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目的研究软肝丸质量控制方法,以提高其质量标准。方法在原标准的基础上增加了软肝丸中木香、板蓝根、妇贞子的薄层鉴别,改进了丹参、枳壳的薄层色谱条件;采用HPLC法对芍药苷进行含量测定。结果 TLC法鉴别专属性强;HPLC法测得芍药苷在114.0~1026.4ng(r=0.9997)线性关系良好,平均回收率为99.62%,RSD为1.38%(n=6)。结论本方法操作简单,结果准确,灵敏度高,重复性好;该质量标准可有效地控制软肝丸的质量。
Objective To study the method of quality control of Ruangan Pills in order to improve its quality standard. Methods Based on the original standard, the TLC of Ruanghuang Wan, Radix Isatidis and Ligustrum lucidum were added to improve the TLC conditions of Salvia miltiorrhiza and Fructus Aurantii. The content of paeoniflorin was determined by HPLC. Results The HPLC method was simple and specific. The linearity of paeoniflorin was 114.0 ~ 1026.4 ng (r = 0.9997). The average recovery was 99.62% and the RSD was 1.38% (n = 6). Conclusion The method is simple, accurate, sensitive and repeatable. The quality standard can effectively control the quality of Ruannan Pills.