Zedoary Turmeric Oil And The Preparation Of Microemulsion And The Stability Study

The Zedoary Turmeric oil (ZTO) is extracted from traditional Chinese medicine, Zedoary Rhizome. Its main component is triterpenoid. The Pharmacology study showed that ZTO has many effects such as anti-tumor, anti-viurs, anti-intenal clot, anti-ulcer, anti-fertility etc. At present, the dosage forms of Zedoary Turmeric oil are are Zedoary Turmeric oil Injection and Zedoary Turmeric oil and Glucose Injection, but they have poor stability and many side effects such as local irritation, haemolytic action, ect. This article chooses submicron emulsion as drug carrier to prepare oil-in-water submicron emulsion of Zedoary Turmeric oil for intravenous administration in order to reduce irritations and toxicities, improve the stability of Zedoary Turmeric oil and effective antiviral injection of traditional Chinese herb.In the text, a method was established to analysis Zedoary Turmeric oil for submicron emulsion of Zedoary Turmeric oil. Using the appearances, the stability parameter and the diameter distribution of emulsion as index, the formulation and the preparation process were optimized by single factor investigation. The main influence factors such as oil phase, emulsifier, auxiliary emulsifier and stabilizer were investigated. The best formulation of ZTOSE contains Zedoary Turmeric oil1%, soy oil for injection10%, soy lecithin1.2%, Poloxamer1880.3%, oleic acid0.025%, VE0.05%, and glycerol2.25%. Through the study and optimization of several important factors in the preparation process, we solubled phospholipids in oil phase, first emulsifying temperature75℃for ten minutes, pressure of emulsifying60Mpa for three times, and bottling, nitrogen-filling, then sterilized together at121℃for15minutes.Choosing Germacrone as an index and taking a methodology investigation of ZTOSE by HPLC. The linear relation between Germacrone and Chromatographic peak area was good and the regression equation was y=2033.5x+100.61, r=0.9988. The precision and test sample recovery accord with requirements and it is suitable for the quality control analyst of ZTOSE. Test showed that Germacrone in ZTOSE was0.78mg/g.The physico-chemical property of this emulsion was studied. ZTOSE is a white and uniform emulsion with blue lactic light and good fluidity. Its mean particle diameter size is134.6nm, pH is6.7, zeta potential is-57.9mV, viscosity is2.3mPa-S, osmotic pressure is 283.41mOs/kg H2O.The formulations stability studies showed no significant changes of the diameter of ZTOSE when diluted by5%glucose injection while with a significant variation when diluted by0.9%physiological saline.The results of influence factor testing, accelerated testing, and long-term test showed that there was no much change in the invested parameters and the preparation stability was satisfied. The long-term test also pretested that the expiration date of ZTOSE was more than one year.The safety of ZTOSE was evaluated by blood vessel irritation test and hemolysis test. Results showed that ZTOSE had undesirable irritation to veins. Moreover no hemolysis was observed in the common test tube method in vitro.