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Lansoprazole composition freeze-dried powder for injection

A technology of lansoprazole and its composition, which is applied in the direction of freeze-drying delivery, drug combination, powder delivery, etc., can solve the problems of insufficient excipient formation and unfull appearance, reduce reconstitution time and increase sublimation efficiency , Ease of use

Active Publication Date: 2010-09-15
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reason analysis may be that the amount of lyophilized powder is too small, resulting in the sublimation process excipients not fully forming a good supporting framework, resulting in an unfulfilled appearance

Method used

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  • Lansoprazole composition freeze-dried powder for injection
  • Lansoprazole composition freeze-dried powder for injection
  • Lansoprazole composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Add 30g of lansoprazole, 10g of meglumine, 200g of mannitol, 2g of sodium bisulfite and 2g of disodium edetate into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust with sodium hydroxide pH10~12, add water for injection to 3000ml, add medical activated carbon to the prepared liquid medicine, wherein the weight of medical activated carbon is 0.1% of the solution volume, stir at room temperature for 15 minutes, filter and decarbonize, and then sterilize the filtrate with 0.22μm Fine filter with microporous membrane, measure the pH value and content of the filtrate, add water for injection until the volume of the solution is 630 times that of lansoprazole, pack into 1000 bottles, stopper half, cool the freeze-drying box to 3 ° C, put The packaged medicinal solution is placed in the freeze-drying box for 30 minutes, then the freeze-drying box is cooled to -40°C at a rate of 40°C / min, then heated to -13°C, kept for 0.7 hour...

Embodiment 2

[0049] Add 30g of lansoprazole, 10g of meglumine, 180g of mannitol, 2g of sodium bisulfite and 2g of disodium edetate into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust with sodium hydroxide pH10~11, add water for injection to 3000ml, add medical activated carbon to the prepared liquid medicine, wherein the weight of medical activated carbon is 0.1% of the solution volume, stir at room temperature for 15 minutes, filter and decarbonize, and then sterilize the filtrate with 0.22μm Fine filter with microporous membrane, measure the pH value and content of the filtrate, add water for injection until the volume of the solution is 630 times that of lansoprazole, pack into 1000 bottles, stopper half, cool the freeze-drying box to 3 ° C, put The packaged medicinal solution is placed in the freeze-drying box for 30 minutes, then the freeze-drying box is cooled to -40°C at a rate of 40°C / min, then heated to -13°C, kept for 0.7 hour...

Embodiment 3

[0051] Add 30g of lansoprazole, 10g of meglumine, 220g of mannitol, 1g of sodium bisulfite and 2g of disodium edetate into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust with sodium hydroxide pH11~12, add water for injection to 3000ml, add medical activated carbon to the prepared drug solution, wherein the weight of medical activated carbon is 0.1% of the solution volume, stir at room temperature for 15 minutes, filter and decarbonize, and then sterilize the filtrate with 0.22μm Fine filter with microporous membrane, measure the pH value and content of the filtrate, add water for injection until the volume of the solution is 630 times that of lansoprazole, pack into 1000 bottles, stopper half, cool the freeze-drying box to 3 ° C, put The packaged medicinal solution is placed in the freeze-drying box for 30 minutes, then the freeze-drying box is cooled to -40°C at a rate of 40°C / min, then heated to -13°C, kept for 0.7 hours,...

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Abstract

The invention relates to lansoprazole composition freeze-dried powder for injection. The lansoprazole composition freeze-dried powder is characterized by comprising lansoprazole used as a main material, meglumine, mannitol, sodium hydrogensulfite and ethylene diamine tetraacetic acid, wherein the proportion of the components is 3:(0.1-1):(1-20):(0.01-0.5):(0.01-0.5); preferably, the proportion is 3:(0.5-1):(10-20):(0.1-0.3):(0.05-0.3); and more preferably, the proportion is 3:1:20:0.2:0.2. The preparation method comprises the following steps of: dissolving the raw material and the auxiliary materials by adding water; regulating the pH value; adding active carbon for decolorizing; filtering for decarburizing; fine filtering by using a filter membrane; sub-packaging; cooling to -50 to -46 DEG C according to a speed of 1-1.2 DEG C / minute; preserving heat and freezing for 3 hours; vacuumizing to 15Pa; uniformly heating up to -22 to -18 DEG C within 7-9 hours and then preserving heat for 1-2 hours; uniformly heating up to 3-7 DEG C within 4-6 hours and then heating up to 40 DEG C within 4 hours; preserving heat and drying for 3 hours; and packaging and storing after inspection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a proton pump inhibitor drug, more specifically a lansoprazole composition freeze-dried powder for injection. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug in the world developed by Takeda after Omeprazole (Omeprazole). At the beginning of 1992, this product was officially put on the market in France by Takeda Pharmaceutical Factory and Houde Company (belonging to Roussel Uclaf Company). H on gastric parietal cells + -K + -ATPase. H + It cannot be transported to the stomach, so that the amount of gastric acid in the gastric juice is greatly reduced. It is clinically used for duodenal ulcer, gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome (gastrinoma) ) treatment, the curative effect is remarkable, and it has inhibitory effect on Helicobacter pylori. Lansoprazole is also known as a proton pump inhib...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
Inventor 李明华李明杰宋良伟
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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