盐酸丁卡因胶浆的研制与质量控制

Preparation and quality control of tetracaine hydrochloride mucilage

目的研制一种以泊洛沙姆为基质、含有盐酸丁卡因的胶浆,并制定质量控制标准。方法采用分光光度法对盐酸丁卡因进行含量测定。结果盐酸丁卡因的平均回收率为99.87%,RSD为0.45%。结论用分光光度法测定盐酸丁卡因胶浆中盐酸丁卡因的含量是可行的,本法简便、准确、重现性好,尤其适用于医院制剂快检。

OBJECTIVE To prepare a ploxamer matrix mucilage which contains tetracaine hydroehloride and to work out its quality control standard. METHODS The contents of tetracaine hydrochloride were measured by spectrophotometry. RESULTS The mean recovery rate of tetracaine hydrochloride was 99.87 %, and RSD was 0.45 %.CONCLUSION It＇s advisable to measure the contents of tetracaine hydroehloride of Tetracaine hydrochloride mucilage by spectrophotometry. The present assay is esay, accurate and reproducible . It＇s suitable for rapid analysis in the preparations of hospital.