怡心健脑软胶囊的质量控制

Quality Control of Yixinjiannao Soft Capsule

目的 建立怡心健脑软胶囊的质量控制方法.方法 采用薄层色谱（TLC）法对方中川芎、石菖蒲、益智仁、五味子、黄芪、续断进行定性鉴别;采用高效液相色谱（HPLC）法对五味子醇甲和川续断皂苷Ⅵ进行含量测定.结果 薄层鉴别均斑点清晰,阴性对照无干扰;五味子醇甲在0.08～1.60 μg之间线性关系良好,r＝0.999 96（n＝7）,平均回收率99.56%,RSD为0.82%（n＝6）;川续断皂苷Ⅵ在0.92～11.04 μg之间线性关系良好,r＝0.999 99（n＝7）,平均回收率99.49%,RSD为2.69%（n＝6）.结论 该方法专属性和重复性良好,可作为该制剂的质量控制方法.

Objective To establish a quality control method for yixinjiannao soft capsule. Methods The thin layer chromatography（TLC） for identification of Rhizoma chuanxiong, Rhizoma acori tatarinowii, Fructus schisandrae chinensis, Radix astragali and Radix dipsaci were established and the contents of schizandrin and asperosaponin VI were determined by HPLC. Results The spots on TLC plates were clear and without interference in the blank reference. The calibration curves of Schizandrin and asperosaponin Ⅵ was linear between 0.08-1.60μg （ r = 0. 999 96, n = 7 ） and between 0.92-11.04 μg （ r = 0.999 99, n = 7 ） ,respectively. The average recoveries of these two constituents were 99.56% with RSD = 0.82% （ n = 6）, and 99.49% with RSD = 2.69% （n = 6）, respectively. Conclusion The methods are reliable and reproducible, and which can be used for the quality control of this preparation.