去乙酰真菌环氧乙酯的质量标准和稳定性研究

Study on the Quality Standard and Stability for Deacetylmycoepoxydiene

采用高效液相色谱、红外光谱和热失重等技术,结合影响因素实验、加速实验和长期实验等方法,对抗肿瘤候选药物——去乙酰真菌环氧乙酯(DAM)的性状、鉴别、含量测定以及对光、热等稳定性进行研究.建立了DAM的鉴别和含量测定方法等相应的质量标准;稳定性实验结果表明:DAM对光、热均具有较好的稳定性,提示其可以在密闭常温条件下贮存,为DAM的后续开发奠定了基础.

Deacetylmycoepoxydiene has been proved to be a new and promising anticancer drug by pharmacology and toxicology. By means of influential factor experiment, accelerating experiment and long-term experiment, using the techniques of HPLC, IR, UV and thermal gravitational analysis,the character,identification, purity investigation, content determination and the stability for light, heat of deacetylmycoepoxydiene was studied. And the standard for qualith of deaeetylmyeoepoxydiene was set up. The stability experiment showed that deacetylmycoepoxydiene has a good stability under the harsh condition of high temperature, high moisture and violet light. The results suggested that deacetylmyeoepoxydiene can be stored at airtight and common temperature conditions. This study laid the foundation for open and development deacetylmycoepoxydiene in industrialization.