复方司帕沙星凝胶的制备及质量控制

目的:制备复方司帕沙星凝胶并建立其质量控制方法。方法:以羧甲基纤维素钠为基质制备凝胶;采用系数倍率紫外分光光度法在282、297nm波长处不经分离直接测定其中2种主药的吸收度并计算含量。结果:所制备凝胶涂展性好;司帕沙星、盐酸达克罗宁线性范围均为2～10μg·mL-1(r=0.9996、0.9998);平均回收率分别为99.03%(RSD=1.02%)、99.83%(RSD=0.70%)。结论:本制剂制备工艺简单,质量可控。

Preparation and Quality Control of Compound Sparfloxacin Gel

OBJECTIVE: To prepare compound sparfloxacin gel and establish its quality control method. METHODS: The gel was prepared with CMC- Na as base. The contents of 2 principal constituents in the gel were directly determined at 282nm and 297nm by K- ratio spectrophotometry without separation. RESULTS: The gel obtained was uniform and well- spreading. The linear ranges for sparfloxacin and dyclonine hydrochloride were all within 2～ 10μ g· mL- 1( r=0. 999 6 vs. 0. 999 8) . The average recovery of sparfloxacin vs. dyclonine hydrochloride was 99. 03% ( RSD=1. 02% ) vs. 99. 83% ( ( RSD=0. 70% ) . CONCLUSION: The preparation technique is simple, and the quality of the preparation is controllable.