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Lansoprazole crystalline compound, enteric capsule thereof and preparation method of Lansoprazole crystalline compound

A kind of technology of lansoprazole and crude product of lansoprazole, which is applied in the field of medicine, can solve problems such as poor stability of lansoprazole, and achieve the effects of improving drug safety, good dissolution stability and good stability

Active Publication Date: 2012-07-11
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Yet above-mentioned patent application does not fundamentally solve the problem of the poor stability of lansoprazole

Method used

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  • Lansoprazole crystalline compound, enteric capsule thereof and preparation method of Lansoprazole crystalline compound
  • Lansoprazole crystalline compound, enteric capsule thereof and preparation method of Lansoprazole crystalline compound
  • Lansoprazole crystalline compound, enteric capsule thereof and preparation method of Lansoprazole crystalline compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Get the crude product of lansoprazole, add volume and be that the volume ratio of 13 times of the crude product of lansoprazole is the acetone of 6: 3: 1: ethyl acetate: methanol solution, be heated to reflux; After the crude product of lansoprazole dissolves clear, Adding weight is that lansoprazole crude product weight 0.5 times active carbon decolorization 30min, microporous membrane filtration, under stirring, to filtrate drips the sherwood oil that volume is lansoprazole crude product weight 1.3 times, described stirring is 38rmp, described Dropping is to control the dropping time for 5 minutes and drop at a constant speed; after dropping, stir and cool down. The stirring and cooling is to cool down to 38°C for 10 minutes under stirring at a rotating speed of 18rmp, and then cool down to 17°C for 15min under stirring at a rotating speed of 13rmp, and stand for 18-20 minutes. hour, filter, with 6: 4 methanol: sherwood oil solution washing 2 times, each methanol: sher...

Embodiment 2

[0044] Get the crude product of lansoprazole, add volume and be that the volume ratio of 13 times of the crude product of lansoprazole is the acetone of 6: 3: 1: ethyl acetate: methanol solution, be heated to reflux; After the crude product of lansoprazole dissolves clear, Adding weight is that lansoprazole crude product weight 0.4 times active carbon decolorization 20min, microporous membrane filtration, under stirring, to filtrate drips the sherwood oil that volume is lansoprazole crude product weight 1.3 times, described stirring is 35rmp, described Dropping is to control the dropping time for 4 minutes and drop at a constant speed; after dropping, stir and cool down. The stirring and cooling is to cool down to 38°C for 40 minutes under stirring at a rotating speed of 20rmp, and then cool down to 18°C ​​for 15min under stirring at a rotating speed of 14rmp, and stand for 18-20 minutes. hour, filter, with 6: 4 methanol: sherwood oil solution washing 2 times, each methanol: sh...

Embodiment 3

[0047] Get the crude product of lansoprazole, add volume and be that the volume ratio of 15 times of the crude product of lansoprazole is the acetone of 6: 3: 1: ethyl acetate: methanol solution, be heated to reflux; After the crude product of lansoprazole dissolves clear, Adding weight is that lansoprazole crude product weight 0.5 times active carbon decolorization 30min, microporous membrane filtration, under stirring, to filtrate drips the sherwood oil that volume is lansoprazole crude product weight 1.2 times, described stirring is 38rmp, described Dropping is to control the dropping time for 5 minutes and drop at a constant speed; after dropping, stir and cool down. The stirring and cooling is to cool down to 38°C for 10 minutes under stirring at a rotating speed of 18rmp, and then cool down to 17°C for 15min under stirring at a rotating speed of 13rmp, and stand for 18-20 minutes. hour, filter, with 6: 4 methanol: sherwood oil solution washing 2 times, each methanol: sher...

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Abstract

The invention relates to a lansoprazole crystalline compound. An X-ray powder diffraction pattern represented by a diffraction angle of 2 theta + / - 0.2 DEG displays feature diffraction peaks at the positions of 5.8 DEG, 7.5 DEG, 9.1 DEG, 11.8 DEG, 12.1 DEG, 12.8 DEG, 13.3 DEG, 15.6 DEG, 16.7 DEG, 18.3 DEG, 20.4 DEG, 25.7 DEG, 26.8 DEG and 31.5 DEG. The invention also relates to a lansoprazole enteric capsule containing the lansoprazole crystalline compound. The lansoprazole enteric capsule comprises 20 to 60 parts of l crystalline compound, 90 to 140 parts of microcrystalline cellulose, 1.5 to 3.5 parts of disodium hydrogen phosphate, 2 to 5 parts of anhydrous sodium sulphite, 1 to 10 parts of crospovidone, 0.8 to 4.2 parts of lauryl sodium sulfate, 2 to 8 parts of povidone K30 and 1 to 3 parts of magnesium stearate.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a lansoprazole crystalline compound, an enteric-coated capsule, and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole) is a new generation of proton pump inhibitors, which has a significant inhibitory effect on gastric acid secretion. H + -K + -ATPase, which makes H in parietal cells + It cannot be transported to the stomach, so that the amount of gastric acid in the gastric juice is greatly reduced. It is clinically used in the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma), with remarkable curative effect, and it also has inhibitory effect on Helicobacter pylori. [0003] Patent application 200610029942.8 discloses a preparation method of lansoprazole enteric-coated capsules, which includes taking 20-30 g of lansoprazole raw materials of 0-100 microns, 80-150 g of microcrystalline cellu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61K9/48A61P1/04
Inventor 马鹰军钟正明王小树罗韬
Owner HAINAN JINRUI PHARMA CO LTD
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