盐酸丁卡因凝胶剂的研制和质量控制

Preparation and Quality control of Tetracaine Hydrochloride Gel

目的 制备盐酸丁卡因凝胶剂 ,并建立质量控制标准。方法 以正交试验法筛选基质最佳处方 ,并建立了酸碱度、含量测定等质量控制标准。结果 含量测定平均回收率为 99.86 % ,RSD为 0 .36 %。结论 制备该凝胶剂工艺简单 ,质量可控。

OBJECTIVE To prepare tetracaine hydrochloride gel and work out its quality control standard. METHOD To choose the best formula with orthogonal design, and the quality control standards of pH and content determination etc were established.RESULTS The average recovery rate of the gel was 99.86% and RSD was 0.36%.CONCLUSION The dosage form can be prepared simply and the quality is controllable.