Idarubicin hydrochloride pharmaceutical composition and preparation method thereof

Abstract

The invention discloses idarubicin hydrochloride pharmaceutical composition and a preparation method thereof. The composition contains idarubicin hydrochloride and mannitol. The preparation method comprises the following steps: 1), preparation is performed: ambroxol hydrochloride and mannitol are placed into a preparation tank in a weight ratio of 1:(1-20), water for injection is added, and the mixture is stirred to be completely dissolved and uniformly mixed; 2), sterile filtration, subpackaging and half stoppering are performed; and 3), vacuum freeze drying is performed to obtain a product. 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 is thoroughly dried, and the redissolution performance is better.

Description

technical field [0001] The invention belongs to the field of medical technology preparation, and in particular relates to an idarubicin hydrochloride composition for injection and a preparation method thereof. Background technique [0002] Idarubicin hydrochloride is embedded between the base pairs of DNA double strands, inhibits the extension, replication and transcription of DNA strands, and finally leads to cell death. It was recently discovered that this product can also affect the activity of topoisomerase II (Top II). Top II plays an important role in maintaining the normal spatial structure of DNA and ensuring DNA replication and transcription. This product inhibits the enzyme activity, which can lead to DNA cleavage, and the DNA fragments bound to the protein can be detected by filtration and elution. The DNA damage caused by idarubicin hydrochloride is not closely related to free radicals, nor is it the result of early cell death. At present, it is mainly used cl...

AI Technical Summary

Problems solved by technology

Using the traditional freeze-drying process, because part of the HCl in idarubicin hydrochloride is pumped away under high vacuum conditions, the salt formation of idarubicin hydrochloride is not complete, and part of the idarubicin 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 the idarubicin hydrochloride for injection prepared by the 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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