Anti-cancer drug degarelix acetate injection and preparation method thereof
A technology of degarelix acetate and injection, which is applied in the field of degarelix acetate injection and its preparation, can solve the problems of complex freeze-dried powder preparation process, low level of sterility assurance, long production cycle, etc. High level of bacterial protection, reduced reconstitution process, and short production cycle
Inactive Publication Date: 2016-07-13
张光泉
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- Application Information
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Problems solved by technology
[0007] Because degarelix acetate is easy to degrade in water, and its impurities become larger as the storage time prolongs, the current technology is to make degarelix acetate into a freeze-dried powder preparation, but the freeze-dried powder preparation has complicated processes and production cycles. Long length, high requirements for equipment, and low level of sterility assurance
Method used
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Embodiment 1
[0018] prescription
[0019]
[0020] Preparation Process
[0021] Weigh the prescribed amount of polyoxyethylene 60 hydrogenated castor oil, methyl paraben and sodium bisulfite and dissolve in an appropriate amount of water for injection, stir and mix evenly, add the prescribed amount of degarelix acetate, stir to dissolve, and use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value, dilute to the total volume with water for injection, stir and mix, filter, fill, and visually inspect to obtain the finished product.
Embodiment 2
[0023] prescription
[0024]
[0025] Preparation process: with embodiment 1
Embodiment 3
[0027] prescription
[0028]
[0029] Preparation process: with embodiment 1
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The invention belongs to the technical field of medicines, and particularly relates to a degarelix acetate injection and a preparation method thereof. The injection is mainly prepared from active ingredient degarelix acetate, a dispersant, methylparaben, sodium hydrogen sulfite, pH regulator and water for injection. The degarelix acetate injection is stable in quality and simple in process, and is suitable for industrial popularization.
Description
technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a degarelix acetate injection and a preparation method thereof. Background technique [0002] Prostate cancer ranks first in the incidence of cancer in Europe and the United States. In recent years, its incidence and mortality are still rising significantly. Although the incidence of prostate cancer in China is lower than that in Europe and the United States, due to the westernization of eating habits in the past 20 years, the incidence of prostate cancer has also increased. Prostate cancer is the second most common malignancy among male patients after lung cancer in developed countries in Europe and the United States, and its mortality rate ranks sixth after lung and bronchus cancer, liver cancer, gastric cancer, colorectal cancer, and esophageal cancer. In my country, it occupies the third place among male urological tumors, and it has an increasing trend year by ...
Claims
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IPC IPC(8): A61K38/09A61K9/08A61K47/44A61P35/00
CPCA61K9/0019A61K9/08A61K38/09A61K47/44
Inventor 不公告发明人
Owner 张光泉