Human recombinant follicle stimulating hormone injection and preparation method thereof

The invention discloses a human recombinant follicle-stimulating hormone injection water preparation and a preparation method thereof. The human recombinant follicle-stimulating hormone injection is prepared from the following raw materials in percentage by mass volume: a therapeutically effective a...

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Hauptverfasser: LUO DELUN, PENG HONGWEI, YANG YUTING
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention discloses a human recombinant follicle-stimulating hormone injection water preparation and a preparation method thereof. The human recombinant follicle-stimulating hormone injection is prepared from the following raw materials in percentage by mass volume: a therapeutically effective amount of human recombinant follicle-stimulating hormone and 2-10% of a stabilizer, and the stabilizer is prepared from lactose and maltose in a mass ratio of (3-4): 1. According to the FSH liquid preparation, lactose and maltose in a specific proportion are used as stabilizers in the FSH liquid preparation, so that the FSH liquid preparation has excellent freeze-thaw stability, high stability parameters meeting application requirements can still be kept after five times of freeze-thaw cycles, and the stability level of the FSH liquid preparation is remarkably superior to that of a human FSH liquid preparation added with other stabilizers under the same test condition; the medicine can be sold in the market at prese