| Chinese herbal medicine as a special commodity in China has a long history of use. It must be guaranteed its safety and effectiveness when it was used to treat diseases in human body. However, complex sources and different varieties leaded to chaotic circulating market of herbal medicines. The effectiveness of herbal medicines was in doubt because of confused origin, complex specifications and uneven quality level. While the soil grown herbs is in a great amount of pesticide residues and resulted in excessive herbs of pesticide residues. Sulfitation use to herbs resulted in excessive levels of sulfur dioxide and some moldy herbs may produce aflatoxin. Pesticide residues, sulfur dioxide and aflatoxin seriously affected the safety of the medicine. Safety and effectiveness had become the most important constraints of traditional Chinese medicine to enter the international market, while medicines’ safety and effectiveness evaluation system had been the "bottleneck" of medicinal trading to foreign.To this end, we chose to use Pinellia currently along with the above problem circulating in the market as the model drug. We found the basic status and problems of Pinellia circulation in the market through the literature review and field research, then tried to make its chemistry model evaluation proposed Pinellia genuineness, the defectives of goods classification on the market and the limit standard of sulfur dioxide and pesticide residues. The main study would conclude the following aspects:First, this article learned Pinellia’s practical problems that its origin and breed were confused; it had been divided to three levels just based on the appearance; its exogenous harmful substances included sulfur dioxide, excessive pesticide residues, etc. So the priority was to establish Pinellia chemical model evaluation to evaluate the quality of Pinellia and ensured the effectiveness of it; while the limit standards of exogenous harmful substances drew up, the security of Pinellia would improve.Second, HPLC method was used for simultaneous determination four kinds of genetic molecular substances including uracil, uridine, xanthine and inosine of Pinellia that in different areas, and made a hierarchical cluster analysis. Conclusion Showed: Pinellias of Gansu and other provinces producing areas had a good discrimination on the level of genetic molecules, indicating Pinellia had differences at the genetic molecular level that they grew in different areas. Presumably as genetic molecules changed, Pinellia demonstrated traits would be different, so in terms of efficacy would show different emphases. It was because of changes in the genetic material of the molecule, Pinellia had authentic characteristics, and Pinellia needed to be marked origin in herbal medicine market circulation.Third, acid-base titration was used for determination total organic acid from different origins, different levels of Pinellia, while HPLC method was used for simultaneous determination pyrimidine and purines from different origin, different levels of Pinellia. On the basis of the above three chemical compositions, a comparative analysis of study at three levels of ABC and Gansu, Guizhou, Yunnan origin had been done. Conclusion Showed: Pinellia classification was not reasonable and the difference of quality among levels was not statistically significant. In the circulating market, traditional Chinese medicine had been artificially of the division level according to appearance of the size was undesirable. Origin was the most important factor affecting the quality of Pinellia and Pinellia in different origin had significant difference in quality, which illustrated the importance of Pinellia genuineness’research again from the side, and explained the phenomenon that origin confusion on the herbs market must be effectively controlled, in order to ensure the stability of the efficacy of herbal medicines.Forth, the three exogenous harmful substances including sulfur dioxide, organochlorine pesticides and aflatoxin in Pinellia was measured according to "Chinese Pharmacopoeia" methods and statistical analyzed, then proposed limited standards which were intended to ensure the safety of herbs.In summary, this paper made Pinellia as the model drug and analyzed the basic situation and problems of Chinese herbal medicine in market circulation, while conducting a preliminary evaluation of the chemical model for Pinellia’s safety and effectiveness, demonstrated the necessity of establishing evaluation of chemical pattern for Chinese herbal medicines. It provided a practical case that referred Chinese herbal medicines on the market for the standardized and orderly and flowed into the international market. |