Study On The Preparation Process Research And Quality Standards Of Compound Breynia Fruticosa Ointment

ObjectiveTo establish a method for determining epicatechin and matrine in Compound Breynia fruticosa ointment and optimize the extraction conditions.And optimize the optimum proportion of matrix for the preparation process of Compound Breynia fruticosa Ointnent by PEG4000,PEG400,Tween-80,glycerin and ethylparaben.Then investigate in vitro transdermal absorption properties of Compound Breynia fruticosa ointment to improve its quality standards.Methods(1)The content of epicatechin in leaves of Breynia fruticosa and matrine of Separation Flavescens was detemined by HPLC.Pereating time,ratio of solid to liquid,extraction time and extraction times for the affection of water extraction rate of epicatechin and matrine were detected by the orthogonal test.Character,stability constant,ductility and pH value of the ointment were selected as index,L9(34)orthogonal test was employed to determine the effects of the four factors.(2)Character,stability constant,ductility and pH value of the ointment were selected as index,L9(34)orthogonal test was employed to determine the effects of the four factors.(3)HPLC was adopted to detemine accumulative percutaneous pemeation of epicatechin and matrine.Franz difmsing cells and nude mice were adopted for percutaneous penetration test.(4)The Breynia fruticosa,Sophora flavescens,Fructus Cnidii,CORTEX DICTAMNI and Fructus Kochiae Scopariae radix were qualitatively identified by TLC.The content of L-Epicatechin in Breynia fruticosa and the content of matrine in Sophora flaves cens were determined by HPLC.Results(1)The linear range of Epicatechin was 0.0084?0.0336g/l,the standard curve of Epicatechin was as fbllows y=13346x+11.632,r=1.0000.The optimal water extraction technics were as follows:ratio of solid to liquid at 1:20(w/v)and pemeating for 45 minutes,80? extraction 2 times and 1 hour for each time.The linear range of atrine was 0.0294?0.588g·L-1,the standard curve of matrine was as follows y =1714.9x-3.8355,r=0.9999.(2)The optimal decoction extraction technics were as follows:ratio of solid to liquid at 1:20(w/v)and pemeating for 45 minutes,extraction 2 times and 1 hour for each time.The optimum proportion of matrix of Compound Breynia fruticosa Ointnent was PEG4000-PEG400-Tween-80-glycerin(6:1:0.1:0.5).(3)The standard curve of epicatechin was as fbllows y =14.928+10.382x,r=0.9886.Penetration rate is 10.382?g · cm-2 · h-1,accumulative penetration amount in 12h is 138.8?g · cm-2.The standard curve of matrine was as fbllows y=0.3081+19.923x,r=0.9980.Penetration rate is 19.923?g · cm-2 · h-1,accumulative penetration amount in 12h is 243.7 ?g · cm-2.(4)The spots on TLC plates were clear without interference in the blank reference,t The linearity range of Epicatechin IV was 0.0084?0.0336g · 1-1,r=1.000.The linearity range of matrine IV was 0.0147?0.0588g ·1-1,r=0.999.ConclusionsThe above results showed that the optimized ointment was fine uniform,with ductility and stable properties.With this optimum proportion of matrix better quality Compound Breynia fruticosa Ointnent can be prepared.Franz difmsing cells and nude mice were adopted for percutaneous penetration test,is perfect to investigatein vitro transdermal absorption properties of Compound Breynia fruticosa ointment.HPLC method for determination of epicatechin and matrine is simple and selective and qualitatively identified by TLC is sensitive.And can be used for quality control of Compound Breynia fruticosa Ointnent.The research content in this paper could provide the basis and development of relevant preparations for Breynia fruticosa.