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目的:建立风痛消喷雾剂的质量控制标准。方法:采用薄层色谱法(TLC)对风痛消喷雾剂中的丁香、赤芍、黄藤进行定性鉴别;采用高效液相色谱法(HPLC)法测定有效成分芍药苷及丹酚酸B的含量,色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸水溶液,梯度洗脱,流速1.0 mL·min-1,柱温25℃,检测波长芍药苷为230 nm、丹酚酸B为286 nm。结果:TLC色谱中可鉴别丁香、赤芍、黄藤的特征斑点,阴性对照无干扰;HPLC法测定的芍药苷在0.213 2~2.132 0μg范围内线性关系良好(r=0.999 9),平均回收率为98.48%,RSD为0.93%;丹酚酸B在0.493 6~4.936 0μg范围内线性关系良好(r=0.999 9),平均回收率为96.68%,RSD为1.52%。结论:所建立的定性、定量方法简便、准确、可靠、重复性好,可用于风痛消喷雾剂的质量监控。
Objective: To establish the quality control standard of Fengtong Xiaopei. Methods: The clove, red peony and yellow cane were identified by TLC. The active constituents paeoniflorin and salvianolic acid B were determined by high performance liquid chromatography (HPLC) The column was Kromasil C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.1% phosphoric acid aqueous solution with gradient elution at a flow rate of 1.0 mL · min-1. The column temperature was 25 ℃. The detection wavelength was 230 nm, Salvianolic acid B is 286 nm. Results: The characteristic spots of clove, red peony and yellow cane could be identified by TLC. There was no interference with the negative control. The linearity of paeoniflorin in the range of 0.213 2 ~ 2.132 0μg was good (r = 0.999 9) by HPLC. The average recovery With a RSD of 0.93%. The linear range of salvianolic acid B was 0.493 6 ~ 4.936 0 μg (r = 0.999 9). The average recovery was 96.68% and the RSD was 1.52%. Conclusion: The established qualitative and quantitative methods are simple, accurate, reliable and reproducible. It can be used for the quality control of Fengtong Xiaopei.