Lansoprazole-contained freeze-dried powder injection

Abstract

The invention provides a lansoprazole-contained freeze-dried powder injection and a preparation method thereof, wherein the freeze-dried powder injection comprises 1 part of lansoprazole, 0.05-50 parts of excipient and 0.1-10 parts of polyethylene glycol; the preparation method of the freeze-dried powder injection comprises the following steps of: weighing the lansoprazole, adding into water for injection, adding a pH regulator for regulating the pH value of a solution to be 10-12.5, stirring until the lansoprazole in the solution is completely dissolved, adding the polyethylene glycol and the excipient, adding the water for injection until reaching the whole volume, quantitatively filling into a cillin bottle, and carrying out freeze-drying; and the freeze-dried powder injection can simultaneously solve the problem of stability and solubility puzzling the preparation and has good redissolution property.

Description

technical field

[0001] The invention provides a freeze-dried powder injection, especially a freeze-dried powder injection containing lansoprazole. Background technique

[0002] Lansoprazole is a substituted benzimidazole compound anti-ulcer drug, which belongs to the proton pump inhibitor. It can continuously inhibit the activity of gastric acid and pepsin by inhibiting the proton pump of gastric mucosa parietal cells, that is, inhibiting the activity of H+, K+-ATPase. secretion. According to the research results of peptic ulcer in recent years, lansoprazole is obviously better than omeprazole, which is widely used in clinical practice, in the treatment of duodenal ulcer (DU). Lansoprazole has reliable acid-suppressing effects and a large safety factor, and is a promising new generation of proton pump inhibitors. Only oral preparations are listed on the domestic market at present. Injections have the advantages of quick onset and are not affected by the gastrointestinal e...