for injection at normal temperature to 60°C in the preparation tank, add 8g of meglumine, 0.2g of polyethylene glycol, 4.9g of sodium carbonate, 100g of oligodextran, and 100g of mannitol, stir to dissolve, and then Add Lansoprazole 30g, stir until all dissolve.

[0043] (2) Adjust the pH value of the solution to 9.5-10.5 with 45 ml of 1 mol / L sodium hydroxide aqueous solution. Add 5g of medicinal activated carbon to the solution to absorb impurities, add water for injection to 4000ml, stir at room temperature for 30 minutes, filter and decarbonize, then sterilize and filter with a 0.22μm microporous filter membrane, and fill it evenly in a sterile environment There are about 1000 bottles in glass bottles.

[0044] (3) Put the medicinal glass bottle into a freeze-drying box, lower the temperature to -45°C, and gradually increase the temperature in a vacuum state to implement freezing and drying. During the freezing process, the following temper...

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Abstract

The invention provides a Lansoprazole lyophilized powder injection preparation and its preparing method. The preparation is used for treating peptic ulcer and belongs to the field of medicines. The Lansoprazole lyophilized powder injection preparation provided in the invention comprises Lansoprazole, a chemical stabilizing agent, a physical form stabilizing agent and a pH conditioning agent; and through quantified proportioning and synergism of the above-mentioned components, stability of the preparation can be effectively improved. According to the invention, the preparation has stable quality and is safe to use; and the preparation method is simple and is convenient for industrial large-scale production.

Description

technical field [0001] The invention relates to a lansoprazole freeze-dried powder preparation and a preparation method thereof, belonging to the field of medicines. Background technique [0002] Lansoprazole is the second-generation proton pump inhibitor after omeprazole, developed by Takeda Corporation of Japan, put on the market in 1992, and approved for listing in the United States in June 2004. The structural feature of lansoprazole is a substituted benzimidazole compound with fluorine introduced into the side chain. Due to the introduction of fluorine, lansoprazole exhibits higher bioavailability and stronger proton pump inhibition . [0003] Pharmacological studies have shown that after lansoprazole is distributed in the acidic environment of gastric mucosal parietal cells in the human body, it will be converted into active metabolites, which will react with the H present at the site of acid generation. + 、K + -Sulfhydryl binding of ATPase, by inhibiting H + 、K +...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61K47/34A61P1/04
Inventor 汪志超姚建林阎政沈建伟顾志锋
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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