复方沙塔干口服液质量标准研究

Study on Quality Standards for Compound Shatagan Oral Liquid

目的 建立复方沙塔干口服液的质量标准.方法 采用薄层色谱法对该制剂中的君药川芎进行专属性鉴别;采用高效液相色谱法对川芎中有效成分阿魏酸进行含量测定.色谱柱：Diamonsil C18柱（4.6 mm×250 mm,5 μm）;流动相：甲醇-1%冰醋酸,梯度洗脱（0～5 min,35%甲醇;5～8 min,35%→23%甲醇;8～22 min,23%甲醇）;检测波长：322 nm;流速：1.0 mL/min;柱温：30 ℃;进样量：5 μL.结果 阿魏酸进样量在0.039 4～0.630 0 μg 范围内线性关系良好（r =0.999 7,n =7）,平均加样回收率为98.22%,RSD=2.62%（n =6）.结论 本研究所建立的质量标准结果准确,灵敏度高,重复性良好,可用于复方沙塔干口服液的质量控制.

Objective To establish the quality standards for compound Shatagan Oral Liquid. Methods Chuanxiong Rhizoma was identified by TLC. The content of ferulic acid was determined by HPLC. Separation was performed on a Diamonsil C18 column(4.6 mm × 250 mm, 5 μm) with a mobile phase consisting of methanol-1% acetic acid solution in gradient elution(0-5 min, 35% methanol;5-8 min, 35%→23% methanol;8-22 min, 23% methanol) at 30 ℃;The flow rate was 1.0 m L/min;The injection volume was 5 μL;The detection wavelength was 322 nm. Results Ferulic acid showed a good linear relationship in the range of 0.039 4-0.630 0 μg(r =0.999 7, n =7). The average recovery was 98.22% and RSD was 2.62%(n =6). Conclusion The method is reliable, sensitive and with repeatability, which can be used as the quality control method for compound Shatagan Oral Liquid.