Doxorubicin hydrochloride pharmaceutical composition and preparation method thereof

Abstract

The invention discloses doxorubicin hydrochloride pharmaceutical composition and a preparation method thereof. The composition contains doxorubicin hydrochloride and mannitol. The preparation method comprises the following steps: 1), preparation: the ambroxol hydrochloride and the mannitol at a weight ratio of 1:(1-20) are placed into a preparation tank, water for injection is added, and the mixture is stirred until the mixture is completely dissolved and uniformly mixed 2), sterile filtration, subpackaging and half stoppering; and 3), vacuum freeze drying, thereby obtaining the composition. The composition and the preparation method have the advantages that the formula is simple, the technology is advanced, the quality is uniform and stable, moisture drying is thorough, and the redissolution performance is better.

Description

technical field [0001] The invention belongs to the field of medical technology preparation, in particular to a doxorubicin hydrochloride composition for injection and a preparation method thereof. Background technique [0002] Doxorubicin hydrochloride is a cell cycle non-specific drug, and its main site of action is the nucleus. The mechanism of action of this product is related to its ability to bind to DNA. Adding this product to cells cultured in vitro can quickly penetrate into the cell, enter the nucleus and combine with DNA, thereby inhibiting the synthesis and mitosis of nucleic acid. It has been confirmed that doxorubicin has a broad-spectrum anti-experimental tumor effect and also has an inhibitory effect on topoisomerase. The curative effect is equal to or slightly higher than that of adriamycin, and the toxicity, especially cardiotoxicity, is lower than that of adriamycin. It is suitable for the treatment of malignant lymphoma, breast cancer, lung cancer, sof...

AI Technical Summary

Problems solved by technology

Using the traditional freeze-drying process, because part of the HCl in doxorubicin hydrochloride is pumped away under high vacuum conditions, the salt formation of doxorubicin hydrochloride is not complete, and part of the doxorubicin hydrochloride exists in the form of bases. It cannot be completely dissolved, and there are visible foreign matter, insoluble particles and unqualified clarity. These phenomena all indicate that there may be more tiny particles in doxorubicin hydrochloride for injection prepared by traditional freeze-drying process

Among these particles, particles with a diameter of 5-20 microns and above can block blood flow when passing through pulmonary capillaries, thereby causing complications such as pulmonary embolism and even death. Exogenous particles can also form phlebitis at the injection site, At the same time, it may also cause venous vascular obstruction and patient injury, and there is a large clinical safety hazard.

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