六经头痛片质量标准

Quality Standard for Liujing Toutong Tablets

摘要:

目的: 研究六经头痛片以提高其质量标准。 方法: 采用薄层色谱法对制剂中白芷、葛根进行定性鉴别;采用高效液相色谱法测定制剂中葛根素含量,岛津C₁₈柱(4.6 mm×250 mm,5 μm),流速1 mL·min^-1,流动相甲醇-0.025 mol·L^-1磷酸溶液(20:80),柱温30℃,检测波长250 nm。 结果: 在薄层色谱中均可检出白芷、葛根的特征斑点;葛根素在0.042~0.378 μg线性关系良好(r=0.999 9),回收率98.368% (RSD 1.87%)。 结论: 方法简便可行、重复性好,能有效控制该制剂的质量。

Abstract:

Objective: To study the quality standard of Liujing Toutong tablets in order to improve its quality standard. Method: The herbs of preparation were identified by TLC, the content of puerarin in Puerariae Lobatae Radix was determined by HPLC. The separation was performed on shimadzu C₁₈ column with methanol-0.05 mol·L^-1 phorsphoric acid solution as mobile phese. The flow rate was 1 mL·min^-1. The column was kept at 30℃ and detected at 250 nm. Result: The herbs of preparation could be identified by TLC. Puerarin showed a good linear relationship in a range of 0.047 2-0.378 μg (r=0.999 9). The average recovery was 98.368% (RSD 1.87%). Conclusion: The methods are available with a good reproducibility and can control the quality of this preparation effectively.