Lafutidine lyophilized powder injection and preparing method thereof

Abstract

The invention relates to lafutidine freeze-dried injection, which can treat gastric ulcer, duodenal ulcer and ulcer on the anastomosed part. The lafutidine freeze-dried injection is composed of lafutidine and mannitol, wherein, the mass ratio of the lafutidine and the mannitol is 1 : 10 to 100; the preferable mass ratio is 1 : 20 to 50; and one or the mixture of sodium chloride and citrate can be added into the lafutidine freeze-dried injection so as to prevent the medicine bottle from exploding in the process of freeze-drying the lafutidine freeze-dried injection. The preparation processes are as following: the lafutidine is taken to be placed inside the aseptic container, and then the water for injection is added to be heated until the temperature reaches 70 DEG C so that the lafutidine can be dissolved in the water for injection; and then the mannitol is added to be mixed so that the mannitol can be dissolved and is mixed evenly; the content of the intermediate is measured; after the content of the intermediate is qualified, in the aseptic condition, the solution is filtered until to be clear by microporous membrane of 0.22 microns; the filtrate is filled inside the aseptic silin bottle; and part of the silin bottle is plugged by butyl rubber closure, with the posterior steps of tray filling, freeze-drying in the freeze dryer, tamponing, unpacking, mouth rolling, quality inspecting and packaging.

Description

technical field

[0001] What the present invention relates to is a kind of lafutidine freeze-dried powder injection, the lafutidine freeze-dried powder injection prepared by the technical scheme of the present invention can be used as the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer; can improve Acute gastritis, mucosal lesions (such as erosion, bleeding, redness) in the acute malignant transformation of chronic gastritis; it can also be used for administration before anesthesia. Background technique

[0002] Peptic ulcer is a common disease, frequently-occurring disease, and the incidence rate accounts for about 10% of the total population. According to the statistics of "National Medical Medication Situation in 1998", the amount of drugs used in hospitals that act on the digestive system increased by 74% in 1998 compared with 1997, and the total amount reached 7.25 billion yuan.

[0003] Lafutidine (lafutidine, 1) is an H2 receptor antagonist jointly devel...

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