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Lansoprazole lyophilized powder injection and its preparing method

A technology for freeze-dried powder injection and lansoprazole, which is applied to the lansoprazole freeze-dried powder injection containing ethylenediaminetetraacetic acid and/or its salts and the field of preparation thereof, and can solve the problem that lansoprazole is unstable, Low bioavailability, easy to be destroyed and other problems, to achieve the effect of easy quality control, simple production process, fast cure speed

Inactive Publication Date: 2005-12-21
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Lansoprazole is unstable under acidic conditions and is easily destroyed in gastric acid. After being made into tablets or capsules, it is slowly absorbed orally and has low bioavailability

Method used

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  • Lansoprazole lyophilized powder injection and its preparing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: 30mg / bottle specification, 1000 lansoprazole freeze-dried powder injection formulations:

[0031] Lansoprazole 30g

[0032] Disodium EDTA 5g

[0033] Mannitol 50g

[0034] Sodium hydroxide 30g

[0035] Add water for injection to 2000ml, make 1000 tubes in total

[0036] Its preparation process is as follows:

[0037] a. Ingredients according to the formulation prescription, add 1600ml of water for injection, stir, adjust to pH 10.0-11.5 with pH regulator sodium hydroxide, stir to dissolve.

[0038] b. Filter and sterilize the prepared solution with a pH of 10.0 to 11.5 under sterile conditions with a 0.22 μm microporous membrane, store it in a liquid storage tank, measure the content of intermediates, and add 400 ml of water for injection to the prescribed amount.

[0039] c. Divide the medicinal liquid into 10ml vials, each bottle is filled with 2ml, half-tighten the stopper, put it into a p...

Embodiment 2

[0040] Embodiment 2: 10mg / bottle specification, 1000 lansoprazole freeze-dried powder injection formulations:

[0041] Lansoprazole 10g

[0042] Disodium EDTA 0.5g

[0043] Mannitol 100g

[0044] Sodium hydroxide 10g

[0045] Add water for injection to 2000ml, make 1000 tubes in total

[0046] Its preparation process is as follows:

[0047] a. Ingredients according to the formulation prescription, add 1600ml of water for injection, stir, adjust to pH 10.0-11.5 with pH regulator sodium hydroxide, stir to dissolve.

[0048] b. Filter and sterilize the prepared solution with a pH of 10.0 to 11.5 under sterile conditions with a 0.22 μm microporous membrane, store it in a liquid storage tank, measure the content of intermediates, and add 400 ml of water for injection to the prescribed amount.

[0049]c. Divide the medicinal liquid into 10ml vials, each bottle is filled with 2ml, half-pressed, put on a plate, put into ...

Embodiment 3

[0050] Embodiment 3: 60mg / bottle specification, 1000 lansoprazole freeze-dried powder injection formulations:

[0051] Lansoprazole 60g

[0052] Disodium EDTA 30g

[0053] Mannitol 120g

[0054] Sodium hydroxide 120g

[0055] Add water for injection to 2000ml, make 1000 tubes in total

[0056] Its preparation process is as follows:

[0057] a. Ingredients according to the formulation prescription, add 1600ml of water for injection, stir, adjust to pH 10.0-11.5 with pH regulator sodium hydroxide, stir to dissolve.

[0058] b. Filter and sterilize the prepared solution with a pH of 10.0 to 11.5 under sterile conditions with a 0.22 μm microporous membrane, store it in a liquid storage tank, measure the content of intermediates, and add 400 ml of water for injection to the prescribed amount.

[0059] c. Divide the medicinal liquid into 10ml vials, each bottle is filled with 2ml, half-pressed, put on a plate, put into...

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Abstract

The present invention relates to a lansoprazole freeze-dried powder injection and its preparation method. Said lansoprazole freeze-dried powder injection contains ethylene diamine tetraacetic acid (EDTA) and / or its salt, and is made up by using active component lansoprazole, ethylene diamine tetraacetic acid and / or its salt, stabilizing agent, excipient, pH regulator and injection water through a certain preparation process. Besides, said invention also provides the concrete steps of said preparation process.

Description

technical field [0001] A lansoprazole freeze-dried powder injection and a preparation method thereof of the present invention relate to a lansoprazole freeze-dried powder injection containing ethylenediaminetetraacetic acid (EDTA) and / or a salt thereof and a preparation method thereof. Background technique [0002] The chemical structural formula of Lansoprazole: [0003] [0004] Chemical name: 2-{[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridine]methylene]sulfoxide-1H-benzimidazole lansoprazole ( Lansoprazole) is a benzimidazole substitute developed after omeprazole, which is a strong inhibitor of the intramembrane proton pump secreted by the parietal cell tip, and Lansoprazole specifically inhibits H + -K + - The activity of ATPase, which is a key enzyme in gastric acid production. It must have an inhibitory effect on the basic gastric acid and the stress gastric acid caused by stimulation. Lansoprazole is suitable for gastric ulcer, duodenal ulcer, erosive gastroeso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439
Inventor 陈庆财宗在伟赵俊陈祥峰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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