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(S)-Pantoprazole sodium lyophilized powder preparation for injection

A technology for pantoprazole sodium and injection, which is applied in the field of medicine, and can solve the problems of preparation stability, failure to completely isolate activated carbon, activated carbon desorption, etc., and achieve the effect of reducing irritation and reducing the introduction of insoluble particles

Active Publication Date: 2017-03-08
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In the previous patent literature, there have been many reports on S-pantoprazole sodium freeze-dried powder injection, but the influence of the interaction between the drug and activated carbon on the preparation has not been considered.
The stability of S-pantoprazole sodium solution is highly dependent on the pH value, and the degree of degradation increases with the decrease of the pH value; activated carbon sometimes appears "sol" or desorption in alkaline solution, which makes the solution in the opposite direction. The increase of impurities affects the quality of the preparation; light has a great impact on the stability of the preparation, but no measures have been taken to protect it.
[0011] Chinese patent CN102000034B is a kind of S-pantoprazole sodium composition and preparation method thereof for injection, because S-pantoprazole sodium itself is an alkaline medicine, so the pH value of the preparation solution of medicine is higher (9.8-10.5 ); although this invention carries out simple pretreatment to gac, experiment does not completely isolate gac and contact with S-pantoprazole sodium, desorption still can occur in gac
[0012] Chinese patent CN 103536563A freeze-dried powder injection of S-pantoprazole sodium composition for injection, the preparation process of the invention is very complicated, which is not conducive to the industrial production of the product; the auxiliary material chitosan nanoparticles used in the prescription process results in poor resolubility of the product , and the safety needs to be evaluated
This invention does not solve the problem of activated carbon desorption under alkaline conditions, and the problem of the influence of light on the stability of the preparation, and no solution is given

Method used

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  • (S)-Pantoprazole sodium lyophilized powder preparation for injection
  • (S)-Pantoprazole sodium lyophilized powder preparation for injection
  • (S)-Pantoprazole sodium lyophilized powder preparation for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0029]

[0030] Weigh 400g of sulfobutyl-β-cyclodextrin and place it in a preparation tank, add 15L of water for injection cold to below 20°C, stir to dissolve; then add the active ingredient S-pantoprazole sodium to it, stir for 15~ After 20 minutes, add water for injection below 20°C to 20L, and stir for 5 minutes. Using 0.22μm polyethersulfone material filter element to sterilize and filter, divide the liquid medicine into cillin bottles, half-filled with rubber stoppers, 2ml per bottle, and freeze-dry it.

Embodiment 2

[0032]

[0033] Weigh 800g glucosyl-β-cyclodextrin and place it in a preparation tank, add 15L of water for injection cold to below 20°C, stir to dissolve; then add the active ingredient S-pantoprazole sodium to it, and stir for 15~ After 20 minutes, add water for injection below 20°C to 20L, and stir for 5 minutes. Using 0.22μm polyethersulfone material filter element to sterilize and filter, divide the liquid medicine into cillin bottles, half-filled with rubber stoppers, 2ml per bottle, and freeze-dry it.

Embodiment 3

[0035]

[0036]

[0037] Weigh 1200g of hydroxypropyl-β-cyclodextrin and place it in a preparation tank, add 15L of water for injection cold to below 20°C, stir to dissolve; then add the active ingredient S-pantoprazole sodium to it, and stir for 15~ After 20 minutes, add water for injection below 20°C to 20L, and stir for 5 minutes. Using 0.22μm polyethersulfone material filter element to sterilize and filter, divide the liquid medicine into cillin bottles, half-filled with rubber stoppers, 2ml per bottle, and freeze-dry it.

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PUM

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Abstract

The invention relates to (S)-Pantoprazole sodium lyophilized powder preparation for injection, made from an active ingredient (S)-pantoprazole sodium, a stabilizer and a lyophilizing protectant, wherein the stabilizer is one of sulfobutyl ether-Beta-cyclodextrin, hydroxypropyl- Beta-cyclodextrin, and glucosyl-Beta-cyclodextrin. After the (S)-pantoprazole sodium lyophilized powder preparation for injection is placed for 24 months, R-configuration isomers are less than 0.3%; the number of insoluble microparticles is significantly decreased through optimization of a preparation process; the preparation process is simple and feasible and is suitable for industrial large-scale production.

Description

Technical field [0001] The invention relates to the field of medicine, in particular to a lyophilized powder preparation of Levopantoprazole sodium for injection. Background technique [0002] Gastric ulcer is one of the common and frequently-occurring diseases in the Chinese population. Its occurrence is mainly related to the imbalance between gastroduodenal mucosal damage factors and mucosal defense and repair factors. Helicobacter pylori (H. pylori) infection, non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin), and abnormal gastric acid secretion are common causes of ulcers. The typical ulcer pain has long-term, periodic and rhythmic characteristics. [0003] In the stomach cavity, gastric acid and pepsin are important digestive substances in gastric juice. Gastric acid is a strong acid substance, which is highly corrosive; pepsin has the function of hydrolyzing protein and can destroy the protein on the stomach wall. However, in the presence of these corrosive f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/61A61P1/04
Inventor 张贵民吕永超
Owner SHANDONG NEWTIME PHARMA
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