复方天麻钩藤口腔崩解片质量标准研究

Study on Quality Standard for Fufang Tianma Gouteng Orally Disintegrating Tablets

目的建立复方天麻钩藤口腔崩解片的质量标准。方法采用薄层色谱法对制剂中的天麻、钩藤、当归、白芍进行定性鉴别，采用高效液相色谱法测定制剂中的天麻素。结果薄层鉴别图谱清晰，阴性对照无干扰。天麻素进样量在0．1912～1．1472μg范围内线性关系良好（n=0．9999），平均回收率为97．72％（RSD=1．40％，n=6）。结论本方法简便、重复性好，可有效控制制剂的质量。

Objective To establish the quality standard of Fufang Tianma Gouteng Orally Disintegrating Tablets. Methods Gastrodiae Rhizoma, Uncariae Ramulus Cure Uncis, Angelicae Sinensis Radix and Paeoniae Radix Alba in the preparation were identified by TLC, the content of gastrodin in gastrodia was determined by HPLC. Results The herbs of preparation could be identified by TLC without interference. Gastrodin showed a good linear relationship in the range of 0.191 2-1.147 2 lag （r=0.999 9）. The average recovery was 97.72% （RSD=1.40%, n=6）. Conclusion The methods are available with a good reproducibility, and can control the quality of the preparation effectively.