复方盐酸丁卡因凝胶剂的制备及质量考察

Preparation and quality control of compound tetracaine hydrochloride gel

目的:制备复方盐酸丁卡因凝胶,并建立质量控制方法。方法:用卡波姆-940作为凝胶剂基质,制备复方盐酸丁卡因凝胶,建立酸碱度、鉴别、含量测定等质控方法,进行加速实验和室温留样观察。结果:复方盐酸丁卡因凝胶剂的pH值为6．0～7．0,其他各项检查均符合2005年版中国药典凝胶剂的各项规定,含量测定丁卡因平均回收率98．22%,RSD=1．47%(n=5)。结论:制备该凝胶剂工艺简单,性质稳定,质量可控,适于作为医院制剂开发。

Objective ：To establish a quality control of compound tetracaine hydrochloride gel newly prepared. Methods： Carbopol-940 was used as an herbal stroma in the preparation of compound tetracaine hydrochloride gel. The quality control of the gel was featured with acid-base value and assay of main components. The stability of gel was assessed by an accelerated test at room temperature. Reslllts： The quality of compound tetracaine hydrochloride gel with pH 6.0-7.0 met the specifications of gel preparation described under China Pharmacopeias （2005 version）. The average recovery was 98.22% with RSD of 1.47% （n =5）. Conclusion： Compound tetracaine hydrochloride gel is stable and the quality control is feasible.