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Dextral lansoprazole freeze-drying preparation and preparation method thereof

A technology of dexlansoprazole sodium and freeze-dried preparations, which is applied in the field of pharmaceutical preparations to achieve the effects of enhancing convenience and safety, good resolubility and solution stability

Inactive Publication Date: 2013-02-06
NANJING YOKO PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

另外,CN101804035A、CN101313895A、CN101502493A、CN101829065A、CN102451181A、CN102151265A、CN102302463A、CN102512381A、CN102552181A、CN102600088A、CN101129368A等专利公开了兰索拉唑的注射剂型的处方和制备工艺,但是这些处方无一例外地都以甘露 Alcohol as an excipient, but mannitol as an excipient has the risks mentioned above

Method used

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  • Dextral lansoprazole freeze-drying preparation and preparation method thereof
  • Dextral lansoprazole freeze-drying preparation and preparation method thereof
  • Dextral lansoprazole freeze-drying preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 dexlansoprazole sodium freeze-dried preparation

[0021] Prescription 1

[0022]

[0023]

[0024] Preparation:

[0025] (1) Take about 140ml of water for injection, add 3.0g of hydroxypropyl-β-cyclodextrin, stir until completely dissolved, add 1mol / L sodium hydroxide solution, cool down to 10°C, and adjust the pH to about 11.0;

[0026] (2) Add 3.0 g of dexlansoprazole sodium raw material again, stir until fully dissolved, and make up water for injection to 200 ml;

[0027] (3) Add 0.05% activated carbon for needles, stir at room temperature for 15min to 30min, coarsely filter out carbon with a titanium rod, filter with a 0.45μm filter membrane, and fine filter with two 0.22μm filter membranes. degree, content, pH, endotoxin), filled after passing the test, and freeze-dried in a freeze dryer (LGJ-18S freeze dryer, Beijing Songyuan Huaxing Technology Development Co., Ltd., the same below).

Embodiment 2

[0028] Embodiment 2 dexlansoprazole sodium freeze-dried preparation

[0029] Prescription 2

[0030]

[0031] Preparation:

[0032] (1) Take about 140ml of water for injection, add 6.0g of hydroxypropyl-β-cyclodextrin, stir until completely dissolved, add 1.5mol / L sodium carbonate solution, cool down to 15°C, and adjust the pH to about 11.5;

[0033] (2) Then add 3.0g of dexlansoprazole sodium raw material, stir until completely dissolved, and add water for injection to 200ml;

[0034] (3) Add 0.05% activated carbon for needles, stir at room temperature for 15min to 30min, remove carbon by coarse filtration with titanium rod, filter with 0.45μm filter membrane, and fine filter with two 0.22μm filter membranes. degree, content, pH, endotoxin), filled after passing the test, and freeze-dried in a freeze dryer.

Embodiment 3

[0035] Embodiment 3 dexlansoprazole sodium freeze-dried preparation

[0036] Prescription 3

[0037]

[0038] Preparation:

[0039] (1) Take about 140ml of water for injection, add 12.0g of hydroxypropyl-β-cyclodextrin, stir until completely dissolved, add 1mol / L sodium hydroxide solution, cool down to 15°C, and adjust the pH to about 11.5;

[0040] (2) Then add 3.0g of dexlansoprazole sodium raw material, stir until completely dissolved, and add water for injection to 200ml;

[0041] (3) Add 0.05% activated carbon for needles, stir at room temperature for 15min to 30min, remove carbon by coarse filtration with titanium rod, filter with 0.45μm filter membrane, and fine filter with two 0.22μm filter membranes. degree, content, pH, endotoxin), filled after passing the test, and freeze-dried in a freeze dryer.

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Abstract

The invention relates to a dextral lansoprazole freeze-drying preparation, which comprises the following components: dextral lansoprazole, Hydroxypropyl-Beta-Cyclodextrin and PH modifier. The invention also provides a preparation method for the freeze-drying preparation. The freeze-drying preparation obtained according to the technical scheme of the invention can maintain better redissolving performance and solution stability, and enhance the convenience and security of clinical application; and furthermore, the Hydroxypropyl-Beta-Cyclodextrin used in the preparation method plays the function of stabilizer and excipient, that is, on one hand, the racemization of the dextral lansoprazole is effectively reduced, and on the other hand, the freeze-drying preparation obtained through the preparation method is loose, full and integral in appearance and is suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried preparation of dexlansoprazole sodium and a preparation method of the freeze-dried preparation. Background technique [0002] Lansoprazole (Lansoprazole, Cas No.: 103577-45-3) is a benzimidazole derivative with gastric acid secretion inhibitory effect developed by Takeda Pharmaceutical Company in Japan. It was first synthesized by Nohara Akira et al. in 1986, and passed Clinical experiments have proved that the compound has the characteristics of anti-ulcer activity, control of gastric acid secretion, protection of gastric mucosa, and low toxicity. It was first listed in Japan in 1992. The chemical name of lansoprazole is 2-[3-methyl-4-(2,2,2-trifluoroethyl)-2-pyridyl]-methylsulfinyl-1H-benzimidazole, which has The chemical structure shown in formula (Lansoprazo]e). [0003] [0004] Akira et al first disclosed the chemical structure and preparation ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 薛峪泉杨勇包玉胜张峰晁阳叶海
Owner NANJING YOKO PHARMA GRP CO LTD
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