参榆颗粒的质量标准研究

Quality standard for Shenyu granules

目的建立参榆颗粒的质量标准。方法采用薄层色谱法对方中丹参、地榆、黄芩、茵陈进行薄层鉴别;采用高效液相色谱法对制剂中没食子酸、黄芩苷进行含量测定。结果薄层鉴别斑点清晰、分离度好、专属性强、阴性对照无干扰。含量测定中没食子酸在10～90μg/mL(r=0.999 9)的范围内线性关系良好;平均回收率为101.89%,RSD为1.45%;黄芩苷在0.208 8～1.252 8μg(r=0.999 9)的范围内线性关系良好;平均回收率为103.4%,RSD为2.46%。结论本方法能有效控制参榆颗粒的质量。

Objective To establish the quality standard of Shenyu granules. Methods Thin layer chromatography （TLC） was employed to identify Salvia rniltiorrhiza, Sanguisorba officinalis, Herba Artemisiae Scopariae and Scutellaria baicalensis, and the contents of gallic aeid and baiealin in Shenyu granules were determined by high performance liquid chromatography （HPLC）. Results The TLC spots were clear, well- separated and specific without interference from negative control. The linear range of gallie aeid was 10 to 90μg/mL （r =0. 999 9） with an average recovery rate of 101.89% and RSD of 1.45%. The linear range of baiealin was 0.208 8 to 1. 252 8μg （ r = 0. 999 9 ） with an average recovery rate of 103.4% and RSD of 2. 46%. Conclusion The established standard is effective for the quality control of Shenyu granules.