扎冲十三味丸的质量标准研究

Study on quality standard of Zhachong Shisanwei Pill

目的建立扎冲十三味丸的质量标准。方法采用薄层色谱法、气相色谱法进行定性鉴别,以反相高效液相色谱法测定α-细辛醚的含量。采用C18柱,以甲醇为流动相A,水为流动相B进行梯度洗脱,检测波长为257 nm。结果薄层色谱、气相色谱分离度较好,专属性强。α-细辛醚的线性范围为4.305～861 ng(r=0.999,n=5),平均回收率为101.3%(RSD=1.3%,n=9)。结论所建立的定性、定量方法简便、准确、专属性强。可有效地控制扎冲十三味丸的质量。

Objective To establish a method for the quality control of Zhachong Shisanwei Pill. Methods Using TLC and GC to identify the Zhachong Shisanwei Pill, α - asarone was determined by RP - HPLC. C18 Column was adopted, and the gradient elution was carried out with methanol as mobile phase A and water as mobile phase B. The detection wavelength was 257 nm. Re- sults TLC and GC had good resolution and specificity. The linear range ofα - asarone was 4. 305 - 861 ng（ r = 0. 999, n = 5 ） , and the average recovery was 101.3 % （ RSD = 1.3 % , n = 9 ）. Conclusion The method was simple, accurate and specific and can efficiently control the quality of Zhachong Shisanwei Pill.