莲蒿颗粒的质量标准研究

目的建立莲蒿颗粒的薄层鉴别和含量测定方法。方法采用薄层色谱法(TLC)定性鉴别莲蒿颗粒中的一枝蒿、干姜及甘草;采用HPLC法测定制剂中荭草苷及一枝蒿酮酸的含量。结果莲蒿颗粒中一枝蒿、干姜及甘草的TLC图谱斑点清晰、重复性好、分离较好、专属性强、方法简便,阴性对照无干扰。荭草苷和一枝蒿酮酸的质量浓度分别在9.42~75.36(r=0.999 5)和4.83~77.28μg·mL-1(r=0.999 8)范围内呈良好的线性关系,平均加样回收率分别为100.47%和98.57%,RSD值分别为1.82%和1.38%;2个指标测定的精密度、重复性、稳定性和准确度实验RSD值均低于2.0%。结论该方法简便、快捷,结果准确、可靠,可作为该制剂的质量控制标准。

Study on the quality standard for Lianhao Granules

Objective To establish the methods of TLC identification and content determination for Lianhao Granules.Methods Herba Artemisiae rupestris,Zingiberis Rhizoma and Glycyrrhizae Radix were identified by TLC.The contents of orientin and rupestonic acid were determined by HPLC.Results The TLC spots were clear and specific in good repeatability without interference from negative sample.The linear range of orientin was 9.42-75.36 μg·mL-1 (r=0.999 5) with an average recovery of 100.47% (RSD was 1.82%).The linear range of rupestonic acid was 4.83-77.28 μg·mL-1 (r=0.999 8) with an average recovery of 98.57% (RSD was 1.38%).The RSDs of precision,reproducibility,stability and accuracy were all less than 2%.Conclusion The methods are easy,fast and reliable,and could be used to control the quality of Lianhao Granules.