宫瘤消胶囊的质量标准研究

Study on Quality Standard for Gongliuxiao Capsule

摘要: 目的建立宫瘤消胶囊的质量标准，为完善其质量标准提供科学依据。方法采用TLC鉴别方中三棱、三七、沉香及丹参；采用HPLC对方中丹酚酸B的含量进行测定。结果 TLC中可检出三棱、三七、沉香与丹参的特征斑点，阴性对照无干扰；丹酚酸B在0.202 2~2.022 0μg具有良好的线性关系，平均回收率为96.83%，RSD为1.69%（n=6）。结论该方法能准确可靠的进行定性、定量检测、重复性好，可作为宫瘤消胶囊的质量控制标准。

Abstract: OBJECTIVE To establish the quality standard for Gongliuxiao capsule, and provide scientific evidence for the improvement of quality standard. METHODS TLC method was used to identify Sparganii Rhizoma, Notoginseng Radix et Rhizoma, Aquilariae Lignum Resinatum, Salviae Miltiorrhizae Radix et Rhizoma. The concentration of salvianolic acid B was determined using HPLC. RESULTS TLC could detect qualitatively Sparganii Rhizoma, Notoginseng Radix et Rhizoma, Aquilariae Lignum Resinatum, Salviae Miltiorrhizae Radix et Rhizoma. The spots were clear and the negative controls had no interference. Salvianolic acid B linearity was found in the range of 0.202 2-2.022 0 μg, the average recovery was 96.83%, RSD was 1.69%(n=6). CONCLUSION The method is accurate and reliable, has good reproducibility, which can be used as quality control standard of Gongliuxiao capsule.