Pantoprazole sodium enteric coatel tablet composition and preparation method thereof

Abstract

The invention relates to a pantoprazole sodium enteric coatel tablet composition and a preparation method thereof. The composition is characterized by consisting of a proton pump inhibitor pantoprazole sodium and a gastrointestinal excitomotor itopride hydrochloride. The composition is used for treating gastric ulcer, gastroesophageal reflux diseases and functional dyspepsia. In the combined preparation, the weight ratio of pantoprazole sodium and itopride hydrochloride is (2:5)(-2:10). Compared with a single component preparation, the cure rate is relatively increased remarkably, the occurrence rate of untoward effect is greatly reduced, and the symptom recurrence rate is remarkably reduced. The composition has important effect of treating gastric ulcer, gastroesophageal reflux diseases and functional dyspepsia, and is simple and convenient in preparation method, low in cost, suitable for oral administration of patients and good in compliance.

Description

Technical field [0001] The invention belongs to the field of oral pharmaceutical compositions, and particularly relates to a proton pump inhibitor pantoprazole sodium enteric-coated tablet composition and a preparation method thereof. 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 hype...

AI Technical Summary

Problems solved by technology

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

[0018] 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 agents alone; but there are some side effects after the combination

Combined with test results on the basis of references, it is shown that the composition of pantoprazole sodium and etopride hydrochloride is more definite in curative effect than using proton pump alone and using etopride hydrochloride alone, and the cure rate is obviously increased. Disadvantages of higher relapse rates when pump inhibitors are used in combination with domperidone, cisapride, and mosapride

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