Esomeprazole freeze-dried powder injection and preparation method thereof

2014 
The invention discloses esomeprazole freeze-dried powder injection and a preparation method thereof. The preparation method comprises the following steps: preparing a main agent esomeprazole, auxiliary agents comprising a protective agent, a stabilizer and an excipient, a PH regulator and water for injection at a weight ratio of 1:(0.45-0.65):(0.25-0.5):50, arranging the components in a mixing tank, introducing inert gases, accelerating stirring until the mixture is foaming in a vacuum state, and performing filtering, split charging, pretreatment and freeze drying to obtain the finished esomeprazole freeze-dried powder injection. In the preparation process, a vacuum foaming technology is adopted, and the moisture in liquid medicine is greatly reduced, so that the freeze drying time of the liquid medicine is only 50 percent of that of an existing process, the specific surface area of the foamed materials is obviously enlarged, the properties of medicines are obviously improved, and the prepared finished powder injection is bulk in volume, difficult in agglomeration, high in re-dissolubility and high in clarity and has the advantage of high heat resistance. Moreover, the pharmacological activity of the medicines can be kept after injection, and the bioavailability of the medicines is greatly improved.
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