[关键词]
[摘要]
目的 建立高效液相色谱法(HPLC)同时测定唇齿清胃丸中大黄酚、黄芩苷、橙皮苷、盐酸小檗碱、栀子 苷、龙胆苦苷 6 种成分的含量。方法 采用 CAPCELL PAK-C18 色谱柱(250 mm × 4.6 mm,5 µm),以甲醇- 0.1% 磷酸为流动相进行梯度洗脱;流速为 1.0 mL·min-1 ;柱温为 30 ℃;切换波长(240、280 、254 nm);进样 量为 10 µL,同步测定唇齿清胃丸中大黄酚、黄芩苷、橙皮苷、盐酸小檗碱、栀子苷、龙胆苦苷 6 种成分的含 量。结果 唇齿清胃丸中龙胆苦苷、栀子苷、盐酸小檗碱、橙皮苷、黄芩苷、大黄酚的质量浓度分别在 5.79~ 57.92、7.44~74.40、4.07~40.74、5.62~56.15、11.97~119.67、1.73~17.32 µg·mL-1 范围内与其峰面积呈良 好的线性关系(r≥0.999 5);各成分平均加样回收率范围为 98.62%~102.28%,RSD 范围为 1.09%~2.26%;中 间精密度、稳定性、重复性和耐受性良好,RSD 均<3.0%。15 批唇齿清胃丸样品中龙胆苦苷、栀子苷、盐酸 小檗碱、橙皮苷、黄芩苷、大黄酚 6 个成分含量范围分别为 2.343~3.736、4.160~5.612、2.161~2.996、2.478~ 4.138、6.847~8.804、0.606~0.856 mg·g-1 。结论 本测定方法简单、准确,可用于唇齿清胃丸的质量控制与 综合评价。
[Key word]
[Abstract]
Objective To develop a high-performance liquid chromatography (HPLC) method for the simultaneous quantification of six components—chrysophanol, baicalin, hesperidin, berberine hydrochloride, geniposide, and gentiopicroside—in Chunchi Qingwei Pills. Methods Chromatographic separation was achieved on a CAPCELL PAKC18 column (250 mm × 4.6 mm, 5 µm) with gradient elution using methanol -0.1% phosphoric acid as the mobile phase. The flow rate was 1.0 mL·min-1 ,the column temperature was maintained at 30 ℃,and the detection wavelengths were switched between 240,280,and 254 nm. The injection volume was 10 µL. The six components—chrysophanol, baicalin, hesperidin, berberine hydrochloride, geniposide, and gentiopicroside—in Chunchi Qingwei Pills were simultaneously determined. Results Good linear relationships were observed between the mass concentrations and peak areas of gentiopicroside, geniposide, berberine hydrochloride, hesperidin, baicalin, and chrysophanol within the ranges of 5.79–57.92,7.44–74.40,4.07–40.74,5.62–56.15,11.97–119.67,and 1.73–17.32 µg·mL-1 , respectively (r≥0.999 5). The average recoveries of the components ranged from 98.62% to 102.28%,with RSD values between 1.09% and 2.26%. The method demonstrated good intermediate precision, stability, repeatability, and ruggedness, with RSD values all below 3.0%. The content ranges of gentiopicroside, geniposide, berberine hydrochloride,hesperidin,baicalin,and chrysophanol in 15 batches of Chunchi Qingwei Pills were 2.343–3.736, 4.160–5.612,2.161–2.996,2.478–4.138,6.847–8.804,and 0.606–0.856 mg·g⁻¹,respectively. Conclusion The established method is simple and accurate,and can be used for the quality control and comprehensive evaluation of Chunchi Qingwei Pills.
[中图分类号]
R284.1
[基金项目]
湖南省自然科学基金科药联合项目(2025JJ80182)。