Lansoprazole freeze-dried powder for injection and preparing method thereof

A technology of lansoprazole and freeze-dried powder, applied in the field of medicine, can solve problems such as insufficient formation of excipients, incomplete appearance, etc., and achieve the effects of increasing sublimation efficiency, plump appearance and low water content

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PHARMA GRP 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 freeze-dried powder for injection and preparing method thereof
  • Lansoprazole freeze-dried powder for injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Add 30g of lansoprazole, 10g of meglumine and 200g of mannitol into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust the pH to 10-12 with sodium hydroxide, add water for injection to 3000ml, and add to the prepared Add 0.1% medical activated carbon to the liquid medicine, stir at room temperature for 15 minutes, filter and decarburize, and then fine filter the filtrate with a 0.22 μm sterile microporous filter membrane, measure the pH value and content of the filtrate, divide it into 1000 bottles, and half stoppered, Cool the subpackaged medicinal solution to -48°C at a rate of 1.1°C / min, keep it warm and freeze for 3 hours, open the vacuum valve to evacuate to 15Pa, then slowly raise the temperature to -20°C within 8 hours at a uniform speed, and keep it dry for 1 hour. Then the temperature was raised to 5°C at a uniform rate within 5 hours, and then the liquid was heated to 40°C at a constant rate within 4 hours, kep...

Embodiment 2

[0047] Add 30g of lansoprazole, 10g of meglumine and 180g of mannitol into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust the pH to 10-11 with sodium hydroxide, add water for injection to 3000ml, and add to the prepared Add 0.1% medical activated carbon to the liquid medicine, stir at room temperature for 15 minutes, filter and decarburize, and then fine filter the filtrate with a 0.22 μm sterile microporous filter membrane, measure the pH value and content of the filtrate, divide it into 1000 bottles, and half stoppered, Cool the subpackaged medicinal solution to -50°C at a rate of 1.2°C / min, keep it warm and freeze for 3 hours, open the vacuum valve to evacuate to 15Pa, then slowly heat up to -20°C at a uniform speed within 9 hours, and keep it dry for 2 hours. Then, the temperature was raised to 3°C at a uniform rate within 6 hours, and then the liquid was heated to 40°C at a constant rate within 4 hours, kept warm and d...

Embodiment 3

[0049] Add 30g of lansoprazole, 10g of meglumine and 220g of mannitol into the liquid mixing tank, add 2500ml of water for injection and stir until completely dissolved, adjust the pH to 11-12 with sodium hydroxide, add water for injection to 3000ml, and add to the prepared Add 0.1% medical activated carbon to the liquid medicine, stir at room temperature for 15 minutes, filter and decarburize, and then fine filter the filtrate with a 0.22 μm sterile microporous filter membrane, measure the pH value and content of the filtrate, divide it into 1000 bottles, and half stoppered, Cool the subpackaged medicinal solution to -46°C at a rate of 1°C / min, keep it warm and freeze for 3 hours, open the vacuum valve to evacuate to 15Pa, then slowly raise the temperature to -19°C within 7 hours at a uniform speed, and keep it dry for 1.5 hours. Then, within 4 hours, the temperature was raised to 4°C at a constant speed, and then the liquid was heated to 40°C within 4 hours, and then dried fo...

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Abstract

The invention provides a freeze-dried powder of lansoprazole for injection and a preparation method of the freeze-dried powder which consists of lansoprazole, meglumine and mannitol with the weight ratio of 3:1:18 to 22. The invention provides the preparation method: dissolving raw and supplemental materials with water and adjusting the pH, and adding activated carbon to remove the color and filtering to remove the carbon; making fine filtration with a filtering film and loading separately and cooling rapidly to minus 50 to minus 46 DEG C with the speed of 1 to 1.2 DEG C per minute; preserving the heat and freezing for 3 hours and pumping the vacuum to 15Pa; heating uniformly to minus 22 to minus 18 DEG C in 7 to 9 hours and preserving the heat for 1 hour to 2 hours; heating rapidly to 3 to 7 DEG C in 4 to 6 hours and then heating to 40 DEG C in 4 hours; preserving the heat and drying for 3 hours and packaging and warehousing after the measuring there. Products prepared by the method are low in water content, beautiful in appearance and easy in storage and transportation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a proton pump inhibitor drug and a preparation method thereof, more specifically a lansoprazole freeze-dried powder for injection and a preparation method thereof. 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. It prevents the H+ of parietal cells from being 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, and Zollinger-Ellison syndrome (gastrinoma) treatment, the curative effect is remarkable, and it has inhibi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61K47/18A61P1/04
Inventor 刘保起李明华宋显荣
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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