复方二氧化钛凝胶的制备及其稳定性考察

目的:制备复方二氧化钛凝胶并考察其稳定性。方法:以维生素E、二氧化钛为主药,卡波姆-940为基质制备凝胶;采用高效液相色谱法测定其中主药含量,并通过高温加速试验、强光试验等考察其稳定性。结果:所制凝胶涂展性好;维生素E检测浓度的线性范围为102.4～512.0μg.mL-1(r=0.9998),平均回收率为100.66%(RSD=0.65%);稳定性试验考察结果表明,该制剂的各项指标无明显变化。结论:该制剂制备工艺简便可行,质量稳定可控。

Preparation and Stability of Compound Titanii Dioxydi Gel

OBJECTIVE:To prepare compound titanii dioxydi gel and to study its stability.METHODS:The gel was prepared with vitamin E and titanii dioxydii as principal agents and carbopol-940 as base.The content of principal agents in the gel were determined by HPLC and its stability was investigated by high-temperature accelerated test and light-radiation test.RESULTS:The gel was proved to be well-spread.Vitamin E exhibited a good linear relationship in the range of 102.4～ 512.0μ g· mL-1(r=0.999 8).The average recovery was 100.66%(RSD=0.65%).The parameters of the preparation were proved to be of no marked change.CONCLUSION:The preparation technology of the gel is simple and feasible,and its quality is stale and controllable.