天宁颗粒的质量标准研究

Study on Quality Standards of Tianning Granules

目的建立天宁颗粒的质量标准。方法采用TLC法对天宁颗粒中的天麻和川芎进行鉴别;采用RP-HPLC法测定天麻素的含量。应用Ecosil ODS C18色谱柱,流动相为甲醇-0.1%磷酸溶液(3∶97),检测波长为221 nm。结果天麻素的线性范围为2.0～160μg.ml-1;平均回收率为100.29%,RSD为1.69%,精密度,稳定性等均符合测定要求。结论本方法操作简便,灵敏准确,重复性好,可有效的控制该制剂的质量。

Objective To establish a method for quality control of Tianning granules. Methods TLC was used to identify gastrodiae rhizoma and chuanxiong rhizoma. The RP-HPLC method was adopted to determine the content of gastrodin. The sample was separated on Ecosil ODS-Cls column with a mobile phase of methanol-0.1% phosphoric acid （3： 97） at a detection wavelength of 221 nm. Results The linear range was 2.0-160 μg ·ml^-1 for gastrodin. The average recovery was 100.29% （ RSD = 1.69% ）. Conclusion This method is simple, sensitive, ac- curate, reproducible, reliable, and can be used for quality control of Tianning granules.