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Lyophilized preparation of D-sodium lansoprazole, and preparation method thereof

A technology of dexlansoprazole sodium and freeze-dried preparations, applied in the field of pharmaceutical preparations, can solve problems such as carcinogenicity and toxic side effects, and achieve the effects of small toxic and side effects, high bioavailability, and stable products

Inactive Publication Date: 2013-09-18
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because hypromell-β-cyclodextrin is rarely used in injections, and some data show that this excipient has certain nephrotoxicity, hemolysis, and carcinogenicity, and there may be unknown and more serious side effects

Method used

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  • Lyophilized preparation of D-sodium lansoprazole, and preparation method thereof
  • Lyophilized preparation of D-sodium lansoprazole, and preparation method thereof
  • Lyophilized preparation of D-sodium lansoprazole, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Prescription:

[0026]

[0027]

[0028] Preparation:

[0029] (1) Take 80% of the prescribed amount of water for injection, and dissolve the prescribed amount of mannitol, meglumine, and sodium biphosphite;

[0030] (2) Adjust the pH value of the solution to 10.5-12.0 with 1M sodium hydroxide solution;

[0031] (3) Ice bath the above solution to ensure that the temperature of the solution is within the range of 10°C-20°C;

[0032] (4) Add the prescribed amount of dexlansoprazole sodium and stir to dissolve;

[0033] (5) Dilute to the total volume with water for injection;

[0034] (6) Add 0.05% activated carbon, stir at room temperature for 20 minutes, filter and decarburize;

[0035] (7) Intermediate detection (pH value, content);

[0036] (8) Filling, freeze-drying and filling with nitrogen;

[0037] (9) PACKAGING.

[0038] Quality Evaluation:

[0039]

Embodiment 2

[0041] Prescription:

[0042]

[0043] Preparation:

[0044] (1) Take 80% of the prescribed amount of water for injection, and dissolve the prescribed amount of mannitol, meglumine, and sodium biphosphite;

[0045] (2) Adjust the pH value of the solution to 10.5-12.0 with 1M sodium hydroxide solution;

[0046] (3) Ice bath the above solution to ensure that the temperature of the solution is within the range of 10°C-20°C;

[0047] (4) Add the prescribed amount of dexlansoprazole sodium and stir to dissolve;

[0048] (5) Dilute to the total volume with water for injection;

[0049] (6) Add 0.05% activated carbon, stir at room temperature for 20 minutes, filter and decarburize;

[0050] (7) Intermediate detection (pH value, content);

[0051] (8) Filling, freeze-drying and filling with nitrogen;

[0052] (9) PACKAGING.

[0053] Quality Evaluation:

[0054] .

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PUM

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Abstract

The invention relates to a lyophilized preparation of D-sodium lansoprazole, and a preparation method thereof. The lyophilized preparation is prepared from D-sodium lansoprazole, mannitol, sodium hydroxide, meglumine and sodium hydrogen phosphate. The defects of low content of the traditional lansoprazole main drug for injection, high impurity and instability of the main drug are overcome by the constituents. The lyophilized preparation is simple in preparation technology; the obtained D-sodium lansoprazole for injection is loose, plump and intact in appearance, good in stability and high in safety, and has development value.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. The invention relates to a freeze-dried preparation of dexlansoprazole sodium and a preparation method thereof. The dexlansoprazole sodium prepared by the invention is clinically used for treating reflux esophagitis, gastric ulcer, duodenal ulcer and the like. Background technique [0002] Lansoprazole (lansoprazole) is the world's second proton pump inhibitor anti-ulcer drug developed by Takeda. It was put on the market in 1992 and was approved to go on the market in the United States in June 2004. Lansoprazole inhibits the proton pump of gastric parietal cells and inhibits H + 、K + -ATPase activity that makes parietal cell H + It cannot be transported to the stomach, thereby continuously inhibiting the secretion of gastric acid and pepsin. Lansoprazole introduces fluorine into the 4-position side chain of the pyridine ring, and has a trifluoroethoxy substituent, which improves i...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K47/04A61K31/4439A61P1/04
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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