A kind of 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 significant side effects, small side effects, and high market price, and achieve simple preparation process, high bioavailability, and effective quick effect
Active Publication Date: 2017-11-03
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 a basis for the preparation process, packaging and storage conditions of the Lafutidine composition, the present invention carried out influencing factor tests, accelerated tests and tests on the Lafutidine composition (specification 5 mg: batch number 040502; specification 10 mg: batch number 040503). In the long-term test, the stability of the Lafutidine composition was investigated using appearance properties, dissolution, content, and related substances as indicators.
[0087] Lafutidine compositions prepared in Examples 1 to 4 of the present invention have good stability. This experiment lists the stability data of Lafutidine compositions using Example 1 as an example.
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The invention relates to an anti-peptic ulcer drug lafutidine composition and a preparation method thereof. The lafutidine composition is prepared from the following components in the following weight percentages: lafutidine: 5-20%; filler: 70-95%; disintegrant: 0-15%; lubricant: 0-15% 5%; surfactant: 0‑5%; appropriate amount of binder; coating material: 1‑10%. The preparation method is wet granulation and tabletting. The lafutidine composition prepared by the invention has reliable quality, stable properties, simple production process, meets the requirements of large-scale production of preparations and is low in 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 invasion factors of the gastrointestinal mucosa exceeding the defensive ability of the mucosa's own protective factors. Its incidence is 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 sites of disease are the stomach and duodenum. The incidence rate is 98%. Among them, the number of patients with duodenal ulcer is far For patients with gastric ulcer. [0003] The formation of peptic ulcer is related to the digestive effects of gastric acid and pepsin, as well as the loss of balance between gastric and duodenal mucosal damage (ulcer-causing) factors and mucosal protection (mucosal resista...
Claims
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IPC IPC(8): A61K9/36A61K9/42A61K31/4545A61P1/04
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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