Study On The Oral Granule Of Brucea Javanica Oil Dry Emulsions

In recent years, emulsion of Chinese medicine have played an vital role as carriers inanti-tumor drugs, anti-cardiovascular disease drugs, anti-virus drugs, etc. Brucea javanicaoil emulsions is one of the most important anti-tumor injection. At present, only in clinicalthe intravenous emulsion and oral emulsion containing Brucea javacina oil(BJO) has beenwidely used in the treatment of tumors, cancers, gastrelcoma, hydrothorax, ascites and otherdiseases. To the emulsion itself,it is unstable thermodynamic and kinetic systems. Duringlong-term storage, in the cause of temperature, light and so on, it may result creaming,condensation, consolidation, etc. for the emulsion, making emulsion particle size larger,finally appear two phase of oil and water stratified. Which can not guarantee a goodstability, seriously affected the quality of Brucea javanica oil emulsion. On the other side, italso bring a lot of inconvenience to transportation.For the purpose of extending the storage period of Brucea javanica oil emulsion andimproving the physical and chemical stability, this issue was intend to make the oralgranule of Brucea javanica oil emulsion by screening prescription, optimizing preparationprocess and adding with suitable protective agent. Store in the form of solid state,redissolution prior to use. Actually the stability of oral granule emulsion is better thanconventional emulsion, thereby enhancing the quality of finished products. This subjectmainly includes the following four parts.The first point, the preparation of the Brucea Javanica oil Emulsion.The appearance of the emulsion, the particle size of emulsion, centrifugal stabilityconstant Ke value were used as the evaluation index.The emulsifiers were selected andoptimizated by single factor experiment, and the orthogonal experiment, and then we confirm emulsifier of emulsifier no.1and no.2emulsifier, the proportion of5:1, and theamount of11.5%of the oil. The70℃conditions preparation colostrum, colostrum againlead high pressure homogenizer circulation four times,the emulsion preparation get lessthan3μm particle size.The second point, the preparation of the oral granule of Brucea javanica oil.The dissolve the particles scattered sex, rest Angle, blunt dissolve the breast after particledrops were used as the evaluation index. Sucrose and mannitol were selected for excipientsby single factor experiment, and the ratio of them were1:2.HPMC (6cp) as bond. Theprocessing technology made of wet granulation, boiling dry, and the final product of all theindexes meet the requirements.The third point, study on the quality standard of the oral granule of Brucea javanica oil.GC method for determination of oleic acid and linoleic acid in the oral granule of Bruceajavanica oil was presented. Gas chromatography of FAMEs was performed on a0.32mm(i.d.)×30m fused silica column lined with a0.50μm film of polyethylene glycol(CP-WAX52CB).Samples (1μl) were injected in split mode (split/column flow ratio5:1).The flow rate of carrier gas (nitrogen) was1.0ml/min. The oven temperature was205℃;the injection temperature was250℃;the detector temperature was300℃.And on thischromatographic condition the paper discussed the influence of different extractionconditions andmethods on the extraction yield of oleic acid and Linoleic acid in the oral granule ofBrucea javanica oil. The best extraction conditions: add saturated sodium sulfate solutionas mixed demulsifiers, and normal hexane and isopropyl alcohol-normal hexane-ice aceticacid mixture (40:10:1) as extraction solvent, and vortex extraction, oleic acid and linoleicacid extraction are completely, repeatability.The fourth point, study on the stability of the oral granule of Brucea javanica oil.This paper examines the stability of oral granule of Brucea javanica oil in the differentconditions. It composed of influence factor test, accelerate test and the long-term test. Hightemperature on the index of granule has no obvious effect, strong light environment makeeasily oleic acid and linoleic acid content low, high humidity moldy easily absorbing moisture, save for granule adverse. aluminum-plastic composite film bag was selected toseal granules to accelerate and the long-term test. Acceleration and the long-term test showthathe oral granule of Brucea javanica oil placed six months (are continuing toexpedition),granules and appearance of the oleic acid, linoleic acid content no change,explain basic stability.