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Method for preparing lansoprazole freeze-dried injection for injection

A technology of freeze-dried powder injection and lansoprazole, which is applied in the field of preparation of lansoprazole freeze-dried powder injection, can solve the problem of high insoluble particles, achieve less adverse reactions, reduce insoluble particles, improve product quality and The effect of storage stability

Inactive Publication Date: 2009-08-12
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Existing technology prepares in the process of lansoprazole for injection, if lansoprazole and sodium hydroxide can not react completely and form sodium salt, there is a small amount of free lansoprazole that can cause insoluble particles to be on the high side, wherein impurity lansoprazole The solubility of prazole sulfide is smaller than that of lansoprazole under the same alkaline conditions. If this impurity cannot be removed, it may cause high insoluble particles

Method used

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  • Method for preparing lansoprazole freeze-dried injection for injection

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Experimental program
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Effect test

Embodiment 1

[0017] Add 52g of lansoprazole to 200ml of isopropanol, add 17g of 33% sodium hydroxide aqueous solution to the slurry, stir at room temperature until the solution is clear, filter to remove insoluble matter, cool to 5-10°C, filter, and filter cake Wash twice with 40 ml of isopropanol at 5° C., and dry under vacuum at 50° C. to obtain 48.0 g of solid lansoprazole sodium with an HPLC purity of 99.9%.

Embodiment 2

[0019] Weigh 32g of lansoprazole sodium salt, add 400ml of water for injection, stir until completely dissolved at 20-30°C to obtain solution A, weigh 10g of meglumine, add 100ml of fresh water for injection and stir until completely dissolved to obtain solution B, weigh Take 60 parts of mannitol, add 800ml of fresh water for injection, stir until completely dissolved, add 3‰ needles and stir with activated carbon for 20 minutes, decarbonize and filter to obtain solution C, first combine solution B and solution C, and then mix with solution A, Add fresh water for injection to the full volume of 2000ml. The liquid medicine is firstly filtered with a 0.45μm microporous membrane, and then sterilized and filtered with a 0.22μm microporous membrane. Sampling is used to measure the content and alkalinity pH (the pH value is controlled at 10.4-12.0 Between), heat source, and after the clarity inspection is qualified, the filtrate is half-stoppered and divided into 10ml control antibio...

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Abstract

The invention provides a method for preparing a lansoprazole lyophilized powder injection for injection. By pre-preparing high-purity lansoprazole sodium salts, the impurities introduced during the procedures for synthesizing and storing the lansoprazole material and the impurities in auxiliary materials, particularly in sodium hydroxide, can be removed, thereby preventing the impurities from entering the lansoprazole lyophilized powder injection for injection, reducing insoluble particles and improving the quality and the storage stability of the lansoprazole products for injection; furthermore, the safety is high for clinical use and fewer adverse reactions are caused.

Description

technical field [0001] The invention relates to a preparation method of lansoprazole freeze-dried powder for injection. technical background [0002] Lansoprazole 2-[[(3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl]-sulfinyl]-1H-benzene Omeprazole and lansoprazole are substituted benzimidazole derivatives. A trifluoroethoxy group is introduced at the 4-position of the pyridine ring, making it different from omeprazole in structure and properties, increasing physical and chemical stability It has a stronger effect on inhibiting gastric acid secretion, and has a faster effect on the healing of peptic ulcer and the relief of reflux esophagitis than other drugs that inhibit gastric acid. Its mechanism of action is that lansoprazole is converted into active AG-1812 and AG-2000 in the acidic environment of gastric parietal cells, and the two active bodies interact with H + / K + -ATPase inactivation, inhibition of gastric acid secretion regulated by central and peripheral n...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 李海超胡春良白洪丽
Owner YOUCARE PHARMA GROUP
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