Studies On The Quality Standard And Stability Of Class I New Anticancer Drug RAC

Rabdosia rubescens (Hemsl. )Hara, a perennial herb of Labiate, is usually used to treating esophagus cancer and liver cancer in clinical experiments. One of its main components, Rubescensine A, was extracted and expected to become a new Class I drug in Wuhan Botanical Garden, the Chinese Academy of Sciences. For its reliable antitumor function and lower toxicity, RAC takes on a good future of development. So far, there has been no similar drug in the market both at home and abroad, therefore, RAC is potential to become a new class I anticancer drug with independent intellectual property.Fingerprint and stability of both Rubescensine A and RAC were investigated, and their quality standards were established as well. Fingerprint is thought to be an important part in the development research of injections of tradition Chinese medicine(TCM). We tried different chromatogram conditions and various sample treatments to establish fingerprints of RAC and its raw material and drug. The similarity degrees of these fingerprints were also analyzed. The results showed that peaks in the chromatograms, of which the similarity degree was more than 90%, were well separated on condition that acetonitrile and water(25: 75,v/v) were chosen as mobile phase and 238nm as detection wavelength.Quality standard and stability make up a main part in developing new drugs. According to the pharmacopoeia(2005 edition), the items of Rubescensine A about characteristics, melting point, moisture, flaming residue, heavy metal, arsenide, content and related substances were inspected. Moreover, the items of RAC about characteristics, color, value of pH, indiscerptible particulate, volume, eyewinker, sterility, content and related substances were also inspected and the Quality standard was drafted and explained. The establishment of quality standard could provide scientific basis for the production of RAC. With modern techniques of photochemistry and apparatus analysis, the influences to Rubescensine A and RAC of factors, such as illumination, humidity and temperature were inspected and...