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A kind of dexlansoprazole freeze-dried 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 field, can solve the problem of short maintenance time of dexlansoprazole clarity, freeze-dried powder Problems such as poor resolubility and poor practicability of injections, to achieve the effects of easy preparation, simple preparation and rapid onset of action

Active Publication Date: 2019-01-08
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 and poor practicability. The patent application has expired

Method used

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  • A kind of dexlansoprazole freeze-dried composition for injection and preparation method thereof
  • A kind of dexlansoprazole freeze-dried composition for injection and preparation method thereof
  • A kind of dexlansoprazole freeze-dried composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each 1000 vials of lyophilized preparation contains the following components:

[0032]

[0033] Weigh each component according to the above prescription quantity, dissolve it in sterile water for injection with 80% of the prescription quantity, adjust the solution to clarification with an appropriate amount of sodium hydroxide solution, decolorize it with activated carbon, filter and decarbonize it with 1mol / L Adjust the pH value to 12.0 with sodium hydroxide, then add water to the full amount, and after fine filtration with a 0.22 μm microporous membrane, fill it in 1000 10mL vials under aseptic conditions, so that the main drug content is 30mg / bottle.

[0034]Freeze-drying: quickly cool down 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). Heat up to -20°C in about 360 minutes; keep warm until the water line disappears, and continue to keep warm until the product temperature is abov...

Embodiment 2

[0036] Each 1000 vials of lyophilized preparation contains the following components:

[0037]

[0038] The former and auxiliary materials of above-mentioned prescription are prepared into 1000 bottles of dexlansoprazole freeze-dried preparations for injection according to the method of embodiment 1 (when adjusting pH, 1mol / L potassium hydroxide is used to adjust to pH12.5). It is 15mg / support.

Embodiment 3

[0040] Each 1000 vials of lyophilized preparation contains the following components:

[0041] Dexlansoprazole 10g

[0042] Arginine 80g

[0043] Sorbitol 20g

[0044] The former and auxiliary materials of above-mentioned prescription are prepared into 1000 bottles of dexlansoprazole freeze-dried preparations for injection according to the method of embodiment 1 (when adjusting pH, use 2mol / L disodium hydrogen phosphate to adjust to pH11.5). The content is 10mg / support.

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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, in particular to a freeze-dried composition of dexlansoprazole for injection and a preparation method thereof. Background technique [0002] With the development of society, people's pace of life has become faster and faster, leading to an increase in the incidence of digestive tract diseases. If digestive tract diseases are not treated in time and properly, it will seriously affect people's quality of life. [0003] Lansoprazole is a new generation of proton pump inhibitor anti-ulcer drugs 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, The acid-suppressing effect is strong and lasts for a long time, and it can be widely used in the treatment of various digestive disorders related to acid secretion. [0004] Dexlansoprazole is the corresponding isomer of lansoprazole, an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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