天麻头风灵胶囊的质量标准研究

Study of Quality Control for Tianmatoufengling Capsule

目的建立天麻头风灵胶囊的质量标准。方法采用高效液相色谱法测定天麻头风灵胶囊中天麻素的含量。选用Kromasil C18柱(250mm×4.6mm,ID),以甲醇-0.05%磷酸水(2.5∶97.5)为流动相,流速1.0mL/min,检测波长220nm。采用薄层色谱法对天麻头风灵胶囊进行定性鉴别。结果天麻素在6.016～96.256μg/mL范围内,浓度与峰面积线性关系良好(r=0.9999),加样回收率为100.02%,相对标准偏差RSD为2.24%。薄层定性实验方法简便灵敏、专属性强,天麻头风灵胶囊中4种被鉴别的成分均能显示特征斑点。结论本方法操作简便,结果可靠,重现性好,可用于天麻头风灵胶囊的质量控制。

Objective To establish a quality control for Tianmatoufengling Capsule. Methods HPLC method was taken for the determination of Gastrodine in Tianmatoufengling Capsule, A Kromasil C18 column was used, with methanol 0.05% Calcium phosphace （2.5 ： 97.5） as the mobfl.e phase, and its flow rate was 1.0 mL/min. The detection wavelength was 220 nm. TIC method was used for the identification of Tianmatoufengling Capsule. Results Under the used chromatographic condition, Tianmatoufengling had fine linear responses （r=0.999 9） in the concentration range of 6.016-96.256 μg/mL, the average recovery was 100.02%, RSD was 2.24%. The method used in TIC-qualitative analysis was simple and sensitive with high specificity, four ingredients identified in Tianmatoufengling Capsule could be detected and all showed specific spots. Conclusion The method employed in this study was convenient and reliable with good repetition. It can be used for quality control in production of Tianmatoufengling Capsule.