丁地凝胶制剂的工艺研究

目的：优化丁地凝胶制剂的制备工艺。方法：采用正交设计法优化丁地凝胶制剂处方和制备工艺，紫外分光光度法测定盐酸丁卡因含量，HPLC测定醋酸地塞米松的含量。结果：正交试验条件下因素主次关系依次为羧甲基纤维素钠、丙二醇、乙醇。测定3批样品盐酸丁卡因标示含量分别为100.5％，99.4％，98．3％，醋酸地塞米松标示含量分别为99.2％、99.5％、101．3％。结论：采用实验筛选出的制备工艺条件制成的丁地凝胶制剂，符合凝胶剂的质量标准，工艺设备简单，操作方便。

DingDi Gelatin Preparation Technical Study

Aim： To optimize the preparation procedure of Dingdi gel. Methods： The formula and preparation procedure of Dingdi gel were optimized using orthogonal design. Content of tetracaine hydrochloride was measured with UV. and content of dexamethasone acetate was measured using HPLC. Results： In the orthogonal experiments the factors were CMC-Na, propylene glycol and ethanol （from the most important to the most unimportant）. In three batches of samples the contents of tetracaine hydrochloride were 100.5 %, 99.4 %, 98.3% and the contents of dexamethasone acetate are 99.2 %, 99.5 % and 101.3 %. Conclusion： The Dingdi gel prepared with optimized procedure conforms to quality standards. The procedure and equipments were simple.