A kind of esomeprazole freeze-dried powder injection and preparation method thereof

A technology for esomeprazole and freeze-dried powder injection is applied in the field of esomeprazole freeze-dried powder for injection and preparation thereof, and can solve the problems of difficulty in guaranteeing clarity, difficult and difficult to reconstitute esomeprazole and the like , to avoid damaging free radical reaction, not easy to rupture, and the effect of stable foam structure
CN104146967BActive Publication Date: 2016-11-30WUHAN PUSHENG PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
WUHAN PUSHENG PHARMA
Publication Date
2016-11-30

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Abstract

The invention discloses a freeze-dried esomeprazole powder injection and a preparation method thereof. The main agent esomeprazole, auxiliary agents including protective agents, stabilizers and excipients, pH regulators and water for injection are prepared according to The weight ratio of 1:0.45~0.65:0.25~0.5:50 is prepared and placed in a stirring tank, and the inert gas is introduced to accelerate the stirring until foaming in a vacuum state, and then filtered, divided, pretreated, and freeze-dried to obtain Esso Meprazole freeze-dried powder finished product. In the preparation process of the present invention, by adopting vacuum foaming technology, the moisture in the liquid medicine is greatly reduced, the freeze-drying time of the liquid medicine is only 50% of the existing technology, and the specific surface area of ​​the material after foaming is significantly increased , the properties of the drug have been significantly improved, and the finished product for powder injection has a bulky volume, is not easy to agglomerate, has good resolubility, and high clarity. It not only has advantages in heat resistance, but also maintains the pharmacological activity of the drug after injection. Bioavailability is greatly improved.
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Description

technical field

[0001] The invention belongs to a pharmaceutical preparation, in particular to a freeze-dried esomeprazole powder injection and a preparation method thereof. Background technique

[0002] Esomeprazole is the S-isomer of omeprazole, which is the first isomer proton pump inhibitor available for clinical intravenous administration in the world, and has a stronger effect. Its mechanism of action is protonation under acidifying conditions, transforming into a compound sulfenamide that inhibits H+ / K+-ATPase activity, and rapidly combines with the sulfhydryl group of cysteine ​​on H+ / K+-ATPase to form a disulfide bond. Thereby inactivating the enzyme, specifically inhibiting the H+ / K+-ATPase activity in gastric parietal cells, thereby inhibiting gastric acid secretion. Esomeprazole is a proton pump inhibitor, which has a stronger and longer-lasting ability to suppress gastric acid than others, and the individual differences in metabolism and side effects of esomepr...

Claims

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