Irinotecan is a camptothecin derivative isolated from natural plant. It is water-soluble anti-tumor pharmaceutical raw materials.
It is a listed broad-spectrum tumor drug in abroad and mainly used for the treatment of cancer, advanced colon cancer, rectal cancer, small cell lung cancer, cervical cancer, ovarian cancer and non-Hodgkinson's lymphoma, and so on.
At present, commonly used light production of hydrochloric acid irinotecan, response orientation, and impurities are difficult to control, yield instability. China lasted more than two years, independent innovation, to develop a new synthetic route from camptothecin irinotecan hydrochloride for Sport ethyl - hydrogenation - oxidation - acylation technology, quality and fully meet the international requirements. The advanced technology is: to improve the conversion rate of the reaction: the technology to produce hydrochloric acid irinotecan, a substantial increase in the rate of reaction conversion, the total yield of 30% or more. International standards on the hydrochloric irinotecan have high quality requirements. The production products meets the quality standards. At the same time, improve the safety of products: product-related impurities in single ICH regulations are less than 0.1%. Clean production: organic solvent recovery and waste utilization in the production process, a simple process and low cost.
China ranked 1st of mortality caused by tumor. And the incidence is rising. It includes lung cancer, a higher incidence of colorectal cancer. Hydrochloric irinotecan treatment of advanced colorectal cancer effects of drug resistant cases is still valid; of 5 - fluorouracil and also effective for small cell and non-small cell lung cancer and cervical cancer and ovarian cancer. The docetaxel drug has been jointly approved in the United States and the European Union, listing more than 100 countries around the world. It is the U.S. 40 years following the 5 - fluorouracil (5-FU) has been the only chemotherapy drug approved for first-line treatment of advanced colorectal cancer. The market potential is huge.
With the high standard of international market hydrochloric acid irinotecan Kang demand growth, the international pharmaceutical companies are seeking to meet international standards of products imported from China, which is acid irinotecan API products enter the international market provides a good opportunity. Meanwhile, the high levels of hydrochloric acid irinotecan production due to the high cost of foreign natural plant raw material drug production, plant extracts drugs source’s import is instability. And increasingly high demand for foreign raw material drug production is gradually transferred to China. The production of environmental protection will increased considerably.
Studies have shown that Topo-I content of a variety of tumor cells, especially colon cancer, cervical cancer, ovarian cancer cells is much higher than normal tissue. In the S tumor cells, its content has a substantial increase. Because of irinotecan’s unique action mechanism, it has a higher selectivity for these tumor cells, thereby reducing toxicity of normal cells. Irinotecan is used in the treatment of these cancers and their efficacy is encouraging. Its application prospect is very good. Hydrochloric irinotecan has been raised to first-line drugs for the treatment of rectal cancer. It can be predicted that development and production of hydrochloric irinotecan bulk drugs and formulations will have considerable development.Source:http://www.cospcn.com
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