Gemcitabine hydrochloride lyophilized powder injection
A technology for gemcitabine hydrochloride and freeze-dried powder injection, which is applied in the field of gemcitabine hydrochloride freeze-dried powder for injection and its preparation, can solve the problems of lack of improvement, poor stability of gemcitabine hydrochloride, toxic and side effects, etc., and achieves considerable economic and social benefits, moisture drying Thorough, low levels of related substances
Active Publication Date: 2009-10-28
JIANGSU AOSAIKANG PHARMA CO LTD
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Abstract
The invention relates to a gemcitabine hydrochloride lyophilized powder injection and a preparation method thereof. The gemcitabine hydrochloride lyophilized powder injection prepared by the method can be used as a therapeutic medicament for treating middle and late non-small cell lung cancer, pancreatic cancer and the like. The gemcitabine hydrochloride lyophilized powder injection is characterized by consisting of gemcitabine hydrochloride, mannitol and sodium acetate, wherein the weight ratio of the gemcitabine hydrochloride to the mannitol is 1:0.5-5, and the weight ratio of the gemcitabine hydrochloride to the sodium acetate is 1:0.01-0.1. The preparation method comprises the following steps: taking the mannitol and the sodium acetate; dissolving the mannitol and the sodium acetate by adding injection water; adding the gemcitabine hydrochloride to the mixture, stirring and dissolving the mixture, and adjusting the pH to between 2.7 and 3.3; fixing the volume; filtering the product by a 0.22 mu m microporous membrane; filling, dishing up, lyophilizing, and compressing; taking the product out of a box, and tying the product with an aluminum-plastic composite cover; and inspecting the quality, and packaging the product after passing the quality inspection to obtain the gemcitabine hydrochloride lyophilized powder injection.
Application Domain
Powder deliveryOrganic active ingredients +3
Technology Topic
Pancreas CarcinomaDrug +7
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