复方人参乳膏制备及质量控制

Preparation and Quality Control of Complex Ginseng Cream

目的制备复方人参乳膏剂。方法采用微波协助萃取中草药中皂苷有效成分；应用回流法-蒸馏法提取当归有效成分。利用薄层色谱法定性鉴别中草药中皂苷有效成分，紫外分光光度法测定总皂苷含量；采用常温留样观察法考察其稳定性。结果中草药提取工艺方便、快速、制备工艺简单，制剂稳定性好。皂苷线性范围为：0～250ug·L^-1，r=0．9991。平均回收率为98．29％，RSD为1．72％。结论制剂制备方法可行，质量稳定可控，可应用于临床。

Objective To prepare Complex Ginseng Cream. Methods The microwave - assisted extraction （MAE） technology was used to extract the effective constituent of saponin from Chinese medicinal herb. The method of recirculation - and distillation was used to extract the effective constituent from Angelica. The effective constituent of saponin was identified with thin - layer chromatography and was with ultraviolet spectrophotometry. The long - storage specimen test was used to investigate the stability. Results The extracting technology was convenient and fast, the preparation technology was easy and the stability of preparation was good. The linear range of saponin was 0 -250 ug · L^-1 , r =0. 999 1, the mean recovery rate was 98.29%. The relative standard deviation was 1.72%. Condusion The preparation technology was feasible, the quality is stable and can be controlled. It can be used for clinic.