Lafutidine composition and preparation method thereof
A technology of lafutidine and its composition, which is applied in the field of lafutidine composition and its preparation, can solve the problems of small side effects, significant side effects, high market price, etc., achieve high bioavailability, simple preparation process, and effective quick effect
Active Publication Date: 2013-10-16
YOUCARE PHARMA GROUP
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Problems solved by technology
Although antacids are cheap, their curative effect is poor and their side effects are significant, so they are not suitable for long-term use; High; H 2 Among the receptor antagonists, cimetidine was the first to be used for peptic ulcer. It has a definite curative effect, but serious side effects may occur, so it is rarely used. Currently, ranitidine, famotidine, etc. are commonly used. , the curative effect is further improved than cimetidine, the side effects are less, and the price is much lower than that of proton pump inhibitors, so it is often used as the first choice in clinical practice
Method used
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preparation example Construction
[0086] In order to provide the basis for the preparation process, packaging and storage conditions of the lafutidine composition, the present invention has carried out influencing factor test, accelerated test and In a long-term test, the stability of the lafutidine composition was investigated with the appearance, dissolution rate, content and related substances as indicators.
[0087] The lafutidine compositions prepared in Example 1-4 of the present invention all have good stability. This experiment takes Example 1 as an example to list the stability data of the lafutidine composition.
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The present invention relates to an anti-peptic ulcer drug lafutidine composition and a preparation method thereof. The composition is prepared from the following components, by weight: 5-20% of lafutidine, 70-95% of a filler, 0-15% of a disintegrating agent, 0-5% of a lubricant, 0-5% of a surfactant, an appropriate amount of a binder, and 1-10% of a coating material. The preparation method is a wet granulation tableting method. The prepared lafutidine composition has characteristics of reliable quality, stable property, simple production process, meeting of requirements of large-scale preparation production, and low cost.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lafutidine composition and a preparation method thereof. Background technique [0002] Peptic ulcer is a common chronic and recurrent digestive system disease. It is the result of the invasive factors of the gastrointestinal mucosa exceeding the defense ability of the mucosa's own protective factors. Its incidence rate accounts for about 10% of the total population. Peptic ulcer can occur in any part of the gastrointestinal tract that is in contact with acidic gastric juice. The main diseased sites are the stomach and duodenum, with an incidence rate of 98%, and the number of patients with duodenal ulcer is far greater in patients with gastric ulcer. [0003] The formation of peptic ulcer is related to the digestion of gastric acid and pepsin, as well as the imbalance between the local mucosal damage (ulcerogenic) factors and mucosal protection (mucosal resistance) f...
Claims
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Login to View More IPC IPC(8): A61K9/36A61K9/42A61K31/4545A61P1/04
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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