Lansoprazole special superfine powder freeze-dried preparation and preparing method thereof

A technology of lansoprazole and ultra-fine powder, applied in the field of medicine, can solve the problems of low purity, poor stability, easy allergy and the like

Inactive Publication Date: 2015-01-28
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing lansoprazole freeze-dried powder preparations have shortcomings such as low purity, many impurities, poor stability, large particles, poor solubility, large toxic and side effects, and easy allergies

Method used

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  • Lansoprazole special superfine powder freeze-dried preparation and preparing method thereof
  • Lansoprazole special superfine powder freeze-dried preparation and preparing method thereof
  • Lansoprazole special superfine powder freeze-dried preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Mix 300 grams of commercially available lansoprazole crude product (purity 96.5%) and 1500 grams (1900 ml) of absolute ethanol, heat up to 40°C, heat and stir for 40 minutes until the material is completely dissolved, add 15 grams of activated carbon for decolorization for 40 minutes, Remove activated carbon by hot filtration, add 900ml of water for injection dropwise, cool down to 15°C after adding, and keep warm for 3 hours to obtain a white solid precipitate, filter, and rinse the filter cake with 150g (190ml) of absolute ethanol each time, rinse 3 times , to obtain the refined wet product of lansoprazole by suction filtration. Vacuum drying at a temperature of 25° C. for 6 hours gave 271 grams of lansoprazole fine product with a purity of 99.8%.

[0028] The dried lansoprazole refined product is pulverized into superfine powder with two-stage counter-jet jet milling device. The specific process of ultra-fine grinding is as follows: the dry lansoprazole product is p...

Embodiment 2

[0031] Mix 300 grams of commercially available lansoprazole crude product (purity 96.5%) and 1650 grams (2090 ml) of absolute ethanol, heat up to 38 ° C, keep stirring for 30 minutes until the material is completely dissolved, add 22.5 grams of activated carbon and decolorize for 30 minutes, Remove activated carbon by hot filtration, add 1050ml of water for injection dropwise, cool down to 12°C after adding, and keep warm for 3 hours to obtain a white solid precipitate, filter, and rinse the filter cake with 225 grams (285ml) of absolute ethanol each time, rinse twice , to obtain the refined wet product of lansoprazole by suction filtration. Vacuum-dried at 30 DEG C for 5 hours to obtain 270 grams of lansoprazole fine product with a purity of 99.9%.

[0032] The dried lansoprazole refined product is pulverized into superfine powder with two-stage counter-jet jet milling device. The specific process of ultra-fine grinding is as follows: the dry lansoprazole product is passed t...

Embodiment 3

[0035] Mix 300 grams of commercially available lansoprazole crude product (purity 96.5%) and 1800 grams (2280 ml) of absolute ethanol, heat up to 37 ° C, keep stirring for 35 minutes until the material is completely dissolved, add 30 grams of activated carbon and keep it warm for 35 minutes to decolorize. Remove activated carbon by hot filtration, add 1200ml of water for injection dropwise, cool down to 10°C after adding, and keep warm for 2.5 hours to obtain a white solid precipitate, filter, and rinse the filter cake with 300g (380ml) of absolute ethanol each time, rinse twice , to obtain the refined wet product of lansoprazole by suction filtration. Vacuum drying for 4 hours at a temperature of 35°C gave 269 grams of lansoprazole fine product with a purity of 99.9%.

[0036] The dried lansoprazole refined product is pulverized into superfine powder with two-stage counter-jet jet milling device. The specific process of ultra-fine grinding is as follows: the dry lansoprazole...

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Abstract

The invention discloses a lansoprazole special superfine powder freeze-dried preparation and a preparing method thereof. The method comprises the following steps: step 1, mixing a lansoprazole crude product and anhydrous ethanol, heating and stirring to dissolve, decolorizing with activated carbon, carrying out heat filtration to remove activated carbon, dropwise adding water for injection, carrying out cooling crystallization, filtering, leaching the filter cake with anhydrous ethanol, carrying out suction filtration, carrying out vacuum drying, and thus obtaining a lansoprazole refined product; step 2, smashing the dried lansoprazole refined product with gas flow into a superfine powder; and step 3, dissolving the lansoprazole superfine powder in water for injection, dropwise adding a sodium hydroxide solution to regulate a pH value, adding an auxiliary material, stirring evenly, fixing volume, filling, freeze-drying, and thus obtaining the lansoprazole special superfine powder freeze-dried preparation. The lansoprazole special superfine powder freeze-dried preparation has the advantages of high purity, less impurity, high stability, small particles, good solubility, small toxic and side effects, difficult irritability and the like.

Description

technical field [0001] The invention relates to a lansoprazole freeze-dried preparation and a preparation method thereof, in particular to a lansoprazole special ultrafine powder freeze-dry preparation and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Lansoprazole, its chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl-1H-benzene And imidazole. Molecular formula: C 16 h 14 f 3 N 3 o 2 S, molecular weight: 369.36, chemical structural formula as follows: [0003] [0004] This product is white or off-white crystalline powder. Lansoprazole is used to treat gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome (gastrinoma), etc. Lansoprazole is a proton pump inhibitor. After the drug is distributed in the acidic environment of the parietal cells of the gastric mucosa, it is transformed into active metabolites. This metabolite binds to the sulfhydryl grou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61K47/18A61P1/04A61P35/00
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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