天麻灵芝颗粒的质量标准研究

A Study on the Quality Control Standard of Tianma Lingzhi Granules

目的:建立天麻灵芝颗粒的质量标准。方法:采用TLC法对处方中天麻、淫羊藿、灵芝进行定性鉴别;采用HPLC法测定天麻素和淫羊藿苷的含量。结果:薄层色谱上样品与对照品显相同的斑点,分离效果好,阴性对照无干扰;天麻素在0.0502μg^0.3012μg、淫羊藿苷在8.4480μg^84.4800μg与峰面积具有良好的线性关系;平均回收率分别为99.85%和99.78%,RSD分别为0.33%和0.90%(N=9)。结论:该方法简单、可靠、准确,可以作为控制天麻灵芝颗粒的质量标准。

Objective：To establish a quality standard of Tianma Lingzhi Granules. Method： TLC was used to identify qualitatively Gastrodia elata, epimedium, Ganoderma lucidum in the prescription; HPLC was used to measure the contents of Gastrodin and ieariin. Result： On TLC, the samples gave the same spots as the reference substance, had good separation effect, and the negative controlled sustance did not show interference. The results of content determination showed that Gastrodin gave a range of 0. 0502 μg -0. 3012 μg, ieariin gave a range of 8. 4480 μg - 84. 4800 μg, which are both good linear with peak area. RSD present respectively 0. 33% and 1.72% （n = 9）. Conclusion： This method is simple, reliable, accu- rate, and it can be used as the standard for quality control of Tianma Lingzhi Granules.