Lyophilized preparation employing right-handed lansoprazole as active ingredient and preparation method of lyophilized preparation

A technology of dexlansoprazole and freeze-dried preparations, which is applied in the field of medicine, can solve problems such as instability, and achieve the effects of good stability and simple preparation process

Inactive Publication Date: 2015-07-08
FUJIAN INST OF MICROBIOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN103301078A discloses the injection of dexlansoprazole, including dexlansoprazole, mannitol, sodium hydroxide, meglumine, sodium biphosphite, wherein the effect of adding meglumine is to prevent the pH value of the solution from However, studies have shown that meglumine generally can only be maintained within 4 hours without crystallization, so this kind of injection is not stable

Method used

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  • Lyophilized preparation employing right-handed lansoprazole as active ingredient and preparation method of lyophilized preparation
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  • Lyophilized preparation employing right-handed lansoprazole as active ingredient and preparation method of lyophilized preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription:

[0023]

[0024] Preparation:

[0025] (1) Take 80% of the prescribed amount of water for injection, and dissolve the prescribed amount of mannitol and polyethylene glycol 400;

[0026] (2) Adjust the pH value of the solution to between 10.0 and 12.0 with sodium hydroxide solution;

[0027] (3) The above solution is placed in an ice bath to ensure that the temperature of the solution is within the range of 5°C to 20°C;

[0028] (4) Add the prescribed amount of dexlansoprazole and stir to dissolve;

[0029] (5) Dilute to the total volume with water for injection, add activated carbon, stir at room temperature for 30 minutes, filter and decarburize;

[0030] (6) After the intermediates pass the test, they are filled, freeze-dried, filled with nitrogen, and packaged.

[0031] Quality Evaluation:

[0032]

Embodiment 2

[0034] prescription:

[0035]

[0036] Preparation:

[0037] (1) Take 80% of the prescribed amount of water for injection, and dissolve the prescribed amount of mannitol and polyethylene glycol 400;

[0038] (2) Adjust the pH value of the solution to between 10.0 and 12.0 with sodium hydroxide solution;

[0039] (3) The above solution is placed in an ice bath to ensure that the temperature of the solution is within the range of 5°C to 20°C;

[0040] (4) Add the prescribed amount of dexlansoprazole and stir to dissolve;

[0041] (5) Dilute to the total volume with water for injection, add activated carbon, stir at room temperature for 30 minutes, filter and decarburize;

[0042] (6) After the intermediates pass the test, they are filled, freeze-dried, filled with nitrogen, and packaged.

[0043] Quality Evaluation:

[0044]

Embodiment 3

[0046] prescription:

[0047]

[0048] Preparation:

[0049] (1) Take 80% of the prescribed amount of water for injection, and dissolve the prescribed amount of mannitol and polyethylene glycol 400;

[0050] (2) Adjust the pH value of the solution to between 10.0 and 12.0 with sodium hydroxide solution;

[0051] (3) The above solution is placed in an ice bath to ensure that the temperature of the solution is within the range of 5°C to 20°C;

[0052] (4) Add the prescribed amount of dexlansoprazole and stir to dissolve;

[0053] (5) Dilute to the total volume with water for injection, add activated carbon, stir at room temperature for 30 minutes, filter and decarburize;

[0054] (6) After the intermediates pass the test, they are filled, freeze-dried, filled with nitrogen, and packaged.

[0055] Quality Evaluation:

[0056]

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PUM

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Abstract

The invention discloses a lyophilized preparation employing right-handed lansoprazole as an active ingredient and a preparation method of the lyophilized preparation. The lyophilized preparation is mainly prepared from right-handed lansoprazole, polyethylene glycol 400, mannitol and sodium hydroxide, and has the advantages of being simple in preparation technology, good in stability and suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a freeze-dried preparation with D-lansoprazole as an active ingredient and a preparation method thereof. Background technique [0002] Lansoprazole is a benzimidazole derivative with gastric acid secretion inhibitory effect developed by Japan's Takeda Pharmaceutical Company. It was first synthesized by Nohara Akira et al. in 1986, and clinical experiments have proved that the compound has anti-ulcer activity and controls gastric acid secretion. , protection of gastric mucosa, and low toxicity, it was first listed in Japan in 1992. In June 2004, it was approved to go on the market in the United States. Lansoprazole introduces fluorine into the 4-position side chain of the pyridine ring, and has a trifluoroethoxy substituent, which improves its bioavailability by more than 30% compared with omeprazole, and its lipophilicity is also stronger than that of omeprazole. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/34A61K47/10A61K47/04A61P1/04
Inventor 王娟肖丽华陈忠魏宗有傅慧灵陈宇翔
Owner FUJIAN INST OF MICROBIOLOGY
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