Research Of Combined Brucea Javanica Oil Submicroemulsion For Injection

Brucea Javanica oil and coix lachryma-jobi oil were grease materials extracted from the seeds of Brucea Javanica and coix lachryma-jobi, in which the unsaturated fatty acids are effective components.A pre-column derivatization method was established for HPLC, and the four kinds of fatty acids in the Brucea Javanica oil and coix lachryma-jobi oil were determined as well. The method is accurate, reliable and convenient. The results of determination on the Brucea Javanica and coix lachryma-jobi oil showed that the contents of linoleic, palmitic, oleic and steraric acid in two kinds of oil are 21.18%, 17.35%; 11.85%, 8.65%; 50.85%, 61.96%; 2.93%, 5.78% respectively. The contents of linoleic, palmitic, oleic and steraric acid in preparation are 1.94%, 1.26%, 6.05%, 0.49%. The physical and chemical characters of Brucea Javanica oil and coix lachryma-jobi oil were studied. The draft for the raw material oil's fingerprint chromatography standard was established according to the prescriptions on fingerprint chromatography of Chinese medicine injection. The ratio of two kinds of raw materials was 1:1 set down by the result of pharmocodynamic.Referring to the typical formulation of fatty emulsion, the best formulation of the combined emulsion was found by single factor test and the precess of manufacture was groped to produce the 10%(w/w) emulsion with the equally mixed oil . The formulation is 0.6%lecithine, 0.3% F-68, 0.1 % oleat sodium, 10% oil and 2.5% glycerol. The mean diameter and the distribution of the preparation were analyzed by the PSS-380 dynamic light scattering equipment to establish the formulation and manufacturing process of submicroemulsion, and the result showed the mean diameter was 232.7±58.9nm.The stability test of the Brucea Javanica oil and coix lachryma-jobi oil showed the content of the four fatty acids change little under the therml test,...