Lansoprazole freeze-dried injection

Abstract

The invention relates to a lansoprazole frozen powder injection agent and a preparation method thereof. The lansoprazole frozen powder injection agent prepared by the method can be taken as a medicine for treating gastric ulcer, duodenal ulcer, erosive gastroesophageal reflux disease, helicobacter pylori and Zollinger-Ellison Syndrome. The lansoprazole frozen powder injection agent prepared through taking a lansoprazole as an active ingredient, adopting crystallized filtration, freezing and drying. The preparation process comprises the following steps of: adding water for injection and alkalito the lansoprazole, stirring to dissolve and mix uniformly; performing the crystallized filtration; after measuring the content, adjusting pH value of filtrate; using the water for injection for fixing volume and a millipore filter with 0.22 mu m for filtration; filling, partially arranging corks, arranging in trays, freezing out, pressing the corks, taking out from boxes, rolling openings, checking quality and packaging. The prepared lansoprazole frozen powder injection agent has excellent re-dissolving performance, is more stable when used together with transfusion in clinical use, can notseparate out, and has better inspection result for visible foreign matters and insoluble particles.

Description

technical field [0001] What the present invention relates to is a kind of lansoprazole freeze-dried powder injection and preparation method thereof, the lansoprazole freeze-dried powder injection prepared by the method can be used as gastric ulcer, duodenal ulcer, erosive gastroesophageal reaction Drugs for influenza, Helicobacter pylori, and Zollimger-ellison syndrome. Background technique [0002] Lansoprazole (Lansoprazole) is a benzimidazole substitute developed after omeprazole. It is a strong inhibitor of the proton pump in the secretory membrane of the parietal cell tip. Lansoprazole specifically inhibits H + -K + - The activity of ATPase (the enzyme is a key enzyme in the production of gastric acid), which has an inhibitory effect on the secretion of basal gastric acid and stress-induced gastric acid. Lansoprazole is suitable for gastric ulcer, duodenal ulcer, erosive gastroesophageal reflux disease, Helicobacter pylori, and Zollimger-ellison syndrome. Lansoprazol...

AI Technical Summary

Problems solved by technology

[0003] Lansoprazole is unstable under acidic conditions, is easily destroyed in gastric acid, and oral absorption is slower after making tablet or capsule, and bioavailability is low, thereby needs to be prepared into injection, but because lansoprazole The solution has poor stability and cannot be sterilized at high temperature, so its injection can only be prepared by freeze-drying

During the development process, it was found that after reconstitution of lansoprazole freeze-dried powder injection prepared by common preparation method, the inspection results of foreign matter and insoluble particles were not ideal. Particles of 5-20 microns and above can block blood flow when passing through pulmonary capillaries, causing complications such as pulmonary embolism and even death. Exogenous particles can also form phlebitis at the injection site, and may also cause venous vascular obstruction and Patient harm, has a strong impact on clinical drug safety, the lansoprazole ( ) injections are proposed to be added with a disposable filter with a pore size of 1.2 μm to filter out the above-mentioned fine particles during clinical use, but the above-mentioned defects are not fundamentally solved, and the cost of the preparation is greatly increased, which increases the economic burden on the patient. Disposable The sterility assurance level of the filter also increases the risk of bacterial contamination, which is not an ideal solution, and other known technologies have no suggestions to improve the above defects

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