Studies On Brucea Javanica Gel Plaster

Objective:To optimize the extraction method of Brucea javanica oil and the extraction process of Brucea javanic which was took off the oil.The inclusion complex of Brucea Javanic oil was used to research Brucea javanica pel plaster.The quality,stabity and skin irritation were investigated to evaluate its quality and safety.Methods:（1）The HPLC was adopted to establish the content determination method of linoleic acid and uracil;（2）The linoleic acid extract rate was employed to optimize the extraction method of Brucea javanica oil;With the uracil extract rate as the index,the single factors,such as ethanol,ethanol concentration,extraction time and extraction times were used to carry out L₉（3⁴）orthogonal test to optimize the extract technology of the deoiling Brucea javanica;（3）To optimize the formulation of Brucea javanica with Brucea javanica oil inclusion complex,extraction,adhesives,moisturizing agents,fillers and persermatives as raw material;（4）By characters,the cold and heat properties,skin compatibility,adhesion,shape forming ability,paste content,the content of indicative ingredient and stability tests to estimate its quality;（5）The safety of Brucea jananica gel plaster was evaluated by pharmacy to unbroken and scratch skin test.Results:（1）The content determination method of linoleic acid and uracil in the Brucea javanica had been established by HPLC.The linear equation of linoleic acid was y=1201.80x+130.91,r=0.9998,and the sample size and peak area show good linearity in the range of0.202-2.020 mg;The linear equation of Uracil was y=1.307.4x+679.24,in the range of 0.24-2.40μg,the sample size of Uracil and peak area has better linearity.（2）The extraction rate of linear acid was took as index,optimal extraction process of Brucea javanica oil were 7 times petroleum ether of the herbs,extracting 3 times in 60℃condition,2 h each time.The extraction rate was 98.76%.Optimal extraction process of Brucea javanica extact were 5 times 50%ethanol boiling 3h,under the condition of extraction rate of Uracil was chose to index and got best results;（3）The best formulation optimization of product was consisted of the Brucea javanica oil inclusion complex,extraction,sodium polyacrylate,xanthan gum,gelation,AlCl₃,polyvinyl alcohol,glycerin and ethylparaben,and the technological operability was well;（4）The characters,the cold and heat properties,skin compatibility,adhesion,shape forming ability,paste content had been investigated.The results of accelerated stability tests showed that its quality was stable;（5）Multiple administration is relatively safe for the unbroken rat skin,but do some damage to scratch skin that will appear red and swollen plaques.Conclusions:The content determination method of linoleic acid and uracil in Brucea javanica by HPLC is highly accurate,sensitivity and easy to operat.The optimal extrcaction technology of Brucea javanica oil and deoioling Brucea javanica were feasible.The formulation of Brucea javanica gel plaster is reasonable,and it showed good stability in the long-term tests.Those results can provide some datas for Brucea javanica gel plaster further research to cure skin wart.