天麻熄风胶囊质量标准研究

Study on Quality Standard of Tianmaxifeng Capsules

目的:建立天麻熄风胶囊的质量标准。方法:用显微鉴别法及TLC法对处方中各种药材进行定性鉴别,HPLC测定天麻素的含量。采用Thermo Hypersil ODS柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.05%磷酸溶液(3∶97);流速为1 m L·min^(-1);检测波长为221 nm。结果:显微鉴别特征专属,薄层色谱斑点清晰,阴性对照无干扰;天麻素在10.48~94.32μg·m L^(-1)呈良好的线形关系(r=0.999 9,n=5)。结论:本方法专属性强、简便、准确,可用于天麻熄风胶囊的质量控制。

Objective： To establish the quality standard for Tianmaxifeng Capsules. Methods： Microscopical identification and TLC method were used to qualitative identification of all materia medica in prescription, and the content of gastrodin was determined by HPLC with Thermo Hypersil ODS column（4. 6 mm × 250 mm, 5μm） , the mobile phase was composed of aeetonitrile and 0. 05% phosphoric acid （3：97 ） , the flow rate was 1 mL· min^-1 and the detection wavelength was set at 221 nm. Results： Microscopic identification features were exclusive, the TLC sports developed were fairly clear, and the blank test showed no interference. The line of the content of gastrodin in Tianmaxifeng Capsules was nearly straight between 10. 48-94. 32μg·mL（r = O. 999 9, n = 5 ）. Conlcusion： The methods are specific, accurate and quick to operate, and can be used for the quality control of Tianmaxifeng Capsules.