Tropisetron hydrochloride injection and preparation method thereof

Abstract

The invention relates to the field of medicine, in particular to a tropisetron hydrochloride injection and a preparation method thereof. The injection is prepared from the following constituents in parts by weight: 1.13-28.2 parts of tropisetron hydrochloride, 3-75 parts of sodium acetate, 1.7-42.5 parts of glacial acetic acid, 1.2-30 parts of sodium chloride, and 3000-6000 parts of water for injection. The preparation method comprises the following steps: (1) weighing tropisetron hydrochloride, adding the weighed tropisetron hydrochloride into the water for injection, which accounts for 60-95% of the total prescription dosage, adding sodium acetate, glacial acetic acid and sodium chloride to the water, stirring to enable the substances to be dissolved, adding activated carbon for needle, stirring and using a titanium bar to coarsely filtering out and removing carbon; (2) adding the rest water for injection, and sequentially using microfiltration membranes of 0.60-0.45 microns and 0.45-0.10 microns to filter the solution. The tropisetron hydrochloride injection provided by the invention is a colorless clear liquid, high in clarity, good in solubility, low in impurities, free of adverse effects, and convenient and safe to use.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a tropisetron hydrochloride injection and a preparation method thereof. Background technique [0002] Tropisetron hydrochloride is the third 5-HT3 receptor antagonist listed on the market after ondansetron and granisetron. It was developed by the Swiss Sandoz company and was first listed in the Netherlands in 1992. The trade name is Navoban , is the drug of choice for the treatment of nausea and vomiting, and is currently clinically used to prevent and treat nausea and vomiting caused by cancer chemotherapy. Compared with other 5-HT3 receptor antagonists, tropisetron has the characteristics of mild side effects, good tolerance, low drug-drug reaction and long duration of action. [0003] After searching, it was found that the invention patent application with publication number CN 1969847 provides a stable pharmaceutical composition, which is composed of tropisetron or its pharmaceutical...

AI Technical Summary

Problems solved by technology

[0006] The solubility of tropisetron for injection currently on the market is average. After adding water for injection, it needs to be shaken for a few minutes before it can be completely dissolved, which affects the convenience of use, and the solution is slightly cloudy, which affects the safety of use, and it is not very convenient to use.

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