A kind of L-pantoprazole sodium freeze-dried powder preparation for injection

A technology for pantoprazole sodium and injection, which is applied in the field of medicine, can solve the problems of the stability of the preparation, the incomplete isolation of activated carbon, the safety to be evaluated, etc., and achieve the effect of reducing irritation and reducing the introduction of insoluble particles

Active Publication Date: 2021-02-09
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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  • A kind of L-pantoprazole sodium freeze-dried powder preparation for injection
  • A kind of L-pantoprazole sodium freeze-dried powder preparation for injection
  • A kind of L-pantoprazole sodium freeze-dried powder preparation for injection

Examples

Experimental program
Comparison scheme
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 cooled to below 20°C, stir and dissolve; then add the active ingredient S-pantoprazole sodium into it, and stir for 15~ After 20 minutes, add water for injection below 20°C to 20 L, and stir for 5 minutes. Use a 0.22 μm polyethersulfone material filter element to sterilize and filter, divide the drug solution into vials, half-fill with rubber stoppers, 2 ml per bottle, and freeze-dry to obtain the product.

Embodiment 2

[0032]

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

Embodiment 3

[0035]

[0036]

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

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PUM

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Abstract

The invention relates to a sterile freeze-dried powder of S-pantoprazole sodium for injection, comprising active ingredient S-pantoprazole sodium, a stabilizer, and a freeze-drying protective agent; wherein the stabilizer is sulfobutyl-β One of ‑cyclodextrin, hydroxypropyl‑β‑cyclodextrin, glucosyl‑β‑cyclodextrin. The R-configuration isomer of the product of the present invention is less than 0.3% after 24 months of storage; the number of insoluble particles is significantly reduced through the optimization of the preparation process; the preparation process of the present invention is simple and easy, and is suitable for industrial scale production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a freeze-dried powder preparation of levo-pantoprazole sodium for injection. Background technique [0002] Gastric ulcer is one of the common and frequently-occurring diseases among Chinese population. Its occurrence is mainly related to the imbalance between the damage factors of the gastroduodenal mucosa and the self-defense repair factors of the mucosa. Helicobacter pylori (H. pylori) infection, non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin), and abnormal gastric acid secretion are common causes of ulcers. Typical ulcer pain has the characteristics of chronicity, periodicity and rhythmicity. [0003] In the gastric cavity, gastric acid and pepsin are important digestive substances in gastric juice. Gastric acid is a strong acidic substance with strong erosiveness; pepsin has the effect of hydrolyzing protein and can destroy the protein on the stomach wall. However, ...

Claims

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Application Information

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