蜂地麻滴眼液的制备及质量控制

Rreparation of Fengdima eye drops

目的制备蜂地麻滴眼液,并建立其质量标准。方法根据制备工艺制备滴眼液,用薄层色谱法进行鉴别,用高效液相色谱法进行含量测定。结果受试品和对照品的薄层特征性斑点一致,盐酸丁卡因的平均回收率为100.25%,RSD=0.75%,盐酸麻黄碱的平均回收率为99.57%,RSD=0.91%。结论蜂地麻滴眼液的制备方法简便,质量可控。

[Objective] To prepare Fengdima eye drops, and to establish its quality criterion by studying the methods of quality controlling. [Methods] The eye drops was prepared according to the technology, its contents was identified by TLC methods and determined by HPLC methods, [Results] The characteristic spots of tested contents was consistent with referenced contents, the average recovery of tetracaine hydrochloride was 100,25%, RSD=0.75%, the average recovery of Ephedrine Hydrochloride was 99.57%, RSD=0.91%. [Conclusion] The preparation of Fengdima eye drops is simple and convenient, its quality can be under control.