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Freeze-dried dexlansoprazole composition for injection and preparation method thereof

A technology of dexlansoprazole and composition, which is applied in the field of dexlansoprazole freeze-dried composition for injection and its preparation, can solve the problem of short maintenance time of dexlansoprazole clarity and freeze-dried powder. The problem of poor resolubility and poor practicability of the injection is solved, and the effect of easy preparation method, poor resolubility and rapid onset of action can be achieved

Active Publication Date: 2014-08-06
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN1660091A、CN1660092A、CN1709248A、CN1810244A、CN101057846A、CN101874789A、CN101129368A、CN101229136A、CN101502493、CN101559230A、CN101804035A、CN101829065A、CN102772409A等公开了注射用消旋兰索拉唑各种不同的组合物及其制备方法,均未涉及 The problem of poor reconstitution of its freeze-dried powder injection
Experimental studies have found that the dexlansoprazole for injection obtained by this method still has many problems such as short clarity maintenance time after reconstitution, poor practicability, etc., and the patent application has expired

Method used

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  • Freeze-dried dexlansoprazole composition for injection and preparation method thereof
  • Freeze-dried dexlansoprazole composition for injection and preparation method thereof
  • Freeze-dried dexlansoprazole composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each 1000 bottles of freeze-dried preparations contains the following components:

[0032]

[0033] Weigh each component according to the above prescription amount, dissolve it in 80% of the prescription amount of sterile water for injection, adjust the dissolved solution to clear with an appropriate amount of sodium hydroxide solution, decolor with activated carbon, filter and decarbonize, use 1mol / L Sodium hydroxide adjusts the pH value to 12.0, and then replenishes the water to the full amount. After being finely filtered through a 0.22μm microporous membrane, it is filled into 1000 10mL vials under aseptic conditions to make the main drug content 30mg / bottle.

[0034] Freeze drying: quickly cool the vial filled with the composition liquid to -45°C and keep it warm for about 120 minutes (to ensure that the product is frozen solid). It takes about 360 minutes to heat up to -20°C; keep warm until the waterline disappears, and continue to keep warm until the product temperat...

Embodiment 2

[0036] Each 1000 bottles of freeze-dried preparations contains the following components:

[0037]

[0038] Prepare 1000 bottles of dexlansoprazole freeze-dried preparation for injection according to the method of Example 1 (1mol / L potassium hydroxide is used to adjust the pH to 12.5 when adjusting the pH) with the original and auxiliary materials of the above prescription. It is 15mg / bottle.

Embodiment 3

[0040] Each 1000 bottles of freeze-dried preparations contains the following components:

[0041] D-lansoprazole 10g

[0042] Arginine 80g

[0043] Sorbitol 20g

[0044] Prepare 1000 bottles of dexlansoprazole freeze-dried preparation for injection according to the method of Example 1 (use 2mol / L disodium hydrogen phosphate to adjust to pH 11.5 when pH is adjusted) from the original and auxiliary materials of the above prescription. The content is 10mg / bottle.

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PUM

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Abstract

The invention provides a freeze-dried dexlansoprazole composition powder injection for injection and a preparation method thereof. The powder injection comprises the active components consisting of dexlansoprazole and arginine, and meglumine and / or excipients like mannitol. The preparation method comprises the following steps: dissolving raw and adjuvant materials with water; adding a proper amount of a sodium hydroxide solution to allow a solution obtained in the previous step to be clear; then adding active carbon for decoloring; carrying out active carbon removal and then adjusting a pH value; and successively carrying out filtering with a filter membrane, split charging and freeze-drying. The powder injection is clinically applied to treatment of diseases like gastric ulcer, duodenal ulcer, erosive gastro-oesophageal reflux disease, helicobacter pylori infection and Zollinger-Ellison syndrome. The freeze-dried dexlansoprazole composition powder injection for injection provided by the invention overcomes the problem of poor redissolvability of dexlansoprazole, has stable quality and good redissolvability and improves medication security.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a freeze-dried dexlansoprazole composition for injection and a preparation method thereof. Background technique [0002] With the development of society, people's life rhythm has become faster and faster, leading to an increase in the incidence of digestive tract diseases. If the digestive tract diseases are not treated promptly and appropriately, it will seriously affect people's quality of life. [0003] Lansoprazole is a new generation of proton pump inhibitor antiulcer drug after omeprazole. It was first launched in Japan in December 1992 and is now sold in 37 countries. Because of its unique mechanism of action and high specificity, It has a strong acid-suppressing effect and a long time. It can be widely used to treat various digestive disorders related to acid secretion. [0004] D-lansoprazole is the corresponding isomer of lansoprazole and is a new drug for...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
Inventor 余悦东冯卫杨丽红陶建林蒋德军蒋小兰
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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