V_C与V_E复方微乳的制备及其质量评价

Study on the preparation and quality evaluation of vitamin C and vitamin E combination micro-emulsion

用合适的表面活性剂、VE油溶液和VC水溶液制备一种适合皮肤涂抹用药的VC和VE复方微乳，并用透射电子显微镜测定其粒径，高速离心法、温度梯度法和恒温加速试验检验其稳定性，紫外分光光度法测其有效成分含量。急性毒性试验、皮肤刺激性试验、眼刺激性试验检验其安全性。结果表明，制备的VC、和VE复方微乳粒径为10～100nm，符合微乳的粒径要求。样品经4000r／min离心30min和37℃相对湿度为75％的条件下保存3个月均保持澄清透明，未见分层或絮凝，其稳定温度范围为4～60℃。样品中VC和VE的含量分别为（182．91±2．39）和（13．97±0．60）mg／mL，平均回收率分别为103。3％和96．7％。该VC和VE复方微乳无经口毒性、皮肤刺激性和眼刺激性，适合用于皮肤给药。

To prepare a vitamin C and vitamin E combination micro-emulsion with suitable surfactant, vitamin E oily solution and vitamin C aqueous solution and evaluate its average diameter,physical stability, containing concentration of vitamin C or vitamin E and Safety by electron microscope,stability tests,uv spectrophotometry,and safety were tested respectively. The results showed that the average diameter of the sample was 10-100 nm,which accorded with that of micro-emulsion. It was stable after going through centrifugation at 4 000 rpm for 30 min and storage at 37 ℃ for three months ,the range of the stable temperature was 4-60 ℃. The accuracy of assaying was good. The results of the safety evaluations showed that the micro-emulsion had no toxicity and stimulation to the skin and eyes. So,vitamin C and vitamin E combination micro-emulsion is suitable for skin drug delivery systems.