Objective: The Preparation and Evaluation of the compound Chinese medicine Gel of Penyanxiao.Methods:With the orthogonal test , regarding Paeoniflorin and Forsythin as index ,the water extraction technology of Radix Paeoniae Rubra and Forsythia suspensa Vahl and other herbs was well choosed.Regarding Tanshinone Ⅱ_A and Chlorogenic acid as index ,we established the alcohol-extraction conditions of Salvia Miltiorrhiza and Flos Lonicerae. Regarding Essential oil as index ,we selected the extraction technology of Frank incense and Myrrh. Uniformity experiment was used to well choose clarification technology . Regarding inclusive ratio as index ,it was studied theP-cyclodextrin(β-CD) inclusion techniques for Essential oil.Component examination of TLC , X-ray diffraction,differential scanning calorimetric method proved that the Essential oil was enveloped by β-CD. Carbopol 940 was used as the gel matrix, Azone and propylene glycol as penetration enhancer. With the Uniform design , regarding the cumulative release amount of Paeoniflorin and Chlorogenic acid as index ,the optimise prescription matrices was selected.Determined the releasing rate in vitro of the gel,the release coincided with Higuchi Equation.The content of Paeoniflorin , Chlorogenic acid and Tanshinone Ⅱ_A were determined separately by HPLC to establish the tentative quality standard of preparation. The study of Pharmacodynamics and toxicology indicated that it held obvious antiphlogistic ,antibacteriostasis and abirritation effect and had no toxicity or stimulus to guinea pigs skin.Conclusion:The well-chosen technology is stable and feasible,the quality of the Gel of Penyanxiao can be controlled by the established containation testing method. The study on Pharmacodynamics and toxicology of the Gel of Penyanxiao offered a foundation to clinical use. |