Preparation and Quality Control of Podophyllotoxin-Loaded Solid Lipid Gel / 中国药房

ABSTRACT

OBJECTIVE: To prepare podophyllotoxin-loaded solid lipid (PPT-SLN) gel and establish its quality control method. METHODS: With stearic acid, stearylamine, soybean lecithin as cosurfactant and PPT as principal agent, PPT-SLN suspension was prepared by the method of emulsion evaporation and solidification at a low temperature, then prepared into PPT-SLN gel with carbomer used as gel matrix. The physicochemical properties of the preparation were investigated, the content and entrapment efficiency of PPT were determinated by high-performance liquid chromatography (HPLC), respectively. The stability of the preparation was investigated as well. RESULTS: PPT-SLN gel appeared as lacte translucent semisolid, with its property and test results all in conformity with the related specification in Chinese Pharmacopoia (2005 edition). The nanoparticles were well-distributed in round or oval shape, with an average particle size of (105.3?34.7) nm, entrapment efficiency of 72.5% and pH value of (7.2?0.3). The preparation was stable within 6 months under room temperature. CONCLUSION: The preparation technology of PPT-SLN gel is feasible and its quality is controlable.