| Objective According to traditional Chinese medicine (TCM) technology and requir-ements of the examination and approval,We Develop the Clinical experience prescription for pellets.Methods Based on many experiments of Prescription’s each part, establish The best extraction technology of kanggan pellets.And establish The best fashioned technology of by experiment researches.Then, establish TLC methods of herba ephedra, Angelica sinensis and Szechwan Lovage Rhizome, fructus forsythiae, jasmine, glycyrrhiza. Establish HPLC methods of baicalin. And process the long term stability experiments. Draft the quality standards for kanggan pellets. Finally, Do the primary Pharmacodynamics experiments for kanggan pellets based for its clinical effects.Results To begin with, established the extraction process of three parts; Then, Choose pill core starch and dextrin as the auxiliary materials, Developed the Clinical experience prescription for pellets by Determined the process conditions and parameters. Thirdly, The TLC method is simple,accurate and reproducible. The Sample quantity linear range of baicalin is0.0642~0963μg, r=0.9990(n=5), RSD=1.28%(n=5),the recovery rate is97.6%. Drafted the quality standards for kanggan pellets. The effects of kanggan pellets’ are antifebrile, Anti-inflammative, purgative. Disincentived against E, B hammer,taphyloc-occus aureus. Disincentived against Respiratory syncytial virus, Therapeutic index is68.59.Conclusion The established the extraction and fashioned technologies are comprehensive,scientific,rigorous. The quantitative and qualitative methods are portable, exclusive and accurate. Pharmacodynamics experiment design can fully reflect the clinical pharmacological function. The all conformde to requirements of6.1.3new drug approval, The kanggan pellets have wide application prospects. |