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Preparation method for lansoprazole for injection

A technology for lansoprazole and injection, which is applied in the field of preparation of lansoprazole for injection, can solve the problems of equipment, energy, labor and many places, long production time, poor clarity of liquid medicine, etc., and achieve production The effect of short time, good clarity and high production efficiency

Active Publication Date: 2013-05-29
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In the preparation method of existing lansoprazole for injection, its operation is more complicated, and process cost is higher, and the time used for production is longer, and production efficiency is lower, and used equipment, energy, labor and place are more
In addition, the existing preparation method of lansoprazole for injection has problems such as oxidation of lansoprazole and a certain amount of precipitation in the liquid medicine, resulting in poor clarity of the liquid medicine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] The preparation method of Lansoprazole for injection of the present invention may further comprise the steps:

[0021] A, prepare 431ml of 0.2N sodium hydroxide solution, that is, 431ml of 0.2mol / L sodium hydroxide solution, take by weighing 30g of micronized lansoprazole, under nitrogen at a temperature of 8°C-12°C During protection, it is added into the prepared 0.2N sodium hydroxide solution and stirred until the micronized lansoprazole is completely dissolved to obtain an intermediate solution; adopting micronized lansoprazole can increase the dissolution rate, reduce operating time, and improve Work efficiency; Dissolving lansoprazole in nitrogen protection can prevent lansoprazole from being oxidized and improve product quality;

[0022] B, take by weighing the meglumine of 10g, add water for injection 100ml and stir until meglumine dissolves completely, obtain middle two solutions;

[0023] C, take by weighing 60g of mannitol and 2g of edetate disodium, add 800m...

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PUM

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Abstract

The invention relates to a preparation method for lansoprazole for injection. The preparation method comprises the following steps: preparing 431 ml of a 0.2 N sodium hydroxide solution, weighing 30 g of micronized lansoprazole, adding the micronized lansoprazole to the prepared 0.2 N sodium hydroxide solution under nitrogen gas protection, and stirring until the micronized lansoprazole is completely dissolved; weighing 10 g of meglumine, adding 100 ml of medical injection water, and stirring until the meglumine is completely dissolved to obtain an intermediate solution 2; and weighing 60 g of mannitol and 2 g of disodium edentate, adding 800 ml of medical injection water, and stirring until the mannitol and the disodium edentate are completely dissolved to obtain an intermediate solution3. A purpose of the present invention is to provide a preparation method for lansoprazole for injection, wherein the preparation method has characteristics of simple and safe operation, reasonable process conditions, low process cost, short production time, high production efficiency, no three waste pollution, equipment saving, energy saving, labor saving and field saving, and the produced drug liquid has a good clarity.

Description

technical field [0001] The invention relates to a preparation method of lansoprazole for injection. Background technique [0002] In the preparation method of existing lansoprazole for injection, its operation is more complicated, and process cost is higher, and the time used for production is longer, and production efficiency is lower, and used equipment, energy, labor and place are more. In addition, there are problems in the existing preparation method of lansoprazole for injection that the lansoprazole is oxidized and a certain amount of precipitation will be produced in the liquid medicine, resulting in poor clarity of the liquid medicine. Contents of the invention [0003] The object of the present invention is to provide a simple and safe operation, reasonable process conditions, low process cost, short production time, high production efficiency, no three waste pollution, saving equipment, energy, labor and space, and the clarity of the produced liquid medicine Th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K9/08
Inventor 杨磊
Owner YOUCARE PHARMA GROUP