The Pharmaceutical Study On Zuning Granula

Zuning Granule is a compound preparation consisting of6kinds of traditionalChinese herbs as following： Phellodendri Chinensis Cortex, Paulownia FortuneiFlos, Dictamni Cortex, Cnidii Fructus, Pseudolaricis Cortex, Kochiae Fructus. It isused to clear away heat, deprive the evil wetness, kill parasites and relieve itches, butmore extensively to treat tinea pedis.According to Chinese medical science and basedon the clinical practice. Zuning Granule combines the characteristics and tastes ofeach composition with the pharmacological property of active components andpreponderance of external application for treating tinea pedis. Water-extractingTechnology is adopted to prepare Zuning Granule as a kind of safe, efficiency andconvenient formula.The preparations of aquaextraction were optimized by orthogonal experiment.The concentration of berberina hydrochloride in phellodendri Chinese Cortex and theyield of aquaextraction were used to evaluate each preparation procedure; Thepreparation procedure of Zuning Granule was optimized on the basis of the dosage ofsubsidiary granule materials and humectants by Central Composite Design scheme;Phellodendri Chinensis Cortex, Cnidii Fructus, and Cortex Pseudolaricis wereidentified in this study by Thin-layer Chromatography（TLC） method,and comparedwith the controlled medicinal herbs. The results showed that the spots in the TLCwere clear and the negative medicine was free of disturbance. TLC method wasappropriate for the qualitative identification of Zuning Granule. BerberinaHydrochloride content in Zuning Granule was determined by High-performancethin-layer Chromatography （HPLC） method. The results demonstrated that thelinearity, repeatability, precision and the average recovery of HPLC were good. HPLCmethod was appropriate for the quantitative determination of Berberina Hydrochloride content and Osthole content. Berberina Hydrochloride contentlimitation and the weight per package were fixed at the same time. BerberinaHydrochloride content was not less than0.47mg g^-1，Osthole content was not lessthan26.5mg g^-1and the weight per package was21g.Anti-fungus experiment was performed in vitro to observe the inhibiting andkilling effect of five funguses cansed diseases and determine the minimum inhibitingconcentration（MIC）. Anti-inflammation response experiment of xylene in mice andantipruritic experiment on skin were performed to observe the inhibiting inflammationresponse and antipruritic activity of Zuning granule.The results showed that ZuningGranule have the obvious inhibiting effect on five fungus caused diseases andsignificant inhibiting effect on inflammation response in mice and relieve itches inskin.safety of Zuning Granule’s external application was observed by rat acutetoxicity test and rat delayed type hypersensitivity test.The acute toxicity text showedthat the rat in each experiment group had no visible change compared with those inblank control group in skin, eyes, dieting activity, weight and membrane, and nodeath.The rat delayed type hypersensitivity test showed that10rats in positive controlgroup had allergy symptoms in varying degrees after affected and stirred allergy, butthose in Zuning Granule group had no allergy symptoms. The results indicated thatclinical application of Zuning Granule was safe.The study results demonstrated that preparation technology of Zuning Granuleis appropriate and quality is stable and controllable.Our studies provide the foundationfor new anti-fungus traditional Chinese drugs and demonstrate Zuning Granule has apromising application prospect.