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Medicine for treating gastroesophageal reflux disease and functional dyspepsia

A technology for gastroesophageal reflux and dyspepsia, which is applied in the field of drugs for the treatment of gastroesophageal reflux disease and functional dyspepsia. Less, well-tolerated effect

Inactive Publication Date: 2008-03-19
沈阳东宇药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages of this patent: Domperidone has a narrow pharmacological action and therapeutic range, and has side effects of increasing prolactin levels, while the bioavailability of omeprazole is low, which limits the wide application of this preparation
Disadvantages of this patent: it is a relatively simple combination preparation, the number of administrations is frequent, and the phenomenon of "peak and valley" of blood drug concentration is easy to occur after taking the medicine, and the safety is poor, so it is not suitable for patients with long-term administration
Disadvantages of this patent: Although this combination drug can improve diarrhea, abdominal cramps and borborygmi; fatigue, headache, cardiac depression, increased systolic blood pressure, increased heart rate, nerve and CNS effects, but it can also cause obvious arrhythmia
[0022] In 2003, the application number 03120970.X of Beijing Dongfang Kane Pharmaceutical Technology Co., Ltd. was applied for the patent "Use of Gastrointestinal Motility Drugs in the Preparation of Colon-localized Pharmaceutical Compositions", which relates to a combination drug for treating constipation, which is characterized in that it It is composed of 0.1% to 90% of gastrointestinal motility drugs. The disadvantage of this patent is that the colon-directed preparation is better than the common preparation for the treatment of constipation, but the colon-directed preparation does not show its superiority in the treatment of gastroesophageal reflux disease and functional dyspepsia. sex
[0027] In 2002, the patent No. 00806999.9 applied by Sepraco Co., Ltd. was published, "Combined application of norcisapride and proton pump inhibitor or H 2 - methods and compositions of receptor antagonists", relating to methods and compositions for preventing, treating or controlling gastrointestinal diseases or their symptoms, which use two or more agents or compounds to provide anti-5-HT 3 Receptor, 5-HT 4 receptor, and at least one H 2 The triple action of receptors and proton pumps, the disadvantage of this patent is that side effects such as arrhythmia of cisapride greatly limit its application
However, there are still some problems: ① When choosing gastric motility agents, choose domperidone, cisapride and mosapride. agent or use the above gastric motility agent alone; but there are some side effects in combination
In addition, when using itopride alone to treat functional dyspepsia, the adverse reactions of short-term administration are slight, but when it is used for a long time, there are more adverse reactions than that of short-term administration, which seriously affects the long-term use of administration and brings inconvenience to the treatment of seriously ill patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0080] The preparation method of the combined preparation for treating gastroesophageal reflux disease and functional dyspepsia includes the following steps:

[0081] (1) The proton pump inhibitor is made into a solid dosage unit, which has an enteric effect;

[0082] (2) The gastrointestinal motility agent Etopride is made into a solid dosage unit, which has a slow and controlled release effect;

[0083] (3) The solid dosage units of the two active substances can be of the same color or different colors. They can be mixed according to the dosage required for treatment and then filled into capsules or tablets or fixed packaging units to achieve the therapeutic effect.

[0084] The solid dosage unit may be a pill (pill), microtablet, granule, tablet, etc., which are well known in the art according to the situation.

[0085] The proton pump inhibitor is chemically unstable to acid. In the present invention, the proton pump inhibitor is made into an enteric-coated solid dosage unit. ...

Embodiment 1

[0101] Prescription: Pantoprazole 40mg, Etopride Hydrochloride 100mg.

Embodiment 2

[0103] Prescription: Omeprazole 20mg, Etopride hydrochloride 100mg.

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Abstract

A combination preparation for remedying the gastroesophageal reflux disease (GERD) and the functional dyspepsia is characterized in that the prescription of the combination preparation consists of a proton pump depressor and a gastrointestinal power drug of itopride; the proton pump depressor is selected from one of a Pantoprazole, a Omeprazole, a Esomeprazole, a Lansoprazole, a Rabeprazole, a Tenatoprazole and a Leminorazole, wherein the Pantoprazole is preferential, and at the same time the neutral form of the basic salt of the proton pump depressor is also included, such as Naplus, Mg2plus, Ca2plus, Kplus or Li plus salt and a pure optical stereoisomer of the proton pump depressor or an active metabolite of the proton pump depressor; the gastrointestinal power drug is the itopride and a ramification of the itopride or one of the medicinal salts of the itopride; in the combination preparation, the weight ratio of the Pantoprazole and the itopride is 2 to 5 to 2 to 7. The invention has important affect for remedying the gastroesophageal reflux disease and the functional dyspepsia, and the preparation method of the invention is simple and convenient; the cost is low; the invention is fit for being orally taken by the patient; the invention has good conformance performance, high curative effect, low recrudescence rate and little adverse reaction.

Description

Technical field [0001] The invention belongs to an oral medicinal composition, and particularly relates to a medicine for treating gastroesophageal reflux disease (GERD) and functional dyspepsia. Background technique [0002] The World Health Organization survey shows that 80% of people in my country suffer from gastrointestinal diseases of varying degrees, ranking first in the world. In my country’s social population, nearly 10% suffer from gastric ulcers and nearly 30% suffer from various types of gastritis. At present, the total number of gastric patients in the country is roughly 300 million, and 40 of them are % Of people are seriously ill. [0003] Gastrointestinal diseases are common diseases that affect the gastrointestinal tract, namely the stomach and intestines. More common gastrointestinal diseases include: gastroesophageal reflux disease, vomiting, gastrointestinal motility dysfunction, gastrointestinal ulcers, pathological hypersecretion and hyperacidity. [0004] A...

Claims

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Application Information

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IPC IPC(8): A61K31/39A61K9/10A61K9/16A61K9/20A61K9/48A61P1/14A61P1/04
Inventor 王瑞杰沈振宏李春茹邱卫华殷莉莉
Owner 沈阳东宇药业有限公司
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