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L-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection and preparation method thereof

A technology of lev-pantoprazole sodium and freeze-dried preparation is applied in the field of lev-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection and its preparation field, which can solve the problem that freeze-dried powder injection does not have sustained-release long-acting, Oral instability, gastric acid instability and other problems, to achieve the effect of stable properties, prolonging action time, and improving stability

Active Publication Date: 2020-04-17
HUNAN SAILONG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Because gastric acid is a strongly acidic substance, it has very strong erosiveness, and the oral preparation of levopantoprazole sodium on the market is unstable to gastric acid. In order to solve the problem of oral instability, the prior art discloses the preparation of levopantoprazole sodium Freeze-dried preparation for injection, for example CN103536563 discloses a kind of levopantoprazole sodium composition freeze-dried powder for injection, which is composed of levopantoprazole sodium, chitosan nanoparticles and water for injection, the freeze-dried The powder injection solves the problem of the stability of L-pantoprazole sodium freeze-dried powder injection, but the freeze-dried powder injection does not have a sustained-release and long-acting effect

Method used

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  • L-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection and preparation method thereof
  • L-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection and preparation method thereof
  • L-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection and preparation method thereof

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Experimental program
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Embodiment 1

[0044]

[0045]

Embodiment 2

[0047]

Embodiment 3

[0049]

[0050] The sodium chloride microparticles are prepared by the following method:

[0051] S11: dissolving 1.8g of sodium chloride and 0.15g of polyethylene glycol 400400 in 30mL of water to prepare an aqueous phase;

[0052] S12: dissolving the remaining 0.15 g of polyethylene glycol 400400 in 10 mL of ethanol to obtain an oil phase;

[0053] S13: Add the oil phase to the water phase, 5000r·min -1 stirring to form an emulsion;

[0054] S14: Add 3.7% formaldehyde solution to the emulsion prepared in step S13, solidify, centrifuge, wash with distilled water until there is no formaldehyde smell, filter with suction, and dry to prepare sodium chloride particles with a particle size range of 5 μm.

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Abstract

The invention provides an (S)-pantoprazole sodium long-acting microsphere freeze-dried preparation for injection. The microsphere freeze-dried preparation mainly consists of (S)-pantoprazole sodium, polymethyl methacrylate, polyvinyl acetate and sodium chloride microparticles; and microspheres are formed as the various components are combined. An acting duration of the (S)-pantoprazole sodium is longed; the prepared freeze-dried preparation is stable in performance; an in-vitro release degree test conforms to standard; and the freeze-dried preparation is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of microsphere freeze-drying, in particular to a long-acting microsphere freeze-dried preparation of L-pantoprazole sodium for injection and a preparation method thereof. Background technique [0002] Gastric ulcer is one of the common and frequently-occurring diseases, and its occurrence is mainly related to the imbalance between the damage of gastroduodenal mucosa and the self-defense repair of the mucosa. Helicobacter pylori (H. pylori) infection, non-steroidal anti-inflammatory drugs, and abnormal gastric acid secretion are common causes of ulcers. Typical ulcer pain has the characteristics of chronicity, periodicity and rhythmicity. [0003] Medicines to treat stomach ulcers fall into the following categories: [0004] 1. Drugs that inhibit gastric acid secretion: mainly include H2 receptor antagonists (cimetidine, ranitidine, etc.) and proton pump inhibitors (omeprazole sodium, lansoprazole, pantopra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/16A61K31/4439A61K47/32A61K47/02A61K47/10A61K47/12A61K47/26A61K47/36A61K47/20A61P1/04
CPCA61K9/0002A61K9/0019A61K9/1611A61K9/1635A61K9/1641A61K9/19A61K31/4439A61K47/12A61K47/20A61K47/26A61K47/36
Inventor 李剑峰周文
Owner HUNAN SAILONG PHARMA