Study On The Transdermal Drug Delivery System Of Semen Strychni

Semen Strychni is a famous toxic traditional Chinese material medicine. Although Semen Strychni and its complex were used very well in clinic, the application was restricted seriously by its narrow curative window. Therefore, it is very important to study and develop a safe, efficient, accurate, and persistent TTS dosage form of Semen Strychni.By assessing the antipyretic effect on mice of extract and determining the recovery rate of brucine, the suitable extraction procedure of Semen Strychni was screened, then the optimized process was obtained: Semen Strychni was refluxed for 2.5hours by 5 times 70% alcohol each time, 3 times total, then the extract liquid was condensed to relative density 1.2-1.25 (60℃)to prepare the extrct which be used for preparating TTS dosage form.Another result shows that the antipyretic activity of Semen Strychni was decided by the amount of brucine, it was well correlated between them.In terms of the needs of manufacture and characteristics of the drug, the preparation of Semen Strychni patch and babu plaster was studied respectively. The formulation was optimized by using orthogonal design which took the adhesion properties as indexes.the optimized prescription of patch was:the extract 20%, menthol 1%, the rest is Eudragite E100 and Dibutyl Sebacate (ratio is10:5). The optimized prescription of was plaster: the extract 10%,mentho 2%,glycerol 20%,ZnO 25%,tragacanth 10%,and the rest is Carbopol Ultrez10 and PANA 7S (ratio is10:1).Then the optimized formulation was evaluated in percutaneous permeability in vitro and pharmacodynamics potency.The patch and plaster's transdermal release in vitro meet to Higuichi distribution and the release rate of patch and its pharmacodynamics potency were better than that of the plaster. It was confirmed that the patch was the suitable transdermal drug delivery system of Semen Strychni.On the basis of rules of SFDA, the stability and quality control of the Semen Strychni patch was studied.It was proved that the Semen Strychni patch was stable and controllable.