消脂肝颗粒质量标准研究

目的建立消脂肝颗粒的质量标准,以便更有效地控制产品质量。方法采用薄层色谱法对消脂肝颗粒中黄连、赤芍进行定性鉴别;采用高效液相色谱法测定制剂中的黄芩苷。结果薄层色谱法具有专属性,高效液相色谱法准确可靠,黄芩苷在进样量0.095～0.477μg范围内线性关系良好,回归方程为Y=126460X+5200.8,r=0.9990,精密度实验RSD为0.93%,平均回收率为98.24%,RSD为0.60%。结论该法简便、灵敏、准确、重现性好.可作为消脂肝颗粒的质量控制标准。

Study on quality standard of Xiaozhigan Granules

OBJECTIVE To prepare Xiaozhigan Granules and establish the quality standard for Xiaozhigan Gran-ules. METHODS The identification and inspect of Rhizoma coptidis,Radix paeoniae rubra were carried out by TLC. The content of Scutellaria baicalensis glucoside was determined by HPLC. RESULTS TLC method was specific, HPLC method was accurate and reliable,Scutellaria baicalensis glucoside showed a good linear relationship at a range of 0.095-0.477μg, Return e- quation was Y=12 6460 X＋5200.8, r=0.9990, the RSD of accuracy experiment was 0.93%, the average recovery was 98.24%, RSD was 0.60%. CONCLUSION Method was simple,quick and reproducible,which can be used as the quality control methods of Xiaozhigan Granules.