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filingDate 2017-08-28-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2022-02-01-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2022-02-01-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-109419771-B
titleOfInvention Testosterone undecanoate sustained-release pharmaceutical composition, and preparation method and application thereof
abstract The invention belongs to the technical field of medicines, and relates to testosterone undecanoate suspension, and a preparation method and application thereof. Specifically, the invention relates to a testosterone undecanoate suspension comprising testosterone undecanoate, a stabilizer and water, wherein: the content of testosterone undecanoate is 10% -50%; the particle size of the testosterone undecanoate meets the following requirements: d10 is 0.2-0.5 μm, D50 is 0.5-1.5 μm, and D90 is 2.2-6.0 μm; the stabilizer comprises a first stabilizer and a second stabilizer, and the weight ratio of the first stabilizer to the second stabilizer is (1-10): (1-20), and the weight ratio of the testosterone undecanoate to the stabilizer is (1-20): (1-20). The testosterone undecanoate suspension has good stability, good redissolution condition after sedimentation, high bioavailability and small irritation, and can stably maintain the hormone level in the body for a long time.
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