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Esomeprazole magnesium sustained-release dropping pill and preparation method thereof

A technology of esomeprazole magnesium and sustained-release dripping pills, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of decreased bioavailability and out-of-control drug release time , increase in drug-related substances, etc.

Inactive Publication Date: 2008-09-24
北京博智绿洲医药科技有限公司
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  • Abstract
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  • Claims
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AI Technical Summary

Problems solved by technology

The analysis may be affected by factors such as the characteristics of the drug itself, the preparation method, and the external environment, which may cause variation in the structure of esomeprazole magnesium itself and the crystal form of the substance after the drop pill is formed, thereby increasing the number of drug-related substances and making the release The drug time is out of control, and the bioavailability decreases, so to a certain extent, it offsets the unique advantages of dripping pills

Method used

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  • Esomeprazole magnesium sustained-release dropping pill and preparation method thereof

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Embodiment Construction

[0032] First group:

[0033] Based on the total weight of 100g, weigh the base PEG4000 40%, PEG6000 10%, PEG10000 10%, stearic acid 11%, glyceryl monostearate 17%, stabilizer vitamin E 2%, raw material esomeprazole magnesium 10%; heat the substrate in a heating container and stir to melt it, add the corresponding proportion of esomeprazole magnesium, fully stir, and then add the stabilizer vitamin E and stir evenly, under the condition of heat preservation, it will melt or The mixed liquid medicine is dropped into a condensation column containing dimethyl silicone oil, where the temperature during heating and melting is 55°C, the temperature at the upper part of the condensate is 20°C, and the temperature at the bottom is -4°C; take it out after forming.

[0034] The resulting product has a cumulative release percentage of 33 to 56% in 2 hours, 61 to 83% in 6 hours, and 72 to 93% in 10 hours. There is no significant change in the assessment of related substances for 3 consecutive ...

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Abstract

The invention discloses a pharmaceutical preparation used for treating erosive reflux oesophagitis, a gastroesophageal reflux disease, maintaining a long-term therapy to prevent the recurrence of oesophagitis for a cured patient, controlling the symptoms of gastroesophageal reflux diseases, eradicating helicobacter pylori jointly medicated with an appropriate antimicrobial therapy, healing duodenal ulcer related to helicobacter pylori infections and preventing the recurrence of peptic ulcer related to helicobacter pylori, and particularly relates to a prepared sustained-release oral formulation adopting esomeprazole magnesium as the ingredient. The pharmaceutical preparation aims to supplement the deficiency of the prior art and provide a sustained-release esomeprazole magnesium dropping pill. The sustained-release esomeprazole magnesium dropping pill overcomes the defects in the prior art effectively, guarantees no occurrence of an obvious quality change for the drug during the effective storage period and has the advantages of controllable release time, full release and high bioavailability simultaneously.

Description

Technical field [0001] The present invention relates to a treatment for gastroesophageal reflux disease: treatment of erosive reflux esophagitis, long-term maintenance treatment for patients with cured esophagitis to prevent recurrence, and symptom control of gastroesophageal reflux disease; Combined with appropriate antibacterial therapies to eradicate Helicobacter pylori, heal duodenal ulcers associated with Helicobacter pylori infection, and prevent the recurrence of peptic ulcers associated with Helicobacter pylori, especially involving esomeprazole magnesium An oral sustained-release pharmaceutical preparation prepared as a raw material. Background technique [0002] Esomeprazole magnesium is the S-isomer of omeprazole. It reduces gastric acid secretion through a specific targeting mechanism and is a specific inhibitor of proton pumps in parietal cells. Used for gastroesophageal reflux disease: treatment of erosive reflux esophagitis, long-term maintenance treatment for pati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/4439A61K47/34A61P1/04A61K47/10
Inventor 彭晓云曲韵智强振君
Owner 北京博智绿洲医药科技有限公司
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