止汗外用凝胶中姜黄素的定性与定量研究

目的建立止汗外用凝胶中指标性成分姜黄素的定性鉴别与含量测定方法。方法采用TLC法定性鉴别止汗外用凝胶中的姜黄素。采用HPLC法测定制剂中指标性成分姜黄素的含量,色谱柱:Ecosil ODS C18(4.6 mm×250 mm,5μm);流动相:乙腈-水-冰醋酸(45∶55∶6);检测波长:254 nm。结果制剂薄层色谱与化学对照品(姜黄素)及阳性对照药材(郁金)薄层色谱在相应位置上显相同斑点。姜黄素的线性范围为0.1⁰.8mg/mL,r=0.999 4,平均回收率为100.12%,精密度、重现性、稳定性均符合测定要求。制剂样品中姜黄素的平均含量为0.201 6%。结论 TLC法定性鉴别和HPLC法定量测定止汗外用凝胶中姜黄素,方法可行,重现性好,为止汗外用凝胶的质量控制提供了可靠依据。

Study on quality standard of curcumin in Zhihan gel

Objective To establish the method for qualitative identification and determination of curcumin in Zhihan gel. Methods TLC method was adopted to qualitatively identify curcumin in Zhihan gel. HPLC method was adopted to quantitatively identify curcumin in Zhihan gel. Chromatographic conditions were as follows：Ecosil ODS C18column（4. 6 mm × 250 mm,5 μm） was used with mobile phase consisted of acetonitrile-water-phosphoric acid（45∶55∶ 6） under a detection wavelength at 254 nm. Results Zhihan gel had the same chromatograms with reference substance of C. wenyujin and standard reference substance of curcumin by TLC. The linear range of curcumin was 0. 1 ~0. 8 mg /mL（ r = 0. 999 4） with an average recovery rate of 100. 12%,reproducibility,precision and stability were fine. The mean content of curcumin in Zhihan gel was 0. 201 6%. Conclusion The method is simple,reliable and accurate,and can be used for the quality control of Zhihan gel.