复方天麻颗粒质量标准研究

Study on the Quality Standard of Compound Tianma Granule

目的建立复方天麻颗粒的质量控制方法。方法采用薄层色谱（TLC）法对制荆中的天麻、五味子、麦冬进行定性鉴别；采用高效液相色谱（HPLC）法对天麻素及五味子醇甲进行含量测定。结果定性鉴定出制剂中的天麻、五味子及麦冬；经HPLC测定，结果显示天麻素在0．11～4．26μg范围内线性关系良好，平均回收率为97．9％，重现性实验RSD为1．7％；五味子醇甲在0．07—4．50μg范围内线性关系良好，平均回收率为96．7％，重现性实验RSD为1．3％。结论该方法可有效地控制复方天麻颗粒的质量。

Objective To establish the quality standard of Compound Tianma Granule. Methods TLC was used to identify Rhizo- ma C, astrodiae, Fructus Schisandrae Chinensis and Raidix Ophiopogonis in this preparation. HPLC was used to determine the con- tents of gastrodine and schisandrin. Results Gastrodine, deoxyschizandrin and the unique spot in Raidix Ophiopogonis could be detected by TLC. The linear range of gastrodine was within the range of 0.11 - 4.26 μg, the average recovery was 97. 9% , and RSD was 1.7% ; the linear range of schisandrin was within the range of 0.07-4.50μg, the average recovery was 96.7% , and RSD was 1.3%. Conclusion The methods can be used for the quality control of Compound Tianma Granule.