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The “863†project new material field project undertaken by Beijing University of Chemical Technology--a key technology for the preparation of a new fine chemical hypergravity method has recently passed the project acceptance. In response to industrial problems such as large size of traditional medicines, poor water solubility, and low bioavailability, the project team has innovatively developed a new technique for the preparation of nano-structured drug particles by the hypergravity method. At present, nearly 40 kinds of nano-structured drug particle products have been developed using this technology.
The hypergravity method is the next generation of strategic technology for drug nanocrystallization. At present, the project team has constructed a nano-micro structure drug particle hypergravity preparation platform technology system with China's independent intellectual property rights, high-performance and low-cost, applied for invention patents 17, authorized 6 pieces. Many of the technical products of this project have been exported to Europe and the United States and other countries and regions.
According to reports, high value-added fine chemicals with broad market prospects for therapeutic and nutraceutical raw materials. However, the fine chemical industry in China has the problems of low product quality, high process energy consumption, high material consumption, and heavy pollution. For therapeutic drug raw materials, currently more than 40% of newly developed drugs worldwide have poor solubility in water due to poor water solubility, resulting in poor bioavailability.
Under the support of the national "863" program, Beijing University of Chemical Technology, Zhejiang Xinhecheng Co., Ltd., and Beijing Wansheng Pharmaceutical Co., Ltd. cooperated with enterprises, research institutes, and used traditional medicines for large particles, poor water solubility, and low bioavailability. Such industrial problems, through the theoretical study of molecular mixing, transmission and crystallization process control mechanism in the high-gravity crystallizer, innovatively proposed a new technology of nano-structured drug particles prepared by the high-gravity method. The new technologies include high-gravity anti-solvent precipitation, continuous emulsification, reaction crystallization, and new coupling processes. This technology is used to develop silybinum 293 mg and cefuroxime axetil at 293 nm. Nearly 40 kinds of nano-structured drug particle products. Compared with the original drug particles, the nano-structured drug dissolution rate significantly increased, showing a prominent nano-micronization effect.
The project team has further tackled the key technologies for industrialization amplification, built a 5 ton/year ultra-gravity method for the preparation of lipid-lowering drugs Fenobetaner microparticles, and 40 tons/year high-gravity method for the preparation of cefuroxime axetil nanoparticle pilot test. Demonstration device and 5000 tons/year high gravity method for the preparation of industrial demonstration lines of vitamin A nanoparticle products, completed the research and development of new formulations of Fenobiterna microparticles. Compared with the traditional process, the emulsification process can save energy by 70%, and the unit consumption of raw materials can be reduced by 7%. The effective content of the product can be doubled, and continuous and stable production, energy saving and consumption reduction can be realized.
August 30, 2024