| SLM is a kind of flavone mixture that has C-9 substituent.It efficiently cures hepatic injury caused by kinds of liver toxicants.Due to its slightly solubility in both water and oil,there are only oral solid dosage forms on sale.Under the circumstances that the emulsion prepared by normal method was not stable,we prepared SLM-soybean phospholipid compound as the substrate,which is soluble largely in the mixed oil of soybean oil and MCT.Based on the monofactorial research and orthogonal design,we took 0.4%(w/w) oleic acid as the stabilizer, agitated the mixture at 60℃to get the intermediate,which was sheared for 10min and microfluidized for 3 times at 80MPa. Finally we successfully prepared well-stable intravenous emulsion ,whose physico-chemical properties were also investigated.After the preparation,we researched the sterilization and storage condition, completed the assaying by emulsion breaking and gradient elution of HPLC.The physico-chemical properties included: emulsion type identification, particle diameter and distribution, surface potential, viscosity and rheology properties.These investigations showed:the emulsion was o/w type. It got an average particle diameter of 160~190nm, which was Gaussian distribution and fitted the pharmacopoeia requirement.The sur- face potential was -40~ -50mV,better than the stable level of -30mV. With 1.50～1.55 mPa·s of viscosity,the emulsion was Newtonian fluid and got a good syringeability.Moreover,we investigated the stability by high-temperature,illumination and freezing-thawing experiment.The result was the emulsion could keep homogeneous and stable for 3 months on the storage condition of room temperature and being away from light.Within 3 months,the variations of particle diameter and drug content was less than 1%.The preparation and investigation of intravenous emulsion grounded well in bioavailability and target research in vivo. |
