Docetaxel albumin nano composition and preparation method thereof

Abstract

The invention provides a docetaxel albumin nano composition and a preparation method thereof, and particularly provides a docetaxel protein nano preparation which comprises the following components in parts by weight: 1-30 parts of docetaxel, 5-50 parts of albumin and 5-85 parts of a stabilizer, and optional medicinal freeze-drying auxiliary materials.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to a composition or compound used in the field of anti-tumor, and more particularly relates to a preparation method of a nano-composition comprising docetaxel, albumin and stabilizer as a prescription. Background technique [0002] In recent years, the incidence of tumor has risen sharply, its treatment is difficult and the mortality rate is high, and it has become the second leading cause of human death. According to reports, there were about 18.1 million new cancer cases and 9.6 million cancer deaths worldwide in 2018. Among them, there were more than 2.338 million deaths from malignant tumors in China, and the mortality rate exceeded 30%. For every 100 new cancer patients in the world, The Chinese accounted for 21, which has become a serious social problem. At present, the clinical treatment of advanced tumors is mostly combined with radiotherapy and chemotherapy to delay th...

AI Technical Summary

Problems solved by technology

Although docetaxel has a good antitumor effect, it still has the following defects in the practice of treatment: (1) docetaxel is almost insoluble in water, and a large amount of surfactants must be added to the clinically used injections, such as commercially available Docetaxel (Taxotere) contains a high concentration of Tween 80, including the alcohol-free formulation of Eagle Pharmaceuticals, which was approved by the FDA in 2015. Although it can be stored at room temperature and has a longer stable time than Taxotere after dilution, the prescription contains a large amount of Tween 80. The severe sensitization side effects caused by Wen-80 in clinical application have not yet been resolved, such as myelosuppression, allergic reactions, neurotoxicity, skin erythema, cardiovascular adverse reactions, etc.; (2) Docetaxel is a cytotoxic drug and has no Targeting, rapid systemic distribution and metabolism of the drug after injection administration, resulting in systemic toxic and side effects. Once overdose occurs in cancer patients for a long time, there is no antidote available; (3) fat emulsion for docetaxel Drug delivery systems such as microemulsions and liposomes have not made great progress in reducing adverse reactions and side effects

[0004] In summary, there is still a lack of a docetaxel pharmaceutical preparation with good curative effect and low toxic and side effects in this area.

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