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Lansoprazole sustained-release drop pills and preparation method thereof

A technology of lansoprazole and sustained-release dropping pills, applied in the field of lansoprazole sustained-release dropping pills and its preparation, can solve the adverse effects of light, humidity and heat, high manufacturing and medical costs, and prone to allergic reactions To achieve the effect of ensuring the quality of medicines, low production costs, and benefiting labor protection and environmental protection

Active Publication Date: 2008-10-22
BEIJING JIUFA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the lansoprazole sodium preparation is an injection, and its existing problems are: it can only be injected, it cannot be taken orally, it is inconvenient to take, it is inconvenient to store and transport, and light, humidity and heat have adverse effects on the medicine, reducing the stability of the medicine , are also prone to allergic reactions or adverse reactions, etc., and there are also disadvantages such as difficult operation, great pain for patients, high manufacturing and medical costs, heavy economic burden for patients, and inconvenient use, which make its application also subject to certain restrictions. Therefore still be necessary to find a kind of not only convenient to use but also can take effect as soon as possible, the oral preparation of the lansoprazole of long acting time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Based on a total weight of 100g, take by weighing 40% of matrix PEG4000, 20% of PEG6000, 10% of PEG10000, 5% of stearic acid, 12% of glyceryl monostearate, 3% of vitamin E, and 10% of raw material lansoprazole; Put the base in a heating container to heat and stir to make it melt, add the corresponding proportion of lansoprazole, stir well, then add vitamin E and stir evenly, use a dropping pill machine, under the condition of heat preservation, put the melted or mixed medicine The liquid drops into the condensation column filled with simethicone oil, in which the temperature when heated and melted is 70°C, the temperature of the upper part of the condensate is 30°C, and the temperature of the bottom is -4°C; take it out after forming,

[0036] The obtained product has a 2-hour cumulative release percentage of 45%-57%, a 6-hour cumulative release percentage of 52%-74%, and a 10-hour cumulative release percentage of 86%-100%. The dissolution time limit is qualified and the...

Embodiment 2

[0038] In total weight 100g, take by weighing matrix PEG4000 30%, PEG6000 20%, PEG10000 18%, stearic acid 10%, vitamin E 2%, raw material lansoprazole 20%; Stir to make it melt, add the corresponding proportion of lansoprazole, stir fully, after the vitamin E is stirred evenly, use the dropping pill machine, under the condition of heat preservation, drop the molten or mixed liquid medicine into the container filled with simethicone oil. In the condensation column, the temperature when heating and melting is 65°C, the temperature of the upper part of the condensate is 35°C, and the temperature of the bottom is -1°C; take it out after forming,

[0039] The obtained product has a cumulative release percentage of 53%-67% in 2 hours, a cumulative release percentage of 65%-79% in 6 hours, and a cumulative release percentage of 83%-97% in 10 hours. The dissolution time limit is qualified and the roundness is good.

Embodiment 3

[0041]Based on the total weight of 100g, weigh the matrix PEG4000 40%, PEG6000 10%, sodium carboxymethyl starch 9%, stearic acid 10%, glyceryl monostearate 15%, vitamin E 1%, raw material lansoprazole 15%; put the matrix in a heating container and heat it and stir it to melt, add the corresponding proportion of lansoprazole, stir well, then add vitamin E and stir evenly, use a dropping pill machine, under the condition of heat preservation, melt the Or the mixed liquid medicine is dripped into the condensation column filled with liquid paraffin, wherein the temperature when heating and melting is 80°C, the temperature of the upper part of the condensate is 35°C, and the temperature of the bottom is 3°C; take it out after forming,

[0042] The obtained product has a cumulative release percentage of 50%-61% in 2 hours, a cumulative release percentage of 73%-87% in 6 hours, and a cumulative release percentage of 86%-100% in 10 hours. The dissolution time limit is qualified and the...

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PUM

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Abstract

The invention relates to an antiulcer drug Lansoprazole sustained-release preparation and a preparation method thereof; the invention aims at overcoming the defect of oral preparation and providing a Lansoprazole sustained-release pill for oral administration which is characterized by high bioavailability, rapid effect, long acting time, less times of oral administration, convenient application, less toxic and side effect and convenient storage and transportation, and the preparation method thereof. In particular, the Lansoprazole sustained-release pill is added with a stabilizing agent, Vitamin E, which prevents the occurrence of pill aging and leads the pill to be more stable.

Description

technical field [0001] The invention relates to a drug lansoprazole slow-release preparation for treating peptic ulcer and a preparation method thereof. Background technique [0002] Lansoprazole sodium is a C 16 h 14 f 3 N 3 o 2 The benzimidazole compound of S, the molecular weight is 369.37, and its chemical name is: 2-{[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl 〕sulfinyl}-1H-benzimidazole. [0003] Lansoprazole is the second proton pump inhibitor after omeprazole developed by Takeda Corporation of Japan. It was first launched in France in 1992 and is clinically used for duodenal ulcer, gastric ulcer and reflux disease The treatment of esophagitis and Zollinger-Ellison syndrome (gastrinoma) has remarkable curative effect, and has inhibitory effect on Helicobacter pylori. [0004] Lansoprazole is an effective acid pump inhibitor, it acts on the H+-K+-ATPase of the gastric parietal cells, so that the H+ of the parietal cells cannot be transported to the sto...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22
Inventor 曲韵智
Owner BEIJING JIUFA PHARMA
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