Pharmaceutical Reasearch On Broussonetia Papyrifera Leaf Gels

Superficial fungal disease is the most common skin diseases,clinical incidence rate is very high.There is a lot of western medicine treat for superficial fungal diseases,but the price is relatively expensive.many of them were imported or sino-foreign joint venture,such as daktarin,mildew,baolongkang,liaomeishu,and so on.However,there is very few traditional chinese medicine used for superficial fungal disease,such as pseudolarice tincture compound,allicin,etc.,but curative effect is less than western medicine.This study aims at exploring single prescription which treat tinea in folk,riching medicine which treat tinea,improving the curative effect in treating tinea.The reaserch is under the guidance of traditional Chinese Medicine theory,based on the fundamental research of the effective ingredients and pharmacology,according to the requirements by "Methods of Medicine Registration and Management"of SFDA,modern extraction,separation,purification technology were adopted in the pharmacological research of broussonetia papyrifera leaf gels,the mainly research content the literature research,extraction technology research,preparation technology research,quality standards and stability studies.1 Literature researchThis paper state the significance of developing the issue comprehensively,and make a summary of the leaves of broussonetia papyrifera for chemical component and pharmacological action,and sum up the etiological mechanism,epidemiology,and progress in Chinese and western medicine treatment of superficial fungal disease.2 the research of Preparation technology researchIn order to keep the active ingredients in the leaves of broussonetia papyrifera leaf,the diacolation method is adopted to extract.The diacolation rate,soaking time,ethanol concentration and collect multiples was investigated through the single factor method of parallel comparison,total content of flavonoids and the fixed rate were used as an index,finally this paper got the best soaking process for 6 h,with 75%ethanol,with diacolation speed of 4 ml-1min-1·kg-1 collecting 7 times'diacolation liquid.Diacolation liquid was decompression recoveried to relative density 1.05(60 ?),then removing chlorophyll with water storage method,then Sample solution was purified with macroporous adsorption resin.With the static adsorption-desorption and dynamic adsorption-desorption tests,this paper found HPD450 macroporous adsorption resin has excellent adsorption and desorption properties,optimum process was as following:the concentration of sampling solution 4.4 g·L-1,sampling velocity 1 BV·h-l,sample liquid volume 6 BV,eluted by 5 BV deionized water and 8 BV 50%ethanol at speed of 1 BV·h-1.This paper measure the residue of macroporous adsorption resin with gas chromatography,the result is up to specification.At last the eluent was decompression recoveried(60 ?)and dried at the temperature of 65 ?Finally,with the flavonoids powder as raw material,through the prescription optimization of the molding process,the preparation process of gels was confirmed as the following:make hydroxyl ethyl benzene dissolve in Propylene glycol,then add water(600 g),stir evenly,add carbomer,make it swelling;make triethanolamine dissolve in water(100 g),mix and join the above carbomer dispersion,then get the blank gels;make the flavonoids powder dissolve in glycerol(100 g)and water(100 g),then join to the blank gels and mix,finally,partial shipments for the products.3 quality specification studyIn order to make the quality of the product controllability,this paper inspect the leaves of broussonetia papyrifera and broussonetia papyrifera leaf gels on name,character,identify and Content determination,and establish the quality standard draft on the leaves of broussonetia papyrifera and broussonetia papyrifera leaf gels.according to the results of three pilot products of broussonetia papyrifera leaf gels on content determination,this paper set this gels of per gram containing loteolin should not less than 0.14 mg,containing apigenin should not less than 0.28 mg,containing flavonoids content should not less than 3.00 mg.4 stability studyIn order to investigate the stability of the drug and determine the period validity,this test according to the guiding principles of stability study technology on traditional Chinese medicine and natural medicine,The broussonetia papyrifera leaf gels which batch number is 20130911 was used for the test of influencing factors;The broussonetia papyrifera leaf gels which batch number is 20130911,20130913,20130915 was used for accelerated test in 0,1,2,3,6 month and long-term test in 0,3,6,9 month on the character,identify,pH,microbial limit and content of pilot products.